1. 27. For an explanation of the powers and functions of the Institutional Review Board, hereinafter referred to as IRB, See infra notes 83–87.
2. “A Problem of Consent: Kidney Transplantation in Minors,”;Curran;N.Y.U. L. Rev.,1959
3. 8. 21 U.S.C. 355(a). Applications for approval of new drugs must contain, Inter alia, “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.” 21 U.S.C. 355(b)(A). The Secretary of the Department of Health and Human Services may refuse to approve the application if there is a “lack of substantial evidence that the drug will have the effect it purports or is represented to have.” 21 U.S.C. 355(d). “‘Substantial evidence’ means evidence consisting of adequate and well-controlled investigations, including investigations by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could be fairly and responsibly concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labelling or proposed labelling thereof.” 21 U.S.C. 355(d). The regulatory definition of “adequate and well-controlled studies, 21 C.F.R. 314.126 (1988), states that the following types of controls are recognized: “placebo concurrent control,” (experimental drug compared with a placebo) (314.126(i); “dose comparison concurrent control,” (at least two doses of the drug are compared) (314.126(ii), “no treatment concurrent control,” (the experimental drug is compared against no treatment) (314.126(iii), “active treatment concurrent control,” (experimental drug tested against a known effective therapy) (314.126(iv), “historical control,” (“The results of treatment with the test drug are compared with experience historically derived from the adequately documented natural history of the disease or condition, or from the results of active treatment, in comparable patients or populations. Because historical control populations usually cannot be as well assessed with respect to pertinent variables as can concurrent control populations, historical control designs are usually reserved for special circumstances. Examples include studies of diseases with high and predictable mortality (for example, certain malignancies) and studies in which the effect of the drug is self-evident (general anesthetics, drug metabolism)).” 21 C.F.R. 314.126(v).
4. 22. Even the most onerous of tort theories, strict liability, immunizes defendants from liability if they have met the standard of conduct by warning of the dangers of their socially beneficial pursuits or products. Restatement of Torts 2d., sec. 402, Comment k.
5. 15. Editorial, New York Times, supra, note 1, p.A14; Purvis, Andrew , “A Perilous Gap,” Time Special Issue, Fall 1990, p. 66.