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News In Research With Human Subjects for 2006
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Week of December 25, 2006
Ottawa rejects concerns over fertility panel, Globe and Mail, Dec 28, 2006
"…That 10-member board, which was announced late last week to oversee Assisted Human Reproduction Canada, has been criticized as being long on socially conservative values but short on fertility experts and stem-cell researchers…Ultimately, the board members will be responsible for approving more than 20 regulations required under the Assisted Human Reproduction Act. Those regulations will govern such practices as the scanning of embryos for genetically linked diseases, the collection of parental consent for stem-cell research…"
2006: The year in biology and medicine, New Scientist, Dec 27, 2006
"A summary of 2006 scientific, medical and ethical highlights in biology and medicine…"
 
Week of December 18, 2006
So many questions and so little justice, The Guardian, UK, Dec 24, 2006
"Her face was flashed around the world as she wept for her boyfriend, victim of the infamous 'Elephant Man' medical tests. Myfanwy Marshall reveals how the ordeal has brought them closer and tells how they will face the legal and medical battles ahead…"
NIH researcher sentenced in ethics case, Monterey Herald, Dec 22, 2006
"A federal researcher was ordered Friday to forfeit $300,000 and perform 400 hours of community service but will not have to pay a fine for failing to disclose lucrative consulting work with pharmaceutical giant Pfizer…"
Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities, New Zealand National Ethics Advisory Committee, Ministry of Health, Dec 2006 (full guidelines freely available)
 
Week of December 11, 2006
Blood substitute test shouldn't go on, advisers say, CTV.ca, Dec 15, 2006
"A Navy plan to test a blood substitute on civilian trauma victims should remain on hold, federal health advisers recommended Thursday, saying the experiment's risks outweigh its benefits…"
FDA Proposes Broadening Access to Drugs, The San Francisco Chronicle, Dec 11, 2006
"Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would clarify when drug companies could charge for the medicines…"
Proposed Rules for Charging for Investigational Drugs and Expanded Access to Investigational Drugs for Treatment Use, Center for Drug Evaluation and Research (CDER), US FDA, Dec 11, 2006 (90 day public comment period)
FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs, FDA News, Dec 11, 2006
 
Week of December 4, 2006
DNA Gatherers Hit Snag: Tribes Don’t Trust Them, The New York Times, Dec 10, 2006 (free one time registration required; scheduled to be freely available until Dec 16, 2006)
"…Billed as the “moon shot of anthropology,” the Genographic Project intends to collect 100,000 indigenous DNA samples. But for four months, the project has been on hold here as it scrambles to address questions raised by a group that oversees research involving Alaska natives…"
The Genographic Project Web Site, National Geographic Society, accessed Dec 13, 2006
Junk medicine: medical ethics, The Times, UK, Dec 9, 2006
"…It is a fundamental principle of ethical medical research that it should be conducted with the informed consent of its human subjects. When incapacitated patients cannot provide this, next of kin usually can. The court not only sanctioned a medical experiment without this consent, but actively ignored the explicit wishes of the patient and those best placed to speak for her…"
Press Release: Human Research Protection Award Recipients Announced, US Newswire, Dec 8, 2006
"Winners of the 2006 Award for Excellence in Human Research Protection were announced today by Dr. Peter G. Goldschmidt, president and founder of the Health Improvement Institute…"
NIH researcher pleads guilty to charge of improperly taking $285K in consulting fees, San Diego Union-Tribune, Dec 8, 2006
"A government researcher pleaded guilty Friday to misdemeanor conflict of interest for taking $285,000 in consulting fees from pharmaceutical giant Pfizer Inc. for work that improperly overlapped his official duties…"
Senate confirms von Eschenbach, The Scientist, Dec 8, 2006
"The Senate yesterday (Dec. 7) confirmed Andrew C. von Eschenbach to be commissioner of the Food and Drug Administration by an overwhelming vote of 80 to 11, giving the beleaguered agency its first permanent leader in 15 months…"
Request for Public Comment on OHRP Draft Guidance Document on Engagement of Institutions in Human Subjects Research, US Office for Human Research Protections (OHRP), Dec 8, 2006 (comments due by Feb 6, 2007)
"On December 8, 2006, the Office for Human Research Protections (OHRP) announced, in the Federal Register, the availability of a draft guidance document entitled "OHRP Guidance on Engagement of Institutions in Human Subjects Research." The draft guidance would revise and replace two existing OHRP guidance documents on engagement of institutions in human subjects research: (1) the January 26, 1999, document on "Engagement of Institutions in Research," and (2) the December 23, 1999 document on "Engagement of Pharmaceutical Companies in HHS-Supported Research." To facilitate public review of the draft guidance document, OHRP has developed a table presenting a side-by-side comparison of OHRP's draft guidance document with the current guidance documents on the engagement of institutions in human subjects research…"
New body to assess high-risk drug trials, The Guardian, UK, Dec 7, 2006
"An advisory body is to be established to assess high-risk drug trials, meeting one of 22 recommendations made today by experts who investigated a trial that left six men seriously ill in March. However, a lawyer for some of the victims of the trial at Northwick Park hospital, north London, said his clients felt the report by the panel of scientists was yet another "whitewash"…"
Expert Group on Phase One Clinical Trials: Final report, Expert Group on Phase One Clinical Trials, Department of Health, UK, Dec 7, 2006
"Final report of the Expert Scientific Group (ESG) which was set up following the very serious adverse reactions that occurred in the first-in-man clinical trial of TGN412 in March 2006…This report was an independent report to the Secretary of State for Health…"
Institute of Medicine's new drug safety report: implications for Canada, Cassels, Canadian Medical Association Journal 175: 1515-1516, Dec 5, 2006 (full article freely available)
Feds Charge Alzheimer's Researcher, The San Francisco Chronicle, Dec 4, 2006
"In a rare federal prosecution, a leading government Alzheimer's researcher was charged Monday with a criminal conflict of interest for performing lucrative private drug company work that overlapped his official duties. Prosecutors alleged Dr. Trey Sunderland of the National Institutes of Health received $285,000 in improper consulting fees and travel expenses from Pfizer, Inc., for work on early indicators of Alzheimer's at the same time he also oversaw similar NIH business with the drugmaker…"
 
Week of November 27, 2006
Insurers may be made to cover clinical trials, Pittsburgh Tribune-Review, Dec 2, 2006
"…she supports moves in the state House and U.S. House of Representatives to require insurance companies to pay for routine patient costs associated with clinical trials. Those conducting the trials pay for the investigational treatment being studied…"
Sleeping Better at Night: Investigators’ Experiences with Certificates of Confidentiality, Wolf and Zandecki, IRB 28: 1-7, Nov/Dec 2006 (free one time registration required; full article freely available)
The Ethics of Withdrawal from Study Participation, Gordon and Prohaska, Accountability in Research 13: 285 - 309, Oct-Dec 2006 (abstract freely available)
Comparison of Conflict of Interest Policies and Reported Practices in Academic Medical Centers in the United States, Dinan et al., Accountability in Research 13: 325 - 342, Oct-Dec 2006 (abstract freely available)
Herpes Study Put Pregnant Women at Risk, The San Francisco Chronicle, Dec 1, 2006
"Dozens of poor and minority pregnant women were put at risk when they were given dummy pills instead of a drug believed to prevent outbreaks of genital herpes, consumer watchdogs charged Friday. The researchers defended their work, saying in part the study was to assess the uncertain risks of the drug to the women's fetuses…"
Reporting ethics committee approval and patient consent by study design in five general medical journals, Schroter et al., Journal of Medical Ethics 32: 718-723, Dec 2006 (abstract freely available)
A public health perspective on research ethics, Buchanan and Miller, Journal of Medical Ethics 32: 729-733, Dec 2006 (abstract freely available)
The Future of the FDA, The Scientist, Dec 2006
"As the agency celebrates its 100th anniversary, what do Congress and others have in store?"
Office of Research Integrity (ORI) Newsletter, ORI, Dec 2006 (pdf)
A Review of Paying Research Participants: It's Time to Move Beyond the Ethical Debate, Ripley, Journal of Empirical Research on Human Research Ethics 1: 9-20, Dec 2006 (abstract freely available)
The Ethics of Paying Drug Users Who Participate in Research: A Review and Practical Recommendations, Fry et al., Journal of Empirical Research on Human Research Ethics 1: 21-36, Dec 2006 (abstract freely available)
Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective, Ripley et al., Journal of Empirical Research on Human Research Ethics 1: 37-44, Dec 2006 (abstract freely available)
Using Formative Research to Develop A Context-Specific Approach to Informed Consent for Clinical Trials, Corneli et al., Journal of Empirical Research on Human Research Ethics 1: 45-60, Dec 2006 (abstract freely available)
Methods and Practices of Investigators for Determining Participants' Decisional Capacity and Comprehension of Protocol, Kon and Klug, Journal of Empirical Research on Human Research Ethics 1: 61-68, Dec 2006 (abstract freely available)
Ethical Issues in Registry Research: In-Hospital Resuscitation as A Case Study, Dane and Parish, Journal of Empirical Research on Human Research Ethics 1: 69-76, Dec 2006 (abstract freely available)
Trends in Canadian Sociology Master's Theses in Relation to Research Ethics Review, 1995 - 2004, van den Hoonaard, Journal of Empirical Research on Human Research Ethics 1: 77-88, Dec 2006 (abstract freely available)
Financial Relationships between Institutional Review Board Members and Industry, Campbell et al., New England Journal of Medicine 355: 2321-2329, Nov 30, 2006 (abstract freely available)
Patients' Views on Financial Conflicts of Interest in Cancer Research Trials, Hampson et al., New England Journal of Medicine 355: 2330-2337, Nov 30, 2006 (abstract freely available)
Editorial: Conflict of Interest or Conflict of Priorities?, Nabel, New England Journal of Medicine 355: 2365-2367, Nov 30, 2006 (abstract freely available)
Top scientific journal pledges to curb fraud, CNN.com, Nov 29, 2006
"A leading scientific journal that published phony stem cell findings lacks adequate procedures to detect fraudulent work and must do a better job scrutinizing "high-risk" research, a panel appointed by the publication found on Tuesday. Donald Kennedy, editor-in-chief of Science, said the prestigious journal accepted the major findings of the six-member independent committee and pledged to craft new guidelines to guard against fraud…"
Committee Letter, Report and Science Response, Science, Nov 29, 2006 (full report and response freely available)
Health Canada regulation falling short: auditor general, Canada.com, Nov 29, 2006
"Public health and safety is at risk because Health Canada is failing to protect Canadians from dangerous products and many of its regulatory activities are "insufficient,'' warns Auditor General Sheila Fraser…It said the department's activities are "insufficient" when it comes to investigating Internet pharmacies and clinical trials; sharing information with other regulatory bodies; inspecting manufacturers of drug ingredients; and investigating reports, complaints and recalls of medical devices…"
Chapter 8. Allocating Funds to Regulatory Programs - Health Canada, Report of the Auditor General of Canada, Nov 28, 2006 (pdf; full chapter freely available)
Industry ties common on hospital boards, Monterey Herald, Nov 29, 2006 (Campbell et al. New Engl J Med article abstract link available below in Journal Articles)
"A survey of hospital review boards that watchdog experiments on patients shows that one in three members takes money from companies that make drugs and medical devices that come under study. What's more, many of those with conflicts rarely or never disclose their financial ties, researchers found…"
2007 International Compilation of Human Research Protections, US Office for Human Research Protections (OHRP), Nov 28, 2006 (pdf)
"The Compilation lists the human subjects research legislation, regulations, or guidelines for 79 countries, two confederations, and several international organizations. This year’s Compilation includes numerous updates over last year and lists the pertinent laws, regulations, and/or guidelines for 8 new countries: Armenia, Croatia, Cyprus, Iran, Malawi, Moldova, Nigeria, and Tajikistan. This Compilation was developed for IRBs/Ethics Committees, researchers, funding agencies, and others who are involved in international research. Its purpose is to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure that those standards are followed appropriately…"
PRIM&R Comments on the FDA's "Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research", PRIM&R, Nov 27, 2006 (pdf)
 
Week of November 20, 2006
Provincial drug disparity a roadblock to cancer research, Globe and Mail, Nov 22, 2006
"…Canada can't participate in the clinical trial that would confirm whether Avastin should remain part of the standard of care for metastatic colorectal cancer because it does not uniformly provide that care today…"
Court to hear experimental drugs case, Monterey Herald, Nov 21, 2006
"A federal court agreed Tuesday to rehear a case that would have given terminally ill patients early access to experimental drugs unlikely to be approved before they die…"
Human Embryonic Stem Cell Research: Regulatory and Administrative Challenges, American Association of Medical Colleges (AAMC), Nov 2006 (full report freely available)
 
Week of November 13, 2006
Military use of hemophilia drug raises questions, The San Francisco Chronicle, Nov 19, 2006
"American military doctors here have injected more than 1,000 of the war's wounded troops with a potent, and largely experimental, blood-coagulating drug despite mounting medical evidence linking it to deadly blood clots that lodge in the lungs, heart and brain…"
Cardiovascular and Cerebrovascular Events in the Randomized, Controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT), ADAPT Research Group, PLoS Clinical Trials, Nov 17, 2006 (full article freely available)
ADAPT: The Wrong Way to Stop a Clinical Trial, Nissen, PLoS Clinical Trials, Nov 17, 2006 (full article freely available)
Secretary's Advisory Committee on Human Research Protections (SACHRP) Nov 2-3 Meeting Transcripts and Presentation Materials, Office for Human Research Protections (OHRP) website, Nov 16, 2006
FDA Invites Input on Electronic Submission of Regulatory Information, FDA News, Nov 16, 2006 (hearing is Dec 18, 2006; notes of participation and comments due by Dec 8, 2006)
"The Food and Drug Administration (FDA) today announced plans to hold a public hearing to solicit comments and information on the electronic submission of product information. The Agency is also interested in hearing the public's perspectives on issues related to creating an electronic information exchange platform…"
Group gives advice on face transplants, Monterey Herald, Nov 13, 2006
"Britain's Royal College of Surgeons on Monday laid out 15 conditions surgeons must meet before carrying out face transplants. The august medical body said such procedures must be performed in a strict research setting and are not merely as a surgical exercise…"
Working Party on Facial Transplantation: Second Report, Royal College of Surgeons of England, Nov 13, 2006 (full report freely available)
Docs test 'suspended animation' as potential battlefield treatment, CNN, Nov 13, 2006
"…Once the body is cooled, the patient has almost no blood, little to no brain activity and no heartbeat…Currently, Alam and his colleagues are working on the logistics of a possible human trial. They acknowledge that there will be many challenges - in ethics and execution…"
 
