Informed consent for obstetric anesthesia research: factors that influence parturients' decisions to participate

Patients who are approached to participate in clinical studies just before delivery may have insufficient time to make an informed decision and/or may feel pressured into participation. This study was designed to examine factors that influence parturients to consent or decline participation in an anesthesia study related to their delivery. Parturients who had been approached to participate in a continuing clinical obstetric anesthesia study were subsequently given a questionnaire that documented their reasons for consenting or declining participation. There were no demographic differences among the consenters (n = 166) and nonconsenters (n = 109). The most important factors in the patient's decision to consent were related to their understanding and perceived importance of the study and the potential benefit to other women. Forty-one (40. 6%) nonconsenters strongly considered their pain/discomfort a factor in declining participation. Only one patient felt some pressure to consent, suggesting that the overall environment was noncoercive. Logistic regression analysis demonstrated that patients who read the consent form completely, those who had participated in a previous research study, and those who were less anxious about participating were more likely to consent.

Obtaining informed consent for obstetric anesthesia studies presents a challenge to the anesthesiologist. Results from this study suggest that the environment in which consent for obstetric studies is sought is not coercive. However, it is important that the anesthesiologist ensures that the patient fully understands the study and develops a rapport with the patient to allay any anxiety associated with her participation as a potential research subject.