Post-Approval Verification and Education Guidance

What is the PAVE Program?

The purpose of the University of Washington (UW) Human Subjects Division (HSD) Post-Approval Verification and Education (PAVE) Program is to use a collegial approach to confirm by observation that UW human research is conducted in compliance with relevant federal regulations, state laws, UW institutional polices and Institutional Review Board (IRB)-approved procedures.

The PAVE program provides targeted education and tools to the researcher to address identified gaps. It also contributes to the University’s Human Research Protection Program by identifying (1) needs for systemic education and clarification, and (2) areas of strength and best practice.

All IRB-reviewed human research conducted at the UW is eligible for monitoring by the PAVE program. In most cases, a study will be monitored by the PAVE program only once. A second visit may be scheduled if the IRB determines additional aspects of the study need to be reviewed.

The PAVE program may overlap in some areas with other site monitoring efforts but will also include areas not typically addressed elsewhere such as:

1. Adherence to the IRB-approved study protocol
2. Data security and confidentiality
3. Data and Safety Monitoring Plan (DSMP) adherence
4. Research collaborations with non-UW partners

The implementation of this program is grounded in both regulatory and institutional authority. Federal regulations grant Institutional Review Boards (IRBs) the authority to observe, or to have a third party observe, the consent process and the conduct of research (45 CFR 46.109(g), 21 CFR 56.109(f)). In addition, institutional authority is established through the Vice Provost for Research Delegation Memo (December 30, 2010). This memo assigns the HSD Director the responsibility to develop and oversee this program to ensure compliance with the IRB’s regulatory obligations.

What to Expect During a PAVE Visit

Logistics

Participation in the PAVE program is mandatory if your study is selected. The PAVE monitor will work with you to schedule the review at a mutually agreeable time.

PAVE visits can be conducted in-person or remotely via Zoom. Visits consist of a review of the study records followed by an interview with the PI and study staff identified by the PI. The PI must attend the interview portion of the visit but is not required to be present during the study document review. This interview should take 30-60 minutes. The PAVE monitors will discuss any preliminary observations during this interview, or work with the study team to identify a time to discuss the observations.

In-person visits typically begin at 10am and last 3-6 hours.

For remote visits, a one-hour Zoom meeting will be scheduled for the date you have selected. You will be asked to provide electronic access to your study records a week prior to the day of your PAVE interview.

Scope

The following aspects of a research study, if applicable, will be reviewed:

1. Subject recruitment
2. Subject eligibility – including documentation of inclusion and exclusion criteria
3. Consent process and documentation
4. Confirmation that study procedures are conducted per IRB approval
5. Involvement of non-UW collaborators
6. Confidentiality and data security
7. Data and safety monitoring procedures
8. Drug or device administration and accountability
9. Compliance with applicable federal regulations, state laws, and institutional policies regarding human subjects research

It is anticipated that between 10-20% of the study’s research records will be reviewed, though all study participant records may be reviewed if time permits or only a small number of participants have been enrolled. PAVE monitors will review research records for the selected participants including (but not limited to):

1. Consent documents
2. Screening forms
3. Source documentation of eligibility
4. Data collection forms (e.g., diaries, questionnaires, case report forms, etc.)

The PAVE monitor will send an email before the visit requesting additional information about the study to be provided approximately 4 weeks in advance of the visit. This will include:

1. A list of all study participants with date of enrollment
2. Blank copies of all data collection forms currently in use
3. The location of the study site where the visit will occur (in-person visit only)

Approximately 5 business days prior to the visit you will need to provide or have available:

1. The location of and instructions for accessing electronic study records for selected study participants (remote monitoring only)
2. A signed attestation that applicable data security protections are being met
3. Copies of written policies or contracts required to meet the applicable data security requirements
4. A copy of the Delegation of Authority Log if one is being used

What Happens After a PAVE Visit

The PAVE monitor will discuss their findings with the study team during the exit interview portion of the visit. A draft PAVE Evaluation Report with a summary of observations will be sent to the PI, and those members of the research team the PI designates, approximately 3 – 4 weeks after the PAVE visit with a request for the study team’s comments and suggestions.

The report is reviewed by the PAVE Monitor as a Report of New Information (RNI), to determine if any observations meet the regulatory criteria for required reporting to University of Washington (UW) officials, regulatory officials, funding agencies, and sponsors.

PAVE Evaluation Reports may be reviewed by the convened IRB in the following circumstances:

1. The IRB has requested the evaluation
2. The report describes serious noncompliance, continuing noncompliance, or an unanticipated problem
3. At the discretion of HSD

After the IRB reviews the final PAVE Evaluation Report, the PAVE monitor will inform the researcher if there are any actions required by the IRB. This might include modifying the study through a modification in Zipline.

The final report is always distributed to:

1. The PAVE Monitor
2. The IRB with oversight of the study
3. The PI of the study

Additional individuals, groups, and compliance offices may be notified of the observations described in the report depending upon the outcome of the review by HSD and the IRB.

Post-Visit Survey

HSD will send a survey to the PI to collect feedback about the PAVE program and your experience with it after the final PAVE Evaluation Report has been submitted in Zipline as a Report of New Information. Responses to the survey are anonymous to the PAVE monitors.

Who to Contact

For additional questions, contact the HSD PAVE program at hsdpave@uw.edu.

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Keywords: PAVE, Regulatory Affairs