Week of November 6, 2006
Oral History Under Review, Chronicle of Higher Education, Nov 10, 2006
"Historians who work on events that occurred within living memory bridle at having to submit their projects to institutional review boards…"
German scientists urge review of stem cell laws, Reuters, Nov 10, 2006
"…Genetic research is a sensitive subject in Germany due to Nazi experiments to create a master race and the country has strict laws on stem cell research…"The 2002 law means German scientists are largely denied access to new stem lines and unable to work in international projects," the institute said…"
FDA Might Expand Access to Experimental Medications, kaisernetwork.org, Nov 9, 2006
" FDA plans to consider two separate proposals that would expand access to experimental medications for certain patients and allow pharmaceutical companies to charge patients fees for such treatments in some cases, the Wall Street Journal reports…"
FDA to keep closer eye on medical device safety, MSNBC, Nov 9, 2006
"The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates…"
FDA Announces Actions to Strengthen its Postmarket Program for Medical Devices, FDA News, Nov 9, 2006
Medical Device Postmarket Transformation Initiative, FDA, Nov 9, 2006
 
Week of October 30, 2006
Drug trial company slammed over pay, The Guardian, Nov 3, 2006
"The lawyer for four of the men who nearly died after a disastrous medical trial have accused the US research company involved of "astonishing" double standards after it emerged that its boss has received a £900,000 bonus…"
The woman falsely labelled alcoholic by the NHS, The Guardian, UK, Nov 2, 2006
"Helen Wilkinson was mistakenly labelled an alcoholic after a simple computer error by the NHS. An unknown official at a hospital was updating her medical records and inputted a wrong code. The mix-up meant she was recorded as having received treatment for alcoholism, instead of surgery…She was also angry that the records had been shared with a private company which distributes personal medical records to academic researchers…"
Ethical Conflicts in Public Health Research and Practice: Antimicrobial Resistance and the Ethics of Drug Development, Aiello et al., American Journal of Public Health 96: 1910-1914, Nov 2006 (abstract freely available)
"It’s Like Tuskegee in Reverse": A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research, Malone et al., American Journal of Public Health 96: 1914-1919, Nov 2006 (abstract freely available)
Research Recruitment Through US Central Cancer Registries: Balancing Privacy and Scientific Issues, Beskow et al., American Journal of Public Health 96: 1920-1926, Nov 2006 (abstract freely available)
Voluntary Participation and Informed Consent to International Genetic Research, Marshall, American Journal of Public Health 96: 1989-1995, Nov 2006 (abstract freely available)
Exploring the Ethics of Clinical Research in an Urban Community, Grady et al., American Journal of Public Health 96: 1996-2001, Nov 2006 (abstract freely available)
Privacy Protection Versus Cluster Detection in Spatial Epidemiology, Olson et al., American Journal of Public Health 96: 2002-2008, Nov 2006 (abstract freely available)
Consistency in decision making by research ethics committees: a controlled comparison, Angell et al., J Med Ethics 2006; 32: 662-664, Nov 2006 (abstract freely available)
An Inverse Relationship Between Perceived Harm and Participation Willingness in Schizophrenia Research Protocols, Roberts et al., American Journal of Psychiatry 163: 2002-2004, Nov 2006 (abstract freely available)
Model Policy for Responding to Allegations of Scientific Misconduct, US Office of Research Integrity (ORI), Nov 2006 (please send comments to Brenda.Harrington@hhs.gov by December 29, 2006)
Disclosing Genetic Results to Research Participants, American Journal of Bioethics 6, Nov/Dec 2006 (numerous articles on this topic, some abstracts freely available)
 
Week of October 23, 2006
Ethics rules send NIH scientists packing, Monterey Herald, Oct 28, 2006
"Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income…"
Office for Human Research Protections (OHRP) Frequently Asked Questions and Answers Page on Investigator Responsibilities, US Office for Human Research Protections, Oct 26, 2006 (this link goes directly to investigator FAQ page; for OHRP's general FAQ page, use link below)
"The Office for Human Research Protections (OHRP) has added a Frequently Asked Questions page on its website. This FAQ page includes a new set of FAQs on Investigator Responsibilities…"
OHRP FAQ Web Page
Protecting the Health of the Public - Institute of Medicine Recommendations on Drug Safety, Psaty and Burke 355:1753-1755, New England Journal of Medicine, Oct 26, 2006 (full text freely available)
American Association of Medical Colleges (AAMC) Comments on Informed Consent Exception in Emergency Research, AAMC, Oct 26, 2006 (pdf)
UK surgeons get go-ahead for full face transplant, Reuters, Oct 25, 2006 (scheduled to be freely available until Nov 24, 2006)
"British surgeons were on Wednesday given the final go-ahead to perform the world's first full face transplant, a radical procedure that has raised concerns about its physical and psychological risks. The UK Face Transplantation team at the Royal Free Hospital in London received permission for four transplants from the hospital's Research Ethics Committee…"
HIV Screening in Health Care Settings: Public Health and Civil Liberties in Conflict?, Gostin, Journal of the American Medical Association 296:2023-2025, Oct 25, 2006 (extract freely available)
 
Week of October 16, 2006
An Unwelcome Discovery, New York Times, Oct 22, 2006 (free one time registration required; scheduled to be freely available until Oct 28, 2006)
"On a rainy afternoon in June, Eric Poehlman stood before a federal judge in the United States District Court in downtown Burlington, Vt…A year earlier, in the same courthouse, Poehlman pleaded guilty to lying on a federal grant application and admitted to fabricating more than a decade’s worth of scientific data on obesity, menopause and aging…"
FDA Regulation of Stem-Cell Based Therapies, Halme and Kessler, New England Journal of Medicine 355:1730-1735, Oct 19, 2006 (full article freely available)
Former FDA chief pleads guilty to conflict of interest, Seattle Times, Oct 18, 2006 (free one time registration required; scheduled to be freely available until Oct 23, 2006)
"Former FDA Commissioner Lester Crawford pleaded guilty Tuesday to conflict of interest and false reporting of information about stocks he owned in food, beverage and medical-device companies he was in charge of regulating…"
Mandatory Anthrax Shots to Return, Washington Post, Oct 17, 2006 (free one time registration required)
"The Defense Department will resume mandatory anthrax vaccinations for more than 200,000 troops and defense contractors within 60 days, a Pentagon official said yesterday, rejecting the concerns of some veterans and service members who say that the vaccine has not been proved safe or effective…"
Health Canada introduces trial rules in wake of tuberculosis scare, CBC News, Oct 16, 2006
"Health Canada has quietly introduced new rules for clinical drug trials after a man with tuberculosis was included in a trial at a Montreal lab last year, exposing dozens of staff and other participants to the contagious disease…"
Notice: To Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties, Health Canada, Jul 23, 2006
 
Week of October 9, 2006
Drugs trial disaster warning missed, The Guardian, Oct 13, 2006
"…A new report by two Dutch experts pointed to glaring omissions of scientific evidence that should have prevented the trial going ahead in the way it did…"
Establishing risk of human experimentation with drugs: lessons from TGN1412, The Lancet 368:1387-1391, Oct 12, 2006 (registration and payment required for access)
More Internet users may be taking phishing bait than thought, EurekAlert! Press Release, Oct 13, 2006
"A higher-than-expected percentage of Internet users are likely to fall victim to scam artists masquerading as trusted service providers, report researchers at the Indiana University School of Informatics. "Designing Ethical Phishing Experiments: A study of (ROT13) rOnl query features," published online, simulated phishing tactics used to elicit online information from eBay customers…The experiment was unusual in that it did not involve debriefing of subjects, given that this step was judged to be the one and only aspect of the experiment that could potentially pose harm to subjects, who might be embarrassed over having been phished or wrongly conclude that sensitive information had been harvested by the researchers…"
Body of Research — Ownership and Use of Human Tissue, Charo, New England Journal of Medicine 355:1517-1519, Oct 12, 2006 (full article freely available)
Tell public about trauma tests, experts urge, CTV.ca, Oct 12, 2006
"The public has a right to know more about the risks and benefits of emergency research performed on victims of trauma, cardiac arrest and stroke without their informed consent, experts told federal health officials Wednesday…The Food and Drug Administration convened a public hearing to discuss whether decade-old regulations guiding the ethical conduct of emergency research are adequate…"
Disagreement about FDA nanotech oversight, The Scientist, Oct 11, 2006
"The U.S. Food and Drug Administration (FDA) needs greater authority and financial resources to properly regulate nanotechnology materials in drugs, biologics, food, cosmetics and other products, many academics and representatives of environmental and consumer groups said at the first open meeting of the FDA Nanotechnology Task Force…"
Report: Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science, Engineering and Technology Subcommittee, Committee on Technology, National Science and Technology Council, Sept 2006 (pdf)
National Nanotechnology Initiative Web Site
Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?, Michael Taylor, Project on Emerging Nanotechnologies, Oct 5, 2006
Doctors allegedly abuse elderly patients, Jerusalem Post, Oct 10, 2006
"Four senior doctors at the Kaplan Medical Center's Harzfeld Rehabilitation Hospital, who are suspected of carrying out illegal medical experiments on hundreds of elderly patients, faced the inside of a court room for the first time Monday evening…"
Mixed response to NIH database plan, The Scientist, Oct 9, 2006
"Scientists, academics, and industry representatives appear to have mixed feelings about the National Institutes of Health's plan to create and make publicly available a centralized database of human genomic and phenotypic information derived from NIH-funded genome wide association studies (GWAS)…An informal survey by The Scientist of researchers, academics, and industry representatives found general support for having a public GWAS database, but also concern over how to insure subjects' privacy and other issues…"
The FDA and Drug Safety. A Proposal for Sweeping Changes, Furberg et al., Archives of Internal Medicine 166:1938-1942, Oct 9, 2006 (abstract freely available)
 
Week of October 2, 2006
Breaking the cycle, Washington Post, Oct 8, 2006 (free one time registration required)
"…The volunteers understand that if the vaccine doesn't work, even those treated quickly are likely to experience a few days of nasty flu-like symptoms that could include screaming headaches, high fever, chills and vomiting fits. Some admit to feeling spooked ever since they volunteered to be bitten by an infected anopheles…"
 
Week of September 25, 2006
Developing capacity to protect human research subjects in a post-conflict, resource-constrained setting: procedures and prospects, Kennedy et al., Journal of Medical Ethics 32:592-595, Oct 1, 2006 (abstract freely available)
Right of the living dead? Consent to experimental surgery in the event of cortical death, Sparrow, Journal of Medical Ethics 32:601-605, Oct 1, 2006 (abstract freely available)
Living patients in a permanent vegetative state as legitimate research subjects, Curry, Journal of Medical Ethics 32:606-607, Oct 1, 2006 (extract freely available)
Research and patients in a permanent vegetative state, Draper, Journal of Medical Ethics 32:607, Oct 1, 2006 (extract freely available)
Relatives of the living dead, Thompson, Journal of Medical Ethics 32:607-608, Oct 1, 2006 (extract freely available)
Respecting rights ... to death, Levy, Journal of Medical Ethics 32:608-611, Oct 1, 2006 (extract freely available)
Capacity of Persons With Mental Retardation to Consent to Participate in Randomized Clinical Trials, Fisher et al., American Journal of Psychiatry 163:1813-1820, Oct 2006 (abstract freely available)
Altruistic Discourse in the Informed Consent Process for Childhood Cancer Clinical Trials, Simon et al., American Journal of Bioethics 6: 40-47, Sept/Oct 2006 (abstract freely available)
Draft Guidance to Submitters of Human Research, Environmental Protection Agency (EPA), Sept 2006 (pdf)
Ethics and research with undergraduates, Richman and Alexander, Ethics and Education 1: 163 - 175, Oct 2006 (abstract freely available)
Ethical and Regulatory Challenges Associated With the Exception From Informed Consent Requirements for Emergency Research, Vaslef et al., Archives of Surgery 141:1019-1023, Oct 2006 (abstract freely available)
Workshop Report: Protection of research subjects with diminished capacity, Center for Practical Bioethics, Oct 2006 (full report freely available)
Trial of the Heart, The Scientist, Oct 2006
"Doug Bergman drove 240 miles to have his heart stabbed by a needle from the inside out. Now he hopes the stem cells that may be in that needle will change his life…"
Three Steps to Protecting Pediatric Research Participants from Excessive Risks, Wendler, PLoS Clinical Trials 1(5): e25, Sep 29, 2006 (full article freely available)
French doctors operate on man in zero-gravity setting, Monterey County Herald, Sep 28, 2006
"A team of French doctors said they successfully operated on a man in near zero-gravity conditions Wednesday on a flight looping in the air like a roller coaster to mimic weightlessness…"
Office of Research Integrity Newsletter, Office of Research Integrity (ORI), Sept 2006 (pdf)
Effect of the HIPAA Privacy Rule on Health Research: Proceedings of a Workshop Presented to the National Cancer Policy Forum, Institute of Medicine, Sep 26, 2006
 
Week of September 18, 2006
CDC Recommends Routine HIV Testing for U.S. Residents Ages 13 to 64, Dropping Written Consent, Pretest Counseling Requirements, Kaisernetwork.org, Sep 22, 2006
"CDC on Thursday released revised recommendations on HIV testing in the U.S. that say HIV tests should become a routine part of medical care for residents ages 13 to 64 and requirements for written consent and pretest counseling be dropped…"
Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, Centers for Disease Control and Prevention (CDC), Sep 22, 2006
Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, Centers for Disease Control and Prevention (CDC), Sep 22, 2006
"These recommendations for human immunodeficiency virus (HIV) testing are intended for all health-care providers in the public and private sectors, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities, and primary care settings. The recommendations address HIV testing in health-care settings only…"
Strengthening the U.S. Drug Safety System, Committee on the Assessment of the U.S. Drug Safety System Committee on the Assessment of the U.S. Drug Safety System, Institute of Medicine, Sep 22, 2006
"A lack of clear regulatory authority, chronic underfunding, organizational problems, and scarcity of data hamper the U.S. Food and Drug Administration’s ability to evaluate and address the safety of prescription drugs after they have reached the market, according to a new report from the Institute of Medicine…"
Legislation Would Allow Researchers To Use Medicare Data To Study Safety, Effectiveness of Medical Treatment, Kaisernetwork.org, Sep 19, 2006
"Senate Finance Committee Chair Chuck Grassley (R-Iowa) and ranking member Max Baucus (D-Mont.) have introduced a bill (S 3987) that would provide federal and academic researchers with more access to data on hospital, physician and prescription drug services used by Medicare beneficiaries…"
Grassley, Baucus sponsor bill for research on effectiveness and safety of medical treatments, Press Release, United States Senate Committee on Finance, Sep 18, 2006 (pdf)
S.3897 Medicare Data Access and Research Act, Introduced in US Senate, Sep 14, 2006
UK stem cell bank to begin distribution, The Scientist, Sep 19, 2006
"…By September 29, the bank will tell scientists the details of an initial six embryonic cell lines that have passed its stringent quality controls and are available for withdrawal…All requests to deposit or withdraw lines must be given ethical and legal approval by its high-level steering committee, which is chaired by Lord Naren Patel. The committee scrutinizes whether lines are ethically sourced with fully informed consent and aims to ensure that they are used only in projects with ethical approval…"
FDA, NCI Agree to MOU Regarding FIREBIRD, National Cancer Institute (NCI) News, Sep 19, 2006
"An agreement has been reached by the FDA and the NCI to manage and share information about clinical investigators using the Federal Investigator Registry of Biomedical Information Research Data, or FIREBIRD, system. Drug makers are encouraged to also submit information about investigators electronically to the new registry…"
Memorandum of Understanding Regarding FIREBIRD Between the Food and Drug Administration and the National Cancer Institute, Sep 14, 2006 (pdf)
Clinical Research Information Exchange (CRIX) Wesite and FIREBIRD Demo, National Cancer Institute, Sep 13, 2006
FIREBIRD, Federal Investigator Registry, National Cancer Institute, Sept 2006
 
