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News In Research With Human Subjects for 2010
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Week of December 27, 2010
2010 Year in Review: Stem cell research, CNN Health, Dec 30, 2010
"From the start, 2010 was a fascinating year for stem cell research…"
Week of December 20, 2010
NCI announces plans to reinvigorate clinical trials, NIH News, Dec 23, 2010
"…In a major transformation, NCI intends to consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved trials of cancer therapies. These changes are designed to provide greater benefits for cancer patients and more information for researchers. These moves come in response to an NCI-requested April 2010 report from the Institute of Medicine (IOM)…"
Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome, Kaptchuk et al., PLoS ONE 5(12): e15591. doi:10.1371/journal.pone.0015591, Dec 22, 2010 (full article freely available)
Week of December 13, 2010
Research on Research Integrity (R21) Exploratory/Developmental Research Grant Award RFA-ES-11-004, National Institutes of Health (NIH), Dec 17, 2010 (letter of intent due Feb 5, 2011; application due Mar 4, 2011)
"This FOA, issued by NIEHS, NIDCR, and ORI, encourages applications for research that will improve understanding of the basic mechanisms of research integrity by bridging work in the laboratory and the field. This understanding will advance several goals, including: the identification of the optimal targets and time points in the life course for Responsible Conduct of Research (RCR) education and the identification of common mechanisms of behavior change related to research integrity. This initiative seeks to capitalize on emerging basic science to accelerate the investigation of common mechanisms that play a role in initiating or maintaining research integrity and are applicable across a broad range of research-related behaviors…"
Anthropology Group Tries to Soothe Tempers After Dropping the Word ‘Science’, New York Times, Dec 13, 2010 (free one time registration required)
"The battle of the anthropologists — those who hew closely to scientific tradition versus those who take a more humanistic approach — flared again Monday, as the organization that represents both sides tried to patch things up. The American Anthropological Association had caused a stir by dropping the word “science” from its long-range plan, angering the evidence-based anthropologists who worry about their field’s growing too soft. All three mentions of the word “science” were excised, and two were replaced by the phrase “the public understanding of humankind.” On Monday, the association issued a statement of clarification…"
Week of December 6, 2010
To Test Housing Program, Some Are Denied Aid, New York Times, Dec 8, 2010 (free one time registration required)
"Now, New York City is applying the same methodology to assess one of its programs to prevent homelessness. Half of the test subjects — people who are behind on rent and in danger of being evicted — are being denied assistance from the program for two years, with researchers tracking them to see if they end up homeless…"
U ethics profs seek inquiry into drug study, subject's death, Star Tribune, Dec 6, 2010
"Eight University of Minnesota bioethics professors are asking the Board of Regents to investigate a drug study that lost a participant to suicide six years ago…we are persuaded that there is a disturbing and unjustifiable gap between how the University has responded to this death and the careful, critical investigation it warrants," the professors wrote…"
2010 Human Research Protection Award Recipients Announced, PR Newswire, Dec 6, 2010
"Awards for Excellence in Human Research Protection for 2010 were announced today by Dr. Peter G. Goldschmidt, President and Founder of the Health Improvement Institute…"
Week of November 29, 2010
International Compilation of Human Subject Protections 2011 Edition, US Office for Human Research Protections (OHRP), Dec 2010
"The updated Compilation includes a listing of over 1,000 laws, regulations, and guidelines on human subject protections in 101 countries and from several international organizations. The new Compilation also features the standards regarding device research, which were identified in 44 countries. These laws, regulations, and guidelines are classified into six categories: General Drugs and Devices, Privacy/Data Protection, Human Biological Materials, Genetic issues, Embryos, Stem Cells, and Cloning, New countries included in this year’s edition are Belarus, Grenada, Pakistan, Rwanda, and Tunisia. Many of the listings include a hyperlink, allowing the reader to link directly to the law, regulation, or guideline of interest…"
Research with Aboriginal Peoples: Authentic Relationships as a Precursor to Ethical Research, Bull, Journal of Empirical Research on Human Research Ethics 5 (4): 13-22, Dec 2010 (abstract and first page freely available)
Researchers' Perspectives on Collective/Community Co-authorship in Community-based Participatory Indigenous Research, Castleden, Journal of Empirical Research on Human Research Ethics 5 (4): 23-32, Dec 2010 (abstract and first page freely available)
Increasing Research Literacy in Minority Communities: CARES Fellows Training Program, Goodman et al., Journal of Empirical Research on Human Research Ethics 5 (4): 33-41, Dec 2010 (abstract and first page freely available)
Ethical Challenges in a Randomized Controlled Trial of Peer Education among Veterans Service Organizations, Whittle et al., Journal of Empirical Research on Human Research Ethics 5 (4) 43-51, Dec 2010 (abstract and full article freely available)
Community-Based Participatory Research in Disaster Preparedness among Linguistically Isolated Populations: A Public Health Perspective, Nepal et al., Journal of Empirical Research on Human Research Ethics 5 (4) 53-63, Dec 2010 (abstract and first page freely available)
Faculty Beliefs, Perceptions, and Level of Community Involvement in Their Research: A Survey at One Urban Academic Institution, Goldberg-Freeman et al., Journal of Empirical Research on Human Research Ethics 5 (4): 65-76, Dec 2010 (abstract and first page freely available)
The Research Ethics Committee Is Not the Enemy: Oversight of Community-Based Participatory Research, Wolf, Journal of Empirical Research on Human Research Ethics 5 (4): 77-86, Dec 2010 (abstract and first page freely available)
Pa. Firm Admits Crimes in Human Bone-Cement Trial, ABC News, Nov 30, 2010
"A medical device company near Philadelphia pleaded guilty to dozens of crimes Tuesday for conducting unauthorized tests of its bone cement on about 200 spinal surgery patients, three of whom died on the operating table…In court papers, prosecutors argue that the four acted knowingly, especially after a Synthes medical consultant warned early on that the tests amounted to "human experimentation."…"
Release of the 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or "TCPS 2", Panel on Research Ethics (PRE), Canada, Nov 29, 2010
"…Based on a decade of experience with the original Policy, TCPS 2 is the culmination of over two years of dialogue with the research community on draft revisions issued in 2008 and 2009…"
Week of November 22, 2010
Presidential Memorandum--Review of Human Subjects Protection, US Office of the White House, Nov 24, 2010
"…I ask you, as the Chair of the Presidential Commission for the Study of Bioethical Issues, to convene a panel to conduct, beginning in January 2011, a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government. I also request that the Commission oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study…"
U.S. Orders Vast Review of Bioethics, New York Times, Nov 24, 2010 (free one time registration required; for White House Memorandum, see section above)
"President Obama on Wednesday ordered a vast review to ensure the ethical treatment of people who take part in research backed by the federal government…"
Social Sciences and Human Decency, Inside Higher Ed, Nov 22, 2010
"…The quandary described in this real-life case is, at its root, the same ethical dilemma that more than 1,100 practicing and student anthropologists identified in a recent survey as the one they confront most: How does one work with human subjects in a way that honors their traditions and wishes while also fulfilling the duties of scientific inquiry?…"
Week of November 15, 2010
Streamlining Ethical Review, Millum and Menikoff, Annals of Internal Medicine 153:655-657, Nov 16, 2010 (abstract freely available)
US scientists “more prone” to fake research? No., Nature, Nov 16, 2010
"A peer-reviewed study that claimed “American scientists are significantly more prone to engage in data fabrication or falsification than scientists from other countries” caused surprise when it dropped into Nature’s inbox. Could a researcher in the United States really be more likely to publish fake research?…"
Week of November 8, 2010
National Science Foundation Press Release:, National Science Foundation (NSF), Nov 12, 2010
"…NSF has made a five-year, $5 million grant to the University of Illinois at Urbana-Champaign to develop a national center for professional and research ethics in science, mathematics and engineering…"
Regulation of genetic tests unnecessary, government says, Canadian Medical Association Journal, Nov 9, 2010
"Industry forecasts indicate that Canadians will soon face a marketing avalanche to persuade them to purchase personal genetic test kits. But while American officials are moving to regulate do-it-yourself genetic testing kits because of concerns that results may be erroneous or may prompt patients to alter their medications or make other unhealthy choices, Health Canada says it is open season for companies hunting for Canadian sales…"
Stage Set for Showdown on Online Privacy, New York Times, Nov 9, 2010 (free one time registration required)
"… Now, privacy advocates are pushing for a similar “do not track” feature that would let Internet users tell Web sites to stop surreptitiously tracking their online habits and collecting clues about age, salary, health, location and leisure activities. That proposal and other ideas to protect online privacy are setting up a confrontation among Internet companies, federal regulators, the Obama administration and Congress over how strict any new rules should be…"
Medical Devices and the FDA Approval Process. Balancing Safety and Innovation, Redberg, Archives of Internal Medicine 170(20):1831-1833, Nov 8, 2010 (extract freely available)
Week of November 1, 2010
Lies, Damned Lies, and Medical Science, Atlantic Magazine, Nov 2010
"Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong. So why are doctors—to a striking extent—still drawing upon misinformation in their everyday practice? Dr. John Ioannidis has spent his career challenging his peers by exposing their bad science…"
Ideal vs. Real: Revisiting Contraceptive Guidelines, Schonfeld et al., IRB: Ethics & Human Research 32 (6): 13-16, Nov -Dec 2010 (full article freely available with free one time registration)
Guidance on IRB Continuing Review of Research, US Office for Human Research Protections (OHRP), Nov 2010
"The guidance document supersedes OHRP’s January 15, 2007 guidance entitled “Guidance on Continuing Review.”…"
Working Group on Information Technology Security and Privacy in VA and NIH-Sponsored Research, American Association of Medical Colleges (AAMC), Nov 2010
"A new report is the product of an AAMC-convened working group on information technology security and data sharing between the U.S. Department of Veterans Affairs and researchers at medical schools and teaching hospitals…offers strategies for shared practices and processes to ensure the security of data and facilitate its appropriate use for research purposes…"
Week of October 25, 2010
