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Week of December 31, 2007 Child Psychiatrist to Curtail Industry-Financed Activities, New York Times, Dec 30, 2008 (free one time registration required) "…The psychiatrist, Dr. Joseph Biederman, a world-renowned and controversial researcher on childhood mental illness, has agreed to stop participating in speaking engagements and other activities paid for by pharmaceutical companies, and also to stop his work on industry-financed activities within the hospital. That includes clinical trials that are under way…" New OHRP Frequently Asked Questions and Answers on Quality Improvement Activities, US Office for Human Research Protections (OHRP), Dec 30, 2008 "OHRP has posted a new set of Frequently Asked Questions and Answers (FAQs) on quality improvement activities. These FAQs provide guidance on OHRP’s current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited…" Press Release: 2008 Human Research Protection Award Recipients Announced, PRNewswire, Dec 29, 2008 "…The winner of the annual award was the University of Texas M.D. Anderson Cancer Center -- for its best practice "IND Regulatory and Monitoring Program." …"

Week of December 15, 2008 Replicating Milgram: Most People Will Administer Shocks When Prodded By 'Authority Figure', Science Daily, Dec 19, 2008 "Nearly 50 years after one of the most controversial behavioral experiments in history, a social psychologist has found that people are still just as willing to administer what they believe are painful electric shocks to others when urged on by an authority figure…Burger implemented a number of safeguards that enabled him to win approval for the work from his university's institutional review board…" Commentary: Access to Experimental Drugs for Terminally Ill Patients, Falit and Gross, Journal of the American Medical Association 300: 2793-2795, Dec 17, 2008 (extract freely available) Woman gets near-total face transplant in Cleveland, Seattle Times, Dec 17, 2008 "A woman who had suffered severe facial trauma got essentially a whole new face in a first-of-its-kind operation at the Cleveland Clinic, hospital officials said Wednesday…" Transplanting a Face: The Ethical Issues, New York Times, Dec 17, 2008 (free one time registration required) "A face transplant is different from other kinds of transplants, medical ethicists said on Wednesday, and the risks and benefits to the patient must be weighed carefully…" Press Release: Drug tests will prevent repeat of Northwick Park trial, EurekAlert!, Dec 15, 2008 "Scientists investigating the 2006 Northwick Park drug-trial disaster that left six healthy volunteers hospitalised say they have developed new pre-clinical tests that could have stopped the trial from ever going ahead…"

Week of December 8, 2008 Vatican Issues Instruction on Bioethics, New York Times, Dec 12, 2008 (free one time registration required) "The Vatican issued its most authoritative and sweeping document on bioethical issues in more than 20 years on Friday, taking into account recent developments in biomedical technology and reinforcing the church’s opposition to in vitro fertilization, human cloning, genetic testing on embryos before implantation and embryonic stem cell research…" The latest industry being outsourced to India: clinical drug trials, St Petersburg Times, Dec 11, 2008 "…This overstretched government hospital and medical college treats about 4-million people a year. It's also one of a growing number of Indian hospitals that use their patients to gather data on experimental drugs destined for Western markets…" Audit leads to enrollment halt in research at veterans hospital, Seattle Times, Dec 10, 2008 "The veterans hospital in Seattle has halted all new enrollments in research involving human subjects after a federal audit found that patient safeguards weren't properly documented…"

Week of December 1, 2008 Psychologists Doing Research in Virtual World Pay Subjects in Virtual Money, Chronicle of Higher Education, Dec 4, 2008 "…Mr. Gilbert says that two of the surveys — one about addiction to online worlds and another about sexuality in Second Life — just won approval from the university’s institutional review board…The project was a harder sell than usual, he says, because the board had not dealt with virtual worlds before. “I had to meet with them and sort of explain what we’re doing,” he says…" Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), Interagency Advisory Panel on Research Ethics (PRE), Canada, Dec 3, 2008 "…To facilitate a comparison to the first edition of the TCPS (1998), the Panel has provided two Tables of Concordance…launch of the new PRE website scheduled to go live in early December. The new website will include schedule information and online registration for the 2009 TCPS Regional Consultation Tour…" Cleveland Clinic Discloses Doctors’ Industry Ties, New York Times, Dec 2, 2008 (free one time registration required) "The Cleveland Clinic plans to announce this week it has begun publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers…a complete disclosure of doctors’ and researchers’ financial ties available on its Web site, www.clevelandclinic.org…" Whose Blood Is It?, Inside Higher Ed, Dec 1, 2008 "…a decision Friday by an Arizona appeals court to revive a lawsuit by a small Indian tribe against the Arizona Board of Regents and some researchers involved in the use of blood collected from the tribe. Tribe members consented to the blood being used for research on why they may have been experiencing high rates of diabetes…Some of the additional research challenged the tribe’s religious beliefs and members say they never would have contributed to such studies…" Draft Guidance for When Participation of Human Subjects in Research Is Discontinued, US Office for Human Research Protections (OHRP), Dec 1, 2008 (pdf; email comments by Jan 30, 2008 to discontinueparticipation@hhs.gov, with subject line "Guidance on Discontinuation of Subject Participation") "…The proposed guidance document would provide guidance on important considerations for when participation of human subjects in research is discontinued, either because a subject voluntarily chooses to discontinue participation during the course of the research, or because an investigator terminates a subject's participation in the research without regard to the subject's consent. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. OHRP will consider comments received before issuing the final guidance document…" Communicating Clinical Trial Results to Research Participants, Dorsey et al., Archives of Neurology 65: 1590-1595, Dec 2008 (abstract freely available) Partnering for Care in HIV Prevention Trials, MacQueen et al., Journal of Empirical Research on Human Research Ethics 3: 5–18, Dec 2008 (abstract freely available) Sharing Data and Results with Study Participants: Report on a Survey of Cultural Anthropologists, Cooper, Journal of Empirical Research on Human Research Ethics 3: 19–34, Dec 2008 (abstract freely available) Trust in Health Research Relationships: Accounts of Human Subjects, McDonald et al., Journal of Empirical Research on Human Research Ethics 3: 35–47, Dec 2008 (abstract freely available) International Analysis of Institutional Review Boards Registered with the U.S. Office for Human Research Protections, Bartlett, Journal of Empirical Research on Human Research Ethics 3: 49–56, Dec 2008 (abstract freely available) Survey of U.S. Human Research Protection Organizations: Workload and Membership, Catania et al., Journal of Empirical Research on Human Research Ethics 3: 57–69, Dec 2008 (abstract freely available) Survey of U.S. Boards that Review Mental Health-related Research, Catania et al., Journal of Empirical Research on Human Research Ethics 3: 71–79, Dec 2008 (abstract freely available) The Convergence of Research and Clinical Practice: Institutional Review Board Review of Humanitarian Use Device Applications, Gordon and Philpott, Journal of Empirical Research on Human Research Ethics 3: 81–98., Dec 2008 (abstract freely available) IRB Chairs' Perspectives on Genomics Research Involving Stored Biological Materials: Ethical Concerns and Proposed Solutions, Wolf et al., Journal of Empirical Research on Human Research Ethics 3: 99–111, Dec 2008 (abstract freely available)

