Ensuring a HIPAA- Compliant Informed Consent Process
Kimberly Irvine, Eileen Hilton, MD, CenterWatch
Softbound: 158 pages
CenterWatch Inc / Thomson American Health Consultants
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The new HIPAA regulations substantially impact clinical research activity - most notably the informed consent process. This 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. This book features:
- Practical approaches to incorporating HIPAA language into a wide variety of informed consent forms
- Ways to avoid unnecessary IRB objections
- Discussion of Common Rule requirements and GCP-ICH recommendations
- How to examine whether the consent language puts your institution at risk
- Sample HIPAA-compliant language and useful templates
This book is from the same reliable publisher that publishes the PDR and the RedBook. Thomson Healthcare businesses support critical healthcare delivery and management decisions through a broad array of information and educational solutions. Thomson provides up-to-date drug, critical care, and toxicology information to clinical professionals. Thomson develops and delivers medical education services and communications programs to pharmaceutical companies, physicians, and other health professionals.
Thomson is also the industry's leading source for clinical trials information and publishes CenterWatch. Their corporate health and safety databases address occupational medicine, chemical safety hazardous products, and regulatory compliance needs. Finally, Thomson is the leading supplier of information solutions to support healthcare management, analytical, and health services research needs across the industry.
(information from the publisher)
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