NIH Scientists See Crackdown on Consulting as Too Restrictive, Science, Oct 28, 2010
"Five years ago after a scandal erupted over employees who were consulting for drug companies, the National Institutes of Health (NIH) banned most such relationships by in-house scientists. A new study finds mixed effects. The rules apparently haven't hindered scientific productivity, the survey finds. But a whopping 80% of NIH scientists find the rules too restrictive, and many say they have hampered the agency's ability to recruit new faculty members…"
Obtaining Valid Laboratory Data in Clinical Trials Conducted in Resource Diverse Settings: Lessons Learned from a Microbicide Phase III Clinical Trial, Crucitti et al., PLoS ONE 5(10): e13592. doi:10.1371/journal.pone.0013592, Oct 27, 2010 (full article freely available)
Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study, Lundh et al., PLoS Medicine 7(10): e1000354. doi:10.1371/journal.pmed.1000354, Oct 26, 2010 (full article freely available)
Who owns your genes? In many cases, not you,, Oct 25, 2010
"…Many gene-patent holders don't fully reserve those rights for themselves; Myriad, however, is more restrictive. It doesn't stop outside researchers from studying the BRCA 1 and 2 genes for mutations, but they can't tell study subjects what they find. Moreover, four years ago, Myriad stopped sharing information with the Breast Cancer Information Core, an online breast cancer—mutation database sponsored by the National Institutes of Health…"
Week of October 18, 2010
Grassley quizzes FDA chief on conflicts, Star Tribune, Oct 22, 2010
"A U.S. senator has asked the head of the Food and Drug Administration whether the agency monitors medical device companies' payments to doctors who are involved in clinical studies of the companies' products…"
Making Research Consent Transparent, Menikoff, Journal of the American Medical Association 304(15):1713-1714, Oct 20, 2010 (extract freely available)
Blood Doping Now a Problem in Cancer Trials, Med Page Today, Oct 20, 2010
"Cancer patients have gotten blood transfusions for the sole purpose of meeting eligibility criteria for clinical trials, raising ethical and patient safety concerns, a Canadian group warned…"
Regulators giving closer scrutiny to proposed weight-loss drugs, St Petersburg Times, Oct 19, 2010
"…"These trials are so attractive to people suffering from obesity that you need to do all you can to protect people so they make an informed decision," she said. "That's a lot of risk to take on an obesity trial."…"
Week of October 11, 2010
Tracking Professional Guinea Pigs, Abadie, Bioethics Forum, The Hastings Center, Oct 15, 2010 (full article freely available)
Revision for FAQ #4: When is an institution engaged in research?, US Office for Human Research Protections (OHRP), Oct 14, 2010
"OHRP has revised the answer to Frequently Asked Question #4: When is an institution considered to be “engaged in research”? The revisions include: Adding obtaining informed consent as an activity that can make an institution engaged; Removing the statement that pertained to awardee institutions bearing the ultimate responsibility for protecting human subjects, even when all human subjects activities are carried out by other institutions; and correcting the link at the end of the FAQ to link to the current guidance document…"
The Paradoxical Problem with Multiple-IRB Review, Menikoff, New England Journal of Medicine Online First 10.1056/NEJMp1005101, Oct 13, 2010 (full article freely available)
Being More Realistic about the Public Health Impact of Genomic Medicine, Hall et al., PLoS Medicine 7(10): e1000347. doi:10.1371/journal.pmed.1000347, Oct 12, 2010 (full article freely available)
Intentional Infection of Vulnerable Populations in 1946-1948. Another Tragic History Lesson, Frieden and Collins, Journal of the American Medical Association Early Release Article doi:10.1001/jama.2010.1554, Oct 11, 2010 (full article freely available)
First patient treated in Geron stem cell trial, Reuters, Oct 11, 2010 (scheduled to be available until Nov 11, 2010)
"U.S. doctors have begun treating the first patient to receive human embryonic stem cells, but details of the landmark clinical trial are being kept confidential, Geron Corp said on Monday…"
Week of October 4, 2010
Building a National Framework for the Establishment of Regulatory Science for Drug Development - Workshop Summary, Institute of Medicine, Oct 8, 2010
"…FDA Commissioner Margaret Hamburg describes "regulatory science" as "the critical bridge between basic scientific research discoveries and new marketed medical products," including drugs. Regulatory science, therefore, touches upon a range of disciplines--not only biomedical science, but also law, public health, and statistics. In 2010, FDA established a Regulatory Science Initiative…"
Developing a Simplified Consent Form for Biobanking, Beskow et al., PLoS ONE 5(10): e13302. doi:10.1371/journal.pone.0013302, Oct 8, 2010 (full article freely available)
Evaluating the Risks of Clinical Research, Rid et al., Journal of the American Medical Association 304:1472-1479, Oct 6, 2010 (abstract freely available)
Commentary: What Physician-Investigators Owe Patients Who Participate in Research, Litton and Miller, Journal of the American Medical Association 304:1491-1492, Oct 6, 2010 (extract freely available)
After the Media Frenzy, Preventing Another `Guatemala’, Reverby, Bioethics Forum, The Hastings Center, Oct 6, 2010 (full article freely available)
A Field Training Guide for Human Subjects Research Ethics, Merritt et al., PLoS Medicine 7(10): e1000349. doi:10.1371/journal.pmed.1000349, Oct 5, 2010 (full article freely available)
Manufacturer pleads guilty to improper use of bone cement, Philadelphia Inquirer, Oct 5, 2010
" West Chester medical device manufacturer Synthes Inc. and its Norian Corp. subsidiary agreed Monday to plead guilty to felony charges related to illegally experimenting with a bone cement on human patients without FDA consent, and to pay fines of $23.2 million…."
OHRP Correspondence: Clarification of "noninvasive" in expedited review category 3, US Office for Human Research Protections (OHRP), Oct 4, 2010
"Expedited Review Category 3 applies to the prospective collection of biological specimens for research purposes by noninvasive means. In response to a recent question, OHRP has clarified its view about the meaning of "noninvasive." Under Expedited Review Category 3, the following procedures are considered noninvasive: Vaginal swabs that do not go beyond the cervical os; Rectal swabs that do not go beyond the rectum; and Nasal swabs that do not go beyond the nares. This clarification is consistent with the Food and Drug Administration's position on these procedures…"
Rediscovering the First Miracle Drug, New York Times, Oct 4, 2010 (free one time registration required)
"…These are the blockbuster medications that can virtually raise the dead, and while the debuts of some, like the AIDS drugs, are still fresh in memory, the birth of the first one is almost forgotten. It was injectable insulin, long sought by researchers all over the world and finally isolated in 1921 by a team of squabbling Canadians. With insulin, dying children laughed and played again, as parents wept and doctors spoke of biblical resurrections…"
Week of September 27, 2010
Wellesley professor unearths a horror: Syphilis experiments in Guatemala, Boston Globe, Oct 2, 2010 (for paper draft, see link directly below this article)
"Picking through musty files in a Pennsylvania archive, a Wellesley College professor made a heart-stopping discovery: US government scientists in the 1940s deliberately infected hundreds of Guatemalans with syphilis and gonorrhea in experiments conducted without the subjects’ permission…Reverby found in the files a story of almost singular exploitation and deception, conducted in a foreign land because, the nation’s surgeon general at the time acknowledged, it could not have been done in the United States…"
“Normal Exposure” and Inoculation Syphilis: A PHS “Tuskegee” Doctor in Guatemala, 1946-48, Reverby, Journal of Policy History Special Issue on Human Subjects, Jan 2011, In press, Oct 2, 2010 (pdf)
Protecting Human Subjects Newsletter Issue 20, US Department of Energy (DOE), Oct 2010 (pdf)
Information on the 1946-1948 United States Public Health Service STD Inoculation Study, US Department of Health and Human Services (DHHS), Oct 1, 2010
"Includes statement by Secretary of State Hillary Rodham Clinton and Secretary of Health and Human Services Kathleen Sebelius, fact sheets, findings from a CDC report on the study, and more…"
Guidance for Industry. Investigational New Drug Applications (INDs). Determining Whether Human Research Studies Can Be Conducted Without an IND, US Food and Drug Administration (FDA), Oct 2010 (pdf)
"…This guidance describes when an IND is required, specific 27 situations in which an IND is not required, and a range of issues that, in FDA’s experience, have 28 been the source of confusion or misperceptions about the application of the IND regulations…"
Americans Should Not Be on a Game Show in U.S. Emergency Rooms and Ambulances, Grassley, American Journal of Bioethics 10 (10): 9 - 10, Oct 2010 (full text freely available)
An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial, Kipnis et al., American Journal of Bioethics 10 (10): 5 - 8, Oct 2010 (full article freely availalble)
Biotech Pilgrims and the Transnational Quest for Stem Cell Cures, Song, Medical Anthropology 29 (4): 384 - 402, Oct 2010, published online Jan 2011 (abstract freely available)
Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, US Food and Drug Administration (FDA), Sep 28, 2010
"The Food and Drug Administration is issuing final regulations addressing the safety reporting requirements for investigational new drug applications (INDs) found in 21 CFR part 312 and for bioavailability and bioequivalence studies found in 21 CFR part 320. This final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials…"
Incidental Findings in Imaging Research: Evaluating Incidence, Benefit, and Burden, Orme et al., Archives of Internal Medicine 170 (17):1525-1532, Sep 27, 2010 (abstract freely available)
Week of September 20, 2010
Draft Revised Federalwide (FWA) Form and Terms of Assurance – Request for Comments, US Office for Human Research Protections, Sep 23, 2010 (comments due by Oct 25, 2010)
"OHRP is announcing the availability of the draft revised FWA form and Terms of Assurance, and is seeking comment on these draft documents. Institutions engaged in non-exempt human subjects research conducted or supported by the Department of Health and Human Services must hold an OHRP-approved FWA. The draft revised FWA form and Terms of Assurance, when finalized, will supersede the current FWA documents…The Federal Register notice of availability describes key changes in the revised draft FWA documents in comparison to the current FWA documents…"
Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, US Office for Human Research Protections (OHRP), Sep 21, 2010
"OHRP has posted on its website a finalized guidance document entitled, “Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues.” The guidance document provides OHRP’s first formal guidance on this topic and finalizes the draft guidance entitled, 'Guidance on Important Consideration for When Participation of Human Subjects in Research is Discontinued,' …"
U of M's 'DNA on a stick' study becomes platform for debate on genetic-research ethics,, Sep 21, 2010
"…Should kids be enticed to give over their individual genetic codes in exchange for tickets to fair rides — and, more central to the study, for the chance to further understanding of the relationship between genes and childhood growth and health? Debate over that question is giving this study an unintended purpose. It has become a platform for exploring the latest ethical considerations about genetic research, considerations that can't be left to scientists alone…"
