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News In Research With Human Subjects for 2007
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Week of December 24, 2007
Op-Ed: A Lifesaving Checklist, New York Times, Dec 30, 2007 (free one time registration required)
"In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case…"
 
Week of December 17, 2007
Blood experiment disproportionate, Detroit Free Press, Dec 21, 2007
"A controversial clinical trial in which hundreds of people were unknowingly injected with an experimental blood substitute primarily took place in cities with a disproportionate number of minorities, including Detroit…"
Notice of Change in Access to OHRP FAQs, US Office for Human Research Protections, Dec 19, 2007
"The content of OHRP’s FAQs has not changed, but the access and appearance of the FAQs has been altered. The FAQs previously were available through a software system that allowed retrieval of individual FAQs. A recent transition from that software system makes the FAQs available in sets by category, in HTML format or as PDF format documents. The FAQ categories include: Assurances (FWAs); IRB Registration; 45 CFR 46; Research with Children; Investigator Responsibilities; Prisoner Research; and Informed Consent…"
 
Week of December 10, 2007
Face-Transplant Patient 'Satisfied', Washington Post, Dec 13, 2007 (free one time registration required)
"…although some experts remain uncomfortable with the experiment, including its lack of psychological follow-up, some who were initially critical of the attempt said they are impressed…a disturbing pattern with tests of new surgical techniques, said Karen Maschke of the Hastings Center…Instead of running them as medical experiments, with careful collection of data, they are promulgated as "innovations," often without proper consent in advance or analysis after, she said…"
Outcomes 18 Months after the First Human Partial Face Transplantation, Dubernard et al., New England Journal of Medicine 357: 2451-2460, Dec 13, 2007 (full article freely available)
Outcomes 18 Months after the First Human Partial Face Transplantation, Dubernard et al., New England Journal of Medicine 357: 2451-2460, Dec 13, 2007 (full article freely available)
Widows' VA suit thrown out, Albany Times Union, Dec 11, 2007
"…U.S. District Court Senior Judge Thomas J. McAvoy cited the fact there is no proof the veterans, all of whom were terminally ill cancer patients, had died prematurely or endured added pain and suffering as a result of being fraudulently enrolled in studies designed to test drugs for marketability…"
Press Release: 2007 Human Research Protection Award Recipients Announced, PR Newswire, Dec 10, 2007
"Winners of the 2007 Award for Excellence in Human Research Protection were announced today…"
 
Week of December 3, 2007
Court papers detail dark chapter at VA, Albany Times Union, Dec 9, 2007
"…New information surfaced last month in hundreds of pages of depositions and internal reports filed in a lawsuit by several widows of veterans who died after enrolling in Stratton's drug studies, providing a spotlight on a government research program that had spiraled out of control…"
Coercion used on patient, family says, Albany Times Union, Dec 9, 2007
"…The family claims a former research physician at Stratton hospital, Dr. James A. Holland, "coerced" Merritt into joining a drug study against his will. Their account is supported by Holland's former staffers, who testified that Holland encouraged research assistants to enroll as many veterans as possible in drug experiments…"
Pa. inmate recounts 'guinea pig' tests, Courier Post Online, Dec 3, 2007
"As an inmate test subject for medical experiments being conducted at Holmesburg State Prison, Edward "Butch" Anthony says he had mysterious substances dabbed on his skin and injected in his veins…"
 
Week of November 26, 2007
The stem cell debate continues: the buying and selling of eggs for research, Baylis and McLeod, Journal of Medical Ethics 33: 726-731, Dec 2007 (extract freely available)
Ethics committees and the legality of research, Douglas, Journal of Medical Ethics 33: 732-736, Dec 2007 (abstract freely available)
US Office of Research Integrity Newsletter, ORI, Dec 2007 (pdf)
2008 Edition International Compilation of Human Research Protections, US Office for Human Research Protections (OHRP), Dec 2007 (pdf)
"This Compilation lists the approximately 900 laws, regulations, and guidelines that govern human subjects research in 84 countries, as well as from a number of international and regional organizations. This Compilation was developed for IRBs/Ethics Committees, researchers, sponsors 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 those standards are followed appropriately. This year’s Compilation features a new section on research standards for Embryos, Stem Cells, and Cloning. The 2008 Edition includes numerous updates to the 2007 Edition…"
Research Participants' Perceptions of the Certificate of Confidentiality's Assurances and Limitations, Catania et al., Journal of Empirical Research on Human Research Ethics 2: 53-59, Dec 2007 (abstract freely available)
The Reporting of Monetary Compensation in Research Articles, Klitzman et al., Journal of Empirical Research on Human Research Ethics 2: 61-67, Dec 2007 (abstract freely available)
Education Level, Primary Language, and Comprehension of the Informed Consent Process, Breese ?et al., Journal of Empirical Research on Human Research Ethics 2: 69-79, Dec 2007 (abstract freely available)
The Impact of Minor Adverse Event Tracking on Subject Safety: A Web-Based System, Shenvi and Gebhart, Journal of Empirical Research on Human Research Ethics 2: 81-91, Dec 2007 (abstract freely available)
Guide to Researching Human Research Subjects Laws in West Africa, Szabó and Britt, Journal of Empirical Research on Human Research Ethics 2: 93-105, Dec 2007 (abstract freely available)
Questions, Anger and Dissent on Ethics Study, Inside Higher Ed, Nov 30, 2007
"Can an association urge its members to apply the principle of “do no harm” in research when there isn’t much agreement on what “harm” is? Is “doing less harm” a moral standard worthy of consideration or a cop out?…Those were among the issues considered Thursday when the rank and file of the American Anthropological Association had a first chance to question members of a panel that on Wednesday evening released a report on the issues raised by doing anthropological research for the military or security agencies…"
CAREB response to the Sponsors’ Table for Human Research Participant Protection in Canada consultation process on its Experts Committee report entitled “Moving Ahead”, Canadian Association of Research Ethics Boards, Nov 30, 2007 (word document)
Ethics and Engagement With the Military, Inside Higher Ed, Nov 29, 2007
"A special panel of the American Anthropological Association…studying the question of whether its ethical standards should bar ties to the military and intelligence agencies, issued a report Wednesday that recommended tighter scrutiny of such work, but explicitly affirmed the possibility that it could be conducted ethically in some cases…The panel urged that the standards of informed consent should be changed to “develop specific language regarding work with vulnerable populations and contexts in which consent may not be free, voluntary, or non-coerced…"
Report: Ad Hoc Commission on the Engagement of Anthropology with Security and Intelligence Communities, American Anthropological Association, Nov 28, 2007 (full report and appendices freely available)
Clinical Trials and Medical Care: Defining the Therapeutic Misconception, Henderson et al., PLoS Medicine 4(11): e324, Nov 27, 2007 (full article freely available)
Targeted Genetics restarts trial after woman's death, Seattle Times, Nov 26, 2007
"The U.S. Food and Drug Administration has allowed Targeted Genetics to restart its gene-therapy trial for rheumatoid arthritis after an investigation indicated the treatment did not contribute to the death of an Illinois woman in July…"
 
Week of November 19, 2007
A Gap in Knowledge About Kids, Medication, Washington Post, Nov 23, 2007 (free one time registration required)
"…The alarming gap in medical knowledge is the legacy of many factors. The testing of drugs in children was shunned for decades as unnecessary and unethical; Congress and the pharmaceutical industry did not provide adequate funding; and conducting medical experiments on children is difficult…"
Response to the Draft Report of the Experts Committee for Human Research Participant Protection in Canada, Interagency Advisory Panel on Research Ethics (PRE), Nov 22, 2007, posted online Dec 2007 (pdf)
Spread of illegal devices causes alarm, Seattle Times, Nov 21, 2007
"U.S. Rep. Jay Inslee on Tuesday called for a congressional investigation into medical-device manufacturers and operators who use unproven "energy medicine" machines to exploit patients…Inslee said Congress should determine whether the FDA has adequate resources to oversee the institutional review boards (IRBs) that govern clinical studies for devices. Inslee wants the FDA to prevent "IRB shopping," in which a device maker can hire a private overseer for a study…"
WMA starts process for revising Helsinki Declaration, World Medical Association, Nov 20, 2007 (comments on revisions due Feb 25, 2008)
"…being proposed are ideas for providing extra protection for participants in medical research and a new provision making it clear that the well-being of the individual should take precedence over the interests of the sponsors of research as well as those of science and society. Other changes suggested relate to the treatment of participants who suffer injury as a result of research interventions, the ability of the public to access a register of all clinical trials and the need for populations that have previously been underrepresented in medical research, such as children and pregnant women, to be provided equitable access to participation in research…"
World Medical Association Declaration of Helsinki Web Page
Public never warned about dangerous device, Seattle Times, Nov 19, 2007
"…sold the machines to scores of practitioners in the United States who used them to exploit patients. They avoided detection by taking advantage of federal regulations that allow them to operate on an honor system in clinical studies…"The approval of the IRB study was a means to sell more machines," she said…"
PAP-IMI fan sought military study, Seattle Times, Nov 19, 2007
"…Berkley Bedell, a former U.S. congressman…came up with a plan to validate the machine for use on U.S. soldiers in one of Samueli Institute's government-funded clinical studies. But after an FDA investigation linked injuries and death to the device, Bedell reluctantly dropped his support of the PAP-IMI…"We're scared to death of the conventional medical community, FDA and so on," Bedell said. "We're doing our work mostly offshore. We're quite anxious to keep under the radar screen until we have things adequately documented…"
Subjects are grown, but still her 'kids', Boston Globe, Nov 19, 2007
"…As the head of one of the longest-running mental health projects in the country, the Simmons Longitudinal Study, she has used her kids to compile a repository of important statistics on human emotional development. But Reinherz, who is 84 with a regal bearing, has never let her position as a research scientist overshadow her natural empathy as a human…"
 
Week of November 12, 2007
Primed by civilians, troops become test subjects, Seattle Times, Nov 18, 2007
"During the past two years, injured Marines at Camp Pendleton near San Diego have been used as unwitting test subjects for an unproven energy-medicine device. Troops were not given a choice about being treated by the InterX 5000, a handheld device purported by its manufacturer to reduce pain by using electrical frequencies. Micah Allison, an athletic-trainer intern involved in the treatments, said she tried to downplay to the troops that the device was experimental…"
Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration, National Institutes of Health (NIH), Nov 16, 2007
"…Public Law 110-85, which was enacted on September 27, 2007 amends the Public Health Service Act to expand the scope of clinical trials that must be registered in ClinicalTrials.gov. It also increases the number of registration fields that must be submitted, requires certain results information to be included and sets penalties for noncompliance. This notice provides information for NIH grantees and contractors on new responsibilities related to the first part of the law, the registration of clinical trials…"
Secretary's Advisory Committee for Human Research Protections (SACHRP) Oct 29-30, 2007 Meeting Materials, Office for Human Research Protections (OHRP), Nov 15, 2007 (meeting agenda, presentation materials, transcripts)
Volunteers to be told who got HIV vaccine, Seattle Times, Nov 14, 2007
"Volunteers in a failed worldwide AIDS-vaccine study headed by Seattle researchers will be told whether they were given the experimental vaccine — and may face a higher risk of getting HIV than those who got a placebo…"
Influence of the HIPAA Privacy Rule on Health Research, Ness; for the Joint Policy Committee, Societies of Epidemiology, Journal of the American Medical Association 298: 2164-2170, Nov 14, 2007 (abstract freely available)
Editorial: The Dysregulation of Human Subjects Research, Fost and Levine, Journal of the American Medical Association 298: 2196-2198, Nov 14, 2007 (extract freely available)
Too much privacy? U.S. law makes research harder, Reuters, Nov 13, 2007 (for JAMA article and editorial referenced herein, see Journal Articles below; this article scheduled to be freely available until Dec 12, 2007)
"U.S. privacy laws designed to protect patients' health information have had the unintended effect of impeding scientific research, stalling clinical studies and halting others altogether, U.S. researchers said on Tuesday…"
 
