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Week of September 1, 2008 Genetic research on rare familial disorders: consent and the blurred boundaries between clinical service and research, Ponder et al., Journal of Medical Ethics 34: 690-694, Sep 2008 (abstract freely available) Research ethics committees: the role of ethics in a regulatory authority, McGuinness, Journal of Medical Ethics 34: 695-700, Sep 2008 (abstract freely available) Ethical reflections on clinical trials with human tissue engineered products, Trommelmans et al., Journal of Medical Ethics 34: e1, Sep 2008 (abstract freely available)

Week of August 18, 2008 Hospital released vet who refused study, Washington Times, Aug 22, 2008 "An Army veteran seeking treatment for his sudden loss of motor skills was turned away from a veterans hospital in the Bronx, N.Y., in May 2007 after he refused to participate in a human subject experiment on Alzheimer's disease…" Response of James Peake, Secretary of Veterans Affairs, Washington Times, Aug 26, 2008 Judge Orders Drug Maker to Provide Experimental Treatment to Terminally Ill Teenager, New York Times, Aug 20, 2008 (Free one time registration required) "A 16-year-old patient, terminally ill with a rare form of muscular dystrophy, should be allowed to use an experimental drug treatment despite objections from the drug’s developer, a federal judge in Newark ruled on Wednesday…" Merck Vioxx Trial Was Strategy to Boost Drug's Sales, Bloomberg, Aug 19, 2008 (for Ann Int Med article and editorial, see journal section below) "A Merck & Co. study of Vioxx that the company said showed whether the painkiller was easier on the stomach than an older drug was actually a marketing tool to boost sales, according to researchers…"a practice that appears to be widespread, that really involves an element of deception because patients aren't told the true purpose of the trial,'' Sox said…" The ADVANTAGE Seeding Trial: A Review of Internal Documents, Hill et al., Annals of Internal Medicine 149: 251-258, Aug 19, 2008 (full article freely available) Editorial: Seeding Trials: Just Say "No", Sox and Rennie, Annals of Internal Medicine, Aug 19, 2008 (full article freely available) Clinical Trial Touches Off Drug Access Fight, New York Times, Aug 19, 2008 (free one time registration required) "Lawyers for a Gonvick, Minn., family suing to gain access to an experimental muscular dystrophy drug for their 16-year-old son argued on Tuesday that a drug company led them to believe he could participate in a clinical trial but then went back on its word…" Ensuring the Involvement of Children in the Evaluation of New Tuberculosis Treatment Regimens, Burman et al., PLoS Medicine 5, Aug 19, 2008 (full article freely available)

Week of August 11, 2008 Infant Transplant Procedure Ignites Debate. Ethicists Question Strategy in Which Hearts Are Removed Minutes After They Stop Beating, Aug 14, 2008 (free one time registration required; for New Engl J Med article and commentaries, see journal section below) "…The doctors who performed the operations as part of a federally funded research project defended the practice…Critics, however, are questioning the propriety of removing hearts from patients, especially babies, who are not brain-dead…" Brief Report: Pediatric Heart Transplantation after Declaration of Cardiocirculatory Death, Boucek et al., New England Journal of Medicine 359: 709-714, Aug 14, 2008 (full text freely available) Editorial: Cardiac Transplantation in Infants, Curfman et al., New England Journal of Medicine 359: 749-750, Aug 14, 2008 (full text freely available) Perspective: The Boundaries of Organ Donation after Circulatory Death, Bernat, New England Journal of Medicine 359: 669-671, Aug 14, 2008 (full article freely available) Donating Hearts after Cardiac Death — Reversing the Irreversible, Veatch, New England Journal of Medicine 359: 672-673, Aug 14, 2008 (full article freely available) The Dead Donor Rule and Organ Transplantation, Truog and Miller, New England Journal of Medicine 359: 674-675, Aug 14, 2008 (full article freely available) Children Are Not Just Small Adults: The Urgent Need for High-Quality Trial Evidence in Children, Klassen et al., PLoS Medicine 5, Aug 12, 2008 (full article freely available)

