Ethical Guidelines for Clinical Trials

Introduction: According to importance of respect the human subjects’ rights in clinical trials, many nationals and international ethical guidelines have been developed in the world, to enforce researchers to respect codes of research ethics in this type of study. During recent years, regarding to th...

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Autores principales: A Feiz zadeh, F Asghari, A Keshtkar, A Fotouhi, GH.A Hamed Barghi, R Sobhani, S Homami, R Sadeghi, SH Akhondzadeh, A Yousef
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FA
Publicado: Babol University of Medical Sciences 2006
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Acceso en línea:https://doaj.org/article/e0f3b67686e046bdb3d278b9ce8125d1
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spelling oai:doaj.org-article:e0f3b67686e046bdb3d278b9ce8125d12021-11-10T09:13:03ZEthical Guidelines for Clinical Trials1561-41072251-7170https://doaj.org/article/e0f3b67686e046bdb3d278b9ce8125d12006-10-01T00:00:00Zhttp://jbums.org/article-1-2567-en.htmlhttps://doaj.org/toc/1561-4107https://doaj.org/toc/2251-7170Introduction: According to importance of respect the human subjects’ rights in clinical trials, many nationals and international ethical guidelines have been developed in the world, to enforce researchers to respect codes of research ethics in this type of study. During recent years, regarding to the increasing number of medial researches in Iran, the necessity of developing ethics codes for special types of research such as clinical trial has became more cleared. Medical ethics and History of medicine research center did a project based on a grant from the National Medical Research Center, on development of ethical guidelines for six domains of medical research. One of them presented in this paper is ethical guideline for clinical trials.Methods and Materials: After a broad search and review of literature on international or national ethics guidelines and clinical trial research regulations in other countries, draft of the guideline was written. Then the draft was evaluated for the practical and cultural aspects in several meetings with cooperation of some researcher who had experience in clinical trial and some research ethics committee members. Next it was appraised for agreement with law and Islamic jurisprudence by some experts. Finally it was edited for Farsi syntactic rules. Discussion: This guideline is a big step toward teaching ethical standards to medical researcher and guiding research ethics committees to systematize their ethical evaluation. Definitely this guideline needs to be evaluated and revised periodically to fit best to practical matters raised in clinical trial, so authors welcome to all readers’ appraisal comments.A Feiz zadehF AsghariA Keshtkar,A FotouhiGH.A Hamed BarghiR Sobhani,S HomamiR SadeghiSH AkhondzadehA YousefBabol University of Medical Sciencesarticleclinical trialcode of ethicsethics committeeMedicineRMedicine (General)R5-920ENFAMajallah-i Dānishgāh-i ̒Ulūm-i Pizishkī-i Bābul, Vol 8, Iss 5, Pp 23-32 (2006)
institution DOAJ
collection DOAJ
language EN
FA
topic clinical trial
code of ethics
ethics committee
Medicine
R
Medicine (General)
R5-920
spellingShingle clinical trial
code of ethics
ethics committee
Medicine
R
Medicine (General)
R5-920
A Feiz zadeh
F Asghari
A Keshtkar,
A Fotouhi
GH.A Hamed Barghi
R Sobhani,
S Homami
R Sadeghi
SH Akhondzadeh
A Yousef
Ethical Guidelines for Clinical Trials
description Introduction: According to importance of respect the human subjects’ rights in clinical trials, many nationals and international ethical guidelines have been developed in the world, to enforce researchers to respect codes of research ethics in this type of study. During recent years, regarding to the increasing number of medial researches in Iran, the necessity of developing ethics codes for special types of research such as clinical trial has became more cleared. Medical ethics and History of medicine research center did a project based on a grant from the National Medical Research Center, on development of ethical guidelines for six domains of medical research. One of them presented in this paper is ethical guideline for clinical trials.Methods and Materials: After a broad search and review of literature on international or national ethics guidelines and clinical trial research regulations in other countries, draft of the guideline was written. Then the draft was evaluated for the practical and cultural aspects in several meetings with cooperation of some researcher who had experience in clinical trial and some research ethics committee members. Next it was appraised for agreement with law and Islamic jurisprudence by some experts. Finally it was edited for Farsi syntactic rules. Discussion: This guideline is a big step toward teaching ethical standards to medical researcher and guiding research ethics committees to systematize their ethical evaluation. Definitely this guideline needs to be evaluated and revised periodically to fit best to practical matters raised in clinical trial, so authors welcome to all readers’ appraisal comments.
format article
author A Feiz zadeh
F Asghari
A Keshtkar,
A Fotouhi
GH.A Hamed Barghi
R Sobhani,
S Homami
R Sadeghi
SH Akhondzadeh
A Yousef
author_facet A Feiz zadeh
F Asghari
A Keshtkar,
A Fotouhi
GH.A Hamed Barghi
R Sobhani,
S Homami
R Sadeghi
SH Akhondzadeh
A Yousef
author_sort A Feiz zadeh
title Ethical Guidelines for Clinical Trials
title_short Ethical Guidelines for Clinical Trials
title_full Ethical Guidelines for Clinical Trials
title_fullStr Ethical Guidelines for Clinical Trials
title_full_unstemmed Ethical Guidelines for Clinical Trials
title_sort ethical guidelines for clinical trials
publisher Babol University of Medical Sciences
publishDate 2006
url https://doaj.org/article/e0f3b67686e046bdb3d278b9ce8125d1
work_keys_str_mv AT afeizzadeh ethicalguidelinesforclinicaltrials
AT fasghari ethicalguidelinesforclinicaltrials
AT akeshtkar ethicalguidelinesforclinicaltrials
AT afotouhi ethicalguidelinesforclinicaltrials
AT ghahamedbarghi ethicalguidelinesforclinicaltrials
AT rsobhani ethicalguidelinesforclinicaltrials
AT shomami ethicalguidelinesforclinicaltrials
AT rsadeghi ethicalguidelinesforclinicaltrials
AT shakhondzadeh ethicalguidelinesforclinicaltrials
AT ayousef ethicalguidelinesforclinicaltrials
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