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	Week of December 24, 2007 Op-Ed: A Lifesaving Checklist, New York Times, Dec 30, 2007 (free one time registration required) "In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case…"

Week of December 17, 2007 Blood experiment disproportionate, Detroit Free Press, Dec 21, 2007 "A controversial clinical trial in which hundreds of people were unknowingly injected with an experimental blood substitute primarily took place in cities with a disproportionate number of minorities, including Detroit…" Notice of Change in Access to OHRP FAQs, US Office for Human Research Protections, Dec 19, 2007 "The content of OHRP’s FAQs has not changed, but the access and appearance of the FAQs has been altered. The FAQs previously were available through a software system that allowed retrieval of individual FAQs. A recent transition from that software system makes the FAQs available in sets by category, in HTML format or as PDF format documents. The FAQ categories include: Assurances (FWAs); IRB Registration; 45 CFR 46; Research with Children; Investigator Responsibilities; Prisoner Research; and Informed Consent…"

Week of December 10, 2007 Face-Transplant Patient 'Satisfied', Washington Post, Dec 13, 2007 (free one time registration required) "…although some experts remain uncomfortable with the experiment, including its lack of psychological follow-up, some who were initially critical of the attempt said they are impressed…a disturbing pattern with tests of new surgical techniques, said Karen Maschke of the Hastings Center…Instead of running them as medical experiments, with careful collection of data, they are promulgated as "innovations," often without proper consent in advance or analysis after, she said…" Outcomes 18 Months after the First Human Partial Face Transplantation, Dubernard et al., New England Journal of Medicine 357: 2451-2460, Dec 13, 2007 (full article freely available) Outcomes 18 Months after the First Human Partial Face Transplantation, Dubernard et al., New England Journal of Medicine 357: 2451-2460, Dec 13, 2007 (full article freely available) Widows' VA suit thrown out, Albany Times Union, Dec 11, 2007 "…U.S. District Court Senior Judge Thomas J. McAvoy cited the fact there is no proof the veterans, all of whom were terminally ill cancer patients, had died prematurely or endured added pain and suffering as a result of being fraudulently enrolled in studies designed to test drugs for marketability…" Press Release: 2007 Human Research Protection Award Recipients Announced, PR Newswire, Dec 10, 2007 "Winners of the 2007 Award for Excellence in Human Research Protection were announced today…"

Week of December 3, 2007 Court papers detail dark chapter at VA, Albany Times Union, Dec 9, 2007 "…New information surfaced last month in hundreds of pages of depositions and internal reports filed in a lawsuit by several widows of veterans who died after enrolling in Stratton's drug studies, providing a spotlight on a government research program that had spiraled out of control…" Coercion used on patient, family says, Albany Times Union, Dec 9, 2007 "…The family claims a former research physician at Stratton hospital, Dr. James A. Holland, "coerced" Merritt into joining a drug study against his will. Their account is supported by Holland's former staffers, who testified that Holland encouraged research assistants to enroll as many veterans as possible in drug experiments…" Pa. inmate recounts 'guinea pig' tests, Courier Post Online, Dec 3, 2007 "As an inmate test subject for medical experiments being conducted at Holmesburg State Prison, Edward "Butch" Anthony says he had mysterious substances dabbed on his skin and injected in his veins…"