Week of September 11, 2006
Experimental drug given to British troops in Iraq and Afghanistan, The Guardian, UK, Sep 16, 2006
"Soldiers in Afghanistan and Iraq are being treated with an experimental blood-clotting drug that has not been fully tested…It is thought that the US and Israeli militaries are also using the drug…"
NIH Punishments Criticized, Washington Post, Sep 14, 2006 (free one time registration required)
"Angry members of Congress took federal health officials to task yesterday for what they said was a pattern of being "soft" on government scientists found to have violated ethics rules…"
New Battle Lines Are Drawn Over Egg Donation, Sun-Sentinel, Sep 13, 2006
"…A spirited disagreement over payment has split feminists, with some calling compensation to research subjects coercive and others contending that banning it is paternalistic…"
Researchers Escape Ethics Punishment, The San Francisco Chronicle, Sep 12, 2006
"The majority of federal scientists investigated for improperly accepting personal money from drug companies or biotechnology firms escaped serious punishment, and investigators declined to proceed with several cases involving possible crimes, according to the National Institutes of Health…"
Prescription drug research in kids often doesn't get published where docs will look, San Diego Union Tribune, Sep 12, 2006
"…He said an FDA program meant to encourage drug companies to test how drugs affect children has led to hundreds of studies. The problem is that about half the time, the results don't get published in peer-reviewed medical journals, mainly because researchers and sponsors don't submit them for publication, Benjamin said…"
Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity, Benjamin et al., Journal of the American Medical Association 296:1266-1273, Sep 13, 2006 (abstract freely available)
 
Week of September 4, 2006
Review faults scientist's conduct, Seattle Times, Sep 10, 2006
"A senior researcher at the National Institutes of Health (NIH) engaged in "serious misconduct" by entering into dozens of unauthorized private arrangements with drug companies and failing to report annually the outside income, totaling more than $100,000, an internal review has found…"
US clinical researchers resist full financial disclosure, according to Conflicts-of-Interest Study, EurekAlert Press Release, Sep 8, 2006
"…The study, a survey of attitudes, beliefs and practices among members of institutional review boards, conflict-of-interest committees and researchers, reveals a key reason for the reluctance among researchers to share the full dollar amount: the belief that because potential research subjects may lack the sophistication to put conflicts of interest in context, they may overestimate the influence of money on the researcher's behavior and possibly refuse to participate…"
F.D.A. Seeks to Regulate New Types of Diagnostic Tests, New York Times, Sep 6, 2006 (free one time registration required; scheduled to be freely available until Sept 12, 2006)
"The Food and Drug Administration took a step yesterday toward regulating a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients…"
FDA Drafts Regulatory Guidance to Industry and Labs for Group of Medical Tests. Agency accepting public comment on guidance, FDA News, Sep 5, 2006
Study: Medical Instructions Stump Many, The San Francisco Chronicle, Sep 6, 2006
"…A new report by the National Center for Education Statistics found that most adults have an intermediate health literacy. However, intermediate is far from good, because so many health instructions are written in a way that's foreign to how people talk and think, said Dr. Rima Rudd of the Harvard School of Public Health. "Intermediate skills means that a majority of U.S. adults will have some difficulty using health-related materials with accuracy and consistency," Rudd said…"
The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy, National Center for Education Statistics, US Department of Education, Sep 6, 2006 (full report freely available)
Diabetes patients, therapy undergo trial by fire. Afflicted Canadians go to bat for method some call unproven, The Globe and Mail, Canada, Sep 5, 2006
"…To his patients, the 57-year-old Dr. Valdes is a hero who pushes the boundaries of science and is ushering in a new era of hope. But he has been forced to stop the trials at the Federico Gomez Children's Hospital in Mexico City while it and the National Committee for Bioethics review his results and the ethics of Dr. Valdes's study. The International Xenotransplantation Society, a prestigious body of 300 scientists, has published a letter in the September issue of Xenotransplantation concluding that the information from Dr. Valdes's clinical trials was "insufficient to justify the use of children" as research subjects…"
 
Week of August 28, 2006
ORI Introduction to the Responsible Conduct of Research, Steneck, Office of Research Integrity (ORI), Sept 2006 (updated from June 2004 revised print version)
Publish and perish: a case study of publication ethics in a rural community, Fraser and Alexander, Journal of Medical Ethics 32:526-529, Sep 1, 2006 (abstract freely available)
Review of a mock research protocol in functional neuroimaging by Canadian research ethics boards, de Champlain and Patenaude, Journal of Medical Ethics 32:530-534, Sep 1, 2006 (abstract freely available)
Ethical international research on human subjects research in the absence of local institutional review boards, Bhat and Hegde, Journal of Medical Ethics 32:535-536, Sep 1, 2006 (extractfreely available)
Enhancing the ethical conduct of genetic research: investigating views of parents on including their healthy children in a study on mild hearing loss, Gillam et al., Journal of Medical Ethics 32:537-541, Sep 1, 2006 (extract freely available)
Trust based obligations of the state and physician-researchers to patient-subjects, Miller and Weijer, Journal of Medical Ethics 32:542-547, Sep 1, 2006 (extract freely available)
Should desperate volunteers be included in randomised controlled trials?, Allmark and Mason, Journal of Medical Ethics 32:548-553, Sep 1, 2006 (extract freely available)
Report: Research on Human Subjects: Academic Freedom and the Institutional Review Board, American Association of University Professors (AAUP), Sept 2006
"…The report takes issue with aspects of the federal government’s regulations for research on human subjects that constitute a threat to academic freedom. The application of the federal regulations to research methodologies that present no serious risk of harm to research subjects has long been of concern…"
Informed Consent for Genetic Research Involving Pleiotropic Genes: An Empirical Study of ApoE Research, Cooper et al., IRB, Sept/Oct 2006 (free one time registration required; full article freely available)
Children, Research and Guinea Pigs: Reflections on a Metaphor, Gordon et al., IRB, Sept/Oct 2006 (free one time registration required; full article freely available)
Empirical Research to Evaluate Ethics Committees' Burdensome and Perhaps Unproductive Policies and Practices: A Proposal, Levine, Journal of Empirical Research on Human Research Ethics 1: 1-4, Sept 2006 (abstract freely available)
Women's Autonomy and Informed Consent in Microbicides Clinical Trials, Woodsong et al., Journal of Empirical Research on Human Research Ethics 1: 11-26, Sept 2006 (abstract freely available)
The Importance of Story-Telling: Research Protocols in Aboriginal Communities, Poff, Journal of Empirical Research on Human Research Ethics 1: 27-28, Sept 2006 (abstract freely available)
Ethical Issues in Trauma-Related Research: A Review, Newman et al., Journal of Empirical Research on Human Research Ethics 1: 29-46, Sept 2006 (abstract freely available)
Introduction: Data Sharing and Disclosure Limitation Techniques, Sieber?, Journal of Empirical Research on Human Research Ethics 1: 47-50, Sept 2006 (abstract freely available)
Essentials of the Disclosure Review Process: A Federal Perspective, Zarate and Zayatz?, Journal of Empirical Research on Human Research Ethics 1: 51-62, Sept 2006 (abstract freely available)
Solving Problems of Disclosure Risk While Retaining Key Analytic Uses of Publicly Released Microdata, O'Rourke et al., Journal of Empirical Research on Human Research Ethics 1: 63-84, Sept 2006 (abstract freely available)
Solving Problems of Disclosure Risk in An Academic Setting: Using A Combination of Restricted Data and Restricted Access Methods, Rodgers and Nolte, Journal of Empirical Research on Human Research Ethics 1: 85-98, Sept 2006 (abstract freely available)
UK tissue act consolidates samples, The Scientist, Aug 31, 2006
"Britain's new Human Tissue Act, which comes into force Friday (September 1), has prompted some research institutions to begin consolidating their tissue samples into central repositories, a phenomenon that is likely to make life easier for researchers, scientists said today…It is designed to put consent at the center of all human tissue use, and will have widespread implications for organ donation and other areas of medicine, as well as research…"
Request for Information (RFI): Proposed Policy for Sharing of Data obtained in NIH supported or conducted Genome-Wide Association Studies (GWAS), National Institutes of Health (NIH), Aug 30, 2006 (comments due Oct 31, 2006)
"The NIH is seeking comments regarding a proposed policy for NIH supported or conducted Genome-Wide Association Studies (GWAS). A genome-wide association study is currently defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. The proposed policy addresses (1) data sharing procedures, (2) data access principles, (3) intellectual property and (4) issues regarding the protection of research participants through all phases of GWAS…"
Suit over sex questions reaches Supreme Court, The San Francisco Chronicle, Aug 30, 2006
"Southern California parents represented by a conservative organization have gone to the U.S. Supreme Court to challenge an elementary school's right to survey their children about their sexual feelings…"
Opinion: Fields v. Palmdale School District, United State Court of Appeals for the Ninth Circuit, Nov 2, 2005
Request for Information (RFI): Proposed Policy for Sharing of Data obtained in NIH supported or conducted Genome-Wide Association Studies (GWAS), National Institutes of Health (NIH), Aug 30, 2006 (comments due Oct 31, 2006)
"The NIH is seeking comments regarding a proposed policy for NIH supported or conducted Genome-Wide Association Studies (GWAS). A genome-wide association study is currently defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. The proposed policy addresses (1) data sharing procedures, (2) data access principles, (3) intellectual property and (4) issues regarding the protection of research participants through all phases of GWAS…"
Comment Page for Request for Information (RFI): Proposed Policy for Sharing of Data obtained in NIH supported or conducted Genome-Wide Association Studies (GWAS), National Institutes of Health (NIH)
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research, Docket No. 2006D-0331, OC 2006163, Food and Drug Administration (FDA), Aug 29, 2006 (comments due Oct 30, 2006)
"This draft guidance, when finalized, is intended to assist Institutional Review Boards (IRBs), clinical investigators, and sponsors in the development and conduct of emergency research.The draft guidance also describes the additional specific human subject protection requirements for emergency research…"
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research, Food and Drug Administration (FDA), Aug 29, 2006 (pdf)
Conduct of Emergency Clinical Research; Public Hearing, Food and Drug Administration (FDA), Aug 29, 2006 (meeting presentation intentions and abstract due Sept 20, 2006; comments due Nov 27, 2006))
Report: Doctors' $275M Study Questioned, The San Francisco Chronicle, Aug 29, 2006
"Cancer doctors received about $275 million from the federal government and the elderly last year as part of a yearlong research project that many doctors believe won’t produce any useful findings. Under the program, the federal government paid $130 each time a chemotherapy provider assessed a Medicare patient’s pain, fatigue and nausea. The payments were designed to encourage doctors to report information that might one day lead to improved care for cancer patients…While the federal government will foot the bill for most of the unreliable data, senior citizens and disabled Americans on Medicare paid, too. That's because they were charged $26 each time their doctors billed Medicare for submitting information about their side effects…"
Cost and Performance of Medicare's 2005 Chemotherapy Demonstration Project (OEI-09-05-00171), Office of the Inspector General (OIG), Health and Human Services (HHS), Aug 30, 2006 (pdf)
 
Week of August 21, 2006
Medicare's Requirement for Research Participation as a Condition of Coverage: Is It Ethical?, Pearson et al., Journal of the American Medical Association: 296:988-991, Aug 23, 2006 (extract freely available)
Researchers Yearn to Use AOL Logs, but They Hesitate, New York Times, Aug 23, 2006 (free one time registration required; scheduled to be freely available until Aug 29, 2006)
"When AOL researchers released three months’ worth of users’ query logs to a publicly accessible Web site late last month, Jon Kleinberg, a professor of computer science at Cornell, downloaded the data right away. But when a firestorm over privacy breaches erupted, he decided against using it…many were torn, loath to conduct research with it as they balanced a chronic thirst for useful data against concerns over individual privacy…"
Stem-cell advance could change ethical debate, Monterey County Herald, Aug 23, 2006
"A U.S. company's ground-breaking technique for growing human stem cells without destroying an embryo has triggered hope the procedure may resolve the ethical and legal dilemmas that have severely limited stem-cell research in this country…"
Human embryonic stem cell lines derived from single blastomeres, Klimanskaya et al., Nature early publication, Aug 23, 2006 (abstract freely available)
Mark Israel: The ethical puzzler, The Guardian, UK, Aug 22, 2006
"…Not only in Australia, he and his fellow Flinders author, Iain Hay, argue, but in Canada, Europe, New Zealand and the US, social scientists are "angry and frustrated" at being constrained by the same darn thing over and over: regulators of ethical practice who don't really understand social science investigations. How, they ask, did things get to this point? And can the bickering sides ever sort out their differences?…"
National patient safety agency to build on improvements to NHS research ethics committees, Central Office for Research Ethics Committees (COREC), UK, Aug 21, 2006 (pdf)
"…the NPSA today launches its plan to implement the recommendations of the Department of Health's Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees…A new independent group of National Research Ethics Advisors will ensure that full committees consider only those studies needing intensive scrutiny…"
Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees, Department of Health, UK, Jun 6, 2006
 
Week of August 14, 2006
Keeping research on track: a guide for Aboriginal and Torres Strait Islander peoples about health research ethics, National Health and Medical Research Council, Australia, Aug 20, 2006
Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research, National Health and Research Council, Australia, 2003
Experts Cite Distribution as Key in Fighting H.I.V., New York Times, Aug 15, 2006 (free one time registration required; scheduled to be freely available until Aug 21, 2006)
"…[the Global H.I.V. Prevention Working Group] urged the world to address a significant number of practical and ethical challenges that it said threaten to slow or derail critical research projects concerning many prevention measures…"
Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents, Steinman et al., Annals of Internal Medicine 145: 284-293, Aug 15, 2006 (full article freely available)
Guidance for Investigators for Collaborative Biomedical Research in India, Fogarty International Center, National Institutes of Health, Aug 2006 (pdf)
Report: New Approaches to HIV Prevention: Accelerating Research and Ensuring Future Access, Global HIV Prevention Working Group, August 2006 (pdf)
Drug trial victims suffered immune system overload, Reuters, Aug 14, 2006 (scheduled to be available until Spet 13, 2006)
"Six British men who became seriously ill while testing an experimental drug had an immune system overreaction known as a cytokine storm, the doctors who cared for them reported on Monday…"
Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412, Suntharalingam et al., New England Journal of Medicine early release, Aug 14, 2006 (full article scheduled to be freely available until Sept 7, 2006)
China to release tougher rules for research ethics, SciDev.net, Aug 14, 2006
"China is set to release detailed new rules to improve ethical standards in medical research on human subjects…"
Human Embryonic Stem Cell Research: An Argument for National Research Review, Baylis and Robert, Accountability in Research 13: 207 - 224, Jul-Sept 2006 (abstract freely available)
Deception in Psychology: Moral Costs and Benefits of Unsought Self-Knowledge, Bortolotti and Mameli, Accountability in Research 13: 259 - 275, Jul-Sept 2006 (abstract freely available)
 