Week of September 13, 2010
New Drugs Stir Debate on Rules of Clinical Trials, New York Times, Sep 18, 2010 (free one time registration required)
"…Controlled trials have for decades been considered essential for proving a drug’s value before it can go to market. But the continuing trial of the melanoma drug, PLX4032, has ignited an anguished debate among oncologists about whether a controlled trial that measures a drug’s impact on extending life is still the best method for evaluating hundreds of genetically targeted cancer drugs being developed…"
Could a clinical trial be right move for you?, Houston Chronicle, Sep 18, 2010
"Suppose you are ill with a serious or chronic condition — cancer, diabetes, psoriasis or any of a number of diseases - and your doctor suggests you consider taking part in a "clinical trial" of a new therapy that may or may not prove better than the current standard of care. How do you decide if this is a good idea for you or not?…"
The Public’s Quiet Savior From Harmful Medicines, New York Times, Sep 13, 2010 (free one time registration required)
"Dr. Frances Oldham Kelsey…was once America’s most admired civil servant — celebrated for her dual role in saving thousands of newborns from the perils of the drug thalidomide and in serving as midwife to modern pharmaceutical regulation…"
Medical Industry Ties Often Undisclosed in Journals, New York Times, Sep 13, 2010 (free one time registration required; for Arch Int Med article, see journal section below)
"Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year, according to a study released on Monday…"
From Disclosure to Transparency. The Use of Company Payment Data, Chimonas et al., Archives of Internal Medicine Online First doi:10.1001/archinternmed.2010.341, Sep 13, 2010 (full article freely available)
Letter RE: Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act, American Associaton of Medical Colleges (AAMC), Sep 13, 2010 (pdf)
"…The AAMC is pleased that OCR recognizes the barriers that the current privacy rule has imposed on researchers engaged in research to improve the health of the nation, and has proposed several important changes to the HIPAA Privacy Rule as it applies to research. The Privacy Rule should balance the need to protect the privacy of the health information of patients who have generously chosen to participate in research with the need for researchers to have appropriate access to that information to advance knowledge…"
Week of September 6, 2010
James Watson: 'cancer research is over regulated', The Guardian, Sep 10, 2010
"…Watson told journalists that he was in favour of less regulation for clinical trials as this could speed up the process of finding a cure for cancer: "We're terribly held back on clinical tests by regulations which say that no one should die unnecessarily during trials; but they are going to die anyway unless we do something radical. I think the ethics committees are out of control and that it should be put back in the hands of the doctors…"
Appeals Court Allows Stem Cell Funding for Now, New York Times, Sep 9, 2010 (free one time registration required)
"The government may resume funding of embryonic stem cell research for now, an appeals court said Thursday, but the short-term approval may be of little help to research scientists caught in a legal battle that has just begun…"
Exclusion of Genetic Information From the Medical Record: Ethical and Medical Dilemmas, Klitzman, Journal of the American Medical Association 304(10):1120-1121, Sep 8, 2010 (extract freely available)
Do IRBs Protect Human Research Participants?, Grady, Journal of the American Medical Association 304(10):1122-1123, Sep 8, 2010 (extract freely available)
Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research - Workshop Summary, Institute of Medicine (IOM), Sep 2010
"…On May 24, 2010, the IOM held a workshop to examine the issues surrounding the use of newborn screening samples for translational research, including autonomy, confidentiality, privacy, informed consent, and consent to future use of samples originally taken for a different purpose. This document summarizes the workshop…"
Volunteers at Walter Reed endure mosquito bites to help find a malaria vaccine, Washington Post, Sep 7, 2010 (free one time registration required)
"Jesse Bolton is a pretty buff guy. He's in the Navy, and a few mosquitoes don't scare him much. But he has seen what the bite of a malaria-carrying insect can do. One of his squadmates picked it up in Africa a few years ago. That's why Bolton was sitting in a suite at the Residence Inn in Bethesda in June, getting ready to give a blood sample. As part of a scientific experiment, Bolton had allowed himself to be bitten by a pretty buff mosquito…"
The Haunting of Medical Journals: How Ghostwriting Sold “HRT”, Fugh-Berman, PLoS Medicine 7(9): e1000335, Sep 7, 2010 (full article freely available)
Week of August 30, 2010
Determination Letter, Office for Human Research Protections (OHRP), Sep 2, 2010 (pdf)
"The Office for Human Research Protections (OHRP) posted on its website OHRP's September 2, 2010 letter of determination along with a U.S. Food and Drug Administration (FDA) memorandum. OHRP received allegations concerning activities conducted by Dr. Maria New at Weill Cornell Medical College and Mount Sinai School of Medicine involving the use of dexamethasone in pregnant women at risk of carrying a female fetus with congenital adrenal hyperplasia. [OHRP] determined that the allegations raised by the complainants are unproven and did not find any evidence that Dr. Maria New violated the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46)…"
Kids swap DNA for fairground rides, Nature, Sep 1, 2010
"…This week, researchers from the University of Minnesota in Minneapolis are collecting DNA from young fair-goers and their parents as part of an effort to uncover genetic influences on normal child health and development…In return for their DNA, participants receive ride tickets and other small gifts, as well as passes to attend the fair next year, where Spector hopes they will continue their participation in the study…But the Gopher Kids Study is not without its critics, who worry about the setting, the involvement of children and the consent forms parents sign…"
People want to be asked before sharing genetic data, EurekAlert!, Sep 1, 2010
"…When the team asked Group Health patients who participate in ACT whether their "de-identified" (anonymous) genetic and medical record information could be shared in the database, 86 percent said yes. Then the team surveyed 365 ACT study participants who had agreed to let their genetic information be shared, mostly because of a "desire to help others." In the survey, 90 percent of participants said they thought it was important to have been asked for this reconsent…Alternatives to reconsent—including opting out, being notified, or neither individual permission nor notification—were unacceptable to 40 percent, 67 percent, and 70 percent of the surveyed participants…"
Justice Dept. appeals to restart stem cell research, Washington Post, Sep 1, 2010 (free one time registration required)
"…The Justice Department asked U.S. District Judge Royce Lamberth to suspend a temporary injunction he issued last week blocking the funding and filed a notice of plans to appeal the decision to the U.S. Court of Appeals. Lamberth, ruling in a lawsuit filed by two researchers working on alternatives to the cells, said the funding violated a federal rule that prohibits federal tax money from being used for research that involves the destruction of human embryos…"
Ethical, Evidence-Based Guidelines for Contraceptive Use in Research, Kaposy and Baylis, IRB: Ethics & Human Research 32 (5): 1-9, Sep-Oct 2010 (full article freely available with free one-time registration)
When IRBs Review Ethically Challenging Protocols: Views of IRB Chairs about Useful Resources, Sirotin et al., IRB: Ethics & Human Research 32 (5): 10-19, Sep-Oct 2010 (abstract freely available)
Clinical Trials: Professional Guinea Pigs, Time, Sep 2010 (video)
"Human subjects are paid in Phase 1 clinical trials to test the toxicity levels of new drugs. Some make a profession out of it, but researchers worry about health risks…"
International Compilation of Human Research Protections 2010 Edition, US Office for Human Research Protections (OHRP), Sep 2010 (pdf)
"This Compilation lists the approximately 1,100 laws, regulations, and guidelines that govern human subjects research in 96 countries, as well as standards from a number of international and regional organizations. This Compilation was developed for IRBs/Research 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 these standards are followed appropriately. The 2010 Edition includes numerous additions and updates to the 2009 Edition…"
Week of August 23, 2010
First tests for stem cell therapy are near, Washington Post, Aug 29, 2010 (free one time registration required)
"…Scientists are poised to inject cells created from embryonic stem cells into some patients with a progressive form of blindness and others with devastating spinal cord injuries. That's a welcome step for researchers eager to move from the laboratory to the clinic and for patients hoping for cures. But…Some argue that the experiments are premature, others question whether they are ethical, and many fear that the trials risk disaster for the field if anything goes awry…"
DNA test flip-flop stirs debate at UC, San Francisco Chronicle, Aug 28, 2010
" When UC Berkeley changed its controversial DNA-testing program under pressure earlier this month so that incoming students would no longer receive personalized genetic results, Elizabeth Noah considered asking for her sample back…"
U.S. Judge Rules Against Obama’s Stem Cell Policy, New York Times, Aug 24, 2010 (free one time registration required)
"A federal district judge on Monday blocked President Obama’s 2009 executive order that expanded embryonic stem cell research, saying it violated a ban on federal money being used to destroy embryos. The ruling came as a shock to scientists at the National Institutes of Health and at universities across the country, which had viewed the Obama administration’s new policy and the grants provided under it as settled law…"
With Corporate Backing, Stem Cells Go From Irvine Campus to First Human Therapy Test, Chronicle of Higher Education, Aug 24, 2010
"In the last days of July, the Food and Drug Administration gave the green light to a clinical trial that has been nearly a decade in the making. The federal agency approved a test of some of the first fruits of human-embryonic-stem-cell research, in a new therapy that could help patients recover from spinal-cord injury. The trial will be the first to use embryonic stem cells in human beings…"
Stem Cell Scientists Seek Money, Law After Court Bans U.S. Research Funds, Bloomberg, Aug 24, 2010
"About 35 percent of the $200 million the U.S. government planned to award this year in grants for embryonic stem cell research won’t be distributed after a judge’s ruling banned the funding. The National Institutes of Health will withhold $54 million in annual grants it expected to renew in September, plus $15 million to $20 million for new projects being considered in the next month, Francis Collins, the agency’s director, said yesterday…"
Split Ruling on Confidentiality, Inside Higher Ed, Aug 23, 2010
"A federal judge ruled last week that education researchers at Arizona State University and the University of Arizona can't be forced to release records that identify individual teachers they interviewed for their studies, which have become part of a court battle. But the judge ruled that the names of schools and districts studied must be released…"
