Have book, will study

Web-based training is quite popular, but there is effective training available in good old-fashioned textbooks, says the publisher of Protecting Study Volunteers in Research, a manual written for those involved in human subject research. "On-line delivery has its benefits — you can take at your own pace, and it’s often inexpensive. But it’s not very accessible or convenient if you’re traveling or riding the train," says Kenneth Getz, MBA, president of CenterWatch, a Boston-based publisher of information on the clinical trials industry.

Those looking for a more portable way to educate themselves or staff may be interested in the recently updated Protecting Study Volunteers. The book’s seven chapters, which covered topics such as federal regulations and roles and responsibilities of institutions and investigators conducting human subject research, has been expanded to 11 chapters. New chapters include discussions on conflicts of interest, ethical issues in genetic research, and recruitment and retention.

The manual includes a chapter on secondary studies, tissue studies, and records reviews, and discussions of special ethical concerns in clinical research, such as the use of placebos, the roles and responsibilities of data-monitoring committees, and community-based qualitative research. "Investigators have begun to use community-based qualitative research to explore public health problems," says Getz. There are issues unique to the approach, he points out, including the need to engage the community during all stages of the study, from design to dissemination of information.

Readers can earn 6.5 CME hours at no additional charge by completing the test included in the book or by going on-line to access chapter tests. Additionally, the book can be customized to include materials specific to institutions, or institutions may enroll participants on-line as part of a subscription service. The service allows participants to access the manual and tests via the web. For more information or to order the book, visit www.centerwatch.com.