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I.01 |
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Institutional Assurance |
PURPOSE
1. The purpose of this policy and procedure is to describe the process of managing the Federal Wide Assurance for UTHealth.
SCOPE
2. This policy and procedure is applicable to all UTHealth faculty, staff, and students, which include its schools, departments, divisions, and facilities.
3. This policy and procedure is also applicable to any research for which an Assurance or other agreement identifies UTHealth CPHS as the IRB of record.
POLICY
4. The UTHealth and the Department of Health & Human Services (DHHS) have 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.
5. The UTHealth is committed to upholding its Assurance. The UTHealth delegates responsibility for insuring the rights, safety and welfare of human participants in research to the Executive Vice-President for Research (EVPR). It is the EVPR’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.
5.1. All UTHealth 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.
5.2. 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
6. The EVPR 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).
7. The EVPR 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.
8. The EVPR or his/her designee will promptly report amendments to the Assurance or IRB Roster to OHRP via their electronic system.
9. The ORSC Director will maintain a copy of the Assurance within the ORSC office.
RESPONSIBILITY
10. The EVPR is responsible for maintaining an active assurance with the OHRP. The EVPR may delegate this responsibility to the ORSC Director.
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Applicable Regulations and Guidelines
45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html)
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Updated 2/2009, Report
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