Human Research Protection Program

The Human Research Protection Program (HRPP) is composed of institutional leaders, research review committees and agents of Texas A&M University who are responsible for protecting the rights and welfare of participants in research conducted or reviewed by the university, including Texas A&M Health and all of its locations, the School of Law and branch campuses in Galveston and Qatar.

Contact

My IRB Contact

HRPP Staff are assigned to specific colleges or units, please consult this list to determine the liaison for your department.

Find out my IRB Contact

General Contact

irb@tamu.edu
(979) 458-4067
1-855-795-8636 (Toll Free)
(979) 862-3176 (Fax)

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News and Updates

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Getting Started

With HRPP

Huron IRB Submission System

How to submit to the IRB

To submit a new study, access Huron via the provided URL and use the Knowledge Center for guidance. A study protocol is required for submission. Complete CITI training through the Texas A&M SSO. For further assistance, contact the IRB coordinator.

Human Subjects Research Determination

What requires IRB review?

HRPP offers a worksheet to help investigators determine if a research project requires IRB review, along with a table of activities that may or may not need IRB approval as a general guide.

    Research Ancillary Review

    Human Research often involves specialized review by ancillary groups outside the IRB. The ancillary review feature in the Huron IRB module is intended to support compliance reviews across multiple university oversight groups.

      Training

      Texas A&M requires all individuals involved in the design, conduct, or reporting of human subjects research to complete Human Subject Protection Training. Good Clinical Practice training may also be required when using FDA regulated test articles or required by sponsor or funding agency such as an NIH qualifying clinical trial.

        Resources

        Additional guidance and resource links.

          Toolkit

          The HRPP, institutional review boards and the research community follow Standard Operating Procedures (SOP’s) and use checklists, worksheets and templates to guide the design, conduct, review and approval of human research.

          Visit the Toolkit Investigator Manual

          Institutional Review Board

          Reporting to the IRB

          Report any of the events listed to the IRB within five (5) working days of the research staff having knowledge of the event. Reportable New Information must be submitted via the electronic system.

          Collaborative Research and IRB Reliance

          Collaborative research has become more prevalent and researchers are increasingly working across multiple sites and institutions to support complex research projects. When conducting collaborative or multi-site research involving human subjects, it is the investigator’s responsibility to contact their institution’s institutional review board (IRB) office to determine which IRB will have oversight of their research.

          IRB Meeting Information

          The HRPP supports the Texas A&M University IRB and the Texas A&M University College of Dentistry IRB. More than minimal risk studies requiring full board review can be submitted anytime during the published submission window.

          Aggie Research Volunteers

          We are pleased to announce that the research recruitment website is now ready for investigators to start submitting the Aggie Research Volunteers Recruitment Website Submission Form for review and approval by the IRB.

          Find out how to join Volunteers Recruitment Website Submission Form
          Research

          Roles and Responsibilities

          As a Texas A&M University investigator or research staff working on a human subjects study, you are expected to follow the federal, state, and university policies regarding the protection of human subjects. The Investigator Manual outlines Texas A&M University policy in detail. Broadly, investigators and research staff are responsible for:

          • Minimizing risk to subjects and protecting subject rights and welfare
          • Securing IRB and other departmental or institutional regulatory approvals in advance of the research
          • Obtaining and documenting informed consent
          • Disclosing conflicts of interest
          • Complying with sponsor-specific requirements as applicable (e.g., NIH, DoD, FDA requirements)
          • Completing applicable training for the protection of human research subjects

          Quality Assurance / Post Approval Monitoring Program

          The Quality Assurance/Post Approval Monitoring team works closely with the HRPP/IRB staff, the Institutional Review Boards and investigators to ensure the protection of human research participants and facilitate compliance with federal regulations and university rules.

          Read more about the Quality Assurance / Post Approval Monitoring Program
          Research

          Participants

          The Human Research Protection Program, which includes two Institutional Review Boards (IRB), is responsible by federal law for ensuring the protection of the rights, welfare, and well-being of participants involved in research studies conducted by Texas A&M faculty, staff, and students.

          Participant Info

          The Human Research Protection Program, which includes two Institutional Review Boards (IRB), is responsible by federal law for ensuring the protection of the rights, welfare, and well-being of participants involved in research studies conducted by Texas A&M faculty, staff, and students.

          Report an Incident / Concern

          If you have a complaint, concern, or question about a research study or about your rights as a research participant, please contact the Human Research Protection Program.

          Full AAHRPP Accreditation - Association for the Accreditation of Human Research Protection Programs, Inc.

          Human Research Protection Plan

          Texas A&M University has an expansive plan to ensure that the rights and welfare of participants in Human Research are protected. The protection of human subjects requires that all individuals at Texas A&M University, along with key individuals and committees, fulfill their roles and responsibilities as described in the Human Research Protection Plan. The HRPP is entrusted to provide support, guidance, and education to the TAMU campuses and its affiliated agencies in support of the mission to protect the rights and welfare of research volunteers.

          Texas A&M HRPP Key Information

          Texas A&M University has an approved Federalwide Assurance (FWA) with the U.S. Department of Health & Human Services (HHS). Texas A&M University’s IRBs are also registered with the HHS Office for Human Research Protections (OHRP). All IRBs review and approve research in accordance with Department of Health and Human Services (DHHS) regulations at 45 CFR 46, FDA regulations 21 CFR Parts 50 and 56, and International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), as applicable. The Statement of Compliance can be used as documentation of the institutional compliance standards in place for the Texas A&M University HRPP.

          TAMU FWA Number:  FWA00000092

          TAMU IRBs Organization Number:  IORG0000238

          The expiration date for the assurance changes regularly.  If you need the expiration date, please visit OHRP’s registration database, enter the FWA Number above, and click “Search.” 

          IRB Registration Numbers
          • Texas A&M UniversityIRB #1: IRB00000397
          • Texas A&M University College of DentistryIRB #2: IRB00010159