Human Research Protection Program (HRPP)
The Human Research Protection Program (HRPP) is composed of institutional leaders, research review committees, and agents of Texas A&M University that are responsible for protecting the rights and welfare of participants in research conducted or reviewed by Texas A&M University, including Texas A&M Health and all of its locations, the School of Law, and branch campuses in Galveston and Qatar.
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.
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. Ancillary reviews, if required, can be initiated by the Principal Investigator or PI Proxy in Huron. The IRB staff typically assigns ancillary reviews during the pre-review of a submission if it has not already occurred. Once the ancillary review is triggered, investigators should work directly with that office contact.
Group | Examples of Triggers | Contact |
Animal Welfare | animals in research | animalcompliance@tamu.edu |
Biosafety | biohazards | biosafety@tamu.edu |
Conflict of Interest/Commitment | SFI; external employment | coi@tamu.edu |
Contract Admin-SRS | CDA, DUA, MOU, MTA | negotiations@tamu.edu |
Department Head | Departmental Approval | Your Dept Head |
Export Controls | International Component | Exportcontrols@tamu.edu |
Environmental Health & Safety | Food Safety; Chemical Safety | ehs@tamu.edu |
Office of Registrar – FERPA | TAMU Student Records | rhapes@tamu.edu |
Information Technology | New Software, AI, Apps or Platforms; Personal Devices; | JJ@tamu.edu or Local Department IT Team Data Classification + Research Resources | IT.tamu.edu |
Privacy Office | PII, PHI, GDPR, FERPA | jpryde@tamu.edu |
Radiation Safety | Radiation devices, lasers | latha@tamu.edu |
University Youth Programs | Minors in Research | cynolvera@tamu.edu |
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
TAMU 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.”
TAMU IRB | IRB Registration Number |
Texas A&M University – IRB #1 | IRB00000397 |
Texas A&M University College of Dentistry – IRB #2 | IRB00010159 |
Voice a 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:
- irb@tamu.edu
- 979.458.4067
- 1.855.795.8636 toll free
- 979.862.3176 fax
You can also submit a human subjects research concern form or submit a report to Texas A&M EthicsPoint.
Zoom Office Hours
Need help with your IRB submissions? Schedule a help session with your IRB contact. Zoom appointments are available: Monday through Friday from 8:00 a.m. to 5:00 p.m.
To find your IRB contact click here: My IRB Contact