Week of November 24, 2008 New Arena for Testing of Drugs: Real World, New York Times, Nov 25, 2008 (free one time registration required) "…But now there is a growing movement to gather a new kind of evidence, the kind that will fill some of the biggest gaps in medical science: What treatment is best for typical patients with complex symptoms…" Anthropological Engagement, for Good and for Bad?, Inside Higher Ed, Nov 24, 2008 "At the American Anthropological Association’s annual meeting…sessions and meetings focused on the Human Terrain System and other controversial forms of collaboration with the U.S. military, secret research, and a planned comprehensive review of the association’s decade-old Code of Ethics…" Jay Katz dead - authority on medical ethics, The San Francisco Chronicle, Nov 24, 2008 "Dr. Jay Katz, a psychoanalyst and Yale Law School professor whose analysis of the conflicting interests and motivations of doctors and patients made him a leading authority on medical ethics, died Nov. 17 in New Haven, Conn., of heart failure. He was 86…" Research Center Tied to Drug Company, New York Times, Nov 24, 2008 (free one time registration required) "…e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to “move forward the commercial goals of J.& J…"

Week of November 17, 2008 Radio Host Has Drug Company Ties, New York Times, Nov 21, 2008 (free one time registration required) "An influential psychiatrist who was the host of the popular NPR program “The Infinite Mind” earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program…" F.D.A. Scientists Accuse Agency Officials of Misconduct, New York Times, Nov 17, 2008 (free one time registration required) "…The letter says that the scientists have documentary evidence that senior agency managers “corrupted the scientific review of medical devices” by ordering experts to change their opinions and conclusions in violation of the law…The House Committee on Energy and Commerce will investigate the accusations…" NHS medical research plan threatens patient privacy, The Guardian, Nov 17, 2008 "…consulting on a proposal that is buried in the small print of the NHS constitution that would permit researchers for the first time to write to patients who share a particular set of medical conditions to seek their participation in trials. It would result in patients receiving a letter from a stranger who knew their most intimate medical secrets, which would be regarded by many as a breach of trust by doctors who are supposed to keep information confidential…"

Week of November 10, 2008 Medic charged with unauthorised drug trials in Malawi, SciDev.net, Nov 12, 2008 "Police have arrested a hospital technician on charges of conducting unauthorised and unsupervised chemotherapy drug trials on cancer-suffering HIV/AIDS patients in a hospital in southern Malawi…documentation suggesting that none of the regulatory bodies followed up Mac'osano's requests by asking the hospital why a relatively low-level technician was asking for permission to conduct such trials…" Brown, military's research connections up for debate, Brown Daily Herald, Nov 11, 2008 "…The most noticeable upsurge in the discourse on the ethics of collaboration with the military has been among anthropologists…The Human Terrain System program sparked an intense and ongoing debate within the anthropological discipline…Last year, the American Anthropological Association denounced the program on the grounds that researchers could not obtain informed consent from their subjects in a combat environment and could endanger them by providing information to the military. The association also formed a commission to reevaluate the ethics of anthropologists' engagement with the military and intelligence communities…" School spreads bioethics. Union College program trains nations to improve medical standards, Albany Times Union, Nov 10, 2008 "…The school's bioethics program was the first in the nation to receive a grant from the National Institutes of Health to educate people from developing countries about Western standards of medical research. The idea is the students can become bioethics leaders in their own countries…"

Week of October 27, 2008 AAA Executive Board Announces Comprehensive Code of Ethics Review, American Anthropological Association (AAA), Nov 2008 "The Executive Board recommends an extensive review of the Code of Ethics over the next three years…The Committee is charged to consult extensively during this review with relevant AAA committees and commissions, the Section Assembly, and the membership at large…In the last year, a debate has arisen over rules relating to secret research and government work in war zones, but the review will cover the entire set of rules…" American Anthropological Association Code of Ethics (pdf) Is informed consent effective in trauma patients?, Bhangu et al., Journal of Medical Ethics 34: 780-782, Nov 2008 (abstract freely available) New Members Appointed to the Interagency Advisory Panel on Research Ethics (PRE), Canada, Nov 2008 "…PRE was created in November 2001 as a joint initiative of CIHR, NSERC and SSHRC (the Agencies). PRE is mandated to advise the Agencies on the development of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)..," Oncology Consent Forms: Failure to Disclose Off-Site Treatment Availability, Resnik et al., IRB 30, Nov-Dec 2008 (full article freely available with free one time registration) Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions, Wilkes and Johns, PLoS Medicine 5: e223, Nov 2008 (full article freely available) International Compilation of Human Subject Protections, US Office for Human Research Protections (OHRP), Nov 2008 (pdf) "The 2009 version lists about 1,100 laws, regulations, and guidelines on human subject protections from 92 countries. This year’s Compilation includes listings from 7 new countries: Burma, Egypt, the Gambia, San Marino, South Korea, the Sudan, and Vietnam. Many of the listings include the web address, allowing the reader to link directly to the law, regulation, or guideline of interest. Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world…" 21-Year Study of Children Set to Begin, New York Times, Oct 27, 2008 (free one time registration required) "After nearly a decade of planning, researchers will begin recruiting pregnant women in January for an ambitious nationwide study that will follow more than 100,000 children from before birth until age 21…will examine factors like genetics and child rearing, geography, exposure to chemicals, nutrition and pollution…" Pfizer keen to settle Nigeria drug trial lawsuits, Reuters, Oct 27, 2008 (scheduled to be available until Nov 26, 2008) "Pfizer Inc said on Monday it hoped to reach an out-of-court settlement with Nigeria over a 1996 drug trial that the government says caused the death of 11 children and left dozens disabled…"

	Week of October 20, 2008 Jerry Menikoff to Head Office for Human Research Protections, US Office for Human Research Protections (OHRP), Oct 24, 2008 "HHS Assistant Secretary for Health Joxel Garcia M.D., M.B.A., today announced the appointment of Jerry A. Menikoff, M.D., J.D, as the director of the Office for Human Research Protections (OHRP)…"

