Yıl: 2021 Cilt: 49 Sayı: 6 Sayfa Aralığı: 477 - 487 Metin Dili: İngilizce DOI: 10.5543/tkda.2021.55534 İndeks Tarihi: 29-01-2022

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

Öz:
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.
Anahtar Kelime:

Kardiyoloji kliniklerinde kullanılan bilgilendirilmiş olur formlarının etik değerlendirmesi ve kurumsal standart yaklaşımın önemi

Öz:
Amaç: Bu çalışmanın amacı, üniversite, araştırma ve eğitim ve özel hastanelerin kardiyoloji girişimleri sırasında kullanılan bilgilendirilmiş olur formlarının (BOF) içeriğini etik standartlar açısından değerlendirmek ve Türk Kardiyoloji Derneği (TKD) taslak formları ile karşılaştırmak ve kurumlar arasındaki farkları belirlemektir. Yöntemler: Üniversite, araştırma ve eğitim ve özel hastanelerde kullanılan 185 form ve 19 TKD şablon formu seçildi ve 26 kritere göre analiz edildi. Hastanelerde kullanılan formların TKD şablonlarına uyumları da değerlendirildi. Veriler, kriterleri karşılayan BOF’ların yüzdesi olarak sunuldu ve Fisher’in kesin testi kullanılarak karşılaştırıldı, %95 güven aralıkları hesaplandı. Bulgular: TKD şablonları etik standartlarla daha uyumluydu ve her üç tür sağlık hizmeti kurumuna kıyasla etik standartlara uygun daha fazla bilgi içeriyordu. Bu şablonlarda tedavi ve alternatif tedavilere ilişkin beklentiler, yaşam kalitesi, üçüncü taraf onayının açıklaması, hastanede kalış süresi ve normal hayata dönme süresi kriterlerinde bazı eksikler saptandı. Üç hastane türü arasında araştırma ve eğitim hastanelerinde kullanılan BOF’lar TKD şablonlarına daha uyumluydu. Özel hastane BOF’ları TKD şablonlarıyla en zayıf uyuma sahipti. Ayrıca anestezi BOF’u ve radyoaktiviteye maruz kalma hakkında ayrıntılı bilgi sunumu genel olarak eksikti. Sonuç: Kardiyoloji müdahalelerinde kullanılan mevcut BOF’ların büyük etik eksiklikleri vardır ve iyileştirilmesi gerekir. TKD gibi uzmanlık örgütleri, bilgilendirilmiş olur süreci ve çeşitli kurumlar arasında sürecin standardizasyonu ve etik standartlara uyumları için rehberlik sunmak ve BOF şablonları geliştirmek ve sağlamak için önemli ve temel kurumlardır.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
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APA ÇELEBİ S, ekmekci p, Güner M (2021). Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. , 477 - 487. 10.5543/tkda.2021.55534
Chicago ÇELEBİ Sevaş,ekmekci perihan elif,Güner Müberra Devrim Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. (2021): 477 - 487. 10.5543/tkda.2021.55534
MLA ÇELEBİ Sevaş,ekmekci perihan elif,Güner Müberra Devrim Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. , 2021, ss.477 - 487. 10.5543/tkda.2021.55534
AMA ÇELEBİ S,ekmekci p,Güner M Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. . 2021; 477 - 487. 10.5543/tkda.2021.55534
Vancouver ÇELEBİ S,ekmekci p,Güner M Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. . 2021; 477 - 487. 10.5543/tkda.2021.55534
IEEE ÇELEBİ S,ekmekci p,Güner M "Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach." , ss.477 - 487, 2021. 10.5543/tkda.2021.55534
ISNAD ÇELEBİ, Sevaş vd. "Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach". (2021), 477-487. https://doi.org/10.5543/tkda.2021.55534
APA ÇELEBİ S, ekmekci p, Güner M (2021). Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. Türk Kardiyoloji Derneği Arşivi, 49(6), 477 - 487. 10.5543/tkda.2021.55534
Chicago ÇELEBİ Sevaş,ekmekci perihan elif,Güner Müberra Devrim Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. Türk Kardiyoloji Derneği Arşivi 49, no.6 (2021): 477 - 487. 10.5543/tkda.2021.55534
MLA ÇELEBİ Sevaş,ekmekci perihan elif,Güner Müberra Devrim Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. Türk Kardiyoloji Derneği Arşivi, vol.49, no.6, 2021, ss.477 - 487. 10.5543/tkda.2021.55534
AMA ÇELEBİ S,ekmekci p,Güner M Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. Türk Kardiyoloji Derneği Arşivi. 2021; 49(6): 477 - 487. 10.5543/tkda.2021.55534
Vancouver ÇELEBİ S,ekmekci p,Güner M Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach. Türk Kardiyoloji Derneği Arşivi. 2021; 49(6): 477 - 487. 10.5543/tkda.2021.55534
IEEE ÇELEBİ S,ekmekci p,Güner M "Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach." Türk Kardiyoloji Derneği Arşivi, 49, ss.477 - 487, 2021. 10.5543/tkda.2021.55534
ISNAD ÇELEBİ, Sevaş vd. "Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach". Türk Kardiyoloji Derneği Arşivi 49/6 (2021), 477-487. https://doi.org/10.5543/tkda.2021.55534