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News In Research With Human Subjects for 2009
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Week of December 28, 2009
F.D.A. to Seek New Standards on Human Test Data, New York Times, Dec 29, 2009 (free one time registration required)
"The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said…"
Proposed Rule: Informed Consent Elements, Federal Register 74 (248): 68750-68756, US Food and Drug Administration, Dec 29, 2009 (comments due by Mar 1, 2010)
"As required by the Food and Drug Administration Amendments Act of 2007, the Food and Drug Administration on December 29, 2009 issued a proposed rule to amend the informed consent regulations for informed consent documents and processes used in applicable drug, biologic, and device clinical investigations. The proposed amendment would require inclusion of a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank (www.clinicaltrials.gov)…"
 
Week of December 21, 2009
Consent issues nix blood samples, The Scientist, Dec 23, 2009 (free one time registration required)
"More than 5 million blood samples used by researchers in Texas since 2002 must be destroyed because they were stored without parental consent, according to a lawsuit settlement signed by a federal court judge in Texas earlier this month…Since 2001, the [newborn] bloodspots have supported around 35 research projects by outside researchers focused on diagnosing and treating diseases that affect children…"
Strengthening Institutional Review Board Review of Highly Innovative Interventions in Clinical Trials, Lo and Grady, Journal of the American Medical Association 302: 2697-2698, Dec 23/30, 2009 (extract freely available)
NIH's New Year's resolution?, The Scientist, Dec 22, 2009 (free one time registration required)
"…NIH director Francis Collins, in an interview with C-SPAN's "Newsmakers" program, said that the agency would issue a "Proposed Rule" in January or February that will seek to prevent pharmaceutical companies from ghostwriting studies for researchers and require drug makers and other medical companies to disclose financial relationships with NIH-funded scientists and institutions via publicly accessible websites…"
 
Week of December 14, 2009
Grassley queries health groups on industry ties, American Medical News, Dec 20, 2009
"A key senator has sent letters to more than 30 health care organizations requesting information about the financial backing they receive from the pharmaceutical, medical device and insurance industries. The American Medical Association, the American Academy of Family Physicians, the American Hospital Assn., the American Society of Anesthesiologists, the American College of Surgeons and the American Cancer Society were among the groups that received a Dec. 7 letter from Sen. Charles Grassley…"
Release for Final Public Comment – Revised Draft 2nd Edition of the TCPS, Interagency Panel on Research Ethics (PRE), Canada, Dec 18, 2009 (comments due by Mar 1, 2010)
"The Interagency Panel on Research Ethics announces the release of the revised draft 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) for further public comment…"
 
Week of December 7, 2009
Privacy concerns raised over "secondary use" of health records, Canadian Medical Association Journal, Dec 8, 2009
"It took no time at all for Dr. Khaled El Emam’s colleague to identify an infant who had been a patient at the Children’s Hospital of Eastern Ontario (CHEO) in Ottawa…"
Research misconduct agency would undermine "academic self-governance," study says, Canadian Medical Association Journal, Dec 8, 2009
"There’s no need for any manner of national oversight and investigatory agency to handle research misconduct, according to a report commissioned by the Canadian Research Integrity Committee (CRIC)…"
Report: The State of Research Integrity and Misconduct Policies in Canada, Oct 2009 (pdf)
 
Week of November 30, 2009
Panel Criticizes Military’s Use of Embedded Anthropologists, New York Times, Dec 4, 2009 (free one time registration required)
"A two-year-old Pentagon program that assigns social scientists to work with military units in Iraq and Afghanistan has come under sharp criticism from a panel of anthropologists who argue that the undertaking is dangerous, unethical and unscholarly…"
Final Report on The Army’s Human Terrain System Proof of Concept Program, Commission on the Engagement of Anthropology with the US Security and Intelligence Communities (CEAUSSIC), American Anthropological Association (AAA), Dec 3, 2009 (pdf)
Public Perspectives on Informed Consent for Biobanking, Murphy et al., American Journal of Public Health 99: 2128-2134, Dec 2009 (abstract freely available)
International Compilation of Human Subject Protections, US Office for Human Research Protections (OHRP), Dec 2009 (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, and features the laws, regulations, and/or guidelines for five new countries: Dominica, Guatemala, Honduras, Kyrgyzstan, and Qatar…"
Voluntariness of Consent to Research. A Preliminary Empirical Investigation, Appelbaum, IRB: Ethics & Human Research 31 (6): 10-14, Nov - Dec 2009 (full article freely available with free one time registration)
The Role of Numeracy in Informed Consent for Surveys, Couper and Singer, Journal of Empirical Research on Human Research Ethics 4: (4): 17–26, Dec 2009 (abstract freely available)
Ethnographic Research with Adolescent Students: Situated Fieldwork Ethics and Ethical Principles Governing Human Research, Hemmings, Journal of Empirical Research on Human Research Ethics 4 (4): 27–38, Dec 2009 (abstract freely available)
The Appraisal of Quantitative and Qualitative Trauma-Focused Research Procedures among Pregnant Participants, Schwerdtfeger, Journal of Empirical Research on Human Research Ethics 4 (4): 39–51, Dec 2009 (abstract freely available)
Evaluating International Collaboration: Differential Perceptions of Partnership in a CBPR Project in Ghana, de Schweinitz et al., Journal of Empirical Research on Human Research Ethics 4 (4): 53–67, Dec 2009 (abstract freely available)
Ethics Review in a Developing Country: A Survey of South African Social Scientists' Experiences, Mamotte and Wassenaar, Journal of Empirical Research on Human Research Ethics 4 (4): 69–78, Dec 2009 (abstract freely available)
Grant Opportuity: Research on Integrity in Collaborative Research (R21), US Dept of Health and Human Services (DHHS), Dec 2009 (letter of intent due Mar 7, 2010; application due Apr 7, 2010)
"…While OHRP is not participating in funding the opportunities described in the FOA, OHRP supports the importance of this program and the potential for research activities that could shed light on the operation of human research protection programs and how they could be improved. OHRP notes that research activity proposals addressing the areas of particular interest in this program could include investigations of various aspects of collaborative activities related to or including the protection of human subjects in research. OHRP hopes that high quality research proposals of this kind will be submitted for consideration…"
Press Release: 2009 Human Research Protection Award Recipients Announced, Health Improvement Institute (HII), Nov 30, 2009
"Awards for Excellence in Human Research Protection were announced today by Dr. Peter G. Goldschmidt, President and Founder of the Health Improvement Institute…"
 
Week of November 23, 2009
President Obama Establishes New Presidential Commission for the Study of Bioethical Issues, Names Commission Leadership, US White House Press Release, Nov 24, 2009
"…President Barack Obama signed an Executive Order creating a new Presidential Commission for the Study of Bioethical Issues. He also announced today he has appointed Amy Gutmann to serve as Chair and James W. Wagner to serve as Vice Chair of the Commission…"
Ethical Data Release in Genome-Wide Association Studies in Developing Countries, Parker et al., PLoS Medicine (11): e1000143, Nov 24, 2009 (full article freely available)
 
Week of November 16, 2009
Sought-After Speaker, With Script Outlines From Eli Lilly, New York Times, Nov 18, 2009 (free one time registration required)
"In the first half of this year, the drug giant Eli Lilly paid 3,971 doctors and other medical professionals an average of about $11,230 each. The payments were for participating in an average of 12 speaking or consulting engagements during those six months…"
Academic Researchers’ Conflicts of Interest Go Unreported, New York Times, Nov 18, 2009 (free one time registration required)
"Few universities make required reports to the government about the financial conflicts of their researchers, and even when such conflicts are reported, university administrators rarely require those researchers to eliminate or reduce these conflicts, government investigators found…"
Study ethics, NIH!, The Scientist, Nov 17, 2009 (free one time registration required)
"The government agency tasked with funding crucial life science research needs to focus more attention on ethical quandaries and nefarious business practices that often obscure the path from discovery to public benefit, says a strongly worded letter to Francis Collins, the director of the National Institutes of Health (NIH), signed by more than 100 biomedical researchers, journal editors, and health care administrators in the US…"
The Unintended Consequences of Clinical Trials Regulations, McMahon et al., PLoS Medicine 3(11): e1000131, Nov 17, 2009 (full article freely available)
 
Week of November 9, 2009
Clinical Research Sites—The Underappreciated Component of the Clinical Research System, Califf, Journal of the American Medical Association 302: 2025-2027, Nov 11, 2009 (extract freely available)
 
Week of November 2, 2009
OHRP Draft Guidance on IRB Continuing Review of Research, US Office for Human Research Protections, Nov 6, 2009 (submit comments by Jan 5, 2010)
"OHRP is seeking comment on a draft guidance document entitled, “Guidance on IRB Continuing Review of Research.” The draft guidance document, when finalized, will represent OHRP’s current thinking on this topic and will supersede OHRP’s January 15, 2007 guidance document…"
OHRP Draft Guidance on IRB Approval of Research with Conditions, US Office for Human Research Protections, Nov 6, 2009 (submit comments by Jan 5, 2010)
"OHRP is seeking comment on a draft guidance document entitled “Guidance on IRB Approval of Research with Conditions.” The draft guidance document, when finalized, would provide OHRP’s first formal guidance on this topic. The draft document is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS…"
NHLBI Stops Enrollment in Study on Resuscitation Methods for Cardiac Arrest, NIH News, Nov 6, 2009
"Enrollment has ended early in a large, multicenter clinical trial comparing two distinct resuscitation strategies delivered by emergency medical service (EMS) providers to increase blood flow during cardiac arrest…stopped enrollment based on preliminary data suggesting that neither strategy significantly improved survival…"
 
