Disclosure and Consent Problems in Pediatrics

See, for examples of articles on this topic, Holder Angela R. , Medical Malpractice Law, 2nd ed., New York, John Wiley Press, 1978, Chapter 8; Holder Angela R. , “The Minor's Right to Consent: To Medical Treatment”, 41 Connecticut Medicine 579, 1977; Holder Angela R. , “Legal Issues Related to the Health Care of Minors”, 39 Clinical Proceedings, CHNMC 1, March/April, 1983; Pilpel Harriet F. , “Minor's Right to Medical Care”, 36 Albany Law Review 462, 1972; Wadlington Walter J. , “Minors and Health Care: The Age of Consent”, 11 Osgoode Hall Law Journal 115, 1973. Munson Carol F. , “Toward a Standard of Informed Consent by the Adolescent in Medical Treatment Decisions”, 8 Dickinson Law Review 431, 1981; Leikin Sanford L. , “Minors' Assent or Dissent to Medical Treatment”, 102 Journal of Pediatrics 169, 1983; and a particularly informative and well-written article, Linda Sorenson Ewald, “Medical Decisionmaking for Children: An Analysis of Competing Interests,” 25 St Louis Law Journal 689, 1982.

E.g., Zaman v. Schultz, 19 Pa D & C 309, 1933.

Bonner v. Moran, 126 F 2d 121, CA 1941.

Lowrie Luka v. , 136 NW 1106, Mich 1912; Sullivan v. Montgomery, 279 NYS 575, NY 1935.

E.g., Bach v. Long Island Jewish Hospital, 267 NYS 2d 289, NY 1966.

E.g., Swenson v. Swenson, 227 SW 2d 103, Mo 1950.

Full citations of all minor treatment statutes as of the dates of publication may be found in Ewald, supra at 1. See also Pilpel Harriet S. , “Minors' Rights to Medical Care”, 36 Albany Law Review, at 472–487, 1972; Wilkins Lawrence P. , “Children's Rights: Removing the Parental Consent Barrier”, 1975 Arizona State Law Review 31.

Holder Angela R. , “Treating a Minor for Venereal Disease”, 214 JAMA 1949, December 7, 1970.

AMA News, April 17, 1967, page 4.

Pilpel , supra at 1, page 466.

Carter v. Cangello, 164 Cal Rep 361, 1980; Younts v. St. Francis Hospital and School of Nursing, 469 P 2d 330, Kans 1970; Lacey v. Laird, 139 NE 2d 25, Ohio 1956.

Shartel Burke and Plant Marcus , The Law of Medical Practice, Springfield, Ill, Thomas Charles C. Publisher, 1959, page 26. See also Wadlington Walter , “Minors and Health Care: The Age of Consent”, 11 Osgood Hall Law Journal 115, 1973.

Memorial Hospital v. Maricopa County, 415 US 250, 1974.

E.g., In re Gault, 387 US 1, 1967.

Cidis v. White, 336 NYS 2d 362, NY 1972.

Accent Service Company v. Ebsen, 306 N.W. 2d 575, Neb 1981; Poudre Valley Hospital District v. Heckart, 491 P 2d 984, Colo 1971; Ison v. Florida Sanitarium and Benevolent Association, 302 So 2d 200, Fla 1974.

Yarborough v. Yarborough, 290 US 202, 1933.

E.g., Melville v. Sabbatino, 313 A 2d 886, Conn 1973.

In re Smith, 295 A 2d 238, Md 1972; In the Matter of Mary P., 444 NYS 2d 545, NY 1981.

For general discussion of this topic, see Bennett Robert , “Allocation of Child Medical Care Decision-Making Authority: A Suggested Interest Analysis”, 62 University of Virginia Law Review 285, 1976; Ewald Sorenson Linda , “Medical Decisionmaking for Children: An Analysis of Competing Interests”, 25 St Louis Law Journal 689, 1982; Sher Elizabeth J. , “Choosing for Children: Adjudicating Medical Care Disputes Between Parents and the State”, 58 NYU Law Review 157, 1983.

E.g., Craig v. State, 155 A 2d 684, Md 1959; People v. Pearson, 68 NE 243, NY 1903; State v. Clark, 261 A 2d 294, Conn 1969; Eaglen v. State, 231 NE 2d 147, Ind 1967; People v. Edwards, 249 NYS 2d 325, NY 1964.

E.g., Jehovah's Witnesses of Washington v. King County Hospital, 278 F Supp 488, aff'd 390 US 598, 1968; Hoener v. Bertinato, 171 A 2d 140, NJ 1961; Muhlenberg Hospital v. Patterson, 320 A 2d 518, NJ 1974; In re Clark, 185 NE 2d 128, Ohio, 1962; People ex rel Wallace v. Labrenz, 104 NE 2d 769, Ill, 1952; State v. Perricone, 181 A 2d 751, NJ 1962; Holder Angela R. , “Circumstances Warranting Court-Ordered Treatment of Minors”, 24 POF 2d 169; Holder Angela R. , “Parents, Courts and Refusal of Treatment”, 103 Journal of Pediatrics 515, 1983.

