IRBchoice Connections Call: June 10, 2016 IRBchoice Update Institutions Forthcoming amendment to master agreement Institutional Profile Updates Studies Lead IRB Stipends Reliance Manager/Liaison Job Descriptions

*AAHRPP accredited (n=51 | 36) †CTSA institution (n=43 | 27) IRBshare (n=67)  IRBchoice (n=47) States (n=32|24) Alabama Arizona Arkansas California Colorado Florida Georgia Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Massachusetts Michigan Minnesota Mississippi Missouri New Mexico New York North Carolina Ohio Oregon Pennsylvania Rhode Island South Carolina Tennessee Texas Utah Virginia West Virginia Washington (Washington DC) Baylor Research Institute* Northwestern University † University of California, San Francisco† Baystate Health* Ohio University University of Colorado Denver*† Boston University Medical Center*† Oregon Health & Science University† University of Cincinnati* Children’s National Medical Center*† Ochsner Health System* University of Illinois Chicago*† Cincinnati Children’s Hospital Medical Center*† Pennington Biomedical Research Center* University of Iowa*† Clinical Directors Network St. Claire Regional Medical Center University of Kansas*† Columbia University*† Seattle Children’s Hospital University of Kentucky*† Duke University*† Stanford University*† University of Miami*† Georgia Regents University* Sutter West Bay Hospitals University of New Mexico Health Sciences Center*† Indiana University*† Texas A&M University* University of North Carolina at Chapel Hill *† Louisiana State University A & M* The Rockefeller University*† University of Pennsylvania*† Louisiana State University HSC New Orleans* The Scripps Research Institute† University of Pittsburgh*† Louisiana State University HSC Shreveport* The University of Arizona* University of Southern California*† Maine Medical Center* The University of Texas HSC at Houston*† University of Texas HSC at San Antonio*† Marshall University* The University of Utah*† University of Texas Southwestern Medical Center† Medical University of South Carolina*† Tufts Medical Center† University of Washington† Mayo Clinic*† Tufts University † Vanderbilt University Medical Center*† Meharry Medical College† Tulane University* Virginia Commonwealth University*† Michigan State University* University of Alabama Birmingham*† Wake Forest University Health Sciences* Mississippi State University* University of Arkansas for Medical Sciences*† Washington University (St. Louis) *† Mount Sinai Medical School*† University of California, Davis*† West Virginia University* New York University School of Medicine*† University of California, Los Angeles†* Women & Infants Hospital of Rhode Island Northwell Health* University of California, San Diego† Xavier University (Louisiana) *AAHRPP accredited (n=51 | 36) †CTSA institution (n=43 | 27)

IRBchoice Master Agreement Adding more accountability for Relying Sites using the Ceded Model

Institutional Profile Updates Section 2—Local Context Section 3—Local submission/review process when ceding review Section 5—Reliance Preferences when Serving as the IRB of Record

Lead IRB Reliance Preferences (Jan 2016  present) STUDY ID MODEL IRB ID RATIONALE 3 Both 1 I am not sure what path the collaborating institution wants to use for this project, so I have made both choices available at this time. 12 Shared (only) Both sites wish to maintain oversight of local research activities, yet facilitate the collaboration between our institutions. 7 2 There could be a variety of sites/IRBs that conduct a registry study. We would like to offer maximum flexibility for sites who will conduct this study in order to facilitate consistency among the review and continuing review of this study. 13 This study occurred before IRBchoice was up and running. The Lead IRB offered the Shared Model or a cIRB agreement because they already had a reliance agreement with the Relying Site. 10 Ceded (only) Single IRB record model required by funder Site is using shared model only at this time 4 This is the model we have chosen to work with. 6 This is the only model we are currently using 9 17 This is the only model we use 11 5 Preferred model of our IRB 14 We didn't want to approve other sites 16 We do not have processes in place to serve as the IRB of record for the study, but are willing to share the review to facilitate use of the Shared Model

