Research Participant Advocacy
Clinical trials are a way to answer a health-care question, find a better way to control a disease, or discover a cure. The Participant Page is designed to provide you with information to help you decide if enrolling in a research study is right for you, to let you know your rights as a research volunteer, and to give you contact information in case you have any questions or concerns.
- What is an Institutional Review Board (IRB)
- Contact Information
- Questions to Ask Before You Participate in a Research Study
- How to Participate in a Research Study
- Research Subjects' Bill of Rights
- Suggestion Box
- Concerns or Complaints
What is an Institutional Review Board (IRB)
An IRB oversees research conducted on human subjects to ensure the rights, welfare, and safety of the individuals who enroll in the study are protected. At Vanderbilt, there are four IRB Committees that review health science and social/behavioral research. Before any research related procedures may begin, the IRB must review and approve the study protocol, the informed consent document(s), as well as any other study related materials.
Contact Information
If you have questions or concerns related to a research study, or would like someone to be with you during the informed consent process, please contact Jan Zolkower (Research Subject Advocate) at the Vanderbilt University IRB. She can be reached by phone at (615) 322-2918 or via email at jan.zolkower@vanderbilt.edu.
Questions to Ask Before You Participate in a Study
Before you agree to participate in a research study, the Office of Human Research Protections (OHRP) suggests that you ask specific questions. CLICK HERE to download a list of questions that you can bring to your meeting(s) with study personnel.
OHRP supports, strengthens, and provides leadership to the nation's system for protecting volunteers in research that is conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections. http://www.hhs.gov/ohrp/about/ohrpfactsheet.htm
The Food and Drug Administration (FDA) is the Federal agency responsible for protecting public health by assuring the safety, efficacy, and security of human drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. More information on the FDA's role in protecting human subjects can be located at http://www.fda.gov/oashi/clinicaltrials/default.htm.
How to Participate in a Research Study
If you would like to participate in a study, there are several listings to choose from:
- The Clinical Research Trials Registry - to volunteer/sign-up for studies
- The Kennedy Center Study Finder - to browse a list of studies
- The Vanderbilt-Ingram Cancer Center - to find a cancer trial
Research Subjects' Bill of Rights
Anyone who is asked to participate in a research study at Vanderbilt University or who is asked to consent on the behalf of another has the following rights:
- To be fully informed of the nature and purpose of the research study including all procedures to be performed/followed.
- To be treated with respect in every aspect of the research process.
- To have adequate time to consider whether to participate.
- To be given a description of any risks, discomforts, and/or inconveniences reasonably expected from participation.
- To be given a description of any benefits you may reasonably expect from participation or be informed of no possible benefit.
- To be provided an explanation of any alternative procedures and/or treatment that might be available to you.
- To ask any questions about the research study or other procedures involved.
- To be told about how you may be withdrawn and that you may ask to withdraw, at anytime, without changing your rights or healthcare or other services.
- To decide whether to participate in the research study without force, fraud, deceit, duress, coercion, or undue influence.
- To be given a signed and dated copy of the consent form, when one is required for the research.
- To be informed of who to contact if problems from the research study arise.
For more information contact the
Research Subject Advocate at
(615) 322-2918 or (866) 224-8273
Vanderbilt Institutional Review Board
Suggestion Box
The IRB has a suggestion box for you to submit comments regarding your research experience, ask questions, or notify the IRB of a concern or complaint as a result of your or a family member's participation in a study. Information may be submitted anonymously or it may include your name and contact information. You can CLICK HERE to access the suggestion box.
Concerns or Complaints
To formally notify the IRB of a concern or complaint, please download and complete a Complaint Report (Form #1114) and send it as an attachment by clicking HERE or on the Suggestion Box link above. You may also fax the completed form to the IRB at (615) 343-2648. If you prefer to mail a hard copy of the form, please send it to:
Vanderbilt Institutional Review Board
Research Subject Advocate
1313 21st Ave. South
504 Oxford House
Nashville, TN 37232-4315