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Week of December 25, 2006 Ottawa rejects concerns over fertility panel, Globe and Mail, Dec 28, 2006 "…That 10-member board, which was announced late last week to oversee Assisted Human Reproduction Canada, has been criticized as being long on socially conservative values but short on fertility experts and stem-cell researchers…Ultimately, the board members will be responsible for approving more than 20 regulations required under the Assisted Human Reproduction Act. Those regulations will govern such practices as the scanning of embryos for genetically linked diseases, the collection of parental consent for stem-cell research…" 2006: The year in biology and medicine, New Scientist, Dec 27, 2006 "A summary of 2006 scientific, medical and ethical highlights in biology and medicine…"

Week of December 18, 2006 So many questions and so little justice, The Guardian, UK, Dec 24, 2006 "Her face was flashed around the world as she wept for her boyfriend, victim of the infamous 'Elephant Man' medical tests. Myfanwy Marshall reveals how the ordeal has brought them closer and tells how they will face the legal and medical battles ahead…" NIH researcher sentenced in ethics case, Monterey Herald, Dec 22, 2006 "A federal researcher was ordered Friday to forfeit $300,000 and perform 400 hours of community service but will not have to pay a fine for failing to disclose lucrative consulting work with pharmaceutical giant Pfizer…" Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities, New Zealand National Ethics Advisory Committee, Ministry of Health, Dec 2006 (full guidelines freely available)

Week of December 11, 2006 Blood substitute test shouldn't go on, advisers say, CTV.ca, Dec 15, 2006 "A Navy plan to test a blood substitute on civilian trauma victims should remain on hold, federal health advisers recommended Thursday, saying the experiment's risks outweigh its benefits…" FDA Proposes Broadening Access to Drugs, The San Francisco Chronicle, Dec 11, 2006 "Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would clarify when drug companies could charge for the medicines…" Proposed Rules for Charging for Investigational Drugs and Expanded Access to Investigational Drugs for Treatment Use, Center for Drug Evaluation and Research (CDER), US FDA, Dec 11, 2006 (90 day public comment period) FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs, FDA News, Dec 11, 2006

Week of December 4, 2006 DNA Gatherers Hit Snag: Tribes Don’t Trust Them, The New York Times, Dec 10, 2006 (free one time registration required; scheduled to be freely available until Dec 16, 2006) "…Billed as the “moon shot of anthropology,” the Genographic Project intends to collect 100,000 indigenous DNA samples. But for four months, the project has been on hold here as it scrambles to address questions raised by a group that oversees research involving Alaska natives…" The Genographic Project Web Site, National Geographic Society, accessed Dec 13, 2006 Junk medicine: medical ethics, The Times, UK, Dec 9, 2006 "…It is a fundamental principle of ethical medical research that it should be conducted with the informed consent of its human subjects. When incapacitated patients cannot provide this, next of kin usually can. The court not only sanctioned a medical experiment without this consent, but actively ignored the explicit wishes of the patient and those best placed to speak for her…" Press Release: Human Research Protection Award Recipients Announced, US Newswire, Dec 8, 2006 "Winners of the 2006 Award for Excellence in Human Research Protection were announced today by Dr. Peter G. Goldschmidt, president and founder of the Health Improvement Institute…" NIH researcher pleads guilty to charge of improperly taking $285K in consulting fees, San Diego Union-Tribune, Dec 8, 2006 "A government researcher pleaded guilty Friday to misdemeanor conflict of interest for taking $285,000 in consulting fees from pharmaceutical giant Pfizer Inc. for work that improperly overlapped his official duties…" Senate confirms von Eschenbach, The Scientist, Dec 8, 2006 "The Senate yesterday (Dec. 7) confirmed Andrew C. von Eschenbach to be commissioner of the Food and Drug Administration by an overwhelming vote of 80 to 11, giving the beleaguered agency its first permanent leader in 15 months…" Request for Public Comment on OHRP Draft Guidance Document on Engagement of Institutions in Human Subjects Research, US Office for Human Research Protections (OHRP), Dec 8, 2006 (comments due by Feb 6, 2007) "On December 8, 2006, the Office for Human Research Protections (OHRP) announced, in the Federal Register, the availability of a draft guidance document entitled "OHRP Guidance on Engagement of Institutions in Human Subjects Research." The draft guidance would revise and replace two existing OHRP guidance documents on 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." To facilitate public review of the draft guidance document, OHRP has developed a table presenting a side-by-side comparison of OHRP's draft guidance document with the current guidance documents on the engagement of institutions in human subjects research…" New body to assess high-risk drug trials, The Guardian, UK, Dec 7, 2006 "An advisory body is to be established to assess high-risk drug trials, meeting one of 22 recommendations made today by experts who investigated a trial that left six men seriously ill in March. However, a lawyer for some of the victims of the trial at Northwick Park hospital, north London, said his clients felt the report by the panel of scientists was yet another "whitewash"…" Expert Group on Phase One Clinical Trials: Final report, Expert Group on Phase One Clinical Trials, Department of Health, UK, Dec 7, 2006 "Final report of the Expert Scientific Group (ESG) which was set up following the very serious adverse reactions that occurred in the first-in-man clinical trial of TGN412 in March 2006…This report was an independent report to the Secretary of State for Health…" Institute of Medicine's new drug safety report: implications for Canada, Cassels, Canadian Medical Association Journal 175: 1515-1516, Dec 5, 2006 (full article freely available) Feds Charge Alzheimer's Researcher, The San Francisco Chronicle, Dec 4, 2006 "In a rare federal prosecution, a leading government Alzheimer's researcher was charged Monday with a criminal conflict of interest for performing lucrative private drug company work that overlapped his official duties. Prosecutors alleged Dr. Trey Sunderland of the National Institutes of Health received $285,000 in improper consulting fees and travel expenses from Pfizer, Inc., for work on early indicators of Alzheimer's at the same time he also oversaw similar NIH business with the drugmaker…"

