The IRB-Human Subjects
To determine and certify that all human subjects research projects (regardless of funding) conform to the regulations and policies regarding the health, welfare, safety, rights, and privileges of human subjects set forth by the Department of Health and Human Services (DHHS) 45 CFR 46
These goals include ensuring that each research participant is informed of their rights and are able to give informed consent. Researchers (faculty, staff and students) must assure through verified training that the welfare of their research participants is of paramount importance.
The IRB seeks to assist investigators develop and implement practical strategies and solutions that uphold the protection of research subjects rights and welfare.
UTB Assurance Agreement
UT Brownsville’s Federal Wide Assurance # FWA00004472 and IRB Assurance # IRB00003261 with OHRP specifies that the University will follow and comply with regulatory requirements 45 CFR 46 for all funded and non-funded research.
UTB InStiTUtional Review Board (IRB)
Representatives from diverse academic and scientific disciplines, as well as members from outside the academic community compose the IRB. The IRB membership reflects expertise in both science and non-science fields. Members of the IRB generally will have had experience in research involving human subjects. The community members will be knowledgeable about the local community and willing to discuss issues and research from that perspective. At times, the IRB may not have the necessary expertise to judge the scientific soundness of a research protocol and may be unable to make a fair and accurate determination of the risk-benefit ratio. For these protocols, the IRB may call upon ad hoc consultants for assistance in review for scientific merit.
Federal regulations and the university’s “Assurance” agreement require that the IRB have at least five regular voting members, including the Chair. At least one member on the IRB must have primarily scientific concerns, one must have primarily nonscientific concerns, and one must be unaffiliated with the University ("community or lay member").
The IRB approves projects depending on the level of risk to persons who are the subjects or participate in the research project.
Proposed research projects are reviewed according to three principles:
1. Minimize the risk (physical, social and/or psychological) to human subjects (beneficence);
2. Ensure all subjects consent and are fully informed about the research and any risks (autonomy);
3. Promote equity in human subject research (justice).
Institutional Review Board Process
The University’s process for protecting human research subjects reflects federal regulations developed in response to such cases as the Public Health Service syphilis study and the U.S. government radiation experiments. The Department of Health & Human Services (DHHS) Office for Human Research Protections (OHRP) oversees the operation of the IRB.
APPLICATION All investigators who plan to use humans as subjects in research must submit an IRB Protocol Review Application to the IRB for review and approval, before the research is initiated.
IRB APPROVAL Protocol applications are designated as Approved, Approved Pending, Deferred, or Disapproved. The IRB has the authority to disapprove a protocol when the benefit / risk ratio outweighs the scientific merit of the study per 45 CFR 46.
CONTINUING REVIEW Projects are usually approved for 1 - 2 years followed by annual “continuing” review. At the end of the initial approval period initiate a Continuation Report and submit to the IRB for review and approval. Projects which are assessed as high risk to human subjects may be given a shorter approval period and be reviewed more frequently.
PROJECT COMPLETION On completion of the approved study, notify the IRB by submission of a Project Completion Report.