Week of August 4, 2008 Balancing Disclosure of Diagnosis and Assent for Research in Children With HIV, Barfield and Kane, Journal of the American Medical Association 300: 576-578, Aug 6, 2008 (abstract freely available) Ethics of Studies in Poor Countries Lead to Call for New Regulations, New York Times, Aug 5, 2008 (free one time registration required) "Even something as apparently innocuous as health surveys can raise tricky moral questions when conducted in poor countries, researchers wrote in this month’s Bulletin of the World Health Organization…" Demographic and health surveillance: longitudinal ethical considerations, Carrel and Rennie, Bulletin of the World Health Organization 86: 577-656, Aug 1, 2006 (full article freely available) Violations rife in hospital's studies on veterans, Washington Times, Aug 5, 2008 "An investigation of research conducted at an Arkansas veterans hospital has uncovered rampant violations in its human experiments program, including missing consent forms, secret HIV testing and failure to report more than 100 deaths of subjects participating in studies…" FDA Strengthens Policy on Screening Advisers for Conflicts of Interest, Kaisernetwork.org, Aug 5, 2008 "The FDA on Monday issued final guidelines that seek to limit conflicts of interest among advisory committee members…" Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees, US Food and Drug Administration, posted online Aug 7, 2008 (pdf) Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers, US Food and Drug Administration, Aug 5, 2008 "This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for Humanitarian Device Exemption (HDE) authorized by section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). This draft update of the version issued in 2006 reflects the additional requirements set forth in the Pediatric Medical Device Safety and Improvement Act of 2007…"

Week of July 28, 2008 Building and Maintaining Trust in a Community-Based Participatory Research Partnership, Christopher et al., American Journal of Public Health 98: 1398-1406, Aug 2008 (abstract freely available) The Power and the Promise: Working With Communities to Analyze Data, Interpret Findings, and Get to Outcomes, Cashman et al., American Journal of Public Health 98: 1407-1417, Aug 2008 (abstract freely available) Should research ethics committees meet in public?, Sheehan, Journal of Medical Ethics 34: 631-635, Aug 2008 (abstract freely available) FDA Pediatric Ethics Subcommittee June 9-10, 2008 Meeting Materials, US Food and Drug Administration, posted online Aug 2008 (includes agenda, roster, slides, minutes, transcripts) Egg shortage hits stem cell studies, San Francisco Chronicle, Jul 31, 2008 "Facing a human egg shortage they say is preventing medical breakthroughs, scientists and biotech entrepreneurs are pushing the country's top funders of stem cell research to rethink rules that prohibit paying women for eggs…"

Week of July 21, 2008 The Genetic Information Nondiscrimination Act — A Half-Step toward Risk Sharing, Korobkin and Rajkumar, New England Journal of Medicine 359: 335-337, Jul 24, 2008 (full article freely available) Govt likely to relax human trial norms, Rediff News, Jul 24, 2008 "Raising hopes for multinational pharmaceutical research companies, India has begun a consultation on steps to ease the existing clinical trial norms to allow Indian volunteers to be subjected to first-in-human phase I studies of potential medicines developed abroad. The current law prohibits such first time clinical trials in India unless it is tested in the country of origin or it is developed within the country…"

Week of July 14, 2008 Building on the Report of the Experts Committee for Human Research Participant Protection in Canada, the Sponsors' Table Identifies Four Priorities, Sponsors' Table for Human Research Participant Protection in Canada, Jul 18, 2008 "The Sponsors' Table has identified four priorities and, depending on resource requirements, have set targeted dates as follows…" FDA, OHRP Working on Joint IRB Database, FDA News, Jul 17, 2008 "The HHS Office for Human Research Protections (OHRP) is working with the FDA on expanding institutional review board (IRB) registration to create a joint database that would have a unified esubmission form, OHRP Director Ivor Pritchard said…" Advocating a Treatment, but Denied Access to It, New York Times, Jul 17, 2008 (free one time registration required) "…Cheri Gunvalson is suing the company for access to an experimental drug that she says could help her 16-year-old son in his battle with a rare but devastating disease, Duchenne muscular dystrophy…While the specifics of the case are unique, the dispute exposes the sometimes blurry boundaries between medical research and patients’ hope for life-saving treatments. As more patients or their families work closely with companies on treatments for diseases like cystic fibrosis or Parkinson’s, researchers and other experts say conflicts are increasingly frequent…" Plans for Human Trial of H.I.V. Vaccine Canceled, New York Times, Jul 17, 2008 (free one time registration required) "Plans for a large human trial of a vaccine against the AIDS virus in the United States were canceled on Thursday because federal health officials said the vaccine was unlikely to prove effective and might increase the risk of H.I.V. infection among volunteers…" European Practices of Genetic Information and Insurance. Lessons for the Genetic Information Nondiscrimination Act, Van Hoyweghen and Horstman, Journal of the American Medical Association 300: 326-327, Jul 16, 2008 (abstract freely available)

