ethics in clinical trial

نویسندگان

fariba asghari

akbar fotouhi

چکیده

background: clinical trial is the standard method to assess efficacy of a medical intervention. because of its experimental nature, meaning that subjects are exposed to an intervention with uncertain outcome and according to historical evidences of criminal researches, clinical trial is of something of a lightning rod for ethical concerns. ethical issues surrounding clinical trials are very pervasive and in many respects, they are as important as the methodological issues. patients place a great deal of trust in clinical investigators and often participate in trial when the chance of personal benefit is low. the clinical investigators must continue to earn this trust by demon storable commitment to ethical standards. methods: in this article after reviewing the appropriateness and necessity of clinical trial and its required methodological characteristics, ethical issues consisting importance of protocol, informed consent, study on vulnerable subjects, compensation, conflict of interest and responsibility of ethical committees in evaluation of clinical trial will be discussed. conclusion: to assess efficacy of a medical intervention, clinical trial is ethicly not only inevitable but also necessary. however it doesn't reduce necessity of attention to the participants rights.

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

Ethics in Clinical Research

There is no English abstract.

متن کامل

Ethics of Safety Reporting of a Clinical Trial

Clinical trial related injury and serious adverse events (SAE) are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensa...

متن کامل

Clinical ethics protocols in the clinical ethics committees of Madrid.

INTRODUCTION Currently, The nature and scope of Clinical Ethics Protocols (CEPs) in Madrid (Spain) are not well understood. OBJECTIVES The main objective is to describe the features of 'guideline/recommendation' type CEPs that have been or are being developed by existing Clinical Ethics Committees (CECs) in Madrid. Secondary objectives include characterisation of those CECs that have been the...

متن کامل

CLINICAL ETHICS Clinical ethics, information, and communication: review of 31 cases from a clinical ethics committee

Objectives: To summarise the types of case brought to the Clinical Ethics Committee of the National Hospital of Norway from 1996 to 2002 and to describe and discuss to what extent issues of information/ communication have been involved in the ethical problems. Design: Systematic review of case reports. Findings: Of the 31 case discussions, (20 prospective, 11 retrospective), 19 cases concerned ...

متن کامل

Evolution of Ethics in Clinical Research and Ethics Committee

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of p...

متن کامل

Developing clinical ethics committees.

Formal clinical ethics review first developed in the USA and most hospitals there have structures in place. This is often a clinical ethics committee. Developments have been slower in the UK, where there has been uncertainty and variability about the role of clinical ethics committees. Even in the USA, their exact role is uncertain. Although we now have a good idea of the mechanisms for ethical...

متن کامل

منابع من

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


عنوان ژورنال:
مجله دیابت و متابولیسم ایران

جلد ۴، شماره Vol۴, Ethics in Clinical Researchese، صفحات ۴۷-۵۷

کلمات کلیدی

میزبانی شده توسط پلتفرم ابری doprax.com

copyright © 2015-2023