Clinical research professionals need a direct, practical guide to working together to protect human research subjects. This book is a reference for research sponsors, investigators, and IRB members, with documents created by the Biomedical Research Alliance of New York: - Sample pediatric subject assent form - Sample HIPAA authorization form - Sample assent form for genetic testing and/or tissue banking - Sample evaluation/feedback tool for educational programs - Glossary of lay terms for preparing informed-consent documents. - Nuremberg Code, Declaration of Helsinki, Belmont Report, the "Common Rule" are included.

Working Effectively With and Within IRBs: A Practical Guide for Investigators, Sponsors, and IRB Members

Politics & Social Sciences

Hilton, Eileen

Politics & Government

University Publishing Group

The new HIPAA regulations will substantially impact clinical research activity - most notably the informed consent process. This new guidebook from CenterWatch is designed to assist clinical research professionals in complying with the new and final HIPAA regulations. 
Ensuring a HIPAA-Compliant Informed Consent Process - both an instruction manual and reference resource -- provides detailed guidelines on how to manage and conduct a HIPAA compliant and IRB-acceptable informed consent process. The guide includes sample language and templates for the HIPAA Authorization Form and informed consent forms for use in a variety of clinical research studies including genetic testing, tissue banking and assent. An extensive glossary of terms for use in preparing informed consent documents and convenient and easy-to-reference regulatory guidelines are also included. 
Book features: - Practical approaches to incorporating HIPAA language into a wide variety of informed consent forms - Discussion of Common Rule requirements and GCP-ICH recommendations - Sample HIPAA-compliant language and useful templates - How to examine whether the consent language puts your institution at risk - Ways to avoid unnecessary IRB objections

Ensuring a HIPAA-Compliant Informed Consent Process

Medical Books

Irvine, Kimberly

Administration & Medicine Economics

CenterWatch, Inc.

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Books by Hilton, Eileen