Week of November 27, 2006 Insurers may be made to cover clinical trials, Pittsburgh Tribune-Review, Dec 2, 2006 "…she supports moves in the state House and U.S. House of Representatives to require insurance companies to pay for routine patient costs associated with clinical trials. Those conducting the trials pay for the investigational treatment being studied…" Sleeping Better at Night: Investigators’ Experiences with Certificates of Confidentiality, Wolf and Zandecki, IRB 28: 1-7, Nov/Dec 2006 (free one time registration required; full article freely available) The Ethics of Withdrawal from Study Participation, Gordon and Prohaska, Accountability in Research 13: 285 - 309, Oct-Dec 2006 (abstract freely available) Comparison of Conflict of Interest Policies and Reported Practices in Academic Medical Centers in the United States, Dinan et al., Accountability in Research 13: 325 - 342, Oct-Dec 2006 (abstract freely available) Herpes Study Put Pregnant Women at Risk, The San Francisco Chronicle, Dec 1, 2006 "Dozens of poor and minority pregnant women were put at risk when they were given dummy pills instead of a drug believed to prevent outbreaks of genital herpes, consumer watchdogs charged Friday. The researchers defended their work, saying in part the study was to assess the uncertain risks of the drug to the women's fetuses…" Reporting ethics committee approval and patient consent by study design in five general medical journals, Schroter et al., Journal of Medical Ethics 32: 718-723, Dec 2006 (abstract freely available) A public health perspective on research ethics, Buchanan and Miller, Journal of Medical Ethics 32: 729-733, Dec 2006 (abstract freely available) The Future of the FDA, The Scientist, Dec 2006 "As the agency celebrates its 100th anniversary, what do Congress and others have in store?" Office of Research Integrity (ORI) Newsletter, ORI, Dec 2006 (pdf) A Review of Paying Research Participants: It's Time to Move Beyond the Ethical Debate, Ripley, Journal of Empirical Research on Human Research Ethics 1: 9-20, Dec 2006 (abstract freely available) The Ethics of Paying Drug Users Who Participate in Research: A Review and Practical Recommendations, Fry et al., Journal of Empirical Research on Human Research Ethics 1: 21-36, Dec 2006 (abstract freely available) Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective, Ripley et al., Journal of Empirical Research on Human Research Ethics 1: 37-44, Dec 2006 (abstract freely available) Using Formative Research to Develop A Context-Specific Approach to Informed Consent for Clinical Trials, Corneli et al., Journal of Empirical Research on Human Research Ethics 1: 45-60, Dec 2006 (abstract freely available) Methods and Practices of Investigators for Determining Participants' Decisional Capacity and Comprehension of Protocol, Kon and Klug, Journal of Empirical Research on Human Research Ethics 1: 61-68, Dec 2006 (abstract freely available) Ethical Issues in Registry Research: In-Hospital Resuscitation as A Case Study, Dane and Parish, Journal of Empirical Research on Human Research Ethics 1: 69-76, Dec 2006 (abstract freely available) Trends in Canadian Sociology Master's Theses in Relation to Research Ethics Review, 1995 - 2004, van den Hoonaard, Journal of Empirical Research on Human Research Ethics 1: 77-88, Dec 2006 (abstract freely available) Financial Relationships between Institutional Review Board Members and Industry, Campbell et al., New England Journal of Medicine 355: 2321-2329, Nov 30, 2006 (abstract freely available) Patients' Views on Financial Conflicts of Interest in Cancer Research Trials, Hampson et al., New England Journal of Medicine 355: 2330-2337, Nov 30, 2006 (abstract freely available) Editorial: Conflict of Interest or Conflict of Priorities?, Nabel, New England Journal of Medicine 355: 2365-2367, Nov 30, 2006 (abstract freely available) Top scientific journal pledges to curb fraud, CNN.com, Nov 29, 2006 "A leading scientific journal that published phony stem cell findings lacks adequate procedures to detect fraudulent work and must do a better job scrutinizing "high-risk" research, a panel appointed by the publication found on Tuesday. Donald Kennedy, editor-in-chief of Science, said the prestigious journal accepted the major findings of the six-member independent committee and pledged to craft new guidelines to guard against fraud…" Committee Letter, Report and Science Response, Science, Nov 29, 2006 (full report and response freely available) Health Canada regulation falling short: auditor general, Canada.com, Nov 29, 2006 "Public health and safety is at risk because Health Canada is failing to protect Canadians from dangerous products and many of its regulatory activities are "insufficient,'' warns Auditor General Sheila Fraser…It said the department's activities are "insufficient" when it comes to investigating Internet pharmacies and clinical trials; sharing information with other regulatory bodies; inspecting manufacturers of drug ingredients; and investigating reports, complaints and recalls of medical devices…" Chapter 8. Allocating Funds to Regulatory Programs - Health Canada, Report of the Auditor General of Canada, Nov 28, 2006 (pdf; full chapter freely available) Industry ties common on hospital boards, Monterey Herald, Nov 29, 2006 (Campbell et al. New Engl J Med article abstract link available below in Journal Articles) "A survey of hospital review boards that watchdog experiments on patients shows that one in three members takes money from companies that make drugs and medical devices that come under study. What's more, many of those with conflicts rarely or never disclose their financial ties, researchers found…" 2007 International Compilation of Human Research Protections, US Office for Human Research Protections (OHRP), Nov 28, 2006 (pdf) "The Compilation lists the human subjects research legislation, regulations, or guidelines for 79 countries, two confederations, and several international organizations. This year’s Compilation includes numerous updates over last year and lists the pertinent laws, regulations, and/or guidelines for 8 new countries: Armenia, Croatia, Cyprus, Iran, Malawi, Moldova, Nigeria, and Tajikistan. This Compilation was developed for IRBs/Ethics Committees, researchers, funding agencies, and others who are involved in international research. Its purpose is to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure that those standards are followed appropriately…" PRIM&R Comments on the FDA's "Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research", PRIM&R, Nov 27, 2006 (pdf)

