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Week of December 12, 2011 Troubled study at heart of therapy debate, Chicago Tribune, Dec 12, 2011 "…The troubles with the study, called the Trial to Assess Chelation Therapy or TACT, are emblematic of the difficulties faced by the National Center for Complementary and Alternative Medicine as it tries to study alternative treatments in a scientific way…the drug being studied, edetate disodium, turned out to be so risky that the U.S. Food and Drug Administration later withdrew its approval. Yet the study was not halted, and the volunteers were not immediately told…"

Week of December 5, 2011 Social science: Open up online research, Nature, Dec 7, 2011 "…Collecting public musings can create ethical dilemmas for researchers. The messages may be publicly available, but the individuals writing them might not realize just how public they are, and might be surprised when their words are preserved or placed in another context…" Academic funders change rules to reveal dishonest researchers, Canada.com, Dec 6, 2011 "The cloak of secrecy protecting the identity of Canadian academics who plagiarize, fake experiments and misspend taxpayers' money is being lifted by the country's main research funders. The presidents of Canada's three largest research councils have issued a joint statement saying they have introduced a new process that will enable the councils to disclose the names of academics who engage in serious misconduct…" Introducing the New Tri-Agency Framework: Responsible Conduct of Research, Panel on Responsible Conduct of Research (PRE), Canada, Dec 5, 2011 "…the Agencies officially launched the new Tri-Agency Framework: Responsible Conduct of Research. This new Framework sets out the responsibilities and corresponding policies for researchers, institutions, and the Agencies that together help support and promote a positive research environment. It also replaces the previous integrity policy and related documents…"

Week of November 28, 2011 Doctor Accused of Crimes Against Mice and Lab, New York Times, Dec 2, 2011 (free one time registration required) "The authorities say the researcher, Dr. Mohsen Hosseinkhani, burglarized a hospital laboratory — twice — after being fired, taking valuable materials and sabotaging the lab mice by switching their name tags…" What should the ethical protections be in cluster trials?, PLoS Blogs, Dec 2, 2011 "…a consensus conference of researchers, ethicists, editors and other interested parties, aiming to produce a set of guidelines for the ethical conduct and review of cluster randomized trials. A cluster trial has been defined as a trial in which “the study, randomize[s] interventions to groups of patients (e.g., families, medical practices) rather than to individual patients”…" The ethics committee as ghost author, Shaw, Journal of Medical Ethics 37:706 doi:10.1136/medethics-2011-100120, Dec 2011 (abstract freely available) Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board, Zia et al., Journal of Medical Ethics 37:762-765 doi:10.1136/jme.2011.043349, Dec 2011 (abstract freely available) Using human tissue: when do we need consent?, Parker, Journal of Medical Ethics 37:759-761 doi:10.1136/medethics-2011-100043, Dec 2011 (abstract freely available) Ethical practice in internet research involving vulnerable people: lessons from a self-harm discussion forum study (SharpTalk), Sharkey et al., Journal of Medical Ethics 37:752-758 doi:10.1136/medethics-2011-100080, Dec 2011 (abstract freely available) 2012 Edition of the International Compilation of Human Subject Protections, US Office for Human Research Protections (OHRP), Dec 2011 "The International Compilation of Human Subject Protections is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. Many of the listings embed hyperlinks to the source document…" How a Collapsing Scientific Hypothesis Ended in an Arrest, Wired News, Nov 30, 2011 "…Then the story took a strange turn. A long chain of events led not only to the collapse of the XMRV hypothesis, but it landed Mikovits in jail — and brought death threats upon some of the researchers who debunked her ideas…" Study on Cooperation Finds Subjects Online, Harvard Crimson, Nov 28, 2011 "…Researchers have used the Mechanical Turk to organize volunteers through the internet to perform basic tasks for pay, such as text transcription and caption composition for online search engines. Now social scientists like Rand and his team have begun to use the site to hire volunteers for surveys and tests. Compared to a traditional lab, the Mechanical Turk can perform the same studies for a tenth of the time and cost, according to Rand. “It’s really changing the face of social science studies,” he said…" Clinical Trials in the Critically Ill: Practical and Ethical Challenges, Shorr and Chan, Archives of Internal Medicine 171:1946-1947, Nov 28, 2011 (abstract freely available)

Week of November 14, 2011 Anthropologists Consider a New Code of Ethics, Chronicle of Higher Education, Nov 20, 2011 "…Those diverse contexts may explain why it has proved to be no easy job for anthropologists to create a new set of ethical guidelines. After three years spent seeking opinion and working on new guidelines, the American Anthropological Association is moving toward changes that some in the discipline fear will water down anthropologists' obligations to the people they study…" Doing the Ethical Thing May Be Right, but It Isn’t Automatic, New York Times, Nov 18, 2011 (may require registration) "…As much as we would like to think that, put on the spot, we would do the right — and perhaps even heroic — thing, research has shown that that usually isn’t true…" From tragedy to travesty: Drugs tested on survivors of Bhopal, The Independent, Nov 15, 2011 "Secret reports seen by The Independent reveal that drug trials funded by western pharmaceutical firms at the Indian hospital set up for survivors of the Bhopal disaster violated international ethical standards and could have put patients at risk…The Independent has evidence of patients who were unaware that they were taking part in a trial at all. The conduct of the trials has exposed the hospital to furious criticism from activists who say that survivors have been used as guinea pigs without proper informed consent…" Stem cell trial halted, BBC News, Nov 15, 2011 "The world's first official trial using human embryonic stem cells in patients has been halted. Geron, based in California, made the sudden announcement that it was halting further work in this field. In a statement the company said in the "current environment of capital scarcity and uncertain economic conditions" it had decided to concentrate instead on developing cancer treatments…" University officials reviewing instructor's procedure, The Oklahoma Daily, Nov 14, 2011 "OU officials are investigating a professor based on students’ claims that he experimented on them, broke research rules and practiced in unhygienic conditions…" Without consent: how drugs companies exploit Indian 'guinea pigs', The Independent, Nov 14, 2011 "Western pharmaceutical companies have seized on India over the past five years as a testing ground for drugs – making the most of a huge population and loose regulations which help dramatically cut research costs for lucrative products to be sold in the West. The relationship is so exploitative that some believe it represents a new colonialism…" Lab rats step out into the open, CANOE, Nov 14, 2011 "Being a human lab rat wasn't something Steve Scholtz considered pursuing as a career option. But for two years, he found himself giving vials of blood and urine samples to doctors and nurses as part of clinical trials he enrolled in…" Clinical Trials Are a Mess: How to Get Needed Vaccines Out Faster, The Atlantic, Nov 14, 2011 "…The many other drug and vaccine candidates for neglected diseases waiting in the pipeline for late stages of clinical development must face lengthy, inefficient review processes or non-existent regulatory capacity in the poorest, least developed countries before these technologies can reach the millions in need…"

Week of November 7, 2011 Drug trials a safe bet - for some, Toronto Sun, Nov 13, 2011 "Participating in a clinical research trial is safer than most people think, according to the Canadian research chair in Adverse Drug Reactions…" Did Medtronic sell an unsafe product?, Minneapolis Star Tribune, Nov 12, 2011 "…The back surgery product, Infuse, has long been a top seller, reaping $700 million a year for the Fridley-based company. But that success has been marred by allegations that Medtronic paid illegal kickbacks and sham royalties to doctors to entice them to use Infuse in ways regulators hadn't approved, possibly putting patients at risk. Some critics say researchers with financial ties to the company have understated serious complications with Infuse, including cancer. Krumholz and his team at Yale will address fundamental questions: Does Infuse work? Is it safe?…" Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations, Federal Register 76: 70151-70152, Nov 10, 2011 "…This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical investigations in a manner that protects study subjects, FDA has developed methods to allow a clinical investigation to begin under certain circumstances, even when there are outstanding issues regarding the IDE submission…" Biomedical sample destruction stirs debate, The China Post, Nov 7, 2011 "Millions of biomedical samples are set to be destroyed next February due to lack of official participant consent, sparking a heated debate between the research industry and human rights groups - an ethical and scientific dilemma on the genetic material's research value versus the rights of human subjects…"

Week of October 31, 2011 Drugmakers Mine Data for Trial Patients, Bloomberg Businessweek, Nov 3, 2011 "…Five big drugmakers, led by Pfizer, are planning to use electronic health data gathered from patients of 13 hospital systems across New York State to help them identify and enroll participants in drug studies. The effort, which begins testing this month, is projected to make $75 million a year for the hospitals and save the pharmaceutical companies time and money in developing new products…" Fraud Case Seen as a Red Flag for Psychology Research, New York Times, Nov 2, 2011 (free one time registration required) "A well-known psychologist in the Netherlands whose work has been published widely in professional journals falsified data and made up entire experiments, an investigating committee has found. Experts say the case exposes deep flaws in the way science is done in a field, psychology, that has only recently earned a fragile respectability…" Concerns of Newborn Blood Screening Advisory Committee Members Regarding Storage and Use of Residual Newborn Screening Blood Spots, Rothwell et al., American Journal of Public Health 101 (11): 2111-2116, Nov 2011 (abstract freely available) Using social media in your research, American Psychological Association, Nov 2011 "…Institutional review boards often balk at studies that seek to analyze people's behavior on social media websites because it's ethically unclear whether Facebook, Twitter or other types of postings count as public or private behavior, and therefore require their authors' consent to be used in research…"

