IRB Advisor – November 1, 2002
November 1, 2002
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IOM’s recommendations call for new name and more focused role for IRBs
The Institute of Medicine has called for some major changes in IRBs and research, including suggestions that research grants and sponsors, as well as research institutions, put more money into the process of protecting human subjects. -
Special Series: Assessing Risks/Benefits - Risks and benefits must be evaluated separately
Rather than treat the risk of harm and potential for benefit as two weights on opposite sides of a scale, IRBs and researchers should fully explore and express the potentials of each, say research ethics experts. -
Special Series: Assessing Risks/Benefits - ASSERT statement offers guidance in trial design
IRBs and investigators who would like an organized checklist of steps to take to ensure human subject protection and the highest ethical standards in designing clinical trials could look no further than the ASSERT statement. -
Special Series: Assessing Risks/Benefits - Recent clinical trial deaths suggest imbalances
Some high-profile deaths of research participants in the past decade have led to federal scrutiny of IRBs and their roles in protecting human research subjects. Heres a thumbnail sketch of some of these cases. -
Spotlight on Compliance: Improved clinical care or medical research?
A key issue in determining whether IRB review is necessary is whether the program in question is, in fact, research. While at least one federal regulation has defined research, the application of the definition provided by the regulation is not always clear. -
IRB review may include financial connections
Though there are no federal laws mandating that IRBs collect and evaluate the potential impact of financial conflicts of interests, a bill introduced by Sen. Edward Kennedy and a recent Institute of Medicine report recommend that such an evaluation become a critical element in ethics and human subject protection.