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| July 3, 2008 |
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"The problem of incidental findings is important and deserves broad discussion among researchers, research participants, institutional review boards, funders, and oversight bodies. Handling incidental findings responsibly requires clarity about the difference between research and clinical care, coupled with attention to the ethical duties of researchers when faced unexpectedly with information that could save a life, significantly alter clinical care, or prove important to the research participant."—From the conclusions of a National Institutes of Health–sponsored project focused on the dilemmas caused by incidental findings in human subjects research. For the full story, click here.
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Project Offers Guidance for Managing Incidental Findings in Human Subjects Research
Incidental findings about the health of individual research participants that are beyond the aims of a study are an increasingly common byproduct of research using powerful technologies that generate "extra" data. A two-year project of the National Institutes of Health has published the first major recommendations on dealing with the dilemmas that different types of incidental findings can cause for researchers....Read More
AAHRPP Accredits 22 More Research Organizations
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) in June announced that it had accredited another 22 organizations, and is on track to achieve its goal of accrediting the majority of academic health centers by 2010. Forty-two percent of the nation's research-intensive universities, 36 percent of U.S. medical schools, and 52 percent of Department of Veterans Affairs (VA) facilities are now accredited....Read More
Clinical Trial Participants are Motivated by Both Personal Benefit and Helping Others
Most HIV-infected individuals participating in a clinical trial hope to benefit personally from the research, but also understand they are contributing to society, according to a report in the June 23 issue of Archives of Internal Medicine. Although there is a growing body of data explaining why individuals enroll in clinical trials, little research has been conducted regarding their motivation for ongoing participation....Read More
New Protocol for Blood Substitute Trial Includes Prospective Informed Consent
The U.S. Naval Medical Research Center has submitted a new protocol for review by the Food and Drug Administration for a clinical trial of Biopure Corp.'s Hemopure® for resuscitation of operational casualties with severe traumatic hemorrhagic shock without availability of blood transfusions. Subjects will sign an informed consent prospectively, a move intended to eliminate a stumbling block with an earlier proposed trial that would have been conducted prehospital in civilian hospital patients with an exception to informed consent....Read More
Record High Number of Clinical Trials Initiated
According to data tracked by a global biopharmaceutical services organization, the number of new industry-sponsored clinical trial initiations surged another 12 percent to a record high in 2007. An analysis shows that the biopharmaceutical industry submitted 662 commercial Investigational New Drug applications in support of new clinical studies for drugs in 2007, up from the previous record of 593 in 2006....Read More
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In the News: A roundup of major media coverage of issues impacting the conduct of and public perceptions about clinical research (10 items added since the last issue of the Wire)
Clinical Trial Updates: Announcements from corporations, institutions, and journals about findings from recent trials, treated in brief (10 items added since the last issue of the Wire)
Campus Connections: An overview of the latest developments in clinical research at prominent and up-and-coming academic centers and hospitals (5 items added since the last issue of the Wire)
Meetings & Minutes: Highlights and summaries of recent gatherings of importance to members of the clinical research team (including the newly added overview of SLEEP 2008, the latest conference of the Associated Professional Sleep Societies)
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ACRP was saddened to learn of the death of Paula Jones-Wright, BScN, RN, BEd, MEd, CCRC, CCRA, CCRT, 44, of cancer on June 29. She was president of ClinCoach, Inc. in Dartmouth, Nova Scotia, Canada, and had served ACRP as a trainer, as a member of the Association Board of Trustees, and as a leader of Canadian activities. To read her full obituary, click here. For more information about her career, click here.
A new report by researchers at the Manhattan Institute and the Tufts Center for the Study of Drug Development examines case histories for 35 important pharmaceutical innovations. Although skeptics of the private industry assert that the development of new medicines is most attributable to publicly funded sources, the authors debunk this assertion and argue that the private sector plays a critical role in drug development.
A recent University of Rochester Medical Center study disclosed that doctors do not often take the steps necessary to help patients recall medical instructions.
A new study in Health Services Research tried to disentangle the impact of a patient's racial and ethnic background, being poor, and having no health insurance on the likelihood they would report having experienced racial or ethnic bias in the healthcare they received.
The deadline for nominations for ACRP's 2009 Association Board of Trustees is September 5, 2008. For more information and a link to the nomination form, click here.
The deadline for nominations for APPI's 2009 Board of Trustees is August 29, 2008. For more information and a link to the nomination form, click here.
The Academy and APPI have launched a campaign to support a federal effort to honor patient participants in clinical trials. The effort is embodied in House Resolution 248, which encourages public recognition of clinical trial participants, and we need your help. For more information, click here.
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© 2007-2008 Association of Clinical Research Professionals. All rights reserved.
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