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2022 PRIM&R Annual Conference

QA/QI and Postapproval Monitoring

Flexibility and Innovation in Research Oversight Processes

Education, Qualifications, and Training

B03 - "Perfect" Study Submissions: Approaches to Improving IRB Submissions for a Better Review Process

Monday, December 12, 2022

1:30 PM – 2:30 PM ET

Location: Livestreamed

Speaker(s)

Rebecca M. Fasano, BS, CIP

Augusta University
Augusta, Georgia
Ann Hardy, DrPH, CIP (she/her/hers)

Learn eCORE, LLC, Maryland
Petrice B. Longenecker, PhD, CIP

Uniformed Services University of the Health Sciences
Bethesda, Maryland

The quality of an IRB submission significantly affects the review process, both in terms of its length and how smoothly it goes. This session will explore different methods for improving IRB applications before sending them for IRB review, such as training research teams on how to prepare better protocols and IRB applications, and the role of IRB operations and compliance staff before the submission is provided to IRB reviewers. When IRB staff are involved in assessing submissions, how do they determine when it is worthwhile to work with the study team to "perfect" the submission before IRB review?

Learning Objectives:

Identify the challenges posed to the IRB review process due to poor quality submissions
Explore different methods used to improve the quality of IRB submissions, such as those that focus on study team efforts and those that leverage IRB staff expertise
Discuss the pros and cons of different strategies to improve IRB submission quality