Lead IRB Reliance Preferences (Jan 2016  present) STUDY ID MODEL IRB ID RATIONALE 3 Both 1 I am not sure what path the collaborating institution wants to use for this project, so I have made both choices available at this time. 12 Shared (only) Both sites wish to maintain oversight of local research activities, yet facilitate the collaboration between our institutions. 7 2 There could be a variety of sites/IRBs that conduct a registry study. We would like to offer maximum flexibility for sites who will conduct this study in order to facilitate consistency among the review and continuing review of this study. 13 This study occurred before IRBchoice was up and running. The Lead IRB offered the Shared Model or a cIRB agreement because they already had a reliance agreement with the Relying Site. 10 Ceded (only) Single IRB record model required by funder Site is using shared model only at this time 4 This is the model we have chosen to work with. 6 This is the only model we are currently using 9 17 This is the only model we use 11 5 Preferred model of our IRB 14 We didn't want to approve other sites 16 We do not have processes in place to serve as the IRB of record for the study, but are willing to share the review to facilitate use of the Shared Model

Lead IRB Reliance Preferences (Jan 2016  present) STUDY ID MODEL IRB ID RATIONALE 3 Both 1 I am not sure what path the collaborating institution wants to use for this project, so I have made both choices available at this time. 12 Shared (only) Both sites wish to maintain oversight of local research activities, yet facilitate the collaboration between our institutions. 7 2 There could be a variety of sites/IRBs that conduct a registry study. We would like to offer maximum flexibility for sites who will conduct this study in order to facilitate consistency among the review and continuing review of this study. 13 This study occurred before IRBchoice was up and running. The Lead IRB offered the Shared Model or a cIRB agreement because they already had a reliance agreement with the Relying Site. 10 Ceded (only) Single IRB record model required by funder Site is using shared model only at this time 4 This is the model we have chosen to work with. 6 This is the only model we are currently using 9 17 This is the only model we use 11 5 Preferred model of our IRB 14 We didn't want to approve other sites 16 We do not have processes in place to serve as the IRB of record for the study, but are willing to share the review to facilitate use of the Shared Model

Relying Site Reliance Preferences (January 2016  present) STUDY ID MODEL IRB ID RATIONALE 7 Choice: Ceded 8 I would prefer to complete cede review than use the shared model. 9 Prefer ceded reliance over shared reliance Choice: Shared 10 We will use the shared model because it permits the relying institutions an opportunity to be involved with local processes 13 2 Ceding review was available via another reliance agreement; used Shared to avoid executing another/one-off reliance agreement 3 Choice: [tbd] 14 12 No choice: Shared It is in our SOPs 17 5 [no rationale provided; only shared model offered by Lead IRB] 1 4 11 16 N/A Relying site IRB said it would not save time to use Shared Model because the study was minimal risk; thus, the review process would have been a subcommittee anyway. We were the first site or one of the first sites to get approval. I don’t think we knew about IRBchoice being used. Site did not rely on Lead IRB's approval because "no documentation in the minutes about the use of a device even though they were looking at mesh" Unable to Rely OR Opted not to rely: 27%

Relying Site Reliance Preferences (January 2016  present) STUDY ID MODEL IRB ID RATIONALE 7 Choice: Ceded 8 I would prefer to complete cede review than use the shared model. 9 Prefer ceded reliance over shared reliance Choice: Shared 10 We will use the shared model because it permits the relying institutions an opportunity to be involved with local processes 13 2 Ceding review was available via another reliance agreement; used Shared to avoid executing another/one-off reliance agreement 3 Choice: [tbd] 14 12 No choice: Shared It is in our SOPs 17 5 [no rationale provided; only shared model offered by Lead IRB] 1 4 11 16 N/A Relying site IRB said it would not save time to use Shared Model because the study was minimal risk; thus, the review process would have been a subcommittee anyway. We were the first site or one of the first sites to get approval. I don’t think we knew about IRBchoice being used. Site did not rely on Lead IRB's approval because "no documentation in the minutes about the use of a device even though they were looking at mesh" Unable to Rely OR Opted not to rely: 27%

Lead IRB Stipends Do you charge a fee to serve as the Lead/Reviewing IRB? Would financial compensation incentivize your institution to be the Lead IRB and offer "both" models?

Lead IRB Stipends

Two Questions Does anyone have reliance manager/liaison job descriptions? Who’s coming to the OHRP Community Research Forum in Nashville June 21-22?

Upcoming Calls Monday, June 20th—IRBchoice Clinic: Using IRBchoice as a Lead IRB Monday, July 18th—IRBchoice Clinic: Using IRBchoice as a Relying Site Friday, August 12th—IRBchoice Connections Call