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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.
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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.
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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.
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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.
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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.
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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.
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Medical research in developing countries often is conducted by Western institutions, using their own IRBs to ensure the rights of participants who could be half a world away.
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Those advocating research into rare diseases often have an uphill battle, searching for funding and trying to garner public support for treating conditions that don't have the same widespread recognition as HIV or breast cancer.
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One of the truest sayings an IRB professional might hear is that you can't have burnout unless it's a really bright light to begin with, an expert says.
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When planning to expand an IRB office or start a new one to support one or more IRBs, the key principle to keep in mind is that one size does not fit all when it comes to IRBs, an expert says.