Week of November 5, 2007
AIDS trial subjects react to news of heightened infection risk, Seattle Post-Intelligencer, Nov 9, 2007
"Volunteers in the Seattle arm of an international AIDS vaccine clinical trial recently halted because of safety concerns have decidedly mixed feelings about participating…"
Army’s Aggressive Surgeon Is Too Aggressive for Some, New York Times, Nov 6, 2007 (free one time registration required)
"…trauma research can involve trying novel treatments on severely injured patients who cannot give informed consent. But he argues that any ethical problems pale in comparison to the toll that traumatic injuries take on civilians and soldiers every day…"
U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS, Secretary's Advisory Committee on Genetics, Health and Society (SACGHS), Nov 5, 2007 (comments due by Dec 21, 2007)
"The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is seeking public comment on a draft report to the Secretary of Health and Human Services (HHS) on the oversight of genetic testing…"
 
Week of October 29, 2007
Ethical and policy issues relating to progenitor-cell-based strategies for prevention of atherosclerosis, Liao et al., Journal of Medical Ethics 33: 643-646, Nov 1, 2007 (abstract freely available)
The need for additional safeguards in the informed consent process in schizophrenia research, Anderson and Mukherjee, Journal of Medical Ethics 33: 647-650, Nov 1, 2007 (abstract freely available)
Efficiency and the proposed reforms to the NHS research ethics system, Hunter, Journal of Medical Ethics 33: 651-654, Nov 1, 2007 (abstract freely available)
Children, Gillick competency and consent for involvement in research, Hunter and Pierscionek, Journal of Medical Ethics 33: 659-662, Nov 1, 2007 (abstract freely available)
Maintaining Informed Consent Validity during Lengthy Research Protocols, Prentice et al., IRB 29: 1-6, Nov/Dec 2007 (no longer available)
Participants Left Uninformed in Some Halted Medical Trials, New York Times, Oct 30, 2007 (free one time registration required)
"…some patients in clinical studies never learn about test results. The problem may be particularly relevant to those implanted with medical devices that stay with them long after a trial is over…"
 
Week of October 22, 2007
Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review Procedure, US Office for Human Research Protections (OHRP), Oct 26, 2007 (written or electronic comments due Dec 26, 2007)
"The Office for Human Research Protections (OHRP) is requesting written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998…OHRP is proposing to amend expedited review category 5 to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research. Expedited review category 5 also includes research involving materials that will be collected solely for nonresearch purposes. In addition, OHRP is requesting comments on the entire expedited review list that was last published in the Federal Register on November 9, 1998 to determine if other changes are needed…"
Warning Is Sent to AIDS Vaccine Volunteers, Washington Post, Oct 25, 2007 (free one time registration required)
"South African AIDS researchers have begun warning hundreds of volunteers that a highly touted experimental vaccine they received in recent months might make them more, not less, likely to contract HIV in the midst of one of the world's most rampant epidemics…The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine…"
'Identical Strangers' Explore Nature Vs. Nurture, NPR, Oct 25, 2007
"…Unknowingly, Bernstein and Schein had been part of a secret research project in the 1960s and '70s that separated identical twins as infants and followed their development in a one-of-a-kind experiment to assess the influence of nature vs. nurture in child development…Neither parents nor children knew the real subject of the study — or that the children had been separated from their identical twin…"
Are IRB’s Needed for War Zones?, Inside Higher Ed, Oct 22, 2007
"…a kind of anthropology work involving human subjects that is apparently not being subjected to IRB review: work for the U.S. military in Afghanistan and Iraq. The analysis suggests that there is considerable confusion about whether IRB’s must review projects done by their professors who work for the military, and that there are no signs of such reviews taking place…"
Army Enlists Anthropology In War Zones, New York Times, Oct 5, 2007 (free one time registration required)
Request for Information (RFI): To Solicit Input and Ideas on Priorities in Basic Behavioral and Social Sciences Research, US National Institutes of Health (NIH), Oct 22, 2007 (responses due Nov 26, 2007)
 
Week of October 15, 2007
Institutional Academic–Industry Relationships, Campbell et al., Journal of the American Medical Association 298: 1779-1786, Oct 17, 2007 (abstract freely available)
Financial relationships between industry and medical schools, teaching hospitals highly prevalent, Eurekalert, Oct 16, 2007
"In a national survey of department chairs at medical schools and teaching hospitals, more than half report relationships with industry, including receiving financial and in-kind support, according to a study in the October 17 issue of JAMA. The authors suggest that these findings underscore the need for the disclosure and management of these relationships…"
Institutional Academic–Industry Relationships, Campbell et al., Journal of the American Medical Association 298: 1779-1786, Oct 17, 2007 (abstract freely available)
Research on Research Integrity (R21) Exploratory/Developmental Grant Program Announcement, US Office of Research Integrity (ORI), updated Oct 15, 2007 (applications due Dec 11, 2007)
Research on Research Integrity (R03) Small Grant Program Announcement, US Office of Research Integrity (ORI), updated Oct 15, 2007 (applications due Dec 11, 2007)
 
Week of October 8, 2007
New FDA drug center raises ethical questions, MSNBC, Oct 14, 2007
"The Food and Drug Administration is moving with unprecedented speed to launch a drug research center to be paid for by companies it regulates…It’s an ambitious undertaking that puts regulators and companies in a relationship unlike that of any other industry…"
Partners in Research Program (R03), US National Institutes of Health (NIH), Oct 2007 (letters of intent due Dec 12, 2007; applications due Jan 11, 2008)
"This funding opportunity announcement (FOA) solicits research grant applications from academic/scientific institutions and community organizations that propose to forge partnerships (1) to study methods and strategies to engage and inform the public regarding health science in order to improve public understanding of the methods and benefits of publicly funded research, and (2) to increase scientists’ understanding of and outreach to the public in their research efforts…"
States and V.A. at Odds on Cancer Data, New York Times, Oct 10, 2007 (free one time registration required)
"…While other hospitals are required by state laws to submit data, Veterans Affairs hospitals are not. And now, for the first time, veterans hospitals have stopped providing information on their cancer patients. The concern, the Veterans Affairs Department says, is protecting patient privacy…"
How Data on Cancer Are Collected and Used, New York Times, Oct 10, 2007 (free one time registration required)
"Every state has a law requiring it to have a cancer surveillance program and collect specific information about every patient whose cancer was diagnosed by a doctor in that state. Although most patients are not aware of the programs, doctors and hospitals are…"
Data sharing threatens privacy. Analyses of personal information raise spectre of Big Brother, Butler, Nature 449: 644-645, Oct 10, 2007 (extract freely available)
 
Week of October 1, 2007
Commercializing Clinical Trials - Risks and Benefits of the CRO Boom, Shuchman, New England Journal of Medicine 357: 1365-1368, Oct 4, 2007 (extract freely available)
Ethical Review of Interpretive Research: Problems and Solutions, Jacobson et al. 29: 1-8, IRB, Oct 1, 2007 (no longer available)
SOUTH AFRICA: Microbicide trials - what's in it for participants?, IRIN Plus News (United Nations), Oct 2007
"…The challenge for scientists is to design trials that have sufficiently attractive benefits to recruit and retain participants, without offering what ethics committees would deem incentives or inducements…"
EPA's 2006 Human-Subjects Rule for Pesticide Experiments, Shrader-Frechette, Accountability in Research 14: 211 - 254, Oct 2007 (abstract freely available)
Offering Results to Research Subjects: U.S. Institutional Review Board Policy, Kozanczyn et al., Accountability in Research 14: 255 - 267, Oct 2007 (abstract freely available)
 
Week of September 24, 2007
The Food and Drug Administration's Oversight of Clinical Trials, US Dept Health and Human Services Office of the Inspector General, Sep 28, 2007 (pdf)
Report Assails F.D.A. Oversight of Clinical Trials, New York Times, Sep 28, 2007 (free one time registration required)
"…federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed…"
The Food and Drug Administration's Oversight of Clinical Trials, US Dept Health and Human Services Office of the Inspector General, Sep 28, 2007 (pdf)
Trial would give users legal substitute drugs, Vancouver Sun, Sep 27, 2007
"…A Vancouver research team will put in a request this week to run Canada's first trial in giving legal substitute drugs to cocaine and crystal-meth users…"
Gene information opens new frontier in privacy debate, Boston Globe, Sep 24, 2007
"…But will people be able to keep their genetic information to themselves? That may depend if an individual is, at any given time, a research subject, patient, employee, insurance recipient, or customer. The same information could be subject to different principles in different circumstances…"
 
Week of September 17, 2007
Call for Comments: Refinements to the Continuing Research Ethics Review in the TCPS, Interagency Advisory Panel on Research Ethics (PRE), Canada, Sep 19, 2007 (comments due by Nov 19, 2007)
"…The Paper contains preliminary discussions and some draft proposals that clarify some areas and address others not yet considered on the topic of continuing ethics review (CER) in the TCPS. It addresses the concept, goals, and scope of CER, related operational issues, as well the roles and responsibilities of those involved in applying the CER process…"
Role of Gene Therapy In Death Called Unclear, Washington Post, Sep 18, 2007 (free one time registration required)
"Postmortem tests on an Illinois woman who died mysteriously in July after getting an experimental gene treatment show no evidence that she was killed directly by the genetically altered viruses she was given, a committee of experts was told yesterday. But many questions remain, and further tests will have to be done to see if the treatment somehow contributed to her death…Some panelists echoed Robb Mohr's concerns about the way his wife was signed up for the study…"
Appointment of New Chair and Members, Interagency Advisory Panel on Research Ethics, Canada, Sep 18, 2007
 
Week of September 10, 2007
McGill study offers users free cocaine, National Post, Sep 16, 2007
"Human guinea pigs in an unusual McGill University study are being given cocaine for free so researchers can chart the effects of the highly addictive drug on the brain with hopes of finding ways to curb strong cravings…"
Bribery, confusion delay medical advances, doctor says, Vancouver Sun, Sep 11, 2007 (see below for PLoS articles referred to in this report)
"Government bribes and misunderstandings that can halt drug trials and may lead to unsafe sex are among the many pitfalls of doing research in developing countries, says a Canadian-led ethics team advising one of the world's richest couples…"
Grand Challenges in Global Health: The Ethical, Social and Cultural Program, Singer et al., PLoS Med 4: e265, Sep 11, 2007 (full article freely available)
Grand Challenges in Global Health: Ethical, Social, and Cultural Issues Based on Key Informant Perspectives, Berndtson et al., PLoS Medicine 4: e268, Sep 11, 2007 (full article freely available)
Grand Challenges in Global Health: Community Engagement in Research in Developing Countries, Bhan et al., PLoS Medicine 4: e272, Sep 11, 2007 (full article freely available)
Grand Challenges in Global Health: Community Engagement in Research in Developing Countries, Tindana et al., PLoS Medicine 4: e273, Sep 11, 2007 (full article freely available)
 
Week of September 3, 2007
Boston Scientific cited by FDA for procedures, Boston Globe, Sep 8, 2007
"…The FDA cited the company for failure to immediately follow up on several deaths to see whether there was any relationship between the deaths and the device. The company also allegedly failed to promptly notify regulators after at least two dozen of the stents fractured, and failed to provide clinical investigators with all the information they needed to look into any problems with patients, the FDA said…"
NIH genetic database "a good start", The Scientist, Sep 6, 2007
"Researchers say the new NIH policy announced last week for sharing data from genome-wide association studies will increase interest in studies linking genotypes to diseases while securing the anonymity of study participants…Institutions will need new consent procedures to inform subjects that their genetic data will be available not just to the researchers conducting a study, but to other members of the scientific community who apply for access, and potentially to law enforcement officials and insurance companies…"
Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity, Federal Register 72: 50966-50970, US Office for Human Research Protections (OHRP), Sep 5, 2007 (comments due by Dec 4, 2007)
"The Office for Human Research Protections (OHRP), Office of Public Health and Science, is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research…"
 
