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 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, 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:

IRB Director will maintain a copy of the FWA and IRB registration 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 and IRB Registration

Reviewed by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

Revision History:

1 Aug 2011, 1 Jun 2016, 21 Jan 2019

 

 


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
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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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