Week of August 7, 2006
Panel Suggests Using Inmates in Drug Trials, New York Times, Aug 13, 2006 (scheduled to be freely available until Aug 19, 2006)
"An influential federal panel of medical advisers has recommended that the government loosen regulations that severely limit the testing of pharmaceuticals on prison inmates, a practice that was all but stopped three decades ago after revelations of abuse…"
Ethical Considerations for Research Involving Prisoners, Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, Institute of Medicine, Jul 12, 2006 (full report freely available)
Ethicists and biologists ponder the price of eggs, Nature, Aug 9, 2006 (link may be available for a short time only)
"Should women be paid for the time, discomfort and health risks involved in donating eggs for research? The world's largest group of stem-cell scientists is grappling with the question, and has now asked the public for its views…"
Guidelines for the Conduct of Human Embryonic Stem Cell Research, International Human Embryonic Stem Cell Research Guidelines Task Force, Jun 30, 2006 (public comments accepted until Sept 1, 2006)
Volunteer blames cancer on drug trial, Monterey County Herald, Aug 8, 2006
"David Oakley felt grateful to be alive after participating in a disastrous British drug trial in March that left healthy volunteers convulsing and lapsing into comas. Now the 35-year-old driving instructor says he has cancer -- and blames it on the failed test…"
Editorial: The Influence of Money on Medical Science, DeAngelis, Journal of the American Medical Association 296, Aug 7, 2006 (full article freely available)
 
Week of July 31, 2006
Circumcision and HIV prevention research: an ethical analysis, Lie et al., Lancet 368:522-525, Aug 5, 2006 (free one time registration required; full article freely available)
Access before Approval: A Right to Take Experimental Drugs?, Okie, New England Journal of Medicine 355:437-440, Aug 3, 2006 (full article freely available)
Research ethics requirements compromising quality of health research, News-Medical.Net, Aug 3, 2006
"Many ethics committees now insist that researchers approach only people who respond positively to a letter from their doctor informing them about an opportunity to take part in research - that is, people must opt in to being contacted by a researcher. But the ethical benefits of this approach are not proved and it can lead to low response rates, wasted resources, and research of limited validity, argue Professors Jenny Hewison of Leeds University and Andy Haines…"
Confidentiality and consent in medical research: Overcoming barriers to recruitment in health research, Hewison and Haines, British Medical Journal 333:300-302, Aug 5, 2006 (payment or subscription required to access content)
What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent?, Abboud et al., Journal of Medical Ethics 32: 468-472, Aug 1, 2006 (abstract freely available)
Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial, Trevena et al., Journal of Medical Ethics 32: 473-477, Aug 1, 2006 (abstract freely available)
"Fair’s fair argument" and voluntarism in clinical research: But, is it fair?, Perna, Journal of Medical Ethics 32: 478-482, Aug 1, 2006 (abstract freely available)
Research ethics committees in Europe: implementing the directive, respecting diversity, Hedgecoe et al., Journal of Medical Ethics 32: 483-486, Aug 1, 2006 (abstract freely available)
Just another drug? A philosophical assessment of randomised controlled studies on intercessory prayer, Turner, Journal of Medical Ethics 32: 487-490, Aug 1, 2006 (abstract freely available)
Regulating the Market in Human Research Participants, Lemmens and Miller, PLoS Medicine, August 2006 (full article freely available)
Administration and Infrastructure for the Translational and Clinical Research Enterprise, Association of American Medical Colleges, Analysis in Brief 6, Aug 2006 (full article freely available)
Variability in the Costs of Institutional Review Board Oversight, Byrne et al., Academic Medicine 8:708-712, August 2006 (abstract freely available)
 
Week of July 24, 2006
Women who give eggs to science to get cut-price IVF, The Guardian, UK, Jul 28, 2006
"Women undergoing IVF treatment will be able to halve the cost of the expensive procedure thanks to a ruling which allows them to sell some of their eggs for use in cloning research…"
Phase I trials need improvement: UK group, The Scientist, Jul 25, 2006
"An expert group convened by the UK government to review the safety of Phase I trials made 22 recommendations today (July 25) to improve first-in-human studies, responding to an incident last March when six healthy volunteers developed life-threatening side effects during a phase 1 trial of a monoclonal antibody…"
Expert Scientific Group on phase one clinical trials: A consultation, Expert Scientific Group, UK Dept of Health, Jul 25, 2006 (public comments due by Sept 14, 2006)
Rules Planned for Industry Ties on F.D.A. Boards, New York Times, Jul 24, 2006 (free one time registration required; scheduled to be freely available until July 30, 2006)
"The Food and Drug Administration is expected to announce Monday an effort to write guidelines detailing the kind of industry ties that are permitted for those who serve on its powerful advisory boards…"
FDA Announces Plan to Strengthen Advisory Committee Processes, FDA News, Jul 24, 2006
One-Time General Consent for Research on Biological Samples: Is It Compatible With the Health Insurance Portability and Accountability Act?, Wendler, Archives of Internal Medicine 166:1449-1452, Jul 24, 2006 (extract freely available)
Commentary: Therapeutic Intent" in Phase 1 Oncology Trials: A Justifiable Objective, Markman, Archives of Internal Medicine 166:1446-1448, Jul 24, 2006 (extract freely available)
Editorial: Phase 1 Clinical Trials - Not Just for Safety Anymore?, Khandekar and Khandekar, Archives of Internal Medicine 166:1440-1441, Jul 24, 2006 (extract freely available)
New book tells harrowing tale of 1945 starvation study, Grand Forks Herald, Jul 24, 2006
"…The U.S. War Department had turned to Keys for earlier research on the health of soldiers, which included his development of K-rations, an emergency supply intended for stranded paratroopers. Now the War Department wanted Keys to find out how to rehabilitate those who were underfed. The government even had a ready pool of potential volunteers: conscientious objectors…"
 
Week of July 17, 2006
Drug trial dosing caution urged after UK disaster, Reuters, Jul 23, 2006 (scheduled to be available until Aug 22, 2006)
"Greater caution is needed in early stage tests of novel drugs that stimulate the immune system and only one patient should be given active medicine on the first day, a joint industry taskforce said on Monday…"
Early Stage Clinical Trial Task Force: Joint APBI/BIA Report, Jul 24, 2006 (pdf file)
Ethical guidelines on science, industry issued, Seattle Times, Jul 21, 2006
"The nation's largest coalition of research scientists has released new ethics guidelines for working with for-profit companies…"
Shared Responsibility, Individual Integrity: Scientists Addressing Conflicts of Interest in Biomedical Research, Federation of American Societies for Experimental Biology (FASEB), Jul 14, 2006 (pdf file)
FDA scientists blast agency's priorities. Anonymous survey finds safety lacking, The San Francisco Chronicle, Jul 21, 2006
"More than a third of Food and Drug Administration scientists who responded to a survey said agency officials cared more about speeding new drugs and medical devices to market than assuring they are safe, and about the same number said the agency wasn't adequately protecting the public health, according to results released Thursday by an advocacy group…"
Summary of the FDA Scientist Survey, Union of Concerned Scientists Web Page, Jul 20, 2006
Lack of patients to test drugs hinders research, Monterey County Herald, Jul 20, 2006
"…While cancer drug development is booming, the proportion of patients willing or able to take part in research has remained stuck for years at 5 percent to 10 percent…"
Survey questioning can alter subjects' behavior, study says, Monterey County Herald, Jul 20, 2006
"Simply asking college students who are inclined to take drugs about their illegal-drug use in a survey may increase the behavior, according to newly published findings that are making some researchers understandably nervous…"
Simply asking questions about health behaviors increases both healthy and unhealthy behaviors, Williams et al., Social Influence, June 2006 (abstract freely available)
Are Placebos in Advanced Cancer Trials Ethically Justified?, Hampton, Journal of the American Medical Association 296: 265-266, Jul 19, 2006 (extract freely available)
How profits, research mix at Stanford med school, Monterey County Herald, Jul 19, 2006
"…a six-month examination of the financial ties between Stanford researchers and companies trying to market new treatments…"
As promised, Bush vetoes stem cell bill, Seattle Times, Jul 19, 2006
"President Bush cast the first veto of his 5-1/2-year presidency today, rejecting legislation to ease limits on federal funding for research on stem cells obtained from embryos…"
New Members Appointed to Human Research Protections National Advisory Committee, US Dept of Health and Human Services (DHHS) News Release, Jul 19, 2006
"HHS Secretary Michael Leavitt has appointed seven new members to the Secretary’s Advisory Committee on Human Research Protections (SACHRP)…"
Food and Drug Administration: Request for Nominations for Voting Members on a Public Advisory Committee; Pediatric Advisory Committee, Federal Register 71: 40723-40724, [FR Doc. 06-06276], Jul 18, 2006
"The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Pediatric Advisory Committee in the Office of the Commissioner…The committee advises the Commissioner of Food and Drugs on pediatric therapeutics, pediatric research, and other matters involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary of Health and Human Services under 21 CFR 50.54 for products regulated by FDA and 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services and involves a product regulated by FDA…"
 
Week of July 10, 2006
Porton Down 'human tests' attacked, Guardian Unlimited, UK, Jul 14, 2006
"Some trials of chemical agents on human volunteers at Porton Down from the 1940s to the 1970s involved "serious departures" from the ethical standards that should have been observed, according to a report published by the Ministry of Defence…"
Historical Survey of the Porton Down Service Volunteer Programme 1939-1989, Ministry of Defense, UK, Jul 14, 2006
"The Historical Survey of the Porton Down Service Volunteer Programme 1939-1989 sets out a full description of the size and shape of the studies in which volunteers took part, and explores their ethical aspects. Chapter 23 is the report referenced in this news article."
Substitute blood development suffers blow, Monterey County Herald, Jul 13, 2006
"The effort to develop substitutes for human blood, for use in emergencies from highways to battlefields, suffered a setback Thursday. In response to a lawsuit, the Food and Drug Administration canceled what was to have been a closed-door meeting Friday to discuss the U.S. Navy's proposed experiment using a product derived from cow blood on as many as 1,000 unsuspecting civilian trauma victims…"
Group urges research rules for prisoners, Monterey County Herald, Jul 12, 2006
"Federal rules protecting people who are subjects of scientific research should be extended to include prisoners, the Institute of Medicine said in a report released Wednesday…"
Report: Ethical Considerations for Research Involving Prisoners, Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, Institute of Medicine, Jul 12, 2006
Mushrooms' active ingredient expands the mind, study finds, Seattle Times, Jul 11, 2006
"The study, published today in the journal Psychopharmacology, is the first randomized, controlled trial of a substance used for centuries by natives of Mexico and Central America to produce mystical insights. It is also nearly the first research on a psychedelic drug in human subjects in this country since the 1960s…"
Leading Medical Journal Tightens Conflict-of-Interest Rules, CBC News, Jul 11, 2006
"One of the world's most influential medical journals is tightening its conflict-of-interest policy in response to scientists' failure to disclose all financial ties to pharmaceutical companies…"Because we've had some experience where it may not as clear to authors as it should be, we have tightened our conflict-of-interest statement," said Dr. Catherine D. DeAngelis, editor-in-chief of the Journal of the American Medical Association…"
Moving Toward Assured Access to Treatment in Microbicide Trials, Forbes, PLoS Medicine 3, Jul 11, 2006 (full article freely available)
Regulation of Clinical Research Sponsored by Pharmaceutical Companies: A Proposal, Sotelo, PLoS Medicine 3, Jul 11, 2006 (full article freely available)
Protection of Human Subjects: Interpretation of Assurance Requirements, Office of the Secretary, DHHS, Jul 10, 2006 (pdf file)
"The Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) is providing public notice to clarify a requirement contained in the Federalwide Assurance (FWA) form for international (non-U.S.) institutions, approved by the Office for Human Research Protections under the HHS protection of human subject regulations, 45 CFR part 46. HHS clarifies that the requirements of HHS regulations must be satisfied for all HHS-conducted or -supported research covered by an FWA, regardless of whether the research is conducted domestically or internationally. To date, HHS has not deemed any other procedural standards equivalent to 45 CFR part 46…"
FDA says open to more flexible clinical trials, Reuters, Jul 10, 2006 (scheduled to be available until Aug 9, 2006)
"U.S. regulators are preparing guidelines telling drug makers how they can streamline the testing of experimental medicines by conducting more flexible clinical trials, a top official said on Monday. The Food and Drug Administration wants to encourage "adaptive" clinical trials that change mid-way through, said Dr. Scott Gottlieb…"
 
Week of July 3, 2006
FDA's Monitoring of Reports Questioned, The San Francisco Chronicle, Jul 7, 2006
"Drug makers routinely fail to file status reports with the federal government that show what kind of progress they have made in conducting safety studies. That's the conclusion of a review from the inspector general for the Health and Human Services Department…"
FDA's Monitoring of Postmarketing Study Commitments, OEI-01-04-00390, Office of the Inspector General, Jul 7, 2006 (pdf file)
Human Studies Review Board May 2-3, 2006 Meeting Report, US Environmental Protection Agency (EPA), Jul 7, 2006 (pdf file)
Analysis: Conflicts cause FDA to review advisory committees, Kondro, Canadian Medical Association Journal 175, Jul 4, 2006 (full article freely available)
South Korea scientist admits to faking data, Washington Post, Jul 4, 2006 (free one time registration required)
"Disgraced stem-cell scientist Hwang Woo-suk on Tuesday admitted to fabricating some data that went into a landmark paper but said he was duped by junior researchers into believing the bulk of his team's findings were valid…"
Disgraced South Korean scientist heads back to lab, Reuters, Jun 27, 2006 (scheduled to be available until July 26, 2006)
Drugmaker TeGenero files for bankruptcy after drug trial mishap, Boston Globe, Jul 4, 2006
"German drugmaker TeGenero AG filed for bankruptcy Tuesday, saying it was unable to attract investors after a drug trial in Britain that left six healthy volunteers fighting for their lives…"
 