Week of November 26, 2007 The stem cell debate continues: the buying and selling of eggs for research, Baylis and McLeod, Journal of Medical Ethics 33: 726-731, Dec 2007 (extract freely available) Ethics committees and the legality of research, Douglas, Journal of Medical Ethics 33: 732-736, Dec 2007 (abstract freely available) US Office of Research Integrity Newsletter, ORI, Dec 2007 (pdf) 2008 Edition International Compilation of Human Research Protections, US Office for Human Research Protections (OHRP), Dec 2007 (pdf) "This Compilation lists the approximately 900 laws, regulations, and guidelines that govern human subjects research in 84 countries, as well as from a number of international and regional organizations. This Compilation was developed for IRBs/Ethics Committees, researchers, sponsors and others who are involved in international research. Its purpose is to help these groups familiarize themselves with the laws, regulations and guidelines where the research will be conducted, to assure those standards are followed appropriately. This year’s Compilation features a new section on research standards for Embryos, Stem Cells, and Cloning. The 2008 Edition includes numerous updates to the 2007 Edition…" Research Participants' Perceptions of the Certificate of Confidentiality's Assurances and Limitations, Catania et al., Journal of Empirical Research on Human Research Ethics 2: 53-59, Dec 2007 (abstract freely available) The Reporting of Monetary Compensation in Research Articles, Klitzman et al., Journal of Empirical Research on Human Research Ethics 2: 61-67, Dec 2007 (abstract freely available) Education Level, Primary Language, and Comprehension of the Informed Consent Process, Breese ?et al., Journal of Empirical Research on Human Research Ethics 2: 69-79, Dec 2007 (abstract freely available) The Impact of Minor Adverse Event Tracking on Subject Safety: A Web-Based System, Shenvi and Gebhart, Journal of Empirical Research on Human Research Ethics 2: 81-91, Dec 2007 (abstract freely available) Guide to Researching Human Research Subjects Laws in West Africa, Szabó and Britt, Journal of Empirical Research on Human Research Ethics 2: 93-105, Dec 2007 (abstract freely available) Questions, Anger and Dissent on Ethics Study, Inside Higher Ed, Nov 30, 2007 "Can an association urge its members to apply the principle of “do no harm” in research when there isn’t much agreement on what “harm” is? Is “doing less harm” a moral standard worthy of consideration or a cop out?…Those were among the issues considered Thursday when the rank and file of the American Anthropological Association had a first chance to question members of a panel that on Wednesday evening released a report on the issues raised by doing anthropological research for the military or security agencies…" CAREB response to the Sponsors’ Table for Human Research Participant Protection in Canada consultation process on its Experts Committee report entitled “Moving Ahead”, Canadian Association of Research Ethics Boards, Nov 30, 2007 (word document) Ethics and Engagement With the Military, Inside Higher Ed, Nov 29, 2007 "A special panel of the American Anthropological Association…studying the question of whether its ethical standards should bar ties to the military and intelligence agencies, issued a report Wednesday that recommended tighter scrutiny of such work, but explicitly affirmed the possibility that it could be conducted ethically in some cases…The panel urged that the standards of informed consent should be changed to “develop specific language regarding work with vulnerable populations and contexts in which consent may not be free, voluntary, or non-coerced…" Report: Ad Hoc Commission on the Engagement of Anthropology with Security and Intelligence Communities, American Anthropological Association, Nov 28, 2007 (full report and appendices freely available) Clinical Trials and Medical Care: Defining the Therapeutic Misconception, Henderson et al., PLoS Medicine 4(11): e324, Nov 27, 2007 (full article freely available) Targeted Genetics restarts trial after woman's death, Seattle Times, Nov 26, 2007 "The U.S. Food and Drug Administration has allowed Targeted Genetics to restart its gene-therapy trial for rheumatoid arthritis after an investigation indicated the treatment did not contribute to the death of an Illinois woman in July…"

Week of November 19, 2007 A Gap in Knowledge About Kids, Medication, Washington Post, Nov 23, 2007 (free one time registration required) "…The alarming gap in medical knowledge is the legacy of many factors. The testing of drugs in children was shunned for decades as unnecessary and unethical; Congress and the pharmaceutical industry did not provide adequate funding; and conducting medical experiments on children is difficult…" Response to the Draft Report of the Experts Committee for Human Research Participant Protection in Canada, Interagency Advisory Panel on Research Ethics (PRE), Nov 22, 2007, posted online Dec 2007 (pdf) Spread of illegal devices causes alarm, Seattle Times, Nov 21, 2007 "U.S. Rep. Jay Inslee on Tuesday called for a congressional investigation into medical-device manufacturers and operators who use unproven "energy medicine" machines to exploit patients…Inslee said Congress should determine whether the FDA has adequate resources to oversee the institutional review boards (IRBs) that govern clinical studies for devices. Inslee wants the FDA to prevent "IRB shopping," in which a device maker can hire a private overseer for a study…" WMA starts process for revising Helsinki Declaration, World Medical Association, Nov 20, 2007 (comments on revisions due Feb 25, 2008) "…being proposed are ideas for providing extra protection for participants in medical research and a new provision making it clear that the well-being of the individual should take precedence over the interests of the sponsors of research as well as those of science and society. Other changes suggested relate to the treatment of participants who suffer injury as a result of research interventions, the ability of the public to access a register of all clinical trials and the need for populations that have previously been underrepresented in medical research, such as children and pregnant women, to be provided equitable access to participation in research…" World Medical Association Declaration of Helsinki Web Page Public never warned about dangerous device, Seattle Times, Nov 19, 2007 "…sold the machines to scores of practitioners in the United States who used them to exploit patients. They avoided detection by taking advantage of federal regulations that allow them to operate on an honor system in clinical studies…"The approval of the IRB study was a means to sell more machines," she said…" PAP-IMI fan sought military study, Seattle Times, Nov 19, 2007 "…Berkley Bedell, a former U.S. congressman…came up with a plan to validate the machine for use on U.S. soldiers in one of Samueli Institute's government-funded clinical studies. But after an FDA investigation linked injuries and death to the device, Bedell reluctantly dropped his support of the PAP-IMI…"We're scared to death of the conventional medical community, FDA and so on," Bedell said. "We're doing our work mostly offshore. We're quite anxious to keep under the radar screen until we have things adequately documented…" Subjects are grown, but still her 'kids', Boston Globe, Nov 19, 2007 "…As the head of one of the longest-running mental health projects in the country, the Simmons Longitudinal Study, she has used her kids to compile a repository of important statistics on human emotional development. But Reinherz, who is 84 with a regal bearing, has never let her position as a research scientist overshadow her natural empathy as a human…"