Week of October 13, 2008 Genome Database Will Link Genes, Traits in Public View, Washington Post, Oct 18, 2008 (free one time registration required) "…The [Personal Genome Project] database, a nonprofit venture, is scheduled to go online Monday, when Church and up to nine other volunteers -- the "PGP 10" -- will release their genomic data and traits profiles to the public…It has enormous potential to help consumers control their health, proponents say, but critics say the risks outweigh the potential benefits…Church plans to require volunteers to obtain the consent of their first-degree relatives, who also stand to be exposed by having a blood relative's DNA on view. It was the review board's idea that Church become a participant…" Personal Genome Project Web Site Guidance on Engagement of Institutions in Human Subjects Research, US Office for Human Research Protections (OHRP), Oct 16, 2008 (send any comments to OHRP at ohrp@hhs.gov) "This new guidance document replaces two prior OHRP guidance documents on the engagement of institutions in human subjects research: (1) the January 26, 1999 document on “Engagement of Institutions in Research,” and (2) the December 23, 1999 document on “Engagement of Pharmaceutical Companies in HHS Supported Research.”…" Guidance on Research Involving Coded Private Information or Biological Specimens, US Office for Human Research Protections (OHRP), Oct 16, 2008 (send any comments to OHRP at ohrp@hhs.gov) "…Only the following two substantive changes have been made to this guidance document: (1) under the section heading, “Guidance,” OHRP has clarified its interpretation of “obtaining identifiable private information or identifiable specimens;” and (2) in the list of examples of when investigators would not be able to readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain (see page 3), the first example has been deleted. The deleted example had addressed the circumstance when the key to decipher the code was destroyed before the research began. Since this was not an example of research involving coded private information or specimens, this example was deleted for clarity…" Emory University Grant Suspended by U.S. in Disclosure Dispute, Bloomberg, Oct 14, 2008 "The U.S. National Institutes of Health suspended a $9.3 million research grant to Emory University over allegations that the psychiatrist leading the study didn't fully disclose payments from drug companies whose products he was studying…The agency also asked that the psychiatrist, Charles Nemeroff, stop serving as an investigator in any NIH-funded grant…"

Week of October 6, 2008 Special Report: The trial of their lives, Baltimore Sun, Oct 12-17, 2008 "Reporter Stephanie Desmon and photographer Chiaki Kawajiri spent the past six months following the lives of four women enrolled in a trial of an experimental breast cancer vaccine, and the Johns Hopkins oncologist who oversees it…" Request for Nominations to the EPA Human Studies Review Board, US Environmental Protection Agency (EPA), Oct 2008 (nominations due Nov 10, 2008) "The U.S. Environmental Protection Agency Office of the Science Advisor (OSA) is soliciting nominations of people qualified in the areas of bioethics, biostatistics, human health risk assessment and human toxicology to serve on the Human Studies Review Board (HSRB). The HSRB is a Federal advisory committee…providing advice and recommendations to EPA on scientific and ethical aspects of research with human subjects…" Disclosing Genetic Research Results After Death of Pediatric Patients, Sexton and Metcalfe, Journal of the American Medical Association 300: 1693-1695, Oct 8, 2008 (extract freely available)

Week of September 29, 2008 Top Psychiatrist Failed to Report Drug Income, New York Times, Oct 3, 2008 (free one time registration required) "One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers between 2000 and 2007, failed to report at least $1.2 million of this income to his university, and violated federal research rules…Dr. Charles B. Nemeroff of Emory University, is the most prominent example to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers…" UNESCO Global Ethics Observatory: database on ethics related legislation and guidelines, Ang et al., Journal of Medical Ethics 34: 738-741, Oct 2008 (abstract freely available) Informed consent for the study of retained tissues from postmortem examination following sudden infant death, Elliot et al., Journal of Medical Ethics 34: 742-746, Oct 2008 (abstract freely available) "I don’t like that, it’s tricking people too much...": acute informed consent to participation in a trial of thrombolysis for stroke, Mangset et al., Journal of Medical Ethics 34: 751-756, Oct 2008 (abstract freely available) Improving the evidence base in palliative medicine: a moral imperative, Keeley, Journal of Medical Ethics 34: 757-760, Oct 2008 (abstract freely available) Failure to report and provide commentary on research ethics board approval and informed consent in medical journals, Finlay and Fernandez, Journal of Medical Ethics 34: 761-764, Oct 2008 (abstract freely available) Hopes for Helsinki: reconsidering "vulnerability", Eckenwiler et al., Journal of Medical Ethics 34: 765-766, Oct 2008 (abstract freely available) Revised Declaration of Helsinki, World Medical Association (WMA), Oct 2008 "The Declaration of Helsinki (DoH) is the WMA's best-known policy statement. The first version was adopted in 1964 and has been amended six times since, most recently at the General Assembly in October 2008…" The Issue of Consent in Research that Administers Drugs of Addiction to Addicted Persons, Carter and Hall, Accountability in Research 15: 209 - 225, Oct 2008 (abstract freely available) Disclosure Issues in Neuroscience Research, Parker and Kienholz, Accountability in Research 15: 226 - 241, Oct 2008 (abstract freely available) Incidental Findings: A Common Law Approach, Tovino, Accountability in Research 15: 242 - 261, Oct 2008 (abstract freely available) What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment, Pierce, Accountability in Research 15: 262 - 282, Oct 2008 (abstract freely available) A Duty to Participate in Research: Does Social Context Matter?, de Melo-Martin, American Journal of Bioethics 8: 28 - 36, Oct 2008 (abstract freely available) Guidance for Sponsors, Clinical Investigators and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials, US Food and Drug Administration (FDA), Oct 2008, online Dec 2008 (pdf) "…describes the Food and Drug Administration's (FDA) longstanding policy that already accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data…" Addition to OHRP Web Site: OHRP Correspondence, US Office for Human Research Protections, Sep 30, 2008 "OHRP has added a category of “OHRP Correspondence” to the Regulations and Policy Guidance portion of its Web site. In this category OHRP will occasionally post correspondence with institutional review boards (IRBs), investigators, research institutions, or federal agencies when the discussion of issues referenced in the correspondence may be useful to others for understanding the applicability and interpretation of the Department of Health and Human Services (HHS) regulations for the protection of human subjects in research (45 CFR part 46). Two pieces of correspondence have been included, a September 29, 2008 Memorandum to the National Cancer Institute regarding IRB review of protocol and informed consent changes, and a July 30, 2008 letter regarding quality improvement activities designed to reduce catheter- related infections…"

