The Revised Common Rule
& CUNY HRPP Plan to Implement Revised Changes
The purpose of this announcement is to provide you with the Human Research Protection Program (HRPP) plans to implement the revised regulations governing research involving human subjects, the Common Rule. We refer to the revised regulations as 'the revised Common Rule' throughout this notice.
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies issued final revisions to the Common Rule, the Federal Policy for the Protection of Human Subjects, on January 19, 2017. The implementation was delayed twice in the last year. The final implementation and compliance date is January 21, 2019.
The revised rule is not applicable to FDA (Food and Drug Administration) and DOJ (Department of Justice) regulated research. However, FDA plans to post a notice of draft revised FDA regulations intended to harmonize with the revised rule requirements. If you are involved in the conduct of FDA-regulated research, you should be aware that these changes may be directly applicable to your research in the future.
CUNY published revised HRPP policies, procedures and guidelines on the CUNY HRPP Policies & Procedures website.
This communication addresses the following aspects of the revised Common Rule that may be important to you:
1. Application of the revised Common Rule to research approved by the IRB prior to the implementation date
2. Minimal risk research
3. Exempt research/modified and new exemption categories
4. Informed consent requirements
5. Single IRB of Record requirements
6. IDEATE system updates
7. Changes in IRB practices to accommodate the revised rule
8. Next Steps
1) Application of the revised Common Rule to research approved prior to the implementation date
As of January 21, 2019, ALL applications (not just initial applications) will be processed in accordance to the Common Rule changes. Any applications (i.e., Amendment Requests, Continuing Reviews) submitted for existing IRB-approved projects will be required to update their IRB protocols as per the revised Common Rule. Research approved prior to January 21, 2019 will continue to conduct their pre-2018 IRB-approved research procedures until an Amendment Request or Continuing Review is submitted.
IRB protocols submitting Continuing Reviews for the first time after the implementation of the revised Common Rule, will be asked to submit an Amendment Request so the protocol can be updated as per the new federal changes.
2) Minimal Risk Research
The revised Common Rule allows for most minimal risk research to be conducted without IRB continuing review.
- The CUNY UI-IRB will NOT require continuing review for applicable minimal risk research approved after January 21, 2019; unless required by the CUNY UI-IRB.
- Research approved prior to January 21, 2019 with an expiration date:
- Prior to the protocol’s expiration date, a Continuing Review must be submitted along with an Amendment Request so the applicable changes can be made to the protocol.
- Upon submitting an Amendment Request, Investigators must update the protocol as per the federal changes. At that point, the CUNY UI-IRB will determine whether the human subject research study can be approved without the requirement for annual IRB review (elimination of expiration date).
Regardless of the continuing review category above, Investigators must still report modifications and reportable new information to the IRB, including, but not limited to, changes in research or study personnel, study closures, events that may constitute noncompliance, and potential unanticipated problems (e.g., involving risks to subject or others).
3) Exempt Research
The revised common rule changed the categories of research that can be deemed exempt. The revised rule includes a new exemption category 3 (i) (A), (B), and (C), which allows for certain benign behavioral interventions to be considered exempt.
Regardless of the exemption category, the requests for exemption determination must be submitted to the HRPP Office via IDEATE per institutional requirements. Exempt research cannot commence without an HRPP exemption determination from CUNY.
4) Informed Consent Requirements
CUNY UI-IRB will apply additional revised Common Rule consent provisions to new and existing research approved by the IRB after January 21, 2019.
- Required changes to consent forms includes a “concise and focused presentation of the key information” at the beginning (as required under §46.116(a) of the revised Common Rule), which must be organized and presented in a way that facilitates comprehension.
- One new element, added to the basic elements of informed consent at §46.116(b), requires a notice about whether participants’ private identifiable information, or identifiable biospecimens, collected as part of the current research might be stripped of identifiers and used/shared for future research, OR a clear statement that this will not happen.
New consent templates that reflect the new provisions can be found in the CUNY HRPP Policy website. Since these consent templates are subject to future updates, we recommend you bookmark the website page on your online browsers.
If your new study has been submitted and pending IRB approval on January 21, the consent form submitted does not comply with the new regulatory requirements. An HRPP staff member will work with you to ensure that the new elements are added.
5) Single IRB of Record
The revised rule requires a single IRB to review certain NIH-funded multi-site research. This request can be submitted directly to our office (email@example.com) via the IRB of Record Request form found here.
6) IDEATE System Updates
CUNY is working with IDEATE to implement changes to the IDEATE system per the revised rule. Projects that are currently in-development/various stages of the submission/approval process will be automatically updated to include the application updates resulting from the revised Common Rule.
- If you have a pending protocol, it will be returned to your To-Do-List so the application can be updated to incorporate the new changes to the application (answer the newly-prompted questions in the form) and update consent documents to include new elements of informed consent.
- Investigators resubmitting protocols, pending IRB review, should review their IRB application(s) thoroughly before submitting to the HRPP. Ensure all questions that appear in the IRB application are answered. Protocols resubmitted to our office with any unanswered questions will be returned to the Investigator’s To-Do-List for further completion/updating.
7) Changes in IRB practices to accommodate the revised rule
Changes to the Approval stamps on Consent Forms and Protocol: Beginning January 22, 2019, IRB-approved consent forms and research protocols will include an approval date only in the footer of the document. The approval stamp will no longer include a protocol expiration date for protocols whom the CUNY UI-IRB have determined no longer require annual review. Research determined to no longer require annual IRB review, will no longer need to submit a Continuing Review submission.
If your study is determined to not require annual IRB review, it is HIGHLY recommended that Investigators continue to be conscious of their enrollment numbers for the entirety of the project.
8) Next Steps
The Queens College Office of Regulatory Compliance will send additional notices as we get closer to the implementation date. Further, we will hold IDEATE workshops to go over the changes and submission requirements. As a reminder, CUNY Policies and Guidance documents revised as per the Revised Common Rule can be found on CUNY's website. Further detailed information regarding changes to the Common Rule are available on the OHRP ‘Final Revisions to the Common Rule’ webpage.
If you have any questions or concerns regarding the implementation of the revised common rule, please send them to firstname.lastname@example.org. We expect a large volume of inquiries and will compile them into an FAQ document for the research community and address them in the subsequent communication.
Thank you for your patience during this transition period.