Week of October 24, 2011 NBSB urges pre-attack studies of anthrax vaccine in kids, Center for Infectious Disease Research & Policy, University of Minnesota, Oct 28, 2011 "An expert advisory panel today approved a recommendation that the US Department of Health and Human Services (HHS) develop a plan to study the use of anthrax vaccine in children before an attack with Bacillus anthracis…" Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP), National Biodefense Science Board, Oct 28, 2011 (pdf) "…However, a complex array of scientific, medical, ethical, legal, regulatory, and administrative issues complicates the use of AVA for PEP in children. This report, prepared by the National Biodefense Science Board (NBSB), discusses these issues and presents several options for resolving them and a recommendation…" AAMC Responds to HHS Proposed Update of Rules Governing Human Subjects Research, American Association of Medical Colleges, Oct 28, 2011 "The AAMC Oct. 25 submitted a response to the Department of Health and Human Services (HHS) proposal to revise the regulations that govern federally-supported research involving human subjects, known as the Common Rule…"

Week of October 17, 2011 Questioning Privacy Protections in Research, New York Times, Oct 23, 2011 (registration may be required) "Hoping to protect privacy in an age when a fingernail clipping can reveal a person’s identity, federal officials are planning to overhaul the rules that regulate research involving human subjects. But critics outside the biomedical arena warn that the proposed revisions may unintentionally create a more serious problem: sealing off vast collections of publicly available information from inspection, including census data, market research, oral histories and labor statistics…" Perspective: Medical Device Innovation — Is “Better” Good Enough?, Suter et al., New England Journal of Medicine 365:1464-1466, Oct 20, 2011 (full article freely available) Research coordinator's job is all about contact with cancer patients, Muncie Star Press, Oct 20, 2011 "Angie Patterson helps to match interested patients with cancer treatment drug trials…The patients who undergo the clinical trials often jokingly refer to themselves as guinea pigs, Patterson said. Most of the time, however, the drug is in the second or third phase of testing, which could last between three to five years…" Advocates Call for FDA to Take Tougher Stance on Postmarket Safety Studies, Journal of the American Medical Association, Oct 19, 2011 "With high dropout rates threatening the viability of 2 postmarket safety studies of silicone breast implants, the US Food and Drug Administration (FDA) in August convened an advisory committee hearing to determine the best way to assess these devices in the absence of results from these studies…The meeting was closely watched by consumer advocates and clinical experts, who say it highlights the ongoing difficulties the agency has had in ensuring that device makers follow through on required postmarket studies of medical devices…" Research Ethics Interpretation and Education Initiatives, Interagency Advisory Panel on Research Ethics (PRE), Canada, Oct 18, 2011 "The Interagency Advisory Panel on Research Ethics (the Panel) is pleased to share its first selection of TCPS 2 interpretations, compiled from responses to questions of general interest…Starting in November, the Panel will offer a series of webinars on TCPS 2 topics identified by the research community…" Health Information Technology and Privacy, American College of Physicians, Oct 18, 2011 "Fears about re-uses of personal data as well as re-uses of research data and samples are the focus of a policy paper released today by the American College of Physicians (ACP). The new document, which is an update of a paper produced by ACP two years ago, adds a policy position regarding research. It proposes a privacy rule that says researchers should maximize appropriate uses of information to achieve scientific advances without compromising ethical obligations to protect individual welfare and privacy…"

Week of October 10, 2011 Compensation package for clinical trial victims in the offing, Times of India, Oct 14, 2011 "India will soon quantify the amount of compensation to be paid by pharmaceutical companies, if a volunteer dies or gets injured during a clinical trial…The compensation has to be paid by the trial's sponsor or its representative within 90 days of the death or injury to the victim or the next of h/his kin. In the first 30 days, the firm will have to prove to the ethics panel that the death or injury wasn't due to the drug, else it has to pay…" The Coming Explosion in Genetic Testing — Is There a Duty to Recontact?, Pyeritz, New England Journal of Medicine 365:1367-1369, Oct 13, 2011 (abstract freely available)

Week of October 3, 2011 A Conversation With Jonathan D. Moreno, Bioethicist and Professor, The Atlantic, Oct 7, 2011 "…Some doctors and medical scientists tend to see us as cops who just say no to important experiments. Others see us as co-opted by the medical and science establishment. I see the task for academic bioethicists as inherently a critical one, as in but not of the establishment…" Companies Seek Expanded Access to Genetic Specimens, Family Practice News, Oct 6, 2011 "…trial organizers at Merck and many other companies have encountered resistance or restrictions on specimen collection and use from regulatory authorities, academic institutions, and the institutional review boards (IRBs) and ethics committees that oversee trials…" Cloning Research Gives Way To Bioethics Questions, NPR, Oct 5, 2011 "Researchers in New York are reporting that, for the first time, they've used cloning techniques to successfully create human embryos in the lab. Guy Raz talks about the ethical implications of this research with Insoo Hyun, associate professor of bioethics at Case Western Reserve University…" Secrets of the human genome disclosed, Nature, Oct 4, 2011 "Should people be told about any nasty surprises that scientists discover in their DNA during research projects? The question is becoming increasingly pertinent, as thousands of people sign up for studies in which their genomes will be sequenced. But, at present, federal laws in the United States prohibit researchers from telling patients about mutations that might affect them or their families unless a certified clinical lab has confirmed the results — something that is not done in most research projects…" Meeting Agenda and Presentation Materials, Secretary's Advisory Committee on Human Research Protections (SACHRP), Oct 4-5, 2011 "Presentation materials include SACHRP recommendations on the Advance Notice of Proposed Rulemaking (ANPRM), plus a minority opinion on the consensus position expressed by SACHRP about the regulations regarding future uses of human-derived research materials…"

Week of September 26, 2011 A dream realized, and lives reborn, Boston Globe, Oct 2, 2011 "…in May 2008, the hospital’s ethics board approved a face transplant for Maki. Since then, the Brigham has done a total of four, surpassing the Cleveland Clinic as the leading program in the United States and becoming the second busiest center in the world after a French team. Along the way, Pomahac has ruffled some feathers, both by operating on patients other programs won’t take and because he has not done basic research on face transplantation, the traditional starting point for specialists at academic medical centers…" Flashback. Psychedelic research returns, Salon, Sep 28, 2011 "…The 60-year-old New Yorker and professional yachtsman opened the door not to an after-hours techno party, but to the bright reception room at the Bluestone Center for Clinical Research, a large spa-like space occupying the second floor of New York University's College of Dentistry. Kossut was among the first subjects of an NYU investigation into the question: Can the mystical states of mind occasioned by psychedelic drugs help alleviate anxiety and depression in people with terminal and recurrent cancer?…" Draft guidelines for nanomedicine unveiled, Nature, Sep 28, 2011 "…This week, two years into a project funded by the US National Institutes of Health, a research team has proposed what it calls the first comprehensive recommendations for the oversight of nanomedicine…"The one thing that does strike me as being genuinely different in the discussion here is the focus on occupational health and environmental issues as an aspect of the risk assessment," Charo told the conference in Minneapolis. "That is something we don't usually do in human-subjects research."…" Drug companies must report clinical trial results, even when they won't lead to a product, EurekAlert!, Sep 28, 2011 "…In the commentary, titled "Disclosure of Clinical Trial Results When Product Development is Abandoned," Michael Rogawski, chair of the Department of Neurology in the UC Davis School of Medicine, says that far too little attention has been given to the failure to reveal study results for drugs or medical devices for which development has been terminated…Patients participate in clinical trials for many reasons, Rogawski notes, including the desire to contribute to medical knowledge, help the sick and benefit humanity. If sponsors diminish the opportunity for society to benefit from the altruism of research subjects, this subverts an implicit moral contract between sponsors and study participants…" Could History Become an “Information Risk”?, Townsend, AHA Today, American Historical Association, Sep 28, 2011

