Roles and Responsibilities

The following represents language developed in collaboration with and for the Texas A&M University research community. (PDF)

The Texas A&M Human Subjects Protection Program developed from the University’s commitment to address and comply with federal and local requirements regarding the protection of human subjects in research.

Texas A&M University, the Institution

Texas A&M has instituted and maintains the Human Subjects Protection Program for all faculty, staff, and students at Texas A&M and affiliated institutions, including the Texas A&M Health Science Center and certain agencies of the state of Texas (Texas A&M AgriLife Research, Texas A&M Engineering Experiment Station, Texas A&M Engineering Extension Service, and Texas A&M Transportation Institute). The program is designed to achieve and maintain regulatory compliance, as well as provide a way for researchers and the public, to be informed and protected in research with human subjects. The University specifically establishes and implements requirements and policies that provide for the safe conduct of human subject research. The University also ensures proper training for the Institutional Review Board (IRB) chair, its members, and the research community.

Institutional Official (IO)

The president of Texas A&M has appointed the vice president for research (VPR) as the Institutional Official (IO) responsible for the Human Subjects Protection Program. The IO appoints the members and the chair of the IRB. Administratively, the IRB reports to the IO. The chair of the IRB also reports directly to the IO. The final authority for decisions pertaining to conduct of research and research compliance is the IO.

Institutional Review Board

In accordance with the Department of Health and Human Services (HHS), i.e., the Federal Policy 45 CFR 46, the Institutional Review Board has the authority to review, approve, require modifications in, or disapprove all human subjects research activities that fall within its jurisdiction. The IRB is an administrative body within Texas A&M, established by appointment from the vice president of research of the University, to protect the rights and welfare of humans who are recruited to participate in research activities conducted under the auspices of Texas A&M. The jurisdiction of the Texas A&M IRB is defined by its Federal-wide Assurance document (FWA #00000092) with the DHHS and by Texas A&M’s institutional rules.

Chair of the IRB

The chair of the IRB presides at all meetings of the IRB and may assign such additional duties to other members of the IRB as deemed necessary for the conduct of the work of the IRB. The chair of the IRB reports to the IO. The chair of the IRB also ensures that members of the committee are appropriately trained.

Human Subjects Protection Program Office

The Human Subjects Protection Program provides staff support to the IRB. In addition, this office helps ensure safety and compliance by monitoring activities, performing training, and assisting researchers and IRB members in the review and approval process.

Department Heads and Deans

Every IRB protocol includes a signature of the PI’s supervisor as a part of the process. This signature acknowledges that the supervisor is aware of the research and approves of all the information as presented. In addition, supervisors are responsible for ensuring that research involving the use of human subjects is appropriately reviewed and approved by the IRB prior to the initiation of any work.

Principal Investigators (PIs)

The PI is the one individual researcher who is designated by the institution to direct a project or program and who is responsible to the institution for the scientific and technical direction of that project or program. The PI is the ultimate protector of the research participant’s rights and safety and is obligated to be personally certain that each participant is adequately informed and voluntarily consents to participate in the research. The PI must personally ensure that every reasonable precaution is taken to reduce to a minimum any risk to the participant. The PI also assumes responsibility for compliance with all federal, state, and institutional rules and regulations related to research involving humans and human subject-derived information and materials. Investigators may not initiate any research involving humans without prior IRB review and approval.