ABSTRACT
A better educated public has started to challenge the way decisions are made in medical research activities. Although Institutional and National Guidelines on Research are in place, there are fears that Institutional Review Boards (IRBs) and funding agencies are only fairly active in scientific and ethical reviews of research proposals but not on oversight of projects after their initiation. These issues are integral to good research governance and researchers and custodians of research ethics must ensure that public interest is not compromised. Medical progress is based on research including human experimentation carried out according to guiding principles as enunciated in the Declaration of Helsinki (2000), but the quality of compliance with the Declaration is an important issue. Better choice and appropriate training of members of IRBs to improve the quality of decision making and governance processes are urgently needed. Competency in evaluation of proposals requires not only the appropriate scientific knowledge but also access to relevant preclinical and other data. Unfortunately, the completeness and quality of such data may not be adequate. Public interest demands that injury to trial subjects in clinical trials is minimized if not avoided completely. Unfortunately this is not always possible with trials where novel biological modes of action are tested. A more robust evaluation mechanism for project approval may minimize but not completely avoid injury to subjects; thus insurance cover to provide care and compensation to subjects must be compulsory. The decision to approve or reject a project must be based on the balance of potential risks and benefits, taking into consideration justifiable distributive risks to target communities and populations. Economic considerations should never be the primary focus, especially when there are real concerns that the migration of early phase clinical trials including vaccine trials to developing countries is based on the perceived less stringent ethical requirements and oversight there.