Working Effectively With and Within IRBs:

A Practical Guide for Investigators, Sponsors, and IRB Members

 

Edited by Eileen Hilton, MD, and Deirdre Hall, CCRC, CCRA, CIP

 

2005. 184 pages. ISBN 1-55572-083-8.

$44.95 plus $4.75 S&H.

 


 

 

    "If I ran an IRB, I would have multiple copies of this book available to share with board members, staff, investigators

and other study personnel. It is also very worthwhile for IRB personnel.”
    “This book has been selected for The First Clinical Research Bookshelf.”
-- Norman M. Goldfarb, Editor, Journal of Clinical Research Best Practices

    "The authors make a number of excellent points about the importance of attitudes in making the IRB process worthwhile

and provide many tips on managing the many demands of the process and the administration of a human research protection program.”
    “In Chapter 3, ‘Consent Issues,’ readers will find several sample documents and a wealth of sample text for writing effective informed

consent and assent documents.”
    “ . . . there are a number of very useful resources in the text, including a ‘take away messages’ section at the end of each chapter

that highlights the most salient information from the chapter in a series of bullet points.”
-- IRB: Ethics & Human Research review

 


    There are numerous excellent resources about institutional review boards—describing what they are, how they work, and why they exist.

There are other resources that provide guidance to the IRB administrator, members, and chair. There are few, if any, published works

that offer a "how to partner" focus.

 

    The authors realized the need for a book such as this: a guide to working effectively with IRBs. For the research sponsors picking up

this text: How many times have you been exasperated by an IRB’s total rewrite of your informed consent document?

Or frustrated by the IRB’s seemingly interminable review process?

 

    For the investigators picking up this text: how many times have you had to revise your informed consent form or protocol because

of an IRB concern you might not have understood the rationale for? And finally, for the institutional review "boarders" out there:

how many times have you wanted to broadcast your message, "We really aren’t trying to delay or prevent research and medical progress"?

 

    An increased understanding of each group’s expectations is needed, and clinical research professionals need a direct, practical guide

to working together to achieve human subject protections. This is that guide.

 

    This text is a vital reference to guide partnership with IRBs.