Week of November 12, 2007 Primed by civilians, troops become test subjects, Seattle Times, Nov 18, 2007 "During the past two years, injured Marines at Camp Pendleton near San Diego have been used as unwitting test subjects for an unproven energy-medicine device. Troops were not given a choice about being treated by the InterX 5000, a handheld device purported by its manufacturer to reduce pain by using electrical frequencies. Micah Allison, an athletic-trainer intern involved in the treatments, said she tried to downplay to the troops that the device was experimental…" Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration, National Institutes of Health (NIH), Nov 16, 2007 "…Public Law 110-85, which was enacted on September 27, 2007 amends the Public Health Service Act to expand the scope of clinical trials that must be registered in ClinicalTrials.gov. It also increases the number of registration fields that must be submitted, requires certain results information to be included and sets penalties for noncompliance. This notice provides information for NIH grantees and contractors on new responsibilities related to the first part of the law, the registration of clinical trials…" Secretary's Advisory Committee for Human Research Protections (SACHRP) Oct 29-30, 2007 Meeting Materials, Office for Human Research Protections (OHRP), Nov 15, 2007 (meeting agenda, presentation materials, transcripts) Volunteers to be told who got HIV vaccine, Seattle Times, Nov 14, 2007 "Volunteers in a failed worldwide AIDS-vaccine study headed by Seattle researchers will be told whether they were given the experimental vaccine — and may face a higher risk of getting HIV than those who got a placebo…" Influence of the HIPAA Privacy Rule on Health Research, Ness; for the Joint Policy Committee, Societies of Epidemiology, Journal of the American Medical Association 298: 2164-2170, Nov 14, 2007 (abstract freely available) Editorial: The Dysregulation of Human Subjects Research, Fost and Levine, Journal of the American Medical Association 298: 2196-2198, Nov 14, 2007 (extract freely available) Too much privacy? U.S. law makes research harder, Reuters, Nov 13, 2007 (for JAMA article and editorial referenced herein, see Journal Articles below; this article scheduled to be freely available until Dec 12, 2007) "U.S. privacy laws designed to protect patients' health information have had the unintended effect of impeding scientific research, stalling clinical studies and halting others altogether, U.S. researchers said on Tuesday…"

Week of November 5, 2007 AIDS trial subjects react to news of heightened infection risk, Seattle Post-Intelligencer, Nov 9, 2007 "Volunteers in the Seattle arm of an international AIDS vaccine clinical trial recently halted because of safety concerns have decidedly mixed feelings about participating…" Army’s Aggressive Surgeon Is Too Aggressive for Some, New York Times, Nov 6, 2007 (free one time registration required) "…trauma research can involve trying novel treatments on severely injured patients who cannot give informed consent. But he argues that any ethical problems pale in comparison to the toll that traumatic injuries take on civilians and soldiers every day…" U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS, Secretary's Advisory Committee on Genetics, Health and Society (SACGHS), Nov 5, 2007 (comments due by Dec 21, 2007) "The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is seeking public comment on a draft report to the Secretary of Health and Human Services (HHS) on the oversight of genetic testing…"

Week of October 29, 2007 Ethical and policy issues relating to progenitor-cell-based strategies for prevention of atherosclerosis, Liao et al., Journal of Medical Ethics 33: 643-646, Nov 1, 2007 (abstract freely available) The need for additional safeguards in the informed consent process in schizophrenia research, Anderson and Mukherjee, Journal of Medical Ethics 33: 647-650, Nov 1, 2007 (abstract freely available) Efficiency and the proposed reforms to the NHS research ethics system, Hunter, Journal of Medical Ethics 33: 651-654, Nov 1, 2007 (abstract freely available) Children, Gillick competency and consent for involvement in research, Hunter and Pierscionek, Journal of Medical Ethics 33: 659-662, Nov 1, 2007 (abstract freely available) Maintaining Informed Consent Validity during Lengthy Research Protocols, Prentice et al., IRB 29: 1-6, Nov/Dec 2007 (no longer available) Participants Left Uninformed in Some Halted Medical Trials, New York Times, Oct 30, 2007 (free one time registration required) "…some patients in clinical studies never learn about test results. The problem may be particularly relevant to those implanted with medical devices that stay with them long after a trial is over…"

