NIH views clinical research participants as vital partners in turning discovery into health. Ensuring participant safety, rigorous research, and public trust are NIH’s highest priorities. With this in mind, NIH is excited to announce:
The availability of two draft resources aimed at supporting participants in implantable device clinical trials. These two resources provide guidance on post-trial considerations for participants along with points to consider and sample informed consent language. Comments will be accepted on these two resources until May 25, 2026. More information, including how to comment can be found here.
Two stakeholder engagement campaigns to develop NIH policies relating to:
Sharing of Summary Level Study Results with Participants in NIH-Supported Clinical Research (event co-hosted with the MRCT Center of Brigham and Womens Hospital and Harvard); and
Modernizing NIH’s Data and Safety Monitoring Policy
The above stakeholder engagement campaigns will include webinars, the ability to provide on-demand comments through the OSP website, and numerous other opportunities to provide feedback to help inform the development of draft policies.
More information about stakeholder engagement for developing a policy for the sharing of summary level study results can be found here.
Information about how to get involved with the modernizing of NIH’s Data and Safety Monitoring Policy can be found here.
To learn more about how this suite of efforts ties into the NIH mission, please see the most recent Under the Poliscope blog by Dr. Lyric Jorgenson, NIH Associate Director for Science Policy.
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
In December 2025, the National Institutes of Health (NIH) issued a request for public input on its proposal to establish harmonized and transparent policy requirements for protecting human participant research data and in alignment with recent national security directives. Specifically, NIH proposes to:
(1) establish policy requirements for which data should be controlled-access under NIH data sharing policies, and
(2) revise the NIH Genomic Data Sharing Policy to simplify and harmonize requirements.
