Access to clinical trials, like access to medical care, can be financially stressful. While not all trials have costs, some do, and financial stress can depend on whether a trial has any medical costs (e.g., for tests, visits, drugs), the participant has insurance that [adequately] covers the medical costs, the participant’s income level, and other factors such as potentially missing work and paying for non-medical costs like travel or childcare. Many trial sponsors, sites, and research teams work to cover trial-related medical costs, reimburse participants for non-medical costs like travel and childcare, and compensate participants for their time. However, there can be gaps in coverage, reimbursement might not be in the format or time period needed by participants, and in terms of compensation for participant time, and there can be impacts upon receipt of public benefits when participants are compensated for their time.
The MRCT Center has been working independently to bring awareness to this issue and to work on tools to support what is called “financial neutrality,” which is where people do not lose savings, income, or benefits by participating in a clinical trial. This is a developing project that requires collaboration across stakeholders. The MRCT Center has produced publications and tools that you can see listed below under Related Assets. We are also collaborating with the Equitable Access to Clinical Trials Project. You can go to their website to see emerging publications and tools from that consortium.
Related Assets
- An IRB Resource for Participants: Costs and Payments
- An IRB Resource for Investigators and Research Teams– Practical Points to Consider: Payment to Research Participants
- Fair payment and just benefits to enhance diversity in clinical research
Please note: The tools listed above are living documents and will be improved with use. We welcome feedback, suggestions, useful references, resources, and concerns.
Acknowledgments
Many thanks to everyone who has so thoughtfully collaborated on these projects. Members who have chosen to be publicly acknowledged are listed in the links below, with the titles and organizational affiliations that they had at the time of the product launch. Please note that each member served in their individual capacity, and the views and findings expressed in project materials are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work.
eact Project
See EACT Steering Group and Participating Partners here.
IRB/HRPP Toolkit