Week of September 19, 2011 Correspondence on “Non-engaged” Scenarios, US Office for Human Research Protections (OHRP), Sep 22, 2011 "As noted in OHRP’s October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research, the scenarios of when an institution is not engaged in human subjects research are not all-inclusive. Since the guidance document was issued, on a case-by-case basis in response to specific requests from institutions, OHRP has found some institutions in certain circumstances to be not engaged, even though the exact non-engaged scenario is not included in OHRP’s October 16, 2008 guidance document…" HHS anthrax vaccine advisors weigh pediatric use, Center for Infectious Disease Research and Policy, University of Minnesota, Sep 22, 2011 "A federal working group recommends that the US government assess the safety and immunogenicity of anthrax vaccine in children before an attack with Bacillus anthracis occurs rather than after, according to a presentation today before the National Biodefense Science Board (NBSB)…Kids represent a special population that has numerous protections in place that pertain to medical research, Parker said. Studying the anthrax vaccine in children wouldn't have a major benefit to individual children before a bioterror release, but the benefits could extend to thousands of children after such an event…" Texas prepares to fight for stem cells, Nature, Sep 20, 2011 "There's a showdown brewing in the state of Texas — and it could get ugly. On one side stands the US Food and Drug Administration (FDA), which is clamping down on the proliferation of unapproved stem-cell treatments being offered to Americans. On the other is state governor Rick Perry, who is riding high in the polls as the Republican party's favoured candidate for the 2012 presidential elections — and a staunch advocate of the stem-cell treatments…" Second Lawsuit Filed Against Duke for Potti's Research, The Herald-Sun, Sep 19, 2011 "In addition to a lawsuit filed by two cancer patients and the estates of six others last week, another cancer patient has filed a lawsuit against Duke University and its health system, stemming from the treatment she received based on flawed research by Anil Potti…"

Week of September 12, 2011 Consumer groups warn about drug firm gifts to doctors, The Virginian-Pilot, Sep 18, 2011 "…Sorting it all out can be difficult, but transparency will be the new reality when a federal law goes into effect in 2013 requiring all drug and medical device companies to make the payments public. Some states already are strengthening their laws…" In sick economy, many taking part in medical trials, Boston Herald, Sep 16, 2011 "Down-and-out Bay Staters are turning themselves into human guinea pigs — making easy money in a tough economy by subjecting themselves to needles, electrodes and never-before-tested drugs — but possibly risking their health, experts say. “It’s all I do,” said David Morris, 50, a regular in Boston’s Longwood Medical Area who says he’s taken part in more than 100 clinical trials since 2002. “They pay well and I enjoy doing it. . . . This stuff isn’t going to test itself."…" "Ethically impossible" STD Research in Guatemala from 1946 to 1948, Presidential Commission for the Study of Bioethical Issues, Sep 13, 2011 (pdf; full report freely available) "…None of the principles and requirements reflected in the standards noted above were satisfied in the Guatemala experiments. And several—if not all— of these principles were known by the researchers in Guatemala at the time. Their behavior in a similar case—just two years earlier in the United States— and contemporaneous correspondence shows understanding of, and disregard for, generally accepted moral principles such as respect for human dignity in the course of their work in Guatemala. For these reasons, the Commission finds that many of the actions of the researchers were morally wrong and the individual researchers and institutional officials were morally blameworthy…" Report calls 1940s syphilis research 'unconscionable', Pittsburgh Post-Gazette, Sep 13, 2011 "A report on the medical research of John C. Cutler in Guatemala in the 1940s released this morning by a presidential commission concludes that the syphilis experiments he conducted for the U.S. Public Health Service involved "unconscionable" violations of ethics…"

Week of September 5, 2011 Duke, Researchers Sued Over Cancer Clinical Trials, Durham Herald Sun, Sep 10, 2011 "…In 90 pages, the patients and they lawyer, Thomas Henson Jr., accuse Duke and the health system of ignoring numerous warning signs that Potti's research wasn't valid and later trying to cover up its deficiencies…" Request for Comments: Draft Guidance on Exculpatory Language in Informed Consent, US Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA), Sep 7, 2011 "On September 7, 2011, the Office for Human Research Protections (OHRP) and the Food and Drug Administration announced in the Federal Register the availability of a joint draft guidance document entitled, “Guidance on Exculpatory Language in Informed Consent,” and are inviting public comments on that document…" Proposed centralization of trial oversight stirs mixed reaction, Nature, Sep 7, 2011 "…the NIH's parent agency, the Department of Health and Human Services (HHS), proposed that multisite studies conducted in the US should each be overseen by a single IRB for that study. Under the proposal—made as part of a sweeping overhaul to the Common Rule, the 1991 regulation that governs human research funded by 17 federal agencies, including HHS—this centralized IRB would approve protocols on behalf of all institutions involved and oversee midcourse corrections in the study in response to any unexpected adverse events…" Editorial: The need for new mechanisms to ensure research integrity, Stanbrook et al., Canadian Medical Association Journal 183 (12) doi: 10.1503/cmaj.110442, Sep 6, 2011 (full article freely available)

Week of August 29, 2011 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period, The Office of the Secretary, HHS, and the Food and Drug Administration, HHS, Federal Register 76 (170):, Sep 1, 2011 (comments due Oct 26, 2011) "The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective…" Pediatric Magnetic Resonance Research and the Minimal-Risk Standard, Schmidt et al., IRB: Ethics & Human Research 33 (5): 1-6, Sept - Oct 2011 (full article freely available with free one time registration) DOE Protecting Human Research Subjects Newsletter Summer 2011, US Department of Energy, Sep 2011 The Merits of Procedure-Level Risk-Benefit Assessment, Westra and de Beaufort, IRB: Ethics and Human Research 33 (5): 7-13, Sept - Oct 2011 (abstract freely available) Researcher Experiences with IRBs: A Survey of Members of the American College of Neuropsychopharmacology, Wisner et al., IRB: Ethics & Human Research 33 (5): 14-20, Sept - Oct 2011 (abstract freely available) Who Owns Federally Funded Research? The Supreme Court and the Bayh–Dole Act, Kesselheim and Rajkumar, New England Journal of Medicine Online First, DOI 10.1056/NEJMp1109168, Aug 31, 2011 (full article freely available) Complexity Slows Drive to Revise Human-Subjects Rules, Chronicle of Higher Education, Aug 31, 2011 "Universities knew they faced a complicated and far-reaching challenge when the federal government announced last month that it planned the first overhaul in three decades of regulations governing research on humans…Universities are finding the implications far-reaching, making it difficult for their advocacy groups, such as the Association of American Universities, to quickly coordinate recommendations on how the government should proceed…" Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues, Aug 30, 2011 (pdf, full report freely available) "…The International Research Panel presents the following findings, recommendations, and proceedings to the Commission to inform the Commission’s response to President Obama’s charge, which was limited to research funded by the U.S. Government. But, in the panel’s view, the principles and practices to protect the health and well-being of human research subjects apply regardless of funding source. The panel believes that its findings and recommendations may have application to privately funded research as well…" Panel Hears Grim Details of Venereal Disease Tests, New York Times, Aug 30, 2011 "Gruesome details of American-run venereal disease experiments on Guatemalan prisoners, soldiers and mental patients in the years after World War II were revealed this week during hearings before a White House bioethics panel investigating the study’s sordid history…"

Week of August 22, 2011 HIV Surveillance, Public Health, and Clinical Medicine — Will the Walls Come Tumbling Down?, Fairchild and Bayer, New England Journal of Medicine 365:685-687, Aug 25, 2011 (full article freely available) 'Explosive' Growth in Foreign Drug Testing Raises Ethical Questions, PBS.org, Aug 23, 2011 "…Pharmaceutical companies have been shifting research overseas for years and the number of foreign trials has skyrocketed. The Department of Health and Human Services reports more than a 2,000 percent increase in the number of foreign trials for U.S. drugs over the past two decades…"

Week of August 15, 2011 Drug trial scrapped amid outcry, TheAge.com, Aug 21, 2011 "…13 local and international experts lodged a formal complaint calling for the trial not to go ahead due to concerns children who had not yet been diagnosed with a psychotic illness would be unnecessarily given drugs with potentially dangerous side effects. Quetiapine, sold as Seroquel, has been linked to weight gain and its manufacturer AstraZeneca, which was to fund the trial, last month paid $US647 million ($A623 million) to settle a lawsuit in the US…" Clinical Trials Neglect the Elderly, New York Times blog, Aug 19, 2011 (may require free one time registration) "The randomized clinical trial, long the gold standard of medical research, supposedly provides the most reliable data regarding which drugs, devices and procedures prove effective on real patients and which don’t. But when the people enrolled in the trial are quite different from those who will actually use the drug or device or undergo the procedure, the data are far less reliable…"

Week of August 8, 2011 Challenging summer jobs. What it's like to be a clinical trial ‘lab rat', Toronto Star, Aug 13, 2011 "…Cash for a little psyche probing is a trade-off many students or debt-laden grads — broke, but unable to find or commit to a full-time job — are happy to make, especially during the summer break…" Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices, Challoner and Vodra, New England Journal of Medicine Online First 10.1056/NEJMp1109150, Aug 10, 2011 (full article freely available) Medical Devices — Balancing Regulation and Innovation, Curfman and Redberg, New England Journal of Medicine Online First, Aug 10, 2011 (full article freely available) Editorial: Who watches the watchmen?, Nature, Aug 10, 2011 "Some commercial firms that oversee the ethics and scrutiny of clinical trials have been found wanting. Human volunteers in research deserve better…"

