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

Document Number:

101-A01

Document Name:

Federal-wide Assurance

Approved by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

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
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

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