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Policy Update - 2020 Q3


Human Research Protection Program (HRPP) policy development is wrapping up. OHSRP began rolling out the policies late this Summer, the remaining policies will be rolled out through the end of 2020. To aid in understanding key information about each policy, OHSRP has also developed supporting tools for the community, an overview/change table and a narrated presentation.

  • The overview/change table is a tool for investigators and study teams that highlights key points of the policy and any changes from the previous SOP(s).
  • The narrated slides are a brief overview of the key points of the policy and are aimed at a broader audience, for example IRB members or IRBO staff in addition to investigators. These slide decks also include helpful tips for investigators such as what the IRB expects related to the policy.

OHSRP recognizes that the rollout schedule is aggressive, particularly given the large number of policies. This schedule is due to the fact that the NIH HRPP is about to undergo reaccreditation with AAHRP (see Accreditation Updates below for more information).We understand that this can cause anxiety and raise questions about implementation of changes resulting from implementation of the policies.We hope you saw the email regarding the Guide to Implementation of HRPP policies sent on September 15th. Although the policies have a new format and the policy topics have been reorganized, there are not a lot of new policy requirements. The new policy requirements address the revised Common Rule (45 CFR 46), the reorganization OHSRP and consolidation of the NIH IRBs. In addition, we hope that we have fixed issues from the previous SOPs. Below are helpful tips for implementation of the HRPP policies:

  • Each policy has a release date and an implementation date.
    • The release date is the date we post the policy on the web and make it available.
    • The implementation date is when you should begin following the new policy requirement on your research.
  • If a new policy impacts what is written in your protocol or consents, you do not need to immediately revise the protocol or consent(s) to be consistent with the revised policy. In fact, we would prefer that you do not revise your protocol/consent(s) immediately, as this will lead to a surge in amendment submissions which would rapidly overwhelm the IRB office. When to implement these changes in your protocol and consents:
    • With your next planned amendment to the IRB. However, even if you do not update the sections with an amendment, the IRB will not stipulate that you update the documents at this time. OR
    • In early 2021, when the IRB office will begin requiring that the relevant sections of the protocols/consents be updated.
  • However, you should change your actions to implement the new policies on their effective date, even if your protocol or consent(s) is not updated.
    • For example, the new policy on enrolling subjects who cannot consent for themselves (Policy 403) changes who can serve as the LAR for research in Category C research, and specifies a new next of kin hierarchy. You should follow the new next of kin hierarchy described in Policy 403 upon the effective date of Policy 403 (September 14, 2020), even if your written protocol does not reflect this practice.
  • Lastly, we know that when your protocol/consent does not match your actions, concerns arise about protocol deviations and the need to report them. You do not need to submit a Reportable Event Form (REF) for a protocol deviation during the time period between the implementation of new HRPP policies and early 2021 when IRB will start enforcing compliance with the policies in protocols and consents, or when your protocol is revised to match the new policy requirement, whichever is earlier.

If you have any questions about policy implementation, please reach out to OHSRP at irb@od.nih.gov.


Accreditation Activities

The clock is ticking! On September 15, 2020, OHSRP received the 6-month reminder for the AAHRPP Step 1 Application for re-accreditation. The Step 1 Application is due on March 15, 2021. This Fall, OHSRP will be reaching out to IC AAHRPP Liaisons to kick off data collection for the Step 1 application. Once the Step 1 Application is accepted by AAHRPP, OHSRP will be begin the Step 2 Application process leading up to the site visit. Leading up to the site visit, OHSRP will start educating the members of the NIH HRPP community who have been selected by AAHRPP to be interviewed during the site visit scheduled for January 2022. AAHRPP selects a representative cross-section of the NIH HRPP to be interviewed during the site visit including: NIH and IC leadership, Principal Investigators, research team members, IRB members, IRB staff and OHSRP staff. Keep an eye on the OHSRP Policy page accreditation section for more information.