SACHRP recommendations approved March 13, 2018
FAQs Relating to Recommendations on Broad Consent
FAQ #1: Must the exemption at §_.104(d)(8) and the exemption at §_.104(d)(7) be used together?
No, as outlined below, there are several situations in which one of the two exemptions may be available, although the other is not available or is not feasible for the proposed activity.
The final rule contains eight independent categories of human subjects research that are exempt from the policy, except that such activities must comply with the requirements specified for each category. Under §_.104(d)(7), the storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use is exempt, except that such research must involve an institutional review board (“IRB”) conducting a limited IRB review and making the determinations required under §_.111(a)(8). Separately, under §_.104(d)(8), secondary research involving the use of identifiable private information or identifiable biospecimens is exempt if, among other requirements, broad consent was obtained for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens in accordance with §_.116(a)(1) through (4), (a)(6), and (d). As emphasized, the exemption at §_.104(d)(7), involves the storage or maintenance of identifiable private information or identifiable biospecimens, whereas §_.104(d)(8) establishes an exempt pathway for the secondary research use of stored and maintained identifiable private information or identifiable biospecimens. Exempt research under §_.104(d)(7) would require an IRB to determine that broad consent is obtained in accordance with §_.116(a)(1) through (4), (a)(6), and (d) for the storage and maintenance of identifiable private information or identifiable biospecimens. Thus, secondary research use of stored and maintained information and biospecimens exempt under §_.104(d)(7) could qualify for exemption under §_.104(d)(8) as long as the other requirements under §_.104(d)(8)(ii), (iii), and (iv) are satisfied. In fact, the preamble to the final rule specifies that secondary research use exemption under §_.104(d)(8) “would generally be conducted with the information or biospecimens stored and maintained under the exemption at §_.104(d)(7).” See 82 Fed. Reg. 7149, 7196 (Jan. 19, 2017). The preamble also indicates that the two exemptions “will frequently be paired” (82 Fed. Reg. at 7198).
However, secondary research use could be exempt under §_.104(d)(8) even if the storage and maintenance were not exempt under §_.104(d)(7) but instead had undergone full or expedited IRB review. For example, a primary interventional study could include a separate banking component for identified biospecimens and data collected in the primary study, with a “broad consent” covering the future uses of those biospecimens and data. Such a study would undergo full IRB review and approval, and the maintenance and storage would not need to take advantage of the §_.104(d)(7) exemption, even though future uses would take advantage of the §_.104(d)(8) exemption.
Similarly, there could be identifiable biospecimens and data collected with “broad consent” whose storage and maintenance would be exempt under §_.104(d)(7), although the investigator may prefer to submit (or may be required by IRB or institutional policy to submit) a protocol to the IRB for full or expedited review and approval, including a request for waiver of consent and authorization for each future use of those biospecimens and data. This may be necessary in situations in which the future research use includes genetic testing or genomic sequencing, and applicable state law requires that such research be done only under an IRB-approved protocol, thus rendering impossible the use of the §_.104(d)(8) exemption.
Another situation in which the two exemptions would not be used together include a future research use in which investigators seek to return results to subjects, making the §_.104(d)(8) exemption unavailable, even though maintenance and storage of the identifiable data and biospecimens was conducted under §_.104(d)(7).
Finally, a “broad consent” adequate to receive the §_.104(d)(7) exemption for storage and maintenance may not have adequately expressed the future research use now planned, making the §_.104(d)(8) use exemption unavailable.
FAQ #2: For existing databanks and repositories of identifiable private information and identifiable biospecimens, would continued data and biospecimen storage of such materials and information, performed after the compliance date of the final rule be subject to pre-2018 Requirements or the final rule?
A protocol approved by an IRB, prior to the compliance date of the final rule, to establish a databank or repository would continue to remain in effect after the compliance date of the final rule, even if the protocol is later amended or modified. Data and specimen storage and maintenance conducted under a protocol approved before the compliance date of the final rule would not be affected by the final rule. Similarly, the consent language that allowed for the storage and maintenance of identifiable private information and identifiable biospecimens, approved under the pre-2018 Requirements, would remain valid for already stored and maintained biospecimens and information, and consent under the final rule would not need to be obtained again from the human sources of those materials and data. Future acquisition and storage of identifiable data and biospecimens, if undertaken under the same protocol that had been approved prior to the compliance date, would also be handled under the pre-2018 requirements.
FAQ #3: What is the effect of a regulatory “broad consent” that was obtained prior to the effective date of the final rule?
It is possible that a “broad consent” that meets all the requirements imposed by the final rule could be drafted and used prior to the effective date of the final rule. If all “broad consent” requirements of the final rule have been met, then such a “broad consent” could be deemed to be effective, and could be used for exemption purposes, after the effective date of the final rule. However, it is important to note that under the final rule, when a “broad consent” has been offered and refused, a waiver of consent cannot be obtained for that person refusing “broad consent.” For a “broad consent” obtained prior to the effective date of the final rule to be fully effective, therefore, it would be theoretically necessary also to treat pre-effective date refusals of “broad consent” according to final rule standards, and exclude the identifiable information of those refusing from being able to be used under a waiver of consent.
FAQ #4: Could a databank or repository have certain of its stored specimens and data be subject to the pre-2018 Requirements and other stored specimens and data subject to the revised, final rule?
If a regulatory “broad consent” consistent with the final rule is used for new data and/or biospecimen contributions being added to a repository or databank approved prior to the compliance date, some of the collection of identifiable biospecimens or identifiable private information for storage in a repository or databank would fall under the “broad consent” requirements of the final rule, while others not collected under a “broad consent” would not. Thus, the final rule and the pre-2018 Requirements may apply to different protocols within the same databank or repository, or even to different biospecimens and information within the same protocol, depending on whether each set of identifiable data and biospecimens had been obtained under a “broad consent,” or under a consent that does not contain the required elements of “broad consent.” In these situations, to implement fully the final rule, repositories and databanks would need to adopt a system to track, at the least, the identifiable biospecimens and identifiable private information for which individuals had provided their broad consent, as well as the terms of the broad consent, to determine how the materials and information collected under that broad consent may be stored, maintained, and used for secondary research purposes.
FAQ #5: If research is jointly regulated by OHRP and FDA, because FDA has not yet adopted the final rule, can the final rule’s “broad consent” be used as an alternative to general consent requirements?
As noted in the preamble to the final rule, FDA will consider the need to update its regulations to harmonize with the revisions to the Common Rule. In addition, the 21st Century Cures Act enacted in December 2016 requires that the HHS Secretary, to the extent practicable and consistent with other statutory provisions, harmonize the differences between 45 CFR part 46, subpart A, and FDA’s human subject regulations. Unless and until FDA updates its regulations, if research is subject to both FDA regulation and the revised Common Rule, FDA would require that the informed consent satisfy FDA’s applicable requirements at 21 C.F.R. Part 50.