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Sunday, Dec 3rd
10:15 AM – 11:15 AM ETA04 - [IN-PERSON ONLY] VO2 What? Reviewing Exercise Science Research at Primarily SBER InstitutionsLocation: Room 159 AB
Speaker: – University of Northern Iowa
SBEREducation, Qualifications, and TrainingFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Sunday, Dec 3rd
11:30 AM – 12:30 PM ETB01 - [IN-PERSON/RECORDED] What Is Greater than Minimal Risk When Studying Populations Engaged in Risk‐Taking Behaviors?Location: Room 154 AB
Speaker: – University of Arizona
Speaker: – The University of Arizona
HRPP/IRB Administration/Management and ProcessSBERPopulations Requiring Additional ProtectionsFlexibility and Innovation in Research Oversight Processes
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Sunday, Dec 3rd
11:30 AM – 12:30 PM ETB02 - [IN-PERSON/RECORDED] Rethinking the Application of Exempt Category 1Location: Room 152B
Speaker: – University of California San Francisco
Speaker: – Indiana University
Resource Person: – Office for Human Research Protections (OHRP)
HRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Sunday, Dec 3rd
1:45 PM – 3:00 PM ET[IN-PERSON/LIVESTREAMED] Plenary Session: In Community‐‐Research, Partnerships, and the IRBLocation: Room 145 AB
Moderator: – UC Berkeley
Panelist: – University of Nevada, Reno
Panelist: – School of Public Health, UC Berkeley
Panelist: – MASS Design Group
Advancing Equity and Justice in ResearchCommunication With the PublicHRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Sunday, Dec 3rd
3:30 PM – 4:30 PM ETC03 - [IN-PERSON ONLY] Plenary Session Follow‐Up: Continuing Discussion on "In Community‐‐Research, Partnerships, andthe IRB"Location: Room 159 AB
Moderator: – UC Berkeley
Speaker: – School of Public Health, UC Berkeley
Speaker: – MASS Design Group
Speaker: – University of Nevada, Reno
Advancing Equity and Justice in ResearchCommunication With the PublicHRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA07 - [IN-PERSON ONLY] Confessions of a Seasoned IRB Professional: What I Thought I Knew, What I Think I Know, and What I’m Afraid I’ve Been Wrong AboutLocation: Room 202 AB
Speaker: – The Pennsylvania State University
Speaker: – University of Texas, MD Anderson Cancer Center
IRB BasicsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA08 - [IN-PERSON ONLY] One Million or More Considerations for Regulatory Management of a Large Scale Multi‐Site Research ProgramLocation: Room 149 AB
Speaker: – Sage Bionetworks
Resource Person: – OHRP
Speaker: – NYU Langone Health
Speaker: – Indiana University School of Medicine, Indiana CTSI
Flexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA09 - [IN-PERSON ONLY] Designing and Implementing Quality Control (QC) for your Research Compliance ProgramLocation: Room 150 AB
Speaker: – Yale University
Speaker:
Speaker: – OHRP
Small Research ProgramsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA11 - [IN-PERSON ONLY] Working Hard AND Smart: How to Improve Integrity, Effectiveness, and Efficiency with a Collaborative HRPPLocation: Room 151 AB
Speaker: – AAHRPP
Speaker: – Sage Bionetworks
Speaker: – Indiana University
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA05 - [IN-PERSON/RECORDED] Finding the Path Forward: Research that Faces a Difficult Route to ApprovalLocation: Room 147 AB
Speaker: – Columbia University
Speaker: – Office for Human Research Protections
Speaker: – DEVCOM Army Research Laboratory
Legal Considerations in Research OversightEmerging Research Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA14 - [IN-PERSON/RECORDED] Driving Postapproval Monitoring (PAM) Program Priorities by Harnessing Existing DataLocation: Room 143 AB
Speaker: – Memorial Sloan Kettering Cancer Center
Speaker: – Memorial Sloan Kettering Cancer Center
