New Policy Implementation Guidance

September 15, 2020

Dear Research Community

Over the past 18 months, we have rewritten the HRPP policies to be compliant with the revised common rule and consistent with the reorganization of OHSRP and the NIH IRBs.  As these policies are all inter-related, with few exceptions we were not able to implement them as they were developed and cleared.  Now that they are complete, we are rolling them out in groups between now and years end.  We understand that releasing so many new policies rapidly is a little overwhelming.  Hopefully, as you become familiar with the new policies, you will see that in many cases there is not a lot of change in the actual policy requirements, and for those that there is change, it is for the better.

To guide you in the implementation of these new policies, please review the following:

• Each policy has a release date and an implementation date.  The release date is when we post it on the web and make it available.  The implementation date is when you should begin following the new policy requirement in your research.
• If a new policy impacts what is written in your consent or protocol, you do not need to immediately update the consent/protocol to be consistent with the revised policy.  In fact, we would prefer that you don’t, as this will lead to a surge in amendment submissions which would rapidly overwhelm the office.  You can update the documents with the next planned amendment to the IRB.  Even if you do not update the sections with an amendment, the IRB will not stipulate that you update the documents at this time.  At some point in early 2021, the IRB office will begin requiring that the relevant sections of the protocols/consents be updated.

For example, the new policy requires that the protocol and consent describe the compensation plan, even if the plan is that there will be no compensation.  Some protocols that are not compensating subjects are silent on this.  At this time, you do not need to amend your protocol to add a new section stating there is no compensation. With your next planned amendment you can change this.

• You should implement the new policies on their effective date, even if your protocol 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 policy as of the effective date of September 14, but you do not need to immediately amend your protocol.  You should change this section of your protocol only with your next planned amendment.  In this case, even though your protocol does not match your actions, you do NOT need to submit a Reportable Event Form (REF) for a protocol deviation.