In 1997, international debate was prompted by trials designed to prevent the vertical transmission of HIV from pregnant women to their babies [1]. This debate was advanced when HIV vaccine trials were in the planning phases and many ethical concerns were recognized [2,3]. International and national deliberation ensued and culminated in the development of international guidelines [4]. Microbicide research had an unfortunate debut with early trials paradoxically demonstrating an increased risk of contracting HIV – an outcome clearly antithetical to the objectives of such preventive research [5,6]. More recently, similar results have emerged resulting in the premature closure of the cellulose sulphate trials at five developing country sites internationally [7]. However, a wide range of microbicide gels are in various phases of clinical trial testing necessitating on going reflection on the ethics of microbicide research internationally [8-12].
Unique ethical concerns pervade all aspects of the microbicide research process. Unlike HIV vaccine research, microbicide trials involve repeated exposure of both sexual partners to an experimental chemical product. If the product is proven to be efficacious, exposure will most likely continue on a long term basis. As such, exposure to partners and consent to such exposure is important. During the course of trials unintended pregnancy may occur, especially in trials where long term follow-up is being assessed. Safety of these products during pregnancy must be established. Adolescents, as a group, stand to benefit from the availability of an effective microbicide gel yet testing the products on them is fraught with ethical concerns. Due to the potential of microbicides to result in vaginal ulceration either as an adverse effect in normal dosage or due to overuse as self application is involved, the risk of developing HIV infection may increase rather than decrease. These concerns represent an enormous challenge for the research community and regulatory and ethics oversight agencies locally and internationally.
Most microbicide research is conducted by developed sponsor countries in developing host countries where the burden of disease due to HIV/AIDS is greatest. The Council for International Organisations of Medical Sciences (CIOMS) 2002 guideline mandates that dual review of research is conducted on all international collaborative research studies [13]. As such, the ethical concerns relating to safety are a major concern for regulatory agencies in South Africa (SA) and other developing host countries as well as for developed sponsor country Institutional Review Boards (IRBs) and investigators.
While the scientific aspects of microbicide research have been widely published [5-12,14], and extensive research relating to acceptability of microbicides and partner involvement has been conducted [15-24], there is a paucity of literature relating to the ethical deliberation around microbicide research. Ethical concerns published to date relate to treatment of HIV seroconverters during and after trials, use of placebo and condom only arms in trial design, standards of care and informed consent [25-27]. This paper addresses four main safety issues related to microbicide research where methodological and ethical concerns exist.
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