A new look at international research ethics

British Medical Journal, Sept 30, 2000 by Solomon R Benatar, Peter A Singer

The standard of care may not be achieved in practice, even in developed countries.[15-20] In recent months medical research in several US universities has been closed down when several ethical shortcomings associated with a trial were uncovered after the death of a young man with a rare metabolic disorder who agreed to participate in a trial of gene therapy.[21]

It may be even more difficult to achieve the standard of care in practice in developing countries. It would not be possible to meet all the elements shown in box I in any developing country. Moreover, the whole "package" may be either irrelevant to the needs of research subjects in their context or not necessarily the best way to spend the resources in the interests of their society.

The United States's standard of care should not be emulated throughout the world. The United States spends 50% of annual global expenditure on health care on 5% of the world's population.[22] This level of expenditure is not sustainable as a universal model. Another aspect of the United States's standard of care that should not be emulated is "defensive medicine" to protect against litigation.

An alternative concept of standard of care

A standard of care that could be achieved globally despite economic inequalities and that may assist in reducing such inequalities requires a redefinition of the standard of care (elements of which are shown in box 2) and recognition of some of the special problems associated with clinical trials in developing countries.[23-25]

Making moral progress in international health research

It will not be possible to achieve the proposed new standard merely by tampering with research declarations or by advancing the simplistic notion that ethical behaviour can be deduced from or promoted by such declarations. A broader moral agenda is required. To achieve this it is important to recognise the potentially exploitative nature of research in developed and developing countries and to have insight into the economic policies that are currently widening the disparities in human wellbeing through their impact on development, the health of populations, and the provision of health care for individual patients.[13 26 27]

Both to diminish the exploitation of subjects living under inhumane conditions and to respect the dignity of subjects, greater emphasis will need to be placed on certain processes (box 3). The highest achievable standard of care (see box 2) should be the goal. Reasonable limits can be negotiated in specific contexts. The objective should be to ratchet the standard upward rather than to set utopian ideas that cannot be met.

Towards a new research ethics

Traditional research ethics is rooted in responses to abuses of research, such as the Nazi atrocities that resulted in the Nuremberg code and the Tuskegee experiment (where African Americans were deliberately denied effective treatment for syphilis) that led to regulations concerning research ethics in the United States. The protections need to be extended to address systemic deprivation of research subjects through poverty and other threats to freedom.