Week of November 20, 2006 Provincial drug disparity a roadblock to cancer research, Globe and Mail, Nov 22, 2006 "…Canada can't participate in the clinical trial that would confirm whether Avastin should remain part of the standard of care for metastatic colorectal cancer because it does not uniformly provide that care today…" Court to hear experimental drugs case, Monterey Herald, Nov 21, 2006 "A federal court agreed Tuesday to rehear a case that would have given terminally ill patients early access to experimental drugs unlikely to be approved before they die…" Human Embryonic Stem Cell Research: Regulatory and Administrative Challenges, American Association of Medical Colleges (AAMC), Nov 2006 (full report freely available)

Week of November 13, 2006 Military use of hemophilia drug raises questions, The San Francisco Chronicle, Nov 19, 2006 "American military doctors here have injected more than 1,000 of the war's wounded troops with a potent, and largely experimental, blood-coagulating drug despite mounting medical evidence linking it to deadly blood clots that lodge in the lungs, heart and brain…" Cardiovascular and Cerebrovascular Events in the Randomized, Controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT), ADAPT Research Group, PLoS Clinical Trials, Nov 17, 2006 (full article freely available) ADAPT: The Wrong Way to Stop a Clinical Trial, Nissen, PLoS Clinical Trials, Nov 17, 2006 (full article freely available) Secretary's Advisory Committee on Human Research Protections (SACHRP) Nov 2-3 Meeting Transcripts and Presentation Materials, Office for Human Research Protections (OHRP) website, Nov 16, 2006 FDA Invites Input on Electronic Submission of Regulatory Information, FDA News, Nov 16, 2006 (hearing is Dec 18, 2006; notes of participation and comments due by Dec 8, 2006) "The Food and Drug Administration (FDA) today announced plans to hold a public hearing to solicit comments and information on the electronic submission of product information. The Agency is also interested in hearing the public's perspectives on issues related to creating an electronic information exchange platform…" Group gives advice on face transplants, Monterey Herald, Nov 13, 2006 "Britain's Royal College of Surgeons on Monday laid out 15 conditions surgeons must meet before carrying out face transplants. The august medical body said such procedures must be performed in a strict research setting and are not merely as a surgical exercise…" Working Party on Facial Transplantation: Second Report, Royal College of Surgeons of England, Nov 13, 2006 (full report freely available) Docs test 'suspended animation' as potential battlefield treatment, CNN, Nov 13, 2006 "…Once the body is cooled, the patient has almost no blood, little to no brain activity and no heartbeat…Currently, Alam and his colleagues are working on the logistics of a possible human trial. They acknowledge that there will be many challenges - in ethics and execution…"

