id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-271483-33kuvpl7	Shojaei, Amirahmad	COVID-19 and off label use of drugs: an ethical viewpoint	2020-05-08		.txt	text/plain	3184	153	42	Based on USFDA regulation, investigational use of off-label medications helps the development of their safety and efficacy which needs to be used in the context of a clinical study protocol [18] . Likewise, we would like to define pseudo-research as using off-label medications in clinical practice without obtaining the patient's informed consent, and finally publishing the results of drug efficacy as a research article. To do this, the national and international regulatory bodies such as USFDA, and EU, as well as the national ones such as the National Committee of Ethics in Biomedical Research of Iran, should step out of their routine and codify a range of guidelines to address therapeutic and/or investigational use of off-label medications by highlighting the safety concerns of the off-label uses as well as respecting patients autonomy especially in critical situations such as the COVID-19 outbreak. However, the physicians should be careful that the information about the efficacy and safety of off-label medication in clinical practice should not be published as a research article.	./cache/cord-271483-33kuvpl7.txt	./txt/cord-271483-33kuvpl7.txt