Week of October 26, 2009
Recommendations From a Research Consultation to Address Intervention Strategies for HIV/AIDS Prevention Focused on African Americans, Purcell and McCree, American Journal of Public Health 99: 1937-1940, Nov 2009 (abstract freely available)
Partnerships for Environmental and Occupational Justice: Contributions to Research, Capacity and Public Health, Baron et al., American Journal of Public Health 99: S517-S525, Nov 2009 (abstract freely available)
Transferring Knowledge About Human Subjects Protections and the Role of Institutional Review Boards in a Community-Based Participatory Research Project, Hyatt et al., American Journal of Public Health 99: S526-S531, Nov 2009 (abstract freely available)
The Role for Community-Based Participatory Research in Formulating Policy Initiatives: Promoting Safety and Health for In-Home Care Workers and Their Consumers, Gong et al., American Journal of Public Health 99: S531-S538, Nov 2009 (abstract freely available)
Completing the Circle: A Model for Effective Community Review of Environmental Health Research, Watkins et al., American Journal of Public Health 99: S567-S577, Nov 2009 (abstract freely available)
How Grantees Manage Financial Conflcts ofInterest in Research Funded by the National Institutes of Health, OEI-03-07-00700, US Department of Health and Human Services (DHHS) Office of the Inspector General (OIG), Nov 2009 (pdf)
Voluntariness of Consent to Research, IRB: Ethics & Human Research 31 (6): 10-14, Nov-Dec 2009 (full article freely available with free one time registration)
Early Release for Public Comment – TCPS Chapter 9: “Research Involving Aboriginal Peoples in Canada”, Panel on Research Ethics (PRE), Canada, Nov 2009 (written comments due by Mar 10, 2010)
"The Panel on Research Ethics announces the early release of the revised version of Chapter 9 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) for further public comment. Chapter 9 focuses on research involving Aboriginal Peoples. The early release of this chapter is provided in response to requests made by a number of individuals and groups in the Aboriginal community and the research community at large…"
Bending the Rules of Clinical Trials, New York Times, Oct 29, 2009 (free one time registration required)
"…It turns out that I am not the only doctor who has considered bending the admissions criteria of a clinical trial for a patient. There is an essential conflict for doctors involved in clinical research…"
Medical device maker accused of fraud, lying, Boston Globe, Oct 29, 2009
"…Specifically, the indictment accused Stryker Biotech LLC of promoting the use of two devices made for spinal and long bone surgeries for applications that had not been approved by the US Food and Drug Administration…"
Major Gaps In Oversight Of Human Medical Research, Huffington Post, Oct 28, 2009
"…The federal order that directed Columbia to find its heart patients and tell them more about their drug study illustrates the continuing weakness in safeguards of clinical trials and specifically the procedures for obtaining informed consent…"
The Heart of the Matter How Congress and Special Interests Kept Crucial Clinical Trial Data Secret, The Sunlight Foundation, Oct 28, 2009
"…The lobbyists got a few phrases changed in a lengthy bill—phrases that would have required public access to results of clinical trials that did not lead to an approved medical device or drug. Members of the House and Senate rushed to vote on the bill with little time to note the change. For Patrick-Lake, Washington’s standard operating procedures have left her—and the public--in the dark about the device in her heart…"
FDA Steps Up Efforts to Find, Remove Violators of Clinical Trial Regulations, Kuehn, Journal of the American Medical Association 302: 1739-1741, Oct 28, 2009 (extract freely available)
Group receives ethics research grant to protect human subjects, Minnesota Daily, Oct 26, 2009
"…The project will focus on devising safeguards to protect human subjects participating in research on nanomedicine products…"
Disgraced Cloning Expert Convicted in South Korea, New York Times, Oct 26, 2009 (free one time registration required)
"Hwang Woo-suk, a disgraced cloning expert from South Korea who had claimed major breakthroughs in stem-cell research, was convicted Monday of falsifying his papers and embezzling government research funds…"
Industry Years Behind on Testing Approved Drugs, New York Times, Oct 26, 2009 (free one time registration required)
"Federal drug officials have long been criticized for failing to force drug makers to complete studies proving that their drugs work as hoped, and Congressional investigators on Monday released yet another report pointing out that some of these studies remain undone many years after being promised…"
 
Week of October 19, 2009
Research Uproar at a Cancer Clinic, New York Times, Oct 22, 2009 (free one time registration required)
"Two years after becoming vice president for research at the biggest hospital in this university town, Suzanne Stratton said she had finally seen enough. She had clashed repeatedly with a doctor who oversaw the local patients enrolled in more than 130 federally sponsored cancer studies — work that the hospital promoted in local television advertisements but that Dr. Stratton, who has a Ph.D. in molecular biology, said was often putting patients and science at risk…"
F.D.A. Lags in Banning Researchers After Fraud, New York Times, Oct 21, 2009 (free one time registration required)
"…in a report scheduled for release on Thursday, Congressional investigators say the agency pays so little attention to its responsibilities to ban investigators convicted of fraud and is so disorganized about carrying them out that its actions take an average of four years to complete…"
 
Week of October 12, 2009
When 2+2 Equals a Privacy Question, New York Times, Oct 17, 2009 (free one time registration required)
"…While Netflix and some health care concerns say they have been able to offer study data to researchers stripped of specific personal details like your name, phone number and e-mail address, in some cases researchers may be able to re-identify you by correlating anonymous information with the digital trail that you’ve left on blogs, chat rooms and Twitter…researchers say they were indeed able to positively identify Netflix customers, and some privacy advocates say their study raises questions about whether newly strengthened laws governing the security of electronic health records…may offer incomplete privacy protection…"
New OHRP Frequently Asked Questions and Answers on Exempt Research Determination, US Office for Human Research Protections (OHRP), Oct 15, 2009
"OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on Exempt Research Determination. These FAQs provide guidance on OHRP’s current thinking on exempt research determination and should be viewed as recommendations unless specific regulatory requirements are cited…"
Revised Guidance Document, OHRP’s Compliance Oversight Procedures for Evaluating Institutions, US Office for Human Research Protections (OHRP), Oct 15, 2009 (pdf)
"This document summarizes the procedures used by OHRP in performing compliance oversight evaluations of institutions and human subjects research that are under OHRP’s jurisdiction…"
Editorial: Uniform Format for Disclosure of Competing Interests in ICMJE Journals, Drazen et al., New England Journal of Medicine 10.1056/NEJMe0909052, Oct 13, 2009 (full article freely available)
 
Week of October 5, 2009
Accuracy of Conflict-of-Interest Disclosures Reported by Physicians, Okike et al., New England Journal of Medicine 361:1466-1474, Oct 8, 2009 (full article freely available)
Government Orders Columbia to Tell Patients 'True Nature' of Drug Study, Huffington Post, Oct 7, 2009
"…Patient No. 1, along with more than 200 other open-heart surgery patients, was part of a two-year medical study at Columbia that government regulators now say was carried out with ethical and regulatory mistakes and may have caused harm to some patients…"
 
Week of September 28, 2009
Public Access to Genome-Wide Data: Five Views on Balancing Research with Privacy and Protection, P3G Consortium, PLoS Genetics 5(10): e1000665. doi:10.1371/journal.pgen.1000665, Oct 2, 2009 (full article freely available)
Compensation for Incarcerated Research Participants: Diverse State Policies Suggest a New Research Agenda, Smoyer et al., American Journal of Public Health 99: 1746-1752, Oct 1, 2009 (abstract freely available)
News Release: New Rules Protect Patients’ Genetic Information, US Department of Health and Human Services, Oct 1, 2009 (for link to regs, see bottom of this article)
"Individuals’ genetic information will have greater protections through new regulations issued today by the U.S. Departments of Health and Human Services (HHS), Labor, and the Treasury. The interim final rule will help ensure that genetic information is not used adversely in determining health care coverage and will encourage more individuals to participate in genetic testing, which can help better identify and prevent certain illnesses…"
Final Revised Accreditation Standards, Association for the Accreditation of Human Research Protection Programs (AAHRPP), Oct 2009
"…This page provides a commentary on the Final Revised Accreditation Standards for each Domain, followed by a link to the specific Standards…"
Considering Usual Medical Care in Clinical Trial Design, Dawson et al., PLoS Medicine 6(9): e1000111. doi:10.1371/journal.pmed.1000111, Sep 29, 2009 (full article freely available)
Nanomaterials Under Study by the E.P.A., New York Times, Sep 29, 2009 (free one time registration required)
"The Environmental Protection Agency detailed its plans on Tuesday for research into the possible health and environmental risks of nanomaterials, tiny substances that are finding growing use in products like sunscreens and industrial adhesives…"
Nanomaterial Research Strategy, US Environmental Protection Agency (EPA), final version issued Sep 2009 (pdf)
Drug firms hiding test results: Study, Ottawa Citizen, Sep 28, 2009 (for link to JAMA article, see Journal section below)
"Doctors and patients may not get the full story on some prescription drugs because companies sidestep rules and hide test results, according to researchers in Canada, France and Britain…"
 
Week of September 21, 2009
Whistleblower at UC Davis Fired Allegedly For Reporting IRB Non-Compliance and Ethical Violations, People's Vanguard, Sep 24, 2009
"Doctoral Candidate and former UC Davis (UCD) nurse researcher Janet Keyzer has filed a lawsuit against the Regents of the University of California, alleging that she and her husband were terminated from their employment at UC Davis after Ms. Keyzer reported research violations…"
GAO-09-866: New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints, US Government Accountability Office (GAO), Sep 23, 2009
NIH Opens Website for Human Embryonic Stem Cell Lines for Approval and Announces Members of Working Group, NIH News, Sep 21, 2009
"National Institutes of Health (NIH) Director Francis S. Collins, M.D., Ph.D., announces that NIH is now accepting requests for human embryonic stem cell (hESC) lines to be approved for use in NIH-funded research. The NIH Director is also pleased to announce the members of a new working group of the Advisory Committee to the Director (ACD): the Working Group for Human Embryonic Stem Cell Eligibility Review…"
NIH Stem Cell Information Web Site
Doctor Is Pressed Again on Ties to Device Makers, New York Times, Sep 21, 2009 (free one time registration required)
"Two leading senators have charged that a well-known heart doctor affiliated with Columbia University may have failed to tell the university about millions of dollars in payments and other income he received from medical device makers…"
 
Week of September 14, 2009
Reports: VA researchers drew patients' blood without their consent, Pittsburgh Tribune-Review, Sep 16, 2009
"Researchers at the Veterans Administration Medical Center in Philadelphia drew blood samples from veterans for a research project without their knowledge or consent, resulting in "serious noncompliance" with federal law and regulations, according to reports from several internal reviews…"
Evaluating eHealth: Undertaking Robust International Cross-Cultural eHealth Research, Bates and Wright, PLoS Medicine 6(9): e1000105. doi:10.1371/journal.pmed.1000105, Sep 15, 2009 (full article freely available)
 
Week of September 7, 2009
Research subjects want to know investigators' financial ties, American Medical News, Sep 9, 2009 (For related journal article, see section below)
"Research participants want to be told about clinical investigators' financial conflicts, and sharing that information usually enhances trust, a new study says…"
 
