Compliance Oversight

POLICY

It is the policy of UTHealth to measure and improve compliance with human research protection policies and procedures and to measure and improve the effectiveness of the human research protection program. CPHS has the authority to request for random or ‘for cause’ study reviews of protocols under its oversight. The study review may include review of CPHS processes and documentation, study site documentation, observation of consent process and research.

PROCEDURE

HRPP Quality Improvement Activities – The UTHealth HRPP program has several projects to measure and improve the effectiveness of the HRPP. Some of the ongoing projects are:

IRB Review – Research compliance staff conduct routine monitoring of CPHS minutes to ensure compliance with policies and procedures.

Study Reviews – Research Compliance staff (monitor) conduct routine post approval monitoring visits. The research compliance staff pick random studies from the iRIS system for routine monitoring.  CPHS may request for a for cause audit at any time, including after the research is closed. Factors that may cause the CPHS to request an audit include, but are not limited to:

The monitor will inform the Principal Investigator at least a week in advance of the upcoming review and set up an agreeable time for the review. The PI and the study staff should be available for questions, have documents accessible, and respond to any written requests within the time frame agreed with the monitor.

The monitoring shall include, but not be limited to:

The monitor will communicate preliminary findings to the Principal Investigator to facilitate understanding of the process and collaboration in resolving any outstanding issues/concerns at an exit interview that will occur after each compliance review.

The monitor will submit a report to the Principal Investigator. The PI will address and respond to the recommendation(s) suggested by the monitor within a timely manner. When the CPHS has requested a ‘for cause’ study review, the monitor will submit a copy of the report to the CPHS. The CPHS will review this at a convened meeting.

Should the monitor discover an issue that potentially places participants at risk he/she will report the findings immediately to the IRB Director, Institutional Official or the Chairperson of the IRB responsible for the study. This will be handled as described in the policy and procedure on problem report.

APPLICABLE REGULATIONS

1.       None.

REFERENCES TO OTHER SOP

1.       None.

ATTACHMENTS

1.       Monitoring Checklist

2.       Monitoring Report Template

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

Document Number: 101-E05
Document Name: Compliance Oversight
Approved by: Executive Director, Research Compliance
Effective: 1 Jan 2009
Revision History: 1 Aug 2011, 1 Jun 2016


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

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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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