اعتبار قرارداد مشارکت در پژوهشهای پزشکی بر مبنای قواعد عمومی قراردادها
محورهای موضوعی : Medical lawمحسن پورعلی 1 , محسن پور محمد 2
1 - دانشجوکارشناسی ارشد حقوق خصوصی، گروه حقوق، دانشکده ادبیات و علوم انسانی، دانشگاه گیلان، رشت، ایران.
2 - استادیارگروه معارف اسلامی، گروه معارف اسلامی، دانشکده پیراپزشکی، پرستاری مامایی حضرت زینب لنگرود، دانشگاه علوم پزشکی گیلان ، رشت، ایران.
کلید واژه: قرارداد, پژوهش پزشکی, رضایت آگاهانه, داوطلب, آزادی قراردادی, ماده 10 قانون مدنی ,
چکیده مقاله :
متغیّر بودن زندگی اجتماعی، موجب پیدایش قراردادهای جدیدی شدهاست که بهراحتی نمیتوان قواعد آن را در قوانین موجود یافت. قرارداد مشارکت در پژوهشهای پزشکی، یکی از این پیمانهای نوظهور میباشد و به این معنی است که پژوهشگر در چهارچوبی خاص، آزمایشاتی را روی آزمودنی انسانی برای رسیدن به اهداف پزشکیِ مشروع انجام میدهد. اصولاً عوض و معوّض در این عمل حقوقی با دیگر اعمال متفاوت بوده و تعاریف مخصوص به خود را دارد و همین امر این پرسش را ایجاد میکند که آیا این پیمان درست است یا خیر؟ دیگر نکتۀ قابل توجّه این است که بسیاری از پژوهشها الزاماً باید روی افراد فاقد اهلیّت یعنی صغار و مجانین و یا روی بیماران فاقد هوشیاری کافی انجام گیرد؛ بررسی نحوۀ اخذ رضایت از این اشخاص نیز از جمله مواردی است که در قوانین موجود به راحتی نمیتوان به پاسخ قانعکنندهای دربارۀ آن رسید. مطالعۀ منابع کتابخانهای و توجه به نیازهای جدید جامعه، ما را به این نتیجه میرساند که باید صحت این پیمان را پذیرفت و با وجود شرایط ویژهای، اجازۀ انجام پژوهش روی افرادی که قانوناً فاقد قدرت اعلام رضایت اند را نیز صادر کرد. دیگر نکته اینکه رضایت در این پیمان ماهیت ویژهای داشته و به جهت مخدوش ساختن قصد، عدم رضا موجب بطلان قرارداد میگردد.
The variability of social life has led to the emergence of new types of contracts whose governing rules cannot easily be found in existing laws. The contract of participation in medical research is one of these emerging agreements. It refers to a situation in which a researcher, within a specific framework, conducts experiments on human subjects in order to achieve legitimate medical objectives. In principle, the consideration and counter‑consideration in this legal act differ from those in other legal transactions and have their own specific definitions. This raises the question of whether such an agreement is valid or not. Another important point is that many studies must necessarily be conducted on individuals who lack legal capacity, such as minors and the mentally incapacitated, or on patients who do not possess sufficient consciousness. Examining the manner of obtaining consent from such individuals is also among the issues for which it is not easy to find a satisfactory answer in existing laws. A study of library sources and attention to the new needs of society lead to the conclusion that the validity of this agreement should be recognized and that, under special conditions, permission should also be granted to conduct research on individuals who legally lack the power to express consent. Another point is that consent in this agreement has a particular nature, and because it affects the element of intention, the absence of consent results in the invalidity of the contract.
1. Ahangaran, M. R., & Saeidi, M. (2016). Reconsideration of the foundations of the legitimacy of innominate contracts with a comparative approach in Islamic law. Danesh-e Hoquq-e Madani, 5(2), 1–15. [In Persian]
2. Amini, M., & Sayyadi, S. (2022). An analysis of the legal and jurisprudential status of clinical trial contracts. Law of New Technologies, 3(5), 1–18. [In Persian]
3. Asadi-Nejad, S. M. (2014). Principles of civil law (Vol. 3). Tehran: Haghigh Legal Publications. [In Persian]
4. Askari, M. (2018). The effect of mutual mistake on contractual obligations in Iranian law. Journal of Legal Studies, 28, 209–223. [In Persian]
5. Badini, H., & Banshi, M. (2021). Foundations of the human right over one’s own body: The labor theory and the “body for body” theory. Judiciary Law Journal, 85(113), 45–67. [In Persian]
6. Chaqamirza, S. (2017). Analysis of the characteristics of nullity in contracts. Qanunyar Quarterly Journal, 1, 81–100. [In Persian]
7. Falah-Mahmoudi, J., Soltan-Ahmadi, J., & Shoarian-Sattari, E. (2020). The proprietary nature of human body organs in light of Article 75 of the Citizens’ Rights Charter and Islamic jurisprudence regarding organ sales. Medical Law Quarterly, 525–536. [In Persian]
8. Gharibeh, A. (2008). The scope of the impact of mistake in contracts. Law Quarterly, 40(101), 203–217. [In Persian]
9. Imami, S. H. (1956). Civil law (Vol. 1) (2nd ed.). Tehran: University of Tehran Press. [In Persian]
10. Katouzian, N. (2010). Civil law course (Vol. 2): Family, children, parent–child relations. Tehran: Enteshar Joint Stock Company. [In Persian]
11. Katouzian, N. (2011). Preliminary course of civil law: Juridical acts (contracts and unilateral acts) (4th ed.). Tehran: Enteshar Joint Stock Company. [In Persian]
12. Rajai, F., Mohaghegh Damad, S. M., & Mousavi, S. M. S. (2011). A jurisprudential and legal study of the human relationship with one’s own body organs. Journal of Islamic Jurisprudence and Law, 2, 45–62. [In Persian]
13. Rahpeyk, H. (1996). Defects of will and consent: Mistake in contracts. Judicial Legal Perspectives, 2, 43–56. [In Persian]
14. Roshandel, G. (2023). Ethical considerations in research on human-origin biological data and samples. Encyclopedia of Islamic Medical Ethics, 1, 1–20. [In Persian]
15. Saberi, H., Ahangaran, M. R., & Sadeghi Bahmani, S. (2013). A jurisprudential–legal reexamination of separating intention from consent. Teachings of Civil Jurisprudence, 7, 27–52. [In Persian]
16. Safaei, S. H. (2019). Introductory course of civil law (Vol. 2): General rules of contracts (31st ed.). Tehran: Mizan Legal Foundation. [In Persian]
17. Safaei, S. H., & Emami, A. (2017). A concise guide to family law (47th ed.). Tehran: Mizan Legal Foundation. [In Persian]
18. Shahidi, M. (2011). Civil law (Vol. 3): Obligations (15th ed.). Tehran: Majd Publications. [In Persian]
19. Talebi, M., Moradkhani, A., & Shafiei, S. M. (2020). An examination of the jurisprudential and legal foundations of human ownership over the body. Fiqh Research, 16, 173–192. [In Persian]
20. Legal and Regulatory Sources [In Persian]
21. Executive By-law of the Law on Organ Transplantation from Deceased or Brain-Dead Patients. (2002).
22. Guidelines on General Ethics in Medical Research Involving Human Subjects in the Islamic Republic of Iran. Ministry of Health and Medical Education. (2013). [In Persian]
23. Directive on the Formation, Procedures, and Duties of Research Ethics Committees. Ministry of Health and Medical Education. (2020). [In Persian]