Post-Approval Support Services (PASS)

The PASS Initiative was developed by the ORARC Quality Improvement Program (QIP) to support investigators in maintaining compliance during the life of their Human Research projects.  The services incorporated into the PASS Initiative are an opportunity for QIP to provide additional catered education and resources to help researchers establish and maintain good study conduct and regulatory compliance after IRB approval is received. Following a short discussion (approximately 10-15 minutes) with a QIP member so that they can understand research timelines, experience, and availability of investigators, a PASS plan will be developed by the QIP member and emailed to the study team.  The PASS plan will include an anticipated menu of services selected specifically for the study.  Study start-up and regulatory binder orientation, investigator self-assessment, check-in meetings/calls, compliance assessments, or any other service deemed useful for the specific project by QIP staff may be included.

The services outlined in the plan will begin after the IRB approval, but failure to complete the services prescribed by QIP may result in a change in IRB approval status at any point during the life of the study.  As the study and/or its timeline fluctuate based on the needs of the project, QIP may reconfigure the PASS plan as appropriate and will communicate any changes with the researchers.

The Harvard Longwood Campus (HLC) IRB will require a PASS plan prior to giving final approval for any non-exempt human subjects protocol in two specific scenarios:

• Those that have a faculty member (PI) conducting research through one of the HLC IRBs for the first time.
• Those being driven by a non-faculty member (e.g., student, post doc, staff, exception PI).

The PASS Initiative is meant to complement the role of your Faculty PI and to provide additional support for success after IRB approval.  The PI is welcomed to take part in the PASS call and services, however, the non-faculty driver of the research will be required to participate.

QIP’s goal is to develop a Post-Approval Support Services plan tailored to the protocol.  Most PASS plans at minimum include a study start up and regulatory binder orientation and compliance check (i.e., investigator interview, regulatory binder review and participant file review).

• Investigator(s) become more knowledgeable about regulatory and IRB requirements
• Study documentation is better organized and research files are audit ready
• Investigator(s) have direct experience with QIP services/tools (e.g., self-assessment checklist, QIP compliance checks, ongoing consultation, etc.)
• IRB approval remains in good standing