In the Interests of E.G., 161–91 Ill App Third Division, 765, 515 NE 2d 286, 1987; In re Green, 292 A 2d 387, 307 A 2d 279, Pa 1972.

In re Hamilton, 657 SW 2d 425, Tenn 1983.

In re D.L.E., 645 P 2d 271, Colo 1982.

In re Karwath, 199 NW 2d 147, Iowa 1972.

In re Sampson, 328 NYS 2d 686, NY 1972.

In re Welfare of Wachlin, 245 NW 2d 183, Minn 1976.

See, e.g., Jacobson v. Massachusetts, 197 US 11, 1905; Zurcht v. King, 260 US 174, 1922; Board of Education of Mountain Lakes v. Maas, 158 A 2d 330, NJ 1959; McCartney v. Austin, 293 NYS 2d 188, 1968; Dalli v. Board of Education, 267 NE 2d 219, Mass 1971; Itz v. Penick, 493 SW 2d 506, Tex, 1973.

E.g., Connecticut General Statutes 10–204a.

See, e.g., In re Eric B. v. Ted B., California Court of Appeals, First District, Ct. No JUV- 69430, February 8, 1987; In re Custody of a Minor, 379 N.E. 2d 1053, 393 N.E. 2d 836, 1979; In re D.P., No. 91590, Superior Court of the State of California, Santa Clara County, July 3, 1986; Ainsworth Marilyn V. and Wall Jerry , “Laetrile: May the State Intervene on Behalf of a Minor?” 30 Kansas Law Review 409, 1982; Horowitz Eva T. , “Of Love and Laetrile: Medical Decisions Made in a Child's Best Interest”, 5 American Journal of Law & Medicine 271, 1979.

In re Hofbauer, 47 NYS 2d 648, 419 NYS 2d 936, 393 NE 2d 1009, 1979.

E.g., Weber v. Stony Brook Hospital, 467 NYS 2d 685, NY Ct App No. 672, October 28, 1983; In re Seiforth, 127 NE 2d 820, NY 1955; In re Hudson, 126 P 2d 765, Wash 1942; In re C.F.B., 497 SW 2d 831, Mo 1973.

In re Hudson, 126 P 2d 765, Wash 1942; In re Seiforth, 127 NE 2d 820, NY 1955; In re Tuttdendario, 21 Pa Dist 561, Pa 1912.

For a somewhat similar case, see In re B., 92 Cal App 3d 796, Cert den 445 US 949, 1980; In re Guardianship of Philip B., 188 Cal Rptr 781, 1983.

45 CFR Part 467, Subpart A, Section 46. 116.

Durfee v. Durfee, 87 NYS 2d 275, NY 1949.

Burge v. City and County of San Francisco, 262 P 2d 6, Cal 1953; Campbell v. Campbell, 441 SW 2d 658, Tex 1969; Leithold v. Plass, 413 SW 2d 698, Tex 1967.

Research is defined as a class of activities solely designed to develop or contribute to generalizable knowledge. Practice, on the other hand, refers to a class of activities designed to enhance the well-being of an individual. A third class of activities is “non-validated practice,” which may include application of novel procedures or interventions, but these are performed in the course of rendering treatment. Such activities do not constitute research unless formally structured as such, but many formal research projects, such as randomized clinical trials, compare two (or more) forms of known therapy to see which is most effective. Thus, by definition, research is never intended to benefit the subject. If benefit is intended, the intervention is “practice.” Within the category of practice, there are two subsets. “Customary practice” is the currently accepted method of treating the patient's problem, “non-validated practice” is either an innovative, perhaps alternative, method of treatment or an attempt to verify in a systematic way that an older therapy is actually beneficial, such as the randomized trials mentioned above.

For general reading on the legal, ethical and regulatory aspects of research on human subjects, see Levine Robert J. , Ethics and Regulation of Clinical Research, 2nd Edition, Baltimore, Urban and Schwarzenberg, 1986. Chapter 10 discusses research on children. See also Katz Jay , Experimentation with Human Beings, New York, Russell Sage Foundation, 1972, at pages 999–1011; See e.g., Levine Robert J. , “Clarifying the Concepts of Research Ethics”, Hastings Center Report 21, June 1979, page 21.

E.g., Ramsey Paul , The Patient as Person, New Haven, Yale University Press, 1974, at page 17 ff.; McCormick Richard A. , “Proxy Consent in the Experimental Situation”, 18 Perspectives in Biology and Medicine 2, Autumn, 1974.

Prince v. Massachusetts, 321 US 158 at 170, 1944.