Week of July 7, 2008 Psychiatric Group Faces Scrutiny Over Drug Industry Ties, New York Times, Jul 12, 2008 (free one time registration required) "…After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing…" VA faults self over Chantix test, Washington Times, Jul 10, 2008 "Department of Veterans Affairs watchdogs have concluded that the department failed to alert veterans suffering from post-traumatic stress disorder in a timely manner to the dangers posed by a drug it was prescribing…legislators also were told that the department's inspector general has begun investigating a report that research personnel falsified certain study records at the VA Medical Center in the District…the agency's Institutional Review Board will analyze how drugs are distributed to soldiers with PTSD "to ensure that there is appropriate sensitivity to the study population in the context of FDA alerts and warnings."…" Secretary's Advisory Committee for Human Research Protections (SACHRP) March 27-28, 2008 Meeting Materials, US Office for Human Research Protections (OHRP), posted online Jul 10, 2008 (includes minutes, presentation materials, transcripts) Accepting More Federal Oversight, Inside Higher Ed, Jul 9, 2008 "Recent high-profile revelations and a growing consensus on Capitol Hill are leaving research universities ready — or, as the case may be, resigned — to a stronger federal role in regulating the management and disclosure of biomedical researchers’ financial interests…" When a University Kills Suicide Research, Inside Higher Ed, Jul 7, 2008 "…Kwantlen Polytechnic University, the British Columbia institution where Ogden works, is trying to prevent him from observing assisted suicides. An ethics review board at the university approved the research, but the university has since barred Ogden from carrying out his plans…"

Week of June 30, 2008 Ethics training for human studies?, The Scientist, Jul 2, 2008 (for Federal Register notice, see 2nd link in this section) "All researchers conducting studies with human subjects and members of institutional review boards may soon have to undergo mandatory training in human research ethics. According to a notice in the Federal Register yesterday (July 1), the Office for Human Research Protections (OHRP) is seeking public comment on whether such training should be required…" Decades Later, Still Asking: Would I Pull That Switch?, New York Times, Jul 1, 2008 (free one time registration required) "…Researchers, social commentators and armchair psychologists have pored through Milgram’s data ever since, claiming psychological and cultural insights. Now, decades after the original work (Milgram died in 1984, at 51), two new papers illustrate the continuing power of the shock experiments — and the diverse interpretations they still inspire…" Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs, US Office for Human Research Protections (OHRP), Jul 1, 2008 (Submit written or electronic comments by September 29, 2008) "The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments from affected entities and individuals about (a) Whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research, or (b) whether HHS should develop a regulation requiring the implementation of such training and education programs…" Self-assessed understanding as a tool for evaluating consent: reflections on a longitudinal study, Swartling and Helgesson, Journal of Medical Ethics 34: 557-562, Jul 2008 (abstract freely available) Ethics review of research: in pursuit of proportionality, Edwards and Omar, Journal of Medical Ethics 34: 568-572, Jul 2008 (abstract freely available) Special Issue: Incidental Findings in Human Subjects Research, Journal of Law, Medicine and Ethics 36, Summer 2008 (abstracts freely available) The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research, Hadskis et al., Accountability in Research 15: 133-151, Jul 2008 (abstract freely available) Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs, Amin et al., Accountability in Research 15: 168-187, Jul 2008 (abstract freely available) The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research, Borenstein, Accountability in Research 15: 188-204, Jul 2008 (abstract freely available) The Research and Family Liaison: Enhancing Informed Consent, Salas et al., IRB 30: 1-8, Jul-Aug 2008 (free one time registration required; full article freely available until Sept 2008) FDA Pediatric Advisory Committee June 9-10, 2008 Meeting Materials, US Food and Drug Administration, posted online Jul 2008 (included roster, briefing information, slides, minutes, transcript) After hip replacements, a lawsuit, Philadelphia Inquirer, Jun 30, 2008 "Fed up with the constant pain in her hips, Katrina McKenzie took her surgeon's advice and had them replaced with experimental implants. The 31-year-old from Galloway, N.J., who agreed to participate in a clinical study, knew there was a risk that her new hips could fail. But she didn't know that the manufacturer financing the study, Smith & Nephew, was also paying her surgeon tens of thousands of dollars a year as a consultant…"

Week of June 23, 2008 Publication of Reports from Working Committees Informing the Evolution of the TCPS, Interagency Advisory Panel on Research Ethics (PRE), Canada, Jun 27, 2008 (Public input on the reports should be forwarded to: reports@ pre.ethics.gc.ca) "…The Panel is pleased to share its working committees’ reports that address key and diverse policy recommendations for changes and clarifications to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)…In the Fall 2008 PRE plans a public consultation on a draft 2nd edition of the TCPS…" Qualitative Research: A Chapter for Inclusion in the TCPS, Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC), Feb 2008 Proposed Textual Changes for Concept of Risk in the TCPS, Subgroup on Procedural Issues for the TCPS (ProGroup), Feb 2008 Towards a Revised Definition of Research in the TCPS, Subgroup on Procedural Issues for the TCPS (ProGroup), Jan 2008 Prescription for Protecting Online Health Records, Washington Post, Jun 25, 2008 (free one time registration required) "Hoping to persuade more people to store their medical records online, Google Inc., Microsoft Corp. and a hodgepodge of health care providers and insurers have agreed on ground rules for protecting the privacy of the sensitive information…Like other companies outside the traditional health care industry, neither Google nor Microsoft is subject to the Health Insurance Portability and Accountability Act…" The Common Framework for Networked Personal Health Information, Markle Foundation, Jun 2008 (full report freely available) Why Patients Continue to Participate in Clinical Research, Wendler et al., Archives of Internal Medicine 168: 1294-1299, Jun 23, 2008 (abstract freely available)

