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Week of November 27, 2006
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Insurers may be made to cover clinical trials, Pittsburgh Tribune-Review, Dec 2, 2006
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"…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…"
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Sleeping Better at Night: Investigators’ Experiences with Certificates of Confidentiality, Wolf and Zandecki, IRB 28: 1-7, Nov/Dec 2006 ()
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The Ethics of Withdrawal from Study Participation, Gordon and Prohaska, Accountability in Research 13: 285 - 309, Oct-Dec 2006 ()
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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 ()
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Herpes Study Put Pregnant Women at Risk, The San Francisco Chronicle, Dec 1, 2006
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"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…"
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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 ()
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A public health perspective on research ethics, Buchanan and Miller, Journal of Medical Ethics 32: 729-733, Dec 2006 ()
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The Future of the FDA, The Scientist, Dec 2006
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"As the agency celebrates its 100th anniversary, what do Congress and others have in store?"
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Office of Research Integrity (ORI) Newsletter, ORI, Dec 2006 ()
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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 ()
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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 ()
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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 ()
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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 ()
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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 ()
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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 ()
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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 ()
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Financial Relationships between Institutional Review Board Members and Industry, Campbell et al., New England Journal of Medicine 355: 2321-2329, Nov 30, 2006 ()
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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 ()
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Editorial: Conflict of Interest or Conflict of Priorities?, Nabel, New England Journal of Medicine 355: 2365-2367, Nov 30, 2006 ()
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Top scientific journal pledges to curb fraud, CNN.com, Nov 29, 2006
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"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…"
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Committee Letter, Report and Science Response, Science, Nov 29, 2006 ()
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Health Canada regulation falling short: auditor general, Canada.com, Nov 29, 2006
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"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…"
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Chapter 8. Allocating Funds to Regulatory Programs - Health Canada, Report of the Auditor General of Canada, Nov 28, 2006 ()
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Industry ties common on hospital boards, Monterey Herald, Nov 29, 2006 ()
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"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…"
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2007 International Compilation of Human Research Protections, US Office for Human Research Protections (OHRP), Nov 28, 2006 ()
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"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…"
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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 ()
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