Week of August 31, 2009
CIA doctors face human experimentation claims, The Guardian, Sep 2, 2009
"Doctors and psychologists the CIA employed to monitor its "enhanced interrogation" of terror suspects came close to, and may even have committed, unlawful human experimentation, a medical ethics watchdog has alleged…"
Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials, Mathieu et al., Journal of the American Medical Association 302:977-984, Sep 2, 2009 (abstract freely available)
Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board, Bozeman et al., American Journal of Public Health 99: 1549-1556, Sep 2009 (abstract freely available)
Planning for Posttrial Access to Antiretroviral Treatment for Research Participants in Developing Countries, Shah et al., American Journal of Public Health 99: 1556-1562, Sep 2009 (abstract freely available)
Ethical Considerations in HIV/AIDS Biobehavioral Surveys That Use Respondent-Driven Sampling: Illustrations From Lebanon, DeJong et al., American Journal of Public Health 99: 1562-1567, Sep 2009 (abstract freely available)
US Office of Research Integrity (ORI) Quarterly Newsletter, US Department of Health and Human Services, Sep 2009 (pdf)
AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research, US Agency for Healthcare Research and Quality, Sep 2009
"The Agency for Healthcare Research and Quality (AHRQ) has developed the Informed Consent and Authorization Toolkit for Minimal Risk Research to facilitate the process of obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from potential research subjects. This toolkit contains information for people responsible for ensuring that potential research subjects are informed in a manner that is consistent with medical ethics and regulatory guidelines…"
An Analysis of Toxicology and Medical Journal Conflict-of-Interest Polices, Krimsky and Sweet, Accountability in Research 16: 235 - 253, Sep 2009 (abstract freely available)
Competing Commitments in Clinical Trials, Lidz et al., IRB 31:1-6, Sep-Oct 2009 (full article freely available with free one time registration)
U.S. Research Universities' Institutional Conflict of Interest Policies, Slaughter et al., Journal of Empirical Research on Human Research Ethics 4: 3–20, Sep 2009 (abstract freely available)
Challenges In Measuring a New Construct: Perception of Voluntariness for Research and Treatment Decision Making, Miller et al., Journal of Empirical Research on Human Research Ethics 4: 21–31, Sep 2009 (abstract freely available)
Privacy and Confidentiality Resources, Zayatz, Journal of Empirical Research on Human Research Ethics 4: 33–34, Sep 2009 (abstract freely available)
Towards Realizing the Health-Related Millennium Development Goals for Migrants from Burma in Thailand, Ditton and Lahane, Journal of Empirical Research on Human Research Ethics 4: 37–48, Sep 2009 (abstract freely available)
Ethical and Effective Ethnographic Research Methods: A Case Study with Afghan Refugees in California, Smith, Journal of Empirical Research on Human Research Ethics 4: 59–72, Sep 2009 (abstract freely available)
Parents' Online Portrayals of Pediatric Treatment and Research Options, Schaffer et al., Journal of Empirical Research on Human Research Ethics 4: 73–87, Sep 2009 (abstract freely available)
Benefits and Burdens of Participation in a Longitudinal Clinical Trial, Lazovski et al., Journal of Empirical Research on Human Research Ethics 4: 89–97, Sep 2009 (abstract freely available)
Prospective Biorepository Participants' Perspectives on Access to Research Results, Beskow and Smolek, Journal of Empirical Research on Human Research Ethics 4: 99–111, Sep 2009 (abstract freely available)
Report GAO-09-807: Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators, US Government Accountability Office, Sep 2009 (pdf)
 
Week of August 24, 2009
Disclosure of Financial Relationships to Participants in Clinical Research, Weinfurt et al., New England Journal of Medicine 361:916-921, Aug 27, 2009 (full article freely available)
Disclosure of Financial Relationships to Participants in Clinical Research, Weinfurt et al., New England Journal of Medicine 361:916-921, Aug 27, 2009 (extract freely available)
Update on PRE’s Aboriginal Research Ethics Initiative (AREI), Panel on Research Ethics (PRE), Canada, Aug 26, 2009
"…In early fall, the Panel plans to release a revised version of Chapter 9, reflecting the work of the Harmonization Committee as well as comments received from public consultations. This release of Chapter 9 in advance of the December release of the full revised draft of the TCPS, will allow additional time for comment , as requested…"
Extension of Release Date and Expanded Opportunities to Comment on Revised Draft 2nd Edition of the TCPS, Panel on Research Ethics (PRE), Canada, Aug 26, 2009
"…The Panel will release a revised version of the draft to the public for further comment in December 2009, followed by a 60-day period for written comments. The Panel intends to prepare a final draft based on those comments. In April 2010, the Panel will submit the final revision…"
Inside the human guinea pig capital of North America, Macleans, Aug 25, 2009
"In Quebec’s quest to please Big Pharma, has it become more industry cheerleader than watchdog?…"
S.Korea seeks 4-year prison term for stem cell fraud, Reuters, Aug 24, 2009 (scheduled to be available until Sep 23, 2009)
"South Korean prosecutors told a Seoul court on Monday they wanted a four-year prison term for disgraced scientist Hwang Woo-suk, whose research team has been linked to major fraud in its once-celebrated stem cell studies…"
Research Trove: Patients’ Online Data, New York Times, Aug 24, 2009 (free one time registration required)
"…Since the Internet’s earliest days, patients have used the Web to share experiences and learn about diseases and treatments. But now advocates like Dr. Farber say that online communities have the potential to transform medical research — especially into rare diseases like hers…"
 
Week of August 17, 2009
Testing begins on experimental flu vaccine for children, Baltimore Sun, Aug 20, 2009
"…Hunter was pediatric volunteer No.1 of an expected 600 nationwide for an experimental vaccine against the H1N1 influenza virus, a new strain of flu that appeared in April and which officials fear will be widespread come fall…"
National Science Foundation Responsible Conduct of Research, Federal Register 74: 42126 - 42128, Aug 20, 2009 (pdf)
"…Effective Jan. 4, when a funding proposal is made to the NSF by an institution, the institution must have a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to all undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct the research. While training plans are not required in the proposals, the NSF reserves the right to review such plans upon request…"
HHS Issues Rule Requiring Individuals Be Notified of Breaches of Their Health Information, US Department of Health and Human Services, Aug 19, 2009
"New regulations requiring health care providers, health plans, and other entities covered by the Health Insurance Portability and Accountability Act (HIPAA) to notify individuals when their health information is breached were issued today by the U.S. Department of Health and Human Services (HHS)…"
Breach Notification for Unsecured Protected Health Information, Office for Civil Rights, Department of Health and Human Services, Aug 19, 2009 (pdf)
Surgeon Tied to Bone Product Inquiry Resigns, New York Times, Aug 19, 2009 (free one time registration required)
"A former Army surgeon accused of falsifying a study on a bone growth product used on severely injured Iraq war veterans has resigned his teaching position at Washington University in St. Louis…"
Senator Moves to Block Medical Ghostwriting, New York Times, Aug 18, 2009 (free one time registration required)
"A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products…"
Probing Doctors' Ties to Industry, Washington Post, Aug 18, 2009 (free one time registration required)
"You may not be able to trust your mortgage broker, your car salesman or your congressman, but you can trust your doctor. Can't you?…"
Ethics Forum. Take care when discussing phase I trial options, American Medical News, Aug 17, 2009
"…Due to the lack of expected benefit to the immediate participant, and the trials' controversial nature, an oncologist who decides not to raise the possibility of phase I studies with some patients has not violated professional obligations or ethics. In fact, discussing phase I trials with every patient may have unintended negative consequences for some, particularly if their decision comes at the expense of more intensive palliation or even a hospice referral…"
 
Week of August 10, 2009
U.S. rules aim to help dying patients access drugs, Reuters, Aug 12, 2009 (scheduled to be available until Sept 11, 2009)
"The U.S. government finalized rules on Wednesday meant to make it easier for seriously ill patients to gain access to unapproved medicines when they have run out of other options…"
Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs, US Food and Drug Administration (FDA), Aug 12, 2009
"The final rule, “Expanded Access to Investigational Drugs for Treatment Use,” amends regulations on expanded access to investigational new drugs for treating patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use…"
 
Week of August 3, 2009
Fabry trial set to answer “political problem”, Canadian Medical Association Journal, Aug 6, 2009
"…The players in this drama — patient advocacy groups, industry, the federal and provincial governments, and researchers — differ on the purpose and usefulness of the Canadian Fabry Disease Initiative study, a 10-year clinical investigation that was launched with only a 3-year funding agreement in place. The study has not been fully enrolled, yet the funding agreement ends Sept. 30, leaving the 133 patients who receive treatment through the study uncertain about who will pay for their approximately $300 000 per year per person enzyme replacement therapy…"
Medical Papers by Ghostwriters Pushed Therapy, New York Times, Aug 4, 2009 (free one time registration required)
"Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known…"
 
Week of July 27, 2009
Lack of Study Volunteers Hobbles Cancer Fight, New York Times, Aug 2, 2009 (free one time registration required)
"…Forty years after President Richard M. Nixon declared war on cancer, death rates have barely changed. “Why aren’t we getting cures?” Dr. Ramsey said. “This is one of the biggest reasons.”…"
The Limits of Collaboration: A Qualitative Study of Community Ethical Review of Environmental Health Research, McGrath et al., American Journal of Public Health 99: 1510-1514, Aug 2009 (abstract freely available)
Paediatric Research in Canada, Knoppers et al., Les Editions Themis, Aug 1, 2009 (abstract freely available)
"This book represents the results of a project undertaken by the National Council on Ethics in Human Research to study the ethical and legal issues of research involving children and adolescents. It has been funded through the Canadian Institutes for Health Canada. This 2 year project collected and critically reviewed international and Canadian policies on research involving children as well as the relevant literature since 1993 “Report on Research Involving Children” of the National Council on Bioethics in Human Research…"
Pfizer to Pay $75 Million to Settle Trovan-Testing Suit, Washington Post, Jul 31, 2009 (free one time registration required)
"Pfizer signed a $75 million agreement Thursday with Nigerian authorities to settle criminal and civil charges that the pharmaceutical company illegally tested an experimental drug on children during a 1996 meningitis epidemic…"
Comments to AAHRPP Regarding Proposed Revised Accreditation Standards for Human Research Protection Programs, Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Jul 30, 2009 (pdf)
"…The letter, co-signed with the Association of American Universities, praised the proposals for reducing duplication and ambiguity, urged changes relating to the proposals for financial conflicts of interest and community-based research, and recommended a lengthening of the current accreditation cycle…."
U surgeon's deals with Medtronic draw fire, Minneapolis Star Tribune, Jul 29, 2009
"A top spine surgeon at the University of Minnesota who has reaped more than $1 million consulting for Medtronic Inc. is facing tough questions from a prominent U.S. senator investigating financial conflicts in medicine. In a July 24 letter, Sen. Charles Grassley, R-Iowa, also asks the university pointed questions about how it monitors potential conflicts of interest involving medical school doctors…"
NHLBI Stops Study of Treatment for Pulmonary Hypertension in Patients with Sickle Cell Disease Due to Safety Concerns, NIH News, Jul 28, 2009
"The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly one year early due to safety concerns…"
2nd Medtronic Consultant Draws Senate’s Scrutiny, New York Times, Jul 28, 2009 (free one time registration required)
"…That physician, Dr. David W. Polly Jr., urged members of a Senate panel in 2006 to continue paying for Defense Department medical research into combat-related injuries. But Dr. Polly did not disclose during his testimony that he was a Medtronic consultant and was billing the company $6,000 for his appearance, according to documents released Tuesday. Instead, he told lawmakers that he was representing a professional medical association of orthopedic surgeons, according to the documents…"
Research Ethics Review in Humanitarian Contexts: The Experience of the Independent Ethics Review Board of Médecins Sans Frontières, Schopper et al., PLoS Medicine 6(7): e1000115. doi:10.1371/journal.pmed.1000115, Jul 28, 2009 (full article freely available)
New York OKs paying women who donate eggs for research, American Medical News, Jul 27, 2009
"…The policy makes New York the first American government body, state or federal, to use taxpayer dollars to do more than reimburse egg donors for direct expenses incurred in donating. Opponents of the move said it would encourage women to undertake a painful, sometimes risky procedure for speculative research…"
 
