Thank you for attending PRIMR23/SBER23! The 90-day access period for recordings and evaluations has now expired (cut-off was March 31, 2024). Recordings can be purchased via a link in the left hand navigation; members receive access to the recordings for free after one year (starting on December 3, 2024). Contact registration@primr.org with questions.
For information on how to download your Certificate of Attendance, please see our CE/CIP/CPIA webpage for more information (located below) .
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC04 - [IN-PERSON/RECORDED] Exception From Informed Consent (EFIC): Overview and Common PitfallsLocation: Room 145 AB
Speaker: – Yale University
Speaker: – Office of Clinical Policy / US Food and Drug Administration
Speaker: – Food and Drug Administration
FDA Regulated ResearchInformed Consent
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD02 - [IN-PERSON/RECORDED] Ethical and FDA Regulatory Considerations for Returning Individual Genetic Testing ResultsLocation: Ballroom C
Speaker: – Boston Children's Hospital
Speaker: – US Food and Drug Administration (FDA)
Speaker: – National Institutes of Health
FDA Regulated ResearchEmerging Research Challenges and Breaking IssuesShared Research Oversight Challenges
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD03 - [IN-PERSON/RECORDED] A Tale of Two Institutions: Examining the Impact of the FDA Single (sIRB) MandateLocation: Ballroom AB
Speaker: – University of Michigan
Speaker: – Pearl IRB
Speaker: – University of Alabama at Birmingham
Single IRBEmerging Research Challenges and Breaking IssuesFDA Regulated ResearchHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
2:30 PM – 3:45 PM ET[IN-PERSON/LIVESTREAMED] Plenary Session: The Lifespan of a Research Protocol: The Journey From Research Using Nonhuman Animals to Research Involving HumansLocation: Ballroom AB
Moderator: – University of Pennsylvania
Panelist: – Providence Health and Services
Panelist: – Advarra
Panelist: – Division of Comparative Medicine, Massachusetts Institute of Technology
Shared Research Oversight ChallengesIACUC Protocol ReviewFDA Regulated Research
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE09 - [IN-PERSON ONLY] Zen and the Art of IRB Meeting MinutesLocation: Room 150 AB
Speaker: – FDA
Speaker: – The Ohio State University
Speaker: – OHRP
IRB BasicsFDA Regulated ResearchHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE01 - [IN-PERSON/RECORDED] A Dialogue With FDALocation: Ballroom C
Speaker: – US Food and Drug Administration
Speaker: – US Food and Drug Administration
Speaker: – FDA
Speaker: – US Food and Drug Administration
Speaker: – USFDA
A Dialogue With the FedsFDA Regulated Research
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF02 - [IN-PERSON ONLY] FDA Remote Regulatory Assessments (RRAs): Another Tool for Regulatory OversightLocation: Room 158 AB
Speaker: – FDA
Speaker: – Food and Drug Administration
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF05 - [IN-PERSON/RECORDED] IRB Review of FDAâregulated Research: From Comfort to Competence!Location: Ballroom C
Speaker: – Mayo Clinic
Speaker: – University of Illinois Urbana-Champaign
QA/QI and Postapproval MonitoringFDA Regulated ResearchHRPP/IRB Administration/Management and Process
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG12 - [IN-PERSON ONLY] Recent Updates from FDA Guidances on Informed Consent and IRB Review for Expanded Access Use of Investigational DrugsLocation: Room 150 AB
Speaker: – Boston Children's Hospital
Speaker: – CDER/FDA
FDA Regulated ResearchInformed Consent
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH11 - [IN-PERSON ONLY] When Secondary Data Use Involves an FDA Regulated Device StudyLocation: Room 202 AB
Speaker: – National Institutes of Health
Speaker: – United States Food and Drug Administration
Speaker: – Digital Health Center of Excellence, FDA
Research Involving Data and BiospecimensFDA Regulated Research
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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 ETH02 - [IN-PERSON/RECORDED] OHRP, FDA, and the General Accountability Office (GAO) Report on IRB Oversight and Effectiveness: A Conversation With the PRIM&R CommunityLocation: Ballroom AB
Speaker: – DHHS Office for Human Research Protections
Speaker: – North star Review Board
Speaker: – FDA
