Obtaining informed consent for clinical pain research: patients' concerns and information needs

Investigators who conduct clinical pain research are required to obtain vol untary informed consent from patients. However, little is known about what information patients expect when they decide whether to enroll in such stud ies. It is important that investigators understand these information needs so they can effectively and clearly describe the research risks and potenti al benefits that matter to potential subjects. By understanding these needs for information, investigators may also be better able to anticipate patie nts' concerns and to recruit subjects more efficiently. This study was desi gned to define information needs that patients have when they decide whethe r to participate in clinical pain research. This paper describes these info rmation needs, and identifies clinical and demographic variables associated with specific needs. (C) 2001 International Association for the Study of P ain. Published by Elsevier Science B.V. All rights reserved.