Week of June 26, 2006
Distinguishing treatment from research: a functional approach, Lewens, Journal of Medical Ethics 32: 424-429, Jul 1, 2006 (abstract freely available)
Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?, Sheard et al., Journal of Medical Ethics 32: 430-434, Jul 1, 2006 (abstract freely available)
Consent and anonymization in research involving biobanks: Differing terms and norms present serious barriers to an international framework, Elger and Caplan, EMBO Reports 7: 661-666, Jul 1, 2006 (full article freely available)
The battle of Helsinki: Two troublesome paragraphs in the Declaration of Helsinki are causing a furore over medical research ethics, Wolinsky, EMBO Reports 7: 670-672, Jul 1, 2006 (full article freely available)
Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?, Emanuel et al., PLoS Medicine 3, July 2006
Giving Voice to Research Participants: Should IRBs Hear From Research Participant Representatives?, Hadskis, Accountability in Research 14: 155 - 177, Jul 2006 (abstract freely available)
Former UVM professor sentenced to jail for fraud, Burlington Free Press, Jun 29, 2006
"Former University of Vermont professor Eric Poehlman on Wednesday became the first academic researcher in the country to be sentenced to prison time for fabricating data in scientific studies…"
Compelled Disclosure of Health Information: Protecting Against the Greatest Potential Threat to Privacy, Rothstein and Talbott, Journal of the American Medical Association 295: 2882-2885, Jun 28, 2006 (extract freely available)
FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring, FDA News, Jun 26, 2006
"The Food and Drug Administration (FDA) today announced a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative. The Human Subject Protection and Bioresearch Monitoring (HSP /BIMO) Initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine…"
RFA-NR-07-001 Research on Research Integrity, National Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ), released Jun 26, 2006 (applications due Sept 14, 2006)
"…invite applications to support empirical research on research integrity. Proposals must have clear relevance to biomedical, behavioral health sciences, and health services research. Applicants are strongly encouraged to take into consideration problems or issues that have relevance to specific missions of DHHS, AHRQ, or NIH institutes and centers. Funding for FY is anticipated to be between $1M and $2M. Funding is anticipated to support 5-8 new R01 awards…may request up to $175,000/year in direct costs for a maximum of two years. Smaller, pilot projects will be considered…"
 
Week of June 19, 2006
Final Rule: Environmental Protection Agency Protections for Subjects in Human Research; Nursing Women, Federal Register 71: pages 36171-36176, Jun 23, 2006
"EPA published a direct final rule that bans using nursing women from participating in intentional dosing research for pesticides. This action guarantees nursing women are not involved in human studies and provides protection to nursing infants who may also be exposed. EPA will not rely on data from previous studies that included nursing women. The new restrictions mirror the protections explicitly provided for studies involving pregnant women and children in the final rule issued by EPA in January 2006…"
Senators Prepare to Unveil New Drug Safety Proposals, The New York Times, Jun 21, 2006 (free one-time registration required; scheduled to be freely available until June 27, 2006)
"After more than a year of quiet negotiations, two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States…"
VU to put patient DNA in vast research pool, Tennessean.com, Jun 20, 2006
"DNA from as many as 400,000 people will be fed over five years into a database at Vanderbilt University Medical Center under a $5 million research program expected to launch in the fall. Patients at the hospital and its clinics will have the option to call a hot line and opt out. The data will be extracted from blood that would otherwise be thrown out, from lab tests or other uses…"
 
Week of June 12, 2006
US scientist accused of selling tissue samples, Boston Globe, Jun 14, 2006
"A senior government scientist pocketed hundreds of thousands of dollars as a drug company consultant in exchange for human tissue samples that cost the federal government millions to acquire, congressional investigators said yesterday…"
NIH Scientist Exploited Human Tissue Samples For Personal Gain, Report Finds, US House of Representatives Committee on Energy and Commerce, Jun 13, 2006
Staff Report, Committee on Energy and Commerce, released Jun 13, 2006 (pdf file)
NIH Statement Regarding House Hearing on Human Tissue Samples, National Institutes of Health Press Release, Jun 13, 2006
 
Week of June 5, 2006
Volunteers wanted for laboratory on Everest, The Guardian, Jun 10, 2006
"Wanted: 200 volunteers to climb 5,300 metres (17,300ft) up to Mount Everest base camp and take part in medical experiments at the highest laboratory in the world…"
Consent not needed to test patients in emergency, Seattle Times, Jun 8, 2006
"In a public-health emergency, suspected victims would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts called the exception unnecessary, ripe for abuse and an override of state informed-consent laws…"
Food and Drug Administration, Medical Devices; Exception From General Requirements for Informed Consent, Interim Final Rule, Federal Register 71, pages 2827-32834, Jun 7, 2006
"The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances…"
Harvard researchers will clone embryos, Seattle Times, Jun 7, 2006
"Harvard University on Tuesday announced a privately funded, multimillion-dollar program to create cloned human embryos as sources of medically promising stem cells…Much of the ethical wrangling leading up to Tuesday's announcement related to the procurement of human eggs…"
Harvard Stem Cell Institute Web Site
Office for Human Research Protections (OHRP) Guidance: Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e), OHRP, Jun 7, 2006
"This document addresses how to determine whether the HHS regulations at 45 CFR part 46 are applicable to the activities covered by the Food and Drug Administration's (FDA's) interim final rule, "Medical Devices; Exception From General Requirements for Informed Consent" (21 CFR 50.23(e))…"
Food and Drug Administration, Medical Devices; Exception From General Requirements for Informed Consent, Interim Final Rule, Federal Register 71, pages 2827-32834, Jun 7, 2006
"The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances…"
Ethical questions complicate the recruitment of egg donors, Boston Globe, Jun 7, 2006
"Recruiting women to donate eggs for stem cell research brings scientists into new ethical territory where the standards are still being worked out, ethicists say…"
Clinical Trials: Seeking salvation in experimental drugs, Salt Lake Tribune, Jun 6, 2006
"…When conventional treatments fail, hundreds of Utahns with life-threatening diseases scrounge for developmental drugs that might offer another week, another month with loved ones. Not every clinical trial deals with potentially life-saving drugs, but when taking on deadly diseases, doctors and drug companies rely on the ill to help show the effectiveness of potential treatments…"
Clinical Trials: Tough questions when kids are involved, Salt Lake Tribune, Jun 5, 2006
"…That's one of the trade-offs parents face when considering enrolling their child in a clinical trial. Benefits are not guaranteed, nor are they necessarily known…"
Clinical Trials: Utahns willing to be 'guinea pigs' for medical studies, Salt Lake Tribune, Jun 5, 2006
"… Some do it for compensation. Some do it out of desperation. Some just want to contribute…"
Medical Privacy Law Nets No Fines, Washington Post, Jun 5, 2006 (free one time registration required)
"In the three years since Americans gained federal protection for their private medical information, the Bush administration has received thousands of complaints alleging violations but has not imposed a single civil fine and has prosecuted just two criminal cases. Of the 19,420 grievances lodged so far, the most common allegations have been that personal medical details were wrongly revealed, information was poorly protected, more details were disclosed than necessary, proper authorization was not obtained or patients were frustrated getting their own records…"
 
Week of May 29, 2006
Partnership as an ethical model for medical research in developing countries: the example of the "implementation trial", Dowdy, Journal of Medical Ethics 32: 357-360, Jun 1, 2006 (abstract freely available)
Gene therapy for children with cystic fibrosis—who has the right to choose?, Jaffé et al., Journal of Medical Ethics 32: 361-364, Jun 1, 2006 (extract freely available)
Office of Research Integrity (ORI) Newsletter, June 2006 (pdf file)
Office of Research Integrity (ORI) Annual Report 2005, released June 2006 (pdf file)
EU Adopts New Rules on Children's Medicine, Washington Post, Jun 1, 2006 (no longer available)
"The European Union is offering drug makers extended patents as an incentive to produce children's versions of drugs for diseases such as cancer, AIDS or psychiatric disorders…Companies will not be obliged to develop a children's version of every drug, but they will have to conduct clinical tests and clearly indicate what effect the drug has on children…"
European Commission Medicines for Children Web Page
Groups Challenge EPA’s ‘Industry-friendly’ Pesticide Rules, The NewStandard, Jun 1, 2006
"Two recent actions by environmental health watchdogs foreshadow a showdown between corporations and public-interest advocates over the safety of toxins marketed as pesticides…"
Documents referred to in this article:
Letter to Stephen Johnson (EPA Administrator) from Local Residents of EPA Unions, May 24, 2006 (pdf file)
White House Office of Management and Budget, EPA, Pesticide Groups Meeting Notes, Aug 9, 2005 (pdf file)
Research Sponsorship, Financial Relationships, and the Process of Research in Pharmaceutical Clinical Trials, Gardner and Lidz, Journal of Empirical Research on Human Research Ethics 1: 11-18, June 2006 (abstract freely available)
Resisting Power and Influence: A Case Study in Virtue Ethics, Vasgird, Journal of Empirical Research on Human Research Ethics 1: 19-22, June 2006 (abstract freely available)
A Needs Assessment to Build International Research Ethics Capacity, Sidle et al., Journal of Empirical Research on Human Research Ethics 1: 23-38, June 2006 (abstract freely available)
U. S. Health Researchers Review their Ethics Review Boards: A Qualitative Study, Burris and Moss, Journal of Empirical Research on Human Research Ethics 1: 39-58, June 2006 (abstract freely available)
Anthropological Research in Light of Research-Ethics Review: Canadian Master's Theses, 1995–2004, van den Hoonaard and Connolly, Journal of Empirical Research on Human Research Ethics 1: 59-69, June 2006 (abstract freely available)
If Ethics Committees were Designed for Ethnography, Tolich and Fitzgerald, Journal of Empirical Research on Human Research Ethics 1: 71-78, June 2006 (abstract freely available)
The Anthropologist and the Crayons: Changing our Focus from Avoiding Harm to Doing Good, Childress, Journal of Empirical Research on Human Research Ethics 1: 79-88, June 2006 (abstract freely available)
Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects, Shamoo and Resnik, American Journal of Bioethics 6, June 2006 (abstract freely available)
Are You Sitting Comfortably? Perspectives of the Researchers and the Researched on 'Being Comfortable', Morris and Balmer, Acountability in Research 13: 111-133, Jun 1, 2006 (abstract freely available)
A Qualitative Study of Non-Affiliated, Non-Scientist Institutional Review Board Members, Anderson, Accountability in Research 13: 135-155, Jun 1, 2006 (abstract freely available)
Research Subjects with Limited English Proficiency: Ethical and Legal Issues, Resnick and Jones, Accountability in Research 13: 157-177, Jun 1, 2006 (abstract freely available)
Does Random Treatment Assignment Cause Harm to Research Participants?, Gross et al., PLoS Medicine 3, June 2006 (full article freely available)
UA doctor barred from research on humans, Tucson Citizen, May 31, 2006
"A University of Arizona cardiologist has been permanently barred from conducting medical research on humans after the Food and Drug Administration found serious violations by him of federal rules that protect patient safety. The cardiologist's research involved implanting a biventricular pacemaker device in individuals with serious heart disease…"
 
Week of May 22, 2006
British regulators criticize company over trial that left 6 ill, Boston Globe, May 25, 2006
"British drug regulators on Thursday issued a report that was heavily critical of a Massachusetts-based company responsible for conducting a drug trial that left six healthy volunteers fighting for their lives…"
Medicines and Health Care Products Regulatory Agency (MHRA) Press Release and Report: Final Report on TGN1412 Clinical Trial, MHRA Website, May 25, 2006
Prostitutes' protests end Cambodia test, Seattle Times, May 24, 2006
"…Objections have focused on the study's subjects: prostitutes, usually poor, who critics say are being taken advantage of. They cite low payments, lack of information about side effects and no health insurance, should something go wrong. In trying to get a better deal for those women, they have slowed the testing of what many scientists consider the best hope to stop AIDS in the underdeveloped world…"
Draft Report on Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease, Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS), May 23, 2006 (comments due July 31, 2006)
"SACGHS is seeking public input on a draft report, Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease. The draft report focuses on preliminary and intermediate questions, steps, and strategies in five areas that should be addressed before an informed decision can be made about whether the United States should undertake a large population cohort project on the interaction of genes, environment and disease. These five areas are: research policy; research logistics; regulatory and ethical issues; public health implications of the research results; and social implications of the research results. The report also identifies options for how these issues might be addressed. Comments on any aspect of the draft report are welcome…"
AIDS Vaccine Testing Goes Overseas. U.S. Funds $120 Million Trial Despite Misgivings of Some Researchers, Washington Post, May 22, 2006 (free one time registration required))
"Inside a ramshackle Buddhist temple here on the country's southeastern coast, curious villagers gathered last fall as part of the United States' biggest gamble yet on stopping the AIDS pandemic. The informational meeting was almost like a game show as attractive young hosts revved up the crowd, working up to the big question, boomed out over loudspeakers: Would the audience be willing to volunteer to test an experimental HIV vaccine?…But as the trial moves forward, at a cost of more than $120 million, some researchers are raising questions about its validity. They disparage its science, question its ethics and doubt its efficacy…"
 
Week of May 15, 2006
Helping researchers understand the human condition, Urbana/Champaign News-Gazette, May 21, 2006
"…Though the Champaign-Urbana campus doesn't do a lot in the way of touchy medical research involving, for instance, invasive surgical procedures or experimental drugs, largely the purview of the UI Medical School in Chicago, it still requires people for a diverse array of studies…“We mostly do behavioral and social science research,” said Susan Keehn, director of the UI's Institutional Review Board, which reviews proposed studies involving human subjects to make sure safety protocols are followed…"
Comment: Clinical trial registration: transparency is the watchword, Sim et al., Lancet 367:1631-1633, May 20, 2006 (free one time registration required; full article freely available)
Comment: Trial registers: protecting patients, advancing trust, Horton, Lancet 367:1633-1635, May 20, 2006 (free one time registration required; full article freely available)
Comment: Trial summaries on results databases and journal publication, Rockhold and Krall, Lancet 367:1635-1636, May 20, 2006 (free one time registration required; full article freely available)
Request for Comments: External Consultation on Public Health Issues, Nuffield Council for Bioethics, May 19, 2006 (comments due Sept 15, 2006)
"The Nuffield Council on Bioethics would like to hear about your views on a number of questions raised by the ethical issues surrounding public health…"
Patient Safety Requires a New Way to Publish Clinical Trials, Smith and Roberts, PLoS Clinical Trials, May 19, 2006
City health agencies move to streamline HIV testing. San Francisco drops counseling requirement, The San Francisco Chronicle, May 18, 2006
"San Francisco's public medical clinics and hospitals will no longer require written consent and counseling sessions before HIV tests, and public health officials say they hope the easier, less time-consuming process will prompt more people to get tested…San Francisco is the first city in the country to adopt the new policy, under which people will have to give verbal, not written, permission for testing…"
Pharma firms told to end secrecy in drug trials, Nature.com, May 18, 2006 (no longer freely available)
"The World Health Organization (WHO) has rebuffed requests from the pharmaceutical industry to tone down its plans for openness in drug testing…"
The World Health Organization announces new standards for registration of all human medical research, WHO News Release, May 19, 2006
SFBC Ordered to Demolish Miami Drug Test Center, Bloomberg, May 18, 2006
"…The company's decision to pull out of Florida is “going to send a signal through the entire drug industry that human-subject protection is not a nicety or a courtesy, but a bold-faced moral and legal requirement,” said Kenneth Goodman, a director of the University of Miami's Bioethics program who visited SFBC's Miami facility last year…"
Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000-2005, Ridker and Torres, Journal of the American Medical Association 295:2270-2274, May 17, 2006 (abstract freely available)
Environmental Protection Agency (EPA) Human Studies Review Board Apr 4-6, 2006 Draft Meeting Report, May 16, 2006 (pdf file)
"…On February 6, 2006 (71 FR 24, 6137), EPA published its final rule for protection of subjects in human research. This new rule included creating an independent Human Studies Review Board (HSRB) to provide advice, information and recommendations related to the scientific and ethical issues of such research…The HSRB reviewed toxicity studies involving intentional exposure of human subjects to eight pesticide active ingredients…"
A Good Death, Boston Globe, May 15, 2006
"After a 40-year virtual ban on research involving psychedelic drugs, scientists look anew at their potential for treating pain and anxiety in terminally-ill patients…"
 
