Developing, Approving and Maintaining Policy and Procedures

VI.01

 

 

Developing, Approving and Maintaining Policy and Procedures

 

 

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PURPOSE

1. To describe the policy and procedures for developing, reviewing, revising and distributing policy and procedures (P & P) for the Committee for Protection of Human Subjects (CPHS) and Executive Committee.

SCOPE

2. This policy and procedures maintained by the CPHS.

POLICY

3. The CPHS maintains written policies and procedures that are in compliance with federal regulations, State/local laws, University of Texas Health Science Center at Houston (UTHealth) policies and procedures, and standards of regulatory, accrediting, and funding agencies that apply to research conducted under its jurisdiction.

PROCEDURE

4. Procedure for developing and revising policy and procedures

4.1. The ORSC Director or designee will revise policy and procedures or develop new policy and procedures during regular biannual reviews or in response to changes to applicable regulations, OHRP Guidelines, AAHRPP standards, etc.

4.2. All new policy and procedures shall be numbered and logged into the policy and procedure management system. Each policy and procedure should include the following general information:

  1. Title
  2. P & P number
  3. Date of the original version
  4. Revision date
  5. Approval authority

4.3. The information in the policy and procedure shall be organized in the following manner:

  1. Purpose
  2. Scope
  3. Definition
  4. Policy
  5. Procedure
  6. Reference to Other policy and procedures
  7. Responsibility
  8. Applicable Regulations
  9. References
  10. Attachments

4.4. The ORSC Director or designee will consult the Office of Legal Affairs and Institutional Compliance to discuss applicable federal, state and local regulations, as necessary.

5. Procedure for approving and distributing policies and procedures

5.1. The ORSC Director or designee will circulate the new or revised policy and procedure to relevant individuals as appropriate including CPHS Members, ORSC Staff, EVPR etc. for comments and suggestions. Some policies and procedures will be approved by the ORSC Director and some will be submitted to the Executive Chairperson / Committee for review and approval.

5.2. The ORSC Director or designee will ensure that all ORSC staff are trained on the new or revised policy and procedure. If a particular policy and procedure is relevant to CPHS Members, the ORSC Director will ensure that the members are informed of the change either at a IRB Panel meeting, via written correspondence or at a training event.

5.3. If changes to the policy and procedure affect investigators, the ORSC Director or designee will ensure that this information is posted as an announcement in iRIS and updated on the CPHS website. If there is a need to communicate this information urgently, the ORSC staff will also send notices to all affected investigators.

6. Record Keeping

6.1. The ORSC Director or designee will maintain the policy and procedure management system. When a policy and procedure is revised, the ORSC Director or designee will maintain a historical archive of all previous versions. If no changes are required after the biannual review, the ORSC Director will document the review process and file appropriately.

RESPONSIBILITY

7. The ORSC Director is responsible for ensuring that the policy and procedures are up to date by conducting regular biannual reviews.

8. The ORSC Director is also responsible for revising the policy and procedure and ensuring that the changes are communicated to all users of the policy and procedure.

 

 

Applicable Regulations and Guidelines

1. 45 CFR 46.103(b)(4)
2. 45 CFR 46.108(a)
3. 21 CFR 56.108

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