NIH is seeking feedback from stakeholders to assist in defining specific, measurable indicators and incentives that reflect the collaborative, rigorous, and mission-driven nature of modern biomedical science.
NIH is particularly interested in comments that include specific examples of measurable indicators, implementation approaches, potential benefits or unintended consequences, and considerations for feasibility across career stages, disciplines, and institution types.
Comments must be received no later than August 19, 2026, and must be submitted through the online comment portal found here.
Questions about any of the above information may be sent to [email protected] If you are not yet a subscriber to this listserv, please sign up here.
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
On February 12, 2026, from 3:00 PM – 4:15 PM ET (2:00–3:15 PM CT/1:00–2:15 PM MT), NIH and the Front Range Biosafety Association will co-host the 5th virtual listening session on advancing efforts to modernize and strengthen biosafety oversight.
The meeting is free and open to the public. Registration is required if planning to make an oral statement at the listening session. Those planning to only view the listening session are kindly requested, but not required, to register. Priority speaking slots will be given to participants located in Region 5 of NIH’s stakeholder map. More information about the goals of the listening session, as well as a draft agenda, webcast information, and registration information can be found on the meeting page of the OSP Website.
For additional information on NIH’s Biosafety Modernization Initiative, including how you can provide on-demand ideas and comments, please visit here.
The use of Artificial Intelligence (AI) tools can be helpful in limited aspects of preparing NIH research applications. However, it is critical to maintain the fairness and originality of NIH’s research application process. The rapid submission of large numbers of research applications from a single Principal Investigator (PI) may also unfairly strain NIH’s application review processes.
With this in mind, NIH is issuing a policy to outline guidance for appropriate usage of AI in research applications. To support this goal, NIH is also limiting the number of applications that NIH will consider per PI per calendar year.