Week of August 1, 2011 Opinion: Shortchanging Cancer Patients, New York Times, Aug 6, 2011 (free one time registration required) "…Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply…This shortage is even inhibiting research studies that can lead to higher cure rates: enrollment of patients in many clinical trials has been delayed or stopped because the drugs that are in short supply make up the standard regimens to which new treatments are added or compared…" Report Questions 'Offshoring' in U.S. Heart Studies, Reuters, Aug 3, 2011 (scheduled to be available until Sept 2, 2011) "Major U.S.-sponsored clinical trials on heart disease often turn to other countries to recruit patients and a new report questions whether that undermines the evidence they generate and the health of the American clinical trial system…" TCPS 2 Interpretations, Panel on Research Ethics (PRE), Canada, Aug 2011 "The Interagency Advisory Panel on Research Ethics (the Panel) is pleased to share a growing collection of its responses to written requests for interpretation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2)…" Implementing a National Cancer Clinical Trials System for the 21st Century - Workshop Summary, An American Society of Clinical Oncology and Institute of Medicine Workshop, National Cancer Policy Forum, Institute of Medicine, Aug 2011 (full report freely available) "…Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation…"

Week of July 25, 2011 Study Faults Approval Process for Medical Devices, New York Times, Jul 29, 2011 (free one time registration required) "The government’s system for regulating many medical devices like artificial hips should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to a report released Friday by one of the nation’s top scientific groups. The report’s unequivocal recommendation to scrap the current system was unexpected, and it unleashed reactions ranging from outright rejection by industry officials, an embrace by patient groups and seeming disbelief from federal regulators, who had commissioned the review…" Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Board on Population Health and Public Health Practice, Institute of Medicine, Jul 29, 2011 (full report freely available) "…The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report…" Op Ed: Useless Studies, Real Harm, New York Times, Jul 28, 2011 (free one time registration required) "…In an age of for-profit clinical research, this is the new face of scandal. Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naïvely sign up, unaware of the ways in which they are being used…" Study of Medical Device Rules Is Attacked, Unseen, New York Times, Jul 27, 2011 (free one time registration required) "Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry…a business group and others have taken the highly unusual step of making a pre-emptive strike, arguing that the report is biased. That attack began even before the study panel finished its review, and has intensified in recent weeks…" Advance Notice of Proposed Rulemaking: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, The Office of the Secretary and the Food and Drug Administration, US Department of Health and Human Services (HHS), Federal Register 76 (143): 44512-44531, Jul 26, 2011 (public comments due September 26, 2011) Sounding Board: Reforming the Regulations Governing Research with Human Subjects, Emanuel and Menikoff, New England Journal of Medicine 10.1056/NEJMsb1106942, Jul 25, 2011 (full article freely available)

Week of July 18, 2011 U.S. proposes rule changes for human-subject research, Washington Post, Jul 23, 2011 (free one time registration may be required) "The federal government on Friday proposed sweeping revisions to rules governing scientific research involving human subjects with the intent of extending protections to a larger number of people while simultaneously streamlining the oversight and paperwork required of scientists. The proposed changes would be the first in two decades to the “Common Rule” that governs nearly all human-subject research financed by American taxpayers…" Scientist Under Inquiry Resigns From Harvard, New York Times, Jul 20, 2011 (free one time registration required) "The behavioral psychologist Marc Hauser has resigned from the Harvard faculty, 11 months after the university accused him of being “solely responsible” for eight counts of scientific misconduct…" Press Release: Government Must Investigate Human Experiments That Test a Dangerous Novartis Drug, Public Citizen, Jul 19, 2011 "The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), which is housed in the U.S. Department of Health and Human Services, should suspend studies of a dangerous drug and promptly investigate allegations that these studies are unethical and fail to comply with federal regulations that protect human subjects, Public Citizen said today in letters to the two agencies…" Marijuana May Be Studied for Combat Disorder, New York Times, Jul 18, 2011 (free one time registration required) "…researchers are seeking federal approval for what is believed to be the first study to examine the effects of marijuana on veterans with chronic post-traumatic stress disorder…Getting final approval from the federal government could prove difficult, Mr. Doblin and Dr. Sisley conceded. They said it was far more challenging to get authorization for a study that examines the benefits of an illegal drug than its risks…"

Week of July 11, 2011 Kenya’s ‘guinea pigs’ short-changed, Capital News, Jul 14, 2011 "At least 300 clinical trials are currently being conducted in the country, yet chances of Kenyans benefiting from them are close to nil, according to the Kenya Medical Research Institute Ethics Committee…" Communication about Children's Clinical Trials as Observed and Experienced: Qualitative Study of Parents and Practitioners, Shilling et al., PLoS ONE 6(7): e21604. doi:10.1371/journal.pone.0021604, Jul 12, 2011 (full article freely available, may require free one time registration)

Week of July 4, 2011 Harvard Researchers Accused of Breaching Students' Privacy, Chronicle of Higher Education, Jul 10, 2011 "In 2006, Harvard sociologists struck a mother lode of social-science data, offering a new way to answer big questions about how race and cultural tastes affect relationships. The source: some 1,700 Facebook profiles, downloaded from an entire class of students at an "anonymous" university, that could reveal how friendships and interests evolve over time…But today the data-sharing venture has collapsed. The Facebook archive is more like plutonium than gold—its contents yanked offline, its future release uncertain, its creators scolded by some scholars for downloading the profiles without students' knowledge and for failing to protect their privacy…" New FDA Regulation to Improve Safety Reporting in Clinical Trials, Sherman et al., New England Journal of Medicine 365: 3-5, Jul 7, 2011 (full article freely available) University research needs fraud oversight, MD says, CBC News, Jul 7, 2011 "…unlike the U.S., Canada has no power to investigate an allegation of research fraud at universities. Hébert says universities have an inherent conflict of interest when it comes to revealing scandals that will harm their reputations…" GOP wants FDA bill to boost drug industry's role, The Hill, Jul 7, 2011 "Republicans want to roll back new conflict-of-interest rules they say are depriving the Food and Drug Administration of needed expertise from the drug industry…Technically, the purpose of the FDA bill is to reauthorize the programs through which drug and medical device companies pay the FDA to review their products for approval. But because it's a must-pass measure - the people and offices that approve new products are paid for almost entirely by industry fees - it consistently becomes a magnet for broader policy changes,,," Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials, Kass et al., Journal of General Internal Medicine Online First DOI: 10.1007/s11606-011-1778-6, Jul 6, 2011 (first page freely available) Guidance on Reporting Incidents to OHRP, US Office for Human Research Protections (OHRP), Jul 5, 2011 "OHRP has posted on its website a finalized guidance document entitled, “Guidance on Reporting Incidents to OHRP.” This guidance replaces OHRP'S May 27, 2005 guidance entitled "Guidance On Reporting Incidents To OHRP"…" Updated OHRP Guidance on Written IRB Procedures, US Office for Human Research Protections (OHRP), Jul 5, 2011 "OHRP has updated its Guidance on Written IRB Procedures. The July 1, 2011 guidance document replaces OHRP’s January 15, 2007 guidance on this topic…" Tough checks on clinical trials mooted, Times of India, Jul 5, 2011 "…The bio-medical research on human participation (promotion and regulation) bill which is expected to be introduced in Parliament later this year will provide for a single agency monitoring mechanism. As of now there is confusion between various government agencies on who exactly should be monitoring the clinical trials on human subjects…"

Week of June 27, 2011 Decisional Capacity and Consent for Schizophrenia Research, Kaup et al., IRB: Ethics & Human Research 33 (4): 1-9, July - August 2011 (abstract freely available) Justifying Research Risks in a Clinical Trial for Treatment of Multidrug-Resistant Tuberculosis, Heilig et al., IRB: Ethics & Human Research 33 (4): 10-17, July - August 2011 (full article freely available with free one time registration) Examining the Evidence: A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials, Zulman et al., Journal of General Internal Medicine 26 (7): 783-790, Jul 2011 (abstract and first page freely available) UW battle over Baby Einstein settled, maybe, Seattle Times, Jun 30, 2011 "Four years ago, a University of Washington study largely debunked the educational value of early-childhood education videos, showing that products like Baby Einstein might slow, rather than enhance, language development of very young children…Clark said he wanted the data to see if the study could be replicated and to restore his and his wife's legacy. But his quest was bogged down by competing concerns between the state's broad mandate for open public records and the privacy rights afforded to human research subjects. Now that he has it, he says, a series of "irregularities" has emerged and that goal is impossible…" Spine Experts Repudiate Medtronic Studies, New York Times, Jun 29, 2011 (free one time registration required) "In an extraordinary move, a group of spine specialists are publicly repudiating the research of other experts that has backed the widespread use of a Medtronic bone growth product…Infuse is used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year. The articles published on Tuesday charge that researchers with financial ties to Medtronic overstated Infuse’s benefits and vastly understated its risks by claiming there were none…" OHRP announces new SACHRP members, US Office for Human Research Protections (OHRP), Jun 27, 2011 "OHRP is pleased to announce the selection of four new members of the Secretary’s Advisory Committee for Human Research Protections (SACHRP)…" Revised Frequently Asked Questions and Answers on the Assurance Process, US Office for Human Research Protections (OHRP), Jun 27, 2011 "OHRP has posted on its website a revised set of Frequently Asked Questions and Answers (FAQs) on the Assurance Process…These FAQs include information on recent changes in the Federalwide Assurance (FWA) form and Terms of Assurance…"