Week of May 8, 2006
S.Korea charges stem cell scientist with fraud, Boston Globe, May 12, 2006
"A South Korean stem cell scientist once hailed as a national hero has been charged with criminal fraud and embezzlement, a senior prosecutor said on Friday…"
House panel OK's allowing FDA to compel more drug tests, Boston Globe, May 11, 2006
"The Food and Drug Administration could compel drug makers to conduct additional clinical trials after it approves their products under an amendment passed by a US House committee… Under the amendment, which was attached to a must-pass appropriations bill, the agency could begin proceedings to stop the sale of specific drugs if promised clinical trials for those products are not done…"
Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations., Federal Register 71, Pages 27264-27266, FDA Docket No. 2006D-0172, May 10, 2006 (Comments due July 10, 2006)
The Draft Guidance (pdf file)
Cleveland Clinic Moves to Fight Conflicts of Interest, New York Times, May 10, 2006 (free one time registration required; scheduled to be freely available until May 16, 2006)
"The Cleveland Clinic's board has agreed to take steps to address concerns about potential conflicts of interest that have dogged the institution and its doctors for more than a year… The clinic also plans to review its patient consent forms to address concerns that patients may not be fully aware of potential conflicts…"
Controversial blood trial continues, The Scientist, May 8, 2006
"A clinical trial that has been criticized for allegedly violating research ethics and Federal regulations is nearing completion. PolyHeme, an oxygen-carrying resuscitative fluid to treat uncontrolled bleeding, is in the final stages of a Phase III trial at some 30 Level 1 trauma centers in 18 states, and is expected to finish in the coming months…"
Sen. Grassley asks SEC to step up probe into leaks of drug secrets, Seattle Times, May 8, 2006
"Congressional analysts have concluded that the purchase by Wall Street brokers of secret information from doctors conducting ongoing drug research may constitute insider trading…"
 
Week of May 1, 2006
Panel Faults Pfizer in '96 Clinical Trial In Nigeria. Unapproved Drug Tested on Children, Washington Post, May 7, 2006 (free one time registration required)
"A panel of Nigerian medical experts has concluded that Pfizer Inc. violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital…"
Perspective: Injury to Research Volunteers — The Clinical-Research Nightmare, Wood and Darbyshire, New England Journal of Medicine 354:1869-1871, May 4, 2006 (full article freely available)
Audio interview with author Alastair Wood (freely available, Macromedia Flash Player required)
Perspective: Compensation for Injured Research Subjects, Steinbrook, New England Journal of Medicine 354:1871-1873, May 4, 2006 (full article freely available)
Bill Seeks Access to Tax-Funded Research, Washington Post, Washington Post, May 3, 2006 (free one time registration required)
"A smoldering debate over whether taxpayers should have free access to the results of federally financed research intensified yesterday with the introduction of Senate legislation that would mandate that the information be posted on the Internet…"
Court allows suit for drug access, Seattle Times, May 3, 2006
"Terminally ill patients, seeking early access to experimental drugs unlikely to be approved before they die, won a legal reprieve Tuesday in a federal appeals court. A three-judge panel reinstated a lawsuit against the Food and Drug Administration filed on behalf of the patients and returned the case to the district court that had dismissed it in 2004…"
TeGenero Drug Was Too Perilous to Test on Healthy Volunteers, Bloomberg, May 2, 2006
"An experimental drug that left six men with multiple-organ failure this year in London shouldn't have been tried first on healthy volunteers because it supercharged the immune system in a new way that wasn't fully understood, said researchers who reviewed the trial…"
Ministry to write new guidelines for medical research, The Nation Multimedia, Thailand, May 2, 2006
"The Public Health Ministry is working on national guidelines for all human research projects. "While attracting the [international] pharmaceutical industry to launch clinical trials here, we have to protect our people who are going to be the subjects of the research," Dr Chatri Bancheun, director-general of the Medical Services Department, said last week…"
Informed Consent for Research and Authorization under the Health Insurance Portability and Accountability Act Privacy Rule: An Integrated Approach, Shalowitz and Wendler, Annals of Internal Medicine: 144, 685-688, May 2, 2006 (full article freely available)
New Committee Will Provide Updates to Stem Cell Research Guidelines; Scientists and Others Invited to Comment On Use of Guidelines, National Academies News, May 2, 2006
"The National Academies' National Research Council and Institute of Medicine today announced the appointment of a committee to monitor and revise voluntary guidelines on the conduct of human embryonic stem cell research. The committee…will provide updates to the voluntary guidelines issued last year by the Academies. The updates will be issued in periodic reports. The Research Council and IOM also today encouraged researchers and others to comment on the usefulness of the 2005 guidelines and whether they need to be updated to reflect new scientific findings, public policies, and legal rulings, as well as evolving ethical issues…"
Human Embryonic Stem Cell Research Advisory Committee Web Page, National Research Council/Institute of Medicine, May 2, 2006
Report: Guidelines for Human Embryonic Stem Cell Research, National Research Council and Institute of Medicine, Apr 26, 2005 (full document freely available)
Submit comments on 2005 Report
US lawmakers question FDA OK of Sanofi antibiotic, Reuters, May 1, 2006 (no longer available)
"…At issue is whether the FDA dismissed problems with a major trial after several physicians were cited by agency investigators for falsifying data or improper record-keeping, said the lawmakers, two Democrats and a Republican…"
A questionnaire on factors influencing children’s assent and dissent to non-therapeutic research, Wolthers, Journal of Medical Ethics 32: 292-297, May 1, 2006 (abstract freely available)
Moving Human Embryonic Stem Cells from Legislature to Lab: Remaining Legal and Ethical Questions, Greely, PLoS Medicine 3, May 2006 (full article freely available)
Principles for Strengthening the Integrity of Clinical Research, Korn and Ehringhaus, PLoS Clinical Trials, May 2006 (pdf file; full article freely available)
The Informed Consent Process in a Rural African Setting: A Case Study of the Kassena-Nankana District of Northern Ghana, Tindana et al., IRB 28, May-June 2006 (free one time registration required; full article freely available)
 
Week of April 24, 2006
Race issues highlighted in dispute over Schering-Plough research, Monterey County Herald, Apr 30, 2006
"…The dispute highlights a collision of scientific research and social realities in the development of life-saving medicines. It also illustrates conflicting principles of risk vs. benefit in the ethical guidelines that have governed all human experimentation since the Nazi era Nuremberg Trials and the notorious Tuskegee Syphilis Study…"
UK: optimism over new regulator, The Scientist, Apr 27, 2006
"The Human Tissue Authority (HTA), a new regulatory agency in Britain, announced this week that the rules governing live kidney donation would be relaxed. But for the research community, the new watchdog's most significant impact won't be felt for another four months, when it begins regulating research aspects of human tissue use…"
UK Human Tissue Authority
Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings, Lurie et al., Journal of the American Medical Association 295:1921-1928, Apr 26, 2006 (abstract freely available)
Funding Announcements: Three programs for "Research on Ethical Issues in Human Subjects Research", National Institutes of Health, posted Apr 25, 2006
Research On Ethical Issues In Human Subjects Research (R03) PA-06-367
Research On Ethical Issues In Human Subjects Research (R21) PA-06-368
Research On Ethical Issues In Human Subjects Research (R01) PA-06-369
South Africa: Guinea Pigs 'Should Be Insured', AllAfrica.com, Apr 25, 2006 (paid subscription now required for access)
"Health Minister Manto Tshabalala-Msimang has called for the introduction of insurance cover for participants involved in clinical trials intended to prove the effectiveness of certain medical products…"
Study: Money sways federal drug voting, Seattle Post-Intelligencer, Apr 25, 2006 (no longer available)
"…The JAMA study underscored how pervasive the conflicts are: In 73 percent of drug advisory committee meetings, at least one panelist reported a financial conflict of interest…"
Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings, Lurie et al., Journal of the American Medical Association 295:1921-1928, Apr 26, 2006 (abstract freely available)
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, Apr 25, 2006 (pdf file)
 
Week of April 17, 2006
Lax oversight by Pitt enabled Schatten fiasco, Pittsburgh Tribune-Review, Apr 23, 2006
"The University of Pittsburgh's lax policies and disregard for federal guidelines allowed biologist Gerald Schatten to participate in one of the biggest scientific frauds in history, according to a Pittsburgh Tribune-Review examination…"
No end to FDA disclosure debate, Boston Globe, Apr 21, 2006
"New waiver law fails to quiet criticism over experts' financial ties to drug companies…"
Genetics: No longer de-identified, McGuire and Gibbs, Science 312: 370 – 371, Apr 21, 2006 (full article freely available)
2 studies vindicate mercury fillings: No link found to birth defects, Seattle Post-Intelligencer, Apr 19, 2006 (scheduled to be available until Apr 25, 2006)
"Two new studies, one from the University of Washington involving orphans in Portugal, found no evidence of IQ or other neurological impairment caused by dental fillings made with mercury. But the studies have come under fire from some groups who say researchers unnecessarily exposed children to a known toxic substance, failed to get the proper consent from parents and guardians and overstated the results…"
Neurobehavioral Effects of Dental Amalgam in Children. A Randomized Clinical Trial, DeRouen et al., Journal of the American Medical Association 295:1784-1792, Apr 19, 2006 (abstract freely available)
Neuropsychological and Renal Effects of Dental Amalgam in Children, Bellinger et al., Journal of the American Medical Association 295: 1775-1783, Apr 19, 2006 (abstract freely available)
Judge rules univ. owns research samples, Monterey County Herald, Apr 19, 2006
"…Limbaugh cited two earlier cases in which courts found that donors do not own tissue they donate. He also expressed concerns for the "great potential for prejudicial influences into medical research," if donors could redirect their samples for their own reasons. The St. Louis case is the first involving a university, tissue donors and a researcher asserting that donors have the right to reclaim their tissue and send it to him…"
Judge Limbaugh Rules in Favor of Washington University in Washington University v. William J. Catalona, Washington University St Louis News and Information, Apr 14, 2006 (includes full opinion)
Getting It Right: Being Smarter about Clinical Trials. A major NIH meeting led to recommendations for conducting better clinical trials, Kramer et al., PLoS Medicine, early release Apr 18, 2006 (full article freely available)
Enrolling Adolescents in Research on HIV and Other Sensitive Issues: Lessons from South Africa, Singh et al., PLoS Medicine, early release Apr 18, 2006 (full article freely available)
Documentation of Approval of FWAs and Processing of IRB Registrations, Office for Human Research Protections (OHRP), Apr 17, 2006
 
Week of April 10, 2006
Taking the least of you, New York Times, Apr 16, 2006 (free one time registration required; scheduled to be freely available until Apr 22, 2006)
"…Today most Americans have their tissue on file somewhere. In 1999 the RAND Corporation published a report (the first and, so far, the last of its kind) with what it called a "conservative estimate" that more than 307 million tissue samples from more than 178 million people were stored in the United States. This number, the report said, was increasing by more than 20 million samples each year…"
Chinese man gets partial face transplant, Boston Globe, Apr 14, 2006
"A man whose face was badly disfigured after an attack by a black bear received a partial face transplant Friday, in what a hospital described as a first for China…"
Secretary’s Advisory Committee for Human Research Protections (SACHRP) March 13-14 Meeting Agenda and Materials, Office for Human Research Protections (OHRP) Web Site, posted Apr 11, 2006
Parexel Misled Subjects Sickened in London Study, Ethicists Say, Bloomberg, Apr 10, 2006
"Parexel International Corp. hid risks from healthy volunteers enlisted into a clinical drug test in London that left six men fighting for their lives, say medical ethicists who reviewed confidential study documents…"
 
Week of April 3, 2006
British Rethinking Rules After Ill-Fated Drug Trial, New York Times, Apr 8, 2006 (free one time registration required; scheduled to be freely available until Apr 14, 2006)
"…On Wednesday, after releasing its interim report on the trial as well as previously confidential scientific documents that were part of the application for a trial permit, the British government announced it was convening an international panel of experts to "consider what necessary changes to clinical trials may be required" for such novel compounds. The outcome "could potentially affect clinical trials regulation worldwide," the announcement said…"
Testing Antibody Therapies: Position Paper, Academy of Medical Science, Apr 5, 2006 (pdf file)
"…a small working group was convened to discuss some of the broad questions and issues arising from the TGN1412 trial…"
Regulator says no contamination in drug used in failed trial, Boston Globe, Apr 5, 2006
"Investigators have found no explanation for what went wrong in a clinical drug test which made six men seriously ill in Britain, regulators said Wednesday…"
Latest findings on clinical trial suspension, Medicine and Healthcare Products Regulatory Agency (MHRA) UK, Apr 5, 2006 (includes interim report, press release, study protocol, investigator’s brochure)
"The MHRA has today released its interim report into the adverse incidents which occurred on 13th March 2006 during the clinical trials of TGN1412…"
Firms seek ethics amid wariness of drugs, GMOs, Reuters, Apr 4, 2006 (no longer available)
"Companies involved in businesses such as drug testing on animals or production of genetically modified foods are creating methods to address ethical dilemmas to overcome public distrust, a study said on Tuesday…"
Lessons on Ethical Decision Making from the Bioscience Industry, Mackie et al., Public Library of Science: Medicine 3, May 2006 (full article freely available)
Ex-test subjects may be in danger, Los Angeles Daily News, Apr 3, 2006 (no longer available)
"Thousands of former servicemen who volunteered for chemical and biological tests in the 1960s and 1970s might have been exposed to highly toxic substances that could jeopardize their health, and the U.S. government is scrambling to locate them…"
 