What to Tell the Patients After a Trial Goes Awry, New York Times, Aug 23, 2010 (free one time registration required)
"…when Eli Lilly announced last week that its promising Alzheimer’s drug was making patients worse and that it was halting two large clinical trials, it seemed likely that Dr. Ross would hear from family members of his patients. Are other experimental Alzheimer’s drugs safe? They might ask. Should they get their family members out of those Alzheimer’s studies? Not a single family member called. And Dr. Ross is not sure why…"
Week of August 16, 2010
Disturbing suicide tale: U of M professor reexamines ethics questions of drug trial,, Aug 20, 2010
"…But Elliott’s purpose in writing the article wasn’t only to revisit the tragic details of Markingson's story. “[T]he more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported,” he writes. “The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.”…"
Preparing for a Consumer-Driven Genomic Age, Evans et al., New England Journal of Medicine Online First 10.1056/NEJMp1006202, Aug 18, 2010 (full article freely available)
Risks of Presymptomatic Direct-to-Consumer Genetic Testing, Annes et al., New England Journal of Medicine Online First 10.1056/NEJMp1006029, Aug 18, 2010 (full article freely available)
The Costs and Underappreciated Consequences of Research Misconduct: A Case Study, Michalek et al., PLoS Medicine 7(8): e1000318, Aug 17, 2010 (full article freely available)
Letter: Comment on NIH Proposed Rule Concerning the Management of Financial Conflicts of Interest in Federally-Funded Research, Association of American Universities, Association of American Medical Colleges, American Council on Education, Association of Public and Land-grant Universities, Aug 17, 2010 (pdf)
"…The organizations noted that the rule generally balances the disclosure and reporting of financial conflicts of interest with institutional resources required to conform to the new regulations, but urged HHS to consider mechanisms to help reduce the regulatory burdens that will be placed on institutions and investigators…"
Week of August 9, 2010
Another Subpoena for Research, Inside Higher Ed, Aug 13, 2010
"…The UCLA center has been coordinating a major research effort on Arizona's controversial policies about education for schoolchildren learning English…Horne is seeking all of the raw data behind the study -- even though the research protocols as reviewed by Institutional Review Boards stipulated confidentiality for the teachers, schools and districts that were studied. The university has released district names in its partial compliance. The researchers believe (and their IRBs believed) that the state might retaliate against individual teachers who questioned the state's policies or against the schools or districts employing these teachers…"
U.S. Inquiry of Drug Makers Is Widened, New York Times, Aug 13, 2010 (free one time registration required)
"At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries…Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad…"
UC Berkeley will not send students DNA results, San Francisco Chronicle, Aug 13, 2010
"Under pressure from state public health officials, the professors behind UC Berkeley's controversial plan to genetically test incoming freshmen and transfer students said Thursday they will scale back the program so that participants will not receive personal results from their DNA samples…On Wednesday, officials from the state Department of Public Health said the university must use certified laboratories that meet specific standards, rather than the campus labs, if the school planned to release individualized test results, identified only by barcodes, to students…"
Disclosing Industry Relationships — Toward an Improved Federal Research Policy, New England Journal of Medicine 363:604-606, Aug 12, 2010 (full article freely available)
Should Sensitive Information From Clinical Trials Be Included in Electronic Medical Records?, Dunlop, Journal of the American Medical Association 304(6): 685-686, Aug 11, 2010 (extract freely available)
Interview With Kimberly Tallbear, Gene Watch, Aug 11, 2010
"…IRBs vary from university to university, and some are much stricter than others. For example, the Arizona State University IRB is, after the Havasupai lawsuit, incredibly strict where tribes are concerned. If you’re going to do research with native populations, whether it’s biological research or even social science research, you have to get approval from the tribal council before the university will even look at your protocol. On the other hand, I’m doing a project at Berkeley where I’m interviewing both genetic scientists and tribal government people, and Berkeley didn’t look twice at my interview with indigenous people…"
Author on leave after Harvard inquiry, Boston Globe, Aug 10, 2010
"…It is unusual for a scientist as prominent as Hauser — a popular professor and eloquent communicator of science whose work has often been featured on television and in newspapers — to be named in an investigation of scientific misconduct. His research focuses on the evolutionary roots of the human mind…"
Week of August 2, 2010
Internet research raises institutional review boards,, Aug 7, 2010
"… the boards don't talk to each other about it and there's a real gap in the literature base and understanding of what is happening at the national level." Buchanan and co-researchers spent a year surveying IRBs and received more than 300 responses that formed an interesting dataset of how IRBs were handling Internet research. Based on 2007-08 data, the study found that about half of the IRBs surveyed considered Internet research a concern or of interest to their boards. The study also found that less than 8% of IRBs had Internet research protocols, including checklists, review tools, policies, and guidelines. Another 17% said these protocols were under development…"
Pentagon questions drug study on troops, The Boston Globe, Aug 3, 2010
"The Department of Defense is investigating whether 80 wounded American service members in Iraq were improperly used as subjects in a test of a possible treatment for brain injuries, according to the Pentagon’s Office of Inspector General…"
Outcome Reporting Among Drug Trials Registered in, Bourgeois et al., Annals of Internal Medicine 153 (3): 158-166, Aug 3, 2010 (abstract freely available)
Week of July 26, 2010
Community Engagement in Research: Frameworks for Education and Peer Review, Ahmed and Palermo, American Journal of Public Health 100: 1380-1387, Aug 2010 (abstract freely available)
Workshop Report: Transforming Clinical Research in the United States, Institute of Medicine, Aug 2010
"The IOM held a public workshop October 7-8, 2009, to evaluate the state of clinical research in the U.S. and to identify strategies for improving clinical trials’ efficiency and effectiveness. Clinical trial experts discussed their successes, failures, and challenges in conducting clinical research. This document summarizes the workshop…"
Expected Release Date for the 2nd Edition of the TCPS: December 2010, Panel on Research Ethics (PRE), Canada, Aug 2010
"The Interagency Advisory Panel on Research Ethics (the Panel) plans to submit their final version of the revised draft 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) by late summer…"
Senator Seeks Data on Artificial Hips and Knees, New York Times, Jul 31, 2010 (free one time registration required)
"A top Senate Republican is asking the nation’s biggest maker of artificial hips and knees to disclose information about how it handles complaints about possible product flaws from its medical consultants…"
Stem Cell Trial Wins Approval of F.D.A., New York Times, Jul 30, 2010 (free one time registration required)
"The world’s first authorized test in people of a therapy derived from human embryonic stem cells has been cleared by the Food and Drug Administration…"
Week of July 19, 2010
Jobless get by as medical guinea pigs, Contra Costa Times, Jul 25, 2010
"…The CNS Network, a clinical research organization based in Garden Grove, has seen a 20 percent spike in study participation since the economic downturn, said Jack Stephen, president and co-founder of the network. Officials say the increase is due largely to money-strapped participants. Such is the case with Bonano. Though he was planning to work at a grocery store, a hiring freeze left Bonano unemployed, and he has struggled to find a job. He heard about clinical trials through a friend and has since participated in about nine studies testing drugs for a myriad of different conditions, including allergies and diabetes…"
Direct-to-Consumer Genetic Tests. Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices, Statement of Gregory Kutz, Managing Director Forensic Audits and Special Investigations, US Government Accountability Office, Jul 22, 2010 (pdf)
Should Patients Read the Doctor’s Notes?, New York Times, Jul 22, 2010
"…researchers have begun the largest study to date of open access, aptly named Open Notes, involving over 100 primary care physicians and approximately 25,000 patients from three health care centers — the Beth Israel Deaconess Medical Center in Boston, the Geisinger Health System in Danville, Pa., and the Harborview Medical Center in Seattle. In the study, patients who have just seen their doctors will receive an e-mail message directing them to a secure Web site where they can view the signed physician notes…"
Duke Scientist Suspended Over Rhodes Scholar Claims, New York Times, Jul 20, 2010 (free one time registration required)
"Duke University School of Medicine has suspended a researcher and stopped patient enrollment in three cancer studies upon learning of reports that the researcher had overstated his academic credentials…"
Week of July 12, 2010
Studies Halted at Brain Lab Over Impure Injections, New York Times, Jul 16, 2010 (free one time registration required)
"Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities…."
The Havasupai Indian Tribe Case — Lessons for Research Involving Stored Biologic Samples, Mello and Wolf, New England Journal of Medicine 363:204-207, Jul 15, 2010 (extract freely available)
Disclosing Industry Relationships — Toward an Improved Federal Research Policy, Campbell and Zinner, New England Journal of Medicine 10.1056/NEJMp1006973, Jul 15, 2010 (full article freely available)
Modifications to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act, Notice of Proposed Rulemaking, Federal Register Volume 75, Number 134: 40868-40924, Jul 14, 2010
"…The purpose of these modifications is to implement recent statutory amendments under the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act” or “the Act”), to strengthen the privacy and security protection of health information, and to improve the workability and effectiveness of these HIPAA Rules…"
Announcement: Educational Videos Now Available, US Office for Human Research Protections (OHRP), Jul 14, 2010
"OHRP is pleased to announce the availability for the first time of educational videos on the HHS YouTube channel. The videos include "Research Use of Human Biological Specimens and Other Private Information" and "Reviewing and Reporting Unanticipated Problems and Adverse Events," in addition to two new videos "Institutional Review Board (IRB) Membership" and "General Informed Consent Requirements Parts I Research Investigator and Part II Research Subject"…"
F.D.A. Panel Votes to Restrict Avandia, New York Times, Jul 14, 2010 (free one time registration required)
"A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks…panel members voiced great skepticism about the company’s trustworthiness after questions were raised about its clinical trials. And internal company documents showed that the company for years kept crucial safety information about Avandia from the public…."
