How are US institutions implementing the new key information requirement?
Ontology highlight
ABSTRACT:
SUBMITTER: Mozersky J
PROVIDER: S-EPMC7681124 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
Publications
How are US institutions implementing the new key information requirement?
Mozersky Jessica J Wroblewski Matthew P MP Solomon Erin D ED DuBois James M JM
Journal of clinical and translational science 20200110 4
Recent revisions to the Federal Policy for the Protections of Human Subjects require that informed consent documents begin with a "concise and focused presentation" of the key information a participant requires. Key information "must be organized and presented in a way that facilitates comprehension." The regulations do not specify what information be included, nor how it must be presented to facilitate comprehension. It is unknown how institutions and Institutional Review Boards (IRBs) are inte ...[more]
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