Week of July 20, 2009
Can the Relationship between Doctors and Drug Companies Ever Be a Healthy One?, D'Arcy and Moynihan, PLoS Medicine 6(7): e1000075. doi:10.1371/journal.pmed.1000075, Jul 21, 2009 (full article freely available)
Two Executives Plead Guilty in Illegal Use of Bone Cement, New York Times, Jul 20, 2009 (free one time registration required)
"Two executives of Synthes Inc., a medical device maker, pleaded guilty for their role in the company’s illegal trials of bone-mending cement that led to the deaths of three patients…"
 
Week of July 13, 2009
"Research" in Community-Partnered, Participatory Research, Wells and Jones, Journal of the American Medical Association, Jul 15, 2009 (extract freely available)
Medical School Says Former Army Surgeon Hid Ties to Medtronic, New York Times, Jul 14, 2009 (free one time registration required)
"A former military doctor and Medtronic consultant at the center of a research scandal did not tell his medical school employer for a year about his Medtronic ties even as he was conducting company-sponsored research, according to that institution, Washington University in St. Louis…"
 
Week of July 6, 2009
Investigation of the Cause of Death in a Gene-Therapy Trial, Frank et al., New England Journal of Medicine 361:161-169, Jul 9, 2009 (abstract freely available)
Gene Therapy — Still a Work in Clinical and Regulatory Progress, New England Journal of Medicine 361:193-195, Jul 9, 2009 (extract freely available)
Pick to Lead Health Agency Draws Praise and Some Concern, New York Times, Jul 8, 2009 (free one time registration required)
"President Obama on Wednesday nominated Dr. Francis S. Collins, a pioneering geneticist who led the government’s successful effort to sequence the human genome, as head of the National Institutes of Health…"
Rules on Stem Cell Research Are Eased. More Lines Eligible For Federal Funding, Washington Post, Jul 7, 2009 (free one time registration required)
"Hundreds of embryonic stem cell lines, whose use in the United States had effectively been curtailed by the Bush administration, can be used to study disorders and develop cures if researchers can show the cells were derived using ethical procedures, according to new rules issued by the federal government yesterday…"
National Institutes of Health Guidelines on Human Stem Cell Research, Jul 6, 2009
"These Guidelines implement Executive Order 13505, as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law…"
 
Week of June 29, 2009
Federal probe finds problems with chelation study, Associated Press, Jul 2, 2009
"A federal investigation has found that heart attack survivors enrolled in a study of a controversial alternative medicine treatment were not told enough about potential dangers from the drug being tested, including death…"
The Obligation to Participate in Biomedical Research, Schaefer et al., Journal of the American Medical Association 302: 67-72, Jul 1, 2009 (abstract freely available)
Ethical Collection, Storage, and Use of Public Health Data. A Proposal for a National Privacy Protection, Lee and Gostin, Journal of the American Medical Association 302: 82-84, Jul 1, 2009 (abstract freely available)
The Case for Public Ownership of Patient Data, Rodwin, Journal of the American Medical Association 302: 86-88, Jul 1, 2009 (abstract freely available)
Guidance for Institutional Review Boards (IRBs). Frequently Asked Questions – IRB Registration, US Food and Drug Administration (FDA), Jul 2009 (pdf)
"This guidance is intended to assist institutional review boards (IRBs) in complying with the new requirement for IRB registration…"
Risk of Tumorigenesis in First-in-Human Trials of Embryonic Stem Cell Neural Derivatives: Ethics in the Face of Long-Term Uncertainty, Hess, Accountability in Research 16: 175 - 198, Jul 2009 (abstract freely available)
HIV Infections as Unanticipated Problems During Medical Research in Africa, Gisselquist, Accountability in Research 16: 199 - 217, Jul 2009 (abstract freely available)
International Standards for Research Integrity: An Idea Whose Time has Come?, Resnick, Accountability in Research 16: 218 - 228, Jul 2009 (abstract freely available)
Blood Samples Raise Questions of Privacy. Some Samples Are Stored and Used For Research Without Parents' Consent, Washington Post, Jun 30, 2009 (free one time registration required)
"…The couple is among a group of parents challenging Minnesota's practice of storing babies' blood samples and allowing researchers to study them without their permission. The confrontation, and a similar one in Texas, has focused attention on the practice at a time when there is increasing interest in using millions of these collected "blood spots" to study diseases…"
 
Week of June 22, 2009
New York State Allows Payment for Egg Donations for Research, New York Times, Jun 26, 2009 (free one time registration required)
"Stem cell researchers in New York can now use public money to pay women who give their eggs for research, a decision that has opened new possibilities for science but raised concern among some bioethicists and opponents of such research…"
Operator of drug trials charged with unlicensed medical practice, St Petersburg Times, Jun 23, 2009
"Vladimir Martin called himself "doctor" and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license…"
Medtronic Gets Subpoena Regarding Disputed Study, New York Times, Jun 23, 2009 (free one time registration required)
"Medtronic disclosed on Tuesday that it had received a Justice Department subpoena seeking information about its ties with a company consultant, a former Army doctor accused of falsifying a favorable medical journal article about a Medtronic bone growth product called Infuse…"
 
Week of June 15, 2009
$788,000 Paid to Doctor Accused of Faking Study, New York Times, Jun 17, 2009 (free one time registration required)
"Medtronic said on Wednesday that it had paid nearly $800,000 over an eight-year period to a former military surgeon who has been accused by the Army of falsifying a medical journal study involving one of the company’s products…"
Device-maker accused of fraudulent testing, UPI, Jun 17, 2009
"A medical device-maker and four executives were indicted Wednesday on charges of conducting unauthorized clinical trials, the U.S. Justice Department said…"
Obama Plans to Replace Bush’s Bioethics Panel, New York Times, Jun 17, 2009 (free one time registration required)
"Members of the President’s Council on Bioethics were told by the White House last week that their services were no longer needed and were asked to cancel a planned meeting…President Obama will appoint a new bioethics commission, one with a new mandate and that “offers practical policy options,”…"
Pa. firm illegally tested bone cement, feds say, MSNBC, Jun 16, 2009
"A medical-device company illegally tested bone cement during spinal surgery on about 200 patients, three of whom died on the operating table, U.S. prosecutors in Philadelphia charged Tuesday…"
First hand and face transplant patient dies, The Guardian, Jun 15, 2009
"…The 30-year-old man, whose name has not been made public, had a heart attack while surgeons tried to tackle an infection that had set in weeks after the dual transplant, the doctor who led the pioneering transplant said…"
 
Week of June 8, 2009
Drawing Lines on Conflicts of Interest, Inside Higher Ed, Jun 11, 2009
"…the AAU and AAMC have sought to strike a balance between continuing to recognize conflicts of interest as a problem and discouraging the overinvolvement of the federal government in the affairs of their members. That tension is very much in evidence in the two groups' response Tuesday to May's announcement by the National Institutes of Health that it was contemplating toughening the regulations that govern financial conflicts of interest in research financed by the Public Health Service…"
AAMC comments on NIH conflict of interest proposals, Association of American Medical Colleges (AAMC), Jun 10, 2009 (pdf)
"…The letter expresses support for, among other things, requiring investigators to report all external financial interests related to their research responsibilities (regardless of the amount) to their institution, and lowering the NIH threshold to $5,000 for disclosing to grant-making agencies any related external financial interests. The NIH proposals closely follow the recommendations of a 2008 AAMC-AAU report on conflicts of interest…"
In Global Health Research, Is It Legitimate To Stop Clinical Trials Early on Account of Their Opportunity Costs?, Lavery et al., PLoS Medicine 6(6): e1000071. doi:10.1371/journal.pmed.100007, Jun 9, 2009 (full article freely available)
Call for Nominations for Members: The Interagency Advisory Panel on Research Ethics (PRE), Jun 9, 2009 (deadline Sept 18, 2009)
"The Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC) are pleased to invite nominations of potential members to serve on the Interagency Advisory Panel on Research Ethics (PRE)…"
 
