ethicsplaceborandomizationBeneficence, non-maleficence, autonomy and justice: these are the four pillars of modern medical ethics. To ensure beneficence, and non-maleficence, in our treatment of patients, we need the evidence of clinical trials. The Declaration of Helsinki of 1964, and its numerous...
That's the ethics of clinical trials. In 2016, the World Health Organization (WHO) released the “Guidance for Managing Ethical Issues in Infectious Disease” to ensure the safety of participants during the outbreak of disease.9 The guidance notes that it is morally obligatory to conduct ...
Editorial Facilitating Efficient and Ethical Trials at the Intersection of Research and Clinical Care JAMA Full Text Read More About Ethics Research, Methods, Statistics Download PDF Full Text Cite This Permissions CME & MOC Access through your institution JAMA+ AI Trending Research...
Whether clinical trials add risk or burden to what patients would otherwise have experienced, and whether studies restrict meaningful decisions patients would or should have had the opportunity to make, should help to determine whether clinical studies are designated as greater than vs minimal ri...
Objectives On completing this course, learners will have improved knowledge of the ethics of (1) subject recruitment and procedures for informed consent, and (2) subject privacy and confidentiality. Also, they will better recognize and resolve (3) the distinction betweenM Rizzo...
Whalan DJ. The ethics and morality of clinical trials in man. Medical Journal of Australia . 1975;1:491–94.Whalan DJ. The ethics and morality of clinical trials in man. Med J Aust 1975; 1: 491-4.Whalan DJ. The ethics and morality of clinical trials in man. Med J Aust. 1975;1...
Equipoise and the ethics of clinical research. The ethics of clinical research requires equipoise--a state of genuine uncertainty on the part of the clinical investigator regarding the comparative thera... B Freedman - 《N Engl J Med》 被引量: 3307发表: 0年 Placebo-controlled trials in ...
新分子的临床研究 (clinical investigations of a new molecule)必须在研究性新药 (IND)申请中进行,以评估其安全性和有效性,而上市批准则通过新药申请程序获得。 01 研究性新药申请 向FDA提交IND是在美国市场开发新药的一个重要里程碑。在开始任何临床试验之前,必须填写并向FDA提交FDA 1571表。 事实上,美国联邦...
and insufficient knowledge of Dutch or English or incapability to understand training or instructions of telemonitoring devices. All participants provided written informed consent. The trial protocol was approved by the Medical Resea...
The American Journal of MedicineRosner, F. 1987. The ethics of randomized clinical trials. Am. J. Med. 82:283-290.Rosner F. The ethics of randomized clinical trials. Am J Med 1987; 82(2): 283-90.Rosner, F. : The ethics of randomized clinical trials. Amer. J. Med. 1987; 82: ...