Editorial: Are we keeping research participants safe enough?, Hébert and Fergusson, Canadian Medical Association Journal, Jul 13, 2010 (full article freely available)
Researcher urges Health Canada to suspend "unethical" diabetes drug trial, Canadian Medical Association Journal, Jul 13, 2010
"…The FDA has announced it will hold its own public hearing in July to present all known heart-related safety data on rosiglitazone, and to provide an updated assessment of the risks and benefits of using the drug. But Juurlink and Dr. Sidney Wolfe, the director of health research at Public Citizen, believe the FDA should suspend the trial immediately, on the grounds that it is unethical to knowingly give participants in the rosiglitazone arm a drug that is more harmful than pioglitazone, the medication administered in the other arm of the trial…"
Avandia Panel Hints at Doubts Over Credibility, New York Times, Jul 13, 2010 (free one time registration required)
"A panel of medical advisors listened on Tuesday as a parade of feuding government experts gave conflicting views about whether the controversial diabetes medicine Avandia should be withdrawn from the market…Such frank skepticism about the trustworthiness of a large drug maker is almost unheard of during a meeting of a Food and Drug Administration advisory committee meeting. Almost as unusual was the sight of the agency’s scientists openly disagreeing with one another. But the controversy surrounding Avandia has split the agency down the middle…"
Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review, Hines et al., PLoS Medicine 7(7): e1000280. doi:10.1371/journal.pmed.1000280, Jul 13, 2010 (full article freely available)
Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report, Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, US Institute of Medicine (IOM), Jul 12, 2010 (pdf)
"…FDA requested a letter report addressing question 1 of the charge: What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?…"
Week of July 5, 2010
HHS Strengthens Health Information Privacy and Security through New Rules, UD Department of Health and Human Services News Release, Jul 8, 2010 (for notice of proposed rulemaking, see Regulatory and Government section)
"…The proposed rule announced today would strengthen and expand enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Enforcement Rules by: 1) expanding individuals’ rights to access their information and to restrict certain types of disclosures of protected health information to health plans; 2) requiring business associates of HIPAA-covered entities to be under most of the same rules as the covered entities…"
Exposing the Student Body: Stanford Joins U.C. Berkeley in Controversial Genetic Testing of Students, Scientific American, Jul 6, 2010
"…Stanford and Berkeley faced the same essential ethical dilemmas in creating their programs: avoiding coercion, protecting students' privacy and adequately preparing students to interpret the results of their tests. But the two universities took markedly different approaches to designing and executing their respective projects…"
Pitt always on lookout for human subjects, Pittsburgh Tribune-Review, Jul 6, 2010
"…The Taubes are among more than 10,000 names on a Pitt registry of people who either take part in or are interested in getting information on research studies. The registry is expected to grow as all medical practices affiliated with the University of Pittsburgh Medical Center get registration materials for their outpatients…Although most of the studies deal with health, some address subjects such as communication or education…"
Week of June 28, 2010
Discrepancies between research advertisements and disclosure of study locations in trial registrations for USA-sponsored research in Russia, Patrone, Journal of Medical Ethics 36:431-434, Jul 2010 (abstract freely available)
Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada, Canadian Association of Research Ethics Boards (CAREB), Jul 2010 (includes historical background to document and Health Canada response)
"…This document is intended to assist the research ethics community in Canada in standardizing the reporting of unanticipated problems, including certain adverse events, and should be viewed as a recommendation only. This is the first guidance document ever issued by CAREB…"
Assessing the Readability of Non-English-Language Consent Forms: The Case of Kiswahili for Research Conducted in Kenya, Kithinji and Kass, IRB: Ethics & Human Research 32 (4): 10-15, Jul-Aug 2010 (full article freely available with free one time registration)
Research at the Auction Block: Problems for the Fair Benefits Approach to International Research, London and Zollman, Hastings Center Report 40 (4): 34-45, Jul - Aug 2010 (abstract freely available)
In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making, Task Force on Financial Conflicts of Interest in Clinical Care, Association of American Medical Colleges (AAMC), Jun 30, 2010 (full report freely available)
"This new report by the Association of American Medical Colleges urges U.S. teaching hospitals to establish policies that manage financial relationships between physicians and industry so they do not influence patient care. "In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making" provides guidance on how academic medical centers can identify, evaluate, and disclose conflicts of interest in clinical care…"
China pushing the envelope on science, and sometimes ethics, Washington Post, Jun 28, 2010 (free one time registration required)
"…Unburdened by social and legal constraints common in the West, China's trailblazing scientists are also pushing the limits of ethics and principle as they create a new -- and to many, worrisome -- Wild West in the Far East…"
Week of June 21, 2010
Web genomics exposes ethics gaps, The Scientist, Jun 24, 2010 (may require free one time registration; for companion journal article and editorial, see Journal section below)
"With contributions from 9,000 web-savvy customers, the personal genetics company 23andMe has linked a suite of genes to eight rather playful traits, such as the ability to smell post-asparagus pee or the tendency to sneeze in sunlight. But in getting the results published today (June 24) in PLoS Genetics, they unintentionally illuminated an ungoverned landscape of human genetics research. The study wasn't previewed by a human research ethics committee, but neither the company nor publishers acted illegally…"
Web-Based, Participant-Driven Studies Yield Novel Genetic Associations for Common Traits, Eriksson et al., PLoS Genet 6(6): e1000993. doi:10.1371/journal.pgen.1000993, Jun 24, 2010 (full article freely available)
Consent and Internet-Enabled Human Genomics, Gibson and Copenhaver, PLoS Genet 6(6): e1000965. doi:10.1371/journal.pgen.1000965, Jun 24, 2010 (full editorial freely available)
EPA Reverses Controversial ‘Human Guinea Pig’ Rule, Wired Science, Jun 22, 2010 (for EPA statement and policy guidance, see first section)
"Under proposed changes to federal research ethics standards, the Environmental Protection Agency will no longer accept studies that use people as guinea pigs in chemical tests. In 2006, under chemical-industry pressure, and over arguments that the studies were scientifically and ethically bankrupt, the EPA declared such data acceptable. On June 16, the EPA reversed its decision…"
Concern Over Foreign Trials for Drugs Sold in U.S., New York Times, Jun 21, 2010 (free one time registration required, for report see first section)
"Medical ethicists have worried for years about the growing share of new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected, but no one knew how big the potential problem was. But according to a report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites…"
Week of June 14, 2010
Expanded Protections for Subjects in Human Studies Research, US Environmental Protection Agency (EPA), Jun 18, 2010
"On June 16, 2010, EPA settled a lawsuit over its 2006 regulation that established protections for subjects of human research. Under the settlement agreement, EPA agrees to propose amendments to the final human studies rule consistent with language negotiated with groups who challenged that rule. The changes will address the three principal areas identified by the petitioners: 1. the scope of the rule; 2. its consistency with the 2004 National Academy of Science recommendations; and 3. its consistency with the Nuremberg Code. The amendments will formalize many current procedures that EPA has been following as it implemented the 2006 rule. The Agency will propose the changes in a Federal Register notice before January 16, 2011, and at the same time open a public comment period. The settlement requires EPA to finalize the amendments by December 16, 2011…"
Enrolling Pregnant Women in Research — Lessons from the H1N1 Influenza Pandemic, Goldkind et al., New England Journal of Medicine 362:2241-2243, Jun 17, 2010 (full article freely available)
Cancer Clinical Trials — A Chronic but Curable Crisis, Young, New England Journal of Medicine, Jun 17, 2010 (full article freely available)
How Are the Interests of Incapacitated Research Participants Protected through Legislation? An Italian Study on Legal Agency for Dementia Patients, Gainotti et al., PLoS ONE 5(6): e11150. doi:10.1371/journal.pone.0011150, Jun 16, 2010 (full article freely available)
The Path to Personalized Medicine, Hamburg and Collins, New England Journal of Medicine 10.1056/NEJMp1006304, Jun 15, 2010 (full article freely available)
FDA seeks to ban Chicago HIV doctor from research. Regulators say his clinic submitted phony data, forms with forged signatures, Chicago Tribune, Jun 14, 2010
"…Berger, who has been involved in drug research from the early days of the AIDS crisis, has served as a principal investigator on more than 100 clinical trials involving HIV drugs. With about 3,000 patients, his Northstar Medical Center describes itself as the largest private HIV treatment and research center in the Chicago area…"
Week of June 7, 2010
F.D.A. Faults Companies on Unapproved Genetic Tests, New York Times, Jun 11, 2010 (free one time registration required)
"The Food and Drug Administration is cracking down on 23andMe and other companies that sell genetic tests directly to consumers. The F.D.A. sent letters this week to five companies involved in that business, saying their tests are medical devices that must receive regulatory approval before they can be marketed…"
NIH chief Collins faces stem cell donation dilemma, USA Today, Jun 11, 2010
"…On Thursday, A National Institutes of Health panel ruled one sentence of legal language in the consent form used by RGI meant these hundreds of cell "lines", or colonies, shouldn't receive federal research funding…The trouble came from a sentence at the end, "We further agree that we, our heirs, successors, relatives, representatives, and/or agents will not bring any action in law or in equity, or in any administrative setting, related to our participation in this study." That's "exculpatory" language, which waives a patient's rights to sue for negligence or harm, 4 of the 5 ACD panel members agreed, something forbidden under the federal "Common Rule" governing research…"
At the NIH, conflicting stories of conflict of interest, Washington Post, Jun 9, 2010 (free one time registration required)
"It's been just three weeks since the National Institutes of Health announced new guidelines to deal with long-standing concerns that federally funded researchers were being influenced by millions of dollars from the drug industry and other companies, which would naturally love to see the researchers' efforts reach the right conclusions. The NIH's tougher disclosure requirements came in response to a spate of bad press showing huge private-sector bucks flowing to researchers at universities and institutes…"
Week of May 31, 2010
Medical Ethics Lapses Cited in Interrogations, New York Times, Jun 6, 2010 (free one time registration required)
"Medical professionals who were involved in the Central Intelligence Agency’s interrogations of terrorism suspects engaged in forms of human research and experimentation in violation of medical ethics and domestic and international law, according to a new report from a human rights organization…"
As He Worked to Strengthen Ethics Rules, NIMH Director Aided a Leading Transgressor, Chronicle of Higher Education, Jun 6, 2010
"A yearlong effort by the National Institutes of Health to toughen its policies against financial conflicts of interest was led by an administrator who quietly helped one of the most prominent transgressors get hired by the University of Miami after a decade of undisclosed corporate payments led to his departure from Emory University, a Chronicle investigation has found…"
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs. Frequently Asked Questions – Statement of Investigator (Form FDA 1572), US Food and Drug Administration (FDA), Jun 4, 2010 (pdf)
"…The Food and Drug Administration (FDA or agency) has received a number of questions about Form FDA 1572. The most frequently asked questions are answered…"
Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials (OEI-01-08-00510), US Department of Health and Human Services (DHHS) Office of the Inspector General (OIG), Jun 2010 (pdf)
New Conflict of Interest Rules Help Spur Financial Disclosures Online, American Association of Medical Colleges AAMC Reporter, Jun 2010
"With lawmakers and the public ever more vigilant of the conflicts of interest that may occur between private industry and the clinical and research communities, more medical institutions and companies are disclosing financial relationships online. No definitive lists exist, but informal Web analysis shows that pharmaceutical companies and academic medical centers are establishing Web sites to publicize and track physician-industry relationships…"
Week of May 24, 2010
When Patients Meet Online, Are There Side Effects?, New York Times, May 28, 2010 (free one time registration required)
"Could we cure diseases faster, or at least better control them, through crowd-sourcing? That is the premise behind social networking sites like and, which offer online communities for patients and collect members’ health data for research purposes…"
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections, Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services, Federal Register 75 (101): 29549-29550, May 26, 2010 (nominations due by July 12, 2010)
"The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research…"
Under Fire, Berkeley Modifies One Part of DNA Testing Program, Chronicle of Higher Education, May 25, 2010 (see also 'The DNA Assignment')
"In response to a wave of criticism, the University of California at Berkeley is modifying one aspect its controversial plan to allow many freshmen this fall to submit a personal DNA sample…drop a plan to give more-extensive DNA-testing kits as prizes to four students…"
British doctor who linked vaccine to autism struck off register, Vancouver Sun, May 25, 2010
"A British doctor who linked the measles, mumps and rubella (MMR) vaccine with autism was struck off the medical register Monday after being found guilty of serious professional misconduct…"
Managing Financial Conflict of Interest in Biomedical Research, Rockney and Collins, Journal of the American Medical Association Early Release Article 303(23):(doi:10.1001/jama.2010.774), May 24, 2010 (full article freely available)
Was this ethical? Scientists dare to deceive, Philadelphia Inquirer, May 24, 2010
"Wharton's Katherine L. Milkman and Columbia's Modupe N. Akinola sent e-mails to 6,300 professors at top institutions. The messages, purporting to be from a student interested in their work, asked for a 10-minute meeting - half said quickly (to test an impulsive response), the other half said next week (to assess a thought-out response). The students' names also varied to reflect sex, ethnicity, and race (Lamar Washington vs. Brad Anderson). Those professors who responded (67 percent) got an immediate "debriefing" e-mail…"
Secretary's Advisory Committee for Human Research Protections (SACHRP) March 9-10, 2009 Meeting Materials, May 24, 2010 (includes agenda, minutes, presentation materials)
Week of May 17, 2010
Chasing Conflicts of Interest, Inside Higher Ed, May 21, 2010 (for proposed rule, see Regulatory and Government Section above)
"The National Institutes of Health on Thursday proposed significant changes in federal regulations governing financial conflicts of interest in biomedical research -- changes that would increase the expectations (and, they are likely to argue, the burden) on universities to examine and report potentially problematic entanglements…the proposed rules, which would update the regulations set in 1995, would significantly alter the nature and extent of the information that researchers must report to their employers and that institutions must report to the government, as well as the extent to which the public will be made aware of possible conflicts of interest…"
Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors; Proposed Rule, US National Institutes of Health (NIH), May 21, 2010 (comments due by July 20, 2010)
"…the proposal of amendments that would expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutional oversight and management of investigators' financial conflicts of interests, as well as NIH's compliance oversight.."
