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Informed Consent Recent Projects
Simplified and Targeted Approaches to Informed Consent – This project is devoted to developing easily replicable methods for simplifying how informed consent information is presented and increasing dialogue with between investigators and consenters with potential subjects. These interventions are being tested in the context of 6 ongoing clinical trials at Johns Hopkins. It is funded by the NIAID, NIH, and investigators included Nancy Kass (PI), Jeremy Sugarman, Holly Taylor, and Steven Goodman.
Improving Understanding of Early Phase Cancer Trials – A multicenter project that examined descriptively what cancer patients understand about early phase cancer trials they are considering joining, and then subsequently developed a computer-based intervention to try to improve patients’ understanding of the purpose and benefits of these trials. The project was funded by the NIAID, the NCI, and the NIH. The results of the study were published in two papers, by investigators Nancy Kass, Holly Taylor, Steven Goodman, and Jeremy Sugarman, with Linda Fogarty and their co-investigators from Duke University in IRB and JERHRE
Assent and Dissent for Dementia Research– This project is devoted to identifying standards for how to define assent and dissent for dementia research participation and what procedures should be used to respect and safeguard adults who lack consent capacity. Qualitative research methods were used to obtain opinions on these issues from a panel of nationally known experts in dementia research and research ethics, and local panels of dementia researchers and caregivers and advocates for individuals who have dementia. Betty Black is the PI of this project, with Jeremy Sugarman, Peter Rabins, and Jason Karlawish (from the University of Pennsylvania) as co-investigators.
Enhancing the Quality of Informed Consent – This project developed, field-tested, and validated an independent, real-time measure of the quality of informed consent encounters in actual clinical trials. To do so, investigators assembled a small group of experts in ethics research, informed consent, and the oversight of clinical research to inform the development of an instrument to assess the quality of informed consent. The goal of the research was to develop a measure that facilitates assessing, monitoring, and ultimately improving the quality of informed consent for clinical research. Jeremy Sugarman and Peter W. Lavori were the principal investigators. Article
Publications
Fortune-Greeley AK, Hardy NC, Lin L, Friedman JY, Lawlor JS, Muhlbaier LH, Hall MA, Schulman KA, Sugarman J, Weinfurt KP. Patients’ reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research. Circ Cardiovasc Qual Outcomes 2010; 3;151-158.
Czarny MJ, Kass NE, Flexner C, Carson KA, Myers RK, Fuchs EJ. Payment to healthy volunteers in clinical research: the research subject's perspective. Clin Pharmacol Ther. 2010; 87:286-93.
Kass NE, Sugarman J, Medley AM, Fogarty LA, Taylor HA, Daugherty CK, Emerson MR, Goodman SN, Hlubocky FJ, Hurwitz HI, Carducci M, Goodwin-Landher A. An intervention to improve cancer patients’ understanding of early-phase clinical trials. IRB 2009; 31: 1-10.
Kass N, Taylor H, Fogarty L, Sugarman J, Goodman SN, Goodwin-Landher A, Carducci M, Hurwitz H. Purpose and benefits of early phase cancer trials: What do oncologists say? What do patients hear? J Empirical Research on Human Research Ethics 2008; DOI 10.1525/jer.2008.3.3.57.
Black BS, Rabins PV, Sugarman J, Karlawish JH. Seeking assent and respecting dissent in dementia research. Am J Geriatr Psychiatry. 2010; 18: 77-85.
More
Sugarman J, Roter D, Cain C, Wallace R, Schmechel D, Welsh-Bohmer KA. Proxies and consent discussions for dementia research. J Am Geriatr Soc 2007; 55: 556-561.
Lavori P, Wilt T, Sugarman J. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clin Trials 2007; 4: 638-649.
Sugarman J, Lavori PW, Boeger M, Cain C, Edson R, Morrison V, Yeh SS. Evaluating the quality of informed consent. Clin Trials 2005; 2:1-8
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