On Wednesday, September 18, PRIM&R hosted a webinar titled Doing More with Less: Best IRB Practices for Institutions with Small Research Programs. Scott Lipkin, DPM, CIP, chief of the Network Office of Research and Innovation at the Lehigh Valley Health Network, and Lori Roesch, CIM, CIP, manager or the research subject protection program at Aurora Health Care, Inc, participated as speakers, with Elisa A. Hurley, PhD, education director at PRIM&R, as moderator.
Following the webinar, we connected with the presenters, and they kindly answered a few more questions that came in from webinar participants, exclusively for Ampersand.
Alexandra Shlimovich (AS): Where should you start when developing a set of policies and procedures?
Scott Lipkin (SL): This is a difficult question to answer in general terms. Institutional review boards (IRBs) are required to have policies and procedures to review and approve human subjects research. Writing effective and compliant IRB policies requires a working
knowledge of applicable regulations and of the status of your terms of assurance under your institution’s Federalwide Assurance (FWA). Once you have this information, you then need to understand the policy approval and formatting requirements of your institution. Finally, you need to inventory existing policies and determine which policies are in order, which are missing, and which require revision. After these questions are addressed, you can begin the process of actual policy writing. I suggest that you keep copies of all applicable regulations by your side during the writing process. Many policies from reputable institutions are available online, and I would recommend looking them over as part of the process.
Lori Roesch (LR): Here are some helpful resources for doing a gap analysis:
- Food and Drug Administration (FDA) Self-Evaluation Checklist for IRBs
- Office for Human Research Protections (OHRP) Quality Assurance Self-Assessment Tool
- Association for the Accreditation of Human Research Protection Programs (AAHRPP) Evaluation Instrument for Accreditation
Don’t hesitate to use AAHRPP’s evaluation instrument even if you are not planning to seek accreditation. Domain II outlines in a systematic way what IRBs must have in place, and provides regulatory references to support each requirement. You could also consider contracting with a consulting company or asking your legal counsel for assistance. It might be a higher cost upfront, but can be done very quickly. A word of caution – do not implement unless you have an in-depth working knowledge of what you are implementing.
AS: How do you earn the professional respect of your investigators/physicians who think that they are doing your hospital a favor by doing research there and that you are there to serve them?
SL: I recommend focusing on providing professional, accurate, and timely customer service to all investigators that utilize your services. Respect will be earned by maintaining professionalism at all times.
LR: Also, make sure you know why you are doing or requiring something. If you aren’t able to back something up, it casts doubt in the minds of investigators and/or physicians. View yourself as a key component of your IRB leadership team. You shouldn’t be alone. Having a strong and knowledgeable IRB chair and institutional official that support and echo your efforts will help greatly; it’s essential to be on the same page.
AS: How do you get your institution to realize that your attendance at professional conferences and pursuit of Certified IRB Professional (CIP®) certification is worth their investment?
SL: This largely depends on the culture and financial disposition of your organization. Assuming that your organization values quality and is financially solvent, I think the question is why wouldn’t they realize that attending conferences and obtaining CIP certification is a valuable investment? CIP certification affirms quality in you as an individual and in your organization as well.
LR: You might also want to consider investing in yourself if such opportunities are not available through your organization. CIP certification is $335 for PRIM&R members (and $435 for nonmembers), and is valid for three years before you need to recertify. Continuing to educate your leaders about human subject protections and sharing what can happen if you don’t (check out recent FDA warning letter) can do wonders!
AS: What follow up readings or resources would you suggest people take a look at?
LR: Here are some “must read” resources for IRB administrators:
- IRB Management and Function, Second Edition
- From the FDA’s website:
- IRB Information Sheets
- International Conference on Harmonisation E6 Good Clinical Practice
- Adverse Event Reporting
- In Vitro Diagnostic Testing of Anonymous Samples – Waiver of Informed Consent
- Device Frequently Asked Questions
- Significant and Nonsignificant Risk Device Guidance
- HIPAA and Stand Alone Consent
- From OHRP’s website:
- Recent Compliance Oversight Determinations
- Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
- Human Research Questions and Answers
- Policy Guidance by Topic
- Quality Assurance/Quality Improvement: A Guided Self-Assessment for Human Research Protection Programs
- AAHRPP Standards
- Office for the Protection of Research Subjects Flexibility Coalition information
If you’re interested in learning more about best IRB practices for institutions with small research programs and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.