Two Perspectives on Ethical Review of Research Involving Human Subjects
Daniel Wikler, Ph.D., Mary B. Saltonstall Professor of Population Ethics, Professor of Ethics and Population Health, and Co-Director of the Program on Ethical Issues in Global Health Research, Harvard School of Public Health
Daniel Wikler, PhD, is Mary B. Saltonstall Professor of Ethics and Population Health in the Department of Global Health and Population at the Harvard School of Public Health and in the Harvard Program in Ethics and Health, a university-wide research and training initiative. He has co-taught Ethical Issues in International Health Research at Harvard for many years and in over 15 developing countries.
He served as the first “staff ethicist” at the World Health Organization in Geneva, working with WHO health programs on ethical issues arising in departments throughout the organization, including health resource allocation, research involving human subjects, and genetics. While at WHO, Professor Wikler directed an international collaboration among philosophers and economists on ethical, methodological, and philosophical issues raised by WHO’s work in measurement of the global burden of disease and in developing methods for improving health resource allocation.
Prof. Wikler was co-founder and second president of the International Association of Bioethics, which places particular emphasis on developing countries, and of the American Association of Bioethics. His published work addresses many issues in bioethics, focusing in recent years on population health, including issues in resource allocation. Among his recent publications is A Casebook on Ethical Issues in International Health Research (Geneva: WHO), edited with Harvard and WHO colleagues.
Scientific investigators have many ethical responsibilities, ranging from the need to maintain careful lab records to using public funds for their intended purposes and not for personal gain. The duties that have received the most emphasis – and are the most stringently regulated – involve the treatment of human subjects in experiments, the topic for this webinar.
Concern over the treatment of human subjects was triggered by the revelations of ghastly, lethal experiments by Nazi doctors on innocent civilians who had been herded into concentration camps in Europe in the 1930s and 1940s. These grisly practices, hidden from public view by the Nazis, were documented in the postwar Nuremberg Doctors Trial. In response, several organizations formulated and publicized ethical codes for research with human subjects that sought to place medical research on a solid ethical foundation. With revisions over time, these codes – particularly the World Medical Association’s “Declaration of Helsinki” – remain influential. Today, rules for the use of human subjects are enforced by an elaborate system of ethical review and oversight, requiring prior review by an ethical review committee (in the US: “IRB”, or institutional review board).
We have come a very long way from the barbarities of Nazi experimentation. Though the ethics of some research practices are still matters of dispute, there is a consensus that the ethical basis of research with human subjects has never been so secure.
Nevertheless, fundamental questions about the ethics of research with human subjects remain unanswered, both at the level of principle and at the level of oversight and enforcement. After a brief review of the progress made in recent years in the field of research ethics, we will discuss these objections to current practices and the conventional wisdom, reviewing the central arguments of both sides.
The webinar was held on Monday, April 28th, from 1:00 PM – 2:00 PM ET. Click here to view the recorded meeting.
Read more about PROTECT webinars here.