Week of June 16, 2008 VA reports more Chantix effects, Washington Times, Jun 19, 2008 "War veterans with post-traumatic stress disorder suffered a total of 26 serious adverse events while participating in a Veterans Affairs study of the anti-smoking drug Chantix, a VA official said Wednesday night…" Keeping Pace with the Times — The Genetic Information Nondiscrimination Act of 2008, Hudson et al., New England Journal of Medicine 358:2661-2663, Jun 19, 2008 (full article freely available) Companies’ Use of Web to Recruit Patients for Studies Brings Opportunities, Risks, Kuehn, Journal of the American Medical Association 299: 2733-2734, Jun 18, 2008 (extract freely available) Congress demands VA investigation, Washington Times, Jun 18, 2008 "Democratic presidential candidate Sen. Barack Obama and congressional leaders on both sides of the aisle Tuesday called for investigations into the Department of Veterans Affairs (VA) failure to inform in a timely manner veterans participating in medical tests that a drug they were taking has side effects that can lead to psychosis and suicide…" House panel chair: Stop drug tests on veterans, Washington Times, Jun 18, 2008 "House Veterans' Affairs Committee Chairman Bob Filner on Wednesday demanded that the Department of Veterans Affairs (VA) immediately terminate experiments in which a drug now linked to psychotic and suicidal behavior is being administered to soldiers suffering from post-traumatic stress disorder (PTSD)…" VA testing drugs on war veterans. Experiments raise ethical questions, Washington Times, Jun 17, 2008 "The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found…" Statement by the Department Of Veterans Affairs On Smoking Cessation Research Program, Jun 17, 2008 "Reports in the news media today that the Department of Veterans Affairs (VA) is testing drugs on war veterans are inaccurate and misleading…In our PTSD and smoking cessation study, our research is to learn if it is easier to stop smoking when smoking cessation treatment is combined with PTSD therapy, or whether the two therapies are more effective if they are provided separately…" Report: HIPAA Creating Barriers to Research and Discovery, Association of American Health Centers, Jun 16, 2008 (pdf)

Week of June 9, 2008 Researchers’ Financial Disclosures in the Spotlight, Inside Higher Ed, Jun 12, 2008 "…More names are widely expected to drop as Grassley continues his investigation, which has again raised questions over how federal and university disclosure requirements are enforced…All universities that conduct federally funded biomedical research must abide by the same basic disclosure guidelines, but relatively few have found a researcher in violation of the rules, suggesting either that the current system already sufficiently encourages transparency — or that oversight mechanisms are not rigorous enough, or effectively nonexistent…" Ethical Implications Of Modifying Lethal Injection Protocols, Science Daily, Jun 10, 2008 (for PLoS article, see Journal Section below) "A team of medical, ethical, and legal scholars argues in PLoS Medicine that in some US states the modification of lethal injection protocols is tantamount to experimentation upon prisoners without the prisoners' consent and without any ethical safeguards…" Ethical Implications of Modifying Lethal Injection Protocols, Koniaris et al., PLoS Medicine 5: e126, Jun 10, 2008 (full article freely available) AIDS Vaccines May Not Warrant Tests in U.S. Teens (Update1), Bloomberg, Jun 9, 2008 "Early testing of experimental AIDS vaccines in teenagers may be ethically justified in countries where the disease is spreading more quickly than in the U.S., scientific advisers said today. The risks of such trials may not outweigh the benefits in the U.S., according to the panel advising the Food and Drug Administration…" Children's Medical Research Draws Scrutiny on Safety, Need, Bloomberg, Jun 9, 2008 "The U.S. Food and Drug Administration is reviewing how to do pediatric studies on drugs for disorders such as asthma, on potential AIDS vaccines and for the medical use of stem cells…``The feeling was that the regulations don't need revision, but that the IRB's need guidance in how apply them,'' [Robert Nelson] said June 6 in a telephone interview. ``This is an early step toward that.''…"

