Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Rajiv Sarkar, Thuppal V. Sowmyanarayanan, Prasanna Samuel, Azara S. Singh, Anuradha Bose, Jayaprakash Muliyil & Gagandeep Kang
BMC Medical Ethics 11 (1):8- (2010)
BackgroundStudies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.MethodsParents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents.ResultsA total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm.ConclusionsThe results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.Trial RegistrationClinical Trial Registry - India (CTRI): CTRI/2009/091/000612
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Farhad Dalal (1998). Taking the Group Seriously: Towards a Post-Foulkesian Group Analytic Theory. J. Kingsley.
Stephen Wear (1999). Enhancing Clinician Provision of Informed Consent and Counseling: Some Pedagogical Strategies. Journal of Medicine and Philosophy 24 (1):34 – 42.
Martin Gunderson, David J. Mayo & Frank S. Rhame (1996). Routine HIV Testing of Hospital Patients and Pregnant Women: Informed Consent in the Real World. Kennedy Institute of Ethics Journal 6 (2):161-182.
Matthew K. Wynia (2006). Routine Screening: Informed Consent, Stigma and the Waning of HIV Exceptionalism. American Journal of Bioethics 6 (4):5 – 8.
David B. Resnik, Paul L. Ranelli & Susan P. Resnik (2000). The Conflict Between Ethics and Business in Community Pharmacy: What About Patient Counseling? [REVIEW] Journal of Business Ethics 28 (2):179 - 186.
Erica K. Lucast (2007). Informed Consent and the Misattributed Paternity Problem in Genetic Counseling. Bioethics 21 (1):41–50.
Bill LaBauve & Kimberly Rynearson (2001). The Impact of Conceptualization Skills in Counseling Children. Inquiry 20 (3):33-38.
Shlomit C. Schuster (1999). Philosophy Practice: An Alternative to Counseling and Psychotherapy. Praeger.
N. Waller Bruce (1995). Individual Autonomy and the Double-Blind Controlled Experiment: The Case of Desperate Volunteers. Journal of Medicine and Philosophy 20 (1).
M. Carmela Epright (2003). Philosophical Counseling. Philosophy in the Contemporary World 10 (2):17-22.
R. Sarkar, E. W. Grandin, B. P. Gladstone, J. Muliyil & G. Kang (2009). Comprehension and Recall of Informed Consent Among Participating Families in a Birth Cohort Study on Diarrhoeal Disease. Public Health Ethics 2 (1):37-44.
Mary Terrell White (1998). Decision-Making Through Dialogue: Reconfiguring Autonomy in Genetic Counseling. [REVIEW] Theoretical Medicine and Bioethics 19 (1):5-19.
Sara Waller (2003). Philosophical Counseling. Philosophy in the Contemporary World 10 (2):23-31.
Added to index2010-08-24
Total downloads9 ( #165,736 of 1,101,983 )
Recent downloads (6 months)4 ( #91,864 of 1,101,983 )
How can I increase my downloads?