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
Investigators and their study teams should be included as key stakeholders if an organization is initiating a Return of Results program to allow for their expertise and perspectives to be incorporated
Protocol Writing
Planning
- It is essential to plan for the return of IRR during protocol writing, similar to plans for recruitment, data collection and storage, and analysis. While an organizational policy may be helpful, each study will require a tailored plan
Stakeholder collaboration
- Make sure that key stakeholders have the opportunity to provide input on a study’s plans for IRR. This will enable a better plan and will clarify responsibilities among the investigator, site staff, sponsor, and even a participant’s healthcare provider if they are involved in communication. This is also an opportunity to solicit feedback from patients or patient advocates about which results are most meaningful to them and how best to return them
Regulations
- Different countries and even states will have varied legal, ethical, and clinical frameworks. Investigators and their study teams should rely on their HRPPs and general counsel for guidance in these areas
IRB/Ethics Review
IRB Review Expectations
- There should be clear expectations set and communicated around what should be included in IRB review as it pertains to IRR. Make sure to communicate with your IRB/HRPP and/or sponsor as to their expectations and/or any resources, policies, or guidance they can provide
On Study
Screening/Enrollment
- It is possible that screening data will be returned to participants, particularly for screen-failures or participants who have urgent incidental findings during screening. This return, including requisite referral, should be included in the IRR Plan. In some cases, it will be appropriate to prepare a referral pathway for the participant
Informed Consent
Decision making
- Participants should have the option to decide whether to receive their results, be able to review this decision and/or change their mind later during the study, and receive support to make that decision. Investigators and their study staff can facilitate these decisions in a variety of ways
Early and Mid-Study
Reviewing participant decisions
- Participants should be able to review their decision to receive results and/or change their mind during the study. Clear processes should be planned and established to maintain and update participant decisions
Returning results during the study
- Results may be returned during the study. Sponsors may need to support investigators and their study teams with this if results will not be returned through a portal or other external vendor
Changing plans during the study
- Plans for IRR should be made during protocol development. If the plan for IRR changes mid-study, make sure to consult with your IRB, re-consent participants as necessary, and gather all of the requisite contact information for participants and/or their healthcare provider
Returning IRR to withdrawn/discontinued participants
- Plans should include whether, which, and how results will be returned to participants who withdraw from a study before it ends. Investigators and study teams should be able to look to sponsors to provide this guidance
End of Study
Participant’s Last Visit
Managing expectations
- A participant’s last visit is an important time to revisit and manage expectations. This could include reviewing:
- Which results will or will not be returned
- When results will be returned
- The participant’s decisions to receive their results, updated if necessary
- The participant’s (and, if necessary, their healthcare provider’s) contact information
- Click here for a template to gather a participant’s healthcare provider’s contact info
- Click here for a template to support and guide the IRR process
End of Study
Planning for return
- Results from a study are often returned at the end of or after the study. During protocol development, plans should be made for who will return results, and how. Sponsors may need to support the investigator and their study teams in returning results if results will not be returned through a portal or other external vendor
Stakeholder responsibilities
- As a study ends, it is important to reinforce how responsibilities are separated between the investigator, site staff, sponsor, and participant’s healthcare provider (HCP) and who is or will be involved in communication
Connecting to HCP or follow-up care
- It may be necessary to connect with a participant’s HCP or another medical provider for follow-up care. It is often best to make these plans before returning results to participants
Supporting results communication
- Whoever is explaining the results to participants will likely need guidance. This could include an information sheet about the results that will be returned and how they can be interpreted, a script or answers to frequently asked questions, plain-language take-home documentation for the participant, health literacy training, translated documents or translator services, and more