Week of June 2, 2008 Researchers Fail to Reveal Full Drug Pay, New York Times, Jun 8, 2008 (free one time registration required) "A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials…In some cases, the income seems to have put the researchers in violation of university and federal rules…" Press Release: Human Mobility Study Meets Ethics Approval, Northeastern University, Jun 6, 2008 (see article directly below) "…The Institutional Review Board at the U.S. Office of Naval Research, which funded this study as part of a larger pool of research into human mobility patterns, reviewed the proposal in June 2007 and determined that it did not involve human subjects…" Study secretly tracked cellphone users, Seattle Times, Jun 5, 2008 "Researchers secretly tracked the locations of 100,000 people outside the United States through their cellphone use…The first-of-its-kind study by Northeastern University raises privacy and ethical questions for its monitoring methods, which would be illegal in the United States…Barabasi said he did not check with any ethics panel. Hidalgo said the researchers were not required to do so because the experiment involved physics, not biology…" Walter Reed says patient data may be compromised, Yahoo News, Jun 2, 2008 "Sensitive information on about 1,000 patients at Walter Reed Army Medical Center and other military hospitals was exposed in a security breach, sparking identity theft concerns and an investigation by the Army…" AIDS Vaccine Linked to Failed Merck Product Nears Human Testing, Bloomberg, Jun 2, 2008 "An AIDS vaccine similar to one tied to higher infection rates in an earlier study may soon be tested in about 3,000 people by U.S. scientists…Panel members who backed the government's test said it may yield valuable data about vaccines that rely on the action of immune system cells…Researchers against the VRC trial said that, since it is no longer a test of a shot that may be widely used, it should be considered to make sure it provides maximum information…"

Week of May 26, 2008 Payment for research participation: a coercive offer?, Wertheimer and Miller, Journal of Medical Ethics 34: 389-392, Jun 2008 (full article freely available) Editorial: Phase IV research: innovation in need of ethics, Ghislaine and van Delden, Journal of Medical Ethics 34: 415-416, Jun 2008 (abstract freely available) The experiences of ethics committee members: contradictions between individuals and committees, Elliott and Hunter, Journal of Medical Ethics 34: 489-494, Jun 2008 (abstract freely available) Genes, race and research ethics: who’s minding the store?, Hunt and Megyesi, Journal of Medical Ethics 34: 495-500, Jun 2008 (abstract freely available) What to tell and how to tell: a qualitative study of information sharing in research for adults with intellectual disability, Andre-Barron et al., Journal of Medical Ethics 34: 501-506, Jun 2008 (abstract freely available) Scientific responsibility for the dissemination and interpretation of genetic research: lessons from the "warrior gene" controversy, Wensley and King, Journal of Medical Ethics 34: 507-509, Jun 2008 (abstract freely available) Revisions: Declaration of Helsinki, World Medical Association (WMA), available online Jun 2008 (comments due by Aug 21, 2008) "The WMA has initiated a review of the Declaration of Helsinki and now the consultation draft is open for your comments…" Introduction to Special Issue: Advancing the Ethics of Community-Based Participatory Research, Shore et al., Journal of Empirical Research on Human Research Ethics 3: 1-4, Jun 2008 (abstract freely available) Creating Community-Based Participatory Research in a Diverse Community: A Case Study, Silka et al., Journal of Empirical Research on Human Research Ethics 3: 5-16, Jun 2008 (abstract freely available) Balancing Power Among Academic and Community Partners: The Case of El Proyecto Bienestar, Postma, Journal of Empirical Research on Human Research Ethics 3: 17-32, Jun 2008 (abstract freely available) Enacting Research Ethics in Partnerships with Indigenous Communities in Canada: "Do it in a Good Way", Ball and Janyst, Journal of Empirical Research on Human Research Ethics 3: 33-51, Jun 2008 (abstract freely available) Developing a Participatory Aboriginal Health Research Project: "Only if it's Going to Mean Something", Jacklin and Kinoshameg, Journal of Empirical Research on Human Research Ethics 3: 53-67, Jun 2008 (abstract freely available) Variability in Institutional Approaches to Ethics Review of Community-Based Research Conducted in Collaboration with Unaffiliated Organizations, Silverstein et al., Journal of Empirical Research on Human Research Ethics 3: 69-76, Jun 2008 (abstract freely available) An HIV Prevention Protocol Reviewed at 15 National Sites: How do Ethics Committees Protect Communities?, Deeds et al., Journal of Empirical Research on Human Research Ethics 3: 77-86, Jun 2008 (abstract freely available) Perspective: Exploiting a Research Underclass in Phase 1 Clinical Trials, Elliott and Abadie, New England Journal of Medicine 358: 2316-2317, May 29, 2008 (full article freely available) Opinion: Africa: Women And Scientific Experiments - Is Informed Consent Enough?, Jegede Ademola Oluborode, All Africa, May 29, 2008 (full article freely available)