Week of August 27, 2007
Improving Disclosure and Consent: "Is It Safe?": New Ethics for Reporting Personal Exposures to Environmental Chemicals, Brody et al., American Journal of Public Health 97: 1547-1554, Sept 1, 2007 (abstract freely available)
The three official language versions of the Declaration of Helsinki: what’s lost in translation?, Carlson et al., Journal of Medical Ethics 33: 545-548, Sep 2007 (abstract freely available)
Attitudes of research ethics board chairs towards disclosure of research results to participants: results of a national survey, MacNeil and Fernandez, Journal of Medical Ethics 33: 549-553, Sep 2007 (abstract freely available)
The History, Purpose, and Future of Instruction in the Responsible Conduct of Research, Steneck and Bulger, Academic Medicine 82: 829-834, Sep 2007 (full article freely available)
US Office of Research Integrity Newsletter, ORI, Sep 2007 (pdf)
Questioning the Need for Informed Consent: A Case Study of California's Experience with a Pilot Newborn Screening Research Project, Feuchtbaum et al., Journal of Empirical Research on Human Research Ethics 2: 3-14, Sep 2007 (abstract freely available)
Cancer Patients' Attitudes Toward Future Research Uses of Stored Human Biological Materials, Helft et al., Journal of Empirical Research on Human Research Ethics 2: 15-22., Sep 2007 (abstract freely available)
Ethics Committee Experience with Emergency Exception from Informed Consent Protocols, DeIorio et al., Journal of Empirical Research on Human Research Ethics 2: 23-30, Sep 2007 (abstract freely available)
Respondent Reactions to Sensitive Questions, Fendrich et al., Journal of Empirical Research on Human Research Ethics 2: 31-37, Sep 2007 (abstract freely available)
Two Methods of Obtaining Informed Consent in a Genetic Epidemiological Study: Effects on Understanding, Matsui et al., Journal of Empirical Research on Human Research Ethics 2: 39-48, Sep 2007 (abstract freely available)
Debriefing in Deceptive Research: A Proposed New Procedure, Oczak and Niedzwienska, Journal of Empirical Research on Human Research Ethics 2: 49-59, Sep 2007 (abstract freely available)
Perceptions of Stress Among Students Participating in Psychology Research: A Canadian Survey, Flagel et al., Journal of Empirical Research on Human Research Ethics 2: 61-67, Sep 2007 (abstract freely available)
Effects of Human Subjects Requirements on Classroom Research: Multidisciplinary Evidence, Lopus et al., Journal of Empirical Research on Human Research Ethics 2: 69-78, Sep 2007 (abstract freely available)
REB Community Member Educational Needs: A PRE Pilot Project Report, Standing Committee on Education, Interagency Advisory Panel on Research Ethics (PRE), Canada, Sep 2007 (pdf)
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), Federal Register 72: 49290-49297, Aug 28, 2007
"…The potential for public benefit to be achieved through sharing GWAS data is significant. However, genotype and phenotype information generated about individuals…may be sensitive. Therefore, protecting the privacy of the research participants and the confidentiality of their data is critically important. Risks to individuals, groups, or communities should be balanced carefully with potential benefits of the knowledge to be gained through GWAS. The sensitive nature of GWAS information about participants and the broad data distribution goals of the NIH GWAS data repository highlight the importance of the informed consent process to this research…"
 
Week of August 20, 2007
International Trials Seen as Challenge for Patient Protection, FDA News, Aug 23, 2007
"In an exclusive interview on the eve of his retirement, Schwetz listed the increase in international trials as one of the major human research protection challenges his successor will face…The next OHRP director should also keep trying to focus on clinical investigators, Schwetz said. "…OHRP was traditionally and naturally connected to the IRB [institutional review board] community, but the greatest risk to subjects is at the hands of investigators.”…"
 
Week of August 13, 2007
Fungus Infected Woman Who Died After Gene Therapy, Washington Post, Aug 17, 2007 (free one time registration required)
"The 36-year-old Illinois woman who died last month after being treated with an experimental gene therapy was infected with a fungus that usually causes only a mild illness. But the infection spun out of control and ravaged her organs, suggesting that her immune system was seriously impaired…"
Iowa to pay subjects $925K for stuttering study, MSNBC, Aug 17, 2007
"The state has agreed to pay $925,000 to unwitting subjects of an infamous 1930s stuttering experiment — orphans who were badgered and belittled as children by University of Iowa researchers trying to induce speech impediments…"
Secretary's Advisory Committee for Human Research Protections (SACHRP) July 30-31, 2007 Meeting Materials, Office for Human Research Protections (OHRP), Aug 15, 2007 (meeting agenda, presentation materials, transcripts)
Call for Comments: "Moving Ahead", Draft Report of the Experts Committee for Human Research Participant Protection in Canada, Sponsors' Table for Human Research Participant Protection in Canada, Aug 15, 2007 (pdf, comments due by Nov 30, 2007)
"The Sponsors' Table for Human Research Participant Protection in Canada is a group of organizations that shares a common interest in promoting research involving humans that meets the highest standards in excellence and ethics…Part of the Sponsors' Table process included the establishment of an Experts Committee to provide independent analysis and recommendations…have now submitted a draft report. Before the Sponsors' Table organizations formally consider the contents and recommendations of the Experts Committee's report, they wish to consult with each members' constituent groups and/or stakeholders and other interested parties on its content as well as on other pertinent issues…"
Web Site of the Sponsors' Table for Human Research Participant Protection in Canada, accessed Oct 3, 2007
Who’s Afraid of Incestuous Gay Monkey Sex?, Inside Higher Ed, Aug 14, 2007
"…some of their colleagues may feel enough heat right now that they are avoiding certain topics or are being forced to compromise on either the language or substance of their research. The problems come from a variety of sources, the scholars here said: from politicians, from institutional review boards on their own campuses, and from too narrow a definition of what “good science” may be…"
Institutional Review Boards Should Require Clinical Trial Registration, Levin and Palmer, Archives of Internal Medicine 167: 1576-1580, Aug 13/27, 2007 (extract freely available)
 
Week of August 6, 2007
Pfizer Facing 4 Court Cases in Nigeria, Washington Post, Aug 11, 2007 (free one time registration required)
"…New York-based Pfizer is facing four court cases…over a decade-old drug study…The fallout provides a case study of the ethical dilemmas that arise when Western medical priorities run into Third World poverty and ignorance…"
South Africa: HIV Trial Gets Long-Awaited Go Ahead, AllAfrica.com, Aug 10, 2007 (registration required to access archives)
"A clinical trial investigating ways to prevent newborns from contracting HIV through breast milk is set to proceed in South Africa, following a court judgement overruling the apparent reluctance of the country's drugs regulators to let the trial go ahead. South Africa's Medicines Control Council (MCC) finally approved the trial last week (30 July) after a protracted battle between the MCC and paediatric HIV/AIDS researchers that ended in court…"
Court won't bend drug rule for dying patients, Seattle Times, Aug 8, 2007
"Dying people do not have the right to obtain unapproved drugs that are potentially lifesaving, even if their doctors say the treatment offers the best hope for survival, a U.S. appeals court in Washington ruled Tuesday…"
Text of US Court of Appeals Decision, Aug 7, 2007 (pdf)
Committee Defines When Informed Consent May Be Waived, FDA News, Aug 8, 2007
"The Office of Human Research Protections (OHRP) should develop guidance for the institutional review boards (IRBs) that oversee research studies on human subjects to help them decide when to grant requests to alter or waive informed consent requirements, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended at its July 30-31 meeting…"
Targeted Genetics defends handling of fatal test case, Seattle Times, Aug 7, 2007
"As more details emerged about the recent death of a patient during a clinical trial conducted by Targeted Genetics of Seattle, the company Monday defended its handling of the case…"
Development of New Tuberculosis Vaccines: A Global Perspective on Regulatory Issues, Brennan et al., PLoS Medicine 4, Aug 7, 2007 (full article freely available)
Death Points to Risks in Research. One Woman's Experience in Gene Therapy Trial Highlights Weaknesses in the Patient Safety Net, Washington Post, Aug 6, 2007 (free one time registration required)
"…Jolee Mohr died from massive bleeding and organ failure July 24, leaving behind a 5-year-old daughter and a host of questions about why she was recruited into a gene therapy experiment whose chief goal was to test the safety of a novel arthritis treatment that had virtually no chance of helping her…Breaches of clinical research standards and a federal oversight system that allowed key decisions to be made behind closed doors may have helped draw Mohr into an experiment that was not, her husband says, what she thought it was…"
Scrutiny of Researcher-Industry Ties, Inside Higher Ed, Aug 6, 2007
"…Grassley…called for a national reporting system of drug company payments to doctors, which he said was essential to ensuring that patients might know about potential conflicts of interest for doctors who might prescribe medications — or researchers who might study the efficacy of such drugs…"
 
Week of July 30, 2007
US genetic privacy bill hits snag, New Scientist, Aug 4, 2007
"Attempts in the US to ban genetic discrimination in insurance and employment have hit a speed bump. After 12 years of political wrangling, the Genetic Information Nondiscrimination Act was poised to pass a Senate vote last week - until Oklahoma Republican senator Tom Coburn suddenly moved to block the bill…"
Conflict of Interest Toolkit, Federation of American Societies for Experimental Biology (FASEB), Aug 1, 2007
"Recommendations, tools, and resources for the conduct and management of financial relationships between academia and industry in biomedical research…"
Assessing research risks systematically: the net risks test, Wendler and Miller, Journal of Medical Ethics 33: 481-486, Aug 1, 2007 (abstract freely available)
Refuting the net risks test: a response to Wendler and Miller’s "Assessing research risks systematically", Weijer and Miller, Journal of Medical Ethics 33: 487-490, Aug 1, 2007 (abstract freely available)
 
Week of July 23, 2007
Suspended Gene Therapy Test Had Drawn Early Questions, Washington Post, Jul 28, 2007 (free one time registration required)
"A gene therapy experiment that has triggered a federal investigation after the death of a patient on Tuesday raised a variety of concerns when it was first proposed to federal reviewers in 2003…"
Alnylam succeeds in sickening subjects so it can test drug, Boston Globe, Jul 27, 2007
"…before Alnylam can test its drug, it needs a pool of guaranteed sick people -- which means it needs to create them…Such tests are unusual in medicine, but not unprecedented. In academic research, patients are sometimes infected with diseases as serious as malaria or cholera so that cures or vaccines can be tested reliably…"
Funding Opportunity: International Research Ethics Education and Curriculum Development Award (R25), Request For Applications (RFA) Number: RFA-TW-08-002, National Institutes of Health (NIH), US Department of Health and Human Services (DHHS), Jul 26, 2007 (Letters of Intent Receipt Date: November 14, 2007; Application Submission/Receipt Date: December 14, 2007)
"Purpose: To develop masters level curricula and provide educational opportunities for developing country academics, researchers and health professionals in ethics related to performing research involving human subjects in international resource poor settings…"
Health Canada Discussion Paper for Consultation: Investigational Testing of Medical Devices, Therapeutic Products Directorate, Jul 25, 2007 (comments due by Oct 25, 2007)
"Health Canada is pleased to share with you the following discussion paper on proposed changes to the regulatory framework for Investigational Testing of Medical Devices. Health Canada is considering the proposed changes as a means to better manage the risks related to the conduct of investigational testing of medical devices, and to support Health Canada's interest in applying a risk management approach that is consistent with the approaches applied by other regulators, including the regulatory framework that Health Canada applies for clinical trials of drugs…"
EU project publishes bioethics guidelines for nutrigenomics research, Cordis News, Jul 24, 2007
"The European Nutrigenomics Organisation (NuGO) has published a set of bioethics guidelines designed to help scientists undertaking nutrigenomics research using human subjects. Nutrigenomics is the study of how nutrients and genes interact and how genetic variations can cause people to respond differently to food nutrients…nutrigenomics also raises many ethical questions about the privacy aspects of personalised foods and diets, genetic testing and the potential high cost of new functional foods…"
NuGO Bioethics Guidelines Tool, Nutrigenomics Organisation, European Commission, Jul 2007 (guidelines freely available)
 
Week of July 16, 2007
School Conducts Anti-Phishing Research, Washington Post, Jul 22, 2007 (free one time registration required)
"…As universities nationwide study ways to protect online security, methods at Indiana are raising ethical and logistical questions for researchers elsewhere: Does one have to steal to understand stealing? Should study participants know they are being attacked as part of a study? Can controlled phishing ever mimic real life?…"
MMR scare doctor 'breached fundamental rules', The Guardian, UK, Jul 17, 2007
"Vulnerable children were subjected to "inappropriate and invasive" tests by a doctor who prompted one of the biggest health controversies of the past 10 years, it was alleged today…"
 
