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Week of August 30, 2010
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Determination Letter, Office for Human Research Protections (OHRP), Sep 2, 2010 ()
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"The Office for Human Research Protections (OHRP) posted on its website OHRP's September 2, 2010 letter of determination along with a U.S. Food and Drug Administration (FDA) memorandum. OHRP received allegations concerning activities conducted by Dr. Maria New at Weill Cornell Medical College and Mount Sinai School of Medicine involving the use of dexamethasone in pregnant women at risk of carrying a female fetus with congenital adrenal hyperplasia. [OHRP] determined that the allegations raised by the complainants are unproven and did not find any evidence that Dr. Maria New violated the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46)…"
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Kids swap DNA for fairground rides, Nature, Sep 1, 2010
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"…This week, researchers from the University of Minnesota in Minneapolis are collecting DNA from young fair-goers and their parents as part of an effort to uncover genetic influences on normal child health and development…In return for their DNA, participants receive ride tickets and other small gifts, as well as passes to attend the fair next year, where Spector hopes they will continue their participation in the study…But the Gopher Kids Study is not without its critics, who worry about the setting, the involvement of children and the consent forms parents sign…"
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People want to be asked before sharing genetic data, EurekAlert!, Sep 1, 2010
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"…When the team asked Group Health patients who participate in ACT whether their "de-identified" (anonymous) genetic and medical record information could be shared in the database, 86 percent said yes. Then the team surveyed 365 ACT study participants who had agreed to let their genetic information be shared, mostly because of a "desire to help others." In the survey, 90 percent of participants said they thought it was important to have been asked for this reconsent…Alternatives to reconsent—including opting out, being notified, or neither individual permission nor notification—were unacceptable to 40 percent, 67 percent, and 70 percent of the surveyed participants…"
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Justice Dept. appeals to restart stem cell research, Washington Post, Sep 1, 2010 ()
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"…The Justice Department asked U.S. District Judge Royce Lamberth to suspend a temporary injunction he issued last week blocking the funding and filed a notice of plans to appeal the decision to the U.S. Court of Appeals. Lamberth, ruling in a lawsuit filed by two researchers working on alternatives to the cells, said the funding violated a federal rule that prohibits federal tax money from being used for research that involves the destruction of human embryos…"
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Ethical, Evidence-Based Guidelines for Contraceptive Use in Research, Kaposy and Baylis, IRB: Ethics & Human Research 32 (5): 1-9, Sep-Oct 2010 ()
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When IRBs Review Ethically Challenging Protocols: Views of IRB Chairs about Useful Resources, Sirotin et al., IRB: Ethics & Human Research 32 (5): 10-19, Sep-Oct 2010 ()
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Clinical Trials: Professional Guinea Pigs, Time, Sep 2010 ()
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"Human subjects are paid in Phase 1 clinical trials to test the toxicity levels of new drugs. Some make a profession out of it, but researchers worry about health risks…"
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International Compilation of Human Research Protections 2010 Edition, US Office for Human Research Protections (OHRP), Sep 2010 ()
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"This Compilation lists the approximately 1,100 laws, regulations, and guidelines that govern human subjects research in 96 countries, as well as standards from a number of international and regional organizations. This Compilation was developed for IRBs/Research Ethics Committees, researchers, sponsors, 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 these standards are followed appropriately. The 2010 Edition includes numerous additions and updates to the 2009 Edition…"
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