RT Journal Article
SR Electronic
T1 Implementation of a consent for chart review and contact and its impact in one clinical centre
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 425
OP 428
DO 10.1136/medethics-2013-101765
VO 41
IS 5
A1 Druce, Irena
A1 Ooi, T C
A1 McGuire, Debbie
A1 Sorisky, Alexander
A1 Malcolm, Janine
YR 2015
UL http://jme.bmj.com/content/41/5/425.abstract
AB 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.