Information for Research Participants
Research is a process to discover new knowledge. It includes planning and conducting a study to see if an answer to a research question can be found.
What is human subjects research?
There are different types of research. Human subject research involves studies with people or samples and data that can identify people. Some research is designed to see if this knowledge can help people in the study. Other research is not designed to directly help current participants but is intended to hopefully gain information that can be used to help people in the future.
What is the NIH Institutional Review Board (IRB)?
The NIH Institutional Review Board (IRB) helps protect the rights, privacy and welfare of people participating in studies done by NIH researchers.
The IRB reviews all research involving human participants before the research can begin. The NIH IRB follows specific federal regulations that govern reviewing and approving research involving humans.
The IRB has at least five members of varying backgrounds. The Board will include at least one member who is not connected with NIH and one member who is not a scientist. The IRB also has consultants who help review research studies.
Find a Clinical Trial at NIH
You can use the NIH Clinical Center's Search the Studies tool to search for clinical trials occurring at NIH
Find Information on All Clinical Trials
You can use the National Library of Medicine's Clinical Trial Search for information on all active clinical trials.
Learn More About Participating in Clinical Research
Deciding to participate in research can be a difficult decision. It is important to understand what clinical research is and what might happen in a clinical trial.
The Office of Human Research Protections has created several useful resources for research participants to help you decide. These can be found here:
Alt Text: Image shows a button you can click. Text inside button reads: About Research Participant, What you need to know before you decide.
In addition, the National Institutes of Mental Health (NIHM) have made nine brief YouTube videos that explain important concepts about participating in clinical research as well as several procedures that commonly take place as part of clinical research studies.
Right To Try
Federal and state Right to Try laws generally permit the use of unapproved, experimental drugs and biological products by individuals diagnosed with a life-threatening condition who (1) have exhausted approved treatment options, and (2) are unable to participate in clinical trials involving the product.
However, NIH is a federal research agency. Therefore, it cannot provide an unapproved drug or biological product to an individual unless the subject is enrolled in an NIH protocol. Further, Right to Try laws do not establish a “right” to participate in a clinical trial or protocol, i.e., the laws do not entitle patients to participate in an NIH-sponsored clinical trial.
If you are unable to enroll in an NIH protocol involving an unapproved drug or biological product, the Right to Try Act may provide another option. Interested individuals should speak to their home-based treating physician about the possibility of receiving an unapproved drug or biological product from a source other than the NIH through the Right to Try pathway. The federal Right to Try Act became law on May 30, 2018. More information is available at https://www.congress.gov/bill/115th-congress/senate-bill/204/text.
Questions & Concerns about an Ongoing Study at NIH
You can contact OHSRP by phone (301) 402-3713 or by email at irb@od.nih.gov. Our main office is located at 6700B Rockledge Drive, Suite 4300, Bethesda, MD 20897.
Please note, if you send information to the email above, please do not include sensitive information or personal health information.
About the Office of Human Subjects Research Protection (OHSRP)
The Office of Human Subjects Research Protections (OHSRP) carries out the day-to-day operations and regulatory oversight of human research activities within the Human Research Protections Program (HRPP). The OHSRP promotes the protection of rights, safety and welfare of human subjects, and the NIH’s research mandate. You can find more information on our About page.
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