TAG ARCHIVES FOR human subjects protections


by Meghan Timmel, Communications Coordinator

PRIM&R is only successful in advancing ethical research thanks to the work of our committed members. At December’s 2014 Advancing Ethical Research Conference, we recognized the substantial achievements and contributions of two such members, Susie Hoffman and Paula Knudson.

Susie Hoffman, RN, BSN, CIP, was the recipient of the 2014 Applied Research Ethics National Association (ARENA) Legacy Award, [...] Read more


In October, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance “discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with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Following up on the release of the draft guidance, PRIM&R held a session at the 2014 Advancing [...]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

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