Central to the tenet of biomedical ethics is the issue of informed consent, which affords a research subject the ability to exercise their rights to beneficence and autonomy. Despite this premise, there is concern that the ideals of informed consent are imperfectly realized. A recent review by the National Bioethics Advisory Commission suggest several areas of concern regarding informed consent, including potentially coercive recruitment practices, failure to assess decision-making capacity, and the down-playing of risks. In anesthesiology and surgical research, there is increasing concern that the environment in which consent is sought may be coercive. This is largely due to the nature of the anesthesiologist/surgeon-patient relationship which dictates that consent is often sought just before surgery, in a less than private setting, and at a time when the patient is most anxious. Furthermore, our preliminary studies suggest that many research subjects do not fully understand all the elements of the informed consent document. This proposal is designed to characterize factors that influence adult patients and parents of pediatric patients to consent to participate in clinical anesthesia and surgical research. This proposal will quantitate the contribution of several factors to the decision-making process, including: characteristics of the subject and researcher, environmental characteristics and psycho- social characteristics. This information will be used to develop structural models that will help explain, predict and ultimately influence decision-making behaviors of consent. This study will further measure the readability of informed consent documents and the ability of research subjects to understand the elements of consent therein. This study will also measure the ability of children to give assent. Obtaining consent for anesthesia and surgical research represents a unique challenge with special considerations. Despite this, there is a paucity of studies addressing this critical issue. This proposal represents a novel, multi-dimensional approach that addresses many of the priorities outlined in the current Program Announcement and the Healthy People 2000 initiative. Our preliminary data indicate that the proposed studies will be important in developing strategies to optimize the environment in which consent is sought, to ensure that subjects are truly informed and that their ethical and legal rights are protected.
