Committee For the Protection of Human Subjects

FEDERAL-WIDE ASSURANCE

 POLICY

UT Houston has signed a Federal Wide Assurance (FWA #00000667) that defines the obligation of the UT Houston 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. 

UT Houston is committed to upholding its Assurance. UT Houston delegates responsibility for insuring the rights, safety and welfare of human participants in research to the Vice-President of the Human Research Protection Program. It is the VP HRPP’s responsibility to exercise appropriate administrative oversight to assure that UTHSC-H’s policies and procedures for protecting the rights and welfare of human participants are applied in compliance with its Assurance.

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

UT Houston 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 36 months, 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. 

ORSC Director will maintain a copy of the Assurance within the ORSC office.

APPLICABLE REGULATIONS

1.                   45 CFR 46.103

 REFERENCE TO OTHER POLICIES

1.       None

ATTACHMENTS

1.       None

 

Document Number:	101-A01
Document Name:	Federal-wide Assurance
Approved by:	ORSC Director
Effective:	1 Aug 2008
Revision History:	1 Aug 2011