Speaker: – Rutgers University
QA/QI and Postapproval MonitoringACU Program ManagementFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA22 - [IN-PERSON/RECORDED] Promoting a Culture of Scientific Integrity in Federal ResearchLocation: Room 154 AB
Speaker: – Centers for Disease Control and Prevention
Speaker: – CDC
Speaker: – U.S. Environmental Protection Agency
Speaker: – USGS
Speaker:
Emerging Research Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesShared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsEducation, Qualifications, and Training
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB06 - [IN-PERSON ONLY] IRB Closet Clean‐Out: Keep, Toss, TBD (to be determined)Location: Room 140 AB
Speaker: – Weill Cornell Medicine
Speaker: – Northwestern University
Speaker: – University of Utah
HRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB08 - [IN-PERSON ONLY] Artificial Intelligence (AI) Is Not the Boogey Man: Simplifying the Concept of "Data" in the Context of AI to Enable Knowledge and Know‐How in ReviewLocation: Room 202 AB
Moderator: – Beth Israel Deaconess Medical Center
Speaker: – The Mayo Clinic
Speaker: – Prudential Financial
Speaker: – North star Review Board
Research Conducted in the Digital WorldCommunication With the PublicFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB09 - [IN-PERSON ONLY] Determining the Undefined: Research Development and Generalizable KnowledgeLocation: Room 151 AB
Speaker: – The Ohio State University
Speaker: – The Office for Human Research Protections (OHRP), DHHS
Speaker: – National Institutes of Health
IRB BasicsFlexibility and Innovation in Research Oversight ProcessesSBER
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB20 - [IN-PERSON ONLY] Wildlife Research Across Jurisdictions: Navigation of Protocol Reviews and IACUC OversightLocation: Room 209 BC
Speaker: – KBR
Speaker: – National Parks Service, BRD, Wildlife Health Branch
Speaker: – USDA Forest Service
Oversight of Non-Typical Animals and SituationsACU Program ManagementFlexibility and Innovation in Research Oversight ProcessesIACUC Administration/Management and ProcessIACUC Protocol Review
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB03 - [IN-PERSON/RECORDED] Progress in Defining and Evaluating HRPP/IRB Quality and EffectivenessLocation: Ballroom C
Speaker: – Perelman School of Medicine, University of Pennsylvania
Speaker: – Neiswanger Institute for Bioethics, Loyola University Chicago
Speaker: – National Institutes of Health
Speaker: – University of Utah
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight ProcessesQA/QI and Postapproval Monitoring
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB05 - [IN-PERSON/RECORDED] Local Considerations: Navigating the Regulations, Recommendations, and ReviewLocation: Room 147 AB
Speaker: – AAHRPP
Resource Person: – OHRP
Speaker: – University of California, Los Angeles
Single IRBFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB22 - [ON-DEMAND] Did I Mention I'm in a Hurry? Improving Efficiency in the Animal Care and Use ProgramPresenter: – NIH Office of Animal Care and Use
Presenter: – UCLA
ACU Program ManagementFlexibility and Innovation in Research Oversight ProcessesIACUC Basics
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB25 - [IN-PERSON ONLY] Institutional Review: What HRPPs and IACUCs Can Learn from Each OtherLocation: Room 152A
Speaker: – Cedars Sinai Medical Center
Speaker: – Cedars-Sinai
Speaker: – Yale University
Speaker: – Yale University
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessIACUC Administration/Management and ProcessShared Research Oversight Challenges
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC01 - [IN-PERSON/RECORDED] Single IRB (sIRB) Coordination Models: Innovative Approaches from Four Clinical and Translational Science Award (CTSA) ProgramsLocation: Ballroom AB