Week of May 19, 2008 Doctors lack female participants in clinical trials, Canada.com, May 23, 2008 "Fifteen years after rules limiting female participation in clinical trials were changed, women are still under-represented in research despite evidence that many conditions such as lung cancer and depression have gender-based differences…" President Bush Signs Genetic Nondiscrimination Legislation Into Law, Kaiser Network, May 22, 2008 "President Bush on Wednesday signed into law a bill (HR 493), the Genetic Information Nondiscrimination Act, that prohibits discrimination based on the results of genetic tests…" Genetic Information Nondiscrimination Act of 2008 (HR 493), May 22, 2008 Google Makes No-Cost Online Medical Records Service Available to Public, Kaiser Network, May 20, 2008 " Google on Monday opened public access to Google Health, an online personal health record service, after about 18 months of development…Patient advocates and privacy experts have "expressed concern that, despite password protection, sensitive health records stored online could be compromised,"…" The Ancillary-Care Obligations of Medical Researchers Working in Developing Countries, Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries, PLoS Medicine 5: e90, May 20, 2008 (full article freely available) Drug companies rely on volunteers to test their wares, Paramus Post, May 19, 2008 "Stevan Vela was watching an old episode of the television show "Bonanza" when he stumbled across his chance to become a human guinea pig…"

Week of May 12, 2008 “Cash for safe sex” program hopes to stop AIDS in Tanzania, iWire, May 16, 2008 "The World Bank is experimenting on a test program that provides money to people in Tanzania who do not contract sexually transmitted diseases. Will it work? Is it ethical?…" F.D.A. Delays Clinical Trial of Embryonic Stem Cells, New York Times, May 15, 2008 (free one time registration required) "The Geron Corporation announced Wednesday that its plans to begin the first clinical trial using embryonic stem cells had been delayed by federal regulators…" Genetics firm to build online health database, San Francisco Chronicle, May 15, 2008 "The Google-backed consumer genome service 23andMe staked out a role in the growing medical database industry Wednesday, announcing that it will collaborate with Parkinson's disease researchers to collect key information from patients in an all-online format…"We hope to establish an entirely new paradigm for how genetic research is conducted that actively involves the patient," said 23andMe co-founder Linda Avey…" Improving the Quality of Cancer Clinical Trials. Workshop Summary, National Cancer Policy Forum, Institute of Medicine, May 13, 2008 (freely available to read online) Communicating the Results of Clinical Research to Participants: Attitudes, Practices, and Future Directions, Shalowitz and Miller, PLoS Medicine 5: e91, May 13, 2008 (full article freely available) Tales of the unexpected: Medicine's accidental discoveries, The Independent, May 13, 2008 "From Botox and viagra to penicillin, some of the greatest breakthrough cures have been discovered by happy serendipity…"

Week of May 5, 2008 FDA Official Sees Push for Clinical Trial Rules, FDA News, May 9, 2008 "The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials…" Coalition to Transform Clinical Trials Names Executive Board, US Food and Drug Adminstration (FDA), May 5, 2008 "The Clinical Trials Transformation Initiative (CTTI)…has named a 12-member Executive Board that will oversee its activities. Founded by the U.S. Food and Drug Administration (FDA) and Duke University as a public-private partnership, CTTI seeks to improve the quality and efficiency of clinical trials…"

Week of April 28, 2008 Congress Passes Bill to Bar Bias Based on Genes, New York Times, May 2, 2008 (free one time registration required) "A bill that would prohibit discrimination by health insurers and employers based on the information that people carry in their genes won final approval in Congress on Thursday by an overwhelming vote…President Bush has indicated he will sign…" Ethics in Public Health Research: Privacy and Public Health at Risk: Public Health Confidentiality in the Digital Age, Myers et al., American Journal of Public Health 98: 793-801, May 2008 (abstract freely available) Bioterrorism Surveillance and Privacy: Intersection of HIPAA, the Common Rule, and Public Health Law, Nordin et al., American Journal of Public Health 98: 802-807, May 2008 (abstract freely available) Marginalized Populations and Drug Addiction Research: Realism, Mistrust, and Misconception, Fisher et al., IRB 30: 1-9, May-June 2008 (full article schedule to be freely available until July 2008; free one time registration required) New Listing of International Ethics Resources Available, NIH Program on Clinical Research Policy Analysis and Coordination, May 2008 "…Recently, the NIH CRpac Program augmented the site through the addition of a compilation of international guidelines, codes, regulations, policies and declarations. These materials will be of interest to researchers, IRB members, administrators and others involved in international research activities…" U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services, Secretary's Advisory Committee on Genetics, Health and Society (SACGHS), Apr 30, 2008 (pdf) Review: FDA Allowed Testing of Artificial Blood Despite Risk of Death, Washington Post, Apr 29, 2008 (free one time registration required; for JAMA article and editorial see Journal section below) "A new analysis concludes that the Food and Drug Administration approved experiments with artificial blood substitutes even after studies showed that the controversial products posed a clear risk of causing heart attacks and death…" Editorial: The Future of Clinical Trials Evaluating Blood Substitutes, Fergusson and McIntyre, Journal of the American Medical Association, early release Apr 28, 2008 (full article freely available) Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death. A Meta-analysis, Natanson et al., Journal of the American Medical Association, early release Apr 28, 2008 (full article freely available) Final Rule: Human Subjects Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application, US Food and Drug Administration, Apr 28, 2008 (pdf)

