Human Research Protection Program (HRPP)

HURON Announcement

The HRPP plans roll out a new online system Huron designed to simplify the IRB submission process. Huron will replace the existing iRIS system. The Division of Research’s Technology Services and the HRPP staff are currently conducting multiple data integrity activities to prepare for the migration of active non-exempt studies to Huron. We will communicate important dates and information as they become available on the HRPP website. Time frame is late second quarter or third quarter of 2023.  

The HRPP is seeking faculty volunteers

The HRPP is organizing a faculty investigator advisory group to assist with the transition to the new Huron IRB submission system. If you are interested in this opportunity, please contact the HRPP Director, Aliese Seawright at a.seawright@tamu.edu.  Meetings will start in the first quarter of 2023.

New Guidance on Use of Deception and Incomplete Disclosure in Research

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 Review Units

Human Research often involves specialized review by ancillary groups outside the IRB. Ancillary reviews, if required, should be initiated by the investigator in parallel with the IRB submission. Requests for ancillary reviews should be directed to the applicable ancillary group, as needed.

• Biosafety Program/IBC
• Animal Welfare Program/IACUC
• Export Controls Office
• Conflict of Interest/Commitment

• Sponsored Research Services
• Radiation Safety Program
• Environmental Health and Safety
• Office of the Registrar
• Privacy Officer
• Chief Information Security Officer
• University Youths Programs

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.” 

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