Informed Consent of Couples in IVF Practices: A Limited Study in Turkey

Year 2023, , 28 - 34, 02.02.2023

Pervin Şahiner , Mine Şehiraltı

https://doi.org/10.30934/kusbed.1132624

Cited By: 1

Abstract

Objective: The aim of this study is to obtain informed consent in vitro fertilization applications and to determine the factors affecting this process.
Methods: This article is a full-text original research article. Descriptive and cross-sectional study was conducted with 193 women and 54 men, undergoing in vitro fertilization treatment. Study form consisted of questions regarding sociodemographic features and informed consent. The form was filled on the day the eggs were collected. The ethical committee approved the protocol of the study and all participants were provided with verbal informed consent.
Results: According to result of the study, it was found that more than one third (38.5%) of the participants were not informed verbally, 34.1% of those who were informed could not understand what was told. Those who applied to a private physician were more informed. The explanations were not understood mainly due to the problems arising from informing process. The consent form was given to all participants after starting treatment. Two thirds of the participants read the consent form and 22.7% of them did not understand what they read. Almost half (41.3%) of those who did not read the consent form stated that they consider the reading and signing the form as a procedure for the implementation of the transaction. Those who had time to read the consent form read more (p<0.001) and understood more (p=0.036).
Conclusion: In this study, it was concluded that there were problems with the transferring and understanding of information, and that valid consents were not taken from some patients.

Keywords

Medical ethics, informed consent, in vitro fertilization, infertility

Tüp Bebek Uygulamalarında Çiftlerin Aydınlatılmış Onamı: Türkiye' de Sınırlı Bir Çalışma

Abstract

Amaç: Bu çalışmanın amacı, tüp bebek uygulamalarında aydınlatılmış onam elde edilmesi ve bu süreci etkileyen faktörleri belirlemektir.
Yöntem: Bu makale tam metin özgün bir araştırma makalesidir. Tanımlayıcı ve kesitsel araştırma tüp bebek tedavisi gören 193 kadın ve 54 erkek ile yapılmıştır. Çalışma formu, sosyodemografik özellikler ve aydınlatılmış onam ile ilgili sorulardan oluşmuştur. Form, yumurtaların toplandığı gün doldurulmuştur. Etik kurul, çalışmanın protokolünü onaylamış ve tüm katılımcılardan sözlü bilgilendirilmiş onam alınmıştır.
Bulgular: Araştırmanın sonucuna göre, katılımcıların üçte birinden fazlasının (%38,5) sözlü olarak bilgilendirilmediği, bilgilendirilenlerin ise %34,1'inin anlatılanları anlayamadığı tespit edildi. Özel doktora başvuranlar daha fazla bilgilendirilmiştir. Açıklamalar, başlıca bilgilendirme sürecinden kaynaklanan sorunlar nedeniyle anlaşılamamıştır. Onam formu tüm katılımcılara tedavi başladıktan sonra verilmiştir. Katılımcıların üçte ikisi onam formunu okumuş ve %22,7'si okuduğunu anlamamıştır. Onay formunu okumayanların yaklaşık yarısı (%41,3) formu okumayı ve imzalamayı işlemin uygulanması için bir prosedür olarak gördüğünü belirtmiştir. Onam formunu okumak için zamanı olanlar daha çok okumuş (p<0,001) ve daha çok anlamıştır (p=0,036).
Sonuç: Bu çalışmada bilgilerin aktarılmasında ve anlaşılmasında sorunların olduğu, bazı hastalardan geçerli onam alınmadığı sonucuna varıldı.

