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Policy Statement

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Policy Number PA-4002
Effective Date July 21, 2011
Revision Date  
Subject Matter Expert Chair, DSHS Institutional Review Board
Approval Authority Commissioner
Signed by:David L. Lakey, M.D., Commissioner
1.0 Purpose
  The purpose of this policy is to ensure that the Department of State Health Services (DSHS) has appropriate policies and procedures in place for the review, approval, and oversight of proposed human subjects research involving agency clients, or data and/or specimens in the possession of DSHS, and to ensure the protection of the rights, privacy, and welfare of human subjects involved in such research. This policy is to ensure that such research is conducted in accordance with applicable sections of state and federal laws, as well as to overlay additional agency policy and procedures so that appropriate agency management review is part of the process.
   
2.0

Policy

 
2.1 It is the policy of DSHS that all proposed human subject research which would involve DSHS clients or data and/or specimens in the possession of DSHS, regardless of the research funding source, will be reviewed by an Institutional Review Board (IRB) that is either sponsored or approved by DSHS.  This policy is inclusive of research proposed by private or public entities, including research proposed by a DSHS program area.  The department may have more than one IRB under this policy.  This policy covers IRB #1 and IRB #2 and any future IRBs established by DSHS.
2.2

Prior to submission to a DSHS IRB, all proposed research of the type described herein must first be reviewed by an authorized representative of the DSHS program(s) which possesses and manages the data and/or specimens in question (or who service the DSHS clients in question).  The authorized representative will conduct an initial scientific review of the proposal’s validity, ensure that the submission meets all the legal requirements for the program to release the requested data and/or specimens, that the data and/or specimens are actually in the possession of DSHS, and that the program(s) has sufficient resources to meet the time commitments of the request without compromising agency functions.  When appropriate, the authorized representative will consult with the program attorney.

Review process flow:

  • Proposed research is reviewed by an authorized representative of the DSHS program;
  • The authorized representative submits valid proposals to the appropriate Assistant Commissioner or designee for review;
  • The authorized representative submits proposals to a DSHS IRB;
  • A DSHS IRB will submit all initial applications (full board review, expedited review, exempt applications) to the DSHS Research Executive Steering Committee for review.

2.3

DSHS Research Executive Steering Committee.  In accordance with 45 CFR §46.112, the research covered by this policy that has been approved by the DSHS IRB may be subject to further review and approval or disapproval by officials of the DSHS. This committee is comprised of the General Counsel, State Epidemiologist, Chief Operating Officer and one or more Assistant Commissioners.  The purpose of the committee is to provide DSHS management review of proposed research studies approved by any DSHS IRB to determine whether the study should be approved or sent to the Commissioner of Health for further review and approval.

The Research Executive Steering Committee will review all initial applications (full board review, expedited review, exempt applications) submitted to IRB#1 and IRB#2.
   
3.0 Definitions
3.1 Authorized Institutional Official – An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.
3.2

Exemption/Exempt Research - Term used in the Federal Regulations (45 CFR §46.110) to describe six categories of research to which the Federal Regulations do not apply.

3.3 Expedited Review - Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal regulations (45 CFR §46.110) permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. In the context of research review by an IRB, expedited does not necessarily mean quick or fast.
3.4 Human Subjects - Individuals whose physiologic, biologic, genetic, or behavioral characteristics and responses are the object of study in a research project. Human subjects are defined as living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information; or (3) any other stored or collected biological specimen(s).
3.5 IRB – Institutional Review Board - Is a specially constituted review body established or designated by an entity to protect the rights and welfare of human subjects research.
3.6

IRB Membership – Total membership will vary, but at all times will meet the requirements of 45 CFR §46.107:

  • At least five members with varying backgrounds;
  • At least one member whose primary concerns are in scientific areas;
  • At least one member whose primary concerns are in nonscientific areas; and
  • At least one member not affiliated with the institution

In addition, DSHS will include other members required by state or federal law and will have at least one member representing the general public.
3.7 Public Health Purpose - a purpose that relates to cancer, birth defects, infectious disease, chronic disease, environmental exposures, newborn screening, or behavioral health.
3.8

Research - A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalized knowledge. (Commissioner’s Directive 2010.01 Management of Newborn Screening Specimens and Data)

   
4.0 Persons/Programs Affected
 

This policy applies to all DSHS programs and employees.

 
5.0 Responsibilities
   
5.1 DSHS Programs and Employees
  Assume responsibility for assuring all proposed research involving DSHS clients, or data and/or specimens in the possession of DSHS, is handled in accordance with this policy and as directed by law.
   
5.2 DSHS Review Process
  Specific review processes and procedures including roles and responsibilities of DSHS IRBs are outlined on the DSHS Internet at http://www.dshs.state.tx.us/irb/Default.shtm.
   
5.3 DSHS authorized Institutional Official
  The DSHS Commissioner shall appoint an individual to serve as the DSHS Authorized Institutional Official (AIO).  This individual must be authorized to act and speak for DSHS, ensure that the DSHS effectively fulfills its research oversight function, provide oversight for IRB functions, and select the chair of the IRB.  The AIO will approve recommendations made by the IRB Chair for appointing new members of the IRB. The AIO will also provide oversight and administrative support to the Research Executive Steering Committee.
5.4 IRB Chair
  The IRB Chair, or designee, will conduct full IRB meetings by directing discussions, leading reviews, and serve as a voting member on research proposals.  The Chair, or designee, will be responsible for conducting expedited reviews and making exemption determinations in accordance with 45 CFR §46.110, take an active role in establishing and reviewing IRB policies and procedures, and resolve any issues that arise during the work of the board or refer unresolved issues as appropriate. The Chair is responsible for making recommendations for appointments of new IRB members to the AIO for approval.  The Chair, or designee, will provide quarterly reports on IRB activities to the AIO and the Commissioner of State Health Services.
   
6.0 Procedures
Applications, submission manuals and specific DSHS procedures can be obtained at http://www.dshs.state.tx.us/irb/Default.shtm.
   
7.0 Issuance and Revision History

Date
Action
Section
5/1/2011

Changed title of policy from “Institutional Review Board” to “Institutional Review Boards”

Title
5/1/2011

Added a statement to clarify that the policy covers both DSHS IRBs and any future IRB

2.1    
5/1/2011 New language 2.2
5/1/2011 New language 2.3
5/1/2011 Added definition for “Exemption/Exempt Research” 3.2
5/1/2011 Added definition for “Expedited Review” 3.3
5/1/2011 Amended definition for clarity 3.4, 3.5, 3.6
5/1/2011 Added definition for “Public Health Purpose” 3.7
5/1/2011

Clarified responsibilities for “Authorized Institutional Official” and “IRB Chair”

5.3, 5.4
9/1/2004 New policy.  
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Last updated September 02, 2011