Week of June 20, 2011 Vaccine trial's ethics criticized, Nature, Jun 22, 2011 "A clinical trial that came under fire in India threatens to have a dual legacy: inflaming unfounded fears about a lifesaving vaccine and raising new questions about the management of medical research in the country…" OMB Approval of the Federalwide Assurance (FWA) Form, Terms of the FWA, and Related Documents, US Office for Human Research Protections (OHRP), Jun 20, 2011 "The Office for Human Research Protections (OHRP) is pleased to announce the availability of the revised Federalwide Assurance (FWA) form, Terms of Assurance and related documents, which have been approved by the Office of Management and Budget (OMB)…"

Week of June 13, 2011 India: deadly drug trials, GlobalPost, Jun 19, 2011 "India's huge population, many of whom have hardly been exposed to medication, makes it one of the world's most promising markets for drug research. But as the $400 million business accelerates, critics say it is exposing the dark side of the country's health-care sector…" Genetic Basis for Crime: A New Look, New York Times, Jun 19, 2011 (free one time registration required) "It was less than 20 years ago that the National Institutes of Health abruptly withdrew funds for a conference on genetics and crime after outraged complaints that the idea smacked of eugenics. The president of the Association of Black Psychologists at the time declared that such research was in itself “a blatant form of stereotyping and racism.”…" Brokers Jailed For Hiring Women For Clinical Trials, Pharmalot, Jun 17, 2011 "Two people working as brokers for an unnamed Indian drugmaker were arrested for allegedly recruiting poor and illiterate women from a rural section of India as guinea pigs in unauthorized clinical trials for a breast cancer drug…" Is Boehringer Providing Proper Informed Consent?, Pharmalot, Jun 15, 2011 "…Boehringer Ingelheim which, along with Pfizer, markets Spiriva, is conducting a study in 17,000 patients that compares two different versions - a mist that is delivered with the Respimat inhaler and a powder that is delivered with a Handihaler device…say Boehringer is not providing proper informed consent to the 17,000 study participants. In their view, Boehringer has failed to warn about the risks…" Panel on Research Ethics Launches the TCPS 2 Tutorial, Panel on Research Ethics (PRE), Canada, Jun 15, 2011 "The Interagency Advisory Panel on Research Ethics (Panel) is pleased to announce the launch of a new, online tutorial, TCPS 2: Course on Research Ethics (CORE)…" Ethics Questions at Bioethics Journal, Inside Higher Ed, Jun 13, 2011 "A prominent philosopher and bioethics expert has quit the editorial board of The American Journal of Bioethics, calling into question the way articles are reviewed and the process for reviewing an article that criticized her and her colleagues…"

Week of June 6, 2011 Financial transparency skin-deep at medical journals, Reuters, Jun 8, 2011 (scheduled to be freely avaialble until July 8, 2011) "…Reuters Health has learned that the senior researcher, Dr. Fernand Labrie, holds patents for DHEA and owns companies dedicated to marketing it for certain medical problems. His lack of disclosure, a routine requirement at medical journals, points to a bigger problem in the field: Nobody is making sure that authors declare their conflicts of interest…" Feds seek prison for Pa. execs over surgery deaths, Fox News, Jun 7, 2011 "…In a rare move, U.S. prosecutors are seeking prison time for four top Synthes executives who pleaded guilty last year to misdemeanors as "responsible corporate officers." The closely-watched criminal case is playing out this week in Philadelphia, where attorneys for the government and the executives are making their cases before U.S. District Judge Legrome D. Davis. The judge has not yet scheduled individual sentencing dates. Prosecutors call their crimes intentional and say a Synthes consultant warned early on that the tests amounted to "human experimentation."…"

Week of May 30, 2011 UCSD's HIV Privacy Gap, San Diego Reader, Jun 1, 2011 "The U.S. Department of Health and Human Services has determined that a research project conducted by UCSD’s Antiviral Research Center violated the privacy and confidentiality rights of an unspecified number of human research subjects taking part in an HIV infection study…the investigation was triggered by a research subject who alleged that researchers had “…sent out all my laboratory specimens [sic] to private laboratory with my first name, last name, DOB and SSN.”…" Relative Versus Absolute Standards for Everyday Risk in Adolescent HIV Prevention Trials: Expanding the Debate, Snyder et al., The American Journal of Bioethics 11 (6): 5 - 13, Jun 2011 (abstract freely available) News Release: HHS announces proposed changes to HIPAA Privacy Rule, US Department of Health & Human Services (HHS), May 31, 2011 "A Notice of Proposed Rulemaking concerning the accounting of disclosures requirement under the Health Insurance Portability and Accountability (HIPAA) Act Privacy Rule, is available for public comment. The proposed rule would give people the right to get a report on who has electronically accessed their protected health information…" HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act, US Health and Human Services Department, Federal Register 76: 31426-31449, May 31, 2011 (submit comments on or before Aug 1, 2011) "…the Department proposes to expand the accounting provision to provide individuals with the right to receive an access report indicating who has accessed electronic protected health information in a designated record set…"

Week of May 23, 2011 Boiling Springs veteran among volunteers used in experiments, GoUpstate.com, May 29, 2011 "…Boughman did not serve on a battlefield but in a program called Operation Whitecoat. He was one of about 2,300 Seventh-day Adventists who volunteered for medical research. Participants consented to be test subjects in the research of vaccines and safeguards against biological weapons…" Senate OKs Changes to Newborn Screening Program, Texas Tribune, May 23, 2011 "State health officials can no longer use infant blood samples for non-approved purposes without parental approval, under a measure Senate lawmakers approved today…House Bill 411 would flip the procedure around by requiring parents to opt in — rather than opt out — before the department could use the blood samples for any purpose other than screening for disease. The bill would also prevent the department from releasing any information that could be used to identify the child with the samples…"

Week of May 16, 2011 Patients at heart of medical device issue, Chicago Tribune, May 22, 2011 "…Patients in need of permanently implantable, life-sustaining medical devices may assume that the products have undergone rigorous clinical and regulatory scrutiny and that rules put in place to protect their rights are enforced to the letter of the law. But that wasn't the case at Northwestern and other hospitals where two different annuloplasty rings co-invented by McCarthy were sewn into the hearts of more than 700 patients to treat their valve diseases over a number of years though the FDA didn't clear the rings until 2009…" Heart-valve rings slip through FDA loophole, Chicago Tribune, May 22, 2011 "…a decade ago, the FDA downgraded the regulatory class of the rings. Instead of being grouped with heart valves and implantable pacemakers, annuloplasty rings were put into a class with most catheters, sutures and hearing aids, which allows the medical device industry to gain approval for new rings without clinical studies…Today, annuloplasty rings have had more deaths associated with them during the past five years than any other device in their class, according to a Tribune analysis of FDA data on adverse events…" EPA blocking innovation in insect repellent, S.C. Johnson charges, Milwaukee Journal Sentinel, May 21, 2011 "Saying innovation is being stifled and research costs are being unnecessarily increased, S.C. Johnson & Son Inc. wants the Environmental Protection Agency to ease its rules on protecting human subjects in pesticide research. The Racine firm's bid to relax the 5-year-old regulations comes as the EPA is proposing to stiffen them…" Expert panel calls for reform in human subject protection, Nature Newsblog, May 19, 2011 "…Obama has asked his Commission on for the Study of Bioethical Issues to take a good hard look at whether human subjects today are adequately protected in federally funded research. At the commission's 5th meeting on 18-19 May in the Warwick New York Hotel, an invited panel's words rang loud and clear: the system may provide adequate protection, but it's a mess…" Do Presidential Bioethics Committees Shape Science Policy?, Genetic Engineering & Biotechnology News, May 18, 2011 "When President Barack Obama’s Commission for the Study of Bioethical Issues reconvenes tomorrow, May 18, the agenda will include the Guatemalan governments’ investigations into the intentional infection of people from 1946–48 by the U.S. Public Health Service during research on sexually transmitted diseases. It’s a far cry from the original issue for which the president formed his commission last year—the ethics of synthetic biology research…" Webcast: May 18-19, 2011 Meeting of the Presidential Commission for the Study of Bioethical Issues, May 18-19, 2011

