TAG ARCHIVES FOR human subjects protections

9
Dec2014

In October, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance “discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with standards of care. It also discusses disclosing certain reasonably foreseeable risks to prospective subjects when seeking their informed consent to participate in such research activities.”

Following up on the release of the draft guidance, PRIM&R held a session at the 2014 Advancing [...] Read more

14
Nov2014

by James E. Lewis, PhD, an independent consultant and formerly a columnist for the Association of American Medical Colleges blog, Wing of Zock

A little known, but intentional, loophole in the federal regulations allows activities involving human subjects to be labeled “innovative care.” In spite of all that has been done since World War II to protect human subjects in clinical research, this ambiguity offers a mechanism through which unscrupulous individuals can avoid the ethical and regulatory obligations for the protection of human research subjects and the norms of professional and scholarly behavior. Recent cases demonstrating this dilemma can be found on the internet, but my purpose here is not [...] Read more

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