Week of October 22, 2007 Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review Procedure, US Office for Human Research Protections (OHRP), Oct 26, 2007 (written or electronic comments due Dec 26, 2007) "The Office for Human Research Protections (OHRP) is requesting written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998…OHRP is proposing to amend expedited review category 5 to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research. Expedited review category 5 also includes research involving materials that will be collected solely for nonresearch purposes. In addition, OHRP is requesting comments on the entire expedited review list that was last published in the Federal Register on November 9, 1998 to determine if other changes are needed…" Warning Is Sent to AIDS Vaccine Volunteers, Washington Post, Oct 25, 2007 (free one time registration required) "South African AIDS researchers have begun warning hundreds of volunteers that a highly touted experimental vaccine they received in recent months might make them more, not less, likely to contract HIV in the midst of one of the world's most rampant epidemics…The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine…" 'Identical Strangers' Explore Nature Vs. Nurture, NPR, Oct 25, 2007 "…Unknowingly, Bernstein and Schein had been part of a secret research project in the 1960s and '70s that separated identical twins as infants and followed their development in a one-of-a-kind experiment to assess the influence of nature vs. nurture in child development…Neither parents nor children knew the real subject of the study — or that the children had been separated from their identical twin…" Are IRB’s Needed for War Zones?, Inside Higher Ed, Oct 22, 2007 "…a kind of anthropology work involving human subjects that is apparently not being subjected to IRB review: work for the U.S. military in Afghanistan and Iraq. The analysis suggests that there is considerable confusion about whether IRB’s must review projects done by their professors who work for the military, and that there are no signs of such reviews taking place…" Army Enlists Anthropology In War Zones, New York Times, Oct 5, 2007 (free one time registration required) Request for Information (RFI): To Solicit Input and Ideas on Priorities in Basic Behavioral and Social Sciences Research, US National Institutes of Health (NIH), Oct 22, 2007 (responses due Nov 26, 2007)

Week of October 15, 2007 Institutional Academic–Industry Relationships, Campbell et al., Journal of the American Medical Association 298: 1779-1786, Oct 17, 2007 (abstract freely available) Financial relationships between industry and medical schools, teaching hospitals highly prevalent, Eurekalert, Oct 16, 2007 "In a national survey of department chairs at medical schools and teaching hospitals, more than half report relationships with industry, including receiving financial and in-kind support, according to a study in the October 17 issue of JAMA. The authors suggest that these findings underscore the need for the disclosure and management of these relationships…" Institutional Academic–Industry Relationships, Campbell et al., Journal of the American Medical Association 298: 1779-1786, Oct 17, 2007 (abstract freely available) Research on Research Integrity (R21) Exploratory/Developmental Grant Program Announcement, US Office of Research Integrity (ORI), updated Oct 15, 2007 (applications due Dec 11, 2007) Research on Research Integrity (R03) Small Grant Program Announcement, US Office of Research Integrity (ORI), updated Oct 15, 2007 (applications due Dec 11, 2007)

Week of October 8, 2007 New FDA drug center raises ethical questions, MSNBC, Oct 14, 2007 "The Food and Drug Administration is moving with unprecedented speed to launch a drug research center to be paid for by companies it regulates…It’s an ambitious undertaking that puts regulators and companies in a relationship unlike that of any other industry…" Partners in Research Program (R03), US National Institutes of Health (NIH), Oct 2007 (letters of intent due Dec 12, 2007; applications due Jan 11, 2008) "This funding opportunity announcement (FOA) solicits research grant applications from academic/scientific institutions and community organizations that propose to forge partnerships (1) to study methods and strategies to engage and inform the public regarding health science in order to improve public understanding of the methods and benefits of publicly funded research, and (2) to increase scientists’ understanding of and outreach to the public in their research efforts…" States and V.A. at Odds on Cancer Data, New York Times, Oct 10, 2007 (free one time registration required) "…While other hospitals are required by state laws to submit data, Veterans Affairs hospitals are not. And now, for the first time, veterans hospitals have stopped providing information on their cancer patients. The concern, the Veterans Affairs Department says, is protecting patient privacy…" How Data on Cancer Are Collected and Used, New York Times, Oct 10, 2007 (free one time registration required) "Every state has a law requiring it to have a cancer surveillance program and collect specific information about every patient whose cancer was diagnosed by a doctor in that state. Although most patients are not aware of the programs, doctors and hospitals are…" Data sharing threatens privacy. Analyses of personal information raise spectre of Big Brother, Butler, Nature 449: 644-645, Oct 10, 2007 (extract freely available)

Week of October 1, 2007 Commercializing Clinical Trials - Risks and Benefits of the CRO Boom, Shuchman, New England Journal of Medicine 357: 1365-1368, Oct 4, 2007 (extract freely available) Ethical Review of Interpretive Research: Problems and Solutions, Jacobson et al. 29: 1-8, IRB, Oct 1, 2007 (no longer available) SOUTH AFRICA: Microbicide trials - what's in it for participants?, IRIN Plus News (United Nations), Oct 2007 "…The challenge for scientists is to design trials that have sufficiently attractive benefits to recruit and retain participants, without offering what ethics committees would deem incentives or inducements…" EPA's 2006 Human-Subjects Rule for Pesticide Experiments, Shrader-Frechette, Accountability in Research 14: 211 - 254, Oct 2007 (abstract freely available) Offering Results to Research Subjects: U.S. Institutional Review Board Policy, Kozanczyn et al., Accountability in Research 14: 255 - 267, Oct 2007 (abstract freely available)

