اعتبار قرارداد مشارکت در پژوهشهای پزشکی بر مبنای قواعد عمومی قراردادها
محورهای موضوعی : حقوق پزشکیمحسن 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.
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