Week of July 9, 2007
HIV trial doomed by design, say critics, Nature, Jul 11, 2007 (no longer freely available)
"…The situation has caused leaders in the microbicide field to renew calls for better ways of reviewing and coordinating trial plans. Scientists in the field already share and discuss ideas and data through formal and informal meetings, but there is no mechanism for reviewing and disseminating plans for clinical trials…"
Decision Memo for Clinical Trial Policy (CAG-00071R), US Centers for Medicare and Medicaid Services, Jul 9, 2007
"…we are modifying this language to make clear that such items or services would be covered if they would be covered outside of the clinical research trial…Second, we are adopting the proposed addition of Coverage with Evidence Development…Finally, we are reopening a reconsideration of the clinical trial policy NCD and issuing a new proposed national coverage determination to define a clear path to continued payment for clinical trials…We also expect shortly to propose changes to the regulations that pertain to clinical trials and Medicare payment…"
 
Week of July 2, 2007
Should children have a say in own medical care?, Seattle Post-Intelligencer, Jul 8, 2007 (scheduled to be available until Jul 15, 2007)
"…Experts in pediatric bioethics fiercely debate how much control children should have over their own medical care, especially when it involves experimental treatments or research. At what age is a child old enough to understand what his options are? Do the rules change if it is an experimental treatment, not a research trial? What if the child doesn't have the mental capacity to participate in the decision about treatment?…"
 
Week of June 25, 2007
Ethics in studies on children and environmental health, Merlo et al., Journal of Medical Ethics 33: 408-413, Jul 1, 2007 (abstract freely available)
Participation in biomedical research is an imperfect moral duty: a response to John Harris, Shapshay and Pimple, Journal of Medical Ethics 33: 414-417, Jul 1, 2007 (abstract freely available)
A Case Study of Research Ethics Capacity Development in Africa, Hyder et al., Academic Medicine 82: 675-683, Jul 2007 (full article freely available)
Are Risks and Benefits of Oncological Research Protocols Both Incommensurable and Incompensable?, Musschenga et al., Accountability in Research 14: 179 - 196, Jul 2007 (abstract freely available)
Limited Relevance of the Right Not to Know - Reflections on a Screening Study, Helgesson et al., Accountability in Research 14: 197 - 209, Jul 2007 (abstract freely available)
Who Should Go First in Trials with Scarce Agents? The Views of Potential Participants, Pentz et al., IRB 29: 1-6, Jul-Aug 2007 (no longer available)
Updated Guidelines for Human Pluripotent Stem Cell Research, Canadian Institutes of Health Research, Jun 29, 2007
"Please note: these Updated Guidelines for Human Pluripotent Stem Cell Research supersede the June 2006 version…"
Compact versus Contract — Industry Sponsors' Obligations to Their Research Subjects, Mello and Joffe, New England Journal of Medicine 356: 2737-2743, Jun 28, 2007 (extract freely available)
'A bold gift' in a controversial field, Hamilton Spectator, Jun 28, 2007
"…The university is planning to use $15 million of this week's $50-million commitment from philanthropist David Braley to create Canada's first human embryonic stem cell library, a central repository of genetic data from embryonic stem cells that will be accessible to researchers at McMaster and around the world…"
Experimenting With the Mind, Washington Post, Jun 27, 2007 (free one time registration required)
"The CIA was eager to examine the use of dangerous pharmaceutical drugs to modify the behavior of targeted individuals, and so it asked commercial drug manufacturers to pass along samples of medicines rejected for commercial sale "because of unfavorable side effects," according to an undated memorandum included in dozens of CIA documents released today…drugs that showed promise…"were then tested at Edgewood, using volunteer members of the Armed Forces."…"
Probe Finds NIH Official Violated Government Regulations, Washington Post, Jun 27, 2007 (free one time registration required)
"A high-powered institute director at the National Institutes of Health disregarded conflict-of-interest guidelines by making decisions affecting the university where he was a faculty member, broke government spending rules, and raised concerns with his growing involvement as an expert witness in legal cases, according to sources within NIH and Congress and hundreds of pages of confidential documents…"
Letter to Center for Medicare and Medicaid Services (CMS) Regarding Clinical Research Policy, American Association of Medical Colleges (AAMC), Jun 27, 2007 (pdf)
"In advance of a July 9 deadline, the AAMC sent a second letter to the Centers for Medicare and Medicaid Services (CMS) regarding the agency's proposed Clinical Research Policy. The AAMC believes the policy would result in impediments to the enrollment of Medicare beneficiaries in clinical trials, and may put research institutions at risk for incorrect Medicare billing…"
UNAIDS Releases New Guidelines To Ensure Confidentiality of People Living With HIV/AIDS, Kaisernetwork.org, Jun 26, 2007
"…The guidelines…provide principles, definitions and technical recommendations to maintain confidentiality, privacy and security when working with HIV-related information…"
Interim Guidelines on Protecting the Confidentiality and Security of HIV Information, UNAIDS, May 15, 2007 (pdf)
 
Week of June 18, 2007
Be vigilant about data mining, The Coloradoan, Jun 22, 2007 (no longer available)
"Recently my daughter's elementary school brought in a community organization to conduct a health survey on our children. Parents were asked to complete a brief survey on diet and exercise and sign a permission slip authorizing the extraction of a blood sample to test for future heart problems. The parent authorization absolved the involved parties of all liability but this time neglected to fully disclose what would happen to the data mined from our children's bodies…"
Whose Blood Is It, Anyway?, Inside Higher Ed, Jun 21, 2007
"…U.S. Court of Appeals for the Eighth Circuit in Washington University v. William J. Catalona, a case watched closely by research universities across the country. In a ruling Wednesday, the court upheld a lower court’s decision and offered the first appellate level answer to the thorny question of where a research subject’s rights to a sample stop and institutional rights begin…"
President Bush Vetoes Stem Cell Research Enhancement Act, Issues Executive Order Encouraging Methods That Do Not Destroy Embryos, Kaisernetwork.org, Jun 21, 2007
"President Bush on Wednesday as expected vetoed a bill (S 5) that would have allowed federal funding for research using stem cells derived from human embryos originally created for fertility treatments and willingly donated by patients…Bush also issued an executive order to NIH asking scientists to pursue research on stem cells that "are derived without creating a human embryo for research purposes or destroying, discarding or subjecting to harm a human embryo or fetus,"…"
In the Amazon, Giving Blood but Getting Nothing, New York Times, Jun 20, 2007 (free one time registration required; scheduled to be freely available until Jun 26, 2007)
"As the Karitiana Indians remember it, the first researchers to draw their blood came here in the late 1970s, shortly after the Amazon tribe began sustained contact with the outside world. In 1996, another team visited, promising medicine if the Karitiana would just give more blood, so they dutifully lined up again…Now they have been enraged by a simple discovery: their blood and DNA collected during that first visit are being sold…"
Ethical Issues in Stopping Randomized Trials Early Because of Apparent Benefit, Mueller et al., Annals of Internal Medicine 146: 878-881, Jun 19, 2007 (abstract freely available)
Stopping at Nothing? Some Dilemmas of Data Monitoring in Clinical Trials, Goodman, Annals of Internal Medicine 146: 882-887, Jun 19, 2007 (abstract freely available)
Volunteers wanted for trip to 'Mars', CBC News, Jun 19, 2007
"The European Space Agency is looking for people who would like to go on a pretend trip to Mars — for about a year and a half. The 520-day experiment involves a crew of six living in sealed modules at the Institute of Biomedical Problems in Moscow…"
ESA seeks candidates for simulated 'Missions to Mars' in 2008/2009, European Space Agency (ESA), Jun 19, 2007
New OHRP Frequently Asked Questions and Answers on Informed Consent, Office for Human Research Protections (OHRP), Jun 18, 2007
"OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on informed consent. These FAQs provide guidance on OHRP’s current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required…"
 
Week of June 11, 2007
Boston's college kids: lab rats for hire, Monterey Herald, Jun 14, 2007 (no longer available)
"…Researchers here can tap into a pool of about a quarter-million college students to find willing participants for scientific studies. For some students, including Yochim, taking part can almost be a full-time summer job…"
Online Patient Groups Assist in Medical Research, Kaisernetwork.org, Jun 13, 2007
"Online patient groups -- which over the last decade have become an "increasingly powerful" source of information for patients and funds raised for medical research -- are "becoming invaluable partners to researchers and physicians searching for cures," the Wall Street Journal reports…"
 
Week of June 4, 2007
PRIM&R Comments to FDA on: Draft Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting, June 7, 2007, Public Responsibility in Medicine & Research, Jun 7, 2007 (pdf)
Testing Pesticides in Humans. Of Mice and Men Divided by Ten, Krimsky and Simoncelli, Journal of the American Medical Association 297: 2405-2407, Jun 6, 2007 (extract freely available)
Many people seek to "opt out" of no-consent medical studies, Seattle Times, Jun 6, 2007
"Local researchers testing experimental treatment on unconscious or gravely injured patients without their consent say they are overwhelmed by requests for "No Research Study" bracelets by people who do not wish to participate. A story in Sunday's Seattle Times outlined ethical concerns about two local studies that are part of a national test of experimental pre-hospital treatments on about 21,000 patients…"
Comments on FDA's Draft Guidance for Adverse Event Reporting, American Association of Medical Colleges (AAMC), Jun 6, 2007 (pdf)
US children's study escapes knife, Canadian Medical Association Journal, Jun 5, 2007
"A massive study of the genetic and environmental causes of illness in American children is set to begin recruiting subjects next year after a late cash infusion from the US Congress. The National Children's Study hopes to pinpoint causes of many diseases, including autism, asthma, diabetes and obesity, by tracking the health and environments of 100 000 children from the womb to their 21st birthdays…"
Clinical Trial Registration: Looking Back and Moving Ahead, Laine et al., New England Journal of Medicine, Jun 4, 2007 (early release; full article scheduled to be freely available until June 28, 2007)
 
Week of May 28, 2007
You may become medical guinea pig without knowing it, Seattle Times, Jun 3, 2007
"Suppose you happen to be in a serious car wreck. Or maybe you get shot or suffer cardiac arrest. If you live in King County, it might also mean that in that life-or-death moment, you will become part of an experiment - without your consent…The researchers say the experimental treatments are safe…But some experts in medical ethics find the situation troubling…"
After Sanctions, Doctors Get Drug Company Pay, New York Times, Jun 3, 2007 (free one time registration required; scheduled to be freely available until Jun 8, 2007)
"…Medical ethicists have long argued that doctors who give experimental medicines should be chosen with care…Yet Dr. Abuzzahab is far from the only doctor to have been disciplined or criticized by a medical board but later paid by drug makers…"
Scientific misconduct from the perspective of research coordinators: a national survey, Pryor et al., Journal of Medical Ethics 33: 365-369, Jun 1, 2007 (abstract freely available)
Third Party Risks in Research - Should IRBs Address Them?, Hausman, IRB 29: 1-5, May-Jun 2007 (free one time registration required; full article freely available)
US Office of Research Integrity Quarterly Newsletter, ORI, Jun 2007 (pdf)
Emerging Ethical Challenges in Advanced Neuroimaging Research: Review, Recommendations and Research Agenda, Racine and Illes, Journal of Empirical Research on Human Research Ethics 2: 1-10, Jun 2007 (abstract freely available)
Empirically Assessing Participant Perceptions of the Research Experience in a Randomized Clinical Trial: The Women's Self-Defense Project as a Case Example, Weitlauf et al., Journal of Empirical Research on Human Research Ethics 2: 11-24, Jun 2007 (abstract freely available)
Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?, Glass and Kaufert, Journal of Empirical Research on Human Research Ethics 2: 25-40, Jun 2007 (abstract freely available)
Applying Research Ethics Guidelines: The View from a Sub-Saharan Research Ethics Committee, Henderson et al., Journal of Empirical Research on Human Research Ethics 2: 41-48, Jun 2007 (abstract freely available)
Recommending Randomized Trials for Pediatric Leukemia: Observer and Physician Report of Recommendations, Hazen ?et al., Journal of Empirical Research on Human Research Ethics 2: 49-56, Jun 2007 (abstract freely available)
Reported Goals For Knowledge to be Learned in Responsible Conduct of Research Courses, Plemmons and Kalichman, Journal of Empirical Research on Human Research Ethics 2: 57-66, Jun 2007 (abstract freely available)
Pfizer Faces Criminal Charges in Nigeria, Washington Post, May 30, 2007 (free one time registration required)
"Officials in Nigeria have brought criminal charges against pharmaceutical giant Pfizer for the company's alleged role in the deaths of children who received an unapproved drug during a meningitis epidemic…The move represents a rare -- perhaps unprecedented -- instance in which the developing world's anger at multinational drug companies has boiled over into criminal charges…"
Russia bans human tissue export in bioweapon alert, New Scientist, May 30, 2007
"Russia has banned the shipment of medical specimens abroad, threatening hundreds of patients and complicating drug trials by major companies…warned of Russian genetic material being used in Western clinics to prepare biological weapons that would harm only Russians…"
 
