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Grimes v. Kennedy Krieger Institute8/16/2001
d in this country, inherently and implicitly, speaks strongly to the existence of special relationships imposing ethical duties on researchers who conduct nontherapeutic experiments on human subjects. The Nuremberg Code specifically requires researches to make known to human subjects of research "all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment." (Emphasis added.) The breach of obligations imposed on researchers by the Nuremberg Code, might well support actions sounding in negligence in cases such as those at issue here. We reiterate as well that, given the facts and circumstances of both of these cases, there were, at the very least, genuine disputes of material facts concerning the relationship and duties of the parties, and compliance with the regulations.
V. The Ethical Appropriateness of the Research
The World Medical Association in its Declaration of Helsinki included a code of ethics for investigative researchers and was an attempt by the medical community to establish its own set of rules for conducting research on human subjects. The Declaration states in relevant part:
"III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)
1. In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out.
2. The subjects should be volunteers - either healthy persons or patients for whom the experimental design is not related to the patient's illness.
3. The investigator or the investigating team should discontinue the research if in his/her or their judgment it may, if continued, be harmful to the individual.
4. In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject." [Emphasis added.]
Adopted in Declaration of Helsinki, World Medical Assembly (WMA) 18th Assembly (June 1964), amended by 29th WMA Tokyo, Japan (October, 1975), 35th WMA Venice, Italy (October 1983), and the 41st WMA Hong Kong (September 1989).
The determination of whether a duty exists under Maryland law is the ultimate function of various policy considerations as adopted by either the Legislature, or, if it has not spoken, as it has not in respect to this situation, by Maryland courts. In our view, otherwise healthy children should not be the subjects of nontherapeutic experimentation or research that has the potential to be harmful to the child. It is, first and foremost, the responsibility of the researcher and the research entity to see to the harmlessness of such nontherapeutic research. Consent of parents can never relieve the researcher of this duty. We do not feel that it serves proper public policy concerns to permit children to be placed in situations of potential harm, during nontherapeutic procedures, even if parents, or other surrogates, consent. Under these types of circumstances, even where consent is given, albeit inappropriately, policy considerations suggest that there remains a special relationship between researchers and participants to the research study, which imposes a duty of care. This is entirely consistent with the principles found in the Nuremberg Code.
Researchers cannot ever be permitted to completely immunize themselves by reliance on consents, especially when the information furnished to the subject, or the party consenting, is incomplete in a material respect. A researcher's duty
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