Protecting Study Volunteers in Research - Softcover

Chadwick, Dr. Gary; Dunn, Dr. Cynthia

Softcover

ISBN 10: 0967302919 ISBN 13: 9780967302911

Publisher: Centerwatch Inc, 1999

Synopsis

This soft-cover manual presents comprehensive guidelines and references to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their human study subjects.

About this title

About the Author

Cynthia Dunn, M.D. and Gary Chadwick, Pharm.D, MPH -- University of Rochester Medical Center.

Excerpt. © Reprinted by permission. All rights reserved.

As demand for new technology and knowledge increases, research has become more complex. The science, design and conduct of research have all changed dramatically since the human subject protection regulations were consolidated in 1981. Studies are exploring areas only vaguely conceptualized two decades ago. The number and diversity involved in studies are increasing.

Consequently, the ethical considerations associated with research have become more complex. To keep the public's trust, the research community must effectively protect human subjects while allowing appropriate access. All members of the research community have a responsibility to ensure that research is conducted ethically. Rigorous compliance with ethical standards and practices will also promote scientific discovery.

Violations in research ethics are generally caused by lack of awareness rather than malice. Although common sense is valuable, research does present unique circumstances and special considerations. The importance for training for researchers cannot be over-stressed. If all researchers were well versed in ethics and complied with regulations, institutional review boards and other oversight mechanisms would not be necessary. Researchers do not need to be regulatory experts, but they do need a certain level of knowledge about these issues. They need to know and understand a few basic requirements and the underlying ethical principles.

The intent of this manual is to aid researchers in understanding the regulatory requirements and ethical principles upon which they are based. The manual will also identify issues that require sensitivity when designing or conducting human research studies. Ultimately the safety and welfare of human subjects rests in the hands of the investigators. We hope this manual will aid all members of the research community in promoting ethical scientific discovery.

Edition details

• Publisher: Centerwatch Inc
• Publication date: 1999
• Language: English
• ISBN 10: 0967302919
• ISBN 13: 9780967302911
• Binding: Paperback
• Number of pages: 238