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The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is moving in some new directions as Elyse I. Summers, JD, president and chief executive officer, celebrates her first anniversary with the organization.
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How investigators report serious adverse events (SAEs) can be subject to gray zones. Answers are not always a clear yes or no.
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Research institutions sometimes struggle with retaining experienced IRB members as the workload can be significant and there are so many competing duties and projects for these scientists, professors, bioethicists, and other professionals.
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The 21st century IRB office is run by professional-level staff more than in previous years. While 30 years ago an IRB could rely on a long-time employee who had experience without credentials, this model is becoming rare.
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Small IRBs often have a resource dilemma: How do you help the IRB improve consistency and quality of reviews when staffing is limited?
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The 2011 changes to the National Institutes of Health (NIH) Public Health Service (PHS) regulations for reporting investigator conflicts of interest may still be causing confusion for researchers and IRBs.
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While federal regulations require that subjects be informed of the possible alternatives to their participation in a clinical trial, often subjects don't learn enough about those alternatives to make an informed decision, says a bioethicist who has studied the issue.
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Tufts University researchers studying immigrant workers in a nearby community engaged local leaders and teens to help them create a survey and recruit and translate for the immigrant population. It was an example of community-based participatory research (CBPR), involving the community from start to finish.
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Three institutions recently were honored by the Health Improvement Institute for their contributions to enhancing the protection of research subjects.
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The current system of regulating community-based participatory research (CBPR) doesn't truly engage or protect communities as it should and fails to follow up on promises made by researchers to IRBs and to those whom they study, says one community researcher.
