Public—and participant—trust is essential to NIH’s success. At OSP, that work begins with meaningful, two-way engagement to ensure research priorities reflect both scientific goals and the needs of the people we serve. A core part of NIH’s mission is helping researchers design and conduct studies that truly meet public needs.
Last year, we brought together participants, patients, advocates, and community members to help us strengthen this effort. Today, we’re building on that collaboration by releasing a series of draft materials for public input, which reflects another step in deepening our commitment to transparency, trust, and partnership.
Supporting participants in implantable device clinical studies
We’ve released draft materials to support participants who receive implantable devices as part of clinical research. These studies have delivered life-changing advances for millions, but they also raise unique challenges, especially when a device may outlast the study itself. To help navigate this, NIH is developing clear, practical language for consent forms and laying out considerations for planning for post-trial care needs. For more information on the resources and to comment, please visit: https://osp.od.nih.gov/comment-form-draft-nih-resources-to-support-implantable-device-trials/
Advancing new policies in support of our priorities
We’re also launching the development of two new policy areas to strengthen how clinical research data are monitored and shared:
- Return of summary level study results
Participants want access to their results. As a result, NIH is set to begin a comprehensive policy development process to establish requirements for researchers and institutions to responsibly share summary level study results with research participants in plain language for all NIH-funded clinical research. - Data and safety monitoring
NIH’s current policy, established in 1998, has played a critical role in ensuring data quality and participant safety. But clinical research has evolved significantly since then. We’re taking a fresh look to ensure this policy reflects today’s science, technologies, and expectations.
Your voice matters
Everything we do at OSP depends on community input. To support broad engagement, NIH will host webinars, offer opportunities for written feedback, and create multiple ways for stakeholders to share their perspectives. A summary table below provides details on how to get involved.
A clear commitment
NIH’s policy priorities are clear: research participants are the backbone of the clinical research enterprise. Protecting their well-being and respecting their preferences is essential. By doing so, we strengthen public trust, enable more inclusive and effective research, and ultimately improve health outcomes for everyone.
Clinical Research Policy Resources and Links
| Resource/Policy | Website(s) | Key Dates | Additional Information |
| Resources to Support Implantable Trials | |||
| RFI on Draft Resources to Support Implantable Trials | Website NIH Guide Notice Comment Form | Comments on the RFI will be accepted through May 25, 2026. | |
| Developing a Draft Policy on Sharing Summary Level Study Results with Clinical Research Participants | |||
| Engagement on Developing a Draft Policy on Sharing Summary Level Study Results with Clinical Research Participants | Return of Research Results Website On-Demand Comment Form | Stakeholders will be able to provide feedback through online comment portal until draft policy is issued | Stakeholders can visit our new Return of Research Results website to see topics we need feedback on and then provide information immediately! |
| Webinar on Developing a Draft Sharing Summary Level Study Results Policy | Event Page with Information on How to Participate | April 27, 2026 1:00 – 2:30 pm ET | NIH will be co-hosting this event with the Multi-Regional Clinical Trial Center of Brigham and Women’s Hospital and Harvard |
| Developing a Draft Data and Safety Monitoring Policy | |||
| Engagement on Developing Draft Data and Safety Monitoring (DSM) Policy | Website On-Demand Comment Form | Stakeholders will be able to provide feedback through online comment portal until draft policy is issued | Stakeholders can visit our new DSM webpage to see topics we need feedback on and provide information immediately! |
| Webinar on Developing a Draft Data and Safety Monitoring Policy | Event Webpage with Information on How to Participate | May 13, 2026 11:30 am – 1:00 pm ET | |
