Institutional Assurance

I.01

 

Institutional Assurance

 

 

Previous Page


Objective

The University of Texas Health Science Center at Houston (UTHSC-H) is committed to upholding its Assurance filed with the Office of Human Research Protection (OHRP), and this Policy and Procedure describes the Assurances that will be adhered to by UTHSC-H and the Committee for the Protection of Human Subjects (CPHS).

 

Policy/Procedure

I.              The UTHSC-H delegates responsibility for insuring the rights 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 UTHSC-H’s policies and procedures for protecting the rights and welfare of human participants are applied in compliance with its Assurance.

 

II.           A full copy of UTHSC-H’s Assurance will be maintained in the Office of Research Support Committees (ORSC), and is based on the following principles.

 

A.     All UTHSC-H human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles in: 

1.      The Belmont Report which are

a)      Respect for Persons;

b)      Beneficence; and

c)      Justice.

2.      Other appropriate ethical standards recognized by federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule, other Department of Health and Human Services (DHHS) regulations (45 CFR 46, 21 CFR 50, 56, 312, 812), and the ICH Guidelines.

3.      UTHSC-H will also apply additional regulations such as HIPAA, and the VA regulations at 38 CFR 16, when applicable, to research involving human participants undergoing review.

 

B.     UTHSC-H faculty, staff, and students, which include its schools, departments, divisions, and facilities, are subject to the Assurance and these procedures. This includes any research for which an Assurance or other agreement identifies the UTHSC-H CPHS as the IRB of record.

 

III.               The CPHS is appointed as a UTHSC-H standing committee. The CPHS serves UTHSC-H as a whole and any institution for which the UTHSC-H is designated as the IRB of record in an Assurance filed with OHRP.  Ex Officio members of the Committee are the UTHSC-H Executive Vice President for Research, the UTHSC-H Chief Legal and Compliance Officer, Chair of the UTHSC-H Research Conflicts of Interest Committee, and representatives from Memorial Hermann Hospital System.

 

IV.        UTHSC-H’s Assurance presently designates three (3) OHRP-registered Institutional Review Boards (IRB). Designation of additional IRBs under the Assurance requires prior notification of and approval by OHRP. The Committees review all new biomedical, behavioral, and social sciences research and modifications of approved research; Data, Safety, and Monitoring Board reports; deviation/violation reports to existing approved research; all Continuing Reviews of previously approved research; and Serious and Unanticipated Adverse Event Reports.

 

V.           Responsibilities of the CPHS to provide oversight for its Assurance.

 

A.     All research, demonstration, or development projects and clinical training grants involving human participants and/or human derived data and tissue must be reviewed and approved by the CPHS except those that qualify as “Exempt” (see Policy and Procedure I.03)

B.     Through the review process, the CPHS shall have the authority to approve, require modifications in (to secure approval), disapprove, suspend, or terminate all research activities within its control.

C.     Research reviewed and approved by the CPHS may be reviewed and disapproved by officials at UTHSC-H, or any institution for which the CPHS is designated as the IRB of record in accordance with an Assurance or signed agreement with the CPHS. However, officials may not approve research previously disapproved by CPHS.

D.     The CPHS may suspend or terminate approval of research not being conducted in accordance with CPHS requirements or that which has been associated with unexpected serious harm to participants.

E.      The CPHS has at its discretion the authority to require that a third party observe the consent process and observe the conduct of the research.

F.      UTHSC-H’s Assurance must be updated at least every 36 months, even if no changes have occurred, in order to maintain an active assurance approved by OHRP.

G.     Amendments to the Assurance are to be reported promptly to OHRP.  This includes changes to CPHS rosters and the addition or deletion of the legally authorized entity of UTHSC-H.

H.     UTHSC-H will maintain policies and procedures reflecting the current practices of the CPHS in conducting reviews and approvals under its Assurance.

1.      These policies and procedures will be maintained and kept current by the CPHS and ORSC and updated as changes or new processes are implemented. All revision dates will be listed in the appropriate section in each policy and procedure.

2.      All procedures are to be approved by the Executive Committee.

 

VI.        The CPHS shall not be inappropriately influenced.

A.     Any attempts to inappropriately influence the CPHS or Office of Research Support Committees (ORSC) staff shall be reported to the Chairman of a Committee, Chairman of the Executive Committee, and EVPR.

B.     These persons shall have the responsibility and authority to respond to attempts to unduly influence the CPHS or the ORSC staff by

1.      Conducting a prompt and thorough investigation of all allegations of attempts to unduly influence the CPHS or ORSC staff;

2.      Providing a written report of the investigation to the appropriate person(s) listed in VI.A; and

3.      Determining any appropriate corrective action that should be taken.

 

Definitions: 

Research – a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

 

Human Subjects – all living or dead persons about whom an investigator conducting research obtains data (including tissue, specimens, and cognitive phenomena) through intervention or interaction, whether identifiable or not.

 

Applicable Regulations and Guidelines

21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html)

38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html)

45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html)

ICH E6 (http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB)

Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm)

Return to Policies and Procedures Home Page

Updated 6/5/2007, Report broken links