Week of November 6, 2006 Oral History Under Review, Chronicle of Higher Education, Nov 10, 2006 "Historians who work on events that occurred within living memory bridle at having to submit their projects to institutional review boards…" German scientists urge review of stem cell laws, Reuters, Nov 10, 2006 "…Genetic research is a sensitive subject in Germany due to Nazi experiments to create a master race and the country has strict laws on stem cell research…"The 2002 law means German scientists are largely denied access to new stem lines and unable to work in international projects," the institute said…" FDA Might Expand Access to Experimental Medications, kaisernetwork.org, Nov 9, 2006 " FDA plans to consider two separate proposals that would expand access to experimental medications for certain patients and allow pharmaceutical companies to charge patients fees for such treatments in some cases, the Wall Street Journal reports…" FDA to keep closer eye on medical device safety, MSNBC, Nov 9, 2006 "The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates…" FDA Announces Actions to Strengthen its Postmarket Program for Medical Devices, FDA News, Nov 9, 2006 Medical Device Postmarket Transformation Initiative, FDA, Nov 9, 2006

Week of October 30, 2006 Drug trial company slammed over pay, The Guardian, Nov 3, 2006 "The lawyer for four of the men who nearly died after a disastrous medical trial have accused the US research company involved of "astonishing" double standards after it emerged that its boss has received a £900,000 bonus…" The woman falsely labelled alcoholic by the NHS, The Guardian, UK, Nov 2, 2006 "Helen Wilkinson was mistakenly labelled an alcoholic after a simple computer error by the NHS. An unknown official at a hospital was updating her medical records and inputted a wrong code. The mix-up meant she was recorded as having received treatment for alcoholism, instead of surgery…She was also angry that the records had been shared with a private company which distributes personal medical records to academic researchers…" Ethical Conflicts in Public Health Research and Practice: Antimicrobial Resistance and the Ethics of Drug Development, Aiello et al., American Journal of Public Health 96: 1910-1914, Nov 2006 (abstract freely available) "It’s Like Tuskegee in Reverse": A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research, Malone et al., American Journal of Public Health 96: 1914-1919, Nov 2006 (abstract freely available) Research Recruitment Through US Central Cancer Registries: Balancing Privacy and Scientific Issues, Beskow et al., American Journal of Public Health 96: 1920-1926, Nov 2006 (abstract freely available) Voluntary Participation and Informed Consent to International Genetic Research, Marshall, American Journal of Public Health 96: 1989-1995, Nov 2006 (abstract freely available) Exploring the Ethics of Clinical Research in an Urban Community, Grady et al., American Journal of Public Health 96: 1996-2001, Nov 2006 (abstract freely available) Privacy Protection Versus Cluster Detection in Spatial Epidemiology, Olson et al., American Journal of Public Health 96: 2002-2008, Nov 2006 (abstract freely available) Consistency in decision making by research ethics committees: a controlled comparison, Angell et al., J Med Ethics 2006; 32: 662-664, Nov 2006 (abstract freely available) An Inverse Relationship Between Perceived Harm and Participation Willingness in Schizophrenia Research Protocols, Roberts et al., American Journal of Psychiatry 163: 2002-2004, Nov 2006 (abstract freely available) Model Policy for Responding to Allegations of Scientific Misconduct, US Office of Research Integrity (ORI), Nov 2006 (please send comments to Brenda.Harrington@hhs.gov by December 29, 2006) Disclosing Genetic Results to Research Participants, American Journal of Bioethics 6, Nov/Dec 2006 (numerous articles on this topic, some abstracts freely available)

