Informed Consent Procedure in Clinical Trials Promoted by the Hospital: Knowledge and Perceptions of Primary Care Physicians

Informed Consent Procedure in Clinical Trials Promoted by the Hospital: Knowledge and Perceptions of Primary Care Physicians
Gómez-Arbonés J, Salazar-Alarcon E, Solanilla-Puertolas M, Ortega-Bravo M, , Vallez-Valero L, Schoenenberger-Arnaiz JA
Journal of Clinical Trials & Research, 24 April 2020; 3(3) pp 197-202
Open Access
Abstract
Objectives
To evaluate Primary Care Physician’s (PCP) awareness degree concerning their patient’s participation in Clinical Trials (CT) analyze the communication methods used and obtain physicians personal views.
Methods
Authors performed a cross-sectional observational study that included CTs approved by the Institutional Review Board at a Regional University Hospital (n=78). Among these 37 CTs were selected. PCPs involved in these trials received a questionnaire regarding aspects of the CTs in which their patients participated. The communication systems established in the study protocols were analyzed.
Results
Out of 89 PCPs contacted, 82.1% were aware of their patient’s participation in CTs. The information reached them through verbal communication from the participant (56.3%). PCPs also accessed it through electronic medical records (EMR) (34.0%). A majority (97.4%) considered being informed about the participation of their patients in CTs should be compulsory.
Conclusion
Communication of patients’ participation in CTs fundamentally takes place through a verbal interaction between patients and their doctor. PCPs consider that the preferred method of communication would be an alarm system in the patient’s EMR.

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