II

III.01

 

 

Compliance Oversight

 

 

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Objective

It is the policy of The University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects (CPHS) to oversee all internal and external compliance review and/or auditing efforts in order to assure the protection of human research participants and compliance with federal regulations, state and local laws as well as UTHSC-H and CPHS policies and procedures. To help ensure compliance, CPHS shall respond to all reports of alleged non-compliance. These include but are not limited to; calls to the UTHSC-H hotline, monitoring reports from the clinical research monitor, and complaints by UTHSC-H faculty, staff, research subjects or their families. This Policy and Procedure describes processes for conducting compliance reviews.

 

Policy/Procedure

I.        Types of Compliance Reviews

A.     Not for Cause Audit - A representative sample of active protocols of greater than minimal risk shall undergo a routine compliance review by the Clinical Research Monitor on a regular basis.

 

B.     For Cause Audit - These audits may be specifically requested by the CPHS or by the Executive Chair to evaluate participant safety and welfare and/or assess compliance with local, State, and Federal laws and regulations, UTHSC-H and CPHS policies and procedures. The determination for a for-cause audit is made by the CPHS on a case-by-case basis at anytime, including after the research is closed. Factors to be considered by the CPHS in determining whether to go forward with an audit may include, but not be limited to:

 

1.      Involvement of vulnerable populations;

2.      Involvement of recombinant DNA or other types of gene transfer protocols;

3.      Research conducted internationally;

4.      Use of waiver or alteration of informed consent procedures;

5.      Research for which subjects would be exposed to additional risks (e.g. breach of confidentiality, Phase 1 studies);

6.      Previous suspension of the research due to compliance issues;

7.      Recommendations from other institutional committees (chemical safety committee, biosafety committee); and

8.      Allegations of suspected noncompliance or misconduct from any source, external or internal.

 

II.     Compliance Review Process

A.           Roles and Responsibilities

1.      Clinical Research Monitor – The Monitor reports to the Director of the Office of Research Support Committees (ORSC), and he/she gathers initial data required for not for cause and for cause audits.

2.      External Monitors – In some instances, external monitors may be utilized in the compliance review process.  External monitors will be required to sign a UTHSC-H HIPAA Business Associate Agreement as required by UTHSC-H policies on PHI (12.00 Business Associate Agreements - http://www.uth.tmc.edu/hipaa/policies/Section_12_Business_Associate_Agreements.html) to address privacy issues.

3.      Director, ORSC – The Director reviews initial data/findings of the Monitor and may request that he/she gather additional information.  The Director then forwards the findings to the Chair of the CPHS Executive Committee for review and action.

4.      CPHS Executive Committee – The Chair of the Executive Committee, in consultation with the Committee members, reviews allegations involving non-compliance in research under the jurisdiction of the CPHS, and determines if inquiries or investigations are required and what actions are required to address findings of noncompliance.

5.      CPHS – The CPHS is informed of allegations, findings, and outcomes of audits of human subjects research under its jurisdiction.

6.      EVPR – The EVPR is responsible for ensuring there are appropriate compliance programs in place for research under the jurisdiction of the CPHS and for keeping the Institutional Compliance Committee appropriately informed about non-compliance findings involving this research.

 

B.           Monitoring Process

1.      The principal investigator (PI) shall be notified in advance of the upcoming review and an agreeable time will be set for the review The PI will work together with the Monitor by making himself or herself available for questions, having documents accessible, and responding to any written requests within the time frame designated by the Monitor.

 

2.      The monitoring shall include, but not be limited to:

a)      Auditing advertisements and other recruiting material and practices;

b)      Recruitment procedures;

c)      Informed consent documentation and, if applicable, observation of the process;

d)      If deemed necessary, observation of research interactions or interventions with research participants;

e)      Verification from sources other than the PI that no unapproved changes have occurred since the previous review;

f)        Storage and use of investigational drugs and devices;

g)      Reporting of serious and unanticipated events; and

h)      Other monitoring activities as deemed appropriate for a particular study.

 

3.      The preliminary findings and recommendations from the Monitor for quality improvement will be communicated to the PI to facilitate understanding of the process and collaboration in resolving any outstanding issues/concerns.  The PI will be present for an exit interview that will occur after each compliance review.  Supplemental pertinent educational materials and instruction will be provided, as needed, to the PI by the CM to enhance human subjects training and data management skills.  The Monitor may schedule a follow-up visit to monitor implementation of requested process changes.

 

C.           CPHS Executive Committee Review of Audit Summaries - Upon receipt and review of audit summaries, the Executive Committee may:

 

1.      Accept the audit report with or without revisions to the currently approved study;

 

2.      Impose additional measures to optimize participant safety and/ or welfare, that may include, but are not limited to:

 

a)      Require more frequent status reports, such as after each participant receives intervention;

b)      Decrease the continuing review interval (e.g. 3 months, 6 months, or after a specific number of participants are enrolled);

c)      Require constitution or reformulation of an independent safety monitor or of an appropriate DSMB to monitor;

d)      Require an off-cycle DSMB review and written report;

e)      Conduct a follow-up audit by the Monitor;

f)        Limit Investigator’s ability to submit new research studies to the CPHS;

g)      Require a research intermediary to participate in or monitor the informed consent process;

h)      Create an education plan which may include, but not be limited to:

 

(1)   One-on-one instruction with a person to be determined by the CPHS responsible for the study;

(2)   Attendance of PI and/or research staff at local, regional or national conferences on human subjects protections;

(3)   Review of additional regulatory documents or materials (e.g. Belmont Report, 45 CFR 46, CPHS policies and procedures, OHRP determination letters)

(4)   Additional instructor-led or web-based human subjects protection training (e.g. OHRP, NIH, NCI).

 

3.      Accept the audit report and place the study on “Administrative Hold” pending further investigation.

 

D.           The Executive Committee will outline its findings and recommendations, if any, in a letter to the PI.

 

E.            PIs Response to Audit Findings/Recommendations

1.      PI shall notify the Chair of the Executive Committee of all currently enrolled subjects who would likely be adversely affected by the study suspension so that action can be taken to ensure their interim safety.  At the discretion of the Chair, the PI and study team may be instructed to provide written notification of potential harm and/or risk to enrolled and/or affected subjects in a timely manner.

2.      The PI may request or be requested to attend a full CPHS meeting to present information addressing any concerns resulting from the audit.

 

F.            Reporting of Audit Outcomes – The Director prepares summary reports of monitoring activity.

 

1.      Reports of all monitoring activity are presented to the CPHS bimonthly or more frequently for findings that required prompt action, and the presentations may include requests for review and approval of recommendations, and the CPHS Executive Committee receives copies of all reports to the CPHS.

2.      Monitoring reports are also forwarded to the EVPR who will have responsibility for insuring their implementation.

3.      Monitoring Reports are part of Institutional Research Compliance Program and will be presented in summary form for consideration by the Institutional Compliance Committee. The ICC may choose to recommend additional measures to insure adequate compliance with institutional, state or federal rules, regulations and guidelines concerning the conduct of human subjects research.

 

 

Applicable Regulations and Guidelines

21CFR 50 (http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html )

21CFR 56 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html )

21CFR 803 ( http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr803_05.html )

21CFR 814 ( http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr814_05.html )

38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html )

45CFR 46.103(b)(5) ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html )

ICH E6 ( http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB )

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Updated 7/13/2007, Report broken links