Week of October 23, 2006 Ethics rules send NIH scientists packing, Monterey Herald, Oct 28, 2006 "Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income…" Office for Human Research Protections (OHRP) Frequently Asked Questions and Answers Page on Investigator Responsibilities, US Office for Human Research Protections, Oct 26, 2006 (this link goes directly to investigator FAQ page; for OHRP's general FAQ page, use link below) "The Office for Human Research Protections (OHRP) has added a Frequently Asked Questions page on its website. This FAQ page includes a new set of FAQs on Investigator Responsibilities…" OHRP FAQ Web Page Protecting the Health of the Public - Institute of Medicine Recommendations on Drug Safety, Psaty and Burke 355:1753-1755, New England Journal of Medicine, Oct 26, 2006 (full text freely available) American Association of Medical Colleges (AAMC) Comments on Informed Consent Exception in Emergency Research, AAMC, Oct 26, 2006 (pdf) UK surgeons get go-ahead for full face transplant, Reuters, Oct 25, 2006 (scheduled to be freely available until Nov 24, 2006) "British surgeons were on Wednesday given the final go-ahead to perform the world's first full face transplant, a radical procedure that has raised concerns about its physical and psychological risks. The UK Face Transplantation team at the Royal Free Hospital in London received permission for four transplants from the hospital's Research Ethics Committee…" HIV Screening in Health Care Settings: Public Health and Civil Liberties in Conflict?, Gostin, Journal of the American Medical Association 296:2023-2025, Oct 25, 2006 (extract freely available)

Week of October 16, 2006 An Unwelcome Discovery, New York Times, Oct 22, 2006 (free one time registration required; scheduled to be freely available until Oct 28, 2006) "On a rainy afternoon in June, Eric Poehlman stood before a federal judge in the United States District Court in downtown Burlington, Vt…A year earlier, in the same courthouse, Poehlman pleaded guilty to lying on a federal grant application and admitted to fabricating more than a decade’s worth of scientific data on obesity, menopause and aging…" FDA Regulation of Stem-Cell Based Therapies, Halme and Kessler, New England Journal of Medicine 355:1730-1735, Oct 19, 2006 (full article freely available) Former FDA chief pleads guilty to conflict of interest, Seattle Times, Oct 18, 2006 (free one time registration required; scheduled to be freely available until Oct 23, 2006) "Former FDA Commissioner Lester Crawford pleaded guilty Tuesday to conflict of interest and false reporting of information about stocks he owned in food, beverage and medical-device companies he was in charge of regulating…" Mandatory Anthrax Shots to Return, Washington Post, Oct 17, 2006 (free one time registration required) "The Defense Department will resume mandatory anthrax vaccinations for more than 200,000 troops and defense contractors within 60 days, a Pentagon official said yesterday, rejecting the concerns of some veterans and service members who say that the vaccine has not been proved safe or effective…" Health Canada introduces trial rules in wake of tuberculosis scare, CBC News, Oct 16, 2006 "Health Canada has quietly introduced new rules for clinical drug trials after a man with tuberculosis was included in a trial at a Montreal lab last year, exposing dozens of staff and other participants to the contagious disease…" Notice: To Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties, Health Canada, Jul 23, 2006

Week of October 9, 2006 Drugs trial disaster warning missed, The Guardian, Oct 13, 2006 "…A new report by two Dutch experts pointed to glaring omissions of scientific evidence that should have prevented the trial going ahead in the way it did…" Establishing risk of human experimentation with drugs: lessons from TGN1412, The Lancet 368:1387-1391, Oct 12, 2006 (registration and payment required for access) More Internet users may be taking phishing bait than thought, EurekAlert! Press Release, Oct 13, 2006 "A higher-than-expected percentage of Internet users are likely to fall victim to scam artists masquerading as trusted service providers, report researchers at the Indiana University School of Informatics. "Designing Ethical Phishing Experiments: A study of (ROT13) rOnl query features," published online, simulated phishing tactics used to elicit online information from eBay customers…The experiment was unusual in that it did not involve debriefing of subjects, given that this step was judged to be the one and only aspect of the experiment that could potentially pose harm to subjects, who might be embarrassed over having been phished or wrongly conclude that sensitive information had been harvested by the researchers…" Body of Research — Ownership and Use of Human Tissue, Charo, New England Journal of Medicine 355:1517-1519, Oct 12, 2006 (full article freely available) Tell public about trauma tests, experts urge, CTV.ca, Oct 12, 2006 "The public has a right to know more about the risks and benefits of emergency research performed on victims of trauma, cardiac arrest and stroke without their informed consent, experts told federal health officials Wednesday…The Food and Drug Administration convened a public hearing to discuss whether decade-old regulations guiding the ethical conduct of emergency research are adequate…" Disagreement about FDA nanotech oversight, The Scientist, Oct 11, 2006 "The U.S. Food and Drug Administration (FDA) needs greater authority and financial resources to properly regulate nanotechnology materials in drugs, biologics, food, cosmetics and other products, many academics and representatives of environmental and consumer groups said at the first open meeting of the FDA Nanotechnology Task Force…" Report: Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science, Engineering and Technology Subcommittee, Committee on Technology, National Science and Technology Council, Sept 2006 (pdf) National Nanotechnology Initiative Web Site Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?, Michael Taylor, Project on Emerging Nanotechnologies, Oct 5, 2006 Doctors allegedly abuse elderly patients, Jerusalem Post, Oct 10, 2006 "Four senior doctors at the Kaplan Medical Center's Harzfeld Rehabilitation Hospital, who are suspected of carrying out illegal medical experiments on hundreds of elderly patients, faced the inside of a court room for the first time Monday evening…" Mixed response to NIH database plan, The Scientist, Oct 9, 2006 "Scientists, academics, and industry representatives appear to have mixed feelings about the National Institutes of Health's plan to create and make publicly available a centralized database of human genomic and phenotypic information derived from NIH-funded genome wide association studies (GWAS)…An informal survey by The Scientist of researchers, academics, and industry representatives found general support for having a public GWAS database, but also concern over how to insure subjects' privacy and other issues…" The FDA and Drug Safety. A Proposal for Sweeping Changes, Furberg et al., Archives of Internal Medicine 166:1938-1942, Oct 9, 2006 (abstract freely available)

