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Common Rule Bulletin #6: Broad Consent


NIH OFFICE OF HUMAN SUBJECTS RESEARCH PROTECTIONS (OHSRP) GUIDANCE ON THE REVISED COMMON RULE

Common Rule Bulletin # 6: Informed Consent Requirements – “Broad Consent”

The revised Common Rule (rCR), referred to as the “2018 requirements” or sometimes as “the Final Rule”, contains several new provisions that take effect for all new research reviewed on and after January 21, 2019. This bulletin will provide a general overview of the “Broad Consent” provision however, at this time, it will not be implemented within the NIH Intramural Research Program (IRP). Note: This guidance is intended for use by the NIH IRP and may be superseded by future NIH guidance or policy, or guidance issued by the Office for Human Research Protections (OHRP).

Broad Consent in the rCR allows subjects to agree to the unspecified future use of their identifiable private information and identifiable biospecimens in secondary research studies. If this type of consent is obtained, investigators can use these identifiable materials without having to obtain additional consent for their storage, maintenance or use in subsequent research, provided the future activities fall within the scope of the original Broad Consent.

The provision is considered consistent with one of the main aims of the rCR, to facilitate the conduct of minimal risk research while enhancing the autonomy of subjects. Broad Consent gives subjects the ability to explicitly decide whether to allow secondary research with their identifiable private information and biospecimens.

What is required for Broad Consent?

To be legally effective, Broad Consent must contain a series of specific components that bring together a subset of traditional consent elements (e.g., a description of any benefits to the subject or to others that may reasonably be expected from the research) with a further six distinct elements - these are outlined in §_.116(d) of the rCR.

When can Broad Consent be used?

  • The mechanism of “Broad Consent” can only be used to allow for the storage, maintenance, and use in secondary research of identifiable data and/or specimens.
    • Secondary research describes future research that falls outside the circumstances in which the data and/or specimens were originally collected. It can therefore include research with data and/or specimens collected for non-research purposes (such as clinical specimens) or collected in unrelated research studies.
  • The secondary research must however fall within the scope of the future research described in the original Broad Consent. Investigators have discretion in the Broad Consent to either limit the scope of secondary research to a narrow focus (e.g., breast cancer in those with a BRCA1 or BRCA2 gene mutation), or allow for a broad scope (e.g., any biomedical research).
  • Broad Consent therefore provides investigators with an alternative to obtaining study-specific consent or obtaining an IRB waiver of consent for previously collected data/specimens.
  • An important limitation to the provision is that unlike study-specific consents, the IRB cannot waive consent for the use of identifiable data and/or specimens in secondary research when a subject has refused to provide Broad Consent. 1 This means that investigators and institutions must be able to reliably track and identify any data and/or specimens where Broad Consent has been refused, to assure that they are not used for future research under a waiver of consent.
  • Secondary research activities using data and/or specimens collected with Broad Consent may also be used to qualify under two new exemption categories (7 and 8), provided the proposed secondary research falls within the scope of the Broad Consent and the IRB performs a limited IRB review.

How will Broad Consent apply at the NIH?

  • For the moment, the NIH has decided not to implement the Broad Consent provision of the rCR.
  • Under the regulation, Broad Consent involves a very specific and detailed set of elements that current consent language about future research does not generally include.
  • There are also inherent challenges in instituting a system that can effectively track the identifiable data and biospecimens of subjects who have provided Broad Consent and the terms of that consent, as well as instances where there has been a refusal to consent, particularly over the lifetime of a subject.
  • Once the NIH IRB centralization has been completed, further consideration will be given to the practicalities of implementing Broad Consent at the NIH.



1 §_.116(f)