Week of March 27, 2006
Ethical Principles and Practices for Research Involving Human Participants With Mental Illness, American Psychiatric Association’s Task Force on Research Ethics, Psychiatric Services 57: 552-557, April 2006 (abstract freely available)
For full text click here, Apr 1, 2006 (pdf file)
Assent in paediatric research: theoretical and practical considerations, Wendler, Journal of Med Ethics 32: 229-234, Apr 1, 2006 (abstract freely available)
Md. Approves Fund To Support Medical Stem Cell Research, Washington Post, Mar 30, 2006 (free one time registration required)
"Maryland will become one of four states that have agreed to fund stem cell research, following final passage yesterday of legislation in the House of Delegates and a pledge from Gov. Robert L. Ehrlich Jr. (R) to sign it, despite misgivings by most lawmakers in his party…"
Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study: The Ethical Justification for Public Health Research on Less Expensive Yet Less Effective Interventions, Buchanan and Miller, American Journal of Public Health, early release Mar 29, 2006 (abstract freely available)
Research Recruitment Through US Central Cancer Registries: Balancing Privacy and Scientific Issues, Beskow et al., American Journal of Public Health, early release Mar 29, 2006 (abstract freely available)
Fostering International Collaboration in Birth Defects Research and Prevention: A Perspective From the International Clearinghouse for Birth Defects Surveillance and Research, Botto et al., American Journal of Public Health, early release Mar 29, 2006 (abstract freely available)
Two Drug-Trial Subjects Out of Hospital, The San Francisco Chronicle, Mar 28, 2006
"Two of six men who became seriously ill and were hospitalized after participating in a clinical drug trial have been released from hospital, officials said Tuesday…"
A Trial of Disclosing Physicians' Financial Incentives to Patients, Pearson et al., Archives of Internal Medicine 166:623-628, Mar 27, 2006 (abstract freely available)
 
Week of March 20, 2006
New Federally Funded Research Program Aims to Improve Survival from Cardiac Arrest and Severe Trauma, NIH News, Mar 24, 2006
"The “Resuscitation Outcomes Consortium” (ROC) will conduct collaborative clinical trials of promising new treatments for cardiac arrest and severe traumatic injury. Along with Emergency Medical Services (EMS) agencies, ROC will involve public safety agencies, regional hospitals, community healthcare institutions and medical centers in 11 regions in the United States and Canada and as many as 15,000 patients over a 3-year period. Communities involved in ROC will learn about the study in a comprehensive community education effort to be conducted over the next 6 months to a year…"
Supervised self-harm plan praised, BBC News, UK, Mar 22, 2006
"Patients who self-harm are being allowed to do so under supervision in hospital in an innovative scheme. The practice is being allowed as part of a six-month investigation into the care of people who self-harm at St George's Hospital, Stafford…"
In China, faculty plagiarism a `national scandal', Monterey County Herald, Mar 22, 2006
"Charges of plagiarism roil China's universities, but they're not about students cheating. They're about professors who filch from one another…At the core of the scandals is an academic system that rewards scholars for prolific results in publishing and pays little regard to quality…"
Illnesses raise drug-safety questions, Monterey County Herald, Mar 22, 2006
"The experimental drug that caused convulsions and organ failure in the first humans it was tested on only left monkeys with swollen glands, and there was nothing to predict the disastrous effects on people, the drug company's chief scientist said Tuesday. The medical study on six previously healthy men has raised fresh questions over safety and whether volunteers have enough information to weigh the risks…"
Bill would make results of clinical drug trials public, Pioneer Press, Mar 22, 2006
"Two lawmakers want Minnesota to make up for failures in the federal drug safety system by requiring drug companies to reveal the results of all clinical studies — good and bad…"
Medical ethicists say Northfield study flawed, Reuters, Mar 20, 2006 (scheduled to be available until Apr 19, 2006)
"…Under the study, some seriously injured patients continue to receive the blood substitute instead of blood transfusions once they arrive at a hospital. Because of the severity of their injuries, it is inevitable that some will die, the researchers warned. "Putting the point most dramatically," the letter said, "these men and women will have died while being denied an available treatment (blood transfusions) that is indicated by the standard of practice, following unconsented-to enrollment in a research study."…"
An Open Letter to IRBs Considering Northfield Laboratories' PolyHeme Trial, Kipnis et al., American Journal of Bioethics, Mar 9, 2006 (pdf file)
 
Week of March 13, 2006
Medical researchers caught faking it, Canada.com, Mar 16, 2006
"More than a dozen scientists and doctors, several of them recipients of sizable federal grants, have been faking research, destroying data, plagiarizing or conducting experiments on people without necessary ethics approvals, the country's lead research agencies report…"
FDA Unveils Critical Path Opportunities List Outlining Blueprint To Modernizing Medical Product Development by 2010. Biomarker Development and Clinical Trial Design Greatest Areas for Impact, FDA News, Mar 16, 2006
"…The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers; clinical trial designs, bioinformatics, manufacturing, public health needs and pediatrics. FDA's outreach efforts uncovered a consensus that the two most important areas for improving medical product development are biomarker development (Topic 1 ) and streamlining clinical trials (Topic 2)…"
The Critical Path to New Medical Products Web Page, FDA Website, Mar 16, 2006 (includes Report)
Guidance for Industry. Using a Centralized IRB Review Process in Multicenter Clinical Trials, FDA, Mar 15, 2006 (pdf file)
British drug trial goes wrong, two critically ill, Reuters, Mar 15, 2006 (no longer available)
"Two men were critically ill in a British hospital on Wednesday and four others serious in intensive care after suffering violent reactions to a new drug they took as part of a clinical trial. Police said they were working with the country's medicines watchdog to establish the circumstances…"
Bush to Nominate Acting Chief to Head FDA, The San Francisco Chronicle, Mar 15, 2006
"President Bush on Wednesday nominated Andrew von Eschenbach as commissioner of the Food and Drug Administration, the agency the urology surgeon has led on an acting basis since September…"
Senator demands FDA answers on blood study, Reuters, Mar 13, 2006 (no longer available)
"A top U.S. lawmaker on Monday called on the Food and Drug Administration to publicly explain benefits of an experimental blood substitute after government advisors said a clinical trial for the product was unethical and never should have been approved. The Office for Human Research Protections raised concerns about Northfield Laboratories Inc's PolyHeme as early as June 2004, but the FDA failed to respond…"
 
Week of March 6, 2006
Alternative Models of IRB Review: Workshop Summary Report, Office for Human Research Protections, posted March 10, 2006 (pdf file)
"The Office for Human Research Protections (OHRP), with the National Institutes of Health, The Association of American Medical Colleges and the American Society of Clinical Oncology has issued a report summarizing the findings of a workshop on "Alternative Models of IRB Review" held in Washington, DC on November 17-18, 2005. The workshop was suggested by the Secretary's Advisory Committee on Human Research Protections (SACHRP) in the fall of 2004 as a means of understanding the issues associated with the use of alternatives to local Institutional Review Boards (IRBs) and informing the committee for its future deliberations…"
20 people test positive for TB after Quebec trial, CTV.ca (Canada), Mar 10, 2006
"Health officials in Quebec have confirmed twenty cases of tuberculosis in subjects who took part in a clinical trial at a biopharmaceutical lab…Health Canada is investigating the situation, which developed at SFCP Anapharm, a Montreal lab that is a subsidiary of the New Jersey-based SFCB International…"
Accidental Communities: Race, Emergency Medicine, and The Problem of PolyHeme, Holloway, American Journal of Bioethics, Mar 9, 2006 (pdf file)
An Open Letter to IRBs Considering Northfield Laboratories' PolyHeme Trial, Kipnis et al., American Journal of Bioethics, Mar 9, 2006 (pdf file)
Handbook for Good Clinical Research Practice (GCP) Guidance for Implementation, World Health Organization, Mar 6, 2006 (pdf file)
"…This handbook…is intended to assist national regulatory authorities, sponsors, investigators and ethics committees in implementing GCP for industry-sponsored, government-sponsored, institution-sponsored, or investigator-initiated clinical research. The handbook is based on major international guidelines…"
 
Week of February 27, 2006
Editorial: Harmful impact of EU clinical trials directive, Hemminki and Kellokumpu-Lehtinen., British Medical Journal 332:501-502, Mar 4, 2006 (extract freely available)
FDA says firms still lagging on follow-up drug studies, Boston Globe, Mar 4, 2006
"Drug companies have yet to even begin nearly two out of three of the follow-up studies they agreed to undertake once their medicines were on the market, according to a government tally released yesterday…"
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies, Federal Register 71, pages 10978-10979, Mar 3, 2006 (pdf file)
Stanford doctors spotlight fatal flaw in multiple sclerosis drug trial, EurekAlert (press release), Mar 2, 2006
"…This tragedy - recounted in an article in the March 4 issue of The Lancet by two Stanford University School of Medicine neurologists - serves as a telling case study of what can go wrong in clinical trials. In their article, Annette Langer-Gould, MD, and Lawrence Steinman, MD, warn of the pitfalls of testing a drug with unknown side effects in patients who would do fine without the drug…"
Universal Stem Cell Principles Proposed, Washington Post, Mar 2, 2006 (free one time registration required)
"Concerned that the world's patchwork of laws and ethics rules governing human embryonic stem cell research is sowing confusion and stymieing international collaborations, scientists, ethicists and others have mounted a major effort to devise a set of universal principles that would guide the research everywhere…"
Consensus Statement of the 'Hinxton Group': An International Consortium on Stem Cells, Ethics and Law, Feb 24, 2006 (no longer available)
Perspective: Facial Transplantation: Brave New Face, Okie, New England Journal of Medicine 354:889-894, Mar 2, 2006 (full article freely available)
Interview with Dr. Maria Siemionow on her protocol for full-face transplantation, New England Journal of Medicine, Mar 2, 2006 (freely available, Macromedia Flash Player required)
Resources and Needs of Research Ethics Committees in Africa: Preparations for HIV Vaccine Trials, Milford et al., IRB 28: 1-9, March/April 2006 (no longer available)
Trials and Errors: Barriers to Oversight of Research Conducted under the Emergency Research Consent Waiver, Kipnis et al., IRB 28: 16-19, March/April 2006 (no longer available)
Serious Adverse Drug Effects — Seeing the Trees through the Forest, Gurwitz, New England Journal of Medicine early release, Mar 1, 2006 (extract freely available)
Ethicists Blast Fake Blood Study, The San Francisco Chronicle, Mar 1, 2006
"…The ethicists say the problem with the study is when the patients arrive at the hospital. Testing Polyheme against blood should be done separately in patients who can give consent or who have family members who can consent, wrote King and University of Hawaii ethicist Ken Kipnis and Philadelphia anesthesiologist Dr. Robert Nelson. Kipnis said if the hospital phase can't be eliminated, the whole study should be suspended…"
Premier Issue: Journal of Empirical Research on Human Research Ethics, March 2006 (all content freely available)
Cognitive Interviewing as a Tool for Improving the Informed Consent Process, Willis, Journal of Empirical Research on Human Research Ethics 1: 9-24, March 2006 (pdf file; full article freely available)
Informed Consent in International Health Research, Marshall, Journal of Empirical Research on Human Research Ethics 1: 25-42, March 2006 (pdf file; full article freely available)
Normal Misbehavior: Scientists Talk about the Ethics of Research, de Vries et al., Journal of Empirical Research on Human Research Ethics 1: 43-50, March 2006 (pdf file; full article freely available)
Scientists' Perceptions of Organizational Justice and Self-Reported Misbehaviors, Martinson et al., Journal of Empirical Research on Human Research Ethics 1: 51-66, March 2006 (pdf file; full article freely available)
What Scientists Want from Their Research Ethics Committee, Keith-Spiegel et al., Journal of Empirical Research on Human Research Ethics 1: 67-82, March 2006 (pdf file; full article freely available)
Enrolling Women into HIV Preventive Vaccine Trials: An Ethical Imperative but a Logistical Challenge, Mills et al., Public Library of Science Medicine 3 (3): e94, March 2006 (full article freely available)
A Nation of Guinea Pigs, Wired News, March 2006
"There's a new outsourcing boom in South Asia - and a billion people are jockeying for the jobs. How India became the global hot spot for drug trials…"
Office of Research Integrity (ORI) Newsletter, March 2006 (pdf file)
The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study, van Luijn et al., Journal of Medical Ethics 32: 170-176, March 2006 (abstract freely available)
Review of measurement instruments in clinical and research ethics, 1999–2003, Redman, Journal of Medical Ethics 32: 153-156, March 2006 (abstract freely available)
The following articles (links 1-3) discuss an industry-funded, placebo-controlled study, performed in India, of risperidone for acute mania (4th link).
Ethics of a placebo-controlled trial in severe mania, Patel, Indian Journal of Medical Ethics, Jan-Mar 2006 (full article freely available)
Placebo-controlled trials in psychiatry on trial, Tharyan, Indian Journal of Medical Ethics, Jan-Mar 2006 (full article freely available)
Response to Dr Vikram Patel, KHANNA, Indian Journal of Medical Ethics, Jan-Mar 2006 (full article freely available)
Risperidone in the treatment of acute mania: Double-blind, placebo-controlled study, Khanna et al., British Journal of Psychiatry 187: 229-234, September 2005 (abstract freely available)
International Clinical Trials Registry Platform, World Health Organization (WHO) Web Page, March 2006 (second round comments due by Mar 31, 2006)
"…Specific goals of the Registry Platform include establishing standards on the scope and content of trial registration, establishing a network of Member Registers that satisfy criteria for internationally acceptable registers, establishing and assigning a Universal Trial Reference Number to globally unique trials, defining minimum standards for the reporting of trial results, and launching a one-stop Search Portal for searching registers worldwide…"
Enrolling Women into HIV Preventive Vaccine Trials: An Ethical Imperative but a Logistical Challenge, Mills et al., Public Library of Science Medicine 3, March 2006
 
Week of February 20, 2006
US senator questions FDA-approved blood study, Reuters, Feb 24, 2006 (no longer available)
"A key Senate Republican pressed the U.S. Food and Drug Administration on Thursday for details on its role in the clinical trial of an experimental blood substitute being tested on trauma patients in 18 states, in some cases without their consent…"
EPA Testing Rule Is Challenged, Chemical & Engineering News, Feb 24, 2006
"A coalition of activist groups filed a lawsuit in federal court on Feb. 23 that seeks to overturn an Environmental Protection Agency rule that allows testing of pesticides on humans…"
Impatient treatment, Documents offer rare glimpse into politics of human research at UAMS [University of Arkansas for Medical Sciences], Arkansas Times, Feb 23, 2006
"…[IRB] Members who spoke to the Arkansas Times on a condition of anonymity said they and others complained for at least two years that Barlogie was not adhering to UAMS and federal standards…their concern was that by straying from protocol, Barlogie eroded patients’ informed consent, compromised his studies, violated agreements with sponsors and regulatory agencies, and set himself outside of requirements to which other researchers were bound…"
A patient/subject’s story. Barlogie offered hope, delivered years, Arkansas Times, Feb 23, 2006
Scientists who studied Vioxx deny ethics breach, Boston Globe, Feb 23, 2006
"Scientists who conducted a pivotal study of the blockbuster painkiller Vioxx yesterday insisted that they violated no ethical obligations by failing to include in a medical journal report all information about heart problems suffered by patients in the clinical trial…"
Editorial: Expression of Concern Reaffirmed, Curfman et al., New England Journal of Medicine Early Release, Feb 22, 2006 (full article scheduled to be freely available until Mar 15, 2006, still available)
Correspondence: Response to Expression of Concern Regarding VIGOR Study, C. Bombardier and Others, New England Journal of Medicine Early Release, Feb 22, 2006 (full article scheduled to be freely available until Mar 15, 2006, still available)
Disputes Over Medical Research Growing, San Francisco Chronicle, Feb 22, 2006
"Dr. Aubrey Blumsohn was stunned: Research results were submitted to a scientific meeting under his name — yet the British bone specialist insists he not only hadn't written or reviewed the report, he wasn't sure it was accurate…It’s the latest in a string of controversies about pharmaceutical industry control of medical research…"
Announcement: Office for Human Research Protections (OHRP), Feb 21, 2006
"OHRP strongly encourages all institutions requiring a Federalwide Assurance (FWA) or the registration of an Institutional Review Board (IRB) to use the Electronic Submission System (ESS). Please know that you may not request a submission number and leave the record inactive for over 30 days, or it will be automatically deleted. Guidance in the use of the ESS is available at this link…"
Brief Communication: Better Ways To Question Patients about Adverse Medical Events: A Randomized, Controlled Trial, Bent et al., Annals of Internal Medicine 144, pages 257-261, Feb 21, 2006 (abstract freely available)
 