Week of October 2, 2006 Breaking the cycle, Washington Post, Oct 8, 2006 (free one time registration required) "…The volunteers understand that if the vaccine doesn't work, even those treated quickly are likely to experience a few days of nasty flu-like symptoms that could include screaming headaches, high fever, chills and vomiting fits. Some admit to feeling spooked ever since they volunteered to be bitten by an infected anopheles…"

Week of September 25, 2006 Developing capacity to protect human research subjects in a post-conflict, resource-constrained setting: procedures and prospects, Kennedy et al., Journal of Medical Ethics 32:592-595, Oct 1, 2006 (abstract freely available) Right of the living dead? Consent to experimental surgery in the event of cortical death, Sparrow, Journal of Medical Ethics 32:601-605, Oct 1, 2006 (abstract freely available) Living patients in a permanent vegetative state as legitimate research subjects, Curry, Journal of Medical Ethics 32:606-607, Oct 1, 2006 (extract freely available) Research and patients in a permanent vegetative state, Draper, Journal of Medical Ethics 32:607, Oct 1, 2006 (extract freely available) Relatives of the living dead, Thompson, Journal of Medical Ethics 32:607-608, Oct 1, 2006 (extract freely available) Respecting rights ... to death, Levy, Journal of Medical Ethics 32:608-611, Oct 1, 2006 (extract freely available) Capacity of Persons With Mental Retardation to Consent to Participate in Randomized Clinical Trials, Fisher et al., American Journal of Psychiatry 163:1813-1820, Oct 2006 (abstract freely available) Altruistic Discourse in the Informed Consent Process for Childhood Cancer Clinical Trials, Simon et al., American Journal of Bioethics 6: 40-47, Sept/Oct 2006 (abstract freely available) Draft Guidance to Submitters of Human Research, Environmental Protection Agency (EPA), Sept 2006 (pdf) Ethics and research with undergraduates, Richman and Alexander, Ethics and Education 1: 163 - 175, Oct 2006 (abstract freely available) Ethical and Regulatory Challenges Associated With the Exception From Informed Consent Requirements for Emergency Research, Vaslef et al., Archives of Surgery 141:1019-1023, Oct 2006 (abstract freely available) Workshop Report: Protection of research subjects with diminished capacity, Center for Practical Bioethics, Oct 2006 (full report freely available) Trial of the Heart, The Scientist, Oct 2006 "Doug Bergman drove 240 miles to have his heart stabbed by a needle from the inside out. Now he hopes the stem cells that may be in that needle will change his life…" Three Steps to Protecting Pediatric Research Participants from Excessive Risks, Wendler, PLoS Clinical Trials 1(5): e25, Sep 29, 2006 (full article freely available) French doctors operate on man in zero-gravity setting, Monterey County Herald, Sep 28, 2006 "A team of French doctors said they successfully operated on a man in near zero-gravity conditions Wednesday on a flight looping in the air like a roller coaster to mimic weightlessness…" Office of Research Integrity Newsletter, Office of Research Integrity (ORI), Sept 2006 (pdf) Effect of the HIPAA Privacy Rule on Health Research: Proceedings of a Workshop Presented to the National Cancer Policy Forum, Institute of Medicine, Sep 26, 2006

