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, CPHS 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 Assurance. The Vice-President of the Human Research Protection Program is the signatory on the federal wide assurance. It is the VP HRPP’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, persons, beneficence, and justice as outlined in the Belmont Report.
UTHealth human subjects research activities will comply with other appropriate regulations and ethical standards such as the Common Rule, other Department of Health and Human Services regulations (45 CFR 46, 21 CFR 50, 56, 312, 812), Health Information Portability and Privacy Act and the ICH Guidelines.
PROCEDURE
VP HRPP or designee will update the Assurance at least every 5 years, even if no changes have occurred, in order to maintain an active assurance approved by Office of Human Research Protections (OHRP).
VP HRPP or designee will update the IRB Registration with OHRP at least every 36 months even if no changes have occurred. The IRB Roster will contain a list of members identified by name; earned degrees; representative capacity indications of experience such as board certifications, licenses, etc.
VP HRPP or his/her designee will promptly report amendments to the Assurance or IRB Roster to OHRP via their electronic system.
IRB Director will maintain a copy of the Assurance within the IRB office.
APPLICABLE REGULATIONS
1. 45 CFR 46.103
REFERENCE TO OTHER POLICIES
1. None
ATTACHMENTS
1. None
If you find errors in this document, contact clinicaltrials@uth.tmc.edu
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Document Number: |
101-A01 |
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Document Name: |
Federal-wide Assurance |
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Approved by: |
Executive Director, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, 1 Jun 2016, 1 Apr 2019 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
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Committee for the Protection of Human Subjects IRIS Support 713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |
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