Week of February 13, 2006
45 CFR Parts 160 and 164, HIPAA Administrative Simplification: Enforcement; Final Rule, Federal Register 71: pages 8389-8433, Feb 16, 2006
"The Secretary of Health and Human Services is adopting rules for the imposition of civil money penalties on entities that violate rules adopted by the Secretary to implement the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (HIPAA)…the final rule clarifies and elaborates upon the investigation process, bases for liability, determination of the penalty amount, grounds for waiver, conduct of the hearing, and the appeal process. This final rule is effective on March 16, 2006…"
Senator questions Cyberonics device approval, Reuters, Feb 16, 2006 (no longer available)
"A senior U.S. regulatory official cleared Cyberonics Inc.'s implanted depression device over objections from staff scientists, Sen. Charles Grassley said on Thursday as he questioned the product's approval…"
Committee to update stem cell research guidelines, San Diego Union-Tribune, Feb 16, 2006
"Ethics guidelines for the conduct of research using human embryonic stem cells will be updated by a new committee, the National Research Council and Institute of Medicine said Thursday. …"
National Academies Advisory: Committee on Stem Cell Research Guidelines to Be Established, National Academies Press Release, Feb 17, 2006
Holding out hope for cure, Concord Monitor, Feb 14, 2006
"…Babin believes the way she dies will be the legacy she leaves her only son. "I want him to see someone he can truly call a hero," Babin said. That's why she's volunteered for two clinical trials to test experimental drugs designed to treat Amyotrophic Lateral Sclerosis, or ALS, commonly known as Lou Gehrig's disease."
 
Week of February 6, 2006
State's stem cell institute adopts 2 ethics policies, San Diego Union-Tribune, Feb 11, 2006
"California's stem cell institute yesterday adopted two controversial but key policies that set ethical standards for research and establish a mechanism for taxpayers to recoup some of their $3 billion investment…"
California Institute for Regenerative Medicine Web Page
California Institute for Regenerative Medicine News Release, Feb 10, 2006
Panel admonishes stem-cell scientist, Seattle Times, Feb 11, 2006
"Investigators at the University of Pittsburgh have concluded faculty member and stem-cell researcher Gerald Schatten committed "research misbehavior" by seeking personal, professional and financial gains from research being conducted by colleagues in South Korea…"
Research injury in clinical trials in South Africa, Cleaton-Jones on behalf of the Network of Chairs of Human Health Research Ethics Committees in South Africa, Lancet 367:458-459, Feb 11, 2006 (free one time registration required; full article freely available)
Policy Forum, Ethics: Incidental Findings in Brain Imaging Research, Illes et al. Science 311, 783-784, Feb 10, 2006 (summary freely available)
Face Transplant Patient Goes Public, The San Francisco Chronicle, Feb 6, 2006
"The Frenchwoman who received the world's first partial face transplant showed off her new features to the public Monday, saying in a heavily slurred voice that she now looks "like everyone else" and hopes to resume a normal life…"
 
Week of January 30, 2006
Office for Human Research Protection (OHRP) Resource Page, OHRP web site, last revised, Feb 3, 2006
"This new web page on the OHRP site provides links to reference documents, historical materials and Common Rule departments/agencies. Additional materials will be added as they become available…"
FDA Docket No. 2006D-0017. Human Subject Protection Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of Food and Drug Administration Guidance Documents, Federal Register 71, pages 5861-5862, Feb 3, 2006 (Comments due April 4, 2006)
"The Food and Drug Administration (FDA) is announcing an initiative, the Information Sheet Guidance Initiative, to update its process for developing, issuing, and making available guidances intended for institutional review boards (IRBs), clinical investigators, and sponsors…The agency is also announcing the availability of five revised Information Sheet Guidances…"
Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators (pdf file)
Guidance For Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug and Biological Product Studies (pdf file)
Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies (pdf file)
Guidance For IRBs, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices (pdf file)
Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Institutional Review Board Inspections (pdf file)
Policies of Academic Medical Centers for Disclosing Financial Conflicts of Interest to Potential Research Participants, Weinfurt et al., Academic Medicine 81: 113-118, February 2006 (abstract freely available)
A Program to Provide Regulatory Support for Investigator-Initiated Clinical Research, Arbit and Paller, Academic Medicine 81: 146-153, February 2006 (abstract freely available)
Stem cell research regulations mulled. Egg donors would be reimbursed, not paid, San Diego Union-Tribune, Feb 1, 2006
"Women who donate eggs for state-funded embryonic stem cell research could be reimbursed for their expenses, including lost wages, under recommendations approved yesterday by a committee charged with setting medical and ethical standards for California's $3 billion stem cell research initiative…"
South Korea widens probe of tainted scientists, Boston Globe, Feb 1, 2006
"South Korean prosecutors have widened their criminal probe of a team led by a disgraced scientist to see if a bioethics law was breached by illegally purchasing human eggs, a prosecution source said on Wednesday…"
Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?, Wendler et al., PLoS Medicine, February 2006 (full article freely available)
Perspective: Why Are Ethnic Minorities Under-Represented in US Research Studies?, Sheikh, PLoS Medicine, February 2006 (full article freely available)
Challenges to Research in Urban Community Health Centers, Lemon et al., American Journal of Public Health, early release Jan 31, 2006 (abstract freely available)
Toward Ethical Review of Health System Transformations, Daniels, American Journal of Public Health, early release Jan 31, 2006 (abstract freely available)
 
Week of January 23, 2006
Receiving a summary of the results of a trial: qualitative study of participants' views, Dixon-Woods et al., British Medical Journal 332:206-210, Jan 28, 2006 (full text scheduled to be freely available until Feb 3, 2006)
EPA Significantly Strengthens and Expands Safeguards on Human Studies Research, EPA Website, Jan 26, 2006 (includes Federal Register final rule, final rule summary, news release)
Perspective: Beyond Fraud — Stem-Cell Research Continues, Snyder and Loring, New England Journal of Medicine 354, Jan 26, 2006 (full article freely available)
Perspective: Egg Donation and Human Embryonic Stem-Cell Research, Steinbrook, New England Journal of Medicine 354, Jan 26, 2006 (full article freely available)
Perspective: Focus on Research: First, Gather the Data, Hunter, New England Journal of Medicine 354, Jan 26, 2006 (extract freely available)
Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, Brennan et al., Journal of the American Medical Association: 295:429-433, Jan 25, 2006 (extract freely available)
Put drug makers at arm's length, doctors urged, Seattle Times, Jan 25, 2006
"Declaring that the pervasive influence of drug-industry money is distorting doctors' treatment decisions and scientific findings, a prestigious panel of medical experts Tuesday called for far-reaching new conflict-of-interest policies…"
Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, Brennan et al., Journal of the American Medical Association: 295:429-433, Jan 25, 2006 (abstract freely available)
EPA to Accept Pesticide Tests on Humans, The San Francisco Chronicle, Jan 23, 2006
"The Environmental Protection Agency for the first time is establishing criteria for tests by pesticide makers on human subjects…The EPA expects a substantial increase in the number of tests it receives involving intentional exposure of humans to pesticides. The draft final rule said the agency anticipates receiving 33 such reports a year…"
 
Week of January 16, 2006
One million people, one medical gamble, New Scientist, Jan 21, 2006
"YOU might donate blood to help save someone's life. But would you donate your blood, your DNA, and your most intimate medical secrets on a promise that it may help save a life years from now? Half a million people will be expected to do just that in the coming months, with another half a million people to follow, as two huge medical research projects get under way in the UK and US…"
FDA Announces New Program to Transform and Strengthen Medical Device Safety, FDA News, Jan 20, 2006
"The U.S. Food and Drug Administration (FDA) is launching a new program to transform and strengthen the way it currently monitors the safety of medical devices after they reach the market — both new technology and existing products…"
Medical Device Postmarket Transformation Initiative, FDA Center for Devices and Radiologic Health (CDRH) WebSite, Jan 20, 2006
Research doesn't stop just because researchers deploy, Fort Detrick Standard, Jan 19, 2006
"…Doing research in a combat theater isn't a novel idea; in fact, it's been done since World War I, the colonel said. What has changed since those research studies were conducted, however, is the regulatory environment overseeing research…Lt. Col. Jennifer Thompson of the Walter Reed Army Institute of Research's institutional review board did deploy to Iraq, namely to the 44th Medical Command, from June to October 2005 to set up a process for researchers to have their protocols reviewed…"
Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report, Institute of Medicine Committee on Clinical Trial Registries, Jan 18, 2006
"…The discussions at the workshop centered on the following five concepts: The purposes of a registry; Inclusion or exclusion of exploratory trials; The need for a delayed disclosure mechanism for certain fields in the registry at the time of trial initiation (hypothesis statement, primary and secondary outcome measures, and projected year of trial completion); The timing and format for reporting results of completed trials; and The appropriate roles for Institutional Review Boards, the FDA, and others in ensuring compliance…"
Institutional Review Boards: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Board Reviews; Withdrawal, Food and Drug Administration, Federal Register Vol 71, Page 2493-2494, Jan 17, 2006
"…Based on these reasons, FDA concluded that IRB shopping either does not occur or does not present a problem to an extent that would warrant rulemaking at this time…"
 
Week of January 9, 2006
FDA rules expand human drug testing, Seattle Times, Jan 13, 2006
"Concerned that too few new drugs are reaching the market and that too much time is spent testing those that don't win approval, the Food and Drug Administration (FDA) on Thursday announced rules for human testing intended to make effective drugs available to the public sooner and possibly more cheaply…"
FDA Issues Advice to Make Earliest Stages Of Clinical Drug Development More Efficient, FDA News, Jan 12, 2006
"…In guidance documents released today, Exploratory IND Studies and INDs—Approaches to Complying with CGMP During Phase 1, the FDA lays out specific approaches for researchers who are planning to conduct very early clinical studies in people and offers approaches for performing appropriate safety testing and producing small amounts of drugs safely…"
Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, Center for Drug Evaluation and Research, FDA, January 2006
Guidance for Industry: INDs — Approaches to Complying with CGMP During Phase 1, Center for Drug Evaluation and Research, FDA, January 2006
Nepal questions US Army vaccine experiments, ISN, Switzerland, Jan 12, 2006
"As US pharmaceutical company GlaxoKlineSmith announces that its new hepatitis vaccine has been found 96 per cent effective, medical researchers are questioning whether the vaccine experiments, conducted on 2,000 Nepalese soldiers from 2001 to 2003, were ethical…"
U.S. Military Sponsored Vaccine Trials and La Resistance in Nepal, Andrews, American Journal of Bioethics 5, May-June 2005
Sounding Board: Reform of Drug Regulation — Beyond an Independent Drug-Safety Board, Ray and Stein, New England Journal of Medicine 354:194-201, Jan 12, 2006 (extract freely available)
Scientists praise new UK ethics code, The Scientist, UK, Jan 10, 2006
"A new ethical code which sets out the values and responsibilities of all scientists will be launched later this year, the British government said this week…"
Report: Universal Ethical Code for Scientists, Council for Science and Technology, UK, Jan 6, 2006
S.Korean scientists faked two papers, Boston Globe, Jan 9, 2006
"A team led by a once-heralded and now disgraced South Korean scientist faked two landmark papers on embryonic stem cells but did produce the world's first cloned dog, an investigation panel said on Tuesday…"
 
Week of January 2, 2006
Report: Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials, American Association of Medical Colleges, Jan 6, 2006 (pdf file)
"…The following principles should apply to all clinical trials conducted in academic medial institutions regardless of the source of funding…"
Expiration of Federalwide Assurances, Office for Human Research Protections (OHRP), Jan 5, 2006
"…Any institution requiring an FWA that has not obtained an OHRP-approved renewal to its FWA prior to the expiration date will no longer be covered by an OHRP-approved assurance of compliance. Therefore, any ongoing human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS) at your institution that is not exempt will need to be suspended until your institution submits, and OHRP approves, an FWA renewal…OHRP strongly encourages you to use the Electronic Submission System (ESS) to update/renew an FWA. The ESS may also be used to submit new and update/renewal IRB registrations…"
Environmental Protection Agency Request for Nominations for a Human Studies Review Board, Federal Register Vol 71, Page 116-118, Jan 3, 2006 (nominations due by Feb 2, 2006)
"The U.S. Environmental Protection Agency (EPA or Agency) Office of the Science Advisor (OSA) is soliciting nominations of qualified individuals to serve on a proposed Human Studies Review Board (HSRB). The Agency anticipates establishment of such a board to provide advice and recommendations on issues related to the scientific and ethical review of human subjects research…"
Ethical frontier: Research on the dead, Chicago Sun-Times, Jan 3, 2006 (no longer available)
"Medical researchers are expressing a growing interest in studying a surprising population of subjects -- dead people. Researchers say they can test new drugs, medical devices and surgical procedures on people who have just died…"
Ethics guidelines for research with the recently dead, Pentz et al. Nature Medicine 11, 1145 – 1149, November 2005 (extract freely available)
Superfluous Medical Studies Called Into Question, Washington Post, Jan 2, 2006 (free one time registration required)
"…one of medicine's most overlooked problems is the fact that some questions keep being asked over and over. Repeated tests of the same diagnostic study or treatment are a waste -- of time and money, and of volunteers' trust and self-sacrifice. Unnecessary clinical trials may also cost lives…"
Editorial Retraction: Jung and Hyun, Oocyte and somatic cell procurement for stem cell research: The South Korean experience, American Journal of Bioethics 6: W19-W22, January/February 2006
Patient-Centered Informed Consent in Surgical Practice, Bernat and Peterson, Archives of Surgery 141:86-92, January 2006 (abstract freely available)
 

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