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There can be murky situations in which the right interpretation of HIPAA is not obvious, says Patricia Wagner, JD, an attorney with the law firm of Epstein Becker Green in Washington, DC.
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One chief hurdle in human research protection program (HRPP) accreditation is the mindset that its all about the IRB, an expert says.
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While the informational quality of internationally registered trials has increased, theres still room for improvement, according to a recent study.
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An IRB member and human research protection expert learned firsthand how complicated informed consent (IC) forms could be when her granddaughter was seriously ill.
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The exponential increase in smartphones and social networking sites has led to concerns from some patients regarding the possible unlawful distribution of images outside the realms of their care.
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The Cincinnati Childrens Hospital Medical Center IRB and a special task force developed guidance and a template for improving and simplifying informed consent forms.
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As technology in genetic and genomic research expands, most if not all IRBs will face the issue of incidental findings, including how to manage them, and whether researchers have a duty to report them to study participants, experts say.
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There are no industry standards for handling incidental findings (IFs) in research.
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IRBs often struggle with determining risks of social and behavioral research studies. Its easy to be both too cautious and too complacent.
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Health care providers frequently have misconceptions about legal requirements of end-of-life care. By educating providers about how to make decisions when people lose capacity, fewer formal ethics or legal consults will be needed.