Week of September 18, 2006 CDC Recommends Routine HIV Testing for U.S. Residents Ages 13 to 64, Dropping Written Consent, Pretest Counseling Requirements, Kaisernetwork.org, Sep 22, 2006 "CDC on Thursday released revised recommendations on HIV testing in the U.S. that say HIV tests should become a routine part of medical care for residents ages 13 to 64 and requirements for written consent and pretest counseling be dropped…" Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, Centers for Disease Control and Prevention (CDC), Sep 22, 2006 Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, Centers for Disease Control and Prevention (CDC), Sep 22, 2006 "These recommendations for human immunodeficiency virus (HIV) testing are intended for all health-care providers in the public and private sectors, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities, and primary care settings. The recommendations address HIV testing in health-care settings only…" Strengthening the U.S. Drug Safety System, Committee on the Assessment of the U.S. Drug Safety System Committee on the Assessment of the U.S. Drug Safety System, Institute of Medicine, Sep 22, 2006 "A lack of clear regulatory authority, chronic underfunding, organizational problems, and scarcity of data hamper the U.S. Food and Drug Administration’s ability to evaluate and address the safety of prescription drugs after they have reached the market, according to a new report from the Institute of Medicine…" Legislation Would Allow Researchers To Use Medicare Data To Study Safety, Effectiveness of Medical Treatment, Kaisernetwork.org, Sep 19, 2006 "Senate Finance Committee Chair Chuck Grassley (R-Iowa) and ranking member Max Baucus (D-Mont.) have introduced a bill (S 3987) that would provide federal and academic researchers with more access to data on hospital, physician and prescription drug services used by Medicare beneficiaries…" Grassley, Baucus sponsor bill for research on effectiveness and safety of medical treatments, Press Release, United States Senate Committee on Finance, Sep 18, 2006 (pdf) S.3897 Medicare Data Access and Research Act, Introduced in US Senate, Sep 14, 2006 UK stem cell bank to begin distribution, The Scientist, Sep 19, 2006 "…By September 29, the bank will tell scientists the details of an initial six embryonic cell lines that have passed its stringent quality controls and are available for withdrawal…All requests to deposit or withdraw lines must be given ethical and legal approval by its high-level steering committee, which is chaired by Lord Naren Patel. The committee scrutinizes whether lines are ethically sourced with fully informed consent and aims to ensure that they are used only in projects with ethical approval…" FDA, NCI Agree to MOU Regarding FIREBIRD, National Cancer Institute (NCI) News, Sep 19, 2006 "An agreement has been reached by the FDA and the NCI to manage and share information about clinical investigators using the Federal Investigator Registry of Biomedical Information Research Data, or FIREBIRD, system. Drug makers are encouraged to also submit information about investigators electronically to the new registry…" Memorandum of Understanding Regarding FIREBIRD Between the Food and Drug Administration and the National Cancer Institute, Sep 14, 2006 (pdf) Clinical Research Information Exchange (CRIX) Wesite and FIREBIRD Demo, National Cancer Institute, Sep 13, 2006 FIREBIRD, Federal Investigator Registry, National Cancer Institute, Sept 2006

Week of September 11, 2006 Experimental drug given to British troops in Iraq and Afghanistan, The Guardian, UK, Sep 16, 2006 "Soldiers in Afghanistan and Iraq are being treated with an experimental blood-clotting drug that has not been fully tested…It is thought that the US and Israeli militaries are also using the drug…" NIH Punishments Criticized, Washington Post, Sep 14, 2006 (free one time registration required) "Angry members of Congress took federal health officials to task yesterday for what they said was a pattern of being "soft" on government scientists found to have violated ethics rules…" New Battle Lines Are Drawn Over Egg Donation, Sun-Sentinel, Sep 13, 2006 "…A spirited disagreement over payment has split feminists, with some calling compensation to research subjects coercive and others contending that banning it is paternalistic…" Researchers Escape Ethics Punishment, The San Francisco Chronicle, Sep 12, 2006 "The majority of federal scientists investigated for improperly accepting personal money from drug companies or biotechnology firms escaped serious punishment, and investigators declined to proceed with several cases involving possible crimes, according to the National Institutes of Health…" Prescription drug research in kids often doesn't get published where docs will look, San Diego Union Tribune, Sep 12, 2006 "…He said an FDA program meant to encourage drug companies to test how drugs affect children has led to hundreds of studies. The problem is that about half the time, the results don't get published in peer-reviewed medical journals, mainly because researchers and sponsors don't submit them for publication, Benjamin said…" Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity, Benjamin et al., Journal of the American Medical Association 296:1266-1273, Sep 13, 2006 (abstract freely available)