Week of September 24, 2007 The Food and Drug Administration's Oversight of Clinical Trials, US Dept Health and Human Services Office of the Inspector General, Sep 28, 2007 (pdf) Report Assails F.D.A. Oversight of Clinical Trials, New York Times, Sep 28, 2007 (free one time registration required) "…federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed…" The Food and Drug Administration's Oversight of Clinical Trials, US Dept Health and Human Services Office of the Inspector General, Sep 28, 2007 (pdf) Trial would give users legal substitute drugs, Vancouver Sun, Sep 27, 2007 "…A Vancouver research team will put in a request this week to run Canada's first trial in giving legal substitute drugs to cocaine and crystal-meth users…" Gene information opens new frontier in privacy debate, Boston Globe, Sep 24, 2007 "…But will people be able to keep their genetic information to themselves? That may depend if an individual is, at any given time, a research subject, patient, employee, insurance recipient, or customer. The same information could be subject to different principles in different circumstances…"

Week of September 17, 2007 Call for Comments: Refinements to the Continuing Research Ethics Review in the TCPS, Interagency Advisory Panel on Research Ethics (PRE), Canada, Sep 19, 2007 (comments due by Nov 19, 2007) "…The Paper contains preliminary discussions and some draft proposals that clarify some areas and address others not yet considered on the topic of continuing ethics review (CER) in the TCPS. It addresses the concept, goals, and scope of CER, related operational issues, as well the roles and responsibilities of those involved in applying the CER process…" Role of Gene Therapy In Death Called Unclear, Washington Post, Sep 18, 2007 (free one time registration required) "Postmortem tests on an Illinois woman who died mysteriously in July after getting an experimental gene treatment show no evidence that she was killed directly by the genetically altered viruses she was given, a committee of experts was told yesterday. But many questions remain, and further tests will have to be done to see if the treatment somehow contributed to her death…Some panelists echoed Robb Mohr's concerns about the way his wife was signed up for the study…" Appointment of New Chair and Members, Interagency Advisory Panel on Research Ethics, Canada, Sep 18, 2007

Week of September 10, 2007 McGill study offers users free cocaine, National Post, Sep 16, 2007 "Human guinea pigs in an unusual McGill University study are being given cocaine for free so researchers can chart the effects of the highly addictive drug on the brain with hopes of finding ways to curb strong cravings…" Bribery, confusion delay medical advances, doctor says, Vancouver Sun, Sep 11, 2007 (see below for PLoS articles referred to in this report) "Government bribes and misunderstandings that can halt drug trials and may lead to unsafe sex are among the many pitfalls of doing research in developing countries, says a Canadian-led ethics team advising one of the world's richest couples…" Grand Challenges in Global Health: The Ethical, Social and Cultural Program, Singer et al., PLoS Med 4: e265, Sep 11, 2007 (full article freely available) Grand Challenges in Global Health: Ethical, Social, and Cultural Issues Based on Key Informant Perspectives, Berndtson et al., PLoS Medicine 4: e268, Sep 11, 2007 (full article freely available) Grand Challenges in Global Health: Community Engagement in Research in Developing Countries, Bhan et al., PLoS Medicine 4: e272, Sep 11, 2007 (full article freely available) Grand Challenges in Global Health: Community Engagement in Research in Developing Countries, Tindana et al., PLoS Medicine 4: e273, Sep 11, 2007 (full article freely available)

Week of September 3, 2007 Boston Scientific cited by FDA for procedures, Boston Globe, Sep 8, 2007 "…The FDA cited the company for failure to immediately follow up on several deaths to see whether there was any relationship between the deaths and the device. The company also allegedly failed to promptly notify regulators after at least two dozen of the stents fractured, and failed to provide clinical investigators with all the information they needed to look into any problems with patients, the FDA said…" NIH genetic database "a good start", The Scientist, Sep 6, 2007 "Researchers say the new NIH policy announced last week for sharing data from genome-wide association studies will increase interest in studies linking genotypes to diseases while securing the anonymity of study participants…Institutions will need new consent procedures to inform subjects that their genetic data will be available not just to the researchers conducting a study, but to other members of the scientific community who apply for access, and potentially to law enforcement officials and insurance companies…" Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity, Federal Register 72: 50966-50970, US Office for Human Research Protections (OHRP), Sep 5, 2007 (comments due by Dec 4, 2007) "The Office for Human Research Protections (OHRP), Office of Public Health and Science, is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research…"

