Turkiye Klinikleri Journal of Medical Ethics-Law and History

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Helsinki Bildirgesi ve Tıbbi Araştırmalarda Plasebo Kullanımı: Bir Eleştirel Karşılaştırmalı Çalışma
The Declaration of Helsinki and the Use of Placebo in Medical Research: A Critical Comparative Study
M. Kemal TEMELa
aİstanbul Üniversitesi İstanbul Tıp Fakültesi, Tıp Tarihi ve Etik ABD, İstanbul Türkiye
Turkiye Klinikleri J Med Ethics. 2022;30(3):274-82
doi: 10.5336/mdethic.2022-89472
Article Language: TR
Full Text
ÖZET
 Helsinki Bildirgesi (HB), tıbbi araştırmalarda gözetilecek etik prensiplere dair temel dokümanlardan biri olagelmiştir. 1964'ten bugüne yedi kez revize ve 2002 ve 2004 tarihli açıklama notları ile iki kez tavzih edilmiştir. Fakat 2000'lerden itibaren bu değişiklikler, tıbbi araştırmalarda plasebo kullanımı konusunda sergilenen duruşa yönelik eleştiriler eşliğinde gerçekleşmiştir. Bu çalışmada, bu eleştirilerin nedenlerini ortaya koymak ve doğruluğunu sabit bulgulara göre tesis etmek amaçlanmıştır. Dünya Tabipler Birliğinin İnternet sitesinde bulunan tarihî ve güncel tüm orijinal İngilizce HB metinleri yeniden okunmuştur. Kontrollü tıbbi araştırmalarda kullanılabilecek kontrol mekanizmalarına, spesifik olarak da plasebo kullanımına dair ibareler saptanmış ve karşılaştırılmıştır. Revizyondan revizyona bu pasajlarda gerçekleşmiş olan değişiklikler tespit edilmiştir. Değişimin nedenleri tıp tarihi üzerinden açıklanmış, kabul edilebilirliği Beauchamp ve Childress tarafından kullanılagelmiş olan tıp etiği kavram, argüman ve metotları çerçevesinde tartışılmıştır. Tarih, revizyonlar sırasında kontrol mekanizmaları/plasebo kullanımı konusunda HB'ye önemli normatif eklentiler yapıldığını, bunların Amerika Birleşik Devletleri Sağlık Bakanlığı kurumları önderliğinde yürütülmüş olan usulsüz araştırmalara tepki olarak gerçekleştiğini göstermektedir. Ne var ki 2002 tarihli açıklama notu ile bir kırılma noktası yaşanmış ve yaklaşık kırk yıl boyunca korunmuş olan standart tedavi ile kontrol ilkesinden taviz verilmiştir. Bu tavizde yine nüfuzlu Amerikan kurumları etkili olmuştur. 2002 yılından, yani kaygan yamaca atılan bu ilk adımdan sonra, HB'de plasebo kullanımı konusunda giderek daha esnek bir tutum sergilendiği görülmektedir.

Anahtar Kelimeler: Helsinki Bildirgesi; insan denekler; klinik araştırmalar; plasebo kullanımı; tıbbi araştırmalar
ABSTRACT
 The Declaration of Helsinki (DoH) has been one of the fundamental documents on the ethical principles to govern medical research. Since 1964 it has undergone seven revisions and, with the notes in 2002 and 2004, two clarifications. Since the 2000s, however, such amendments have been accompanied by criticisms of the stance taken on the use of placebos in medical research. The present study aimed to demonstrate the reasons for these criticisms and establish their accuracy based on factual findings. All of the historical and current original DoH texts in English, available on the website of the World Medical Association, were reviewed. Statements on the possible control mechanisms for use in controlled medical research, specifically the use of placebos, were found and compared. The interrevision changes in these passages were identified. Reasons for them were explained in terms of medical history, while their acceptability was discussed with concepts, arguments and methods used by Beauchamp and Childress. History shows that during its revisions the DoH received critical normative specifications addressing control mechanisms/placebo use, in reaction to unethical research led by divisions of the United States Department of Health and Human Services. However, the 2002 note of clarification constituted a turning point marked by a compromise with the nearly four-decade principle of control with standard treatment, again under the influence of powerful American institutions. It is seen that the DoH policy regarding the use of placebos has been gradually relaxed since 2002, following this first step on the slippery slope.

Keywords: Declaration of Helsinki; human subjects; clinical research; placebo use; medical research
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