What is a Post-Approval Support Services (PASS) Plan?
A PASS Plan is a new initiative 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 a PASS Plan 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. It will include a menu of services and the dates of completion selected specifically for the study. Study initiation/orientation visit, investigator self-assessment, check-in meetings/calls, onsite review, or any other service deemed useful for the specific project by QIP staff may be included.
The Harvard Longwood Campus (HLC) IRBs require that any PIs listed on a non-exempt protocol for the first time or any non-exempt protocol which is being driven by a non-faculty member (e.g., student, post doc, staff) but has a faculty PI named because of ORARC policy, obtain a PASS Plan from QIP before final IRB approval is given. 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.
Which studies require a PASS Plan prior to final approval?
The Harvard Longwood Campus (HLC) IRB will require a PASS plan prior to giving final approval in two specific scenarios:
- For any non-exempt protocol which has a PI listed who has never been listed as PI on a non-exempt human research protocol at one of the HLC IRBs.
- For any non-exempt protocol being driven by a non-faculty member (e.g., student, post doc, staff) but has a faculty PI named on their IRB submission due to ORARC policy.
While the above two scenarios will always require a PASS plan, the IRB may also require one in additional circumstances where they think that it would benefit the study or study leadership. This will be communicated to the researchers during the review of the protocol.
How do I obtain a PASS Plan?
The IRB will notify the ORARC Quality Improvement Program (QIP) when a PASS plan is needed. QIP will contact you get the information that they need in order to to create a PASS Plan for your protocol. Additionally, a PI may request post-approval support services from QIP without a referral from the IRB.
If I am not a faculty member, what are my named Faculty PI’s responsibilities specific to completing a PASS Plan?
A PASS plan is meant to complement the role of your mentor and to provide additional support for success after IRB approval. All members of the study team are invited to take part in any or all aspects of PASS plan process; however, the non-faculty driver of the research will be required to participate. If the PASS Plan is required because the PI is a first time at HLC PI, the PI will be required to take part in all aspects of the PASS Plan process.
Do I need to complete a PASS plan before receiving final IRB approval?
For all IRB-referred projects, the primary PASS planning phone call (10-15 minutes) with a member of the QIP team, and then the subsequent QIP team’s communication of the PASS Plan to the PI and applicable study staff is required prior to receiving final IRB approval. Once a plan is established, QIP will notify the IRB that the requirement has been fulfilled. Failure to complete the services prescribed by QIP in the “plan” 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.
What services could be included in my PASS Plan?
QIP’s goal is to develop a Post-Approval Support Services plan tailored to the protocol. Most PASS plans include a study start up orientation with a regulatory binder consultation, and a mid-point check-in. Additional services may include a QIP onsite review (i.e., investigator interview, regulatory binder review and participant file review), completing the Investigator Self-Assessment checklist, or study conduct observation including the consent process.
What are the benefits of participating in the prescribed QIP Post-approval Support Services?
- PI/Student investigator becomes more knowledgeable about regulatory and IRB requirements
- Study documentation is better organized and research files are audit ready
- Instigator(s) have direct experience with QIP services/tools (e.g. Self-Assessment checklist, onsite reviews, ongoing consultation, etc.)
- Future routine QIP initiatives may not apply to the protocol for which the PASS plan is being utilized