Week of August 27, 2007 Improving Disclosure and Consent: "Is It Safe?": New Ethics for Reporting Personal Exposures to Environmental Chemicals, Brody et al., American Journal of Public Health 97: 1547-1554, Sept 1, 2007 (abstract freely available) The three official language versions of the Declaration of Helsinki: what’s lost in translation?, Carlson et al., Journal of Medical Ethics 33: 545-548, Sep 2007 (abstract freely available) Attitudes of research ethics board chairs towards disclosure of research results to participants: results of a national survey, MacNeil and Fernandez, Journal of Medical Ethics 33: 549-553, Sep 2007 (abstract freely available) The History, Purpose, and Future of Instruction in the Responsible Conduct of Research, Steneck and Bulger, Academic Medicine 82: 829-834, Sep 2007 (full article freely available) US Office of Research Integrity Newsletter, ORI, Sep 2007 (pdf) Questioning the Need for Informed Consent: A Case Study of California's Experience with a Pilot Newborn Screening Research Project, Feuchtbaum et al., Journal of Empirical Research on Human Research Ethics 2: 3-14, Sep 2007 (abstract freely available) Cancer Patients' Attitudes Toward Future Research Uses of Stored Human Biological Materials, Helft et al., Journal of Empirical Research on Human Research Ethics 2: 15-22., Sep 2007 (abstract freely available) Ethics Committee Experience with Emergency Exception from Informed Consent Protocols, DeIorio et al., Journal of Empirical Research on Human Research Ethics 2: 23-30, Sep 2007 (abstract freely available) Respondent Reactions to Sensitive Questions, Fendrich et al., Journal of Empirical Research on Human Research Ethics 2: 31-37, Sep 2007 (abstract freely available) Two Methods of Obtaining Informed Consent in a Genetic Epidemiological Study: Effects on Understanding, Matsui et al., Journal of Empirical Research on Human Research Ethics 2: 39-48, Sep 2007 (abstract freely available) Debriefing in Deceptive Research: A Proposed New Procedure, Oczak and Niedzwienska, Journal of Empirical Research on Human Research Ethics 2: 49-59, Sep 2007 (abstract freely available) Perceptions of Stress Among Students Participating in Psychology Research: A Canadian Survey, Flagel et al., Journal of Empirical Research on Human Research Ethics 2: 61-67, Sep 2007 (abstract freely available) Effects of Human Subjects Requirements on Classroom Research: Multidisciplinary Evidence, Lopus et al., Journal of Empirical Research on Human Research Ethics 2: 69-78, Sep 2007 (abstract freely available) REB Community Member Educational Needs: A PRE Pilot Project Report, Standing Committee on Education, Interagency Advisory Panel on Research Ethics (PRE), Canada, Sep 2007 (pdf) Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), Federal Register 72: 49290-49297, Aug 28, 2007 "…The potential for public benefit to be achieved through sharing GWAS data is significant. However, genotype and phenotype information generated about individuals…may be sensitive. Therefore, protecting the privacy of the research participants and the confidentiality of their data is critically important. Risks to individuals, groups, or communities should be balanced carefully with potential benefits of the knowledge to be gained through GWAS. The sensitive nature of GWAS information about participants and the broad data distribution goals of the NIH GWAS data repository highlight the importance of the informed consent process to this research…"

Week of August 20, 2007 International Trials Seen as Challenge for Patient Protection, FDA News, Aug 23, 2007 "In an exclusive interview on the eve of his retirement, Schwetz listed the increase in international trials as one of the major human research protection challenges his successor will face…The next OHRP director should also keep trying to focus on clinical investigators, Schwetz said. "…OHRP was traditionally and naturally connected to the IRB [institutional review board] community, but the greatest risk to subjects is at the hands of investigators.”…"

Week of August 13, 2007 Fungus Infected Woman Who Died After Gene Therapy, Washington Post, Aug 17, 2007 (free one time registration required) "The 36-year-old Illinois woman who died last month after being treated with an experimental gene therapy was infected with a fungus that usually causes only a mild illness. But the infection spun out of control and ravaged her organs, suggesting that her immune system was seriously impaired…" Iowa to pay subjects $925K for stuttering study, MSNBC, Aug 17, 2007 "The state has agreed to pay $925,000 to unwitting subjects of an infamous 1930s stuttering experiment — orphans who were badgered and belittled as children by University of Iowa researchers trying to induce speech impediments…" Secretary's Advisory Committee for Human Research Protections (SACHRP) July 30-31, 2007 Meeting Materials, Office for Human Research Protections (OHRP), Aug 15, 2007 (meeting agenda, presentation materials, transcripts) Call for Comments: "Moving Ahead", Draft Report of the Experts Committee for Human Research Participant Protection in Canada, Sponsors' Table for Human Research Participant Protection in Canada, Aug 15, 2007 (pdf, comments due by Nov 30, 2007) "The Sponsors' Table for Human Research Participant Protection in Canada is a group of organizations that shares a common interest in promoting research involving humans that meets the highest standards in excellence and ethics…Part of the Sponsors' Table process included the establishment of an Experts Committee to provide independent analysis and recommendations…have now submitted a draft report. Before the Sponsors' Table organizations formally consider the contents and recommendations of the Experts Committee's report, they wish to consult with each members' constituent groups and/or stakeholders and other interested parties on its content as well as on other pertinent issues…" Web Site of the Sponsors' Table for Human Research Participant Protection in Canada, accessed Oct 3, 2007 Who’s Afraid of Incestuous Gay Monkey Sex?, Inside Higher Ed, Aug 14, 2007 "…some of their colleagues may feel enough heat right now that they are avoiding certain topics or are being forced to compromise on either the language or substance of their research. The problems come from a variety of sources, the scholars here said: from politicians, from institutional review boards on their own campuses, and from too narrow a definition of what “good science” may be…" Institutional Review Boards Should Require Clinical Trial Registration, Levin and Palmer, Archives of Internal Medicine 167: 1576-1580, Aug 13/27, 2007 (extract freely available)

