Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach.

OBJECTIVE

This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R-T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions.

METHODS

A total of 185 forms from the university, R-T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated.

RESULTS

TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R-T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking.

CONCLUSION

The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.