The DNA Assignment, Inside Higher Ed, May 18, 2010 (see also 'Under Fire')
"…This summer, the university’s College of Letters and Science -- home to three quarters of Berkeley’s 25,000 undergraduates -- will ask freshmen and transfers to return a cotton swab covered in cells collected from their inner cheeks in an effort to introduce them to the emerging field of personalized medicine…Geneticists will analyze each sample for three genes: metabolism of folate, tolerance of lactose and metabolism of alcohol, all relatively innocuous and perhaps useful in students’ daily lives…“This is all going to be done with institutional safeguards for privacy,” Schlissel said. The university’s Committee for Protection of Human Subjects scrutinized the plans closely to ensure that the project would be “ethical and private and the like."…"
Cellphone cancer study questionable: scientist, National Post, May 17, 2010
"A major new international study on the possible link between cellphone use and brain cancer was seriously undermined by over-zealous ethics boards, helping lead to "perplexing" results from the $27-million project, says one of the Canadian researchers involved…The epidemiologist suggested that the people who sit on ethics committees for research-funding bodies and hospitals do not always have the best interests of science in mind…"
Week of May 10, 2010
Federal agents probing Army's use of trauma drug, Baltimore Sun, May 16, 2010
"Federal criminal investigators are exploring the Army's use of a controversial and expensive blood-clotting drug injected into wounded troops in Iraq and Afghanistan…It has since proved largely ineffective in clinical trials and been the subject of safety warnings by U.S. and European regulators…"
Walgreens Delays Selling Personal Genetic Test Kit, New York Times, May 12, 2010 (free one time registration required)
"Walgreens said late Wednesday that it would postpone selling a personal genetic test through its drugstores after the Food and Drug Administration challenged the legality of the test…the agency suggested that Pathway’s test needed regulatory approval before it could be sold…"
Payment Offers to Egg Donors Prompt Scrutiny, New York Times, May 10, 2010 (free one time registration required; see also journal section below)
"…But a study in the most recent issue of The Hastings Center Report, a leading bioethics journal, found that the compensation being touted in ads aimed at young women often exceeded industry guidelines. The study is the latest development in a long-running debate over how much — or even whether — egg donors should be paid. .."
Week of May 3, 2010
Research ethics council faces dissolution after government yanks funding, Canadian Medical Association Journal, May 6, 2010
"…the one body involved in any manner of review of boards, the National Council on Ethics in Human Research (NCEHR), which largely operated in an educational mode, has had its funding yanked by Health Canada and the Canadian Institutes of Health Research…The lack of oversight is apparent in the whispered concerns expressed by Canadian research ethics experts"
Experimental MS surgery done under radar, CBC News, May 5, 2010
"A handful of Canadians with multiple sclerosis have had an experimental surgical procedure under the radar in this country, despite lack of proof of its safety or effectiveness…it's hard to know what exactly went on, but we're no longer doing the procedure unless we become part of an investigational group," said Dr. Brian Weinerman…"
Report: CNS Clinical Trials: Suicidality and Data Collection, Institute of Medicine (IOM), May 4, 2010
"The Food and Drug Administration (FDA) now requires that all clinical trials for drugs that affect the central nervous system—including psychiatric drugs—are assessed for whether that drug might cause suicidal ideation or behavior. The IOM’s Forum on Neuroscience and Nervous System Disorders hosted a meeting on June 26, 2009, to discuss the FDA’s new policy and how to analyze best whether suicidal thoughts predict actual suicidal behavior in the near future…"
Week of April 26, 2010
Revised Code of Ethics and Practice, American Association of Public Opinion Research (AAPOR), May 2010
The Evolution of Consent Forms for Research: A Quarter Century of Changes, Albala et al., IRB: Ethics & Human Research 32 (3): 7-11, May-June 2010 (freely available with one time free registration)
Pamela Fink Says She Was Fired After Getting a Double Mastectomy To Prevent Breast Cancer, ABC News, Apr 30, 2010
"A Connecticut woman claims she was fireddespite years of glowing reports by her employer after she told them she had tested positive for the breast cancer gene and would undergo a double mastecomy as a preventative measure…She is claiming that by doing so, her employer, MXenergy, a natural gas and electricity provider, violated the Genetic Information Nondiscriminaton Act as well as the Americans with Disabilities Act…"
Use of a Centralized Institutional Review Board (IRB), US Office for Human Research Protections (OHRP), Apr 30, 2010
"OHRP has posted on its website OHRP's April 30, 2010 response to a medical center regarding the use of a central IRB, as well as the incoming letter to OHRP. We have chosen to make these letters available since they address an issue that may be of interest to others…"
Clinical trials hindered by red tape: MDs, CBC News, Apr 26, 2010
"…regulations have grown so burdensome that they are overwhelming the very things they are meant to support and safeguard. Consequently, clinical research has been substantially decreased among industrialized countries…"
Are we keeping research participants safe enough?, Hebert and Fergusson, Canadian Medical Association Journal DOI:10.1503/cmaj.100404, Apr 26, 2010 (early release)
Public Disclosure of Conflicts of Interest. Moving the Policy Debate Forward, Campbell, Archives of Internal Medicine 170 (8): 667, Apr 26, 2010 (extract freely available)
Is Emergency Research Without Initial Consent Justified? The Consent Substitute Model, Largent et al., Archives of Internal Medicine 170 (8): 668-674, Apr 26, 2010 (abstract freely available)
The Impact of Disclosing Financial Ties in Research and Clinical Care: A Systematic Review, Licurse et al., Archives of Internal Medicine 170 (8): 675-682, Apr 26, 2010 (abstract freely available)
Week of April 19, 2010
‘Informed Consent’ and the Ethics of DNA Research, New York Times, Apr 23, 2010 (free one time registration required)
"The cultural gap between the impoverished Havasupai Indians who view their blood as sacred and the Arizona State University researchers who helicoptered in to their Grand Canyon home to collect it was at the heart of a lawsuit over the scope of a genetic study that ended last week with a settlement for the tribe. But the case, scientists and bioethicists said, serves as a cautionary tale about the equally significant gap between scientists and all research subjects…"
Doctor groups set new policy to curb industry sway, Associated Press, Apr 21, 2010
"…These are part of a new ethics code that dozens of leading medical groups announced Wednesday, aimed at limiting the influence that drug and device makers have over patient care. It's the most sweeping move ever taken by the Council of Medical Specialty Societies to curb conflict of interest…"
Code for Interactions with Companies, Council of Medical Specialty Societies, Apr 21, 2010
Indian Tribe Wins Fight to Limit Research of Its DNA, New York Times, Apr 21, 2010 (free one time registration required)
"…Members of the tiny, isolated tribe had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe’s devastating rate of diabetes. But they learned that their blood samples had been used to study many other things…Acknowledging a desire to “remedy the wrong that was done,” the university’s Board of Regents on Tuesday agreed to pay $700,000 to 41 of the tribe’s members, return the blood samples and provide other forms of assistance to the impoverished Havasupai — a settlement that legal experts said was significant because it implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used…"
FDA Announces Draft Revised Guidance on Transparency and Advisory Committees, US Food and Drug Administration, Apr 21, 2010
"…The draft guidance would expand the information disclosed about waivers prior to committee meetings. Specifically, the FDA proposes to post online the name of the company or institution associated with the financial interest along with the type of conflict of interest…"
U.S. warns Pfizer after children overdosed in study, Reuters, Apr 20, 2010 (scheduled to be available until May 19, 2010)
"U.S. health regulators have warned Pfizer Inc over a series of failures that led to the overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon…While the study in question ended in 2007, the FDA is concerned Pfizer has not done enough to ensure the problem does not happen again…"
FDA Warning Letter, Apr 9, 2010
Week of April 12, 2010
U.S. system for testing cancer drugs in crisis: report, Reuters, Apr 15, 2010 (scheduled to be available until May 14, 2010)
"The system for conducting cancer clinical trials in the United States is "at a breaking point" and needs a major overhaul, a panel of experts said on Thursday…"
A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, Board on Health Care Services, Institute of Medicine (IOM), Apr 15, 2010
Anonymizing patient records for genomics, Nature, Apr 12, 2010 (freely available for a short time only)
"Combining genetic information with existing medical records could allow researchers to rapidly identify genes linked to diseases. But bringing together diagnostic and genetic information in one place risks compromising the confidentiality of patients. Now a team from Vanderbilt University in Nashville, Tennessee, has developed a method they say can anonymize electronic medical records, eliminating the risk of individual patients being identified while preserving the ability of researchers to do such work…"
Week of April 5, 2010
Hallucinogens Have Doctors Tuning In Again, New York Times, Apr 11, 2010 (free one time registration required)
"…using rigorous protocols and safeguards, scientists have won permission to study once again the [hallucinogenic] drugs’ potential for treating mental problems and illuminating the nature of consciousness…Because reactions to hallucinogens can vary so much depending on the setting, experimenters and review boards have developed guidelines to set up a comfortable environment with expert monitors in the room to deal with adverse reactions. They have established standard protocols so that the drugs’ effects can be gauged more accurately…"
Cervical cancer vaccine study in ethics glare, The Telegraph, Apr 8, 2010
"An Indian government study to vaccinate thousands of girls in Andhra Pradesh against a sexually-transmitted virus that can cause cervical cancer has breached guidelines for ethics in medical research, women’s groups said today…"
In blood debate, new consent effort aims to open research doors, Detroil Free Press, Apr 8, 2010 (pdf of consent form is also available at this link)
"…The Michigan Department of Community Health is opening to researchers its archive of blood spots taken from every baby born in Michigan in the last 26 years -- information stored on more than 4 million index cards at Wayne State University's TechTown. In addition to research on the old samples, the department is hoping to make available the blood of new babies, too…State officials are quick to note that both the existing samples and any future samples will be used only for medical research. And under the law, they cannot to be released to law enforcement, insurance companies or other third parties…"
President Obama Announces More Key Administration Posts [Bioethics Commission], The White House, Apr 7, 2010
"…President Barack Obama announced his intent to appoint the following individuals to the Presidential Commission for the Study of Bioethical Issues…"
The Ethics Of Studying Crime, KPBS Public Broadcasting, Apr 6, 2010 (audio radio program)
"In order to do accurate research into why crimes occur and who commits them, researchers have to talk with criminals. And sometimes, they have to talk with criminals while those criminals are committing crimes. So, how far does a scientist or researcher go before they have an ethical obligation to report the activities of their research subject? Does it depend on what kind of crime, or how blatant the offense? And what does law enforcement expect from researchers who know about crimes being committed?…"
