Aspects of vulnerable patients and informed consent in clinical trials

نویسندگان

  • Maria Kuthning
  • Ferdinand Hundt
چکیده

SCOPE To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. METHODS Scientific literature search via PubMed, Medline, Google. RESULTS Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual's freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor's assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. CONCLUSION Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials.

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

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

بررسی سیر تغییرات بیانیه‌ی هلسینکی و تفاوت‌های ویرایش سال 2008 نسبت به 2004

The Declaration of Helsinki, the most creditable ethical guideline for medical research on human subjects, has been updated 8 times since its establishment and the last revision was in 2008. Researchers, medical research subjects, authors, members of ethics committees, and editors of medical journals must be informed of the tenets of the Helsinki declaration in order to improve achievements of ...

متن کامل

A Review on Some Aspects of Patient’ Rights in Clinical Education

Clinical education will be possible with involving patients. Many patients who seek medical and diagnostic care can be involved in clinical training. Therefore, teachers and students need to know the legal aspects of patient involvement and adhere to these aspects in order to attract patients’ participation and satisfaction. This study reviewed the importance and necessity of legal aspects, i...

متن کامل

Different Aspects of Informed Consent in Aesthetic Surgeries

Providing an informed consent has an important role in promotion of medical treatments and reduction of judiciary litigations in this process. Today with cultural changes and wide propagation that is usually charming, the request for aesthetic surgery has an increasing trend. These problems with complexity of cosmetic surgeries lead to deeper differences of information between plastic surgeons ...

متن کامل

بیانیه‌ی هلسینکی ویرایش 2008، ترجمه‌ی فارسی و چالش‌‌های آن

The Declaration of Helsinki, the most creditable ethical guideline for medical research on human subjects, has been updated 8 times since its establishment and the last revision was in 2008. Researchers, medical research subjects, authors, members of ethics committees, and editors of medical journals must be informed of the tenets of the Helsinki declaration in order to improve achievements of ...

متن کامل

Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries.

BACKGROUND/RATIONALE Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote hig...

متن کامل

ذخیره در منابع من


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

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

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 11  شماره 

صفحات  -

تاریخ انتشار 2013