Sponsor 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

Addressing Key Topics

Why to get started

  • Highlighting key points on why to get started (e.g., ethical reasons, meeting participant expectations) will help you advocate for return of results at your organization

How to get started

  • Getting started returning results may seem overwhelming. It may help to start small, returning a handful of results and/or starting a small pilot. Our guide on how to start, plus a proposed progression of returning results helps get the program, or pilot, off the ground

Funding Results Return

A common question around returning IRR is how it will be funded. These decisions and the associated costs will vary significantly between organizations, but here are some considerations to start with:

Identify financial resources

  • Different funding resources may be applicable to returning IRR (e.g., innovation, patient engagement, etc.). Explore what’s available at your organization

Develop a budget

  • A detailed plan for returning IRR, considering the points listed here, will lend itself to a clear and thought-out budget. The budget should be feasible given the constraints and resources available

Good plans save resources

  • A robust plan is necessary regardless of the intention to return results given the possibility for urgent/incidental results that must be returned. Early planning will reduce the resources needed in a reactive response while the study is ongoing. CROs or data management vendors could be leveraged to support return of IRR.

Start Small

  • Consider whether the costs will vary according to the quantity and/or types of results that are returned. One strategy is to start small by returning results that are familiar to participants or require less interpretation, and slowly add to the practice once processes are established and positive impacts are realized

Consult participants and return what matters

  • It is also important to discuss your plans with participants or patient advocates to understand which results are most meaningful to them. This could maximize the impact of a Return of Results program while still narrowing its scope

Consider your options

Run a pilot

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 Review Expectations

  • There should be clear expectations set and communicated around what should be included in IRB review as it pertains to IRR (see next)

IRB/Ethics Review

Collaboration and Preparation

  • Collaborating and/or soliciting advice from an IRB/HRPP/Ethics committee while establishing an IRR program will enable its long-term success. Their input can help you to craft IRR policies, procedures, and justifications for when results will be returned and will not be returned. This will support your study teams in creating IRR plans that are adequately thought-out before they reach the IRB for review

Study/Site Kick Off Meetings

Clarifying plans and expectations

  • Study kick off/ Investigator meetings are key opportunities to ensure PIs are aware of expectations and plans for IRR, and to answer any questions early on
  • Site kick off meetings can also be used to clarify plans and procedures for IRR, provide training for the actual return of results, etc.

Establishing a Policy

On Study

Screening/Enrollment

Informed Consent

Decision making

ICF Details

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. Sponsors can provide this guidance and/or policy to study teams

End of Study

Participant’s Last Visit

Managing expectations

End of Study

Planning for return

Study Close Out Visits

  • Close out visits are a good time to check that all results were already returned that were supposed to be returned, and to reiterate plans and expectations around returning any results after the study has ended/data is locked (e.g., study are assignment)

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

Analysis & Reporting

Aggregate Results

Publication

  • It can also be seen as a courtesy to share publication information with participants about research in which they participated

This communication, along with the return of individual results, can contribute to trust and transparency in research, and can convey respect and appreciation for research participation

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