Week of September 22, 2008 AAMC, COGR, AAU comment on human subject protection training and education, Association of American Medical Colleges (AAMC), Sep 26, 2008 (pdf) "The AAMC, along with the Council on Governmental Relations and the Association of American Universities, has submitted a comment letter to the Office for Human Research Protections (OHRP) on the implementation of human subject protection training and education. The letter…denies the need for additional guidance or regulations on the issue of human subject protection and training…" Feds probe chelation-heart disease study, MSNBC, Sep 25, 2008 "The largest alternative medicine study the U.S. government has ever launched has stopped enrolling people while officials investigate whether participants were fully informed of the risks and are being adequately protected…" Drug Maker Pledges to Report Payments to Doctors, New York Times, Sep 24, 2008 (free one time registration required) "In the midst of a national debate over the influence of industry money on medical research and practice, the drug maker Eli Lilly says it will begin publicly reporting all of its payments to outside doctors for speaking and consulting services…" Elias A. Zerhouni to End Tenure as Director of the National Institutes of Health, NIH News, Sep 24, 2008 "Elias A. Zerhouni, M.D., the director of the National Institutes of Health, today announced his plans to step down at the end of October 2008…" Mad Science: Nine of the oddest experiments ever, New Scientist, Sep 2008 "Reto Schneider has collected some of the most bizarre experiments conducted in the name of science for his book The Mad Science Book. Here he selects nine of his favourites…" Proposed Changes to the AAA Code of Ethics, American Anthropological Association (AAA), Sep 24, 2008 (related to AAA discussions regarding "heightened involvement of anthropologists with U.S. military and intelligence institutions") "After a nine-month long process of review, consultation and outreach to a number of AAA members, groups, commissions and committees, the Executive Board recently voted to adopt changes to the association’s Code of Ethics and to forward these revisions to the membership at large for a vote…" Many Trial Reports on FDA-Approved Drugs Go Unpublished, Washington Post, Sep 23, 2008 (free one time registration required) "More than half of all supporting clinical trials for U.S. Food and Drug Administration-approved drugs remain unpublished five years after permission has been given to sell the drugs in the United States, say University of California, San Francisco researchers…" Ethical and Practical Issues Associated with Aggregating Databases, Karp et al., PLoS Medicine 5: e190, Sep 23, 2008 (full article freely available) Clinical trials regulation — how Canada compares, Shuchman, Canadian Medical Association Journal 179: 635-638, Sep 23, 2008 (full article freely available) "…As a result of clinical trials mishaps, the UK and United States have been moving quickly to reform their oversight regimes. Canada, by contrast, has not sought change with any measure of alacrity…" Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis, Lee et al., PLoS Medicine 5: e191, Sep 22, 2008 (full article freely available)

Week of September 15, 2008 Request for Applications: Studies of the Ethical, Legal, and Social Implications (ELSI) of Human Microbiome Research (R01), US National Institutes of Health (NIH), Sep 18, 2008 (letter of intent due Nov 3, 2008; applications due Dec 3, 2008) "…The purpose of this reissued FOA is to solicit applications to address further the ethical, legal, and social issues (ELSI) of HMP research. This continues a tradition established at the inception of the Human Genome Project, which likewise explicitly incorporated an ELSI component. The goal is to facilitate the early identification and deliberation of these complex issues, so that the science can move forward in a responsible way that takes into account its broader societal impact…" Informed Consent in the Genomics Era, Mascalzoni et al., PLoS Medicine 5: e192, Sep 16, 2008 (full article freely available)

Week of September 8, 2008 23andMe cuts DNA scan cost to $399, The San Francisco Chronicle, Sep 9, 2008 "The Google-backed startup 23andMe is slashing the price of its personal DNA scanning service from $999 to $399 in a bid to attract more customers and expand its database of individual genetic profiles as an asset to offer to medical researchers…Greater popular access to the service will also support 23andMe's long-term plan to act as a liaison between drug researchers and groups of people with specific medical and genetic profiles…" House Criticizes VA for Destroying Specimens, Washington Post, Sep 9, 2008 (free one time registration required) "Members of Congress weighed in today on the destruction two years ago of thousands of biomedical specimens on Legionnaires' and other infectious diseases, criticizing the decision to destroy more than 25 years' worth of irreplaceable samples…"

Week of September 1, 2008 FDA to List Drugs Being Investigated, Washington Post, Sep 6, 2008 "The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients…The agency also starts investigations because of data from clinical trials and other studies. Those will not be on the list…" 2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research, Human Embryonic Stem Cell Research Advisory Committee, National Research Council and Institute of Medicine of the National Academies, Sep 2008 (press release and full report freely available) "The National Academies have updated their guidelines for the responsible conduct of research using human embryonic stem cells. These voluntary guidelines are based on a joint National Research Council-Institute of Medicine committee's review of scientific, ethical, and policy issues that have arisen since the guidelines were last updated in 2007…" 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) Increasing the amount of payment to research subjects, Resnick, Journal of Medical Ethics 34: e14, Sep 2008 (abstract freely available) Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception, Durand-Zaleski et al., Journal of Medical Ethics 34: e16, Sep 2008 (abstract freely available) The search for clarity in communicating research results to study participants, Shalowitz and Miller, Journal of Medical Ethics 34: e17, Sep 2008 (abstract freely available) Ethical review of undergraduate student research in the NHS: evolution of the system could benefit us all, Wilkinson, Journal of Medical Ethics 34: e19, Sep 2008 (extract freely available) Hidden Data for Research Ethicists: An Introduction to the Concept and a Series of Papers, DuBois, Journal of Empirical Research on Human Research Ethics 3: 3-5, Sep 2008 (abstract freely available) Hidden Empirical Research Ethics: A Review of Three Health Journals from 2005 through 2006, DuBois et al., Journal of Empirical Research on Human Research Ethics 3: 7-18, Sep 2008 (abstract freely available) Enrolling, Retaining, and Benefiting Out-of-Treatment Drug Users in Intervention Research, Striley et al., Journal of Empirical Research on Human Research Ethics 3: 19-25, Sep 2008 (abstract freely available) Assessing and Improving Research Participants' Understanding of Risk: Potential Lessons from the Literature on Physician-Patient Risk Communication, Anderson and Iltis, Journal of Empirical Research on Human Research Ethics 3: 27-37, Sep 2008 (abstract freely available) Psychotropic Medication Research in Children and Adolescents: Empirical Findings and Ethical Implications, Aman and Farmer, Journal of Empirical Research on Human Research Ethics 3: 39-47, Sep 2008 (absract freely available) Do Incentives Exert Undue Influence on Survey Participation? Experimental Evidence, Singer and Couper, Journal of Empirical Research on Human Research Ethics 3: 49-56, Sep 2008 (abstract freely available) Purpose and Benefits of Early Phase Cancer Trials: What do Oncologists Say? What do Patients Hear?, Kass et al., Journal of Empirical Research on Human Research Ethics 3: 57-68, Sep 2008 (abstract freely available) Decisional Conflict Among Patients Who Accept or Decline Participation in Phase I Oncology Studies, Flynn et al., Journal of Empirical Research on Human Research Ethics 3: 69-77, Sep 2008 (abstract freely available) Online Introductory Tutorial for the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), Interagency Advisory Panel on Research Ethics' (PRE), Canada, Sep 2008 (link is to the online TCPS Tutorial; case studies freely available in each of 5 tutorial sections) "A fourth case study has been added to the TCPS Tutorial with a focus on qualitative research in the social sciences and humanities. The case study is titled: Investigating Student Learning Related to Antiracism. The same 4 case studies are repeated throughout the Tutorial. However, the questions and commentary are specific to each section's topic…" Knowledge of Regulations Governing Pediatric Research, Stroustrup et al., IRB 30: 1-7, Sep-Oct 2008 (abstract freely available; with free one time registration, full article 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 "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) "…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) Children and Clinical Studies Web Site, US National Heart, Lung and Blood Institute, NIH, Aug 2008 "The National Heart Lung and Blood Institute (NHLBI), in partnership with other National Institutes of Health (NIH) institutes, has created a comprehensive award-winning website designed to give parents and healthcare providers alike the information needed to understand clinical research in children and make informed decisions about participating in a study…" DOE Protecting Human Research Subjects Newsletter, US Department of Energy (DOE), Aug 2008, available online Oct 2008 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 (free one time registration required) "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) FDA Pediatric Advisory Committee June 9-10, 2008 Meeting Materials, US Food and Drug Administration, posted online Jul 2008 (includes 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 (no longer available) "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 (no longer available) "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 "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 (no longer available) "…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 (no longer available) "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) Report: Expedited Review of Social and Behavioral Research Activities, Social and Behavioral Research Working Group, Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council, Jun 2008, available online Oct 2008 (full report freely available) ORI Annual Report: 2007, US Office of Research Integrity (ORI), Jun 2008, available online Oct 2008 (pdf, full report 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 (no longer available) 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) FDA Faulted for Approving Studies of Artificial Blood, Washington Post, Apr 29, 2008 (free one time registration required) "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 (no longer available) "…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 "A global team of legal, scientific and ethics experts have put forward eight key recommendations to establish much needed guidelines for conducting human-genome sequencing research. Timothy Caulfield, professor and research director of the Health Law Institute at the University of Alberta in Canada, led a consensus workshop to develop rigorous guideline recommendations for research ethics boards…" Cigarette Company Paid for Lung Cancer Study, New York Times, Mar 26, 2008 (free one time registration required) "…An increasing number of universities do not accept grants from cigarette makers, and a growing awareness of the influence that companies can have over research outcomes, even when donations are at arm’s length, has led nearly all medical journals and associations to demand that researchers accurately disclose financing sources…" Patients' Data on Stolen Laptop. Identity Fraud Not Likely, NIH Says, Washington Post, Mar 24, 2008 (free one time registration required) "A government laptop computer containing sensitive medical information on 2,500 patients enrolled in a National Institutes of Health study was stolen in February, potentially exposing seven years' worth of clinical trial data, including names, medical diagnoses and details of the patients' heart scans. The information was not encrypted, in violation of the government's data-security policy…" Information Security: Department of Health and Human Services Needs to Fully Implement Its Program, US Government Accountability Office (GAO), Feb 2008 (pdf)