Week of August 6, 2007 Pfizer Facing 4 Court Cases in Nigeria, Washington Post, Aug 11, 2007 (free one time registration required) "…New York-based Pfizer is facing four court cases…over a decade-old drug study…The fallout provides a case study of the ethical dilemmas that arise when Western medical priorities run into Third World poverty and ignorance…" South Africa: HIV Trial Gets Long-Awaited Go Ahead, AllAfrica.com, Aug 10, 2007 (registration required to access archives) "A clinical trial investigating ways to prevent newborns from contracting HIV through breast milk is set to proceed in South Africa, following a court judgement overruling the apparent reluctance of the country's drugs regulators to let the trial go ahead. South Africa's Medicines Control Council (MCC) finally approved the trial last week (30 July) after a protracted battle between the MCC and paediatric HIV/AIDS researchers that ended in court…" Court won't bend drug rule for dying patients, Seattle Times, Aug 8, 2007 "Dying people do not have the right to obtain unapproved drugs that are potentially lifesaving, even if their doctors say the treatment offers the best hope for survival, a U.S. appeals court in Washington ruled Tuesday…" Text of US Court of Appeals Decision, Aug 7, 2007 (pdf) Committee Defines When Informed Consent May Be Waived, FDA News, Aug 8, 2007 "The Office of Human Research Protections (OHRP) should develop guidance for the institutional review boards (IRBs) that oversee research studies on human subjects to help them decide when to grant requests to alter or waive informed consent requirements, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended at its July 30-31 meeting…" Targeted Genetics defends handling of fatal test case, Seattle Times, Aug 7, 2007 "As more details emerged about the recent death of a patient during a clinical trial conducted by Targeted Genetics of Seattle, the company Monday defended its handling of the case…" Development of New Tuberculosis Vaccines: A Global Perspective on Regulatory Issues, Brennan et al., PLoS Medicine 4, Aug 7, 2007 (full article freely available) Death Points to Risks in Research. One Woman's Experience in Gene Therapy Trial Highlights Weaknesses in the Patient Safety Net, Washington Post, Aug 6, 2007 (free one time registration required) "…Jolee Mohr died from massive bleeding and organ failure July 24, leaving behind a 5-year-old daughter and a host of questions about why she was recruited into a gene therapy experiment whose chief goal was to test the safety of a novel arthritis treatment that had virtually no chance of helping her…Breaches of clinical research standards and a federal oversight system that allowed key decisions to be made behind closed doors may have helped draw Mohr into an experiment that was not, her husband says, what she thought it was…" Scrutiny of Researcher-Industry Ties, Inside Higher Ed, Aug 6, 2007 "…Grassley…called for a national reporting system of drug company payments to doctors, which he said was essential to ensuring that patients might know about potential conflicts of interest for doctors who might prescribe medications — or researchers who might study the efficacy of such drugs…"

Week of July 30, 2007 US genetic privacy bill hits snag, New Scientist, Aug 4, 2007 "Attempts in the US to ban genetic discrimination in insurance and employment have hit a speed bump. After 12 years of political wrangling, the Genetic Information Nondiscrimination Act was poised to pass a Senate vote last week - until Oklahoma Republican senator Tom Coburn suddenly moved to block the bill…" Conflict of Interest Toolkit, Federation of American Societies for Experimental Biology (FASEB), Aug 1, 2007 "Recommendations, tools, and resources for the conduct and management of financial relationships between academia and industry in biomedical research…" Assessing research risks systematically: the net risks test, Wendler and Miller, Journal of Medical Ethics 33: 481-486, Aug 1, 2007 (abstract freely available) Refuting the net risks test: a response to Wendler and Miller’s "Assessing research risks systematically", Weijer and Miller, Journal of Medical Ethics 33: 487-490, Aug 1, 2007 (abstract freely available)