Week of April 21, 2008 Senate Passes Genetic Discrimination Bill, New York Times, Apr 24, 2008 (no longer available) "…The 95-0 Senate vote sends the Genetic Information Nondiscrimination Act back to the House, which could approve it early next week…The bill, described by Sen. Edward Kennedy as ''the first major new civil rights bill of the new century,'' would bar health insurance companies from using genetic information to set premiums or determine enrollment eligibility. Similarly, employers could not use genetic information in hiring, firing or promotion decisions…" Congress Near Deal on Genetic Test Bias Bill, New York Times, Apr 23, 2008 (free one time registration required) "Congress reached an agreement clearing the way for a bill to prohibit discrimination by employers and health insurers on the basis of genetic tests. Senator Tom Coburn, an Oklahoma Republican who had been almost single-handedly holding up action on the bill, said in an interview Tuesday that most of his concerns had been resolved and predicted that the bill would pass soon…" Serious adverse events in academic critical care research, Cook et al., Canadian Medical Association Journal 178: 1181-1184, Apr 22, 2008 (full article freely available)

Week of April 14, 2008 Drug studies for hire, San Jose Mercury News, Apr 20, 2008 "…It's important for CROs or anyone else to correctly manage the studies - called clinical trials when they involve people - because mistakes potentially could lead to everything from a product's approval being delayed to a test subject developing unanticipated side effects. Yet CRO critics say no one - including the FDA - knows how often the contract outfits cause problems because the businesses operate with scant government oversight…" Clearwater doctor's drug study raises questions, St Petersburg Times, Apr 18, 2008 "When the man at Alliance Medical Research Group introduced himself as Dr. Vladimir Martin, Ruth Weber had no reason to doubt he was a licensed physician. And when he proceeded to enroll her in a study for an experimental drug for lower-back pain, then follow her progress during weekly visits and adjusted the dosage of her medicine, Weber, 73, thought nothing of it…Weber quit in mid December over the doctor's protests. It was only then that she learned the truth…" Victim Ryan Wilson in 'Elephant man' drug trial to get £2m, The Times, UK, Apr 16, 2008 "A victim of the “elephant man” drug trial is set to receive more than £2 million for his horrific injuries, it emerged yesterday…" A Pentagon Olive Branch to Academe, Inside Higher Ed, Apr 16, 2008 "…Defense Secretary Robert M. Gates has proposed a significant expansion of the type of research supported by the Pentagon — moving beyond weapons and technology, to social science and humanities work that could better inform public policy…At the same time, the plans were questioned by scholars who view ties to the Pentagon as posing ethical or other dangers to themselves or their research subjects…" Research in Complex Humanitarian Emergencies: The Médecins Sans Frontières/Epicentre Experience, Brown et al., PLoS Med 5: e89, Apr 16, 2008 (full article freely available) Citing Ethics, Some Doctors Are Rejecting Industry Pay, New York Times, Apr 15, 2008 (free one time registration required) "With little fanfare, a small number of prominent academic scientists have made a decision that was until recently all but unheard of. They decided to stop accepting payments from food, drug and medical device companies…" Drug trials fund woman's wedding, BBC, Apr 15, 2008 "…Miss Hodge, who is due to wed in July, has already tested drugs for back pain, asthma and motor neurone disease and is due to undergo her fourth trial. Despite suffering side effects during her last trial she says her fiancee Wayne Weldon is "100% worth it"…" Sludge Tested As Lead-Poisoning Fix, Washington Post, Apr 14, 2008 (free one time registration required) "The Senate Environment and Public Works Committee will investigate the government's funding of research in poor, black neighborhoods on whether sewage sludge might combat lead poisoning in children, its chairman said Monday. The Associated Press reported Sunday that the mix of human and industrial wastes from sewage treatment plants was spread on the lawns of nine low-income families in Baltimore and a vacant lot next to an elementary school in East St. Louis, Ill., to test whether lead in the soil from chipped paint and car exhausts would bind to it…"