Week of May 9, 2011 Secret Archive of Ulster Troubles Faces Subpoena, New York Times, May 13, 2011 (free one time registration required) "As the war in Northern Ireland was reaching its end in the late 1990s, two interviewers set out to collect memories of the conflict from men and women who had been involved as paramilitary fighters..In exchange for candor, the people being interviewed were assured that the contents would remain sealed until they were dead. Now, however, authorities in the United Kingdom want oral histories that were given to Boston College by two members of the Provisional Irish Republican Army for an investigation into murders and kidnappings committed nearly 40 years ago…" U of M dispute over research ethics morphs into academic freedom flap, MinnPost.com, May 11, 2011 "…A number of faculty members have accused the administration of trying to silence a professor who has repeatedly drawn national attention to research protocols he charges are unethical. It would appear that the simmering dispute is about to become a full-on conflagration…" Conn. hospital settles lawsuits with 32 victims of doctor suspected of molesting children, Minneapolis Star Tribune, May 9, 2011 "A hospital on Monday settled lawsuits with 32 people who say they were sexually abused by a prominent, now-dead doctor believed to have molested scores of children over three decades with a bogus human growth study…" Canada must fix `awful' academic-integrity system: experts, Canada.com, May 9, 2011 "Canada needs a system with much sharper teeth to deal with doctors and researchers who fake data, plagiarize and engage in research misconduct, says the country's leading medical journal…" Editorial: The need for new mechanisms to ensure research integrity, Stanbrook et al., Canadian Medical Association Journal Early Release DOI:10.1503/cmaj.110442, May 9, 2011 (full article freely available)

Week of May 2, 2011 Special report: Big Pharma's global guinea pigs, Reuters, May 6, 2011 "The Polish port city of Gdansk is famous for its shipyards. Hungary's fifth largest city, Pecs, is known for its ancient architecture and brewery. Neither is particularly renowned for medicine. Yet when AstraZeneca Plc tested its big new drug hope Brilinta on heart attack patients in a major clinical study, it was hospitals in these places that enrolled some of the highest number of patients anywhere in the world…" US doctors face sanctions for spine study payments, Reuters, May 4, 2011 "…The New Jersey Board of Medical Examiners reprimanded Thomas Errico, Jeffrey Goldstein and Richard Balderston for not disclosing to their research institutions their financial interests in clinical studies of Synthes' ProDisc spinal device in which they participated. Errico and Goldstein also were ordered to pay civil fines…" Yale Bioethicist Testifies For Defense In St. Francis Case, Hartford Courant, May 3, 2011 "…The assertion by Dr. Robert Levine, an internationally recognized bioethicist at Yale University, supports the hospital's effort in court to portray the sham growth study that Reardon used as a pretext to abuse children as a reflection of what colleagues thought was Reardon's interest in collecting data on pediatric growth rates — not scientific research that the hospital could have been required to approve and monitor…"

Week of April 25, 2011 Dealing With the Long-Term Social Implications of Research, Fleischman et al., The American Journal of Bioethics 11 (5): 5 - 9, May 2011 (abstract freely available) Social Contexts Influence Ethical Considerations of Research, Gordon et al., The American Journal of Bioethics 11 (5): 24-30, May 2011 (abstract freely available) An Ethically Justified Framework for Clinical Investigation to Benefit Pregnant and Fetal Patients, Chervenak and McCullough, The American Journal of Bioethics 11 (5): 39-49, May 2011 (abstract freely available) Broad Data Sharing in Genetic Research: Views of Institutional Review Board Professionals, Lemke et al., IRB: Ethics & Human Research 33 (3): 1-5, May-June 2011 (abstract freely available; full article freely available with free one time registration) Off the Beaten Path: Conducting Ethical Pragmatic Trials with Marginalized Populations, Silva et al., IRB: Ethics & Human Research 33 (3): 6-11, May - June 2011 (abstract freely available) Parents' Understanding and Recall of Informed Consent Information for Neonatal Research, Ballard et al., IRB: Ethics & Human Research 33 (3): 12-19, May - June 2011 (abstract freely available) Controversy rages over stored blood samples, The Lawyers Weekly (Canada), Apr 29, 2011 "A class action filed last May in the Supreme Court of British Columbia challenges the retention and use of newborn blood samples without explicit parental consent…" Court Lets U.S. Resume Paying for Embryo Study, New York Times, Apr 29, 2011 (free one time registration required) "Government financing of human embryonic stem cell research can continue, a federal appeals court ruled Friday. The decision was an important victory for the Obama administration in a legal battle that is far from over…" Avoiding Ethical Quandaries In Embryo Donation, Time, Apr 27, 2011 "…There is very little consistency in terms of how fertility clinics ask patients for their preference. Now a new study from Stanford University looks at one option — donating embryos to science — and makes the case that many more couples may choose to do so, if fertility centers implemented a simple no-pressure policy…" ICMR panel to monitor transfer of biological samples for research, trade, IndianExpress.com, Apr 26, 2011 "The government has decided to tighten its control over the transfer of “biological material” for research and commercial purposes. On Monday, a committee was constituted by the Director General of Indian Council of Medical Research (ICMR), which after analysing “expected outcomes” and its “implications”, will allow “transfer” of such material for commercial and research purposes…"

Week of April 18, 2011 How to Enroll Participants in Research Ethically, Wendler, Journal of the American Medical Association 305 (15):1587-1588, Apr 20, 2011 (extract freely available) Stumbling Into Bad Behavior, New York Times, Apr 20, 2011 (free one time registration required) "…Regulators, prosecutors and journalists tend to focus on corruption caused by willful actions or ignorance. But in our research, and in the work of other scholars who study the psychology of behavioral ethics, we have found that much unethical conduct that goes on, whether in social life or work life, happens because people are unconsciously fooling themselves…" Stored newborn blood samples raise concern, Baltimore Sun, Apr 19, 2011 "A decades-old program to screen newborns for certain hereditary diseases could be at risk because parents across the country have grown concerned about what happens to the leftover blood, according to a Johns Hopkins researcher who has studied state laws…"

Week of April 4, 2011 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent for Emergency Research; Availability, US Food and Drug Administration (FDA), Federal Register 76 (64): 18558 - 18559, Apr 4, 2011 (pdf) "This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in the development, conduct, and oversight of research involving FDA regulated products (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed consent requirements is requested under the Code of Federal Regulations (CFR). FDA determined that guidance is needed in interpreting and complying with these regulations, particularly in the areas of planning and conducting community consultation and public disclosure activities, and the establishment of informed consent procedures to be used when feasible. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2006…"

Week of March 28, 2011 Viewpoint: Why our conceptions of research and practice may not serve the best interest of patients and subjects, Beauchamp, Journal of Internal Medicine 269: 383-387, Apr 2011 (first page freely available) Viewpoint: Are the research ethics committees working in the best interests of participants in an increasingly globalized research environment?, Chalmers, Journal of Internal Medicine 269: 392-395, Apr 2011 (first page freely available) Viewpoint: A method to estimate the cost in lives of ethics board review of biomedical research, Whitney and Schneider, Journal of Internal Medicine 369: 396-402, Apr 2011 (first page freely available) Assessing the Remedy: The Case for Contracts in Clinical Trials, Edwards, American Journal of Bioethics 11 (4): 3 - 12, Apr 2011 (abstract freely available) Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563, US Food and Drug Administration (FDA), Apr 2011 (comments due by Jun 27, 2011) "…the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation…" Results in Brief: Assessment of Allegations Concerning Traumatic Brain Injury Research Integrity in Iraq, US Department of Defense Office of the Inspector General, Mar 31, 2011 "This assessment was initiated in response to allegations brought to the attention of the Department of Defense, Office of Inspector General, concerning the integrity of a traumatic brain injmy research project in Iraq…We identified the following principal concerns: The management and conduct ofthe clinical trial were inconsistent with military standards for human subject medical research, possible sub-standard patient care, weaknesses in the process used to review and approve medical research in Iraq…" The Use of Anti-oxidants to Reduce Sequela of Mild Traumatic Brain Injury (mTBI) After Blast Exposure, ClinicalTrials.gov (study posted Jan 13, 2009; completed August 2010) Most States Unclear About Storage, Use of Babies’ Blood Samples, Newswise, Mar 28, 2011 "State laws and policies governing the storage and use of surplus blood samples taken from newborns as part of the routine health screening process range from explicit to non-existent, leaving many parents ill-informed about how their babies’ left over blood might be used, according to a team led by a member of the Johns Hopkins Berman Institute of Bioethics, in collaboration with researchers from the University of Utah…"

Week of March 14, 2011 IRB Overreach?, Inside Higher Ed, Mar 18, 2011 "An associate professor of education has sued Brown University for barring her from using her own data because she paid her human research subjects different amounts of money based on their economic status. Jin Li, an associate professor of education and human development at Brown, alleges that the university’s Institutional Review Board overstepped its jurisdictional bounds, failed to have minority members on its panel and denied her due process…" Public Citizen Calls for Ethics Probe into Novartis Clinical Trials, AboutLawsuits.com, Mar 18, 2011 "The consumer watchdog group Public Citizen is calling for the Office for Human Research Protections (OHRP) to launch an investigations into clinical trials conducted by Novartis for the drug indacaterol, which is being developed to treat chronic obstructive pulmonary disease (COPD), after accusing the drug maker of ethics violations for allegedly allowing people to suffer a potentially life-threatening respiratory illness for several months without proper care…" Letter to OHRP on Unethical Trials of Indacaterol Maleate (Arcapta Neohaler), Public Citizen, Mar 16, 2011 Fraudulent Medical Research Could Affect Your Diagnosis, The Huffington Post, Mar 18, 2011 "…Breached ethical research standards are not isolated occurrences. A search of online journals for "retracted" papers and reviewing the relatively new, important blog, Retraction Watch, reveals an alarming number of papers retracted for data manipulation and other malfeasances…" A National Registry for Healthy Volunteers in Phase 1 Clinical Trials, Resnik and Koski, Journal of the American Medical Association Online First 10.1001/jama.2011.354, Mar 15, 2011 (full article freely available) The Challenge of Discharging Research Ethics Duties in Resource-Constrained Settings, Singh, PLoS Medicine 8(3): e1000421. doi:10.1371/journal.pmed.1000421, Mar 15, 2011 (may require free one time registration; full article freely available)