Week of June 1, 2009
FDA Transparency Task Force Web Site, US Food and Drug Administration, Jun 3, 2009
"The Food and Drug Administration (FDA) has formed a task force to develop recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format. The Task Force is seeking public opinion on how to make the agency’s information on activities and decision making more transparent, useful, and understandable to the public, while appropriately protecting confidential information…"
AAMC Comments on Proposed IRB Rule, Association of American Medical Colleges, Jun 3, 2009 (pdf)
"On June 3, the AAMC submitted comments on an advanced notice of proposed rulemaking, released by the U.S. Department of Health and Human Services’ Office of Human Research Protection (OHRP), that would enable the office to hold external institutional review boards (IRB) directly accountable for meeting federal regulations on the protection of human subjects. The AAMC comment letter supported an expansion of OHRP’s regulatory oversight…"
Proposed Revised Accreditation Standards, Association for the Accreditation of Human Research Protection Programs (AAHRPP), Jun 1, 2009 (comments solicited)
"…In response to colleagues in client organizations—both accredited and not yet accredited—as well as the highly diverse members of its Standards Revision Committee, the Council on Accreditation, and the Board of Directors, AAHRPP has revised the Accreditation Standards both to sustain their rigor and reduce the unnecessary burden on clients…"
Drug Agency May Reveal More Data on Actions, New York Times, Jun 1, 2009 (free one time registration required)
"…setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study…"
Special Edition: Human Subjects Research and Research Ethics. Evidence, Accountability and Practice, Canadian Network for the Governance of Ethical Health Research Involving Humans, Health Law Review 17 (2 &3), Jun 2009 (link to Table of Contents and ordering information)
Draft Proposed National Standard of Canada: Research Ethics Boards Reviewing Biomedical Clinical Trials, Canadian General Standards Board, Jun 2009 (pdf; public comments accepted until Sept 14, 2009)
"This Standard specifies requirements for the responsibilities for the ethical review of research that organizations must have in place as part of the research organizations framework of human research protections program to oversee the ethical conduct of clinical trials conducted under their auspices…"
Faculty Perspectives on Community-Based Research: "I See This Still as a Journey", Kennedy et al., Journal of Empirical Research on Human Research Ethics 4: 3 - 16, Jun 2009
"abstract freely available"
Action Research in Public Schools: Is it Research? Should it be Reviewed?, Sigler, Journal of Empirical Research on Human Research Ethics 4: 17 - 25, Jun 2009 (abstract freely available)
Exploring the Relationship between Faculty, Students, and the Social and Behavioral Ethics Review Committee through Action Research, Griebling et al., Journal of Empirical Research on Human Research Ethics 4: 27 - 36, Jun 2009 (abstract freely available)
Online Survey Tools: Ethical and Methodological Concerns of Human Research Ethics Committees, Buchanan and Hvizdak, Journal of Empirical Research on Human Research Ethics 4: 37 - 48, Jun 2009 (abstract freely available)
Discourses of Dislike: Responses to Ethics Education Policies by Life Scientists in the U.K., Italy, and the U.S., Smith-Doerr, Journal of Empirical Research on Human Research Ethics 4: 49 - 57, Jun 2009 (abstract freely available)
What Do Prospective Research Participants Want to Know? What Do They Assume They Know Already?, Walkup and Bock, Journal of Empirical Research on Human Research Ethics 4: 59 - 63, Jun 2009 (abstract freely available)
Inclusion of Women, Minorities, and Children in Clinical Trials: Opinions of Research Ethics Board Administrators, Taylor, Journal of Empirical Research on Human Research Ethics 4: 65 - 73, Jun 2009 (abstract freely available)
 
Week of May 25, 2009
Push to link medical research innovations to public good, Canadian Medical Association Journal 180: doi:10.1503/cmaj.090788, May 26, 2009
"…The university is the first in Canada, and 1 of only 4 in North America, to have formally adopted such principles, under which it will provide licences to companies to develop research. In exchange for rights in the developed world, the firms must agree to make the resulting drug or device available at low cost to the developing world. A "wave" of similar approaches is coming within the nation’s universities…"
New Rules on Stem Cells Threaten Current Research, Washington Post, May 25, 2009 (free one time registration required)
"…The concern focuses on strict new ethics criteria that the National Institutes of Health has proposed. Advocates of stem cell research say that most of the work currently underway passed close ethical scrutiny but that the procedures varied and usually did not match the details specified in the proposed new guidelines…"
 
Week of May 18, 2009
Association of American Medical Colleges (AAMC) Comments on Proposed Guidelines for Federally Funded Stem Cell Research, May 22, 2009 (pdf)
"…In the comment letter, the AAMC notes that the NIH’s proposed assurance system is “appropriate, consistent, and workable” for stem cell lines created after the effective date of the final NIH guidelines. The AAMC is concerned, however, about the unresolved status of the hundreds of existing stem cell lines, derived before the guidelines become effective. In the letter, the association urges the NIH to allow federal funding for all human embryonic stem cell lines in existence before the effective date of the final guidelines, based on an “institutional assurance” that specific criteria are met. The AAMC also urged the agency to maintain a registry of eligible stem cell lines…"
 
Week of May 11, 2009
Fighting for a Last Chance at Life, New York Times, May 16, 2009 (free one time registration required)
"…At a time when terminally ill patients have more access to medical research than ever before, and perhaps a deeper conviction in its ability to cure them, many are campaigning for the chance to be treated with drugs whose safety and effectiveness is not yet known…"
Healthcare Inspection. Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research, US Dept of Veterans Affairs, Office of the Inspector General (OIG), May 15, 2009 (pdf)
"…There were 5,993 sampled participants. We found the following: Insufficient IRB documentation for the waiver for 2 of the 33 sampled research protocols that were waived from the required informed consent process. An estimated 1.7 percent of the 367,103 VA research subject consent forms could not be located; we are 95 percent confident that the true percent value is somewhere between 0.6 percent to 4.5 percent. Thirty-one percent of the VA research subjects consent forms on file were estimated to be noncompliant with VHA standards; 97 percent of the noncompliant forms lacked witness signature. One percent of the 110,231 VA noncompliant forms lacked the subject or subject’s authorized representative signature…"
Globalized Clinical Trials and Informed Consent, Annas, New England Journal of Medicine 360: 2050-2053, May 14, 2009 (full article freely available)
Clinical trial registries becoming a reality, but long-term effects remain uncertain, Canadian Medical Association Journal 180. doi:10.1503/cmaj.090625, May 12, 2009
"Advocates for clinical trial registration have in recent years gained several formidable allies, including editors of high-profile medical journals and the United States government, but some warn that publishing incentives and mandatory-registration laws, while strides in the right direction, will not guarantee change in a culture that has traditionally been as transparent as chocolate milk…"
Doctor Falsified Study on Injured G.I.’s, Army Says, New York Times, May 12, 2009 (free one time registration required)
"A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday…"
OHRP Clarifying Language Regarding OHRP-Approved Assurances and OHRP-Registered IRBs or IECs, US Office for Human Research Protections (OHRP), May 11, 2009
"OHRP has posted clarifying language on its website regarding OHRP-approved assurances and OHRP-registered Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs). Regarding registered IRBs, the fact that an IRB or an IEC is registered with OHRP does not mean that OHRP has determined that the IRB reviews research in accordance with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46, and does not mean that the IRB or IEC has the appropriate competence or expertise to review a particular research project. Regarding approved assurances, the fact that OHRP has approved an institution's assurance does not mean that OHRP has determined that the institution is complying with the requirements of the HHS Protection of Human Subjects regulations, 45 CFR part 46. It means that an institution has submitted all of the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in non-exempt human subjects research conducted or supported by HHS or other research covered by the assurance. These clarifications are now included on several of OHRP’s web pages related to IRB registration and assurances…"
 
Week of May 4, 2009
Looking back, years after Penn gene-therapy death, Philadelphia Inquirer, May 8, 2009
"After almost a decade of reflection, University of Pennsylvania researcher James M. Wilson says problems with the gene-therapy experiment that killed an Arizona teenager were "absolutely unacceptable" and ultimately "my responsibility."…"
NIH Requests Comments on Proposed Amendment of Regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors, US National Institutes of Health (NIH), May 8, 2009 (comments due Jul 7, 2009)
"…The NIH believes that the complex and controversial issues surrounding FCOI warrant a carefully considered, open dialogue with all affected parties to enhance regulatory compliance and effective oversight. Consequently, with the ANPRM we invite public comments on all aspects of potential regulation in this area…"
Medical Device Maker Settles Conflict Inquiry in New Jersey, New York Times, May 6, 2009 (free one time registration required)
"The New Jersey attorney general has announced a settlement with a medical device maker accused of failing to disclose financial conflicts of interest among doctors researching its products, and says her office is investigating other similar conflicts in the device industry…"
First U.S. face transplant recipient offers thanks, CNN, May 5, 2009
"…Tuesday, when Culp, 46, the first recipient of a face transplant in the United States, stepped in front of the cameras at a news conference, she was whole…The fact that Culp regained some of her basic functions highlights that "this is not cosmetic surgery in any sense of the word," said Dr. Eric Kodish, the professor and chairman of the Cleveland Clinic's Department of Bioethics. "We remain convinced about the ethical justification for the face transplant in this and potentially in other cases in the future." …"
Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials, Sarzotti-Kelsoe et al., PLoS Medicine 6(5): e1000067. doi:10.1371/journal.pmed.1000067, May 5, 2009 (full article freely available)
 
Week of April 27, 2009
An Intervention to Improve Cancer Patients’ Understanding of Early-Phase Clinical Trials, Kass et al., IRB 31 (3): 1-10, May - June 2009 (full article freely available with free one time registration)
Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research, Schmidt and Downie, Accountibility in Research 16: 153 - 173, May-June 2009 (abstract freely available)
Controlling Conflict of Interest — Proposals from the Institute of Medicine, Steinbrook, New England Journal of Medicine Online First, Apr 29, 2009 (full text freely available, will appear in May 21 issue of the Journal)
Report: Conflict of Interest in Medical Research, Education, and Practice, Committee on Conflict of Interest in Medical Research, Education, and Practice, Institute of Medicine, Apr 28, 2009
"…The committee’s report stresses the importance of preventing bias and mistrust rather than trying to remedy damage after it is discovered. It focuses specifically on financial conflicts of interest involving pharmaceutical, medical device, and biotechnology companies. The committee recommends the implementation of policies and procedures that will reduce the risk of conflicts…"
Now Patients Can Tweet for Trials, Bio-IT World, Apr 27, 2009
"…“do-it-yourself” platform that moves the search for clinical trials onto social media sites like Twitter. It also allows would-be subjects with a personal health record (PHR) in Microsoft HealthVault or Google Health to import the information in lieu of filling out an online pre-screening form to be matched for trials..Although TrialX has yet to be formally marketed, each day it is receiving hundreds of unique visits and an exchange of three to four dozen emails between investigators and patients…"
Extension of the Term for the Interagency Advisory Panel and Secretariat on Research Ethics (PRE), Interagency Secretariat on Research Ethics, Canada, Apr 27, 2009
"…pleased to announce that the term of the Interagency Advisory Panel on Research Ethics (the Panel) and the Secretariat on Research Ethics (Secretariat) has been extended until November 30, 2011. The Panel will continue its work on evolution, education and interpretation of the TCPS. With the continuation of the Panel’s mandate, a public call for nominations for membership on the Panel will be announced in September 2009…"
 