Speaker: – Indiana University School of Medicine, Indiana CTSI
Speaker: – Vanderbilt University Medical Center
Speaker: – University of Utah IRB
Single IRBFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC05 - [IN-PERSON/RECORDED] An Insider's Guide to Utilizing Outside Experts: What We Didn't Know, What We Now Know, and Where We Go From HereLocation: Room 143 AB
Speaker: – Harvard T.H. Chan School of Public Health
Education, Qualifications, and TrainingHRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC13 - [IN-PERSON/RECORDED] Wildlife Studies and Field Project Review: One Size Does Not Fit AllLocation: Room 154 AB
Speaker: – National Parks Service, BRD, Wildlife Health Branch
Speaker: – USGS National Wildlife Health Center
Speaker: – U.S. Fish and Wildlife Service
Oversight of Non-Typical Animals and SituationsACU Program ManagementFlexibility and Innovation in Research Oversight ProcessesIACUC Administration/Management and Process
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD07 - [IN-PERSON ONLY] Adding Another P to the HRPP: The Voice of the Participant in HRPPsLocation: Room 150 AB
Speaker: – National Institutes of Health
Speaker: – UC San Diego
Speaker: – National Institutes of Health
Flexibility and Innovation in Research Oversight Processes
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD10 - [IN-PERSON ONLY] Research or Not? Applying the Common Rule "Carve‐Outs"Location: Room 202 AB
Speaker: – Centers for Disease Control and Prevention
Speaker: – Department of Homeland Security
Speaker: – DHHS Office for Human Research Protections
IRB BasicsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD19 - [IN-PERSON ONLY] Investigators as a Resource for Animal Care and Use InnovationLocation: Room 158 AB
Speaker: – Florida A&M University
Speaker: – Lawrence Berkeley National Laboratory
Speaker: – Emory University
Flexibility and Innovation in Research Oversight ProcessesEducation, Qualifications, and Training
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD04 - [IN-PERSON/RECORDED] Change the Game By Working Together: Tips for Increasing HRPP/IRB and Researcher CollaborationLocation: Hall E
Speaker: – Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health
Speaker: – The Pennsylvania State University
Speaker: – Mayo Clinic
Education, Qualifications, and TrainingFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE04 - [IN-PERSON/RECORDED] Leveraging Logic Tools for Not Human Subjects Research and Exemption DeterminationsLocation: Room 145 AB
Speaker: – University of Michigan
Speaker: – University of Florida
Speaker: – University of Utah
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE21 - [ON-DEMAND] Building and Sustaining Inter-Institutional IACUC CollaborationsPresenter: – NIH Office of Animal Care and Use
Presenter: – Northwestern University
ACU Program ManagementFlexibility and Innovation in Research Oversight ProcessesShared Research Oversight Challenges
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE24 - [IN-PERSON ONLY] Get Your S@!* Done (and Other Helpful Tips for Managing a Remote Oversight Committee Office)Location: Room 201
Speaker: – Yale University
Speaker: – The Pennsylvania State University
Speaker: – North Carolina State University
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessLeadership Skills Development
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Wednesday, Dec 6th
8:30 AM – 9:45 AM ET[IN-PERSON/LIVESTREAMED] Plenary Session: From Compliance to Embracing the Belmont Report Tenets as the Framework for the Operations of the HRPPLocation: Ballroom AB
Moderator: – University of Southern California
Panelist: – National Institutes of Health
Panelist: – AAHRPP, Inc.
