IRB/HRPP Roadmap

HOW TO USE THIS PAGE

The overall study roadmap has been divided into three sections:

  1. Preparation
  2. On Study
  3. End of Study

Within each section, click through the considerations at the left to view relevant guidance and links to additional information or resources.

Preparation

Organizational Buy-In

IRBs and HRPPs are important stakeholders and advisors throughout IRR, particularly during initiation of an IRR pilot or program, at any organization or institution

Make sure to stay involved to both guide practices towards those that are beneficial to participants, and to establish appropriate expectations for what should be included to enable appropriate IRB review

Establishing a Policy

IRBs are encouraged to create policies or guidelines for what they will require and review relating to return of individual results. This will help standardize the review process as programs evolve and enable return of results plans to be better formulated before IRB review takes place

Protocol Writing

Setting Expectations

  • There should be clarity around what should be included in IRB review as it pertains to IRR. Make sure expectations are communicated to study teams so that needed information is provided
  • Note that If you return results you must have full board IRB review (and cannot, e.g., use the broad consent exemption for minimized review) (45 CFR 46.104(d)(8))

Regulations

On Study

Informed Consent

Informed Consent Form

Decision making

  • The participant’s decision must be made carefully so that they understand what will or will not be returned, and why, and to avoid upsetting experiences from receiving results (to the extent that is possible). This process will require preparation before and time during the informed consent process

Early and Mid-Study

Providing mid-study consultation

End of Study

Maintaining oversight

  • IRBs will need to think through whether the return of IRR warrants a study to remain open until all results have been returned, and/or what their level of oversight will be.

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