Illuminata-Inc. News In Research With Human Subjects Main Page

Online Resources for Human Subjects Review

News In Research With Human Subjects for 2010

Return to Main Page for News In Research With Human Subjects

For information about how to have the news delivered weekly to your email inbox

and to receive a FREE 4 week trial subscription, click here.

Week of March 8, 2010

	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…"

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…"

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…"
	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, Physorg.com, 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, WTOP.com, 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)

Last updated March 11, 2010 06:14am PT