4202.0: Tuesday, October 23, 2001 - 2:50 PM

Abstract #22864

Ethical issues in international clinical trials

Alaa Hamed, MBBS, MPH, Health Services, Boston University, 715 Albany St. T3W, Boston, MA 02118, 617-414-1437, hamed@bu.edu

The inherent tension between the rigorous demands of trial design and acting in the patient’s best interest is the immutable feature of biomedical research. The skewed balance of power between researcher and research subject has found a new expression in the recent controversy surrounding the prevention of perinatal HIV transmission trials. The controversy shed light on ethical problems that surrounds trial design and the need to fix them. The controversy also revealed the ambiguity of current guidelines, the probability that their historic evolution make them incompatible within the context of a raging AIDS epidemic and the current realities of the world today, where states fund research outside their borders for a multitude of reasons. This paper recommends that the current guidelines need to be reassessed, that systems for monitoring, policing, arbitrating governmental and privately funded research should be urgently established, that attention should be paid to the size and the scope of these policing bodies. However, the size and responsibility of these bodies shouldn’t hamper them from remaining vigil and proactive. Patent laws should be revisited in the context of deadly epidemics; a life saving remedy and a soda pop shouldn’t be treated similarly. Strengthening research capacities in the third world is a duel edged sword, it could be an empowering tool or a backdoor for facilitating research that is not acceptable in the first world. This paper recommends that strengthening capacities should be accompanied by strengthening policing.

Learning Objectives: N/A

Keywords: Research Ethics, Developing Countries

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

The 129th Annual Meeting of APHA