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6 Health L.J. 169 (1998)
Freebies for Subject 641: A Discussion of the Ethical Prospect of Providing Drug Trial Subjects with Post-Trial Access to the Drug Tested - A Canadian Perspective

handle is hein.journals/hthlj6 and id is 173 raw text is: Freebies for Subject 641: A Discussion of the Ethical Prospect of Providing Drug Trial Subjects with Post- Trial Access to the Drug Tested - A Canadian Perspective Leah E. Hutt Pharmaceutical Company Incorporated is developing a new drug to treat AIDS. The Company is hoping to begin clinical trials soon and has submitted its trial proposal for consideration by the Research Ethics Board (REB). The proposal includes provision to supply the drug free of charge to trial subjects if the drug is shown to be effective and safe. The members of the REB are split as to whether such an offer is acceptable. Some members of the REB are concerned that the offer is an undue inducement for prospective subjects to participate in the clinical trial. I. Introduction This paper presents a discussion of issues concerning one aspect of the compensation of human subjects involved in pharmaceutical industry drug trials. I will argue that it is appropriate and ethically justifiable for pharmaceutical companies to compensate at least some research subjects for their contribution to a particular drug trial, by providing subjects with ongoing access to the drug if it proves to be effective and safe. This concept of providing continued access to an approved drug to trial subjects will be referred to as ongoing access throughout this paper. The format of this paper is as follows: (1) A description of the current situation in the pharmaceutical industry; (2) A discussion of the response of the industry to requests for ongoing access; (3) A discussion of concerns faced by subjects involved in drug research for the treatment of AIDS'; Leah E. Hutt is an associate with Stewart McKelvey Stirling Scales in Halifax, Nova Scotia. This paper was originally written for a health care issues course at Dalhousie Law School and was presented at the Canadian Bioethics Society Conference in October 1997. The author would like to thank Jocelyn Downie, Director of the Health Law Institute, Dalhousie University, Halifax, for her valuable suggestions in preparing this paper. 'Acquired Immune Deficiency Syndrome. My examples will mainly relate to AIDS for the reason that the AIDS community has been active in lobbying both government and the pharmaceutical industry to change their policies concerning access to drugs. I will discuss the problems of demographics involved in highlighting the AIDS community as a unique group of drug trial subjects.

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