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The broad consent would be limited to information and biospecimens in existence at the time consent was granted or collected for up to 10 years thereafter (or up to the age of consent for minors).
Subjects would be informed that they could withdraw consent at any time without penalty or loss of benefits. In the Final Rule, the Agencies permit researchers to obtain broad consent to store, maintain, and use identifiable private information and biospecimens with some changes from the NPRM.
If subjects will not be told about a specific future study’s details, subjects must be told that their specimens may be used for research to which they may not have consented.
Furthermore, if the proposed secondary research is controversial or objectionable, investigators should include a more robust description to meet the “reasonable person” standard.
Institutions that choose to convert approved, waived, or exempted research to the new requirements may do so upon making a formal determination with the IRB overseeing that research that the Final Rule would apply.
The Agencies suggested relegating extraneous technical information to appendices. In the Final Rule, the Agencies allowed more freedom in the drafting of informed consent forms.
Information must be organized and presented with sufficient detail and in such a way as to facilitate the prospective subject’s understanding of why he or she may or may not want to participate.
However, in recognition of the time needed to adjust institutional structures and policies, this requirement will not be effective until January 19, 2020. Despite overwhelming criticism, the Final Rule adopts the NPRM proposal.
As a result, clinical trials conducted or supported by Common Rule Agencies must upload the IRB-approved consent form used to enroll subjects to a yet-to-be-created federal website no later than 60 days after the last study visit by any subject.