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The implementation of the Health Insurance Portability and Accountability Act (HIPAA) has added length and complexity to the process of getting research approved.
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Research institutions are becoming more sophisticated in their recruitment and retention of community IRB members, says Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
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IRB members often begin their new role with many questions and concerns. While these may be answered during a formal training program, there is another way to help ease new members into the role, and that's through a formal mentoring program.
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At least one research institute has found a solution to the problem of finding time for IRB members to review protocols for both the science and ethical issues.
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When the IRB at the University of Utah in Salt Lake City, UT, spent two years seeking accreditation, the institution's electronic system was what helped most, the IRB director says.
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IRBs already are attuned to the dangers of therapeutic misconception, in which research subjects confuse research interventions with personalized medical care. Meaningful informed consent explaining clearly the potential risks and benefits of participation in a study is believed to be the best method of combating the problem.
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Reams have been written about the logistical problems of dealing with local IRBs on multisite trials - the delays, the countless changes demanded by individual boards, the overall hassle.
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Many IRBs spend countless hours of review focusing on the consent documents needed for research studies. Are they too technical? Written at too high a level of readability? Too vague? Not extensive enough in their description of potential risks?
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One of the most important services an IRB can provide is rapid turnaround on protocol reviews. The next most important service is providing quality documents, says the president of a large independent IRB in Austin, TX.
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Major corporate research sponsors and large institutional sponsors in the United States increasingly are conducting clinical trial research overseas. Sometimes this raises concerns among IRBs and human subjects protection leaders about human subjects protection measures taken by these organizations.