CLINICAL TRIALS ON HEALTHY VOLUNTEERS: REVIEW OF ETHICAL CONSIDERATIONS AND A CRITIQUE OF ACCEPTABLE RISK

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PARSAPOOR ALIREZA; ASGHARI FARIBA

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Paper Information

Journal: Iranian Journal of Medical Ethics and History of Medicine Year:2012 | Volume:5 | Issue:SUPPLEMENT 1 Page(s): 19-26

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Information Journal Paper

Title

CLINICAL TRIALS ON HEALTHY VOLUNTEERS: REVIEW OF ETHICAL CONSIDERATIONS AND A CRITIQUE OF ACCEPTABLE RISK

Author(s)

PARSAPOOR ALIREZA | ASGHARI FARIBA | Issue Writer Certificate

Keywords

HEALTHY VOLUNTEERSQ3

RESEARCH ETHICSQ2

CLINICAL TRIALQ3

ACCEPTABLE RISKQ3

Abstract

HEALTHY VOLUNTEERS are the first group who take part in experimental studies on the efficacy of new drugs. Parallel with expanding the boundaries of medical science, medical research has shown rapid growth which has caused new and critical ethical challenges in medical research. A CLINICAL TRIAL is one of the essential methods in clinical research and a very challenging method from the ethical viewpoint.Recruiting healthy volunteer participants is necessary in CLINICAL TRIALs of drugs, and it requires special and careful ethical considerations. Although recruiting HEALTHY VOLUNTEERS is not limited to CLINICAL TRIALs, we have focused our discussion on ethical issues of research on HEALTHY VOLUNTEERS in this kind of study. In this paper, ethical challenges of involving HEALTHY VOLUNTEERS in CLINICAL TRIALs have been discussed in four domains of risk-benefit assessment, fair subject recruitment, incentives, and informed consent.The authors believe and argue that using the daily life risks standard as the ACCEPTABLE RISK for HEALTHY VOLUNTEERS is impractical. We suggest defining a reasonable risk that is acceptable to the RESEARCH ETHICS committee. The ethical committee, as a jury, can then evaluate the public acceptance of the risks.

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APA: Copy

PARSAPOOR, ALIREZA, & ASGHARI, FARIBA. (2012). CLINICAL TRIALS ON HEALTHY VOLUNTEERS: REVIEW OF ETHICAL CONSIDERATIONS AND A CRITIQUE OF ACCEPTABLE RISK. JOURNAL OF MEDICAL ETHICS AND HISTORY OF MEDICINE, 5(SUPPLEMENT 1), 19-26. SID. https://sid.ir/paper/135490/en

Vancouver: Copy

PARSAPOOR ALIREZA, ASGHARI FARIBA. CLINICAL TRIALS ON HEALTHY VOLUNTEERS: REVIEW OF ETHICAL CONSIDERATIONS AND A CRITIQUE OF ACCEPTABLE RISK. JOURNAL OF MEDICAL ETHICS AND HISTORY OF MEDICINE[Internet]. 2012;5(SUPPLEMENT 1):19-26. Available from: https://sid.ir/paper/135490/en

IEEE: Copy

ALIREZA PARSAPOOR, and FARIBA ASGHARI, “CLINICAL TRIALS ON HEALTHY VOLUNTEERS: REVIEW OF ETHICAL CONSIDERATIONS AND A CRITIQUE OF ACCEPTABLE RISK,” JOURNAL OF MEDICAL ETHICS AND HISTORY OF MEDICINE, vol. 5, no. SUPPLEMENT 1, pp. 19–26, 2012, [Online]. Available: https://sid.ir/paper/135490/en

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