Week of April 20, 2009
Medical Review Firm, After Federal Sting, Goes Out of Business, New York Times, Apr 22, 2009 (free one time registration required)
"Companies typically die slow, lingering deaths, the victims of changing technologies or tectonic shifts in global trade. But it is possible to kill a company really fast. Consider the case of Coast Institutional Review Board…"
 
Week of April 13, 2009
Some Stem Cell Research Limits Lifted, New York Times, Apr 17, 2009 (free one time registration required)
"The Obama administration announced Friday that it planned to lift some but not all federal financing restrictions on human embryonic stem cell research, drawing criticism both from abortion opponents and from scientists who had expected a more liberal policy…"
Draft National Institutes of Health Guidelines for Human Stem Cell Research, National Institutes of Health (NIH), Apr 17, 2009
"The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled "National Institutes of Health Guidelines for Human Stem Cell Research" (Guidelines)…"
HITECH Act Breach Notification Guidance and Request for Public Comment, US Dept of Health and Human Services (HHS), Apr 17, 2009
"On April 17, 2009, HHS issued guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals, as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act passed as part of the American Recovery and Reinvestment Act of 2009 (ARRA)…In addition to this guidance, HHS has also concurrently issued a request for information (RFI) soliciting public comment on the breach notification provisions of the HITECH Act to inform future rulemaking and updates to the guidance…"
Overseer of Medical Trials, Under F.D.A. Pressure, Agrees to Suspension, New York Times, Apr 14, 2009 (free one time registration required)
"…Under pressure from the Food and Drug Administration, the company agreed to temporarily suspend approving federally regulated medical studies or enrolling new patients in ones currently under way. The agreement by the company, Coast Independent Review Board of Colorado Springs, could have an impact on its future operations. It may also affect some of 300 active studies involving human patients that Coast currently oversees on behalf of makers of drugs or medical devices…"
 
Week of April 6, 2009
Medical researchers face conflicts of interest, Reuters, Apr 10, 2009 (scheduled to be available until May 9, 2009)
"Dr. Bruce Psaty of University of Washington in Seattle knows how easy it can be to fall under the spell of a friendly relationship with drug companies..he felt "a kind of social duty to reciprocate both the kindness and the investment made by the sponsor in the slide set." Psaty said his own story illustrates the subtleties of conflicts of interest…"
Conflict of Interest, Disclosure, and Trial Reports, Psaty, Journal of the American Medical Association, Apr 8, 2009 (extract freely available)
 
Week of March 30, 2009
Pfizer Reaches Settlement In Nigerian Drug-Trial Case, Washington Post, Apr 4, 2009 (free one time registration required)
"Pfizer has reached a broad agreement to pay millions of dollars to Nigeria's Kano state to settle a criminal case alleging that the drug company illegally tested an experimental drug on gravely ill children during a 1996 meningitis epidemic…"
Navy rips FDA for blocking clinical trial, Boston Globe, Apr 4, 2009
"…The Navy ultimately hopes to use the experimental product, called Hemopure, to treat military personnel wounded in battle, where traditional blood transfusions aren't readily available. But for the past four years, the FDA has consistently rejected Biopure and the Navy's efforts to test the product in clinical trials, citing safety worries and other concerns…"
Scientists who put their lives on the line, New Scientist, Apr 3, 2009
"…we've put together our pick of your suggestions, along with some of the ones we didn't have space for the first time round. And please don't try these experiments at home – the list includes a number who made the ultimate sacrifice in their pursuit of knowledge…"
Professional Medical Associations and Their Relationships With Industry, Rothman et al., Journal of the American Medical Association 301:1367-1372, Apr 1, 2009 (abstract freely available)
Reforming the HIPAA Privacy Rule, Gostin and Nass, Journal of the American Medical Association 301:1373-1375, Apr 1, 2009 (extract freely available)
Is it ethical to deny genetic research participants individualised results?, Affleck, Journal of Medical Ethics 35: 209-213, Apr 2009 (abstract freely available)
Researchers’ preferences and attitudes on ethical aspects of genomics research: a comparative study between the USA and Spain, Ruiz-Canela et al., Journal of Medical Ethics 35: 251-257, Apr 2009 (abstract freely available)
Reporting of ethics-related methods in epidemiological research, Jacobsen, Journal of Medical Ethics 35: 262-267, Apr 2009 (abstract freely available)
Expanded Opportunities to Comment on Draft 2nd Edition of the TCPS, Panel on Research Ethics, Canada, Mar 30, 2009
"…The Panel has decided to accept written comments until June 30, 2009…The Panel will release a revised version of the draft to the public for further comment in October…"
 
Week of March 23, 2009
Part of Study Testing Trauma Treatments Is Shut Down, Washington Post, Mar 27, 2009 (free one time registration required)
"A key part of a controversial project that has been testing experimental treatments on trauma victims has been shut down after the researchers discovered that one new therapy offered no benefit and that patients receiving it appeared to die more quickly. The research has been subject to intense ethical debates because the patients, who were often unconscious or disoriented because of their injuries, could not give consent to participate…"
Press Release: The NHLBI Halts Study of Concentrated Saline for Patients with Shock Due to Lack of Survival Benefit, NIH News, Mar 26, 2009
Israel panel slams anthrax vaccine test on troops, Associated Press, Mar 26, 2009
"An expert panel has accused Israeli defense officials of "grave ethical failures" in testing an experimental anthrax vaccine on hundreds of Israeli soldiers…"
An Overseer of Trials in Medicine Draws Fire, New York Times, Mar 26, 2009 (free one time registration required)
"A Colorado company that drug and medical device makers pay to oversee patient safety during clinical trials drew scorn Thursday at a Congressional hearing on whether such companies adequately supervise medical trials…"
Human Subjects Research. Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation, US Government Accountability Office (GAO), Mar 26, 2009 (pdf)
"Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives…"
Highlights: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation, US Government Accountability Office (GAO), Mar 26, 2009 (pdf)
"…GAO investigated three key aspects of the IRB system: (1) the process for establishing an IRB, (2) the process through which researchers wishing to apply for federal funding assure HHS their human subjects research activities follow ethical principles and federal regulations, and (3) the process that medical research companies follow to get approval for conducting research on human subjects. GAO investigated these three aspects of the IRB system by creating two fictitious companies (one IRB and one medical device company), phony company officials, counterfeit documents, and a fictitious medical device…"
Policies regarding IRB members' industry relationships often lacking, EurekAlert!, Mar 25, 2009
"At a time of heightened concern about conflicts of interest posed by relationships between academic medical researchers and commercial firms, a new study finds that a significant number of academic institutions do not have clear policies covering the industrial relationships of members of Institutional Review Boards (IRBs)…"
Porton Down 'not death sentence', BBC News, Mar 24, 2009
"Porton Down veterans used as guinea-pigs to test chemical weapons face no greater risk of dying from cancer but health worries remain, experts say…"
Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards, US Office for Human Research Protections (OHRP), Mar 24, 2009
"OHRP has posted on its website a finalized guidance document entitled, “Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.” The guidance document provides OHRP’s first formal guidance on this topic…is intended primarily for investigators who conduct, and institutional review boards (IRBs) that review, non-exempt human subjects research involving genetic testing or collection of genetic information. The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services regulations for the protection of human subjects (45 CFR part 46)…"
 
Week of March 16, 2009
Senator broadens inquiry into psychiatrist, Boston Globe, Mar 21, 2009
"Senator Chuck Grassley of Iowa has widened his investigation into well-known Harvard child psychiatrist Dr. Joseph Biederman, questioning whether Biederman promised pharmaceutical giant Johnson & Johnson that his research into the company's drugs would yield positive results before beginning the studies…"
Safety of Drug Trials Tested. A government sting shows that regulations may be failing, AARP Bulletin, Mar 19, 2009
"…Coast Independent Review Board in Colorado Springs approved the study last November. But five months after approving the use of human subjects for the trial, Coast CEO Daniel Dueber says he sensed a problem when he was contacted recently by a congressional subcommittee and asked to testify about the gel trial…"
A Silenced Drug Study Creates An Uproar, Washington Post, Mar 18, 2009 (free one time registration required)
"…The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products, along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs…"
Clinical trials: the balance between protecting participants and promoting drug and product development, Canadian Medical Association Journal, Mar 17, 2009
"They have been called bureaucratic, cumbersome, a liability to the drug and research industries, and even harmful to patients. In fact, so maligned have research ethics boards been in Canada that they have spurred demands for the introduction of national accreditation centralized review for clinical drug trials involving multiple sites…"
Editorial: Research ethics review: Do it once and do it well, Canadian Medical Association Journal 180: doi:10.1503/cmaj.090172, Mar 17, 2009 (freely available)
Being research subject a lure in hard times, Modesto Bee, Mar 17, 2009
"…With the economy careening and millions uninsured, some doctors and researchers believe the lure of volunteering for medical research is growing -- and so are potential ethical pitfalls…"
 
Week of March 9, 2009
Medical clinical research slows for lack of patients, Los Angeles Times, Mar 14, 2009
"…But the reluctance of Americans to participate in clinical trials has been a serious drag on medical research. Enrollment problems delay more than 70% of clinical trials from one to six months, according to a 2007 survey by CenterWatch, a Boston-based company that publishes information on clinical trials. In cancer care, less than 5% of patients enter clinical trials…"
Google Co-Founder Backs Vast Parkinson’s Study, New York Times, Mar 12, 2009 (free one time registration required)
"Sergey Brin, the billionaire co-founder of Google, says he plans to contribute money and his DNA to a large study intended to reveal the genetic underpinnings of Parkinson’s disease. The study, to be announced Thursday, will be conducted by 23andMe, a company co-founded and co-managed by Mr. Brin’s wife, Anne Wojcicki…"
Testing Firm Finds Itself Being Tested, New York Times, Mar 12, 2009
"…But the investigation had an unusual focus: determining whether companies that are paid to oversee the safety of patients in clinical studies of drugs and medical devices do their job. The inquiry came to light this week when one of its targets, a Colorado company, exposed it — via news release. The company, Coast Independent Review Board, said it had been duped by federal officials last year when it agreed to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery. As it turns out, there is no such product…"
Press Release: Clinical Trial Fraud Detected by Independent Review Board, part of a congressional “sting” operation, Coast IRB, Mar 11, 2009
Mass. doctor accused of fabricating pain studies, MSNBC, Mar 11, 2009
"A Massachusetts anesthesiologist has been accused of faking data for a dozen years in 21 published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex…The hospital said a routine review in May found that some of Reuben’s research was not approved by an internal hospital review board…"
Eight scientists who became their own guinea pigs, New Scientist, Mar 11, 2009
"…Many of the stories we turned up proved hard to verify, and others too scurrilous to publish - but here are eight extraordinary (and occasionally disgusting) stories of medical self-experimentation…"
Obama's Order on Stem Cells Leaves Key Questions to NIH, Washington Post, Mar 10, 2009 (free one time registration required)
"…many thought Obama would limit federally funded scientists to working with cell lines derived from embryos destined to be discarded at infertility clinics. Instead, he left that key issue open. The task of deciding what kinds of studies will be supported now falls to the National Institutes of Health, which finds itself confronting far more extensive questions than its officials were contemplating. It has 120 days to do the job…"
 