Week of March 29, 2010
Community-Based Participatory Research Contributions to Intervention Research: The Intersection of Science and Practice to Improve Health Equity, Wallerstein and Duran, American Journal of Public Health 100 (S1): S40-S46, Apr 1, 2010 (abstract freely available)
GINA's Impact on Life Science Research, Genetic Engineering & Biotechnology News, Apr 1, 2010
"…Although GINA and much of the regulatory activity since does not directly address research and other functions of pharmaceutical, device, and biotech companies, these laws and regulations have the potential to significantly impact industry participants in positive and possibly challenging ways…"
OHRP IRB Registration Frequently Asked Questions (FAQs), US Office for Human Research Protections, Mar 30, 2010
"OHRP posted on its website a revised set of Frequently Asked Questions and Answers (FAQs) on Institutional Review Board (IRB) Registration. These revised FAQs include guidance on the Department of Health and Human Services IRB requirements found in subpart E of 45 CFR 46 that were effective on July 14, 2009…"
Scientists Say F.D.A. Ignored Radiation Warnings, New York Times, Mar 29, 2010 (free one time registration required)
"Urgent warnings by government experts about the risks of routinely using powerful CT scans to screen patients for colon cancer were brushed aside by the Food and Drug Administration, according to agency documents and interviews with agency scientists…"
Week of March 22, 2010
Shocking TV Experiment Sparks Ethical Concerns, National Public Radio (NPR), Mar 26, 2010
"A French TV show has raised anew questions about when it's acceptable to subject people to emotional harm as part of a psychological experiment. The show depicted contestants in a TV quiz show. They were instructed to pull a lever that delivered increasingly powerful electric shocks to a man strapped into a chair whenever he got a quiz question wrong. A studio audience lustily cheered as the contestants administered the shocks…"
Ensuring Integrity in Industry-Sponsored Research. Primum Non Nocere, Revisited, DeAngelis and Fontanarosa, Journal of the American Medical Association 303 (12):1196-1198, Mar 24-31, 2010 (extract freely available)
Setting the RECORD Straight, Nissen, Journal of the American Medical Association 303 (12):1194-1195, Mar 24-31, 2010 (extract freely available)
Psychiatrists' Relationships With Pharmaceutical Companies, Insel, Journal of the American Medical Association 303 (12):1192-1193, Mar 24-31, 2010 (extract freely available)
Perspective: Modernizing Device Regulation, Garber, New England Journal of Medicine Online First Article 10.1056/NEJMp1000447), Mar 24, 2010 (full article freely available)
Clinical Trials for HIV Vaccines Now Using Social Media to Attract Trial Participants, PR Newswire, Mar 24, 2010
"…The HVTN, internationally headquartered at Fred Hutchinson Cancer Research Center in Seattle, is running a series of ads on Facebook, seeking men who are interested in men and who live in or near one of the cities with clinics; and a much edgier and more provocative one placed on online gay hook-up sites…One man already participating in an HIV vaccine clinical trial is blogging about his experience at the HVTN site at Vanderbilt University Medical Center in Nashville, Tennessee…"
Week of March 15, 2010
NIH Announces Genetic Testing Registry. Database to Fill Information Gaps and Serve as Research Resource, NIH News, Mar 18, 2010
"The National Institutes of Health announced today that it is creating a public database that researchers, consumers, health care providers, and others can search for information submitted voluntarily by genetic test providers. The Genetic Testing Registry (GTR) aims to enhance access to information about the availability, validity, and usefulness of genetic tests…"
OHRP Educational Videos Available, US Office for Human Research Protections (OHRP), Mar 16, 2010
"OHRP is pleased to announce the availability of educational videos developed by the Division of Education and Development. These videos provide information on a variety of topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human subjects of research described at 45 CFR part 46…Currently available: Research Use of Human Biological Specimens and Other Private Information and Reviewing and Reporting Unanticipated Problems and Adverse Events…"
Name dishonest researchers, government urges, Vancouver Sun, Mar 15, 2010
"…the Natural Sciences and Engineering Research Council has yet to change its rules, despite pointed recommendations from its political masters. The council, which distributes $1 billion in federal funding every year to thousands of researchers across the country, says federal privacy laws prevent it from identifying scientists involved in misconduct…"
Week of March 8, 2010
FDA Task Force Seeks Public Comments on Increasing Transparency With Regulated Industry, US Food and Drug Administration, Mar 12, 2010 (comments due by Apr 12, 2010)
"As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry…"
Stem cell regs to become law?, The Scientist, Mar 10, 2010 (may require free one time registration)
"…Yesterday (March 9), on the one-year anniversary of Obama's announcement, members of Congress Diana DeGette of Colorado and Mike Castle of Delaware reintroduced the Stem Cell Research Advancement Act to "ensure a lasting ethical framework" for such research…"
Lancet retracts 12-year-old article linking autism to MMR vaccines, Canadian Medical Association Journal, Mar 9, 2010
"…In a statement published on Feb. 2, the British medical journal said that it is now clear that "several elements" of a 1998 paper it published by Dr. Andrew Wakefield and his colleagues (Lancet 1998;351[9103]:637–41) "are incorrect, contrary to the findings of an earlier investigation…"
Clinical trials come out of closet in India, The Times of India, Mar 9, 2010
"Clinical trials in India are finally becoming transparent. There has been a dramatic increase in the number of trials that have got officially registered in Clinical Trials Registry-India (CTRI)…"
Week of March 1, 2010
Stem cells: One year later, a long way to go, Medill Reports, Mar 3, 2010
"…One year later, while researchers across the country are actively pursuing that funding and available embryonic stem cell lines, some doctors say the hype has misled the public about how soon treatment could become available…"
Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology, Brunoni et al., PLoS One 5(3): e9479. doi:10.1371/journal.pone.0009479, Mar 3, 2010 (full article freely available)
Registries for Evaluating Patient Outcomes: A User’s Guide: 2nd Edition, Agency for Healthcare Research and Quality, Mar 3, 2010 (comments due by Mar 31, 2010)
"…The handbook includes a discussion of issues related to the protection of human subjects in research registries (see chapter 8)…"
OHRP Compliance Oversight Letters: An Update, Weil et al., IRB: Ethics & Human Research 32 (2): 1-6, Mar - Apr 2010 (full article freely available with free one time registration)
Unethical Research and the C.I.A. Inspector General Report of 2004: Observations Implicit in Terms of the Common Rule, Llanusa-Cestero, Accountability in Research 17: 96 - 113, Mar 2010 (abstract freely available)
Disclosure of Unknown Harms in Magnetic Resonance Imaging Research, Marshall, Accountability in Research 17: 67 - 78, Mar 2010 (abstract freely available)
Dr. Cezanne and the Art of Re(peat)search: Competing Interests and Obligations in Clinical Research, Bluhm et al., Accountability in Research 17: 85 - 95, Mar 2010 (abstract freely available)
US Department of Energy Human Subjects Newsletter Issue 19, Winter 2009/2010, Office of Biological and Environmental Research, Mar 2010 (pdf)
Human Subjects Protections in Community-Engaged Research: A Research Ethics Framework, Ross et al., Journal of Empirical Research on Human Research Ethics 5 (1): 5-18, Mar 2010 (abstract freely available)
The Challenges of Collaboration for Academic and Community Partners in a Research Partnership: Points to Consider, Ross et al., Journal of Empirical Research on Human Research Ethics 5 (1): 19-32, Mar 2010 (abstract freely available)
Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research: Points to Consider, Ross et al., Journal of Empirical Research on Human Research Ethics 5 (1): 33-48, Mar 2010 (abstract freely available)
Perspectives of Canadian Researchers on Ethics Review of Neuroimaging Research, Deslauriers et al., Journal of Empirical Research on Human Research Ethics 5 (1): 49-66, Mar 2010 (abstract freely available)
Informed Consent in Human Subject Research: A Comparison of Current International and Nigerian Guidelines, Fadare and Porteri, Journal of Empirical Research on Human Research Ethics 5 (1): 67-74, Mar 2010 (abstract freely available)
Getting From a to IRB: Developing an Institutional Review Board at a Historically Black University, Howard et al., Journal of Empirical Research on Human Research Ethics 5 (1): 75-82, Mar 2010 (abstract freely available)
Attitudes Toward Genetic Research Review: Results from a National Survey of Professionals Involved in Human Subjects Protection, Lemke et al., Journal of Empirical Research on Human Research Ethics 5 (1): 83-92, Mar 2010 (abstract freely available)
Measuring Coercion to Participate in Research Within a Doubly Vulnerable Population: Initial Development of the Coercion Assessment Scale, Dugosh et al., Journal of Empirical Research on Human Research Ethics 5 (1): 93-102, Mar 2010 (abstract freely available)
Self-Regulation, Compensation, and the Ethical Recruitment of Oocyte Donors, Levine, Hastings Center Report 40 (2): 25-36, Mar - Apr 2010 (abstract freely available)
Week of February 22, 2010
FDA creates partnership to boost regulatory science, Los Angeles Times, Feb 25, 2010
"Reporting from Washington - The Food and Drug Administration and the National Institutes of Health on Wednesday announced a plan to help the FDA make swifter decisions about the safety and effectiveness of new products and procedures that flow from advanced research. The new partnership will promote the development of testing and other tools that FDA regulators need in order to assess drugs and other products coming from fields such as genomics, nanotechnology and stem cell therapy…"
Serving Two Masters — Conflicts of Interest in Academic Medicine, Lo, New England Journal of Medicine 362:669-671, Feb 25, 2010 (full article freely available)
Registering Clinical Trial Results, Miller, Journal of the American Medical Association 303 (8): 773-774, Feb 24, 2010 (abstract freely available)
Part 3 of 3: A Drug Trial Cycle: Recovery, Relapse, Reinvention, New York Times, Feb 24, 2010 (free one time registration required)
"…the results were a promising sign for an approach to treatment for all forms of cancer that he and others had championed as more effective and less toxic than standard chemotherapy. But even as he flashed the slide of his favorite graph, showing tumors shrinking in nearly every patient, his mind was on what had happened to them since…"
American Psychological Association Amends Ethics Code to Address Potential Conflicts Among Professional Ethics, Legal Authority and Organizational Demands, American Psychological Association (APA), Feb 24, 2010
"The American Psychological Association has amended its Code of Ethics to make clear that its standards can never be interpreted to justify or defend violating human rights…"
Part 2 of 3: After Long Fight, Drug Gives Sudden Reprieve, New York Times, Feb 23, 2010 (free one time registration required)
"For the melanoma patients who signed on to try a drug known as PLX4032, the clinical trial was a last resort. Their bodies were riddled with tumors, leaving them almost certainly just months to live. But a few weeks after taking their first dose, nearly all of them began to recover…"
DNA Deception, Texas Tribune, Feb 22, 2010
"When state health officials were sued last year for storing infant blood samples without parental consent, they said it was for medical research into birth defects, childhood cancer and environmental toxins. They never said they were turning over hundreds of dried blood samples to the federal government to help build a vast DNA database — a forensics tool designed to identify missing persons and crack cold cases…"
Part 1 of 3: A Roller Coaster Chase for a Cure, New York Times, Feb 22, 2010 (free one time registration required)
