Variation in recruitment across sites in a consent-based clinical data registry: lessons from the Canadian Stroke Network [Book Review]
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jonathan Jenkins Ichikawa
Jack Alan Reynolds
Learn more about PhilPapers
BMC Medical Ethics 7 (1):1-8 (2006)
Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those approached, the percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%), and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%). Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for those registries that require consent for participation.
|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
Sandra Woien, Mohamad Rady, Joseph Verheijde & Joan McGregor (2006). Organ Procurement Organizations Internet Enrollment for Organ Donation: Abandoning Informed Consent. [REVIEW] BMC Medical Ethics 7 (14):1-9.
Ana Smith Iltis (2005). Timing Invitations to Participate in Clinical Research: Preliminary Versus Informed Consent. Journal of Medicine and Philosophy 30 (1):89 – 106.
Judy Allen & Beverley Mcnamara (2011). Reconsidering the Value of Consent in Biobank Research. Bioethics 25 (3):155-166.
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.
Dennis Drotar, Victoria Miller, Victoria Willard, Kyle Anthony & Eric Kodish (2004). Correlates of Parental Participation During Informed Consent for Randomized Clinical Trials in the Treatment of Childhood Leukemia. Ethics and Behavior 14 (1):1 – 15.
Emma Verástegui (2006). Consenting of the Vulnerable: The Informed Consent Procedure in Advanced Cancer Patients in Mexico. [REVIEW] BMC Medical Ethics 7 (1):1-12.
Loretta M. Kopelman (1994). Informed Consent and Anonymous Tissue Samples: The Case of Hiv Seroprevalence Studies. Journal of Medicine and Philosophy 19 (6):525-552.
Xinqing Zhang (2012). Reflection on Family Consent: Based on a Pregnant Death in a Beijing Hospital. Developing World Bioethics 12 (3):164-168.
Marwan Habiba & Martyn Evans (2002). The Inter-Role Confidentiality Conflict in Recruitment for Clinical Research. Journal of Medicine and Philosophy 27 (5):565 – 587.
Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Laura Buccini, Donald Iverson, Peter Caputi & Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Ritva Halila (2007). Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice? Science and Engineering Ethics 13 (3):305-313.
Deborah Bowman (2011). Informed Consent: A Primer for Clinical Practice. Cambridge University Press.
Jane L. Hutton & Richard E. Ashcroft (2000). Some Popular Versions of Uninformed Consent. Health Care Analysis 8 (1):41-53.
Added to index2010-11-17
Total downloads8 ( #424,995 of 1,938,807 )
Recent downloads (6 months)3 ( #219,228 of 1,938,807 )
How can I increase my downloads?