Author: OSP

Research participants are at the heart of the NIH mission to transform discovery into health. By volunteering to take part in research, participants are key partners in the success of the biomedical research enterprise by helping to advance scientific understanding, improve treatments, and shape a healthier future for everyone.

To uphold our commitment to our partners in research, NIH is announcing a new policy proposal to ensure research participants receive the results of the studies they participate in.

All are encouraged to comment on NIH’s Draft Policy for Sharing Summary Level Study Results with Clinical Research Participants. Comments on the Draft Policy will be accepted until October 26, 2026, and must be submitted through the online comment form found at: https://osp.od.nih.gov/comment-form-draft-sharing-summary-results-policy/. 

Additional information on NIH’s approach to the sharing of summary level and individual level study results with clinical research participants can also be found on the OSP website.

Questions may be sent to [email protected]. 

Today, the Administration released the U.S. Government Policy for Stopping High-Risk Life Sciences Research, pursuant to Executive Order (EO) 14292 on “Improving the Safety and Security of Biological Research.”

This new government-wide policy defines areas of life sciences research that pose the greatest risk to our nation’s security, implements federal funding prohibitions, and establishes a framework for addressing risk and ensuring compliance. In addition to banning federal support for dangerous gain-of-function research, the policy introduces enhanced review and reporting requirements for all life sciences research, including independent, top-down assessments for projects that may increase the harmful consequences of biological agents, and introduces new restrictions for research conducted outside of the United States.

As NIH implements this policy for the science it supports, we will work closely with the research community to reinforce the shared responsibility of every scientist to thoughtfully evaluate the potential benefits and risks of every experiment and ensure that biomedical research advances safely, responsibly, and in service of the American people.

For more information on NIH’s implementation of the Policy, please see a statement issued today by NIH Director, Dr. Jay Bhattacharya, as well as a notice NIH has published in its Guide to Grants and Contracts.

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. 

NIH currently has many opportunities for stakeholders to provide feedback to inform the development of resources and policies vital to the NIH mission.  These opportunities include:

• A request for public feedback on reducing the reliance on human embryonic stem cells. Comments will be accepted until April 24, 2026. Learn more here.

• A request for comment on the two draft resources aimed at supporting participants in implantable device trials.  Comments will be accepted until May 25, 2026. Learn more here.

• Engaging with NIH to help shape a draft policy for the responsible return of summary level study results to participants in NIH-supported clinical research.
  • Information on an NIH webinar to hear public feedback on this topic can be found here.
  • Provide on-demand commenting to help inform the draft policy development process here.

• Providing input to help inform the development of a modernized data and safety monitoring policy.
  • Information on an NIH webinar to hear public feedback can be found here.
  • Provide on-demand commenting to help inform the draft policy development process here.

• Providing input on the development of a new draft NIH biosafety policy.  Comments may be submitted through our Biosafety Badge found here.

Questions about any of the above information may be sent to [email protected]/ov