The Revised Common Rule includes two new exemption categories intended to facilitate the creation of biobanks for future research. Many institutions will struggle with how to implement these exemption categories, and will likely give up or encounter difficulties with compliance.

These new exemption categories allow an investigator to obtain “broad consent” from a subject for participation in a biobank that involves the storage, maintenance, or use of identifiable private information or identifiable biospecimens for future secondary research. Broad consent requires an informed consent process like that required by the current Common Rule, but with an abbreviated set of consent disclosures. These disclosures are a subset of the disclosures required under the current Common Rule along with additional disclosures specific to biobanking. On its face, these exemption categories seem to be a convenient alternative to the current processes used for IRB approval for research biobanks. However, that convenience comes with a price. If an individual is asked to provide broad consent to participate in biobanking for future research and refuses, an IRB can never waive or alter consent for that individual to participate in another research study involving biobanking for future research.

One operational necessity to comply with the requirements for broad consent is to track patient responses. Many institutions have set up biobanks for future research under the current Common Rule where the electronic medical record records whether subjects have been asked to participate, and if so, whether they have agreed or refused. Therefore, tracking subject responses for an individual biobank is feasible, but may be difficult for institutions unable to adapt their electronic medical record to track research participation. However, a unique feature of broad consent is that compliance with the regulations for waiver of informed consent requires attention to all research that was granted an exemption involving broad consent. Therefore, institutions also need to track all biobanks. When multiple departments and research groups each have their own biobank granted an exemption involving broad consent, institutions will find that their ability to track refusals becomes less feasible.

A feature of broad consent that is entirely unique to the new Common Rule is that compliance with the regulations for waiver of informed consent not only requires attention to the research protocol being reviewed, but also requires attention to research that may be unknown to the institution, the IRB, and the investigator. For example, many disease-specific patient advocacy groups have established databanks for future research where subjects sign HIPAA authorizations and researchers obtain data from the subjects’ healthcare providers. If these advocacy groups request broad consent, and the broad consent is refused, the advocacy group can track the refusal, but not the institutions from which information would have been sought. The new Common Rule prohibit waiver of consent for research, if the subject was asked to provide broad consent and refused. There is no limitation on whose research this applies to and who does the asking. Was the intent of the new Common Rule to prohibit waiver of consent for the institution’s research, if the subject was asked by employees or agents of the institution to provide broad consent and refused? In the absence of clarification from OHRP, institutions implementing broad consent will be forced to make assumptions.

Institutions that carefully study the new regulations will likely find alternatives to broad consent that are easier to implement, which will lead to limited acceptance of broad consent as an option. HIPAA-covered entities will find an exemption that permits the secondary research use of identifiable private information or identifiable biospecimens that are protected by HIPAA. It is likely that HIPAA-covered entities can use this exemption to conduct all research that would otherwise fall under the exemption categories requiring broad consent. Another option that institutions will likely adopt is to use current procedures where an IRB approves the collection of information and biospecimens for a databank where an honest broker is used so that subsequent research does not involve human subjects. Another option that institutions may adopt is to apply the waiver requirements only to research that is conducted or supported by a federal department or agency. In general, research that is not conducted or supported by a federal department or agency and is not FDA regulated is not subject to any regulations. In the case of unregulated research, institutions can apply the current Common Rule or other rules that apply equivalent ethical protections.

In summary, institutions will struggle to implement the two new exemption categories that involve broad consent. HIPAA-covered entities will likely use a different exemption category that provides much more flexibility. Institutions that are not HIPAA-covered entities will likely continue with procedures that predate the Revised Common Rule.

Jeffrey A. Cooper, MD, MMM, Vice President of Process and Strategic Improvement, WIRB-Copernicus Group. Dr. Cooper has more than thirty years of experience applying DHHS and FDA regulations with regard to operational efficiency, use of information technology, standards-based evaluation, and quality improvement in human subject research. He was one of the co-founders of the Association for the Accreditation of Human Research Programs (AAHRPP), and is a recipient of the PRIM&R Legacy Award for his work in protecting research participants.

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