Week of July 23, 2007 Suspended Gene Therapy Test Had Drawn Early Questions, Washington Post, Jul 28, 2007 (free one time registration required) "A gene therapy experiment that has triggered a federal investigation after the death of a patient on Tuesday raised a variety of concerns when it was first proposed to federal reviewers in 2003…" Alnylam succeeds in sickening subjects so it can test drug, Boston Globe, Jul 27, 2007 "…before Alnylam can test its drug, it needs a pool of guaranteed sick people -- which means it needs to create them…Such tests are unusual in medicine, but not unprecedented. In academic research, patients are sometimes infected with diseases as serious as malaria or cholera so that cures or vaccines can be tested reliably…" Funding Opportunity: International Research Ethics Education and Curriculum Development Award (R25), Request For Applications (RFA) Number: RFA-TW-08-002, National Institutes of Health (NIH), US Department of Health and Human Services (DHHS), Jul 26, 2007 (Letters of Intent Receipt Date: November 14, 2007; Application Submission/Receipt Date: December 14, 2007) "Purpose: To develop masters level curricula and provide educational opportunities for developing country academics, researchers and health professionals in ethics related to performing research involving human subjects in international resource poor settings…" Health Canada Discussion Paper for Consultation: Investigational Testing of Medical Devices, Therapeutic Products Directorate, Jul 25, 2007 (comments due by Oct 25, 2007) "Health Canada is pleased to share with you the following discussion paper on proposed changes to the regulatory framework for Investigational Testing of Medical Devices. Health Canada is considering the proposed changes as a means to better manage the risks related to the conduct of investigational testing of medical devices, and to support Health Canada's interest in applying a risk management approach that is consistent with the approaches applied by other regulators, including the regulatory framework that Health Canada applies for clinical trials of drugs…" EU project publishes bioethics guidelines for nutrigenomics research, Cordis News, Jul 24, 2007 "The European Nutrigenomics Organisation (NuGO) has published a set of bioethics guidelines designed to help scientists undertaking nutrigenomics research using human subjects. Nutrigenomics is the study of how nutrients and genes interact and how genetic variations can cause people to respond differently to food nutrients…nutrigenomics also raises many ethical questions about the privacy aspects of personalised foods and diets, genetic testing and the potential high cost of new functional foods…" NuGO Bioethics Guidelines Tool, Nutrigenomics Organisation, European Commission, Jul 2007 (guidelines freely available)

Week of July 16, 2007 School Conducts Anti-Phishing Research, Washington Post, Jul 22, 2007 (free one time registration required) "…As universities nationwide study ways to protect online security, methods at Indiana are raising ethical and logistical questions for researchers elsewhere: Does one have to steal to understand stealing? Should study participants know they are being attacked as part of a study? Can controlled phishing ever mimic real life?…" MMR scare doctor 'breached fundamental rules', The Guardian, UK, Jul 17, 2007 "Vulnerable children were subjected to "inappropriate and invasive" tests by a doctor who prompted one of the biggest health controversies of the past 10 years, it was alleged today…"

Week of July 9, 2007 HIV trial doomed by design, say critics, Nature, Jul 11, 2007 (no longer freely available) "…The situation has caused leaders in the microbicide field to renew calls for better ways of reviewing and coordinating trial plans. Scientists in the field already share and discuss ideas and data through formal and informal meetings, but there is no mechanism for reviewing and disseminating plans for clinical trials…" Decision Memo for Clinical Trial Policy (CAG-00071R), US Centers for Medicare and Medicaid Services, Jul 9, 2007 "…we are modifying this language to make clear that such items or services would be covered if they would be covered outside of the clinical research trial…Second, we are adopting the proposed addition of Coverage with Evidence Development…Finally, we are reopening a reconsideration of the clinical trial policy NCD and issuing a new proposed national coverage determination to define a clear path to continued payment for clinical trials…We also expect shortly to propose changes to the regulations that pertain to clinical trials and Medicare payment…"

Week of July 2, 2007 Should children have a say in own medical care?, Seattle Post-Intelligencer, Jul 8, 2007 (scheduled to be available until Jul 15, 2007) "…Experts in pediatric bioethics fiercely debate how much control children should have over their own medical care, especially when it involves experimental treatments or research. At what age is a child old enough to understand what his options are? Do the rules change if it is an experimental treatment, not a research trial? What if the child doesn't have the mental capacity to participate in the decision about treatment?…"

Week of June 25, 2007 Ethics in studies on children and environmental health, Merlo et al., Journal of Medical Ethics 33: 408-413, Jul 1, 2007 (abstract freely available) Participation in biomedical research is an imperfect moral duty: a response to John Harris, Shapshay and Pimple, Journal of Medical Ethics 33: 414-417, Jul 1, 2007 (abstract freely available)