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This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non-therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing counties, and whether it should be upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely.

For bioethicists, challenges are presented by HIV clinical trials in less-developed countries. The same standards should prevail, no matter where the trials take place and the interests f the research subjects should be primary. Clinical trials are profitable for pharmaceutical companies and for clinical researchers. They want to do them as quickly as possible with as few obstacles as possible and that often means going to developing countries. Medical pluralism would suggest that non-Western medical systems could have a role in managing HIV infection and that that should be explored. Non-market forces might facilitate treatment. David B. Resnik has not identified all of the scientific/ethical issues.

David B. Resnik has concluded that perinatal HIV transmission studies in developing countries are justified. He may have missed the essence of the criticism of the trials and may have missed the essence of the defense. To defend the trials, it is said that no other way of establishing the effectiveness of short-term AZT treatment exists. The controversy actually is over whether it is likely that the experimental treatment will cut perinatal transmission to that found in the AIDS Clinical Trial Group (ACTG) 076 regimen and whether reliable judgements about perinatal transmission rate if no treatment is given can be made. It is not ethical to knowingly design a trial in which some women get treatment less effective than is given to others.

Clinical trials that took place in developing countries for testing zidovudine effectiveness in cutting the perinatal HIV transmission rate have been defended by David B. Resnik. The trials are unethical and establish bad precedent. It would not even be defensible to carry out tests on using levels of the drug lower than the AIDS Clinical Trial Group (ACTG) 076 levels. The placebo control groups are not necessary, based on the judgement of a number of eminent scientists who conduct such trials.

Many contemporary moral theorists concern themselves with the question of whether a universal model of ethical reasoning exists. In more political fields that question is of interest as well. Theoretical frameworks are challenged by the practical problems coming from the field of bioethics. Responses tend to fall into the categories of universalist and relativists. An example of a question to be considered is that of female genital mutilation, which is viewed differently from a legal standpoint in different countries and cultures.

Standards of ethical medical research on humans are universal, but they are not absolute. Each situation must be evaluated separately. A dispute has arisen over ethics of research in developing countries on preventing perinatal transmission of HIV. There is no other way to see whether short-term AZT treatment is better than a placebo one and to see whether the AIDS Clinical Trial Group (ACTG) 076 protocol is the only good one. Some argue that the research is unethical on the grounds that the placebo-control group is denied a treatment that is effective. Others argue that that point of view omits the ethical complexities of research in developing countries and that studies can be designed to take into account economic, social and scientific research factors.

The ethics of research in less-developed countries into perinatal transmission of HIV has been discussed by David B. Resnik. Trials in developing countries to test methods applicable mainly for developed countries are unethical. An important question would pertain to whether medical research in general can be ethical in a less-developed or more-advanced country. Even in research in developed nations, some accepted principles of such research are not followed. In the US, nothing ensures that a drug that is found effective is then included in the AIDS Drug Assistance Program.

Research related to AIDS carried out in developing countries poses many questions to bioethicists. Drug industry-sponsored research will be important in the fight against AIDS unless governments up their contributions, and a conflict of interest will continue to exist. Local economics of HIV/AIDS prevention, treatment and research presents many questions. If studies help to find treatment regimens that are less costly than those of the AIDS Clinical Trial Group (ACTG)076 protocol, they might still be too costly for people in less-developed countries. Global economic issues are of great importance relative to AIDS.