The Common Rule
The Revised Common Rule (“New Rule”) Guidance
We want you to be aware of the changes that went into effect on January 21, 2019 (see History and Effective Date information below) stemming from the revision of the Common Rule, which dictates IRB regulations. As we obtain more information, we will provide more detailed information to our researchers. Please review federal guidance and FAQs regarding the implementation of the revised Common Rule.
History and Effective Date of the Revised Common Rule
The process to make changes to the 1991 Common Rule began several years ago in 2011. A Final Rule making the long-awaited changes was published in January 2017, with most provisions to be effective in January 2018. In January 2018, an Interim Final Rule was published, delaying the New Rule until July 2018.
In April 2018, a Proposed Rule was published, seeking public comment on whether the New Rule should be further delayed, until January 2019. The Proposed Rule also introduced the possibility of allowing some of the New Rule to be implemented, while delaying the rest of the New Rule. In June 2018, the general compliance date of the New Rule was delayed until January 21, 2019. While the most recent postponement does include a provision for implementation of three provisions in the interim, ETSU has decided to not implement this New Rule in stages, as doing so is likely to increase confusion and complexity.
Please note that the Food and Drug Administration (FDA) has its own rules, and no changes have been published about FDA rules. That means that none of these changes apply to research subject to FDA rules.
What Changes are Being Made?
The new rule adds new requirements to help make informed consent more understandable.
1. The new rule requires that informed consent begins with a concise and focused presentation of the key information that is most likely to assist someone understand the reasons why they might or might not want to participate in the research. The consent must be organized and presented in a way that facilitates comprehension, and provide sufficient information that a “reasonable person” would want to have. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts.
Shorter consents (3 pages of less) may be determined by the IRB to already meet the concise summary requirement and not require addition of a beginning summary. This will be evaluated on a study-by-study basis. All other studies will be required to include a concise summary at the beginning. Examples of concise summaries will be added to the IRB website.
2. The new rule also adds some additional required elements to the consent document.
A. If your study involves identifiable private information or identifiable biospecimens, then the consent must clearly say whether that information or those specimens could be de-identified and used for additional research.
"Your de-identified information or biospecimens could be used for future research without asking you to give additional informed consent."
"Your information or biospecimens will not be used or distributed for future research even if we remove the identifiers. Please note that if you choose this option, no data or specimens from the study can be shared, even if de-identified."
B. If your study involves biospecimens (with or without identifiers), then the consent must say that biospecimens may be used for commercial profit. The consent also has to say whether the participant will or will not share in the profit. In addition, you must say whether your research will or might include whole genome sequencing.
C. If your study involves clinical procedures, then the consent must say whether you will return clinically relevant research results, including individual research results, to participants. If results will be shared with participants, then the consent has to explain under what conditions they will be told those results.
3. The new rules also add a new criteria for waiving or altering informed consent.
If your study uses identifiable private information or biospecimens, then you will need to explain why you can’t do the research by using information or specimens that are not identifiable.
A revised consent template has been added to the ETSU IRB website.
New Exempt Categories
The new rule changes almost every exempt category and adds a few new ones. The major changes are:
- Addition of a new category that allows benign behavioral interventions
- Revision of category 4 to allow review of records, even if prospective, and to allow recording of identifiers (may require additional limited IRB review)
- Addition of new categories for repositories using broad consent. Please note that ETSU will not implement new repository categories until necessary infrastructure is available to track those who decline to give broad consent.
One of the major changes in the new rule is that continuing reviews will not be required for expedited studies, unless the IRB thinks that the review is needed to help protect participants. In addition, once studies reviewed by the convened board reach a certain point, they would no longer require continuing review.
Please note that these new rules do not apply to FDA studies. All studies subject to FDA rules will still have continuing reviews. In addition, this does not change the requirements for all researchers to submit modifications and unanticipated problems, etc.
During annual continuing review, ETSU IRB staff administratively verify continuing compliance with other requirements such as CITI, HIPAA, and GCP training as applicable. Therefore, the IRB has implemented an administrative check-in process for exempt and approved research that do not require continuing review.
Administrative check-in is a periodic administrative review of ongoing research activities that do not require continuing review. Review of the administrative check-in will be completed by IRB staff and will be documented in the study record. Investigators are informed of the administrative check-in date in the exempt or study approval letter. Investigators will receive electronic reminders with instructions for how to submit the Admin Check-in xform in IRB Manager.
