How Your Study’s Informed Consent Can Help Simplify Study Startup

When research sites require institution-specific language be added to a multisite study’s informed consent form (ICF), the study sponsor typically must approve each custom ICF before a single institutional review board (sIRB) can approve them.  

ICF negotiations happening during the IRB review process can delay study startup (SSU) by two to four weeks.  

Resolution usually involves multiple parties, including the study sponsor, contract research organization (CRO), site research team, site human research protection program (HRPP)/IRB, etc. – these discussions can often resemble a game of telephone.  

Food and Drug Administration’s (FDA’s) sIRB mandate will likely make these delays even more impactful when effective. 

Learning Objectives:

• Describe why institution-specific ICF language delays sIRB review processes 
• Outline the importance of site-specific ICF language to research institutions 
• Explain alternate strategies for informing participants of institution-specific details  
• Discuss ways sponsors and CROs can improve processes and agreements with sites to avoid ICF-related delays  

• Presenter
• CE Credits
• Certificate of Attendance

Naomi Bush

MS, PMP

Senior Vice President, Client Collaborations

Kindra Cooper

JD, MPA, MA, CIP

Director, IRBMED University of Michigan

Joshua Fedewa

MS, CIP

Director, Advarra Consulting – Institutional Research

James Riddle

MCSE, CIP, CPIA, CRQM

Senior Vice President, Global Review Operations

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