The Dilemma of Using Humans as Research Subjects: An Assessment of Risks and Benefits
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The Dilemma of Using Humans as Research Subjects: An Assessment of Risks and Benefits According to The Belmont Report, the prior assessment of potential risks and benefits is essential in determining whether a subject ought to participate in research. This article will present a review of the risks and benefits to which research subjects are exposed, followed by a short summary of the philosophical and C. lneke Neutel, MSc, PLD, FACE, FISPE Health Intelligence, S C O H S , Inc., Ottawa, Ontario, Canada
Dr. Neutel has disclosed that she is an employee of Health C a n a d a and S C O H S Inc, and she will not discuss the unlabeled/unapproved use of any products.
Key Words Research ethics: Research subject: RisUbenefit analysis
Correspondence Address C . lneke Neutel, M S c . PhD, FACE. FISPE, Health Intelligence, S C O H S . Inc., 4 3 Bruyere Street, Ottawa. Ontario, C a n a d a , K I N 5C8 (e-mail [email protected]). The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Drug Information Association designates this educational activity for a maximum of 1 category 1 credit toward the A M A Physician’s Recognition Award. Each physician should only claim those credits that he/she actually spent in the activity. The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for a maximum of 1 contact hour o r . I continuing education units (CEUs). 286-000-04-405-HO4.
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Release Date: May 2004 Expimtion Date: May 31,2005 Estimated time to complete the activity: 1 hour
ethical thinking underlying these issues. The application of the principles of beneficence and nonmaleficenceto the issues of minimizing risk and maximizing benefit might be achieved more effectivelyby changes in how the consent information letter is usually organized.
Learning Objectives Upon completing this article, participants should be able to: Examine the concepts of risk and benefit as related to research subjects Examine some of the philosophical thinking that underiies the concepts of ethical principles and risk and benefit determination Apply the principles of beneficence and nonmaleficence to the issue of minimizing risk, and maximizing benefit, more effe&*v@ Target Audience This continuing education article is aimed largely at principal investigators and Independent Ethic Committees (IECs), to ensure awareness of potential risks and benefits to human subjects of clinical trials, as well as to produce a more systematicapproach to recognizing risks and disseminating information on potential risks.
INTRODUCTION Potential risks and benefits for human subjects need to be assessed prior to conducting clinical trials (1). The Belmont Report, first prepared by the U.S. Food and Drug Administration in 1979 (l),lists three ethical principles: 1. Autonomy, or respect for persons, 2. Benefic
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