Clinical Research

Of NIH’s more than $18B investment in clinical research, clinical trials (~$7B) reflect the point at which the public is most directly engaged in NIH’s clinical research activities, either as dedicated volunteer research participants or users of the resulting data and health interventions. Successful management and oversight of the clinical trial enterprise remains essential to NIH’s mission to translate basic biomedical discoveries into improved health outcomes. OSP works to ensure that NIH’s clinical trial policies enhance the design, conduct and oversight of clinical trials.

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Clinical Trials

NIH Definition of Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Clinical Trial E-Protocol Tool

Clinical Trial E-Protocol Tool and Template Documents

The electronic protocol writing tool aims to facilitate the development of two types of clinical trials involving human participants.  The first type of trials are Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.

NIH developed a second protocol template to help behavioral and social science researchers prepare research protocols for human studies measuring a social or behavioral outcome or testing a behavioral or social science-based intervention.

Both templates found in the electronic protocol tool meet the standards outlined in the International Council on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6). These are international standards of good clinical practice that apply to all clinical trials, and their goals are to ensure research integrity and protect human subjects. In addition, use of the electronic protocol tool allows researchers to interface directly with clincialtrials.gov.

Take me to the Web-based e-Protocol Writing Tool

Informed Consent

As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that data and biospecimens are shared for research ethically, securely, and with respect for the privacy, autonomy, and well-being of research participants and the communities to which they belong. Responsible sharing of data and biospecimens derived from human participants relies on robust informed consent practices that uphold the principles of autonomy and trust in biomedical research. Fundamental to these practices are clear, efficient, and transparent communication strategies for conveying potential risks and benefits of sharing, enabling individuals to make informed decisions to participate in research, retain autonomy in decision making, and understand potential uses and contributions of their data and specimens.

OSP works to ensure robust informed consent practices are understood and in place across NIH, with the goal of protecting research participants altruistically donating data and specimens to advance the scientific enterprise.

Resources

Informed Consent for Secondary Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language

NIH Single IRB (sIRB) Policy

The NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) for all U.S. sites to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. If you have any questions about this policy, please contact us here.

Data and Safety Monitoring

NIH is committed to supporting research studies that are scientifically sound and rigorously designed to produce high quality, reliable scientific data that advances the health of all Americans. NIH provides oversight and stewardship of the clinical research enterprise, supporting the most meritorious and rigorously designed studies, and ensuring our studies adhere to the highest ethical standards.

NIH strives to ensure that all NIH-supported clinical research generates high quality data and holds paramount the safety of all participants. Monitoring is foundational to ensuring scientific rigor, participant safety, accountability and enhancing clinical research efficiency. It is also a key component of NIH’s vision for all clinical research.

Modernizing Data and Safety Monitoring

To enhance efficiency and rigor, NIH intends to modernize the approach to monitoring and is committed to engaging the public in development of an updated policy. Since the 1998 NIH Data and Safety Monitoring (DSM) Policy was published, study designs and monitoring practices have evolved, creating the need for more efficient and flexible practices to monitor data for all clinical research. NIH has a phased plan to modernize the DSM Policy starting with gathering input from the public, DSM experts, and the research community.

NIH’s plan of action for developing a modernized Data and Safety Monitoring Policy is below.

Public Engagement in Developing a Draft Policy

Public engagement is a key component in the successful development of the new Data and Safety Monitoring Policy. We need to hear from a wide array of stakeholders to ensure we develop a responsive, forward-looking, and flexible policy. NIH plans to host a listening session webinar where stakeholders can provide feedback. There is also an opportunity for on-demand commenting where interested parties can provide feedback 24/7 until the draft policy is released. Members of the public will also have the opportunity at that time to provide feedback on the draft policy.

To learn more about on-demand commenting, please click here.
For more information on the webinar, please click the flyer below.

In 1998 and 2000, NIH issued the NIH Data and Safety Monitoring (DSM) Policy and Further Guidance on Data and Safety Monitoring for Phase I And Phase II Trials. The DSM policy expects each NIH Institute and Center (IC) to have a system for appropriate oversight and monitoring of clinical trials to ensure the safety of participants and the validity and integrity of the data. In 2020, NIH issued the Data and Safety Monitoring Board Brief to provide clarity on the role of Data and Safety Monitoring Boards. The NIH requirement for data and safety monitoring is separate and distinct from the requirement for protocol review and approval by an Institutional Review Board (IRB).

