FREQUENTLY ASKED QUESTIONS REGARDING THE
INSTITUTIONAL REVIEW BOARD (IRB) RESTRUCTURING INITIATIVE
Q: Why are we doing this now?
A number of factors converged related to IRB functioning. The first was an FDA inspection that prompted Advocate to hire consultants to review the research oversight within Advocate.
Recommendations from the review suggested that this would be an opportune moment to look at research oversight. Advocate has also articulated a broader vision for research as we move forward as an accountable care organization and meet health care reform challenges. Once the IRB review is complete; Advocate will review, among others, the business, contracting, and billing operations side of the research realm.
Q: When will this initiative start?
Starting in January, 2013, Huron Consultants will be working with the IRB staff to review, revise, and put in place an infrastructure that allows Advocate to meet regulatory standards and its vision. This means a complete review of and revision of the IRBs policies, processes and procedures. The review will include IRB panels and the Local Oversight Committees at sites of care.
Q: What does this mean regarding the day-to-day operations of the IRB?
IRB panels will continue to meet as scheduled unless otherwise notified by the Chair. All IRB submissions are to be sent to the Advocate IRB as usual. Current forms that are posted on the IRB website should continue to be utilized until such time as they are declassified. The Advocate IRB, along with Huron consultants, will determine if a study is greater than “minimal risk”. New studies that are greater than minimal risk will be sent to an outside IRB until the restructuring is completed. Eventually, it is currently anticipated that the review of all studies will return to the oversight of the Advocate IRB. Continuing reviews, amendments, expedited and exempt submissions will continue to be processed by the Advocate IRB.
Q: What is “minimum risk?”
Minimal risk is a classification used by the regulatory bodies for a study involving human subjects. This category is accompanied by required review procedures. A study classified as “minimal risk” is a study in which the human subject encounter risks from being in the study that is no greater that what one encounters in daily activities.
Q: Who makes the determination of minimal risk and what criteria will they be using beyond the federal definition?
The Advocate IRB will make this determination. IRB Leadership in consultation with Huron will create worksheets to make sure the regulatory criteria are consistently interpreted and applied.
Q: Do I still use the Local Oversight Committee (LOC)?
Yes, until further notice, you should use the same local process for initial approval before sending it to the Advocate IRB, as you have in the past.
Q: Who pays for studies that sent to the outside IRB?
If the study is supported by a grant or a company, the fee will be added to the contract.
Physician initiated research by an Advocate employed physician that has no external funding will be covered by Advocate.
Q: What happens with ongoing studies? Are they being turned over to the central IRB or will the Advocate IRB continue to manage them?
They will remain with the IRB entity that granted initial approval for the life of the study.
Q: How long will this initiative take?
This will be an intensive revision and will take time. We expect the consultants to be here from 3-5 months, but anticipate that we would be completed with this initiative by the fourth quarter of 2013.
Q: What will the IRB process look like during this transition time?
Initially, it will look exactly as it does now. The majority of the revisions will be taking place behind the initial submission process. Once the planning and development of new forms, processes, procedures, and structures is completed, we will be implementing those changes coupled with a variety of educational sessions for investigators, administrators, and coordinators to assist in the transition.
Q: What does the IRB accreditation mean?
Accreditation benefits research organizations, participants, and the research enterprise as a whole. The accreditation process requires organizations to take a comprehensive look at their human research protection programs (HRPPs) ―to identify and address any weaknesses and to build upon their strengths. The result is a more cohesive HRPP, with the systems in place not only to protect research participants but also to advance research more efficiently and effectively.
Q: How will this affect relationships with sponsors? What response can we give to sponsors who have concerns?
This initiative should not have a negative impact on our relationship with sponsors as we are improving our structure, processes, and procedures to be more efficient and effective. Sponsors with concerns should be directed to either Jeff Teske or Dr. Mary Ann Clemens.
Q: What happens with multi-site studies with hospitals outside of the system?
This initiative should not affect these studies, but as they arise, the IRB leadership will consult and, as necessary, negotiate with our external partners to ensure the safe oversight of research studies while being as efficient as possible.
Q: AMG investigators perform research at non-Advocate hospitals and we've been able to work out an arrangement of "waivers" between the respective IRBs. How will this initiative affect those arrangements?
Conversations about our change process and transition plans will need to take place with organizations where we have existing arrangements to ensure that we can continue with them.
Q: Who can answer other questions about IRB operations?
Jeff Teske, Esq., Vice President & Chief Compliance Officer, or Joal Hill, J.D., M.P.H., Ph.D., Chair of the IRB,