By the 1990s, the dynamics of the situation changed. Cancer patients and persons with AIDS fought publicly with the medical research establishment about the long time needed to get approval for and complete research into potential cures for fatal diseases. In many cases, it is the ethical assumptions of the previous thirty years that drive this ‘go-slow’ mentality. After all, we would rather risk denying treatment for a while until we achieve enough confidence in a treatment, rather than run the risk of harming innocent people (as in the Nuremberg and Tuskegee events). But now, those who were threatened with fatal illness were saying to the research establishment that they wanted to be test subjects, even under experimental conditions of considerable risk. You had several very vocal and articulate patient groups who wanted to be experimented on coming up against an ethical review system that was designed to protect them from being experimented on.
Although the last few years in the ethics of research have been tumultuous ones, it is beginning to appear that a new consensus is evolving that involves the stakeholder groups most affected by a problem participating more actively in the formulation of guidelines for research. While it’s not entirely clear, at present, what the new consensus will be, it is almost certain that it will not fall at either extreme: protecting against human experimentation at all costs vs. allowing anyone who is willing to be experimented on.
Ethical Issues
There are a number of key phrases that describe the system of ethical protections that the contemporary social and medical research establishment have created to try to protect better the rights of their research participants. The principle of voluntary participation requires that people not be coerced into participating in research. This is especially relevant where researchers had previously relied on ‘captive audiences’ for their subjects — prisons, universities, and places like that. Closely related to the notion of voluntary participation is the requirement of informed consent. Essentially, this means that prospective research participants must be fully informed about the procedures and risks involved in research and must give their consent to participate. Ethical standards also require that researchers not put participants in a situation where they might be at risk of harm as a result of their participation. Harm can be defined as both physical and psychological. There are two standards that are applied in order to help protect the privacy of research participants. Almost all research guarantees the participants confidentiality — they are assured that identifying information will not be made available to anyone who is not directly involved in the study. The stricter standard is the principle of anonymitywhich essentially means that the participant will remain anonymous throughout the study — even to the researchers themselves. Clearly, the anonymity standard is a stronger guarantee of privacy, but it is sometimes difficult to accomplish, especially in situations where participants have to be measured at multiple time points (e.g., a pre-post study). Increasingly, researchers have had to deal with the ethical issue of a person’s right to service. Good research practice often requires the use of a no-treatment control group — a group of participants who do not get the treatment or program that is being studied. But when that treatment or program may have beneficial effects, persons assigned to the no-treatment control may feel their rights to equal access to services are being curtailed.
Even when clear ethical standards and principles exist, there will be times when the need to do accurate research runs up against the rights of potential participants. No set of standards can possibly anticipate every ethical circumstance. Furthermore, there needs to be a procedure that assures that researchers will consider all relevant ethical issues in formulating research plans. To address such needs most institutions and organizations have formulated an Institutional Review Board (IRB), a panel of persons who reviews grant proposals with respect to ethical implications and decides whether additional actions need to be taken to assure the safety and rights of participants. By reviewing proposals for research, IRBs also help to protect both the organization and the researcher against potential legal implications of neglecting to address important ethical issues of participants.
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