Week of March 2, 2009
Office for Human Research Protections; Institutional Review Boards, Federal Register 74: 9578-9583, US Office for Human Research Protections (OHRP), Mar 5, 2009 (Submit written or electronic information and comments by June 3, 2009)
"The Office for Human Research Protections (OHRP), has issued a Federal Register notice requesting information and comments from the public about whether the office should pursue a notice of proposed rulemaking to enable OHRP to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of 45 CFR part 46. OHRP is contemplating this regulatory change to encourage institutions to rely on IRBs that are operated by another institution or organization, when appropriate. OHRP believes that such a regulatory change in its enforcement authority may address one of the main disincentives institutions have cited as inhibiting them from exercising the regulatory flexibility that currently permits institutions to implement a variety of cooperative review arrangements and to rely on the review of an IRB operated by another institution or organization…"
Senator Asks Pfizer About Harvard Payments, New York Times, Mar 3, 2009 (free one time registration required)
"…The request for information about Pfizer payments to Harvard Medical faculty members in the last two years expands Mr. Grassley’s investigation of industry payments to three Harvard psychiatrists who had promoted antipsychotic medicines for children…"
Clinical trial participation poses ethical, practical issues, Canadian Medical Association Journal, Mar 3, 2009
"…Ask a physician for an on-the-record comment about any manner of patient recruitment fees and the invariable response is that physician participation in clinical trials is a necessary to advance knowledge and improve patient care. That, or to cite "confidentiality" as an excuse for silence. Yet many physicians are increasingly concerned about the pressures to commercialize research, which raises potential conflicts of interest, and for some, ethical quandaries about receiving monies to boost patient enrolments in clinical trials. Still others raise concerns about patient safety and welfare…"
Most IRB rules don't ban finder's fees for clinical trials, American Medical News, Mar 2, 2009
"The American Medical Association, the American College of Physicians and others have declared unethical the practice of paying doctors "finder's fees" for recruiting patients as clinical research subjects. But only half of institutional review boards address in writing the conflict of interest these kinds of payment incentives pose…"
Harvard Medical School in Ethics Quandary, New York Times, Mar 2, 2009 (free one time registration required)
"…Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes…"
 
Week of February 23, 2009
US Office of Research Integrity Quarterly Newsletter, Mar 2009 (pdf)
Prevalence of Industry Support and its Relationship to Research Integrity, Tereskerz et al., Accountability in Research 16: 78-105, Mar 2009 (abstract freely available)
Pediatric Assent for a Study of Antiretroviral Therapy Dosing for Children in Western Kenya: A Case Study in International Research Collaboration, Vreeman et al., Journal of Empirical Research on Human Research Ethics 4: 3–16, Mar 2009 (abstract freely available)
Toward a Construct Definition of Informed Consent Comprehension, Buccini et al., Journal of Empirical Research on Human Research Ethics 4: 17–23, Mar 2009 (abstract freely available)
Ethical Perspectives on Emerging Assistive Technologies: Insights from Focus Groups with Stakeholders in Long-Term Care Facilities, Dorsten et al., Journal of Empirical Research on Human Research Ethics 4: 25–36, Mar 2009 (abstract freely available)
Federal Interpretation and Enforcement of Protections for Vulnerable Participants in Human Research, Iltis et al., Journal of Empirical Research on Human Research Ethics 4: 37–41, Mar 2009 (abstract freely available)
Creating A Controlled Vocabulary for the Ethics of Human Research: Towards A Biomedical Ethics Ontology, Koepsel et al., Journal of Empirical Research on Human Research Ethics 4: 43–58, Mar 2009 (abstract freely available)
The Biomedical Ethics Ontology Proposal: Excellent Aims, Questionable Methods, DuBois, Journal of Empirical Research on Human Research Ethics 4: 59–62, Mar 2009 (abstract freely available)
Anonymous Self-Evaluation of Performance by Ethics Board Members: A Pilot Study, Feldman and Rebholz, Journal of Empirical Research on Human Research Ethics 4: 63–69, Mar 2009 (abstract freely available)
Babies’ blood used in research without parents’ OK, Houston Chronicle, Feb 24, 2009
"For almost seven years, the state has been indefinitely storing blood from nearly all newborns in Texas without their parents’ consent for possible use in medical research…"
Hopkins researcher disciplined, Baltimore Sun, Feb 24, 2009
"The Johns Hopkins University has disciplined the lead author of a widely publicized study that reported widespread civilian deaths in Iraq as a result of the U.S. invasion…Burnham and his team partnered with Iraqi doctors…When the surveys came back to him in Jordan, it appeared that some had last names…found that the data form used in the surveys was different from what was originally proposed, and included space for names of respondents. Hopkins found that full names were collected…"
Obtaining Consent for Future Research with Induced Pluripotent Cells: Opportunities and Challenges, Aalto-Setälä et al., PLoS Biology 7: e1000042, Feb 24, 2009 (full article freely available)
Drug development raises ethical issues, Globe and Mail, Feb 24, 2009
"The possibility that one day a drug could cure learning disabilities may have massive societal implications. But as that drug moves slowly from theory to reality, it's also unleashing a host of ethical challenges, including safety issues related to testing drugs on children…"
 
Week of February 16, 2009
Ethical and Scientific Implications of the Globalization of Clinical Research, Glickman et al., New England Journal of Medicine 360: 816-823, Feb 19, 2009 (full article freely available)
Progress and Deficiencies in the Registration of Clinical Trials, Wood, New England Journal of Medicine, Feb 19, 2009 (full article freely available)
The Why and How of Human Terrain Teams, Silverman, Inside Higher Ed, Feb 19, 2009
"…the work I conducted as a field social scientist deployed by HTS. I would like to explain what the goals of the program are, what we do, and why we do it, as well as try to clarify misperceptions that arise from unfamiliarity with military culture, terminology, planning and practice…"
ICMR comes out strict draft norms on clinical trials, Times of India, Feb 19, 2009
"…According to Indian Council of Medical Research's draft guidelines for compensation to participants for research related injury in India, "compensation will have to be paid to a child injured in-utero through the participation of the parent in clinical research." The draft says compensation has to be paid, irrespective of whether injury was foreseeable/predictable or not and the fact that the research participant had consented in writing about participating in the research study…"
Anthropologists Toughen Ethics Code, Inside Higher Ed, Feb 19, 2009
"By an overwhelming margin of 87 to 13 percent, members of the American Anthropological Association have approved changes in its code of ethics that are designed to strengthen its protections of people who are studied, and to promote the values of free dissemination of scholarship…"
Code of Ethics of the American Anthropological Association, Feb 19, 2009 (pdf; marked copy of changes)
Outsourcing of Drug Trials Is Faulted, New York Times, Feb 18, 2009 (free one time registration required; for New Engl J Med article see Journal section below)
"…Now, an article about the globalization of clinical trials, published Thursday in The New England Journal of Medicine raises questions about the ethics and the science of increasingly conducting studies outside the United States — when the studies are meant to gather evidence for new drugs to gain approval in this country…"
Unemployed turn to drug trials, The National, UAE, Feb 18, 2009
"…According to The Telegraph, a daily newspaper in Kolkata, at least 4,000 diamond workers have offered their bodies for medical experiments in Gujarat in the past three months. The newspaper cited medical and industry sources. Although recruiting humans for medical trials is not illegal in India, there are ethical concerns since most of those volunteering are usually poor and illiterate, with little knowledge of the possible side effects…"
Clinical trials: chasing recruits, Canadian Medical Association Journal 180: 375-378, Feb 17, 2009
"In Canada's largest cities, the back pages of free news tabloids carry advertisements designed to entice "healthy volunteers" to participate in phase 1 clinical trials, in which drugs are tested on humans for the first time. The appeal is straightforward: money. The ads are targeted at people who need it, rarely appearing in more "upscale" publications…"
Ethics guidelines strengthened but reach remains limited, Canadian Medical Association Journal 180: 379-380, Feb 17, 2009
"Canada's granting councils have issued an updated draft of ethics guidelines governing human research, including expanded sections about aboriginal and qualitative research, as well as bolstered chapters concerning genetic and human-tissue research and clinical trials. While some researchers are praising the changes as a good response to community concerns and evolving ethical principles, others caution that they do not adequately address emerging governance problems as health research moves from research-based institutions into community settings…"
Inadequate Dissemination of Phase I Trials: A Retrospective Cohort Study, Decullier et al., PLoS Medicine 6(2): e1000034, Feb 17, 2009 (full article freely available)
Stem cell therapy triggers tumor, The Scientist, Feb 17, 2009 (free one time registration required; for PLoS Medicine article, see journal section below)
"A neural stem cell transplant from fetal cells performed in Russia led to a brain tumor in a teenage boy…outside experts raised concerns about the safety of the transplant procedure used in this case…the cells used are a mixture of glial cells, neurons, and progenitors -- "a sort of cell mush," she said. These are "completely uncharacterized populations, populations that would never be accepted in the US or any first-world country,"…"
Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient, Amariglio et al., PLoS Medicine 6(2): e1000029, Feb 17, 2009 (full article freely available)
U.S. to Compare Medical Treatments, New York Times, Feb 16, 2009 (free one time registration required)
"The $787 billion economic stimulus bill approved by Congress will, for the first time, provide substantial amounts of money for the federal government to compare the effectiveness of different treatments for the same illness…"
 
