Dear DePaul Human Subject Research Community,
After careful consideration, the DePaul IRB decided at the August 22, 2016 meeting to eliminate the Local Review Boards (LRB) process as it currently exists and as it currently relates to the Institutional Review Board (IRB) process.
As you may recall, last year we sent out a survey to IRB and LRB members and the DePaul research community in general, regarding whether the LRB process should continue, be altered, or be eliminated. One of our concerns was that eliminating the LRB would abolish one avenue for tenure track faculty to obtain service credit. The feedback we received overwhelmingly indicated that there were enough avenues for faculty to obtain service credit and eliminating the LRB would not impact the tenure and promotion process at DePaul. In the end, the IRB determined that the LRB process was still helpful for students, new faculty, or faculty submitting for the first time to the DePaul IRB. We modified our policy at that time to allow seasoned faculty (those who have submitted to the DePaul IRB previously) to bypass the LRB process, but the LRB process continued.
Over the course of the past year, we have maintained open dialogue with faculty and LRB Chairs who have asked us to reconsider continuing with the LRB process. The arguments against continuing with the LRB process primarily focus on the delay in obtaining IRB approval, as the LRB process adds significantly to the overall protocol review time. We asked that the IRB members go to their schools, colleges, and departments and ask for feedback on this issue. At the August 22, 2016 meeting, we discussed the feedback we had obtained and determined to eliminate the LRB process. As a result, effective immediately, the LRBs are being disbanded.
The IRB would like to thank the many LRB members who have contributed to the LRB process over the years. Your efforts truly have been appreciated as they have made our jobs on the IRB easier. We have enjoyed working with all of you and we appreciate all your effort and hard work.
Please take a moment to read the FAQs below this message and please disseminate this announcement as much as possible.
Susan M. Loess-Perez, MS, CIP, CCRC
Director of Research Compliance
Office of Research Services
FAQsWhat was the purpose of the Local Review Board review process?
The LRB process was meant to function as a scientific review process that focused on the design and field-specific methodology of the research to ensure that the protocol adhered to field-specific norms and ethics, and would result in valid scientific results. The IRB relied upon the LRB in this capacity as the experts in their respective fields, to strengthen the design of the research before the IRB evaluated the research for human subject-related concerns.How will eliminating the LRB process impact the IRB review process?
Having all new protocol submissions come directly to the IRB should shorten the overall review process time (time from submission to final approval) as long as the application materials we receive are complete and well-written. However, the change does mean that the IRB will be the sole scientific review process at DePaul and will need to document that the science of the protocol was reviewed. The IRB has always had a regulatory mandate to review the science of a protocol under 45 CFR 46.111 approval criteria: Risks to subjects are minimized: (i)By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk... However, eliminating the LRB process means that the IRB must look more closely at the science of each protocol and document the determination that the protocol demonstrates sound research design. This means revisions will be made to the IRB's internal documents in which we record our review determinations.How will elimination of the LRB process impact the Principal Investigators (PIs)?
Overall we hope that the change will be a positive one, in that the overall time from submission to approval should be lessened. However, the change does mean that the PI must review their work more thoroughly before submitting it to the IRB. For student PIs, they must get the appropriate assistance from their faculty sponsors or mentors and work to submit well written and complete applications to the IRB. Although we have not done this to date, IRBs at other institutions return poorly written or prepared IRB submissions to the PIs without review. We would need to evaluate at a later date if a drastic measure such as this is needed in the future at DePaul.How will the elimination of the LRB process impact faculty sponsors?
The change means that faculty sponsors need to make a renewed commitment to mentoring students through the IRB process, including but not limited to, thoroughly reviewing the application and supporting materials that are part of the IRB submission package. Faculty sponsors will no longer be able to rely on the LRB to clean up the materials and should not rely on the IRB to do so either. The faculty sponsor signs an assurance on each application submitted by a student that indicates that they have reviewed the materials and are ultimately responsible for the ethical conduct of the research. At times it seemed like some faculty sponsors sign this assurance without reviewing the student's materials. The IRB has noted over the years that submissions that do not receive LRB review tend to be less complete and require far more revisions than applications that received the LRB reviews. Ultimately, this means that the faculty sponsor must be accountable and commit to providing mentoring to the students and reviewing and editing the student's application materials prior to signing the faculty assurance.Can departments, schools, and colleges keep a LRB if they want to?
No. At this time we are eliminating the LRB process and having some LRBs remain intact would be confusing. However, departments, schools, and colleges are free to restructure the LRBs into other groups such as human subject research advisory panels or mentoring panels. These panels could be resources to students and faculty who might need or desire assistance in writing their first human subject research protocol or submitting to the DePaul IRB for the first time. We would ask that terminology similar enough to be confused with the LRB or IRB be avoided when naming these panels or committees, so that there is no misunderstanding regarding who to submit protocols to for IRB review.What do departments, schools, and colleges need to do now?
We ask that any websites or materials dedicated to the individual LRBs be eliminated. We also ask that you disseminate this announcement about the elimination of the LRB.What additional help can the Office of Research Services provide to researchers?
The Office of Research Services (ORS) will continue to offer open office hours each quarter to assist investigators one-on-one with protocol submissions. As always, ORS staff is available daily for emails or phone advice or assistance. In addition, ORS will offer protocol workshops as many times as possible during the academic year. There is currently one scheduled for early October. Please see our website for the details on the workshop. We will be releasing a new version of our expedited/full form, which we hope will aid researchers in creating better protocol applications. Finally, ORS will be looking for other avenues to assist researchers in every way we can to make them successful and to streamline the IRB review process.
For further information please contact:
Susan Loess-Perez, Director of Research Compliance, 312-362-7593, email@example.com or firstname.lastname@example.org