One of the main issues in research ethics is how to balance research interests against the interests of research subjects. Many well-established ethical guidelines state that the interests of the individual shall always prevail over the interests of science and society.1^–7 It is nevertheless unclear what this claim actually amounts to. In this paper we argue that central ethical guidelines fail to bring clarity to this issue. Since the “primacy principle” does not at present fulfil any meaningful role in the guidelines, we argue that we either need to give it some clear and ethically relevant interpretation or otherwise should leave it out. To do the latter would not weaken the protection of research subjects, since the various guidelines seem to address all relevant ethical concerns elsewhere.

THE INDIVIDUAL BEFORE SCIENCE AND SOCIETY

A considerable number of ethical guidelines have been issued in the past few decades, spelling out restrictions on human research. They all agree that research is much needed and has the potential to increase human well-being, but they also say that research interests must be balanced against other interests, in particular those specific to research subjects participating in scientific studies. It seems to be widely agreed that an important way to handle this balancing is by giving the individuals’ interests precedence over those of science and society in situations of conflict. Let us discuss three examples.

An essential European normative document is the Council of Europe’s Convention on human rights and biomedicine.1 Article 2, headed “Primacy of the human being”, states, “The interests and welfare of the human being shall prevail over the sole interest of society or science.” Unesco’s Universal declaration on bioethics and human rights2 similarly states, “The interests and welfare of the individual should have priority over the sole interest of science or society” (Article 3). The World Medical Association’s Declaration of Helsinki3 reads: “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society” (paragraph 5).

As is easily realised from a quick look at these guidelines, there is no obvious simple and straightforward interpretation of the primacy principle—such as that no other research should be allowed than studies where there is an uncontested pay-off for participants that is larger, or at least no less, than the expected disadvantages of participating. This apparent interpretation focuses on the notion of well-being and holds that no research participants should be worse off because they enter, for example, a clinical trial. But much research participation does not have such a pay-off. This interpretation would therefore leave the guidelines extremely hostile vis-è-vis research involving human subjects. As is clearly indicated in other parts of the guidelines, this is not intended.

The Declaration of Helsinki says that “it is the duty of the physician to promote and safeguard the health of the people” and further states that progress in the medical field “is based on research which ultimately must rest in part on experimentation involving human subjects”.3 This seems to imply that it is the duty of physicians to carry out medical research involving human subjects in order to promote and safeguard the health of the people, even if no immediate gain can be expected for the individuals involved in the studies.

The Convention on human rights and biomedicine states that research that does not have the potential to “produce results of direct benefit to the health of the person concerned” may be authorised if (a) the dignity, integrity and other rights and fundamental freedoms of the research participants are respected and protected, (b) they do not object and (c) other standard conditions on research on human beings are applied, such as that there is no alternative to such research and that it entails minimal risk and burden for those participating.1 Thus, the Convention opens the way for much research that does not have a positive welfare balance for those participating as research subjects, both by the principal demand on research that it should have a potential to benefit subjects and by specifying conditions for exceptions.

Unesco’s Universal declaration on bioethics and human rights states that promotion of people’s health is a central task for any government, that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being” and that “progress in science and technology should advance access to quality healthcare and essential medicines”.2 In other words, every government should promote research that can be expected to improve healthcare. To say that only research that has an immediate pay-off to the research participants themselves will be allowed would go against this central governmental task and can therefore hardly be acceptable, according to this line of reasoning.

As these various guidelines seem to say that a direct individual pay-off is not a precondition for research on human subjects, it is not clear how research interests should be balanced against the specific interests of research subjects.

INTERPRETATIONS OF “THE PRIMACY PRINCIPLE”

Let us therefore explore what can be a reasonable ground for defending the inclusion of the primacy principle in ethical guidelines, if such a ground can be found. We need to get a better grip on what the primacy statements of the guidelines actually have aimed for. These constructive interpretations should of course produce an ethically acceptable position but also need to be (1) semantically and logically plausible and (2) not redundant (they should say something beyond what is already stated elsewhere in the guidelines). In addition, the interpretations should preferably fit all guidelines stating this kind of priority—this would be the way to find an interpretation for a single principle of the primacy of the individual running through all guidelines.

One interpretation that perhaps most easily comes to mind has already been rejected, namely that only research with a direct positive balance for the research participants, for instance in terms of well-being, should be permitted. Very few guidelines or bioethicists, if any, are willing to defend this position. This makes sense, since this interpretation creates a contradiction in the guidelines where, for instance, non-beneficial experiments and placebo controls are permitted. It thus fails to meet requirement 1.

A second interpretation understands the primacy principle as prescribing to researchers a certain attitude vis-è-vis research subjects: they must be treated with respect, or as ends in themselves. This includes protecting their dignity and personal integrity and not exposing them to unnecessary risks or burdens. Support can be found for this interpretation. For instance, the Catholic Pontifical Academy for Life’s Proposal of an ethical commitment for researchers in the biomedical field suggests a defence for the view that “science and technology must be at the service of the human person, fully respecting his dignity and rights”.8 The International Council for Nurses’ ICN code of ethics for nurses states that nurses should ensure that “use of technology and scientific advances are compatible with the safety, dignity and rights of people”.9 Indeed, most ethical guidelines take a stand along these lines (although a wide variety of formulations are given). However, it is nevertheless insufficient as an interpretation of the primacy principle, since one can defend the importance of protecting the dignity and integrity of the person without agreeing with the proposition that the interests and well-being of the individual should have precedence over research interests. This shows that the second explication is not plausible.

