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RegulatoryOversight

Institutional Review Board (IRB)

UTMB is committed to protecting the rights and welfare of human subjects who choose to participate in biomedical or socio-behavioral research. UTMB has an organized and systematic program in place for the protection of research subjects that includes a commitment to the principles and guidelines for protecting research subjects contained in the Belmont Report. UTMB maintains a Federalwide Assurance (FWA), FWA#00002729, with the Department of Health and Human Services’ Office of Human Research Protection (OHRP). This Assurance is updated periodically and commits the University to abiding by all federal regulations and guidelines as set forth under 45 CFR 46 with respect to its research activities involving human subjects.

With respect to the Belmont principles, UTMB ensures that:

  1. The sum of the benefits to the research subject and the importance of the knowledge to be gained outweigh the risks to the subjects as to warrant a decision to allow the subject to accept these risks.
  2. Legally effective informed consent is obtained, unless the requirements for a waiver of informed consent are met by adequate and appropriate methods in accordance with the provisions of applicable regulations.
  3. The selection of subjects is equitable and is representative of the group that will benefit from the research.

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