Week of May 21, 2007
Critical Care Without Consent, Washington Post, May 27, 2007 (free one time registration required)
"The federal government is undertaking the most ambitious set of studies ever mounted under a controversial arrangement that allows researchers to conduct some kinds of medical experiments without first getting patients' permission…The project has been endorsed by many trauma experts and some bioethicists. Others question it. The harshest critics say the research violates fundamental ethical principles…"
Company: More deaths on blood substitute, Chicago Tribune, May 23, 2007 (no longer available)
"Evanston-based Northfield Laboratories Inc. said more patients who were on its experimental blood substitute died within 30 days after transfusions than those who didn't get the product…"
Aboriginal Peoples Given Stronger Voice in Health Research, Canadian Institutes of Health Research (CIHR), May 22, 2007
"Aboriginal Peoples will now have greater involvement in the planning, execution and sharing of research outcomes conducted with their communities, as a result of new research ethics guidelines recently released by the Canadian Institutes of Health Research (CIHR)…"
CIHR Guidelines for Health Research Involving Aboriginal People, Canadian Institute for Health Research, May 2007
 
Week of May 14, 2007
Can troops be ID’d from survey?, Air Force Times, May 18, 2007
"A survey cataloging whether soldiers or Marines have ever kicked or hit an innocent Iraqi, changed rules of engagement, or believe torture should be allowed leaves research experts concerned that those service members could be identified. But the Mental Health Advisory Team members who conducted the survey said there’s no way anyone could be identified "with any certainty"…"
Hybrid embryos get go-ahead, The Guardian, UK, May 17, 2007
"The government has overturned its proposed ban on the creation of human-animal embryos and now wants to allow them to be used to develop new treatments for incurable diseases such as Parkinson's and Alzheimer's…"
Prohibiting Genetic Discrimination, Hudson, New England Journal of Medicine 356: 2021-2023, May 17, 2007 (extract freely available)
Issues in the Registration of Clinical Trials, Zarin et al., Journal of the American Medical Association 297: 2112-2120, May 16, 2007 (abstract freely available)
As Demand for Donor Eggs Soars, High Prices Stir Ethical Concerns, New York Times, May 15, 2007 (free one time registration required; scheduled to be freely available until May 21, 2007)
"…The 2005 guidelines of the National Academy of Sciences for human embryonic stem cell research discourage paying for eggs for research. The California Institute for Regenerative Medicine reimburses women only for out-of-pocket expenses like lost wages or cab fare…So far, women have not come forward to give away eggs for research…"
Israel developed anthrax vaccine over Iraqi threat, Reuters, May 15, 2007 (scheduled to be freely availabe until Jun 14, 2007)
"Israel developed its own version of a U.S. anthrax vaccine using soldiers for top-secret experiments that, in several cases, caused permanent side effects, an official involved in the project said on Tuesday. Giora Martinovich, former chief medical officer for the Israeli military, went public after a television expose alleged that several test subjects had developed illnesses and then been neglected by state health services…"
CPR Study to Test Emergency Treatment, Sans Patient Permission, Wired News, May 14, 2007
"…The study is the largest research project ever to not require informed consent, and it's drawing intense criticism from legislators and ethicists. But study organizers say it's the only way to test -- and hopefully improve -- emergency heart treatments. The researchers expect to enroll more than 14,000 people without their permission…"
 
Week of May 7, 2007
Gene advances bring ethical quandaries, Boston Globe, May 11, 2007
"A revolution in genetics is leading to almost weekly discoveries about genes linked with diseases such as diabetes, but also creating a dilemma for medical scientists: Should they tell the patients whose DNA was used in the research that they may be at risk for a serious illness? At present, that's almost taboo because of privacy policies governing most medical research…"
Reestablishing the Researcher-Patient Compact, Kohane et al., Science 316: 836 - 837, May 11, 2007 (summary freely available)
Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects--Supervisory Responsibilities of Investigators, US Food and Drug Administration (FDA), May 10, 2007 (comments due by July 9, 2007)
"…This draft guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The draft guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties…"
Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects--Supervisory Responsibilities of Investigators, US Food and Drug Administation (FDA), May 10, 2007 (pdf)
Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine's Medical and Ethical Standards, Lomax et al., PLoS Medicine 4: e114, May 8, 2007 (full article freely available)
 
Week of April 30, 2007
WHO moves to boost online data of clinical trials, San Diego Union-Tribune, May 5, 2007
"…“WHO believes that the registration of clinical trials is a scientific, ethical and moral responsibility.” Initially, data from 50,000 clinical trials provided by three registers – in Britain, Australia/New Zealand and the United States – have been put on the WHO site…"
World Health Organization (WHO) International Clinical Trials Registry Platform Search Portal, May 2007
Subjects or Objects? Prisoners and Human Experimentation, Lerner, New England Journal of Medicine 356:1806-1807, May 3, 2007 (abstract freely available)
Editorial: Quality Improvement and Ethical Oversight, Grady, Annals of Internal Medicine 146: 680-681, May 1, 2007 (full article freely available)
The Ethics of Using Quality Improvement Methods in Health Care, Lynn et al., Annals of Internal Medicine 146: 666-673, May 1, 2007 (full article freely available)
A qualitative study of institutional review board members’ experience reviewing research proposals using emergency exception from informed consent, McClure et al., Journal of Medical Ethics 33: 289-293, May 2007 (abstract freely available)
Factors influencing the effectiveness of research ethics committees, Schuppli and Fraser, Journal of Medical Ethics 33: 294-301, May 2007 (abstract freely available)
Legal and ethical considerations in processing patient-identifiable data without patient consent: lessons learnt from developing a disease register, Haynes et al., Journal of Medical Ethics 33: 302-307, May 2007 (abstract freely available)
Noninvitation of Eligible Individuals to Participate in Pediatric Studies. A Qualitative Study, Amiel et al., Archives of Pediatric and Adolescent Medicine 161: 446-450, May 2007 (abstract freely available)
Participation of Next of Kin in Research Following Sudden, Unexpected Death of a Child, Taneja et al., Archives of Pediatric and Adolescent Medicine 161: 453-456, May 2007 (abstract freely available)
ORI Sample Policy and Procedures for Responding to Research Misconduct Allegations, US Office of Research Integrity, May 2007 (includes preamble, sample policy and procedures, research integrity officer responsibilities)
"This sample policy and procedures complies with the PHS Policies on Research Misconduct (42 CFR Part 93) that became effective June 16, 2005…"
Summary of Proceedings: Conference on Conflicts of Interest In Research Feb 22-23, 2007, National Council on Ethics in Human Research, Canada (NCEHR), accessed Jun 7, 2007 (pdf)
 
Week of April 23, 2007
2006 National Conference on Alternative IRB Models: Optimizing Human Subject Protection, American Association of Medical Colleges (AAMC) Web Site, Apr 2007 (conference presentations and final report freely available)
House Approves Bill Banning Genetic Discrimination, Kaisernetwork.org, Apr 26, 2007
"…Under the bill, employers could not make decisions about whether to hire potential employees or fire or promote employees based on the results of genetic tests. In addition, health insurers could not deny coverage to potential members or charge higher premiums to members because of genetic test results…"
Canada: Call for Nominations for Members: Interagency Advisory Panel on Research Ethics, CIHR/NSERC/SSHRC, Apr 24, 2007 (nominations due May 31, 2007)
Drug Test Cowboys: The Secret World of Pharmaceutical Trial Subjects, Wired Magazine, Apr 24, 2007
"Every year, millions of volunteers participate in clinical trials in return for quick cash. A few turn pro. Welcome to the guinea pig underground…"
UW doctors zeroing in on oxygen, Seattle Times, Apr 23, 2007
"…The University of Washington lung specialist is part of the largest and most ambitious medical expedition ever mounted to the 29,035-foot peak…About 10 scientists will try to reach the summit. As they climb, they will sample each other's blood and take other measurements to gauge their reactions to low oxygen. They hope to be the first to collect blood samples and snippets of muscle from people atop the world's highest peak…"
 
Week of April 16, 2007
Clinical trial coordinators need more financial conflict-of-interest training, EurekAlert Press Release, Apr 22, 2007
"Medical professionals conducting clinical trials should provide more information about financial conflicts of interest before they talk to patients about participating in the trials. That is one of the main conclusions of a new survey by researchers from Duke University Medical Center and Johns Hopkins University. Their study found that 41 percent of the clinical trial coordinators surveyed had experience disclosing financial aspects of the trial to potential participants, and 28 percent of the coordinators had been asked by participants about potential financial conflicts…"
Secretary's Advisory Committee for Human Research Protections (SACHRP) March 29-30, 2007 Meeting Materials, Office for Human Research Protections (OHRP), posted Apr 2007 (includes agenda, presentation materials, transcripts)
 
Week of April 9, 2007
Africa: All Not Well With Global Aids Vaccine Trials, AllAfrica.com, Apr 13, 2007 (paid subscription now required to access archives)
"Why were phase-1 safety trials for an HIV vaccine started in India days before the release of the results of the same trial in Belgium and Germany? And why were phase-2 trials of the same vaccine conducted in Africa? These are some of the questions that scientists and ethicists knowledgeable about the HIV/AIDS vaccine trials in India are asking about phase-1 trials here…"
Editorial: AIDS vaccine trials in India: ethical benchmarks and unanswered questions, Jesani and Coutinho, Indian Journal of Medical Ethics 4, Jan - Mar 2007 (full article freely available)
Beyond ethics: biomed research and the poor, SciDev.net, Apr 13, 2007
"Biomedical research must adhere to ethical norms, but in poorer countries there are considerations above and beyond them. In particular, attention must be given to understanding community hierarchies and the need for adequate compensation, financial or otherwise, as well as the role of researchers in improving local health education…"
When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?, Evans, PLoS Clinical Trials 2: e18, Apr 13, 2007 (full article freely available)
Editorial: Clinical Trials in the Elderly — A Concept Comes of Age, Siu, New England Journal of Medicine 356: 1575-1576, Apr 12, 2007 (extract freely available)
Diabetes study shows unusual promise - and risk, Monterey Herald, Apr 11, 2007 (no longer available)
"A new diabetes treatment developed at Northwestern University has allowed some patients to stop taking insulin for more than two years, but it also has spurred ethical objections from researchers who say the trial put Brazilian children at unnecessary risk…some experts doubted the protocol could have been approved in this country…"
Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus, Voltarelli et al., Journal of the American Medical Association 297: 1568-1576, Apr 11, 2007 (abstract freely available)
Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting-- Improving Human Subject Protection, Federal Register 72: 17562-17563, Apr 2007 (comments due June 8, 2007)
"…This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board (IRB). FDA developed this draft guidance in response to concerns raised by the IRB community that increasingly large volumes of individual adverse event reports are inhibiting rather than enhancing IRBs' ability to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs…"
Draft: Adverse Event Reporting - Improving Human Subject Protection, US Food and Drug Administration (FDA), Apr 17, 2007 (pdf)
 
