Federal-Wide Assurance

POLICY

UTHealth has signed a Federal Wide Assurance (FWA #00000667) that defines the obligation of the UTHealth to ensure the rights and welfare of human subjects of research are protected. Under the FWA, the UTHealth Institutional Review Board, also known as Committee for Protection of Human Subjects must review all proposed research involving human subjects to determine if adequate measures are in place to protect participants. 

UTHealth is committed to upholding its FWA. The Vice-President of the Human Research Protection Program is the signatory on the federal wide assurance and is the designated Institutional Official (IO). It is the IO’s responsibility to exercise appropriate administrative oversight to assure that UTHealth’s policies and procedures for protecting the rights and welfare of human participants are applied in compliance with its Assurance.

All UTHealth human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles - respect for persons, beneficence, and justice as outlined in the Belmont Report.

UTHealth human subjects research activities will comply with applicable regulations and ethical standards.

 PROCEDURE

The IO or designee will update the UTHealth FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official. The FWA is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA.

The IO or designee is responsible for maintaining the IRB registration and 3 year renewals. The IRB office will maintain IRB Roster that lists all the IRB members identified by name; earned degrees; representative capacity indications of experience such as board certifications, licenses, etc. IO or designee will submit a revised IRB annually at the start of each new term in September, if there are changes to IRB membership.

The IO or designee will register any new IRB panels before it begins to review research.  The IO or designee will revise the registration information:

• Within 90 days, when the IRB's contact or chairperson information changes.
• Within 30 days, when the IRB's decision to review new types of FDA-regulated products (such as a decision to review studies pertaining to food additives whereas the IRB previously reviewed studies pertaining to drug products), or to discontinue reviewing clinical investigations regulated by FDA.
• Within 30 days, when an IRB disbands.
• All other information changes will be reported at the time of renewal of registration.

 IRB Director will maintain a copy of the FWA and IRB registration within the IRB office.

 APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 56 Institutional Review Board
3. OHRP FAQ – IRB Registration Process
4. OHRP FAQ Assurance Process
5. FDA FAQ - IRB Registration

REFERENCE TO OTHER POLICIES

1. None

ATTACHMENTS

1. IRB Registration Statement

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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