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
Addressing Key Topics
- Prepare yourself and your organization to address common topics (e.g., relevant regulations or privacy considerations) to initiate a return of results program
- See our topic-specific pages on informed consent, liability, regulations, study integrity, funders, and genetics
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
- Some methods of return may be more costly than others. Consider low-cost solutions, particularly while the IRR program is being established. Once there is buy-in, consider investments in website portals or decision-tracking systems
Run a pilot
- It is often advantageous to run a pilot as a proof of concept, to learn what works, and to better understand what the funding needs will be
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 regulations. Sponsors (and study teams) should rely on legal counsel and Regulatory Affairs departments for guidance in these areas
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
- In time, it will be beneficial to establish an organizational policy regarding IRR. It is important to involve all stakeholders, including participants, in the creation of an IRR policy
On Study
Screening/Enrollment
- Sponsors can provide supportive instructions to study teams on how to handle return of screening data. 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. Sponsors can support investigators and their study staff to facilitate these decisions in a variety of ways
ICF Details
- Some details will need to be in the Informed Consent Form, and some can be communicated outside of that form. Sponsors (and investigators) should work with the IRBs to determine what is needed in the ICF
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. Sponsors should anticipate this and establish processes 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 or may have more of an active role in results return 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. Sponsors can provide this guidance and/or policy to study teams
End of Study
Participant’s Last Visit
Managing expectations
- Make sure the investigator and their site staff have the information and resources needed to explain expectations around IRR to participants, including what will be returned and the timing of that return
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, or may have more of an active role in results return through a portal or other external vendor
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
- If a participant has consented to receive aggregate results, it can be helpful or interesting to share those in the context of the participant’s individual results
- Click here for our work on Return of 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