The objective of this study is to identify factors associated with improved comprehension and recall of the information contained on informed consent forms.
The specific aims are to assess, in three separate randomized trials, the effects of three informed consent interventions on comprehension and recall of experimental methods. The study participants, African American and Caucasian adults in the Detroit metropolitan area, will be recruited from research protocols at Henry Ford Health System. The Social Support Study consists of using a standard consent form completed by the participant alone vs. the participant and a support person. The Centralization Study consists of using a standard consent form vs. a revised consent form written at or below an 8th-grade level, with an """"""""easy-to-read"""""""" format. The Home Review Study consists of using a standard consent form and requesting the participant to take it home to review it vs. completing it at the time it is administered. A Participant Comprehension Questionnaire (PCQ) has been developed to assess, via blinded telephone interview, comprehension of consent form information within three days following the signing of the form. Recall of consent information will be assessed at one-month follow-up via blinded telephone interview. In each of the three studies, it is hypothesized that comprehension of consent information will be significantly greater in the intervention group than in the control group of each study. A secondary hypothesis is that one-month recall of consent information will be significantly greater in the intervention group than in the control group of each study. Another secondary hypothesis is that in the Social Support Study, the difference in outcomes between the intervention group and control group will be greater for African Americans than Caucasians. An additional secondary hypothesis is that same-race matches between the administrator of the consent form and the study participants, compared with other racial pairings, will significantly improve comprehension and recall of consent procedures. The primary analysis will be intent-to-treat. In the Social Support and Home Review studies, analysis of covariance (ANCOVA) will be done to compare intervention interaction. In the Centralization Study, generalized estimating equations (GEE) will be done to compare the comprehension score between the revised and standard consent form groups. Similar analyses will be done for the secondary endpoint, recall score. Other demographic variables can be included and adjusted for in the ANCOVA and GEE analyses. Study compliance will be included in the analyses as a covariate. Study findings can be used to enhance the quality of future research by improving the informed consent process.
| Teng, Ellen J; Petersen, Nancy J; Hartman, Christine et al. (2012) Effects of depression and social support on comprehension and recall of informed consent information among Parkinson disease patients and their caregivers. Int J Psychiatry Med 43:67-83 |