Week of April 2, 2007
Airman injured in heat-beam test, Air Force Times, Apr 7, 2007
"An airman received second-degree burns April 4 during a test of the Defense Department’s nonlethal millimeter-wave heat beam…Fullwood said more than 600 people have been exposed a total of more than 10,000 times to the beam, and there has only been one other injury that required medical attention: a case of second-degree burns that occurred during lab testing in 1999…"
ESA prepares for a human mission to Mars, European Space Agency, Apr 2, 2007
"Starting in spring next year, a crew of six will be sent on a 500 day simulated mission to Mars. In reality the crew will remain in a special isolation facility in Russia…We have a first draft list of the kind of science we are looking for. Such as crew composition, the influence of confinement on sleep, mood and mental health, and the effect of differences in personality, cultural background and motivation. But also on the medical side – physiological adaptation to an isolated environment, stress effects on health and well-being, changes in the immune system…"
 
Week of March 26, 2007
Patient Confidentiality in the Research Use of Clinical Medical Databases, Krishna et al., American Journal of Public Health 97: 654-658, Apr 1, 2007 (abstract freely available)
Consent gained from patients after breast surgery for the use of surplus tissue in research: an exploration, Hamilton et al., Journal of Medical Ethics 33: 229-233, Apr 2007 (abstract freely available)
Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a Grounded Theory approach, Madsen et al., Journal of Medical Ethics 33: 234-240, Apr 2007 (abstract freely available)
Proportional ethical review and the identification of ethical issues, Hunter, Journal of Medical Ethics 33: 241-245, Apr 2007 (abstract freely available)
HIV patient names to be tracked in all 50 states by year's end, Belleville News Democrat, Apr 1, 2007 (no longer available)
"The names of people infected with HIV will be tracked in all 50 states by the end of 2007, marking a victory for federal health officials and a quiet defeat for AIDS advocates who wanted to keep patients' names out of state databases…Berger, the Chicago doctor, said he has told some patients not to give him their real names. He has enrolled patients anonymously in medical studies of HIV drugs without reporting their names, he said…"
Management Series: Managing the Research Enterprise, Academic Medicine, American Association of Medical Colleges (AAMC), Apr 1, 2007 (all articles freely available)
A Right to Benefit from International Research: A New Approach to Capacity Building in Less-Developed Countries, White, Accountability in Research 14: 73-92, Apr 2007 (abstract freely available)
The Ethical Issues in Uranium Mining Research in the Navajo Nation, Panikkar and Brugge, Accountability in Research 14: 121-153, Apr 2007 (abstract freely available)
Feds Start Review of NIH Policies, The San Francisco Chronicle, Mar 30, 2007
"…HHS inspector general Daniel Levinson explained in a letter that his office is looking beyond the internal NIH ethics restrictions because most NIH research money goes to outside grantees, and the investigative office "determined that this project was an important next step in examining NIH conflict of interest."…The letter also disclosed that criminal investigators under Levinson are examining potential conflicts of interest by 103 NIH scientists who earned outside income from drug and biotech companies and were previously investigated by NIH internally…"
New Members Appointed to Human Research Protections National Advisory Committee, US Department of Health and Human Services, Mar 29, 2007
"HHS Secretary Mike Leavitt has appointed a new chair and three new members to the Secretary’s Advisory Committee on Human Research Protections (SACHRP)…"
The Egg Trade — Making Sense of the Market for Human Oocytes, Spar, New England Journal of Medicine 356: 1289-1291, Mar 29, 2007 (full article freely available)
EMEA issues draft guidelines on clinical trials for potentially high-risk drugs, Cordis News, Mar 28, 2007
"The European Medicines Agency (EMEA) has adopted draft guidelines for first-in-man clinical trials of potentially high-risk medicinal products. The guidelines are released a year after six previously healthy volunteers taking part in a trial at London's Northwick Park Hospital suffered severe, long lasting reactions to the drug TGN1412, which was being tested in humans for the first time. The new guidelines are intended to help those designing first-in-man trials for high risk products to identify and minimise the risks involved, to avoid a recurrence of the events at Northwick Park…"
Guideline on Requirements for First-in-Man Clinical Trials for Potential High-Risk Medicinal Products, Committee for Medicinal Products for Human Use, European Medicines Agency, Mar 22, 2007 (pdf; comments due by May 23, 2007)
Cloning debate brewing once again, Seattle Times, Mar 26, 2007
"…At least three respected teams of British scientists have reignited the moral debate over inserting human genes into animal eggs by proposing similar experiments to Cibelli's. Their goal is to eliminate the need for women to donate eggs for the cloning of human embryos, a research goal they say will enable them to better understand the genetic causes of many diseases and design personalized medicines…"
A recipe for research, Boston Globe, Mar 26, 2007
"…After designing a menu and settling on a schedule, researchers embark on the hunt for humans amenable to spending weeks or months following a prescribed diet. There are inducements: Depending on the duration and complexity of a study, volunteers receive a stipend of several hundred to a few thousand dollars. And then there's all that free food. Still, study recruiters are assiduous in explaining the rigors and requirements of the research…"
 
Week of March 19, 2007
Stern Lessons For Terrorism Expert, Harvard Crimson, Mar 23, 2007
"Jessica E. Stern left for Amsterdam last week, hoping to meet a group of female jihadists…Her decades of research on terrorism, involving confrontations with IRBs, Harvard, and the federal government, shed light on the special obstacles faced by academics hoping to study sensitive issues…"
Draft Report: Realizing the Promise of Pharmacogenomics: Opportunities and Challenges, Secretary's Advisory Committee on Genetics, Health and Society (SACGHS), Mar 2007 (comments due by June 1, 2007)
"The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report to the Secretary of Health and Human Services ( HHS )…The draft report describes opportunities and challenges in pharmacogenomics in three major areas: 1) research and development; 2) “gatekeepers,” i.e., those who are involved in facilitating the progression of pharmacogenomics; and 3) implementation of pharmacogenomics to improve outcomes in clinical and public health practice. Draft recommendations also are presented in each area. SACGHS is requesting comments on all aspects of the draft report and recommendations…"
Final Report: Policy Issues Associated With Undertaking a New Large US Population Cohort Study of Genes, Environment and Disease, Secretary's Advisory Committee on Genetics, Health and Society (SACGHS), Mar 2007 (pdf)
FDA tightens rules for advisers, Monterey Herald, Mar 22, 2007 (no longer available)
"Outside experts with more than $50,000 in ties to drug and medical device companies regulated by the Food and Drug Administration would be barred from advising the agency under draft guidelines…"
Press Release: FDA Proposes New, Tougher Procedures for Membership on Advisory Committees, FDA News, Mar 21, 2007
Draft Guidance for The Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees, Mar 21, 2007
Doctors’ Ties to Drug Makers Are Put on Close View, New York Times, Mar 21, 2007 (free one time registration required; scheduled to be freely available until Mar 27, 2007)
"…The Minnesota records are a window on the widespread financial ties between pharmaceutical companies and the doctors who prescribe and recommend their products. Patient advocacy groups and many doctors themselves have long complained that drug companies exert undue influence on doctors, but the extent of such payments has been hard to quantify…"
Pharmaceutical Company Payments to Physicians. Early Experiences With Disclosure Laws in Vermont and Minnesota, Ross et al., Journal of the American Medical Association 297: 1216-1223, Mar 21, 2007 (abstract freely available)
 
Week of March 12, 2007
VA healthcare research halted, The Scientist, Mar 14, 2007
"Seven research sites were shut down indefinitely last month by the US Department of Veterans Affairs after an employee at the Birmingham, Alabama, site reported an external hard drive was missing. All seven sites, where researchers use medical records to evaluate healthcare quality, have each been inspected but research remains closed until the VA decides how to proceed…"
Call for arm's-length national research integrity agency, Canadian Medical Association Journal, Mar 13, 2007
"…Inevitably, though, Pencharz forecasts Canada will have little alternative but to overcome its recalcitrance and create an independent National Research Integrity Agency. That's exactly what he urged in a report commissioned by Memorial University to assess its practices and policies for handling misconduct in the wake of the highly-publicized case of Dr. Ranjit Chandra, who is alleged to have fabricated data on nonexistent babies for his infant formula studies…"
Report: Royal Statistical Society's (RSS) Working Party on Statistical Issues in First-in-Man Studies, RSS, UK, Mar 12, 2007 (full report freely available)
"…The report concludes that the design of the TGN1412 trial was not well suited to its objectives of testing safety and tolerability of the drug. In addition, a Freedom of Information request lodged by the working party highlighted deficiencies in the linkage of the databases held by the Medicines and Healthcare products Regulatory Agency (MHRA) on first-in-man trials and associated serious adverse events…"
 
Week of March 5, 2007
Exclusive: One Year After Drug Test Horror, Mirror, UK, Mar 10, 2007
"…Twelve months on, their lives blighted by the devastating "Elephant Man" drugs trial, the six men have received no compensation and no apology. TeGenero, the drug's German manufacturer, has gone bust while Parexel, the US firm behind the trial, refuses to accept liability. The volunteers have had enough and this week legal proceedings will finally be launched to force the issue to court…"
Two Charged in UCLA Cadaver Scandal, The San Francisco Chronicle, Mar 7, 2007
"A former UCLA official and an associate were arrested Wednesday on charges that they illegally sold parts of bodies donated for research in a scheme that produced more than $1 million in profits…"
Scientists try to predict intentions, Monterey Herald, Mar 6, 2007 (no longer available)
"…researchers at Berlin's Bernstein Center for Computational Neuroscience claim they have now, for the first time, identified people's decisions about how they would later do a high-level mental activity - in this case, adding versus subtracting. While still in its initial stages, the techniques may eventually have wide-ranging implications for everything from criminal interrogations to airline security checks. And that alarms some ethicists who fear the technology could one day be abused by authorities, marketers, or employers…"
 