Week of March 7, 2011 Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments, Roseman et al., Journal of the American Medical Association 305(10):1008-1017, Mar 9, 2011 (abstract freely available) U.S. Guatemala Syphilis Tests: Attorneys Seek Lawsuit For Thousands Of Victims, The Huffington Post, Mar 8, 2011 "Attorneys representing potentially thousands of Guatemalans who were affected by U.S. syphilis experiments decades ago said Tuesday they will sue top federal health officials unless a system is created out of court to settle claims by the victims or their survivors…" Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty, Kimmelman and London, PLoS Medicine 8(3): e1001010. doi:10.1371/journal.pmed.1001010, Mar 8, 2011 (full article freely available, may require free one time registration) How Can Institutional Review Boards Best Interpret Preclinical Data?, Lavery, PLoS Medicine 8(3): e1001011. doi:10.1371/journal.pmed.1001011, Mar 8, 2011 (full article freely available, may requre free one time registration)

Week of February 28, 2011 Sex doctor case goes to trial, UPI, Mar 6, 2011 "A Hartford, Conn., hospital is being sued by 90 people claiming that as children they were molested by a doctor claiming to be involved in medical research…" Scandal over dubious surgery research rocks Europe, Globe and Mail, Mar 4, 2011 "retracted one of his articles, saying that the study had not received ethics approval, the patients in the study had not received written informed consent and there was no randomization process. The journal further said that Dr. Boldt had falsely claimed all of these things. The journal later said that an investigation had shown the research behind one of Dr. Boldt’s papers was fabricated and retracted 22 further articles when it could find no evidence he had obtained ethics approvals for them…" Medical journals retract "unethical" research, Reuters, Mar 4, 2011 (scheduled to be freely available until Apr 3, 2011) "…In an open letter, 16 editors of various medical journals, including the U.S.-based Anesthesia & Analgesia, the European Journal of Anesthesiology and the British Journal of Anesthesia, said 89 of 102 studies published by Boldt had so far been found not to have had approval from an ethics body known as the institutional review board (IRB)…" Doctor and Patient. When Optimism Is Unrealistic, New York Times, Mar 3, 2011 (free one time registration required) "…For almost four decades, researchers and patient advocates have debated the ethics of informed consent in early-phase clinical trials, studies that test only toxicity and dosing and offer little, if any, therapeutic benefit to those enrolled…" The ClinicalTrials.gov Results Database — Update and Key Issues, Zarin et al., New England Journal of Medicine 364:852-860, Mar 3, 2011 (full article freely available) President’s Bioethics Commission Names International Research Panel, The Presidential Commission for the Study of Bioethical Issues, Mar 1, 2011 "Dr. Amy Gutmann, Chair of the Presidential Commission for the Study of Bioethical Issues, today announced the formation of an International Research Panel to consider the standards for protecting human subjects in scientific studies. The announcement comes in direct response to a request from President Obama…" Professor Says Brown U Has a Lot of Nerve, Courthouse News Service, Mar 1, 2011 "An associate professor sued Brown University for prohibiting her from publishing research from her 3-year study of the education and socialization of Chinese immigrant children, because she paid the poor people who participated more than she paid the families who were financially stable - $600, rather than $300…" Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment, Report on Research Compliance, Mar 1, 2011 (pdf) "In 2010, the Office for Human Research Protections issued and posted 16 determination letters, the lowest number in its 11-year history and less than half the number issued in each of the previous five years. Since 2007, the office has averaged 35 letters a year, down from a peak of 146 in 2002 and another high of 86 in 2006…" How the FDA Got the Markingson Case Wrong, Elliot, Bioethics Forum, Mar-Apr 2011 "…It is true that the FDA investigated the case, in response to a complaint filed by Mike Howard. But the inspection report, issued in 2005, hardly qualifies as an exoneration. In fact, the report is a very puzzling document: occasionally misleading, remarkably uncritical, and often simply baffling…" Viewing Research Participation as a Moral Obligation: In Whose Interests?, Rennie, Hastings Center Report 41 (2): 40-47, Mar - Apr 2011 (abstract freely available) (Mis)Understanding Exploitation, Malmqvist, IRB: Ethics & Human Research 33 (2): 1-5, Mar - Apr 2011 (full article freely available with free one time registration) Informed Consent Language and Parents’ Willingness to Enroll Their Children in Research, Cico et al., IRB: Ethics & Human Research 33 (2): 6-13, Mar - Apr 2011 (abstract freely available) Protecting Research Subjects: IRBs in a Changing Research Landscape, Cook and Hoas, IRB: Ethics & Human Research 33 (2): 14-19, Mar - Apr 2011 (abstract freely available) The Responsible Conduct of Bioethics Research, Master, Accountability in Research 18 (2): 102 - 119, Mar 2011 (abstract freely available) The Singapore Statement on Research Integrity, Resnick and Shamoo, Accountability in Research 18 (2): 71 - 75, Mar 2011 Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty, Kimmelman and London, PLoS Medicine 8(3): e1001010. doi:10.1371/journal.pmed.1001010, Mar 2011 (full article freely available, may require free one time registration) A Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to LearnA Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to Learn, Abbott and Grady, Journal of Empirical Research on Human Research Ethics 6 (1): 3-20, Mar 2011 (first page freely available) A Delphi Study to Establish Important Aspects of Ethics Review, Geisser et al., Journal of Empirical Research on Human Research Ethics 6 (1): 21-24, Mar 2011 (first page freely available) Consequences Identification in Forecasting and Ethical Decision-making, Stenmark et al., Journal of Empirical Research on Human Research Ethics 6 (1): 25-32, Mar 2011 (first page freely available) When the Subject Is More than Just the Subject: Two Case Studies of Family Involvement in Human Subjects Research, Sauder et al., Journal of Empirical Research on Human Research Ethics 6 (1): 33-38, Mar 2011 (first page freely available) Assessment of Consent Capability in Psychiatric and Medical Studies, Tait et al., Journal of Empirical Research on Human Research Ethics 6 (1): 39-50, Mar 2011 (first page freely available) Ethical Behaviors of Latin American Psychotherapy Researchers, Roussos et al., Journal of Empirical Research on Human Research Ethics 6 (1): 51-54, Mar 2011 (first page freely available) Voluntariness to Consent to Research in a Voluntarily and Involuntarily Hospitalized Psychiatric Population, Van Der Veer et al., Journal of Empirical Research on Human Research Ethics 6 (1): 55-62, Mar 2011 (first page freely available) Measuring how people view biomedical research: Reliability and validity analysis of the Research Attitudes Questionnaire, Rubright et al., Journal of Empirical Research on Human Research Ethics 6 (1): 63-68, Mar 2011 (first page freely available) Improving Recruitment in Clinical Trials: Why Eligible Participants Decline, Brintnall-Karabelas et al., Journal of Empirical Research on Human Research Ethics 6 (1): 69-74, Mar 2011 (first page freely available) Strengthening the Educational Value of Undergraduate Participation in Research as Part of a Psychology Department Subject Pool, Moyer and Franklin, Journal of Empirical Research on Human Research Ethics 6 (1): 75-82, Mar 2011 (first page freely available) The Influence of Prior Experience on Research Participants' Perspectives: A Research Agenda, Mitchell and Hobson, Journal of Empirical Research on Human Research Ethics 6 (1): 83-84, Mar 2011 (first page freely available)

Week of February 21, 2011 AP Impact: Past medical testing on humans revealed, Washington Post, Feb 27, 2011 (free one time registration required) "Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates. Such experiments included giving hepatitis to mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in Maryland, and injecting cancer cells into chronically ill people at a New York hospital. Much of this horrific history is 40 to 80 years old, but it is the backdrop for a meeting in Washington this week by a presidential bioethics commission…"

Week of February 14, 2011 Report: Putting Contract Research Organisations on the Radar, SOMO Centre for Research on Multinational Corporations, Feb 16, 2011 "…What happens when offshoring is combined with outsourcing? Do additional ethical risks arise when clinical trials are contracted out? Virtually all pharma ceutical companies publicly declare that they test their drugs in accordance with the highest ethical guidelines, such as the Declaration of Helsinki. But how do pharmaceutical companies safeguard their commitments when they outsource clinical trial activities to CROs in poor regions? These are the central questions that are addressed in this report…" Medical Device Recalls and the FDA Approval Process, Zuckerman et al., Archives of Internal Medicine Online First, doi:10.1001/archinternmed.2011.30, Feb 14, 2011 (abstract freely available)

