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Thanks to a volunteer recruitment registry at Vanderbilt University, potential research subjects even those not currently being treated at the university's medical center or by affiliated doctors can make their names and health information available for future use.
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A well-run human research quality improvement (QI) program can be an IRB's best friend, working with investigators to help them prevent common mistakes and to communicate better with the IRB, while avoiding the back-and-forth questioning that can drag out the review process.
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A new technology solution can help research institutions with a nagging logistical problem ever-larger files that must be routed within an institution or to external partners.
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A new journal about research ethics includes articles in June 2006, that discuss how the ethics review process has gone wrong for qualitative research, including ethnography.
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UK clinical trial disaster: Five subjects sent home; NIH launches MedlinePlus Magazine for public; GAO: Improve post-approval drug oversight
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Guidelines and regulations related to research ethics often are conflicting and difficult to follow, so IRBs are left with a multitude of ways to interpret human subjects research issues that arise during the protocol review process.
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The NIH has created a framework and benchmarks program for evaluating research ethics. Christine Grady, PhD, RN, head of the section on human subjects research in the department of clinical bioethics at NIH, provides these insights into the seven principles outlined in the framework:
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Add one more discipline to the list of those that have issues with IRB review: Oral historians, who maintain that they should not be required to seek review for their interviews with participants.
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As IRBs deal with the privacy provisions of HIPAA, they often must decide whether researchers are allowed to waive individual authorization for use of patients data.
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One of the drawbacks for research conducted in this age of checklists and strong regulatory oversight is that IRBs and research institutions do what theyre required to do and sometimes neglect to address the bigger picture, an ethics expert says.