Week of February 26, 2007
Prosecutors target Russian clinic testing British firm's MMR vaccine, The Guardian, Mar 3, 2007
"Russian prosecutors have opened a criminal investigation into a clinic after unsubstantiated allegations that a vaccine made by the British drugs company GlaxoSmithKline has had disturbing side effects in a clinical trial…"
FDA facing challenge on trial drugs, MSNBC, Mar 2, 2007 (no longer available)
"A US federal appeals court on Thursday struggled to decide whether terminally ill Americans have a constitutional right to gain access to experimental drugs not yet approved by the US drug regulator, the Food and Drug Administration…"
Global bioethics at UNESCO: in defence of the Universal Declaration on Bioethics and Human Rights, Andorno, Journal of Medical Ethics 33: 150-154, Mar 1, 2007 (abstract freely available)
Contesting the science/ethics distinction in the review of clinical research, Dawson and Yentis, Journal of Medical Ethics 33: 165-167, Mar 1, 2007 (abstract freely available)
Implementing the district hospital recommendations for the National Health Service Research Ethics Service in England, Wisely and Lilleyman, Journal of Medical Ethics 33: 168, Mar 1, 2007 (extract freely available)
Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson’s disease, Master et al., Journal of Medical Ethics 33: 169-173, Mar 1, 2007 (abstract freely available)
Ethical reflections on Edward Jenner’s experimental treatment, Davies, Journal of Medical Ethics 33: 174-176, Mar 1, 2007 (abstract freely available)
Rasing the ivory tower: the production of knowledge and distrust of medicine among African Americans, Wasserman et al., Journal of Medical Ethics 33: 177-180, Mar 1, 2007 (abstract freely available)
Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations, Fisher et al., American Journal of Bioethics 7: 5-10, Mar 2007 (abstract freely available)
US Office of Research Integrity Newsletter, ORI, Mar 2007 (pdf)
Forum on IRBs: Negotiating Institutional Review Boards, Shopes, American Historical Association Perspectives 45, Mar 2007 (full article freely available)
Oral History and IRBs: An Update from the 2006 HRPP Conference, Atkins, American Historical Association Perspectives 45, Mar 2007 (full article freely available)
Ethical Training for Oral Historians, Schrag, American Historical Association Perspectives 45, Mar 2007 (full article freely available)
2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research, Human Embryonic Stem Cell Research Advisory Committee, National Research Council, Mar 2007
"The new report makes several amendments to the 2005 National Academies’ Guidelines for Human Embryonic Stem Cell Research based upon feedback from the community. As explained in the introduction, “this report addresses issues that are both in need of amendment and amenable to prompt solution.” The report clarifies what is meant by the phrase “provenance of the cell lines,” discusses the use of NIH-approved hES cell lines, offers additional details on the importation of hES cell lines into an institution, and clarifies the composition of embryonic stem cell research oversight (ESCRO) committees and explicitly allows other models of ESCRO review. The report also discusses the status of frozen IVF blastocysts from anonymous sperm donors and compiles a number of sample questions for ESCRO committees to use in reviewing hES cell research. An updated complete set of Guidelines is attached to the report as an appendix…"
ESCRO Committee Listserv, Human Embryonic Stem Cell Research Advisory Committee, National Academies, Mar 2007
"The National Academies and the Human Embryonic Stem Cell Research Advisory Committee have created a listserv to facilitate discussions among those involved in the oversight of human embryonic stem cell research. The listserv is geared to members and staff of Embryonic Stem Cell Research Oversight (ESCRO) and Stem Cell Research Oversight (SCRO) committees as well as interested members and staff of related committees, such as Institutional Review Boards (IRBs), Institutional Animal Care and Use Committees (IACUCs), and Institutional Biosafety Committees (IBCs)…"
Ethical Issues in Cancer Chemoprevention Trials: Considerations for IRBs and Investigators, Slutsman et al., IRB 29: 1-6, Mar-Apr 2007 (no longer available)
Special Issue: Equipoise and the Ethics of Clinical Trials, Journal of Medicine and Philosopy 32, Mar 2007 (abstracts freely available for most articles)
EPA Announces New Human Health Research Web Site, US Environmental Protection Agency, Mar 2007
"EPA's Human Health Research Program launched a new Web site on the latest information on its research to protect public health. The program's science looks at such questions as why some people are more sensitive to pollution and how exposure to chemicals affects people's health. The site is designed for the general public as well as for the scientific community…"
Human Health Research Program Web Site, Envronmental Protection Agency (EPA)
Sharing Data and Results in Ethnographic Research: Why This Should not be an Ethical Imperative, Cooper, Journal of Empirical Research on Human Research Ethics 2: 3-19, Mar 2007 (abstract freely available)
Establishment of a Standing Ethics/Institutional Review Board in a Nigerian University: A Blueprint for Developing Countries, Falusi et al., Journal of Empirical Research on Human Research Ethics 2: 21-30, Mar 2007 (abstract freely available)
Community-Based Participatory Research and the Ethics Review Process, Shore, Journal of Empirical Research on Human Research Ethics 2: 31-41, Mar 2007 (abstract freely available)
Content Among Locally Approved HIPAA Authorization forms for Research, Breese et al., Journal of Empirical Research on Human Research Ethics 2: 43-46, Mar 2007 (abstract freely available)
PRIM&R Human Tissue/Specimen Banking White Paper Part I: Assessment and Recommendations, Public Responsibility in Medicine & Research, Mar 2007; posted online Jun 2007 (pdf)
"The establishment of the PRIM&R Human Tissue/Specimen Banking Working Group and the development of this White Paper was a collaborative effort between PRIM&R and Partners HealthCare Systems Inc. with support from NIH Clinical Research Policy Analysis and Coordination Program and the NCI Cancer Diagnosis Program. The purpose of the Working Group was to identify current barriers to the collection, storage, distribution, and use of human specimens and data in research and strategies for overcoming those barriers while protecting subjects…"
PRIM&R Human Tissue/Specimen Banking White Paper Part II: Tools for Investigators, IRBs and Repository Managers, Public Responsibility in Medicine & Research, Mar 2007; posted online Jun 2007 (pdf)
As Ethics Panels Expand Grip, No Field Is Off Limits, New York Times, Feb 28, 2007 (free one time registration required; archived, payment required)
"Ever since the gross mistreatment of poor black men in the Tuskegee Syphilis Study came to light three decades ago, the federal government has required ethics panels to protect people from being used as human lab rats in biomedical studies. Yet now, faculty and graduate students across the country increasingly complain that these panels have spun out of control, curtailing academic freedom and interfering with research in history, English and other subjects that poses virtually no danger to anyone…"
Undertaking Research in Other Countries: National Ethico-Legal Barometers and International Ethical Consensus Statements, Skene, PLoS Medicine 4, Feb 27, 2007 (full article freely available)
Justices OK lawsuit against researcher accused of privacy breach, Monterey Herald, Feb 26, 2007 (no longer available)
"Researchers could be liable for damages if they obtain private information through false pretenses, the California Supreme Court ruled Monday…"
 
Week of February 19, 2007
Hospital in brain tissue allegations, The Guardian, Feb 25, 2007
"Allegations that patients at a Liverpool hospital had parts of their brains removed for medical research during neurosurgery without consenting to the procedure, can be revealed today. The University of Liverpool is accused of covering up the procedures, alleged to have resulted in at least 12 patients having brain parts removed. Its medical school, which was embroiled in the Alder Hey organ retention scandal, is facing claims that it tried to silence a senior hospital whistleblower…"
Biomedical Research Involving Prisoners. Ethical Values and Legal Regulation, Gostin, Journal of the American Medical Association 297:737-740, Feb 21, 2007 (extract freely available)
Britain to OK eggs donated for research, Monterey Herald, Feb 21, 2007 (no longer available)
"The British government on Wednesday approved plans to allow women to donate eggs for stem cell and cloning research - and said they will also be entitled to compensation for costs incurred…"
HFEA Statement on Donating Eggs for research, Human Fertilisation and Embryology Authority, UK, Feb 21, 2007
A Silent Epidemic, Washington Post, Feb 20, 2007 (free one time registration required)
"…Low health literacy, the [Institute of Medicine] noted, affects an estimated 90 million Americans, who struggle to understand what a doctor has told them or to comply with treatment recommendations as essential as taking the proper dose of medication. A 1999 report by the American Medical Association found that consent forms and other medical forms are typically written at the graduate school level, although the average American adult reads at the eighth-grade level…"
Dominican prostitutes test AIDS vaccine, CTV.ca, Feb 19, 2007
"…Participants get three injections over their first seven months in the study, and then must keep reporting back for four years of close monitoring. For many, the greatest reward is pride. "We are doing it for the world," said 38-year-old Lucila Mendoza Ovalle…"
 
Week of February 12, 2007
Call for Comments: Qualitative Research in the Context of the Tri-Council Policy Statement (TCPS), Social Sciences and Humanities Research Ethics Special Working Committee, Canada, Feb 2007 (comments due by Apr 16, 2007)
"This is an open invitation to participate in a consultation on evolving the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) to be more inclusive of the full diversity of Canada’s research community by better meeting the needs of Canada’s Social Sciences and Humanities (SSH) Communities with respect to qualitative research issues in the TCPS…"
Kaiser starts major study of members' health, The San Francisco Chronicle, Feb 15, 2007
"Kaiser Permanente launched a survey of its Northern California membership Wednesday in the first phase of an ambitious multiyear study into the genetics and lifestyle factors that give rise to common diseases. Researchers said the project could last 50 years and draw information from 500,000 adult health plan members who agree to participate -- making this potentially the biggest study of its kind in the United States and one of the biggest in the world…"
Web Site: Kaiser Permanente Research Program on Genes, Environment and Health, accessed Feb 15, 2007
Call for "neuroethics" as brain science races ahead, Reuters, Feb 14, 2007 (scheduled to be available until Mar 13, 2007)
"Neuroscientists are making such rapid progress in unlocking the brain's secrets that some are urging colleagues to debate the ethics of their work before it can be misused by governments, lawyers or advertisers…"
Access to Health Care Records After Death. Balancing Confidentiality With Appropriate Disclosure, Robinson and O’Neill, Journal of the American Medical Association 297:634-636, Feb 14, 2007 (extract freely available)
Lawsuit Might Reduce FDA Authority in Allowing Terminally Ill Patients To Use Experimental Medications, Kaisernetwork.org, Feb 13, 2007
"The U.S. Court of Appeals for the District of Columbia on March 1 will reconsider a case that "threatens to shake the foundations of the FDA's regulatory authority covering pharmaceuticals and lead to greatly expanded use" of experimental medications…"
 
Week of February 5, 2007
European Union Publishes Monographs on Ethical Review Laws in 11 Countries, US Office of Research Integrity (ORI), Feb 2007 (links available to all 11 documents)
"The Office for Human Research Protections reports that the European Union has published a series of 11 monographs (about 16 pages each) that provide in-depth discussions of ethical review laws, regulations, and procedures, including laws on research involving human biological materials, personal data, and genetic research, in Bulgaria, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovak Republic, Slovenia, and Turkey…"
Univ. defends its defense against fraud, The Scientist, Feb 8, 2007
"Memorial University's investigation of scientific misconduct by nutrition researcher Ranjit Chandra followed the university's existing policies, according to a new Memorial-commissioned report. The report's author, Paul Pencharz at the University of Toronto and the Hospital for Sick Children's Research Institute, also recommended that Canada establish a national agency to investigate scientific misconduct, based upon the systems already in place in a number of countries, including the US…"
An Examination of Research Integrity Issues Pertaining to Memorial University of Newfoundland, Pencharz, Jan 2007 (pdf; full report freely available)
Twenty women HIV-positive after drug trial, Mail and Guardian, South Africa, Feb 7, 2007
"…Recently, researchers halted two studies of an anti-Aids vaginal gel in Africa and India after early results suggested it might raise the risk of HIV infection instead of lowering it…On Tuesday, Health Minister Manto Tshabalala-Msimang requested an investigation by the research ethics council following concerns about the HIV status of the participants…"
Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report, Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research, Institute of Medicine, Feb 2007 (full report freely available)
Comments: Draft Guidance on the Engagement of Institutions in Human Subjects Research, American Association of Medical Colleges (AAMC), Feb 5, 2007 (pdf)
"The draft guidance focuses on the question of whether institutions involved in some aspects of non-exempt human subjects research are in fact "engaged" in human subjects research and thus required to file certain documents with OHRP. In the comment letter, AAMC strongly supports the government's effort to clarify this issue, but requests additional explanation of provisions relating to statistical centers and coordinating centers for multi-site clinical trials. The AAMC also requests that OHRP reconsider its current position on the responsibilities of a primary recipient of a federal grant award in which all the activities involving human subjects are carried out by other institutions…"
 
Week of January 29, 2007
Exception from Informed Consent Enrollment in Emergency Medical Research: Attitudes and Awareness, Triner et al., Acad Emerg Med 14: 187-191, Feb 2007 (abstract freely available)
A new prescription for empirical ethics research in pharmacy: a critical review of the literature, Cooper et al., Journal of Medical Ethics 33:82-86, Feb 1, 2007 (abstract freely available)
Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries, Moerman et al., Journal of Medical Ethics 33:107-112, Feb 1, 2007 (abstract freely available)
Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial, Seiler et al., Journal of Medical Ethics 33:113-118, Feb 1, 2007 (abstract freely available)
Scientists craft embryonic stem cell ethics rules, MSNBC, Feb 1, 2007
"New international guidelines on human embryonic stem cell research called for close scrutiny of scientists and clear consent from people donating cells, but did not settle the issue of paying women who donate eggs…"
Guidelines for the Conduct of Human Embryonic Stem Cell Research, International Society for Stem Cell Research, Feb 1, 2007 (full guidelines plus sample consent and material transfer documents available)
Institutional Review Board Approval: Why It Matters, Parvizi et al., Journal of Bone and Joint Surg America 89: 418-426, Feb 2007 (full article freely available)
F.D.A. Widens Safety Reviews on New Drugs, New York Times, Jan 31, 2007 (free one time registration required; archived, payment required)
"The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction…"
FDA Reinforces Commitment to Drug Safety (press release), FDA News, Jan 30, 2007
The Future of Drug Safety - Promoting and Protecting the Health of the Public. FDA's Response to the Institute of Medicine's 2006 Report, US Food and Drug Administration, Jan 30, 2007 (full report freely available)
Prospect of Womb Transplant Raises Hopes and Red Flags, New York Times, Jan 30, 2007 (free one time registration required; archived, payment required)
"…The hospital has no immediate plans for a uterine transplant, but even the possibility has been greeted with opprobrium by many medical ethicists, fertility doctors and patient advocates…"
Ethics group publishes opinion on nanomedicine, CORDIS News, Jan 29, 2007
"Addressing safety concerns related to advances in the nanomedicine field is of vital importance, according to the newly published 'Opinion on the Ethical Aspects of Nanomedicine' from the European Group on Ethics in Science and New Technologies…The report also places a strong emphasis on the importance of carrying out more research into the ethical, legal and social implications (ELSI) of nanomedicine…"
Opinion on the Ethical Aspects of Nanomedicine, European Group on Ethics in Science and New Technologies to the European Commission, Jan 17, 2007 (pdf)
 