Week of March 17, 2008 Vaccine Failure Is Setback in AIDS Fight, Test Subjects May Have Been Put at Extra Risk Of Contracting HIV, Washington Post, Mar 21, 2008 (free one time registration required) "…The results of the trials, which enrolled volunteers on four continents, have spurred intense scientific inquiry and unprecedented soul-searching as researchers try to make sense of what happened and assess whether they should have seen it coming. Both field tests were halted last September, and seven other trials of similarly designed AIDS vaccines have either been stopped or put off indefinitely. Some may be modified and others canceled outright…" Volunteers for HIV test vaccines need support: study, CTV.ca, Mar 19, 2008 "…when a promising vaccine developed by pharmaceutical giant Merck not only failed to work in what was known as the international STEP trial, but actually increased the risk of infection in some volunteers…decided to interview a number of people who had volunteered for the Toronto portion of STEP, but decided not to take part after going through the initial enrolment process. Their reasons, he said, should be a cautionary tale for researchers in any future vaccine-testing endeavours…" Did Tuskegee damage trust on clinical trials?, CNN, Mar 18, 2008 (no longer available) "…Even the experts, apparently, can't agree. Two separate studies by Johns Hopkins University physicians took opposing sides on whether the Tuskegee experiment remains a significant factor in turning blacks away from clinical trials at a greater rate than whites. And both tended to contradict an extensive 2005 National Institutes of Health computer survey that found, in fact, blacks are no different than whites in the rate at which they take part in clinical trials when offered the chance…"

Week of March 10, 2008 Defining a Ban on Secret Research, Inside Higher Ed, Mar 13, 2008 "When members of the American Anthropological Association gathered for their annual meeting in November in Washington, the subject of the most intense debate was over the ethics of scholars working with the military or national security and intelligence agencies…Now the association’s leaders — following a board vote — are drafting language that would accept a ban on secret research, but specify a few kinds of cases where the ban might not apply…The board asked its ethics committee to work on identifying possible changes needed to the ethics code that relate to issues of informed consent…" New Ways To Manage Health Data. Giants Join the Push To Put Records Online, Washington Post, Mar 11, 2008 (free one time registration required) "…The new capabilities raise the value of PHRs -- as well as the risk from breaches of privacy. And as the records sites grow in number and sophistication, privacy advocates are stepping up their warnings, especially about PHRs offered by health insurers…" Observational Research, Randomised Trials, and Two Views of Medical Science, Vandenbroucke, PLoS Medicine 5: e67, Mar 11, 2008 (full article freely available)

Week of March 3, 2008 You can get paid to catch malaria, Seattle Times, Mar 5, 2008 "…Seattle-area residents will soon be able to go all the way: allowing themselves to be bitten by malaria-infected mosquitoes to aid in the quest for new vaccines and drugs…" HIV prevention trials 'hindered by obstacles', SciDev.net, Mar 5, 2008 "Developing countries face several challenges to conducting clinical trials on HIV prevention strategies, scientists have cautioned. Africa is particularly vulnerable to political pressure to halt trials, unpaid and over-burdened ethics committees and delays in obtaining ethical approval…" Doctor put study first, Deseret News, Mar 4, 2008 "Attorneys for the parents of Parker Jensen, the 12-year-old boy who made national headlines in 2003 after his cancer prompted state officials to try to force his parents to consent to chemotherapy, claim new evidence shows that a treating physician was more concerned about getting Parker into a clinical study than actually treating the boy's illness…" Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?, Fegan and Lang, PLoS Medicine 5: e6, Mar 4, 2008 (full article freely available)

