The Federal Policy for the Protection of Human Subjects has been revised with new requirements becoming effective 1/19/2018. An overview of the significant changes to
the Common Rule include:
■Establishes
new requirements regarding the information that must be given to prospective
research subjects as part of the informed consent process.
■Allows
the use of broad consent (i.e., seeking prospective consent to unspecified
future research) from a subject for storage, maintenance, and secondary
research use of identifiable private information and identifiable biospecimens.
Broad consent will be an optional alternative that an investigator may choose
instead of, for example, conducting the research on nonidentified information
and nonidentified biospecimens, having an institutional review board (IRB)
waive the requirement for informed consent, or obtaining consent for a specific
study.
■Establishes
new exempt categories of research based on their risk profile. Under some of
the new categories, exempt research would be required to undergo limited IRB
review to ensure that there are adequate privacy safeguards for identifiable
private information and identifiable biospecimens.
■Creates
a requirement for U.S.-based institutions engaged in cooperative research to
use a single IRB for that portion of the research that takes place within the
United States, with certain exceptions. This requirement becomes effective 3
years after publication of the final rule.
■Removes
the requirement to conduct continuing review of ongoing research for studies
that undergo expedited review and for studies that have completed study
interventions and are merely analyzing study data or involve only observational
follow up in conjunction with standard clinical care.
For further information, visit:Federal Policy for the Protection of Human Subjects
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