Week of February 9, 2009
Anthropologist's war death reverberates, Boston Globe, Feb 12, 2009
"…The attack on Loyd, who died in a Texas hospital on Jan. 7 after a two-month struggle for her life, has reverberated from the Wellesley campus, where people grieve for the energetic scholar who seemed to be a natural peacemaker, to national academic circles, where anthropologists carry on a heated debate over whether social scientists should be working for the military, to the Afghan mountains, where soldiers vow to give meaning to her death by fighting on…"
Pfizer to Publicly Disclose Payments to U.S. Doctors, Bloomberg, Feb 9, 2009
"Pfizer Inc., the world’s biggest drugmaker, will make public its payments to U.S. doctors for consulting, speeches and research amid criticism from Congress over the ties between the medical profession and drug companies…"
Recent Compliance Oversight Determinations, US Office for Human Research Protections (OHRP), Feb 9, 2009
"OHRP has revised its 2005 document “Significant Findings and Concerns of Noncompliance,” to delete determinations that have not been made recently, add new determinations that have been made since 2005, and provide additional regulatory citations…"
 
Week of February 2, 2009
Hidden records show MMR truth. A Sunday Times investigation has found that altered data was behind the decade-long scare over vaccination, Times, UK, Feb 8, 2009
"…Wakefield and two professors, John Walk-er-Smith, 72, and Simon Murch, 52, are charged with carrying out unauthorised research on the 12 children. The charges, which they strongly deny, relate to the ethics of the treatment of the 12 children, not the results of the research…however, there has emerged potential explanations of how Wakefield was able to obtain the results he did. This evidence, combined with unprecedented access to medical records, a mass of confidential documents and cooperation from parents during an investigation by this newspaper, has shown the selective reporting and changes to findings that allowed a link between MMR and autism to be asserted…"
Report: Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, Committee on Health Research and the Privacy of Health Information, Institute of Medicine, Feb 4, 2009 (full report freely available)
"…recommends an entirely new approach to protecting privacy in health research. However, if national policy makers choose to continue to rely on the HIPAA Privacy Rule rather than adopt the new approach, the committee recommends a series of changes to improve the rule and the guidance…"
 
Week of January 26, 2009
Commentary: Determining What We Stand for Will Guide What We Do: Community Priorities, Ethical Research Paradigms, and Research With Vulnerable Populations, Perez and Treadwell, American Journal of Public Health 99: 201-204, Feb 2009 (abstract freely available)
Minimal Risk in Pediatric Research as a Function of Age, Wendler, Archives of Pediatric and Adolescent Medicine 163: 115-118, Feb 2009 (abstract freely available)
Racial Differences in Parents' Distrust of Medicine and Research, Rajakumar et al., Archives of Pediatrirc and Adolescent Medicine 163: 108-114, Feb 2009 (abstract freely available)
Doctor experimented on patients, suit alleges, Charleston Gazette, Jan 31, 2009
"A whistleblower complaint accuses former osteopathic surgeon Dr. John A. King of experimenting on 26 of his patients. The federal complaint says King used medical devices in ways that hadn't been approved by the FDA and received illegal kickbacks for doing it…"
Suits Saying Pfizer Experimented on Nigerian Children Are Revived, Washington Post, Jan 30, 2009 (free one time registration required)
"…The U.S. Court of Appeals for the 2nd Circuit in New York ruled that the suits, dismissed earlier by a lower-court judge who said they should have been brought in Nigeria, can now go forward in the U.S. courts. Lawyers said the ruling could set a precedent affecting other American companies accused of wrongdoing overseas…"
Study Refutes Claims on AIDS Drug Trials, New York Times, Jan 27, 2009 (free one time registration required)
"An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race…"
Report: The Experiences of New York City Foster Children in HIV/AIDS Clinical Trials, Ross et al., Vera Institute of Justice, Jan 27, 2009 (full report freely available)
Dissidents at F.D.A. Complain of Inquiry, New York Times, Jan 27, 2009 (free one time registration required)
"Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints…"
 
Week of January 19, 2009
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections, Federal Register 73: 71004-71005, Jan 24, 2009 (nominations due by Jan 23, 2009)
"Please note that OHRP is still seeking nominations for membership on the Secretary’s Advisory Committee on Human Research Protections. The Department of Health and Human Services seeks to maximize the pool of candidates from which to select highly qualified SACHRP members, and encourages submission of nominations…"
F.D.A. Approves a Stem Cell Trial, New York Times, Jan 23, 2009 (free one time registration required)
"In a research milestone, the federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells…"
New Rules on Doctors and Medical Firms Amid Ethics Concerns, New York Times, Jan 23, 2009 (free one time registration required)
"…sign of an ethical makeover under way within the medical device industry, a field that has been troubled by federal investigations and bad publicity over the volatile issue of frequently undisclosed financial ties between companies and physicians. On Thursday, two senators increased the pressure further by reintroducing legislation that would require device and drug makers to report all financial links with doctors on a federal Web site. That bill is known as the Physician Payments Sunshine Act, and a parallel effort is in the House…"
Perspective: Online Disclosure of Physician–Industry Relationships, Steinbrook, New England Journal of Medicine 360: 325-327, Jan 22, 2009 (full article freely available)
Decide for Me When I Can't, Most People Say, Washington Post, Jan 21, 2009 (link to Neurology article in journal section below)
"Older Americans support having their family members enroll them in disease research studies should they become incapable of making the decision themselves, a new study says…"
 
Week of January 12, 2009
New Institutional Review Board Registration Requirements, US Office for Human Research Protections (OHRP), Jan 15, 2009 (for final rule, see attached link; FDA final rule listed separately)
"The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), has added a new subpart E to the HHS protection of human subjects regulations (45 CFR part 46). This new subpart requires institutional review boards (IRBs) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS…"
Final Rule: Office of Public Health and Science; Institutional Review Boards: Registration Requirements, Federal Register 74: 2399-2405, Jan 15, 2009
Final Rule: US Food and Drug Administration (FDA) Institutional Review Boards; Registration Requirements, Federal Register 74: Page 2358-2369, Jan 15, 2009
"The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS)…"
Guidance for Clinical Investigators, Sponsors, and IRBsAdverse Event Reporting to IRBs — Improving Human Subject Protection, US Food and Drug Administration (FDA), Jan 14, 2009 (pdf version also available)
"This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the institutional review board (IRB) under Title 21 of the Code of Federal Regulations (21 CFR) part 56 (Institutional Review Boards), part 312 (Investigational New Drug Application), and part 812 (Investigational Device Exemptions)…"
Surrogate consent for dementia research. A national survey of older Americans, Kim et al., Neurology 72: 149-155, Jan 13, 2009 (abstract freely available)
OHRP Correspondence: Determining When Institutions Are Engaged in Research, US Office for Human Research Protections (OHRP), Jan 13, 2009
"OHRP would like to clarify some of our views about when institutions are engaged in research, in response to a recent query about when survey firms that are involved in the conduct of non-exempt human subjects research would be considered engaged in a research study under the HHS human subject protection regulations (45 CFR part 46). Specifically, two related issues were raised, so we have addressed each in turn: (1) clarifying when a survey firm may be engaged in human subjects research; and (2) clarifying the relationship between engagement and the Federalwide Assurance (FWA)…"
 
Week of January 5, 2009
F.D.A. Is Lax on Oversight During Trials, Inquiry Finds, New York Times, Jan 11, 2009 (free one time registration required)
"The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting. Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort…"
The Food and Drug Administration’s Oversight of Clinical Investigators’ Financial Information, Office of the Inspector General (OIG), US Department of Health and Human Services (HHS), Jan 2009 (pdf)
OHRP Correspondence. Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments, US Office for Human Research Protections (OHRP), Jan 8, 2009
"OHRP has posted a to a commercial company, which provides a web-based system for managing student subject pools, in the belief that others may find the content to be useful. This letter clarifies that imposing penalty credits on students who fail to show up for scheduled appointments with investigators without cancelling by a specified deadline violates the requirement of Department of Health and Human Services (HHS) regulations at 45 CFR part 46.116(a)(8). Such penalties may not be implemented for non-exempt human subjects research conducted or supported by HHS or for non-federally supported research to which an OHRP- approved Federalwide Assurance (FWA) applies. OHRP’s determination in this matter applies to any system used for managing student subject pools…"
Clinical trials: the muddled Canadian landscape, Silversides, Canadian Medical Association Journal 180: 20-22, Jan 6, 2009
"This overview of the landscape of Canadian clinical trials, along with a historical primer (page 23), is the first in a series of articles CMAJ will present this year on the state of clinical trials in Canada and abroad. Many believe the system is in disarray because of spiralling costs and conflicting requirements. Among the issues that will be explored in upcoming articles are costs, recruitment, registration, ethical oversight, patient safety, reporting and the push for reforms…"
Legumes, lemons and streptomycin: A short history of the clinical trial, Collier, Canadian Medical Association Journal 180: 23-24, Jan 6, 2009
"The first documented experiment resembling a clinical trial was not conducted by a scientist or doctor, but by an ingenious military leader who dabbled in architecture and is perhaps best known for the 7 years he spent roaming the wilderness eating grass…"
OHRP Asks for Comments on its Website, US Office for Human Research Protections (OHRP), Jan 5, 2009
"OHRP plans to revise its website (www.hhs.gov/ohrp). We want to make the site easier to use and more useful to you. We welcome any feedback or suggestions on content, format, navigation or any other aspect of the site from web visitors. Please send your comments to OHRPWeb@hhs.gov. If you would prefer to send in your comments anonymously, please go to http://transparency.cit.nih.gov/ohrp/feedback.cfm…"
Change in FDA's ethical guidelines for clinical trials troubling: Lancet, CBC News, Jan 5, 2009 (for link to Lancet article, see Journals section)
"The Lancet medical journal is reporting that the United States Food and Drug Administration is abandoning the Declaration of Helsinki as an ethical foundation for international clinical trials…The FDA is instead adopting the International Conference on Harmonization's Guideline for Good Clinical Practice (GCP), which allows less stringent ethical standards for overseas research…"
 
Week of December 29, 2008
Helsinki discords: FDA, ethics, and international drug trials, Kimmelman et al., Lancet 373: 13-14, Jan 3, 2009 (full article freely available with free one time registration)
Including Persons with Alzheimer Disease in Research on Comorbid Conditions, Wall, IRB, Jan-Feb 2009 (full article freely available with free one time registration)
Clinical Trials in Children Website, World Health Organization (WHO), Jan 2009
"The WHO International Clinical Trials Registry Platform (ICTRP) launched the Clinical Trials in Children website on 19th January 2009. The aim of the site is to improve awareness and make it easier to access accurate, up to date, understandable information relevant to the conduct of clinical trials in children…"
 

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