Committee For the Protection of Human Subjects

Developing and Maintaining CPHS Policies and Procedures

POLICY

CPHS maintains written policies and procedures that are in compliance with federal regulations, State/local laws, University of Texas Health Science Center at Houston (UTHSC-H) 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 ORSC Director or designee 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, etc.

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 ORSC Director or designee will consult the 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 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.

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.

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.

 

Record Keeping - 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.

 

APPLICABLE REGULATIONS

1.       45 CFR 46.103(b)(4)

2.       45 CFR 46.108(a)

3.       21 CFR 56.108

REFERENCE TO OTHER POLICIES

1.       None.

ATTACHMENTS

1.       Policy and Procedure Template

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

 

Document Number:

101-F01

Document Name:

Developing, Approving and Maintaining CPHS Policies and Procedures

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011


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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