Developing and Maintaining CPHS Policies and Procedures
POLICY
IRB 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, accreditation, and funding agencies that apply to research conducted under its jurisdiction.
PROCEDURE
Procedure for developing and revising policy and procedures: The Executive Director, Research Compliance, Education and Support Services will revise policy and procedures or develop new policy and procedures during regular reviews every three years or in response to changes to applicable regulations, OHRP Guidelines, AAHRPP standards, or UT System policy.
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:
- Title
- P & P number
- Date of the original version
- Revision date
- Approval authority
The information in the policy and procedure shall be organized in the following manner:
- Policy
- Key Terms
- Procedure
- Reference to Other policy and procedures
- Applicable Regulations
- References
- Attachments
The Executive Director, Research Compliance, Education and Support Services will consult with the VP Human Research Protection Program, IRB Executive Committee, IRB director, Office of Legal Affairs and Institutional Compliance to discuss applicable federal, state and local regulations, as necessary.
Procedure for approving and distributing policies and procedures: The Executive Director, Research Compliance, Education and Support Services will circulate the new or revised policy and procedure to relevant individuals as appropriate including CPHS Members, IRB Staff, Institutional Official etc. for comments and suggestions. Some policies and procedures will be approved by the Executive Director, Research Compliance, Education and Support Services and some will be submitted to the Executive Chairperson / Committee for review and approval.
The IRB director or designee will ensure that all IRB staff are trained on the new or revised policy and procedure. If a particular policy and procedure is relevant to IRB members, research compliance staff will ensure that the members are informed of the change either at an IRB panel meeting, via written correspondence or at a training event.
If changes to the policy and procedure affect investigators, research compliance staff or designee will ensure that this information is posted as an announcement in iRIS and updated on the IRB website. If there is a need to communicate this information urgently research compliance staff will also send notices to all affected investigators
Record Keeping - Research compliance staff will maintain the policy and procedure management system. When a policy and procedure is revised, the research compliance staff or designee will maintain a historical archive of all previous versions.
APPLICABLE REGULATIONS
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 56 Institutional Review Board
- OHRP and FDA Guidance: Institutional Review Boards – Written Procedure
REFERENCE TO OTHER POLICIES
ATTACHMENTS
- Policy and Procedure Template
If you find errors in this document, contact cphs@uth.tmc.edu
|
Document Number: |
101-F01 |
|
Document Name: |
Developing, Approving and Maintaining CPHS Policies and Procedures |
|
Reviewed by: |
Executive Director, Research Compliance |
|
Effective: |
1 Aug 2008 |
|
Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
|
Committee for the Protection of Human Subjects IRIS Support 713-500-7960 |
|
|
|
CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |
||
