“Advancing and Spreading Flexibility”
Flex Coalition Luncheon
PRIM&R Conference: November 7, 2013
Susan Rose, University of Southern California (USC) welcomed guests and noted that there will be a flex coalition lunch at every PRIM&R and AAHRPP conference and also 2 conference calls a year. This has been designed to keep momentum and interest among members and to provide new ideas on a continuing basis.
Handouts include:
1) A checklist containing all flex options/ideas to date
2) Redefined flexibility as creative solutions to include those with checked box
Susan noted that: Moira Keane (formerly University of Minnesota), and Judy Birk (University of Michigan), are those who initiated these concepts.
It was suggested that future OHRP Notice of Proposed Rulemaking (NPRM) should take note of our efforts and use them because we as a community feel these ideas are useful and brilliant and would like to see them reflected in new regulations. Susan commented that the response to the coalition has been overwhelmingly positive and institutions are sharing great information.
Jason Pitzen, Mayo Clinic: IRB Workflow Streamlining IRB Admin/Ancillary Review Process:
The first speaker, Jason Pitzen,(Administrator-Research Operations), described the streamlined the IRB review and approval process at Mayo. Jason shared that Mayo clinic IRB does not review with stipulations or contingencies and only has about a 3-5% deferral rate of research proposals. Mayo developed a well-defined pre-review screening process that addresses all stipulations and contingencies before the study goes to full committee for review and approval. Mayo has well-trained staff (CIP certified) who conduct the pre-reviews using checklists in the screening process to ensure all requirements are being met. The back and forth between IRB staff and investigators is a collegial process and is also a point of satisfaction for investigators. The turnaround time from submission to approval is 33 days (mean) and 21 days (median).
Michelle Russell-Einhorn (Dana Farber) asked Jason if Mayo had any issues with sponsors pushing back and wanting stipulations/contingencies to come from the convened committee and not from staff. Jason noted that Mayo hasn’t had much experience with sponsors only accepting full board comments. Michelle then asked if you did get pushback what would you do. Jason responded that we would let these studies go to the full board for review and let the committee decide. Jason noted that often times these are the studies that would get deferred.
Rebecca Flores-Stella (Cedars-Sinai Medical Center) shared that Cedars also has a well-established pre-review process and ask the investigator to provide a justification as to why a change is not necessary or explain why they don’t want to meet the contingency. Cedars will also pull in the primary reviewer before the studies goes to committee and have an informed discussion about any issues before the meeting.
Susan asked Michelle if what Cedars does would work for her institution, Michelle responded that they do that too.
Eifaang Li (Cedars-Sinai Medical Center) asked where in the review process do the ancillary committees (e.g. Bio-safety, Radiation Safety) review the study. Jason commented that the IRB does not accept a submission until those reviews are completed. Jason Pitzen (Mayo Clinic) noted that the IRB is the last step in the process at Mayo.
Darcy Spicer asked when in the process is the sponsor contract reviewed. Jason responded that the contract review is basically the last step in the process. The budget is negotiated beforehand, but the contract is not signed and IRB approval is usually granted pending contract approval. Jason also noted that a final contract review with the consent document(s) is done through the contracting office. Susan mentioned that Mayo has a huge team of staff to make the process efficient.
Keren Dunn, Cedars-Sinai Medical Center: Self-Determination of Coded Specimen Research
Action: Keren (handout will be provided with flex notes)
Keren detailed that as part of Cedar’s post-approval monitoring program, CSMC decided to monitor minimal risk retrospective medical chart reviews. Keren gave the example of one study that was approved as a minimal risk, retrospective chart review with a waiver of consent and HIPAA.
The monitoring team found that the study was actually a prospective data registry designed as a retrospective study (1) by but the study team just kept amending the study to extend the dates. The monitoring team also found that the study didn’t appear to meet the requirements for a waiver of informed consent and HIPAA.
(2) Cedars was concerned when separate studies were submitted using data/specimens from the specimen/data repository for review and determination. Many investigators want to conduct multiple studies in a short period of time and have the burden of submitting for a review and determination each time. Cedars created a form for the study team to use and self-determine if they have to go through the IRB process. Investigators can do their own review through the use of the form and it allows the monitoring team to track the uses and ensures the investigators use the form properly. (3) Cedars process also allows investigators running repositories/registries to also conduct studies using the data/specimens which is not allowed using coded and information specimens’ guidance. Keren noted that Cedars was unsure if this process meets OHRPs guidance on coded/data specimens, so until they have confirmation that is does/doesn’t they have only allowed it for use in non-federally funded studies. Keren added mentioned that the investigators also provide assurance that they will not access any identifiable data.
Action: Keren will provide Cedars self-determining form.
Keren will let us know when OHRP approves process for federally funded studies
Linda Halstead (Loma Linda University) mentioned that upon initial approval of the data/specimen repository/registry they require investigators to have a pretty clear protocol on how the data/specimen bank will be managed and then allow investigators to just submit an amendment for any use of the data/specimens from the repository/registry.
Erica Heath (Ethical and Independent ReviewServices) mentioned that she would like to see feedback on whether the process/policy is being used correctly.
Action: (Does this mean audits-ask Erica for follow-up)
Kristin Craun, University of Southern California: Ceded ICOI Review with Cedars-Sinai Medical Center
Kristin shared that the Memorandum of Understanding (MOU) between the two institutions covers Institutional conflict of interest, collaborative research and research studies on a case by case basis. Kristin said for studies where there is an ICOI, the MOU allows one institution to completely defer the IRB review and approval of a study to the other institution. Kristin noted that conceptually the MOU works well although the implementation of the process of ceding review to the other institution for ICOI is imperfect as there is still an unnecessary administrative burden on staff. Both institutions are exploring the following ways to ease the burden: (which pertains to any fully ceded review)
Local context issues must still be addressed locally. COI committee at relying site needs to inform reviewing site of any management plan.