Week of April 7, 2008 Clinical Trial Volunteers Uneasy About Some Financial Ties, Washington Post, Apr 11, 2008 (free one time registration required) "Many volunteers in clinical studies aren't overly concerned if researchers have financial conflicts, but there is some loss of trust, suggests a U.S. study…" When Should Data and Safety Monitoring Committees Share Interim Results in Cardiovascular Trials?, Borer et al., Journal of the American Medical Association 299:1710-1712, Apr 9, 2008 (extract freely available) UCLA employee who allegedly breached patient records identified, San Francisco Chronicle, Apr 8, 2008 "The UCLA Medical Center employee who allegedly breached the records of dozens of high-profile patients is a 49-year-old administrative specialist who had worked at the hospital for 32 years…the hospital had not alerted the patients whose records were viewed nor did it report the breaches to the state health department or law enforcement authorities. At the time, it didn't think it was required to do so. UCLA now plans to notify all the impacted patients by phone and mail that their records had been improperly viewed…" Stem-Cell Studies in People Examined by FDA on Safety, Bloomberg, Apr 8, 2008 "…The first human studies, by Menlo Park, California-based Geron, may start as soon as this summer in patients partly or wholly paralyzed. The FDA is convening a special public session April 10 to discuss the safety concerns. The agency scheduled the meeting to get help in balancing the pleas of patients with risks that may arise should the therapies gain wide use…"

Week of March 31, 2008 Cancer drug trials offer hope, Monterey Herald, Apr 6, 2008 (no longer available) "…Carolyn and other courageous volunteers in clinical trials are crucial forces in the war against cancer. To the enormous frustration of many scientists, however, only a tiny fraction of patients sign up…" Rep. Barton Seeks Probe In Theft of Computer. Energy Panel Member Says His Medical Data Were in Stolen Laptop, Washington Post, Apr 3, 2008 (free one time registration required) "…In a letter to be released today, Barton asks Health and Human Services Department's inspector general to investigate the Feb. 23 theft and the agency's handling of the affair, noting that, "in the interest of full disclosure," he is personally affected. Among the questions raised in the letter is whether the NIH has an adequate system for contacting patients affected by such events. Barton and others were not notified of the breach until last week because of agency record-keeping problems. At least one patient said he found out only after contacting the NIH…" Letter from Joe Barton and John Shimkus, Committee on Energy and Commerce, US House of Representatives to Daniel Levinson, Inspector General, US Department of Health and Human Services, Apr 3, 2008 (pdf) First British human-animal hybrid embryos created by scientists, The Guardian, Apr 2, 2008 "Britain's first human-animal hybrid embryos have been created, forming a crucial first step, scientists believe, towards a supply of stem cells that could be used to investigate debilitating and so far untreatable conditions such as Alzheimer's disease, Parkinson's and motor neurone disease…" Editorial: Full Disclosure and the Funding of Biomedical Research, Schwartz et al., New England Journal of Medicine, published online Apr 2, 2008 (full article freely available) Report Claims Clinical Trials Miss Many Populations, Health Day, Apr 1, 2008 "A new analysis of the American clinical trial process suggests that the system for testing new drugs has routinely excluded or under-represented women, older people, minorities, disabled individuals and rural populations for decades…" White Paper: Eliminating Disparities in Clinical Trials, EDICT Project, Baylor College of Medicine, Apr 2008 (pdf, full report freely available) Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research, Weinfurt, Journal of General Internal Medicine, published online Apr 2008 (full text freely available) "I shall die in the service of science". Self experimentation puts doctors' lives in peril, but MDs persist, National Review of Medicine, Canada, Apr 2008 "Dr James Kennedy held up a glass of 5-aminolevulinic acid, the skin cancer drug he'd been testing on mice in his lab at Queen's University. He was frustrated. The mice weren't responding to the treatment. "It should have worked. But it didn't." He decided to take a sip…" Ethics in a scientific approach: the importance of the biostatistician in research ethics committees, Atici and Erdemir, Journal of Medical Ethics 34: 297-300, Apr 2008 (abstract freely available) How can we provide effective training for research ethics committee members? A European assessment, Davies et al., Journal of Medical Ethics 34: 301-302, Apr 2008 (abstract freely available) Malawians permit research bronchoscopy due to perceived need for healthcare, Mtunthama et al., Journal of Medical Ethics 34: 303-307, Apr 2008 (abstract freely available) Access to medical records for research purposes: varying perceptions across research ethics boards, Willison et al., Journal of Medical Ethics 34: 308-314, Apr 2008 (abstract freely available)

Week of March 24, 2008 Researchers urge ethics guidelines for human-genome research, EurekAlert!, Mar 26, 2008 (for PLoS Biology article referenced, see Journal Articles below)