Week of January 22, 2007
Blood center to collect DNA of donors, Seattle Times, Jan 28, 2007
"For the first time, the Puget Sound Blood Center will begin collecting, testing and storing the DNA of blood donors. Donors may opt out of the program, part of a study funded by the Defense Department to develop better ways of identifying blood types. And the Blood Center is firm that the effort will be limited to that purpose and not shared with the government…"
New OHRP Frequently Asked Questions and Answers on Prisoner Research, Office for Human Research Protections (OHRP), Jan 24, 2007
"OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on prisoner research. These FAQs provide guidance on OHRP’s current thinking on research involving prisoners and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word “must” in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word “should” in OHRP guidance means that something is recommended or suggested, but not required…"
The Structure and Function of Research Ethics Committees in Africa: A Case Study, Kass et al., PLoS Medicine 4, Jan 23, 2007 (full article freely available)
Research ethics committees in Africa report inadequate funding, staffing and training, EurekAlert (press release), Jan 22, 2007
"…The latest case study from Nancy Kass and Adnan Hyder included the active collaboration of nearly a dozen African researchers. The history and operational structure of 12 research ethics committees in nine African countries were examined…"
The Structure and Function of Research Ethics Committees in Africa: A Case Study, Kass et al., PLoS Medicine 4, Jan 23, 2007 (full article freely available)
 
Week of January 15, 2007
Model language unveiled to help clinical researchers disclose financial conflicts, EurekAlert (press release), Jan 19, 2007
"…experts at Johns Hopkins University, Duke University, and Wake Forest University have published new language designed to help clinical researchers better disclose their financial interests in research…"
Developing Model Language for Disclosing Financial Interests to Potential Clinical Research Participants, Weinfurt et al., IRB, Jan/Feb 2007 (no longer available)
Doctors plan first womb transplant in U.S., Seattle Times, Jan 15, 2007
"…But the planned operation, which Del Priore and his colleagues could attempt later this year, is stirring objections among some transplant experts, fertility specialists and medical ethicists. They question whether the procedure has been tested enough on animals and whether the benefit of being able to carry a pregnancy outweighs the risks for the woman and fetus…"
Guidance on Continuing Review, Office for Human Research Protections (OHRP), Jan 15, 2007 (email comments to ohrp@hhs.gov, citing document in the subject line)
"This guidance replaces OHRP's July 11, 2002 guidance entitled "Guidance on Continuing Review". This document describes the requirements of Department of Health and Human Services (HHS) regulations at 45 CFR 46.109(e) for the continuing review of human subjects research by an Institutional Review Board (IRB) at intervals appropriate to the degree of risk, but not less than once per year…"
Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events, Office for Human Research Protections (OHRP), Jan 15, 2007 (email comments to ohrp@hhs.gov, citing document in the subject line)
"This document applies to non-exempt human subjects research conducted or supported by HHS. It provides guidance on HHS regulations for the protection of human research subjects at 45 CFR part 46 related to the review and reporting of (a) unanticipated problems involving risks to subjects or others; and (b) adverse events. In particular, this guidance clarifies that only a small subset of adverse events occurring in human subjects participating in research are unanticipated problems that must be reported under 45 CFR part 46. The guidance is intended to help ensure that the review and reporting of unanticipated problems and adverse events occur in a timely, meaningful way so that human subjects can be better protected from avoidable harms while reducing unnecessary burden…"
Guidance on Written IRB Procedures, Office for Human Research Protections (OHRP), Jan 15, 2007 (email comments to ohrp@hhs.gov, citing document in the subject line)
"This guidance replaces OHRP's July 11, 2002 guidance entitled "Guidance on Written IRB Procedures". This document outlines the required elements of written Institutional Review Board (IRB) procedures under Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR Part 46) and provides an overview of relevant OHRP guidance regarding each required element…"
 
Week of January 8, 2007
Firm infects subjects to seek virus remedy, Boston Globe, Jan 13, 2007
"…The trial, disclosed in a regulatory filing, is "state of the art for how you do clinical trials with viruses," said a company spokeswoman. It has passed review by the Food and Drug Administration and an independent oversight board. But it also illuminates an ethically thorny area of medical research: Sometimes, to learn how a disease works, you need to infect people with it…"
New research funding rules to address potential conflict of interest, Canada.com, Jan 12, 2007
"Institutional conflicts of interest at Canadian universities are becoming such a concern with the growing commercialization of research that Ottawa's granting councils are bringing in rules to deal with the new possibility…"
Activists condemn stunting of girl's growth, Seattle Times, Jan 12, 2007
"…Taylor said that the treatment was essentially a medical experiment and that a hospital institutional review board should have been consulted beforehand. Complaints have been filed with the federal Office for Human Research Protections. But Kristina Borror, a director at the office, said Thursday her agency does not believe it was a research case and thus has no authority to investigate…"
U.S. House passes stem cell bill, The Scientist, Jan 12, 2007
"As expected, the U.S. House of Representatives yesterday (Jan. 11) passed legislation to extend Federal research funding to newly derived stem cell lines. But while the vote (253 to 174) gained 15 affirmative votes over an identical effort in the last session of Congress, it still fell far short of the two-thirds necessary to over-ride an expected presidential veto…"
Salvation by Registration, Drazen and Zarin, New England Journal of Medicine 356:184-185, Jan 11, 2007 (full article freely available)
Britain seeks opinion on stem cell study, Monterey Herald, Jan 11, 2007 (no longer available)
"Britain said Thursday it will conduct a public consultation on the issue of whether scientists should be allowed to create human stem cells from animal eggs. The Human Fertilisation and Embryology Authority said in a statement that only after the consultation process was complete in the autumn would it make a decision on whether to approve the experiments…"
Big stem-cell advance fuels fight over ethics, Seattle Times, Jan 11, 2007
"…the new work shows for the first time that healthy, normal embryonic stem cells can be cultivated directly from embryos without destroying them. That means the work should be eligible for federal financing…said study leader Robert Lanza…But that is not likely, said Story Landis, who heads the National Institutes of Health (NIH) stem-cell task force…"
A New Era of Unapproved Drugs - The Case of Abigail Alliance v Von Eschenbach, Jacobson and Parmet, Journal of the American Medical Association 297: 205-208, Jan 10, 2007 (extract freely available)
Drugmakers doing better on study info, Monterey Herald, Jan 10, 2007 (no longer available)
"Drug companies are doing a much better job of supplying key information about research they are doing since medical journals started pressuring them to enter studies in a government registry…"
Salvation by Registration, Drazen and Zarin, New England Journal of Medicine 356:184-185, Jan 11, 2007 (full text freely available)
Probe Finds Scientist Falsified Images, The San Francisco Chronicle, Jan 10, 2007
"A former University of Pittsburgh researcher who has co-authored papers with a disgraced South Korean scientist falsified images in a draft report on embryonic stem cells derived from monkeys, a university spokeswoman said Wednesday. The U.S. Department of Health and Human Services' Office of Research Integrity found that Park Jong-hyuk, a postdoctoral fellow from August 2004 to February 2006, committed research misconduct while working under Dr. Gerald Schatten, a professor who also worked with South Korea's Hwang Woo-suk…"
Privacy law freezes health research, Vancouver Sun, Jan 9, 2007
"Numerous B.C. health studies are not proceeding, languishing on hold or facing long delays because privacy legislation prevents researchers from actively recruiting participants…"
Researchers say amniotic fluid yields stem cells, Monterey Herald, Jan 8, 2007 (no longer available)
"A report that scientists had found a plentiful source of stem cells that could allow researchers to sidestep the controversy over destroying embryos in experiments has been greeted with enthusiasm and some reservations by experts in the field…"
Montreal clinical trial company calls on feds to protect human test subjects, CBC News, Jan 8, 2007
"A Montreal company that conducts clinical trials is calling on the federal government for an official bill of rights to protect those who take part in human drug trials…"
 
Week of January 1, 2007
U.K. expected to ban hybrid embryo research, MSNBC, Jan 5, 2007
"Britain risks losing its position as a stem cell pioneer if the government goes ahead with a proposed ban on creating embryos made from human DNA and animal eggs, scientists said on Friday. Five experts in the field said such hybrid embryos could provide a plentiful source of stem cells for researching new treatments into diseases such as Alzheimer’s and Parkinson’s…"
Mentally ill patients offered cash incentive to take drugs, The Independent, UK, Jan 3, 2007 (no longer available)
"Mentally ill patients are being paid by the NHS to take their drugs in a radical experiment to improve compliance…"
Threat Seen to Oral History, Inside Higher Ed, Jan 3, 2007
"…historians are protesting plans to specify that oral history is eligible for expedited reviews by institutional review boards because doing so would establish the principle that IRB’s have oversight of such scholarship. In the last week, the American Historical Association, along with a number of individual historians, have weighed in with the Office for Human Research Protections…arguing that the proposal to cover oral history would hinder many scholars’ work while not offering any important protections to those who give oral history interviews…"
Letter from the American History Association to the US Office for Human Research Protections, Dec 20, 2007 (pdf)
Informed Consent: An International Researchers’ Perspective, Rivera et al., American Journal of Public Health 97: 25-30, Jan 2007 (abstract freely available)
Establishing Procedures for Institutional Oversight of Stem Cell Research, Zettler et al., Academic Medicine 82: 6-10, Jan 2007 (abstract freely available)
Rejuvenating a Foundering Institutional Review Board: One Institution's Story, De Ville et al., Academic Medicine 82:11-17, Jan 2007 (abstract freely available)
Incorporating Principles and Practical Wisdom in Research Ethics Education: A Preliminary Study, Deming et al., Academic Medicine 82:18-23, Jan 2007 (abstract freely available)
Responsibilities and obligations of using human research specimens transported across national boundaries, Muula and Mfutso-Bengo, Journal of Medical Ethics 33:35-38, Jan 2007 (abstract freely available)
Should research ethics committees be told how to think?, Sayers, Journal of Medical Ethics 33:39-42, Jan 2007 (abstract freely available)
Acupuncture trials and informed consent, Miller and Kaptchuk, Journal of Medical Ethics 33:43-44, Jan 2007 (abstract freely available)
Is the NHS research ethics committees system to be outsourced to a low-cost offshore call centre? Reflections on human research ethics after the Warner Report, Epstein and Wingate, Journal of Medical Ethics 33:45-47, Jan 2007 (abstract freely available)
Anthrax vaccinations expected to resume in late January, Stars and Stripes, Jan 1, 2007
"Mandatory anthrax vaccinations for some troops are expected to resume in late January, said Defense Department spokesman Maj. Stewart Upton on Friday. Meanwhile, an attorney representing six Defense Department employees who refuse to take the vaccine has vowed that he will try to stop the mandatory vaccination program…"
Developing Model Language for Disclosing Financial Interests to Potential Clinical Research Participants, Weinfurt et al., IRB, Jan/Feb 2007 (no longer available)
Pediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of Direct Benefit: Challenging 45 CFR 46.406, Iltis, Accountability in Research 14: 19 - 34, Jan 2007 (abstract freely available)
Intentional Exposure Studies of Environmental Agents on Human Subjects: Assessing Benefits and Risks, Resnik, Accountability in Research 14:35 - 55, Jan 2007 (abstract freely available)
Research Records and the Resolution of Misconduct Allegations at Research Universities, Wilson et al., Accountability in Research 14: 57 - 71, Jan 2007 (abstract freely available)
Incorporating Principles and Practical Wisdom in Research Ethics Education: A Preliminary Study, Deming et al., Academic Medicine 82:18-23, Jan 2007 (abstract freely available)
Money and Distorted Ethical Judgments about Research: Ethical Assessment of the TeGenero TGN1412 Trial, Emanuel and Miller, The American Journal of Bioethics 7: 76, Jan-Feb 2007 (abstract freely available)
 

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