Week of February 7, 2011 Risk and Reward in Utero, New York Times, Feb 12, 2011 (free one time registration required) "…both women hoped to receive an ambitious surgery that closes the hole in the spine while babies are in the womb. Their only access was through a clinical trial testing whether risky prenatal surgery was better than standard surgery after birth. Participating meant being randomly assigned to one surgery or the other…" The Role of Public-Sector Research in the Discovery of Drugs and Vaccines, Stevens et al., New England Journal of Medicine 364:535-541, Feb 10, 2011 (full article freely available) Sounding Board. Biomedical Research and Health Advances, Moses and Martin, New England Journal of Medicine 364:567-571, Feb 10, 2011 (full article freely available) Duke links up for research in India, News Observer, Feb 8, 2011 "Duke University has forged a partnership with a large medical center in India to create a clinical research company that will study diseases and speed the development of new drugs and therapies, the groups announced Monday… the groups will conduct early-phase clinical trials in diverse populations, establishing dosing, safety and toxicity of drug candidates. Officials said the MDRI will adhere to strict standards for research and human subject protection…" University of Minnesota rules out a new probe in 2004 research suicide case involving West St. Paul man, Pioneer Press, Feb 7, 2011 "University of Minnesota officials said Monday they will not initiate a new investigation into the 2004 suicide of a West St. Paul man who was enrolled in a controversial medication study at the U. Last year, a dozen faculty members and a student group at the U called for an investigation into the death of Dan Markingson after reports that the research study in question might have featured a series of ethical violations…" FDA Says Drug Firms Didn't Finish Follow-Ups, The Wall Street Journal, Feb 7, 2011 "Federal officials Tuesday questioned companies that make six cancer drugs about their failure to complete follow-up studies they promised to conduct in exchange for accelerated approval. At a public meeting, Food and Drug Administration officials and its committee of outside cancer experts discussed the importance of follow-up, while the companies cited challenges including the difficulty of enrolling patients in trials for already-approved drugs…"

Week of January 31, 2011 'Passive consent' triggers complaint. Burnaby parent says survey is 'unethical', Burnaby Now, Feb 5, 2011 "A parents' group lead by a Burnaby woman is filing an ethics complaint over a survey on kindergarten kids. Local resident Helen Ward is the president of Kids First Parent Association of Canada. On Jan. 21, Ward made a complaint to UBC's behavioural research ethics board about a letter sent home to parents regarding the Early Development Instrument, a survey on kindergarten kids…" Returning the Blessings of an Immortal Life, New York Times, Feb 4, 2011 (free one time registration required) "If there was one thing Rebecca Skloot was certain of when writing “The Immortal Life of Henrietta Lacks,” it was that she did not want to profit from the Lacks family without giving something in return…" Proposed Rule: Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides, Federal Register 76 (22): 5735-5755 [FR DOC# 2011-1629], Feb 2, 2011 (comments due by Apr 4, 2011) "EPA proposes to amend the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. They would also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally the proposed amendments would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides…" Feature: Thinking responsibly: The ethics of global health research, The Wellcome Trust, Feb 1, 2011 "The growth of international scientific research, including global collaborations, raises important new ethical issues. How can you ensure that the people taking part in studies aren’t exploited? Should data be shared? How can the interests of all groups involved be represented? Chrissie Giles meets two ethicists - newly qualified PhD Lairumbi Mbaabu from Kenya and his UK supervisor Professor Michael Parker - who have been working together to explore these issues…" The Lab: Avoiding Research Misconduct. Interactive Movie on Research Misconduct, US Office of Research Integrity (ORI), Feb 2011 "In "The Lab: Avoiding Research Misconduct," you become the lead characters in an interactive movie and make decisions about integrity in research that can have long-term consequences. The simulation addresses Responsible Conduct of Research topics such as avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices…" Registering New Drugs for Low-Income Countries: The African Challenge, Moran et al., PLoS Med 8(2): e1000411, Feb 1, 2011 (full article freely available) Protecting Human Research Subjects Newsletter, US Department of Energy (DOE), Feb 2011 (pdf) "The newsletter addresses current issues and concerns about human research supported by DOE. It focuses on DOE laboratories and specific issues DOE laboratories face while conducting human subject research at their facilities…" Puzzle Me This, The Scientist, Feb 2011 "…Hallmarks of good biomedical research, placebos are used throughout the world in double-blind, randomized controlled trials. And recently, they’ve come under intense scrutiny…" Should Patients Have A Voice In FDA Drug Approvals?, KPBS.org, Jan 31, 2011 (audio file and transcript available) "People suffering from rare or chronic diseases often have to wait years for new drugs to get through the complicated regulatory process in the US. But, putting prescription drugs on the market too soon can put patients at risk. On our monthly segment on ethics in science and technology, we'll talk about the ethics of giving patients more of a voice in the regulatory decision-making process…"

Week of January 24, 2011 Clinical trials cited for ignoring previous relevant research, JHU Gazette, Jan 24, 2011 (for Ann Int Med article, see Journal section below) "The vast majority of already published and relevant clinical trials of a given drug, device or procedure are routinely ignored by scientists conducting new research on the same topic, a new Johns Hopkins study suggests. The authors of the findings, reported in the Jan. 4 issue of Annals of Internal Medicine, argue that these omissions potentially skew scientific results, waste taxpayer money on redundant studies and involve patients in unnecessary research…"

	Week of January 17, 2011 Woman Says She Was Burned as a Guinea Pig, Courthouse News Service, Jan 17, 2011 "A woman claims the Consumer Product Testing Company offered her money to become a human guinea pig, then "applied a chemical compound to [her] back" that caused "burns and discoloration," but "dismissed her complaints as groundless and offered no medical services or advice."…"

Week of January 10, 2011 Cancer trial errors revealed, Nature, Jan 11, 2011 "…Months earlier, the same trials had been suspended after critics raised questions about the underlying science. Yet Cuffe and Kornbluth had decided to restart them when a review panel seemed to validate Potti's method…biostatisticians wrote to Kornbluth and Cuffe, pointing out that the data did not match the raw data in the public database from which they were supposedly sourced…they decided not to forward the latest communication from Baggerly and Coombes to the rest of the [institutional review] board or the external reviewers…"

Week of January 3, 2011 Flawed research appalls cancer patient. Duke trial based on bad science, CharlotteObserver.com, Jan 9, 2011 "…she was diagnosed with breast cancer and agreed to participate in a clinical trial at Duke University that was based on now-discredited science by a now-disgraced scientist. Although Shoffner received standard chemotherapy, she was steered to the treatment using what was supposed to be a genetic predictor for its success. But the treatment did nothing to stem the tumor's growth, and instead led to blood clots and other problems that complicated her care…" Journal says doctor faked data linking autism to vaccines, Washington Post, Jan 6, 2011 (free one time registration required, for BMJ article, see Journal section) "The British Medical Journal on Wednesday accused a disgraced British doctor of committing an "elaborate fraud" by faking data in his studies linking vaccines with autism…" Secrets of the MMR Scare. How the case against the MMR vaccine was fixed, Deer, British Medical Journal 342: c5347, Jan 5, 2011 (full article freely available) A Systematic Examination of the Citation of Prior Research in Reports of Randomized, Controlled Trials, Robinson and Goodman, Annals of Internal Medicine 154:50-55, Jan 4, 2011 (abstract freely available) Advanced Cell Technology Cleared to Test Stem-Cell Therapy for Vision Loss, Bloomberg, Jan 3, 2011 "Advanced Cell Technology Inc. said it was cleared by U.S. regulators to test a therapy made from embryonic stem cells in patients with macular degeneration, a leading cause of vision loss…" Office for Human Research Protections (OHRP) New Website, Jan 2, 2011 "…on January 2, 2011, we made comprehensive changes to the OHRP website. The new site retains content from our previous site, but the organization of this material has been revised and streamlined. We hope and intend that this update will make it easier for visitors to find the information they need on our website. This major structural change has been accelerated to meet a year-end deadline and the time for quality assurance review of the changes has been shorter than anticipated…" Deadly Medicine, Vanity Fair, Jan 2011 "Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine…" New Members Appointed to the Panel on Research Ethics, Panel on Research Ethics (PRE), Canada, Jan 2011 "The Presidents of the Agencies are pleased to welcome five new members to the Interagency Advisory Panel on Research Ethics (the Panel)…" Unrealistic Optimism in Early-Phase Oncology Trials, Jansen et al., IRB: Ethics & Human Research 33 (1): 1-8, Jan - Feb 2011 (abstract freely available) Consent for Future Genetic Research: The NHANES Experience in 2007–2008, McQuillan and Porter, IRB: Ethics & Human Research 33 (1): 9-14, Jan -Feb 2011 (abstract freely available) Institutional Not-for-Cause Compliance Review Programs, VandenBosch and Maio, IRB: Ethics & Human Research 33 (1): 15-17, Jan - Feb 2011 (abstract freely available)

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