OBJECTIVE:

To describe the function and process of monitoring VCU IRB-approved research activities

DESCRIPTION:

VCU employs a comprehensive approach to post-approval monitoring through:
 

1.   Continuing Review;
2.   Voluntary Post-Approval Study Evaluations (PASE);
3.   Random (No-Cause) Site Visits; and

4.   Requested (For-Cause) Site Visits.

1. Continuing Review:

VCU IRB-Approved research is monitored through the continuing review process and required reporting processes (for all expedited and full-board IRB-approved protocols):

VCU IRB WPP VIII-4 Continuing Review

VCU IRB WPP VIII-5 Review of Modifications to Research

VCU IRB WPP VIII-7 Unanticipated Problems

 

2. Voluntary Post-Approval Study Evaluations (PASE):

The Post-Approval Study Evaluation (PASE) was developed by VCU as a tool for human research investigators to use in an effort to conduct a voluntary quality improvement exercise at the study-site level.  PASE is designed for use by both biomedical and social science researchers and focuses upon issues regarding quality documentation and recordkeeping consistent with managing overall VCU IRB compliance (for non-exempt IRB-approved protocols).  The primary elements of the PASE are derived from the VCU IRB Written Policies and Procedures, Good Clinical Practice requirements (http://www.fda.gov/cder/guidance/959fnl.pdf) and FDA regulations (http://www.fda.gov/oc/gcp/default.htm).  The goal of PASE is to improve quality by identifying issues that may have come up during the IRB review cycle and reporting them promptly to the VCU IRB.   Specific uses by the investigator and/or research staff include: (1) training new research personnel; (2) preparing for VCU, sponsor, or regulatory agency site visits; or (3) a routine quality improvement exercise. 

 

3. Random / No-Cause Site Visits:

The random or no-cause site visit is known as a "'Random IRB Support Visit".   Random IRB Support Visits are scheduled and carried out by the OECO (without a specific request by the institution or IRB) or may be requested by the principal investigator/research staff.   These visits tend to take on a dual role of assisting with identifying issues, resolving them, and providing educational support.  Random IRB Support Visits are conducted on an ongoing basis.  Records and reports are retained within the ORSP and the OECO.  Protocols involving greater than minimal risk and/or involving vulnerable populations or unique circumstances make up the primary emphasis for Random IRB Support Visits.

 

4. Requested / For-Cause Site Visits:

The requested or for-cause site visit is known as a "Requested IRB Support Visit".  Requested IRB Support Visits are scheduled by the OECO at the request of the ORSP, the VCU IRB, VCU administration, or as determined warranted by the OECO.  While similar to the "Random IRB Support Visit," these visits include a formal audit and reporting component.  This activity may include direct audits of study records at the study site, contact with the research sponsor and/or monitoring organizations, contact with other IRBs, interviews with research staff and research participants, and/or review of records within the IRB.  Areas to be assessed at the monitoring visit may include:

• Compliance of the PI and the research team with the IRB-approved protocol.

• Compliance with all relevant laws, regulations, policies and procedures.

• Respect afforded to research subjects by the PI and the research team as evidenced by the informed consent process, conformity to inclusion and exclusion criteria, special concern for vulnerable subjects,

• Observation of the consent process*,

• Provisions and practices pertaining to safeguarding confidentiality of data.

• Compliance with reporting requirements - particularly reporting SAES (and other terms of VCU IRB approval).

• Concern for the safety of research subjects.

A copy of the outcome of the monitoring visit will be made available to the approving IRB panel Chairperson, the OECO, and to the VCU Institutional Official, as appropriate.  Records and reports are retained within the ORSP and the OECO.  Any IRB-approved protocol may be subject to a Requested IRB Support Visit.

 

*Special Issues for Observation of the Consent Process:  The IRB may request monitoring of the consent process at any time.  Factors that may prompt Consent Observation include any specific complaint or concern raised that relates or may relate to the consent process. 

 

WIRB Program for Monitoring WIRB Approved Research
Western IRB, a central IRB which provides IRB services for industry-sponsored research as part of the VCU Human Research Protections Program, conducts on-site audits (site monitoring visits) of VCU research approved by WIRB at least annually.  The results of these visits are reported to the VCU ORSP and the VCU OECO.  When VCU conducts post-approval monitoring of a WIRB-approved study, the report is promptly provided to WIRB.

RESPONSIBILITY:

It is the responsibility of the OECO to plan for and oversee all IRB Support Visits, monitor audits conducted by the WIRB, facilitate formal investigations (which typically will combine one or more approaches), and monitor the continued development of the PASE program.

REFERENCE:

Post-Approval Study Evaluation (PASE)