Week of February 25, 2008 Participation in dementia research: rates and correlates of capacity to give informed consent, Warner et al., Journal of Medical Ethics 34: 167-170, Mar 2008 (abstract freely available) Human-tissue-related inventions: ownership and intellectual property rights in international collaborative research in developing countries, Andanda, Journal of Medical Ethics 34: 171-179, Mar 2008 (abstract freely available) Exploitation and enrichment: the paradox of medical experimentation, Brazier, Journal of Medical Ethics 34: 180-183, Mar 2008 (abstract freely available) Research ethics and lessons from Hwanggate: what can we learn from the Korean cloning fraud?, Saunders and Savulescu, Journal of Medical Ethics 34: 214-221, Mar 1, 2008 (abstract freely available) Should post-trial provision of beneficial experimental interventions be mandatory in developing countries?, Zong, Journal of Medical Ethics 34: 188-192, Mar 2008 (abstract freely available) Unconscious emotional reasoning and the therapeutic misconception, Charuvastra and Marder, Journal of Medical Ethics 34: 193-197, Mar 2008 (abstract freely available) Is it ethical to keep interim findings of randomised controlled trials confidential?, Miller and Wendler, Journal of Medical Ethics 34: 198-201, Mar 2008 (abstract freely available) Beyond informed consent: the therapeutic misconception and trust, Melo-Martín and Ho, Journal of Medical Ethics 34: 202-205, Mar 2008 (abstract freely available) Views on data use, confidentiality and consent in a predictive screening involving children, Helgesson and Swartling, Journal of Medical Ethics 34: 206-209, Mar 2008 (abstract freely available) Duty to disclose what? Querying the putative obligation to return research results to participants, Miller et al., Journal of Medical Ethics 34: 210-213, Mar 2008 (abstract freely available) US Office of Research (ORI) Integrity Newsletter, Mar 2008 (pdf) Research Ethics Recommendations for Whole-Genome Research: Consensus Statement, Caulfield et al., PLoS Biology 6: e73, Mar 2008 (full article freely available) Research Benefits for Hypothetical HIV Vaccine Trials: The Views of Ugandans in the Rakai District, Grady et al., IRB 30: 1-7, Mar-Apr 2008 (no longer available) Opinions of IRB Members and Chairs Regarding Investigators' Relationships with Industry, Weissman et al., Journal of Empirical Research on Human Research Ethics 3: 3-13, Mar 2008 (abstract freely available) IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies, Luebbert et al., Journal of Empirical Research on Human Research Ethics 3: 15-24, Mar 2008 (abstract freely available) Investigating Perceived Institutional Review Board Quality and Function Using the IRB Researcher Assessment Tool, Reeser et al., Journal of Empirical Research on Human Research Ethics 3: 25-34, Mar 2008 (abstract freely available) Administrators' Perspectives on Ethical Issues in Long-Term Care Research, Hickman et al., Journal of Empirical Research on Human Research Ethics 3: 69-78, Mar 2008 (abstract freely available) Perceived Benefits in Trauma Research: Examining Methodological and Individual Difference Factors in Responses to Research Participation, DePrince and Chu, Journal of Empirical Research on Human Research Ethics 3: 35-47, Mar 2008 (abstract freely available) Children's Perception of Research Participation: Examining Trauma Exposure and Distress, Chu et al., Journal of Empirical Research on Human Research Ethics 3: 49-58, Mar 2008 (abstract freely available) The Effects of Trauma-Focused Research on Pregnant Female Participants, Schwerdtfeger and Goff, Journal of Empirical Research on Human Research Ethics 3: 59-67, Mar 2008 (abstract freely available) Public Disclosure in Research with Exception from Informed Consent: The Use of Survey Methods to Assess its Effectiveness, Jacoby et al., Journal of Empirical Research on Human Research Ethics 3: 79-87, Mar 2008 (abstract freely available) Are We Misjudging How Well Informed Consent Forms are Read?, McNutt et al., Journal of Empirical Research on Human Research Ethics 3: 89-97, Mar 2008 (abstract freely available) Special Issue: Research Ethics, Hastings Center Report 38, Mar-Apr 2008 (no longer available) The Procedure for the Ethical Review of Protocols for Clinical Research Projects in the European Union, European Forum for Good Clinical Practice (EFGCP), updated Mar 2008 "A sub group of the EFGCP Ethics Working Party has tackled the challenge of identifying what over thirty aspects of the ethical review process is for each member state, plus Norway and Switzerland, and has brought this information together in a Report that will be an invaluable reference document for any company, academic department or contract research organisation wishing to conduct clinical research anywhere in Europe…" FASEB Conflict of Interest Toolkit, Federation of American Societies for Experimental Biology (FASEB), updated Mar 2008 "Recommendations, tools, and resources for the conduct and management of financial relationships between academia and industry in biomedical research…" Doctors `Repeatedly or Deliberately' Break FDA Drug-Trial Rules, Bloomberg, Feb 29, 2008 "…The agency has failed to complete disciplinary action against 12 researchers, including Vestal, after proposing that they be disqualified from trials based on findings that they violated rules designed to protect patients and ensure accurate data, FDA records show. Cases have remained unresolved for as long as a decade…" More Aggressive Guidance on Conflicts of Interest, Inside Higher Ed, Feb 29, 2008 "…More than five years after the Association of American Universities and the Association of American Medical Colleges published their initial reports and recommendations on how institutions should deal with real and perceived conflicts, the two groups on Thursday issued a new report that goes quite a bit further in prescribing (and in some cases proscribing) certain activities and behaviors…" Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research, AAMC-AAU Advisory Council on Financial Conflicts of Interest in Human Subjects Research, Feb 2008 (pdf) Google Backs Harvard Scientist's 100,000-Genome Quest, Bloomberg, Feb 29, 2008 "A Harvard University scientist backed by Google Inc. and OrbiMed Advisors LLC plans to unlock the secrets of common diseases by decoding the DNA of 100,000 people in the world's biggest gene sequencing project." Woman Says 'Free' Drug Study Left Her 'A Walking Corpse', KIROtv, Feb 26, 2008 "…During her struggle for reimbursement, Perry turned to the Western Institutional Review Board, an organization that watches out for the rights of medical study participants. It's Chief Compliance Officer, David Forster, tells KIRO 7 that his office has fielded 53 phone calls between Perry, Eli Lilly's law firm and the research center, trying to resolve this issue…" FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?, Medical Devices Today, Feb 25, 2008 "It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do…"

