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Simplification of Informed Consent Documents
After both research participants and investigators voiced concerns that informed consent documents for clinical trials were becoming too long, complicated, and difficult to understand, the National Cancer Institute (NCI), along with the Office for Protection from Research Risks (now the Office of Human Research Protections) and the U.S. Food and Drug Administration, formed an Informed Consent Working Group to propose solutions.
The Working Group included a diverse group of experts: physicians, nurses, patient advocates, Institutional Review Board (IRB) members, ethicists, legal experts, communication experts, and representatives of the pharmaceutical industry.
In 1998, the group issued its "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials." The recommendations are used by investigators writing consent documents and by IRBs reviewing such documents. In addition, a consent form template was created that includes all of the federally required elements for the document, including the explanation of the research procedures, related risks and possible benefits, alternatives to participation, and the rights of research participants.
NCI mailed this packet to thousands of IRBs, hospitals, cancer centers, patient groups, and researchers with a letter encouraging investigators to use these resources to develop "maximally understandable" materials. The letter reads as follows:
Office for Protection from Research Risks
(Now the Office of Human Research Protections)
Informed Consent Materials for National Cancer Institute Clinical Trials
September 8, 1998
The National Cancer Institute (NCI) is facilitating an extensive effort to strengthen the quality of informed consent in its cancer clinical trials. To this end, NCI formed a working group of medical, legal, ethical, communication, and consumer experts to examine ways to (i) increase the understanding of potential subjects about the clinical research in which they are asked to participate; (ii) aid investigators in developing informed consent documents; and (iii) assist Institutional Review Boards (IRBs) in the review of such documents.
OPRR supports NCI's efforts to develop informed consent materials that genuinely enhance subjects' understanding, thus fostering subjects' decision making and fortifying respect for subjects as autonomous persons.
The NCI recommendations, template, and four sample informed consent documents were tested and found to be effective in nine focus groups consisting of physicians, nurses, clinical research associates, and cancer patients.
OPRR encourages investigators to make use of these resources as they attempt to develop maximally understandable informed consent materials. IRBs will also find these resources useful as they strive to ensure that potential subjects are presented with information in a manner that genuinely meets the unique needs of differing subject populations.
J. Thomas Puglisi, Ph.D.
Director
Division of Human Subject Protections
Office for Protection from Research Risks
(Now the Office of Human Research Protections)
National Institutes of Health
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