Keywords

Tıp etiği, aydınlatılımış onam, tüp bebek, kısırlık

References

• Bravo P, Dois A, Cabieses B, Bustamante C, Campos S. Patient-centred care and shared decision making in Chile: Rising momentum for progress and implementation in clinical practice. Z. Evid. Fortbild. Qual. Gesundh. Wesen (ZEFQ). 2017;123–124:28-31 doi: 10.1016/j.zefq.2017.05.014.
• Madeira JL, Kathryn Coyne K, Jaeger AS, Parry JP, Lindheim SR. Inform and consent: more than just ‘‘sign here’’. Fertil Steril. (2017(a);108(1):40–41. Mississippi Medical Center, Jackson, Mississippi http://dx.doi.org/10.1016/j.fertnstert.2017.03.022
• Chan T, Eckert K, Venesoen P, Leslie K, Chin-Yee I. Consenting to blood: What do patients remember? Transfusion Medicine. 2005;(15):461-466. doi: 10.1111/j.1365-3148.2005.00622.x
• Joolaee S, Faghanipour S, Hajibabaee F. The quality of obtaining surgical informed consent: Case Study in Iran. Nurs Ethics.2017;24(2):167-176. doi: https://doi.org/10.1177/0969733015584398
• Krahan TM, Baylis F. A review of consent documents from Canadian IVF clinics, 1991 to 2014. J Obstet Gynaecol Can.2016;38(5):470-482. doi: 10.1016/j.jogc.2016.02.008
• Madeira JL, Kathryn Coyne K, Wiiliamson B, Parry JP, Lindheim SR. Inform and consent: more than just ‘‘sign here’’. Fertil Steril.2017(b); pp-509, e301.
• Maderia JL. The ART of ınformed consent: assessing patient perceptions, behaviors, and lived experience of IVF and embryo disposition ınformed consent processes. Fam. Law Q. 2015;(49(1):7-28.
• World Health Organization. Current practices and controversies in assisted reproduction. Report of a meeting on medical, ethical and social aspects of assisted reproduction” held at WHO Headquarters in Geneva, Switzerland 2002, 17–21, https://wwwhttps://www.researchgate.net/publication/242470726 Accessed December 5, 2019.
• Cedars MC. In vitro fertilization and risk of autistic disorder and mental retardation. JAMA. 2013;310(1):42-43. doi:10.1001/jama.2013.7223
• Rebar RW. What are the risks of the assisted reproductive technologies (ART)and how can they be minimized? Reprod Med Biol. 2013;12(4):151–158. doi:10.1007/s12522-013-0156-y
• Sullivan EA, Zegers-Hochschild F, Mansour R. et al. International committee for monitoring assisted reproductive technologies (ICMART) world report: assisted reproductive technology 2004. Human Reproduction. 2013;28(5):1375–1390. doi.org/10.1093/humrep/det036
• Centers for disease control and prevention. National public health action plan for the detection, prevention, and management of ınfertility, Atlanta, Georgia: Centers for disease control and prevention. 2014;https://www,cdc,gov/reproductivehealth/infertility/Accessed May 20, 2019.
• Turkish Society of Gynecology and Obstetrics. https://www.tjod.org. Accessed: November 15, 2019.
• Assisted Reproductive Treatment. Regulation on assisted reproductive treatment practices and assisted reproductive treatment centers. Official Gazette Date: 30.09.2014, number: 29135.https://www.mevzuat.gov.tr/ Accessed April 10, 2021.
• Advisory committee on assisted reproductive technology. Informed consent and assisted reproductive technology. Proposed advice to the minister of health.New Zealand. 2015. www,acart,health,govt,nz . Accessed: December 12, 2018.
• Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 6th ed. Oxford: United Kingdom Press. (2013).
• Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: A systematic review. Med Decis Making. 2011;31(1):151–173. doi: 10.1177/0272989X10364247
