If you receive a federal grant to conduct human subject research, you are obligated to comply with the applicable regulations of the funding department or agency. The Common Rule found at 45 CFR 46 is the regulation that most funding sources follow. The Common Rule provides the definitions, exemptions and procedures an institution receiving the funds must follow.
On April 20, 2018 The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) proposing to delay for an additional 6 months the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”). Read more here.
Significant revisions to the Common Rule may take effect on July 19, 2018.
Revisions to be aware of:
- Consent forms have a new format and must include additional information.
- There are new requirements for waivers of consent when using or accessing identifiable data and biospecimens.
- Continuing review is no longer required for most studies that qualify for expedited review.
- There are new exemption categories and clarification about existing categories.
- Some exempt research will require limited IRB review.
- Clinical trials must post one IRB-approved informed consent form to a publicly available Federal website within 60 days of study completion.
How will the new rule affect UC Davis Researchers?
- Researchers must use a consent template that complies with the new rule.
- Researchers requesting a waiver of consent for access to or use of private identifiable information or biospecimens must explain why the research cannot practicably be conducted using anonymous or coded data or specimens when completing the protocol template.
- Research qualifying for expedited review will not be given an expiration date.
The revisions to the Common Rule will have no effect on most existing research. All existing research may continue uninterrupted and must follow the old rule (the rule in effect before 2018.)
Investigators must continue to submit continuing review/progress reports before the administrative due date, as is the current practice. During the continuing review process, the IRB will determine if the research complies with the new rule. If the research qualifies for expedited review and complies with the new rule, no expiration date will be issued.
If an investigator wants the IRB to apply the new rule to existing research that is not due for continuing review, s/he may submit a modification to the IRB. If the study is open to enrollment or requires access to private identifiable data or specimens changes will be required to comply with the new rule. To modify a study to comply with the new rule researchers must:
- Provide evidence that the research now qualifies for an exemption or limited IRB review, or
- Update consent forms to comply with the new rule, or
- Request a waiver of consent for access or use of private identifiable information or biospecimens by explaining why the research cannot practicably be conducted using anonymous or coded data or specimens.
Even when continuing review is not required, investigators remain responsible for submitting all modifications to research, reporting all necessary information to the IRB, and closing the project with the IRB when the human subjects research is complete.
What is “Broad Consent?”
The term “Broad Consent” as defined by the Common Rule implemented in 2018 applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, UC Davis is not pursuing broad consent at this time. Investigators can continue to use biospecimens that are coded or to seek a waiver of consent for use of biospecimens with identifiers retained consistent with current practices.
What about the requirement for single IRB review of multisite studies?
The new Common Rule states that federally funded studies where the same protocol will be conducted at more than one domestic site must use a single IRB. The single IRB provision does not take effect until January 20, 2020. UC Davis researchers do not need to comply with this provision at this time unless the study is funded by the NIH. Additional information about NIH single IRB requirements can be found here.
What about FDA-regulated research?
The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed. The FDA still requires annual continuing review for FDA-regulated studies, even those FDA-regulated studies involving only minimal risk.
What if my research does not receive federal funding?
Studies that do not receive federal funds are not required to comply with the new rule. Existing research may continue uninterrupted for the current approval period. New projects that do not receive federal funding may use consent templates that comply with the new rule but are not required to do so.