Although continuing review is no longer required by the regulations for exempt and expedited research, ETSU maintains responsibility for ensuring adequate oversight of ongoing research and must keep our research records current. The administrative check-in process will allow the ETSU IRB to verify compliance with other requirements such as investigator and study training. The check-in process also allows ETSU to maintain an accurate accounting for all active and ongoing research.
Investigators remain responsible for submitting all study modifications and reportable events (i.e., UPIRTSOs, protocol deviations, safety reports, etc.) in accordance with ETSU IRB Policy. Investigators are also responsible for notifying the IRB of all study closures.
Single IRB Review
The revised Common Rule includes a requirement for all federally funded, multisite studies that are not exempt to use a single IRB review model. This means that studies subject to the sIRB mandate must use a single IRB of record to provide IRB oversight for all the study sites. The effective date for the sIRB mandate is January 20, 2020 and applies to all federally funded, cooperative research occurring in the US.
Investigators applying for federal funding for proposed research that will occur at more than one site must develop a plan for complying with the sIRB mandate. Considerations include selecting an IRB to review the study on behalf of all sites, confirming that all sites will rely on the selected IRB, and budgeting for IRB review fees and coordination of the multisite research. More information regarding sIRB is available here. Investigators should contact the ETSU IRB and ORSPA to address sIRB requirements at least 60 days prior to the proposal due date.
The revised Common Rule now defines Clinical Trial as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes." [45 CFR 46.102(b)] All federally funded human subject research meeting this defition must post one (1) consent form used to enroll subjects on a publicly available federal website after the trial has closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. [45 CFR 46.116(h)]
The investigator (primary awardee) is responsible for ensuring compliance with this requirement. OHRP has identified www.clinicaltrials.gov as an acceptable website for posting the clinical trial consent form. The consent form posted does not have to be a particular version, so long as it was IRB-approved and used to enroll subjects.
What does this mean for my research?
All studies determined to be exempt or approved on and after January 21, 2019, must comply with the New Rule. Addtionally all studies that were originally approved prior to January 21, 2019 but subsequently transitioned to the New Rule must comply.
For studies initially approved prior to January 21, 2019:
Studies approved prior to January 21, 2019 were approved to comply with the "Old Rrule." Those studies are not required to comply with the New Rule unless the IRB transitions the study to comply with the revised Common Rule. Exempt studies will remain under the old rule, as there is no benefit in transitioning exempt studies. Full board research that is still open to accrual will not be transitioned to the revised Common Rule. The benefit of transitioning is that the new rule may reduce ongoing burden on both reviewers and researchers. However, transitioned studies must comply with all applicable provisions of the New Rule, which may cause additional work upfront, such as revisions of the informed consent and/or evaluation of new waiver criteria.
The ETSU IRB began transitioning eligible research on June 5, 2020 in a phased process, and the first phase included non-exempt research that in data analysis or long-term follow-up only. The group transition occurred on June 5, 2020, and all eligible studies were transitioned by the IRB Staff with a notification sent to the PI at time of transition. The second phase focuses on the remaining active expedited studies, and the transition will occur at time of next continuing review. The newest version of the Continuing Review xform includes additional questions for studies eligible for transition. Investigators may need to make revisions to study documentation or procedures in order to comply with the revised Common Rule as part of the transition process. The IRB Staff will work with investigators to complete the required changes prior transitioning research to ensure compliance.
The Quillen VAMC decided not to transition any research occuring at its facility; therefore VA studies are not eligible to be transitioned to the New Rule. Additionally, studies that are subject to FDA or DOD regulation will not be transitioned nor will clinical trials that are still enrolling subjects. As each active study will be transitioned on a case-by-case basis, the ETSU IRB may determine that other studies are not eligible.
Changes to the Submission Process beginning January 2019:
In order for ETSU to implement the New Rule, a revised New Protocol Submission xForm was developed that incorporated new questions and requirements as part of the New Rule. There were also new consent templates that include updated consent regulations. Any studies approved after January 21, 2019 must submit using the most current NPS xForm and consent template to ensure that the submission complies with the New Rule requirements. Effectively there are no other changes to the submission and review process, as most changes in the New Rule affect IRB review operations rather than investigator requirements.
Investigators conducting federally funded multisite studies and/or clinical trials do face additional regulatory requirements as noted above. Any questions about those requirements should be directed to our office.
Where can I read more about the Revised Common Rule?
For the full text of the Federal Register April 2018 notice, click here.
For the full text of the Revised Common Rule, click here.
The Human Research Protection Program released a series of Newsletters that covered the revised Common Rule.
Contact us if you have any questions or concerns about the new regulations.