Christine Grady1, Isabella Nogues2, Lori Wiener3, Benjamin S Wilfond4, David Wendler1. 1. Department of Bioethics, NIH Clinical Center. 2. Former summer student, Department of Bioethics. 3. Pediatric Oncology Branch, National Cancer Institute. 4. Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute.
Abstract
BACKGROUND: Evidence shows both a tendency for research participants to conflate research and clinical care and limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite a lack of evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. METHODS: As part of a longer semi-structured interview evaluating assent and parental permission for research, adolescent research participants, including adolescents with illnesses and healthy volunteers (N=177), and their parents (N=177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes identified through an iterative process. RESULTS: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and in logistics. CONCLUSIONS: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceives a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience.
BACKGROUND: Evidence shows both a tendency for research participants to conflate research and clinical care and limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite a lack of evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. METHODS: As part of a longer semi-structured interview evaluating assent and parental permission for research, adolescent research participants, including adolescents with illnesses and healthy volunteers (N=177), and their parents (N=177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes identified through an iterative process. RESULTS: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and in logistics. CONCLUSIONS: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceives a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience.
Entities:
Keywords:
assent and parental consent; clinical research; ethics; therapeutic misconception
Authors: Christine Grady; Lori Wiener; Emily Abdoler; Emily Trauernicht; Sima Zadeh; Douglas S Diekema; Benjamin S Wilfond; David Wendler Journal: J Adolesc Health Date: 2014-03-14 Impact factor: 5.012
Authors: Kevin P Weinfurt; Damon M Seils; Li Lin; Daniel P Sulmasy; Alan B Astrow; Herbert I Hurwitz; Roger B Cohen; Neal J Meropol Journal: J Clin Oncol Date: 2012-10-22 Impact factor: 44.544
Authors: Gail E Henderson; Larry R Churchill; Arlene M Davis; Michele M Easter; Christine Grady; Steven Joffe; Nancy Kass; Nancy M P King; Charles W Lidz; Franklin G Miller; Daniel K Nelson; Jeffrey Peppercorn; Barbra Bluestone Rothschild; Pamela Sankar; Benjamin S Wilfond; Catherine R Zimmer Journal: PLoS Med Date: 2007-11-27 Impact factor: 11.069