"…Dozens of such “targeted” drugs are emerging from the laboratory, rooted in decades of research and backed by unprecedented investment by pharmaceutical companies, which stand to profit from drugs that prolong life even by weeks. But putting them to their truest test falls to a small band of doctors committed to running experimental drug trials for patients they have no other way to heal…"
Week of February 15, 2010
Add pregnant women to draft drug guide: MDs, CBC News, Feb 19, 2010
"Medications are rarely tested for safety in pregnant women, but proposed federal guidelines could discourage studies that might offer better information and help ease the worries of expectant mothers, some researchers and ethicists say…"
Agency Proposes U.S.-Paid Research on Stem Cells, New York Times, Feb 19, 2010 (free one time registration required)
"The National Institutes of Health is proposing to expand its definition of human embryonic stem cells, enabling the university researchers it finances to work with cells derived from a very early human egg…"
Proposed Rule: Reporting Information Regarding Falsification of Data, UD Food and Drug Administration (FDA), Feb 19, 2010 (comments due by May 20, 2010)
"The proposed rule will require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigations, nonclinical laboratory studies, and clinical studies in animals…"
Whistle-Blower Protection a Must, Genetic Engineering and Biotechnology News, Feb 15, 2010
"In November 2008, Suzanne Stratton, Ph.D., was summarily dismissed from her job at the Carle Foundation Hospital in Urbana, IL.The events leading up to her firing, those currently known, paint a chilling picture of rogue research, an institutional culture unwilling to support bedrock bioethical values, and the substantial risks conscientious employees take in blowing the whistle on misconduct in science…"
Private drug tester expands stake in Big Pharma, Associated Press, Feb 15, 2010
"…Now Durham, N.C.-based Quintiles is the world's biggest contract research organization, and more than ever, it's using its deep pockets to entwine itself with the pharmaceutical companies, fronting them cash and services for a piece of the profits once a drug is approved…"
Wanted: Volunteers, All Pregnant, New York Times, Feb 15, 2010 (free one time registration required)
"…Although Alejandra was exactly what the scientists were looking for — a pregnant woman — she was “a bit scared,” she said, about giving herself and her unborn child to science for 21 years…Authorized by Congress in 2000, the National Children’s Study began last January, its projected cost swelling to about $6.7 billion. With several hundred participants so far, it aims to enroll 100,000 pregnant women in 105 counties, then monitor their babies until they turn 21…while the idea is praised by many experts, the study has also stirred controversy over its cost and content…"
Week of February 8, 2010
Protecting patients in ongoing clinical trials, Canadian Medical Association Journal 182: 117, Feb 9, 2010
"In the fall of 2008, retiree John Dennis sued Anapharm, one of Canada’s largest clinical research firms, alleging he’d been injured after participating in a clinical trial three years earlier. Dennis, of Drummondville, Quebec, ingested a trial drug as part of a study in the fall of 2005 and was rushed from the testing facility to the emergency room at McGill University Health Centre in Montréal, Quebec. He demanded $95 000. His case has been settled out of court. Although Canada — and especially Quebec — is home to some of the busiest clinical research sites in North America, according to a study done by market research firm KPMG, no one knows for sure how often research volunteers suffer harm…"
McGill reconsiders restrictions on research tied to military, Vancouver Sun, Feb 8, 2010
"…This week, McGill University's senate will be asked to approve revamped research ethics guidelines which expunge a 22-year-old clause which required researchers accepting money from military sources to indicate whether the research would have "direct harmful consequences."…"
Debate in US over blood from newborn safety tests, Associated Press, Feb 8, 2010
"…After those tiny blood spots are tested for a list of devastating diseases, some states are storing them for years. Scientists consider the leftover samples a treasure, both to improve newborn screening and to study bigger questions, like which environmental toxins can harm a fetus' developing heart or which genes trigger childhood cancers. But seldom are parents asked to consent to such research — most probably do not know it occurs — raising privacy concerns that are shaking up one of public health's most successful programs…"
Week of February 1, 2010
US doing 'scientific research' to boost interrogations,, Feb 3, 2010
"An elite US interrogation unit will conduct "scientific research" to find better ways of questioning top suspected terrorists, US intelligence director Dennis Blair said…A spokesman for Blair, Ross Feinstein, also declined to detail "specific research projects" but stressed that any such projects would follow US law, which forbids torture, and abide by internal review safeguards…"
Book Review: A Woman’s Undying Gift to Science, New York Times, Feb 2, 2010 (free one time registration required)
"…Henrietta Lacks, was a poor and largely illiterate Virginia tobacco farmer, the great-great-granddaughter of slaves. Born in 1920, she died from an aggressive cervical cancer at 31, leaving behind five children…To scientists, however, Henrietta Lacks almost immediately became known simply as HeLa (pronounced hee-lah), from the first two letters of her first and last names. Cells from Mrs. Lacks’s cancerous cervix, taken without her knowledge, were the first to grow in culture, becoming “immortal” and changing the face of modern medicine…"
Call to end exclusion of elderly from drug trials, BBC News, Feb 1, 2010
"A charter against ageism in clinical trials is being launched by a group of geriatricians from Europe. The EU funded project, called PREDICT, says treatments are less likely to be tested on older people even though the elderly take the most medication…"
PREDICT Consortium Web Site
AHRQ Activities Using Community-Based Participatory Research to Address Health Care Disparities, Agency for Health Care Research and Quality (AHRQ), Feb 2010
"Community-based participatory research (CBPR) is an approach to health and environmental research meant to increase the value of studies for both researchers and the communities participating in a study…."
Week of January 25, 2010
Andrew Wakefield found 'irresponsible' by GMC over MMR vaccine scare, The Guardian, UK, Jan 29, 2010
"Andrew Wakefield, the doctor who claimed to have discovered a link between measles virus, bowel diseases and autism and thereby sparked widespread fear of the combined MMR jab, conducted unnecessary, invasive tests on children, the General Medical Council found today…"
Recovery Act Limited Competition: Program to Enhance NIH-supported Global Health Research Involving Human Subjects (S07), US National Institutes of Health (NIH), Jan 28, 2010 (letters of intent due Feb22, 2010; applications due Mar 22, 2010)
"The ARRA International Human Subjects Research Enhancement Program will provide short-term support for U.S. and developing country institutions already collaborating on NIH supported human subjects’ research to jointly strengthen the ethical review and monitoring of such projects through enhanced collaboration and communication. This support is meant to improve the quality as well as enhance the efficiency of the ethical review and monitoring and accelerate global health research. It is expected that the enhancements supported will be sustained by the U.S. and foreign institutions after the award ends…"
Corporate Backing for Research? Get Over It, New York Times, Jan 26, 2010 (free one time registration required)
"…Conflict-of-interest accusations have become the simplest strategy for avoiding a substantive debate. The growing obsession with following the money too often leads to nothing but cheap ad hominem attacks…"
Week of January 18, 2010
Truth of the MMR vaccine scandal, Times Online, UK, Jan 24, 2010
"After an epic misconduct hearing, the doctors who caused panic over the vaccine are about to learn their fate. A report on the greatest health scare of recent times…"
Doctor quits Brigham to speak for pay, Boston Globe, Jan 23, 2010
"…DuBuske is no ordinary speaker. Out of thousands of US doctors hired by drug-maker GlaxoSmithKline to talk about its products, he was the highest paid during a three-month period last year, the company recently disclosed: He made $99,375 for giving 40 talks to other physicians last April, May, and June, almost one every other day…"
Judgement day for MMR rebel: an investigation that has blighted doctor's life for 12 years finally approaches conclusion, Daily Mail, UK, Jan 23, 2010
"The longest and most complex disciplinary hearing ever held by the General Medical Council will reach a conclusion on Friday. Dr Andrew Wakefield, the gastroenterologist who in 1998 raised the possibility of a link between autism, bowel disease and the MMR jab, will learn whether he has been found guilty of ethical breaches in research methods…"
Researchers Find Study of Medical Marijuana Discouraged, New York Times, Jan 18, 2010 (free one time registration required)
"…The University of Mississippi has the nation’s only federally approved marijuana plantation. If they wish to investigate marijuana, researchers must apply to the National Institute on Drug Abuse to use the Mississippi marijuana and must get approvals from a special Public Health Service panel, the Drug Enforcement Administration and the Food and Drug Administration…"
Week of January 11, 2010
Mass. doctor accused of fraud by faking research,, Jan 14, 2010
"…Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield sought and received research grants from pharmaceutical companies but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, court documents allege…"
Draft Guidance: Guidance for IRBs, Clinical Investigators, and Sponsors. IRB Continuing Review after Clinical Investigation Approval, US Food and Drug Administration (FDA), Jan 13, 2010 (pdf, comments due by Mar 15, 2010)
Draft Guidance: Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval, US Food and Drug Administration (FDA), Jan 13, 2010 (pdf, comments due by Mar 15, 2010)
"This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review…"
Clinical trial chiefs more likely tied to industry, Reuters, Jan 11, 2010 (scheduled to be freely available until Feb 10, 2010)
"In a study, researchers found that cancer researchers who design clinical trials, analyze or interpret the data, or play other key scientific roles are four times more likely to have financial ties to industry than their counterparts who have lesser roles in these studies, such as recruiting study subjects or collecting the data…"
Week of January 4, 2010
OHRP Archives Two Guidance Documents on Multicenter Clinical Trials, US Office For Human Research Protections (OHRP), Jan 5, 2010
"OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are “Local IRB Review of Multicenter Clinical Trials” and “Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).” These documents have been archived because OHRP’s policy regarding local IRB review has changed and they no longer represent OHRP’s policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB."
Harvard Teaching Hospitals Cap Outside Pay, New York Times, Jan 2, 2010 (free one time registration required)
"…Medical experts say they believe the conflict-of-interest rules at the institution, Partners HealthCare, go further than those of any other academic medical center in restricting outside pay from drug companies…"
Ethical and Regulatory Challenges in Psychophysiology and Neuroscience-Based Technology for Determining Behavior, Shamoo, Accountability in Research 17: 8-29, Jan 2010 (abstract freely available)
Data Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability, Tereskerz, Accountability in Research 17: 30-50, Jan 2010 (abstract freely available)
Motivated by Money? The Impact of Financial Incentive for the Research Team on Study Recruitment, Unger et al., IRB: Ethics and Human Research 32 (1): 16-19, Jan-Feb 2010 (full article freely available with free one time registration)

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