Irena Druce1, T C Ooi2, Debbie McGuire1, Alexander Sorisky2, Janine Malcolm2. 1. Division of Endocrinology and Metabolism, Department of Medicine, The Ottawa Hospital, University of Ottawa, The Ottawa Hospital, Riverside Campus, Ottawa, Ontario, Canada. 2. Division of Endocrinology and Metabolism, Department of Medicine, The Ottawa Hospital, University of Ottawa, The Ottawa Hospital, Riverside Campus, Ottawa, Ontario, Canada Chronic Disease Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Abstract
OBJECTIVE: Informed consent and protection of patient confidentiality are central to the conduction of clinical research. Consent for chart review and contact (CCRC) allows a patient chart to be screened for research by persons outside the direct circle-of-care and for the patient to be contacted regarding potential studies. This study describes the process of implementation and benefits of such a consent. DESIGN: We present a descriptive report of a CCRC document that was created and presented to patients over a 3.5-year period at a tertiary care Endocrinology and Metabolism centre. To assess the potential impact of such a document on patient recruitment, the basic demographics of patients who did and did not consent were compared. In addition, we compared the recruitment rate at our centre, using our novel approach, with that at other centres for an ongoing study of patients with type 1 diabetes. RESULTS: A large proportion (6501/8025, or 81%) of patients gave their consent for chart review. Patients who denied consent were more likely to be women and older. Compared with other centres, our centre recruited at the highest rate for a known study of patients with type 1 diabetes. The majority (46/60, or 76.7%) of patients were recruited via the novel approach. CONCLUSIONS: Consent for chart review and contact addresses several important ethical issues regarding the use of patient clinical information for research purposes. Our study demonstrated how such a process can be implemented. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
OBJECTIVE: Informed consent and protection of patient confidentiality are central to the conduction of clinical research. Consent for chart review and contact (CCRC) allows a patient chart to be screened for research by persons outside the direct circle-of-care and for the patient to be contacted regarding potential studies. This study describes the process of implementation and benefits of such a consent. DESIGN: We present a descriptive report of a CCRC document that was created and presented to patients over a 3.5-year period at a tertiary care Endocrinology and Metabolism centre. To assess the potential impact of such a document on patient recruitment, the basic demographics of patients who did and did not consent were compared. In addition, we compared the recruitment rate at our centre, using our novel approach, with that at other centres for an ongoing study of patients with type 1 diabetes. RESULTS: A large proportion (6501/8025, or 81%) of patients gave their consent for chart review. Patients who denied consent were more likely to be women and older. Compared with other centres, our centre recruited at the highest rate for a known study of patients with type 1 diabetes. The majority (46/60, or 76.7%) of patients were recruited via the novel approach. CONCLUSIONS: Consent for chart review and contact addresses several important ethical issues regarding the use of patient clinical information for research purposes. Our study demonstrated how such a process can be implemented. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Entities:
Keywords:
Confidentiality/Privacy; Ethics; Informed Consent; Research Ethics; Scientific Research
Authors: Jamie Bryant; Rob Sanson-Fisher; Elizabeth Fradgley; Breanne Hobden; Alison Zucca; Frans Henskens; Andrew Searles; Brad Webb; Christopher Oldmeadow Journal: BMC Med Res Methodol Date: 2016-10-10 Impact factor: 4.615