PI, Study Team, and Site Staff 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

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

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

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

Informed Consent

Decision making

Early and Mid-Study

Reviewing participant decisions

Returning results during the study

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Returning IRR to withdrawn/discontinued participants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

End of Study

Planning for return

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

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