Informed Consent: The Consumer's Guide to the Risks and Benefits of Volunteering for Clinical Trials - Softcover

Getz, Ken; Borfitz, Deborah

Softcover

ISBN 10: 1930624093 ISBN 13: 9781930624092

Publisher: Centerwatch Inc, 2002

Synopsis

Informed Consent(tm) is a 300-page book designed to assist patients, their family and advocates in making more informed decisions before giving their consent to volunteer for a clinical trial and during their participation. This first-of-its-kind consumer guidebook provides comprehensive facts and objective, expert commentary to assist patients and their advocates in understanding their rights and recourse as study volunteers, what to expect when participating in a clinical trial and how research professionals conduct studies on new drug therapies.

Written by Ken Getz and Deborah Borfitz, the book has been reviewed extensively by regulatory and research professionals, patient advocates and consumers. Specific topics covered in the guide include:

- Your rights as a volunteer, and how to protect them

- A detailed review of the clinical trial process

- How to determine if a clinical trial is right for you

- How to find and evaluate clinical trials

- Special considerations for vulnerable populations including children, prisoners and the elderly

- What to do when things go wrong

- A useful and practical appendix of reference information

About this title

About the Author

Ken Getz is the publisher, president and CEO of CenterWatch, which he co-founded in 1994. Ken is a well-known speaker at conferences and he serves on several boards, including the Institute of Medicine's Clinical Research Roundtable, the Drug Information Association's Steering Committee for North America, the Association for Clinical Research Professional's Future Trends Committee and the Doris Duke Foundation's Consortium to Examine Clinical Research Ethics. Ken is a widely known author of articles and chapters in scholarly and trade journals and books. He has appeared on major national radio and television programs to speak with patients and their advocates about the clinical trial process. Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and an undergraduate degree from Brandeis University. He lives with his wife Debra and their three children in southern Massachusetts.

Deborah Borfitz has written for numerous health and business periodicals throughout her 20-year career and now contributes regularly to several of the nation's best-in-class publications, including Medical Economics Magazine, the CenterWatch Newsletter, Strategic Health Care Marketing, and eHealthcare Strategy & Trends. Deborah was born and raised in Norwich, NY, and attended the state's universities in Cortland and Oneonta. She now resides in Florida with her husband, Dale Armstrong, and their two children.

Review

"...A comprehensive and balanced treatment, providing the research participant with the information and tools to make an informed decision." -- Carol Saunders, Executive Director, New England Institutional Review Board

"This book informs the average human being about what to expect and ask when participating in clinical research." -- Paul Gelsinger, From his 'Foreword' in Informed Consent

About this edition

• Publisher: Centerwatch Inc
• Publication date: 2002
• ISBN 10: 1930624093
• ISBN 13: 9781930624092
• Binding: Paperback
• Edition number: 1
• Number of pages: 300