On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance ...
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections ...
Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.
Industry groups, clinical researchers and patient advocates praised draft guidance from the US Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) that makes ...
Office of Human Research Protections slams the NHLBI's review and approval process for two trials in
Rockville, MD - The Office of Human Research Protections (OHRP) issued a 15-page indictment July 3 of the research review and approval process during two trials conducted by the ARDS Network of the ...
New courses from the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) now available on CITI Program’s platform CITI Program makes it easier for institutions ...
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