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Statement of Principles

The Catholic intellectual traditions in which Sacred Heart University operates deeply affirms the value and dignity of the individual person. The value of the person, it is maintained, supersedes and anchors all other values. Persons are never to be treated as mere means but always, at the same time, as ends in themselves.

The doctrine of the supreme worth of the person is reflected in American political society in the theory of human rights that underlies the legal system. It is also articulated in such statements as the United Nations' Universal Declaration of Human Rights (1948), the declaration of the Helsinki Agreement (1964), and the Belmont Report (1979).

Moral principles not only serve as a basis of social unity but also provide guidance for individual decision-making. Cases of perplexity arise in various contexts, including that of research involving human subjects. Moral principles express ways of resolving perplexities that are well established in scientific and medical practice. An examination of these principles may provide insight into the possibility of making morally sound decisions.

The fundamental principle of morality is that of respect for persons, which embodies the conviction that persons are to be treated as autonomous agents. In the context of research involving human subjects, respect for persons requires that subjects be given the opportunity to determine what shall or shall not happen to them. This opportunity is provided by the requirement of informed consent. Consent is informed when the subject is fully appraised of the risks s/he may undergo in participating in a given research study. Consent is genuine when the subject has the right to refuse participation without recrimination.

Apart from the fundamental principle, there are specific precepts that articulate the meaning of respect in particular contexts. Preeminent in this regard are the precepts of beneficence and fairness. Beneficence is the demand that one render assistance to another person or persons when one can do so without serious harm to one's own well-being. Beneficence implies that subjects be protected as far as possible from untoward side-effects of research by exploring alternatives to a given procedure. The demand of beneficence has particular relevance to the IRB since its task is to determine whether proposed research sufficiently protects subjects from harm. The precept of fairness expresses the demand that the benefits and burdens of social life be equitably borne. No one should bear a disproportionate share of the burdens; no one should reap a disproportionate share of the benefits. Rather, burdens and benefits should be grounded in just procedures that recognize the rights of all. If there are some who suffer systematic social disadvantages, then they should, if possible, be favored and in no case be made to bear even greater burdens. Fairness is not consistent with targeting the socially disadvantaged person as the subject of particularly risky experiments.