A third interpretation is that there are certain minimum requirements regarding how research subjects should be treated, so that research or social interests must not be permitted to prevail over these in any circumstances. These requirements put a deontological constraint on what actions are permissible. The need to state such requirements is arguably the historical explanation of the development of modern ethical guidelines regarding biomedical research. The experiments on prisoners from the Nazi camps did not consider the research subjects’ interests, or human dignity, at all. However, conditions for permissible research are normally extensively listed in the guidelines. Since they are listed separately, it does not seem likely that the primacy principle is intended to be equivalent to these requirements—however important, that would only be to say the same thing over again. Thus, requirement 2 is not met.

According to the first interpretation, there should be a positive balance for the individual in the single case of participation in a study. A fourth interpretation contains a related idea, namely that the entire system of biomedical research should leave the individual on an expected positive balance (compared with a society where there is no biomedical research on human subjects). In other words, the system should not involve an individual in research if that person cannot expect to benefit from the system of biomedical research on the whole. People must not be used in this way while others reap the benefits of research. Even though the welfare balance may be negative for the individual in the single instance, the research system in which the particular study is but one part should be expected to benefit the individual. This is a reasonable demand on biomedical research on human beings, but it seems to be a far-fetched interpretation of the primacy principle. The primacy principle underlines the potential dichotomy between individuals’ interests and the interests of society, while this interpretation states that the research system, to be acceptable, should make them coincide. Besides, one may agree that the research system should benefit the individuals but still maintain that the interests of individuals are not hereby given precedence over those of science and society. Therefore this interpretation is not a plausible explication of the primacy principle. This interpretation nevertheless offers a less confrontational way of framing the problem of how to balance the interests involved that seems fruitful.10

A fifth way to understand the principle is that it serves as an instruction on how to make decisions: it is always the individual who shall have the final word on whether or not to participate in research (that is, whether or not to realise the interests of science or society). In other words, autonomous persons should have the right to informed consent. In cases where the decisional capacity of the research subject is absent, the deputy decision-maker should put the interests of the subject before any other interests. But since autonomy and informed consent are major topics in all ethical guidelines, rules are spelled out in considerable detail. Hence, such an interpretation would make the primacy principle redundant.

Finally, the primacy principle could be interpreted as a main guiding principle. Principles and main guiding principles have different functions in a guideline. Principles are intended to be applicable in concrete situations. Main guiding principles are not—their function is to help in interpreting the other principles. They therefore do not need to meet the non-redundancy requirement, but, on the other hand, need to have a meaning more legible than that of the principles they help to interpret; otherwise they will be of no help in interpreting and elucidating them. Although the primacy principle is not described or typographically singled out as such in the guidelines, it is often given a prominent position. Interestingly, it is treated as a main guiding principle by at least one issuing part: the explanatory report to the Convention on human rights and biomedicine states that the “whole convention … is inspired by the principle of the primacy of the human being, and all its articles must be interpreted in this light”.11 But as argued, the primacy paragraph then needs to have a meaning more legible than that of the principles it helps to interpret. As we have seen, it is the other way around; it is only through the various other principles one can come to understand what the primacy principle might be intended to say. Thus, even if it is intended as a main guiding principle, it fails to serve as one.

CONSEQUENCES FOR ETHICAL GUIDELINES AND LAW

Where does this leave us? A number of things can be said in relation to the primacy principle that are fairly well connected to other things said in the guidelines. For instance, the principle could be taken as a call for respect or for securing certain minimum requirements on how research subjects should be treated. Although reasonable and well-meaning, there is nothing in these or the other interpretations given above that gives us a good explication of the idea that the interests and welfare of the individual should have precedence over the interests of science or society. How should we then employ present ethical guidelines containing some statement to the effect that the interests of the individual should have precedence and what should be done in future policy work?

As it stands, the primacy principle does not seem to say anything distinct; rather it seems to be a vacuous figure of speech. Nevertheless, it keeps getting included in guidelines, perhaps because cutting it out would seem too provocative. It might be argued that guidelines should contain a passage about the primacy of the individual, since people might otherwise think that there is nothing to stop us from a straightforward utilitarian cost–benefit calculation. However, this would be a misunderstanding, since ethical guidelines contain a number of restrictions on behaviour that excludes research disregarding individuals’ well-being in the name of the overall instrumental value of research. For instance, the Declaration of Helsinki states that it is “the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject” and that physicians should “minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject”.

While the primacy principle has no positive function, it might have a negative impact. Since the European Court of Human Rights has used the Convention from the Council of Europe as a legal standard in cases against countries of the European Community,12 there is a risk that someone will use the primacy principle as grounds for presenting their case. Although it would be interesting to see how the Court understands the principle, it would create a situation in which grave matters might be decided upon with the help of a problematic principle that is open to many different interpretations. Needless to say, this might bring about an insecure legal situation for both research subjects and researchers.

Our negative result in the search for a reasonable interpretation should have consequences for future work on guidelines: the primacy principle should not be included unless it is given an ethically relevant, clear and non-redundant meaning. If such a meaning can be given to the principle, then it is important to elucidate it in order to protect research subjects. If not, there seems to be no good reason to cling to it.