Week of February 18, 2008 Insurance Fears Lead Many to Shun DNA Tests, New York Times, Feb 24, 2008 (free one time registration required) "…The first, much-anticipated benefits of personalized medicine are being lost or diluted for many Americans who are too afraid that genetic information may be used against them to take advantage of its growing availability…" Google to Store Patients' Health Records, Washington Post, Feb 21, 2008 (free one time registration required) "Google Inc. will begin storing the medical records of a few thousand people as it tests a long-awaited health service that's likely to raise more concerns about the volume of sensitive information entrusted to the Internet search leader…The third-party services are troublesome because they aren't covered by the Health Insurance Portability and Accountability Act, or HIPPA…" Perspective: Quality-Improvement Research and Informed Consent, Miller and Emanuel, New England Journal of Medicine 358: 765-767, Feb 21, 2008 (full article freely available) Perspective: Harming through Protection?, Baily, New England Journal of Medicine 358: 768-769, Feb 21, 2008 (full article freely available) Report: Methodological Challenges in Biomedical HIV Prevention Trial, Lagakos and Gable, Editors, Committee on the Methodological Challenges in HIV Prevention Trials, Institute of Medicine, Feb 21, 2008 (available to read online) Drug research short on minority participants, Monterey Herald, Feb 20, 2008 (no longer available) "…as geneticists and physicians delve deeper into differences that could save lives, many doctors worry about a dangerous gap in one of the biggest arenas of medical research. "Pharmaceutical companies do not require minorities. They're just notoriously low" in diverse participation in clinical trials, said Dr. Charles DeCarli…" Hospital research is cleared, Baltimore Sun, Feb 20, 2008 (no longer available) "Federal regulatory officials have cleared the way for a Johns Hopkins physician to continue with his research after a controversial investigation into whether his study of intensive care units violated federal ethics requirements…"

Week of February 11, 2008 OHRP Concludes Case Regarding Johns Hopkins University Research on Hospital Infections, US Office for Human Research Protections, Feb 15, 2008 "…OHRP noted that the Johns Hopkins project has evolved to the point where the intervention, including the checklist, is now being used at certain Michigan hospitals solely for clinical purposes, not medical research or experimentation. Consequently, the regulations that govern human subjects research no longer apply…In addition, the letters offer new guidance for future quality improvement research that poses minimal risk to human subjects…" Determination Letter to Johns Hopkins University, OHRP, Feb 14, 2008 (pdf) Responses of Medical Schools to Institutional Conflicts of Interest, Ehringhaus et al., Journal of the American Medical Association 299: 665-671, Feb 13, 2008 (abstract freely available) Slow Progress on Institutional Conflicts Policies, Inside Higher Ed, Feb 13, 2008 "More than five years after the Association of American Medical Colleges urged its members to adopt policies governing institutional conflicts of interest, progress by medical schools has been decidedly mixed, a new survey co-sponsored by the association shows…" OHRP Spanish Pamphlet Now Available, US Office for Human Research Protections, Feb 11, 2008 "OHRP is pleased to announce that its pamphlet "Becoming a Research Volunteer: It's Your Decision" is now available in Spanish, "Ser Voluntario en Estudios Clínicos: Es Su Decisión." You may order up to 50 (fifty) free copies by calling OHRP's toll-free number, (866) 447-4777. You may also download at no charge an electronic copy for your own reprinting and distribution…"

Week of February 4, 2008 Making Sense of the Great Suicide Debate, New York Times, Feb 10, 2008 (free one time registration required) "…But now the shadow of suicide has slipped into the corridors of modern medicine as a potential drug side effect, where it is creating a scientific debate as divisive and confounding as any religious clash…" New drug rules pose grave risks: critics, Globe and Mail, Feb 8, 2008 "The federal government is about to overhaul the way drugs are regulated in Canada to give consumers faster access to breakthrough treatments, but some medical experts and political critics are worried the changes will turn Canadians into guinea pigs for new drugs that haven't been adequately tested…" Diabetes Study Partially Halted After Deaths, New York Times, Feb 7, 2008 (free one time registration required) "Federal researchers announced today that they abruptly halted part of a major federal study of more than 10,000 middle-aged and older people with type 2 diabetes. The reason was that a treatment that most experts have long believed would save lives, lowering blood sugar to near normal levels, instead increased the risk of death…" Press Release: For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease, NIH News, Feb 6, 2008 Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, European Commission, Feb 7, 2008 (pdf)

Week of January 28, 2008 Paying for Patients, The Scientist, Feb 2008 (free one time registration required) "…neither the currently used guidelines for human experimentation - including the Nuremberg Code and the Declaration of Helsinki - nor any US bodies such as the Health and Human Services Office of Human Research Protection or the Food and Drug Administration, offer any guiding principles on paying subjects beyond stating that the payment not be coercive and not exert undue influence. So how do researchers decide whether - and, more importantly, perhaps, how much - to pay participants?…" Continuing the Dialogue on Privacy and Confidentiality: Feedback and Recommendations Arising from SSHWC’s Recent Consultation, Social Sciences and Humanities Research Ethics Special Working Committee, Canada, Feb 2008 (available in pdf or html) "…The current paper offers feedback to the research community regarding conclusions SSHWC has drawn, next directions we will pursue and recommendations we have made to PRE for their consideration and, in this way, to continue the dialogue with both PRE and the research community…" When Drug Trials Go Wrong, Patients Have Little Recourse, Wall Street Journal, Jan 31, 2008 "…The case highlights one aspect of the legal and regulatory void surrounding clinical trials. Federal law does not require researchers to compensate participants harmed in such trials. It merely requires that their consent forms spell out whether compensation will be available for research-related injuries in trials that involve more than minimal risk…" Financial Ties Are Cited as Issue in Spine Study, New York Times, Jan 30, 2008 (free one time registration required) "…For better or worse, doctors in this country frequently have financial ties to the companies whose devices or drugs they recommend to patients. But in the case of the Prodisc clinical trial, as with any clinical research, the doctors were supposed to be acting not as advocates for the product but as objective scientists studying whether the disk was safe and effective enough to be widely sold and used in the United States…" Ethical Considerations for Clinical Trials on Medicinal Products Conducted With the Paediatric Population, European Union, Jan 30, 2008 (pdf)

Week of January 21, 2008 A Basic Hospital To-Do List Saves Lives, New York Times, Jan 22, 2008 (free one time registration required) "This is a call to arms for everyone who may someday be hospitalized, or who has a relative who may someday be hospitalized…The federal Office for Human Research Protections recently ruled that because this quality-control program constituted research on human subjects, every participating hospital must first get approval from its institutional review board…Dr. Gawande suggested that consumers write to their members of Congress and the Department of Health and Human Services, asking that the ruling be reversed…" Project to map DNA of 1,000 people, CBC News, Jan 22, 2008 "An international consortium of scientists plans to study the genomes of 1,000 people in an effort to speed up the diagnosis and treatment of some common diseases…The data will be made public through free databases…The 1,000 people will be anonymous volunteer donors who have given informed consent…" 1000 Genomes Web Site Parliamentary Secretary Fletcher announces more than $15 million for the creation of an Aboriginal Health Research Network, Canadian Institutes of Health Research, Jan 22, 2008 "Today the Government of Canada announced an investment of $15.8 million over three years through the Canadian Institutes of Health Research (CIHR) to create the Network Environments for Aboriginal Health Research (NEAHR)…[The program will] Support research that focuses on themes such as population health; health services; child health and development; and ethical issues in aboriginal health research…"

