مرور ملاحظات اخلاقی و نقد میزان خطر قابل قبول در کارآزمایی بالینی بر داوطلب سالم

نویسندگان

  • پارساپور, علیرضا مرکز تحقیقات اخلاق و تاریخ پزشکی، دانشگاه علوم پزشکی تهران
چکیده مقاله:

Healthy volunteers are the first group who take part in experimental studies on the efficacy of new drugs. Parallel with expanding the boundaries of medical science, medical research has shown rapid growth which has caused new and critical ethical challenges in medical research.A clinical trial is one of the essential methods in clinical research and a very challenging method from the ethical viewpoint.Recruiting healthy volunteer participants is necessary in clinical trials of drugs, and it requires special and careful ethical considerations. Although recruiting healthy volunteers is not limited to clinical trials, we have focused our discussion on ethical issues of research on healthy volunteers in this kind of study. In this paper, ethical challenges of involving healthy volunteers in clinical trials have been discussed in four domains of risk-benefit assessment, fair subject recruitment, incentives, and informed consent. The authors believe and argue that using the daily life risks standard as the acceptable risk for healthy volunteers is impractical. We suggest defining a reasonable risk that is acceptable to the research ethics committee. The ethical committee, as a jury, can then evaluate the public acceptance of the risks.

برای دانلود باید عضویت طلایی داشته باشید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

ملاحظات اخلاقی

Background: Nowadays, many progresses have been occurred in medical science and transplantation process. Transplantation is now a life- saving standard treatment for some end stage diseases. Although the organs from brain death donors, are the best resource for cadaverous transplantation, there are many controversies among physicians about it's definition. The other important issue in trans...

متن کامل

ملاحظات اخلاقی

Background: Medical students at all levels of experience, encounter learning opportunities in a wide variety of clinical settings. There are some ethical dilemmas a student may face and possibly carry the burden throughout his file. Most of formal medical ethics teaching focuses on dilemmas that students may face in their future practice, rather than the ethical problems they encounter as med...

متن کامل

ملاحظات اخلاقی

Background: Kidney transplantation is one of the major progresses of medical science with many ethical debates. The shortage of organs and the increases in waiting list for cadaver transplantation has leaded to transplantation from living donors. In this article, we discuss the ethics of transplantation from living kidney donors. Methods: For compiling this article, we searched in Pubmed and...

متن کامل

منابع من

با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

ذخیره در منابع من قبلا به منابع من ذحیره شده

{@ msg_add @}


عنوان ژورنال

دوره 5  شماره 1

صفحات  19- 26

تاریخ انتشار 2012-03

با دنبال کردن یک ژورنال هنگامی که شماره جدید این ژورنال منتشر می شود به شما از طریق ایمیل اطلاع داده می شود.

کلمات کلیدی

کلمات کلیدی برای این مقاله ارائه نشده است

میزبانی شده توسط پلتفرم ابری doprax.com

copyright © 2015-2023