• Agozzino E, Borrelli S, Cancellieri C, Michela Carfora F, Lorenzo TD, Attena F. Does written informed consent adequately inform surgical patients? A cross sectional study. BMC Med Ethics. 2019;20(1):2-8. doi: https://doi.org/10.1186/s12910-018-0340-z
• Alsaihati AM, Alotaibi AB, Alhawaj AM. et al. Knowledge opinions and attitude of surgeons in saudi arabia toward ınformed surgical consent. Egypt. J. Hosp. Med. 2017;69(4):2232-2237. doi: 10.12816/0041522
• Aydın Er R, Özcan M, Akpınar A, Ersoy N. Ethical problems about informed consent in orthopedics: A sample from Kocaeli. Turkiye Klinikleri J Med Sci 2011;31(2):455-63. doi: 10.5336/medsci.2009-15175
• Ertürk T, Yorgancıgil E, Bozbıyık S, Çabuk S, Görgün GH. The assessment of the levels of being informed and consent obtaining of patients admitted to Suleyman Demirel University Research and Training Hospital. Med J SDU. 2013:20(4)/144-148
• Advisory committee on assisted reproductive technology. Informed consent and assisted reproductive technology. Proposed advice to the minister of health.New Zealand. 2015. www,acart,health,govt,nz . Accessed: December 12, 2018
• Departman of Health. Good Practice in Consent İmplementation Guide: Consent to examination or treatment. 2001. http://www.health.wa.gov.au/mhareview/resources/documents/Accessed May 17, 2018
• Inhorn MC, Birenbaum-Carmeli D, Tremaayne S, Gürtin ZB. Assisted reproduction and Middle East kinship: a regional and religious comparison. Reprod Biomed Soc Online, 2017; 4:41–51.
• Keskin and Babacan Gümüs. Infertility: An Examination Hopelessness Perspective. J. Psychiatr. Nurs. 2014;5(1):9-16.
• Ezabadi Z, Mollaahmadi F, Sazvar S, Vesali S, Omani-Samani R. Satisfaction with information provided to infertile patients who undergo assisted reproductive treatment. Int J Fertil Steril. 2019;12(4):324-328. doi: 10.22074/ijfs.2019.5314
• Gonen LD. Satisfaction with in vitro fertilization treatment: patients’ experiences and professionals’ perceptions. Fertil. res. pract. 2016;2(6):1-11. doi: 10.1186/s40738-016-0019-4
• Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: A systematic review. Med Decis Making. 2011;31(1):151–173. doi: 10.1177/0272989X10364247
• Madeira JL, Rehbein J, Christianson MS. et al. Using the EngagedMD multimediaplatform to improve informed consentfor ovulation induction, intrauterineinsemination, and in vitro fertilization. Fertil Steril. 2018;110(7):1338–1346. doi: 10.1016/j.fertnstert.2018.08.045
• Maderia JL, Andraka-Christou B. Paper trails, trailing behind: improving informed consent to IVF througH multimedia applications. J Law Biosci. 2016;3(1):2–38. doi: 10.1093/jlb/lsv054
• Regulation on Patient Rights (2014). Regulation on making changes in the patient rights regulation. Official newspaper..https://www. officialnewspaper.gov.tr/Accessed May 11, 2021.
• McKeague M, Windsor J. Patients’ perception of the adequacy of informed consent: apilot study of elective general surgical patients in Auckland. NZ Med J.2003;116(1170):1-9.
• Oren E, Eren CS, Yesildere FB, Erdogan N. Informed consent of contrast media applications in radiology: assesment of comprehensibility and the anxiety of the patients. Journal of Tepecik Training Hospital. 2010;20 (3):122-130. doi: 10.5222/terh.2010.43760
• Jlala HA, Caljouw MA, Bedforth NM, Hardman JG. Patient satisfaction with perioperative care among patients having orthopedic surgery in a university hospital. Local Reg Anesth. 2010;(3):49–55. DOI: 10.2147/lra.s11381
• Yıldırım G, Bilgin İ, Tokgöz H. Are in surgical clinic health workers' views and practices related to the informed consent consistent with each other? Cumhuriyet Med J. 2014;(36):451-458. https://doi.org/10.7197/cmj.v36i4.5000071066