Ramsey Paul , The Patient as Person, supra at 42, at page 17.

Medical World News, June 8, 1973, at page 41.

Curran William J. and Beecher Henry K. , “Experimentation in Children”, 210 JAMA 77, 1969.

See McCormick, supra at 42, page 4.

See, e.g., H.C. Shirkey, “Therapeutic Orphans”, 72 Journal of Pediatrics 119, 1968; Capron Alexander M. , “Legal Responsibilities Relating to the Use of Unapproved Drugs in Children”, in Mirkin B.L. , Editor, Clinical Pharmacology and Therapeutics: A Pediatric Perspective, at page 305, Chicago, Year Book Medical Publishers, 1978; Levine Robert J. , Ethics and Regulation of Clinical Research, 2nd edition, Baltimore, Urban and Schwarzenburg, 1986 at pages 239–241.

Carter v. Metropolitan Dade County, 253 So 2d 920, Fla 1971; Hirsch Harold L. , “The Medicolegal Implications of the Package Insert”, Case and Comment January 1977, page 14; Lhotka v. Larson, 238 NW 2d 870, Minn 1976; Koury v. Follo, 158 SE 2d 548, NC 1968; Pfizer, Inc. v. Jones, 272 SE 2d 43, Va 1980.

E.g., Mueller v. Mueller, 221 NW 2d 39, SD 1974; Dalke v. Upjohn Co., 555 F 2d 245, CCA 9, 1977.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations on Research on Children, Federal Register January 13, 1978.

E.g., Stephen Goldy, “Experiments in the Willowbrook School”, 1 Lancet 749, 1971; Katz Jay , Experimentation With Human Beings, New York, Russell Sage Foundation 1972 at pages 1007–1010; Rothman David J. and Rothman Sheila M. , The Willowbrook Wars, New York, Harper & Row, 1984; Student Council, New York University School of Medicine, Proceedings of the Symposium on Ethical Issues in Human Experimentation: The Case of Willowbrook State Hospital, New York, Urban Health Affairs Program, New York University Medical Center, 1973.

Krugman Saul Giles J.P. and Hammond J. , “Viral Hepatitis, Type B (MS-2 Strain): Studies on Active Immunization”, 217 JAMA 41, 1975.

PL 93–348, 93rd Cong. July 12, 1974.

45 CFR, Part 46, Section 404.

45 CFR, Pan 46, Section 405.

45 CFR, Part 46, Section 406.

45 CFR, Part 46, Section 408.

45 CFR, Part 46, 408 (c).

48 Fed Reg 9814, March 8, 1983; 45 CFR Part 46, Subpart D.

Mitchell Ross G. , “The Child and Experimental Medicine”, 1 British Medical Journal 721, 1964.

Holder Angela R. , “Mental Illness and Parental Rights”, 216 JAMA 575, 1971; e.g., Ericson v. Ericson, 195 Pac 234, Wash 1921; Stoll v. Stoll, 68 NW 2d 367, Minn 1955; Atkinson v. Atkinson, 231 P 2d 641, Wash 1951.

Baker v. Owen, 423 US 907, 1975.

See, for discussions of children's rights to make decisions in the research context Ferdinand Schoeman, “Children's Competence and Children's Rights”, 4 IRB: A Review of Human Subjects Research No. 6, page 1, June/July 1982; Weithorn Lois , “Children's Capacities to Decide About Participation in Research”, 5 IRB: A Review of Human Subjects Research No. 2, page 1, March/April 1983; Ackerman Terrence F. , “Moral Duties of Investigators Toward Sick Children”, 3 IRB: A Review of Human Subjects Research No. 6, page 1, June/July 1981; Keith-Spiegel Patricia , “Children and Consent to Participate in Research,” in Melton G.B. Koocher G.P. and Saks M.J. , eds, Children's Competence to Consent, New York, Plenum Press, 1983.

45 CFR Part 46, Section 46. 101 (b).

Merriken v. Cressman, 364 F Supp 913, DC Pa, 1973; Sheerer Charles W. and Roston Ronald A. , “Some Legal and Psychological Concerns About Personality Testing in Public Schools”, 30 Federal Bar Journal III, Spring 1971.

See for example, David L. Kirp, “Schools as Sorters”, 121 University of Pennsylvania Law Review 705, 1973; Lau v. Nichols, 412 US 938, 1973.

Holder Angela R. , “Can Teenagers Participate in Research Without Parental Consent?” 3 IRB: A Review of Human Subjects Research No. 2, page 5, February, 1981; Roberta Herceg-Baron, “Parental Consent and Family Planning Research Involving Minors”, 3 IRB: A Review of Human Subjects Research No. 9, page 5, November 1981; Levine Carol , “Teenagers, Research and Family Involvement”, 3 IRB: A Review of Human Subjects Research No. 9, page 8, November 1981.