Week of January 14, 2008 Researchers Go Unchecked, Report Says, New York Times, Jan 19, 2008 (free one time registration required) "The National Institutes of Health do almost nothing to monitor the financial conflicts of university professors to whom it provides grants, a government report found, and the huge federal research agency does not want to start now…" National Institutes of Health: Conflicts in Extramural Research, Dept of Health and Human Services, Office of the Inspector General, Jan 2008 (pdf) Rules for Donations to Tissue Banks — What Next?, Glantz et al., New England Journal of Medicine 358: 298-303, Jan 17, 2008 (extract freely available) Test Subjects Who Call the Scientist Mom or Dad, New York Times, Jan 17, 2008 (free one time registration required) "…Other researchers have studied their own children in the past, but sophisticated technology allows modern-day scientists to collect new and more detailed data. The scientists also say that studying their children allows for more in-depth research and that the children make reliable participants in an era of scarce research financing…" OHRP Statement Regarding The New York Times Op-Ed Entitled "A Lifesaving Checklist", Office for Human Research Protections, Jan 15, 2008 Op Ed: A Lifesaving Checklist, New York Times, Dec 30, 2007 Court rejects appeal seeking unapproved drugs, Reuters, Jan 14, 2008 (scheduled to be freely available until Feb 13, 2008) "The Supreme Court rejected an appeal on Monday by two advocacy groups arguing that dying patients have a constitutional right to access experimental drugs that have not received regulatory approval…" Study probes why U.S. blacks wary of medical trials, Reuters, Jan 14, 2008 (scheduled to be available until Feb 13, 2008) "Distrust of doctors and concern over being abused as human guinea pigs may explain why U.S. blacks have been less willing than whites to volunteer to take part in medical studies, researchers said…" Participants in Phase 1 Oncology Research Trials. Are They Vulnerable?, Seidenfeld et al., Archives of Internal Medicine 168: 16-20, Jan 14, 2008 (abstract freely available)

Week of January 7, 2008 AAMC response to OHRP Request for Information and Comments on Research that Involves Adult Individuals with Impaired Decision-making Capacity, American Association of Medical Colleges, Jan 10, 2008 (pdf) "For Cause" Inspections Find Galloping Clinical Trial Violation Rate, Medical Devices Today, Jan 8, 2008 "The violation rate for clinical trial sponsors shot up in fiscal year 2007, hitting a 10-year high, with FDA finding many of the problems during inspections triggered by complaints…"

Week of December 31, 2007 Paid studies draw more interest in sour economy, Boston Globe, Jan 5, 2008 "…At a time when unemployment levels nationwide have reached a 15-year high, research centers and those familiar with the industry say interest is up among those wanting to participate in studies testing everything from pain medication to cancer drugs…" Indigenous Ways of Knowing: Implications for Participatory Research and Community, Cochran et al., American Journal of Public Health 98: 22-27, Jan 2008 (extract freely available) Low risk research using routinely collected identifiable health information without informed consent: encounters with the Patient Information Advisory Group, Metcalfe et al., Journal of Medical Ethics 34: 37-40, Jan 2008 (abstract freely available) Effect of social support on informed consent in older adults with Parkinson disease and their caregivers, Ford et al., Journal of Medical Ethics 34: 41-47, Jan 2008 (abstract freely available) Informed consent in Ghana: what do participants really understand?, Hill et al., Journal of Medical Ethics 34: 48-53, Jan 2008 (abstract freely available) Against the principle that the individual shall have priority over science, Helgesson and Eriksson, Journal of Medical Ethics 34: 54-56, Jan 2008 (extract freely available) Houston scientists see hope in cocaine vaccine, Houston Chronicle, Jan 1, 2008 (no longer available) "…The vaccine also could raise interesting ethical questions involving who should get inoculated and what happens if confidential information about those receiving it becomes known…the vaccine eventually is expected to be used for prevention, as well. The questions include whether parents would be allowed to have their children inoculated; whether it would amount to coercion to make it a condition for lighter criminal sentences; whether employers might happen upon such information and use it discriminatorily; and whether to use it on pregnant addicts to protect the fetuses…" Children's and Their Parents' Views on Facing Research Risks for the Benefit of Others, Wendler and Jenkins, Archives of Pediatrics and Adolescent Medicine 162: 9-14, Jan 2008 (abstract freely available) Scientific Judgment and the Limits of Conflict-of-Interest Policies, Elliott, Accountability in Research 15: 1-29, Jan 2008 (abstract freely available) Teaching and Learning Responsible Research Conduct: Influences of Prior Experiences on Acceptance of New Ideas, Mcgee et al., Accountability in Research 15: 30-62, Jan 2008 (abstract freely available) A Waiting Trial, The Scientist, Jan 2008 (free one time registration required) "What is the responsibility of the company running a clinical trial when one of its participants develops a serious complication? Last year, Doug Bergman participated in a cardiac stem cell trial; in September, he was diagnosed with acute myelogenous leukemia (AML)…" A Study to Evaluate the Effect of Investigator Attendance on the Efficiency of IRB Review, Taylor et al., IRB 30: 1-5, Jan-Feb 2008 (no longer available) Adverse Events in Gene Transfer Trials and an Agenda for the New Year, Wilson, Human Gene Therapy 19: 1-2, Jan 2008 (pdf; full article freely available) Case of Leukaemia Associated with X-Linked Severe Combined Immunodeficiency Gene Therapy Trial in London, Board of the European Societ of Cell and Gene Therapy et al., Human Gene Therapy 19: 3-4, Jan 2008 (pdf; full article freely available) If It's Broken, Shouldn't It Be Fixed? Informed Consent and Initial Clinical Trials of Gene Therapy, Caplan, Human Gene Therapy 19: 5-6, Jan 2008 (pdf; full article freely available) Informed Consent in Human Gene Transfer Clinical Trials, Kahn, Human Gene Therapy 19: 7-8, Jan 2008 (pdf; full article freely available) Protections for Participants in Gene Therapy Trials: A Patient's Perspective, Pattee, Human Gene Therapy 19: 9-10, Jan 2008 (pdf; full article freely available) Human Gene Therapy, Consent, and the Realities of Clinical Research: Is It Time for a Research Subject Advocate?, Silber, Human Gene Therapy 19: 11-13, Jan 2008 (pdf; full article freely available) Extending the Spectrum: The TCPS and Research Involving Creative Practice. A Report with Questions for Furthering the Dialogue, Social Sciences and Humanities Research Ethics Special Working Committee, Canada, Jan 2008 (available in pdf or html) "…This paper is addressed to a broad audience of academics and artists in recognition of the facts that research involving creative practice has moved across disciplines outside of the Fine Arts and that changes in the TCPS to more appropriately accommodate the Fine Arts could have an impact on researchers in other disciplines as well as independent artists outside of academia…"

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