HOW TO USE THIS PAGE
The overall study roadmap has been divided into three sections:
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
- Ensuring compliance with local, regional, or country-level regulations will often fall within the role of the HRPP
On Study
Informed Consent
Informed Consent Form
- Plans for IRR should be made during protocol development to enable all relevant details around IRR to be given to the participant during the informed consent process. The IRB should determine which details need to be included in the Informed Consent Form, and which can be communicated in other ways
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
- Click here for decision-making resources for participants
- Click here for our work on health literacy in informed consent
- Note that decisions around receiving results should be reviewed as needed throughout study participation, and there should be opportunities to update those decisions as appropriate
Early and Mid-Study
Providing mid-study consultation
- An IRB consult may be needed during the study in the event of urgent or incidental results. Ideally, a thought-out plan for handling urgent results will have been anticipated, included in the protocol, and reviewed by the IRB before the study begins, and thus consult would not be needed
- Note that IRBs should not be expected to interpret results or provide any medical opinion or advice. It may help to involve a specialist in the area of return when the protocol and consent is being reviewed if expert insight is helpful to advise the study team regarding data return (e.g., genomic test results)
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.