· Allow the PI from the institution with the ICOI to submit directly into the reviewing IRB’s electronic submission system
· Allow IRB staff/ committee members of the reviewing IRB to access the study in the conflicted Institution’s electronic system.
Rebecca Flores-Stella (Cedars-Sinai Medical Center) shared that both institutions have to incorporate a way to use their current systems and available resources to help ease the administrative burden. Rebecca noted that USC and Cedars will do a test run of having IRB staff/members navigate each other’s electronic systems for ease of use and feasibility.
Rebecca Flores-Stella, Cedars-Sinai Medical Center: CTSA/CTSI Partnership Agreement
Rebecca briefly mentioned the CTSA/CTSI IRB partnership which includes Cedars Sinai, UCLA, Charles Drew, and Harbor UCLA. An MOU was established between the four institutions that allows for one institution to serve as the reviewing IRB for a study. Rebecca noted that the Investigator has to complete the Protocol Registration notice (PRN) which documents the intent to rely totally on another institution’s IRB. Rebecca also shared that there is no longer a relying IRB review process in the ceded model; there is only an administrative acknowledgment that study has been approved.
Karen Hansen (Fred Hutchinson) asked Rebecca how unanticipated problems and serious and/or continuing non-compliance are managed through the CTSA/CTSI MOU. Rebecca stated that those issues are handled between the Investigator and the IRB of record in collaboration with the reliance institution.
Emily Sheffer, Vanderbilt University: IRBShare
Emily gave a brief overview of IRBShare which is an IRB review model for multi-site studies comprised of participating Institutions utilizing shared review documents and a shared review process that allows expedited review by the relying sites when at least one participated site IRB has documented full board approval, supported by a centralized, secure web portal and the IRB share Master Agreement. Emily mentioned that they are still waiting to get sign-off from OHRP on their expanded process. Emily noted that there is one Master Agreement and each institution can decide it will use the system. Emily also noted that IRB Share cuts down on the review to approval time frame, noting once documents are uploaded they can be reviewed by the other institutions subcommittee/IRB Chair in one day.
Action: Susan Rose noted that once IRBShare has their processes finalized those will be shared with the group.
Action: Provide IRBShare’s finalized approved plan and process
Jonathan Greene, Washington University in St. Louis: IRB Meeting Streamlining
Jonathan presented the process Wash U underwent to streamline the organization of it’s 10 IRB committee meetings. Jonathan said that Wash U went through the drastic change to improve quality, consistency, efficiency, and enhance IRB reviewer’s experience. Jonathan provided the following metrics on where WUSTL started:
· 5500 open studies
· 1500 full board studies
· 190 total IRB members
· 10 independent IRBs (meeting once a month for 2 hours)
· 18-20 items per meeting
· 55-60 days to approval
Jonathan commented that Wash U was experiencing the “Australia effect” there was no intermixing of the gene pool which lead to a lot of inconsistency. Wash U moved to a leaner IRB:
· 1 IRB with 7 members
· 160 alternates
· 6 meetings per week for 1 hour
· 7 items per meeting
With this leaner IRB Wash U increased capacity, held shorter more focused meetings, improved consistency and decreased days to approval to 10-14 days. Jonathan noted that the bottleneck was in the screening process and rescheduling to the next agenda which would take up to 30 days. Jonathan mentioned that IRB member satisfaction has gone up and Investigators have given positive feedback. Jonathan also shared that there has not been any change in IRB staffing needs at all. A question was asked on who takes minutes. Jonathon noted that IRB analysts take minutes and that there is a 48 hour turnaround time for completion of minutes.
Susan Rose asked how he got institutional buy-in and who had to agree to the change?
Jonathan responded that it took a year to implement. Their biggest concern was IRB members. They spent a lot of time thinking of everything that could go wrong and what would fail. They thought not having enough non-scientists as IRB members would be an issue so there was a huge effort to double non-scientist members.
Susan Kornetsky (Boston Children’s Hospital) acknowledged that she visited Wash U and it was the most impressive thing she has seen. Susan Kornetsky shared that Wash U took a central IRB model and successfully brought it to an academic institution.
Action: Susan Rose commented to Susan Kornetsky that she would be counting on her to present something at the next flex coalition meeting.
Rebecca Flores-Stella asked Jonathan that with a seven item agenda how much pre-meeting review time are members given. Jonathan responded that the agenda is sent out 1 week in advance of the meeting.
Erica Heath asked with 160 alternates how Wash U decides who gets invited to attend a meeting. Jonathan responded that their system was configured to allow alternates to choose positions that are available for each meeting, and all members pick in advance what meeting they plan to attend.
Lois Bracko (University of Michigan) asked Jonathan what happens when a study has to come back to committee, who it goes to, and if Wash U paid their IRB members. Jonathan noted that it would come back to the IRB Chair as there may not be the same 7 members at the next meeting and they do not pay IRB members, but IRB Chairs are paid.
Next Meeting:
Susan thanked Jonathan and also thanked Jeff Cooper for finding Jonathan Greene. Susan mentioned that Eifaang Li will talk about Cedars-Sinai Rapid IRB at the next flex coalition meeting/conference call. Susan thanked everyone for coming and asked the group to please share/send ideas. Susan closed by letting everyone know that notes from the meeting will be shared, there will be a conference call next year, and the group will also plan to meet again at the AAHRPP conference in April 2014.