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CUNY HRPP Plan to Implement Revised Regulations

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' or '2018 regulations' throughout this notice.

Summary

The revised common rule was initially issued on January 19, 2017 and was to become effective on January 19, 2018. The implementation was delayed twice in the last year. The final implementation and compliance date is now January 21, 2019.

The revised rule is not applicable to FDA 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. We will let you know if and when those changes occur.

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–Grandfathered Research
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/Grandfathered Research

Research approved prior to January 21, 2019 will continue to be reviewed under pre-2018 regulations. Later this year, we will evaluate whether to transition research approved prior to January 21, 2019 to the revised common rule at the time of continuing review.

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.
  • All research approved prior to January 21, 2019 with an expiration date, will require a continuing review submission.

Regardless of the continuing review category above, you 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).

The Hunter HRPP Office also will check in with the investigator/research team on an annual basis regarding the progress of the study.

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 a Hunter HRPP exemption determination.

4) Informed Consent Requirements

CUNY UI-IRB will apply additional revised common rule consent provisions to new research approved by the IRB after January 21, 2019.  New consent templates that reflect the new provisions will be posted on our website once CUNY publishes these materials (expected 1/18/19). This includes a “concise and focused presentation of the key information” as required under the revised section .116 of the revised common rule, along with other changes. If your new study has been submitted and is under review by the Hunter HRPP on January 21, 2019 but is not yet approved, and the consent form submitted does not comply with the  new regulatory requirements, a 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 via the IRB of Record Request form found here: http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/research-agreements/CUNY-HRPP-Form-for-Selecting-the-IRB-of-Record-12.17.17.pdf

6) IDEATE System Updates

CUNY is working with IDEATE to implement changes to the IDEATE system per the revised rule. These changes will be implemented over the course of the next two weeks. Projects that are currently in-development/under review will be automatically updated as of 1/22/2019. Therefore, we ask that if you have a project in-development, that you do not submit until this date to ensure your application reflects the necessary changes.

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. This change is necessary in order to manage the different regulatory requirements related to continuing review, and to allow for research no longer requiring continuing review per revised regulations to not have a IDEATE-system-generated expiration date added to the consent form.

8) Next Steps

The Hunter HRPP office 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. A number of CUNY Policies and Guidance documents are being revised as per the revisions and will be published on CUNY's website on 1/18/19.

If you have any questions or concerns regarding the implementation of the revised common rule, please send them to hrpp@hunter.cuny.edu.  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.

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