Protections for Participants in Research (Human Subjects Research Protections)

Participants in NIH-funded clinical research studies receive a robust set of protections in accordance with standards established by the U.S. Department of Health and Human Services (HHS) in 45 Code of Federal Regulations (CFR) part 46 (“the Common Rule”), and, when applicable, Food and Drug Administration (FDA) Regulations for 21 CFR Part 50 and 56. Additional protections for research participants are also established under Section 2012 and 2013 of the 21st Century Cures Act, the NIH Certificates of Confidentiality policy, the Privacy Act, and the HIPAA Privacy Rule. Protections provided by the Common Rule ensure the safety, rights, and welfare of participants in research (what the Common Rule calls “human subjects”) under a framework that prioritizes the ethical principles enshrined in the Belmont Report (i.e., respect for persons, beneficence, and justice). These protections include oversight of research by Institutional Review Boards (IRBs), as well as requirements for informed consent, confidentiality, and privacy.

OSP serves as a resource for and advisor to the NIH research community with respect to the implementation of regulations, laws, and policies impacting the protection of participants in NIH research. OSP advises on harmonization and optimization, works with NIH Institute, Center, and Office (ICO) partners to identify and resolve policy issues, and recommends and develops new policies as needed. OSP works closely with colleagues across NIH and HHS, including NIH ICOs as well as FDA, the Department of Defense (DOD), the Department of Veteran’s Affairs (VA), the HHS Office for Human Research Protections (OHRP), and the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP).

Relevant Documents and Resources

Implantable Device Clinical Trials

NIH supports a broad portfolio of clinical trials that implant investigational medical devices (“implant trials”) with the potential for life-changing or life-saving outcomes. Some examples include: the use of spinal cord stimulation to restore movement and bladder function in people with spinal cord injury, development of an ocular implant to treat neurodegenerative retinal disease, and the use of deep brain stimulation (DBS) to mitigate treatment-resistant schizophrenia.

Participants in implant trials have unique post-trial needs that may not be adequately met through existing mechanisms of support. They may face ongoing care needs and potential explantation (removal) surgery. Post-trial care is often complex, and while clinical trials have discrete endpoints, implant trial participants’ needs and interests often extend beyond the study’s conclusion, making it essential to anticipate post-trial care needs during trial planning to allow for continuity of care. OSP and the NIH Office of Extramural Research (OER) coordinate efforts across the agency to consider potential solutions and develop resources to safeguard the welfare of participants enrolled in implant trials.

Request for Information on Draft NIH Resources to Support Implantable Device Trials

On March 25, 2026 NIH released a request for feedback on two draft resources intended to support the research community in planning for the post-trial needs of participants and ensuring transparency during informed consent. More information about these resources can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-061.html.  Comments on the proposal must be submitted through the comment form found at https://osp.od.nih.gov/comment-form-draft-nih-resources-to-support-implantable-device-trials/.  Comments will be accepted until May 25, 2026.

NIH has also created a flyer that can be sent to stakeholders with all the information needed to provide comments.  To download, please click here.

Privacy and Confidentiality in Research

Privacy and confidentiality are essential components of a robust research enterprise. NIH takes seriously the obligation to ensure privacy and confidentiality for individuals who have altruistically provided data and samples for research. Some of the obligations for these protections are outlined in the Common Rule, which describes a framework for protecting the privacy and confidentiality of sensitive, private information. Additional protections are provided by Section 2012 and 2013 of the 21st Century Cures Act and the NIH Certificates of Confidentiality Policy, which ensure appropriate protections for research when identifiable, sensitive information is collected or used. The Privacy Act and HIPAA Privacy Rule outline further protections for when individual data subject to these laws can be released.

OSP serves as a resource and advisor to the NIH research community on privacy and confidentiality regulations, laws, and policies. OSP advises NIH ICOs on these protections and works with ICOs to identify and resolve any policy issues.

Relevant Documents and Resources