Week of September 4, 2006 Review faults scientist's conduct, Seattle Times, Sep 10, 2006 "A senior researcher at the National Institutes of Health (NIH) engaged in "serious misconduct" by entering into dozens of unauthorized private arrangements with drug companies and failing to report annually the outside income, totaling more than $100,000, an internal review has found…" US clinical researchers resist full financial disclosure, according to Conflicts-of-Interest Study, EurekAlert Press Release, Sep 8, 2006 "…The study, a survey of attitudes, beliefs and practices among members of institutional review boards, conflict-of-interest committees and researchers, reveals a key reason for the reluctance among researchers to share the full dollar amount: the belief that because potential research subjects may lack the sophistication to put conflicts of interest in context, they may overestimate the influence of money on the researcher's behavior and possibly refuse to participate…" F.D.A. Seeks to Regulate New Types of Diagnostic Tests, New York Times, Sep 6, 2006 (free one time registration required; scheduled to be freely available until Sept 12, 2006) "The Food and Drug Administration took a step yesterday toward regulating a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients…" FDA Drafts Regulatory Guidance to Industry and Labs for Group of Medical Tests. Agency accepting public comment on guidance, FDA News, Sep 5, 2006 Study: Medical Instructions Stump Many, The San Francisco Chronicle, Sep 6, 2006 "…A new report by the National Center for Education Statistics found that most adults have an intermediate health literacy. However, intermediate is far from good, because so many health instructions are written in a way that's foreign to how people talk and think, said Dr. Rima Rudd of the Harvard School of Public Health. "Intermediate skills means that a majority of U.S. adults will have some difficulty using health-related materials with accuracy and consistency," Rudd said…" The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy, National Center for Education Statistics, US Department of Education, Sep 6, 2006 (full report freely available) Diabetes patients, therapy undergo trial by fire. Afflicted Canadians go to bat for method some call unproven, The Globe and Mail, Canada, Sep 5, 2006 "…To his patients, the 57-year-old Dr. Valdes is a hero who pushes the boundaries of science and is ushering in a new era of hope. But he has been forced to stop the trials at the Federico Gomez Children's Hospital in Mexico City while it and the National Committee for Bioethics review his results and the ethics of Dr. Valdes's study. The International Xenotransplantation Society, a prestigious body of 300 scientists, has published a letter in the September issue of Xenotransplantation concluding that the information from Dr. Valdes's clinical trials was "insufficient to justify the use of children" as research subjects…"

Week of August 28, 2006 ORI Introduction to the Responsible Conduct of Research, Steneck, Office of Research Integrity (ORI), Sept 2006 (updated from June 2004 revised print version) Publish and perish: a case study of publication ethics in a rural community, Fraser and Alexander, Journal of Medical Ethics 32:526-529, Sep 1, 2006 (abstract freely available) Review of a mock research protocol in functional neuroimaging by Canadian research ethics boards, de Champlain and Patenaude, Journal of Medical Ethics 32:530-534, Sep 1, 2006 (abstract freely available) Ethical international research on human subjects research in the absence of local institutional review boards, Bhat and Hegde, Journal of Medical Ethics 32:535-536, Sep 1, 2006 (extractfreely available) Enhancing the ethical conduct of genetic research: investigating views of parents on including their healthy children in a study on mild hearing loss, Gillam et al., Journal of Medical Ethics 32:537-541, Sep 1, 2006 (extract freely available) Trust based obligations of the state and physician-researchers to patient-subjects, Miller and Weijer, Journal of Medical Ethics 32:542-547, Sep 1, 2006 (extract freely available) Should desperate volunteers be included in randomised controlled trials?, Allmark and Mason, Journal of Medical Ethics 32:548-553, Sep 1, 2006 (extract freely available) Report: Research on Human Subjects: Academic Freedom and the Institutional Review Board, American Association of University Professors (AAUP), Sept 2006 "…The report takes issue with aspects of the federal government’s regulations for research on human subjects that constitute a threat to academic freedom. The application of the federal regulations to research methodologies that present no serious risk of harm to research subjects has long been of concern…" Informed Consent for Genetic Research Involving Pleiotropic Genes: An Empirical Study of ApoE Research, Cooper et al., IRB, Sept/Oct 2006 (free one time registration required; full article freely available) Children, Research and Guinea Pigs: Reflections on a Metaphor, Gordon et al., IRB, Sept/Oct 2006 (free one time registration required; full article freely available) Empirical Research to Evaluate Ethics Committees' Burdensome and Perhaps Unproductive Policies and Practices: A Proposal, Levine, Journal of Empirical Research on Human Research Ethics 1: 1-4, Sept 2006 (abstract freely available) Women's Autonomy and Informed Consent in Microbicides Clinical Trials, Woodsong et al., Journal of Empirical Research on Human Research Ethics 1: 11-26, Sept 2006 (abstract freely available) The Importance of Story-Telling: Research Protocols in Aboriginal Communities, Poff, Journal of Empirical Research on Human Research Ethics 1: 27-28, Sept 2006 (abstract freely available) Ethical Issues in Trauma-Related Research: A Review, Newman et al., Journal of Empirical Research on Human Research Ethics 1: 29-46, Sept 2006 (abstract freely available)