Assessing Recall and Understanding of Informed Consent in a Contraceptive Clinical Trial
In: Studies in family planning: a publication of the Population Council, Band 30, Heft 4, S. 339-346
ISSN: 1728-4465
Recall and understanding of information provided to contraceptive study participants in four sites were assessed. Analysis was completed of data for 70 women who were asked about their recollection of information and understanding of participation. Most women understood the purpose of the study. Their reasons for agreeing to participate varied by site and included wanting to try a new method, wanting to help others, and wishing to avoid pregnancy. Most women recalled correctly the burden of participation—number and frequency of visits, tests, and examinations. Most understood that they could withdraw from the study without jeopardizing their care. The women were also asked to recall the risks and benefits of the contraceptive they were testing. Only 23 percent recalled the pregnancy risk correctly; 40 percent underestimated and 19 percent overestimated it. Few women interpreted rates of risk correctly; some perceived high rates as low ones and the rates of the spermicide being studied as better than those of other contraceptives. This study confirms that risk is better recalled than understood. The participants surveyed remembered the information they were questioned about better than did participants in some other studies, a finding that supports earlier research results showing that younger, healthier patients (such as contraceptive users) recall better than older, less healthy ones.