Before they sign, ensure that subjects understand
New book looks at informed consent
One area of particular concern to researchers and IRBs overseeing research activities is informed consent. Under federal guidelines, it is an essential step in the protection process, designed to ensure that volunteers understand the nature of the project for which they are agreeing to participate and that they understand any risks associated with the study.
Though the process of informing study participants sounds easy enough, it’s important to note that it involves more than simply handing a subject a brochure and getting them to sign a piece of paper indicating that they understand what they’ve read, say the authors of a new book, Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials.
"Seventy-nine percent of all volunteers claim that when they first inquired about participating in a clinical trial, they knew virtually nothing about it, and a high percentage of study volunteers give their consent without understanding that there are risks involved and that they have rights and recourse if things go wrong," says Kenneth Getz, MBA, co-author of the book with Deborah Borfitz, and president of CenterWatch, a Boston-based publisher of information on the clinical trials industry. "This book is designed to provide the necessary information for patients, their advocates and consumers to determine if they want to participate and then identify and carefully evaluate clinical trials."
The book includes chapters on the clinical trial process and finding clinical trials, asking the right questions, and what participants can do when things go wrong. Additionally, there are several appendices providing a glossary of terms, federal regulations regarding protecting human subjects, and directories of health associations and biotechnology and pharmaceutical companies.
The chapter titled "Giving Your Informed Consent" is particularly relevant to researchers in that it explains the informed consent process in detail, starting with some basic tenets taken from "The Belmont Report"1:
1. Research subjects are told everything about the study, including risks.
2. The information must be easy to understand.
3. Research subjects who agree to participate must do so voluntarily — they must not be pressured or swayed into it.
The chapter goes on to discuss what should be covered in the consent form, including risks and benefits and time demands, and concludes with an exhaustive list of questions to ask prior to consenting to participate. The chapter can be ordered as a stand-alone handout.
"Believe it or not," says Getz, "there really is no other book out there for the health consumer or patient to get objective facts and information about clinical research. The goal is to provide a balanced, authoritative guide for patients, family, and the general health consumer to make educated and well-informed decisions prior to giving their consent to participate [in research studies]."
The book can be ordered from www.centerwatch.com.
Reference
1. Getz K, Borifz D. Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston: CenterWatch; 2002.
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