Panelist: – Office for Human Research Protections, U.S.DHHS
Panelist: – Baystate Health
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF12 - [IN-PERSON ONLY] Maintaining Compliance at Any Size: How to Get the Most Bang for Your Buck!Location: Room 201
Speaker: – Harvard T.H. Chan School of Public Health
Speaker: – Penn State
Speaker: – Indiana University
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight Processes
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF03 - [IN-PERSON/RECORDED] Utilizing a System of IRB Precedent: Moving Toward Consistency and TransparencyLocation: Ballroom AB
Speaker: – Multi-Regional Clinical Trials Center
Speaker: – Medical College of Wisconsin
Speaker: – Dana-Farber Cancer Institute
Speaker: – Dana-Farber Cancer Institute
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF13 - [IN-PERSON/RECORDED] Bringing the IRB to the People, and the People to the IRBLocation: Room 145 AB
Speaker: – Institution Insights
Speaker: – Neiswanger Institute for Bioethics, Loyola University Chicago
Speaker: – University of Utah
Advancing Equity and Justice in ResearchCommunication With the PublicFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessIRB Chairs
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF16 - [IN-PERSON/RECORDED] Mission Overlap Between IRBs and IBCs and the Institutional ImplicationsLocation: Room 154 AB
Speaker: – Saint Louis University
Speaker: – University of Massachusetts Amherst
Speaker: – Sabai Global/Clinical Biosafety Services
Flexibility and Innovation in Research Oversight ProcessesResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF19 - [IN-PERSON ONLY] One Health, One Welfare: Special Considerations for Wildlife Studies and Field ProjectsLocation: Room 209 BC
Speaker: – National Park Service
Speaker: – U.S. Fish and Wildlife Service
Speaker: – U.S. Fish and Wildlife Service
ACU Program ManagementFlexibility and Innovation in Research Oversight ProcessesOversight of Non-Typical Animals and Situations
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG02 - [IN-PERSON/RECORDED] The Ethics of Data Sharing in SBERLocation: Ballroom C
Speaker: – Qualitative Data Repository
Speaker: – NC State University
Emerging Research Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesSBERResearch Involving Data and BiospecimensHRPP/IRB Administration/Management and Process
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG03 - [IN-PERSON/RECORDED] Improving IRB Quality: Learning from Participants, Investigators, and Outside ExpertsLocation: Ballroom AB
Speaker: – Perelman School of Medicine, University of Pennsylvania
Speaker: – National Institutes of Health
Speaker: – Harvard T.H. Chan School of Public Health
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG04 - [IN-PERSON/RECORDED] QA/QI for Non‐Clinical or Minimal Risk ResearchLocation: Room 147 AB
Speaker: – Office of Research Integrity, University of Kentucky
Speaker: – University of Michigan
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessSmall Research Programs
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH15 - [IN-PERSON ONLY] Oversight Committee Interaction in Clinical Research Beyond the IRBLocation: Room 148
Speaker: – Advarra
Speaker: – Yale University
Flexibility and Innovation in Research Oversight ProcessesFDA Regulated Research
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH06 - [IN-PERSON/RECORDED] Engaging Our Community in the Mission of IRBsLocation: Room 143 AB
Speaker: – MSOE
Speaker: – Medical College of Wisconsin
Speaker: – Yale University
Communication With the PublicFlexibility and Innovation in Research Oversight Processes
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH16 - [IN-PERSON/RECORDED] As Compared to... What? A Data‐Driven Approach to Identifying Peer Institutions in a Research Compliance ContextLocation: Room 152B
Speaker: – University of Nevada, Las Vegas
Speaker: – Virginia Commonwealth University
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessHRPP/IRB Administration/Management and ProcessResearch Oversight Leaders and Institutional Officials
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH17 - [IN-PERSON/RECORDED] Balancing the Pressure of Getting New Therapies to Clinical Trial: Ensuring Robust Study Design, Nonhuman Animal Welfare, and Human Subjects ProtectionsLocation: Room 154 AB
Speaker: – Prevail Therapeutics
Speaker: – Labcorp
Pharma/Biotech PerspectivesFlexibility and Innovation in Research Oversight Processes
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH19 - [IN-PERSON/RECORDED] Welfare as a Tenet in Research Oversight: How do We Apply Welfare To Our Work?Location: Room 206
Speaker: – National Institutes of Health
Speaker: – University of Pennsylvania
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: – University of Texas Southwestern Medical Center
Animal Well-Being and the 3RsFlexibility and Innovation in Research Oversight ProcessesShared Research Oversight Challenges
