This proposal is submitted in response to RFA-OD-03-007 (""""""""Human Subjects Research Enhancements Program"""""""" [HSREP]); the long-term goals are to educate and foster the attention of investigators and research staff to informed consent as a process, rather than merely as a signature on a form. Meaningful consent involves more than handing potential participants a form to sign, but rather involves an interactive dialogue in which relevant material is disclosed, the investigator (or his/her representative) ascertains whether the participant comprehended the essential information, and then re-explains poorly understood information in a way that fosters each participant's eventual understanding of that information so that he or she can make a meaningful choice about whether or not to participate in that protocol. The activities proposed below are intended to foster the likelihood that such an interactive consent process actually occurs.
Specific aims i nclude developing an algorithm and prototypes of 5-item questionnaires to facilitate the process of providing informed consent to research participation, and to disseminate use of these consent procedures in human research at the two facilities described in this proposal. We will identify 5 active protocols at each of the two facilities. We will review these protocols (including the consent forms and any other materials submitted to the local IRB), and based on the five """"""""most essential elements"""""""" for consent to each protocol, we will develop a 5-item questionnaire for each protocol that the PIs of each will then use to ascertain whether potential participants actually understand the essential elements and/or require further explanation of essential details. We will also convene community focus groups (including high functioning research participants or family members) to review these materials and !procedures, and their input will be used to revise our consent algorithm and questionnaires to better approximate community values and standards. Based on the experience using these methods in the initial protocols, we will revise the questionnaires and methods to make the more effective and efficient. With this experience, we will then hold two 60 minute seminars (one at each facility) to disseminate the procedures developed for wider use by all researchers at each of the two facilities.
| Palmer, Barton W; Cassidy, Erin L; Dunn, Laura B et al. (2008) Effective use of consent forms and interactive questions in the consent process. IRB 30:8-12 |
| Palmer, Barton W (2006) Informed consent for schizophrenia research: what is an investigator (or IRB) to do? Behav Sci Law 24:447-52 |
| Palmer, Barton W; Dunn, Laura B; Appelbaum, Paul S et al. (2005) Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry 62:726-33 |
