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Educational Research and the Protection of Human Subjects

Published online by Cambridge University Press:  20 November 2018

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Abstract

Educational research is increasingly subject to legal restrictions designed for the protection of human subjects of research. In this article the author discusses legal restrictions–both in the courts and under HEW regulations–on educational research, comparing these restrictions with those on biomedical research. He finds that although educational research in particular instances may give rise to suits for damages for invasion of privacy or intentional infliction of psychological distress, the legal issues relating to educational research will most often be resolved in proceedings before institutional review boards charged by HEW with the responsibility for passing upon proposals to conduct research on human subjects. He argues that the interests protected in proceedings before institutional review boards are not limited to those that have received judicial recognition in suits for damages. The author finds that the requirement that the informed consent of subjects be obtained presents difficult issues for educational research. He notes in particular the problems presented by research proposals that as an element of the research design contemplate the observation of subjects without their knowledge and the use of children as research subjects.

Type
Research Article
Copyright
Copyright © American Bar Foundation, 1977 

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References

1 On the ethical problems posed by research involving human subjects, see, e.g., Jay Katz, Experimentation with Human Beings (New York: Russell Sage Foundation, 1972); Paul A. Freund, ed., Experimentation with Human Subjects (New York: George Braziller, 1970); Henry K. Beecher, Research and the Individual (Boston: Little, Brown & Co., 1970); Charles Fried, Medical Experimentation: Personal Integrity and Social Policy (New York: American Elsevier Publishing Co., 1974). On the problems of social research in particular, see, e.g., Paul Nejelski, ed., Social Research in Conflict with Law and Ethics (Cambridge, Mass.: Ballinger Publishing Co., 1976) [hereinafter cited as Social Research]; Ad Hoc Committee on Ethical Standards in Psychological Research, Ethical Principles in the Conduct of Research with Human Participants (Washington, D.C.: American Psychological Ass'n, 1973); Alice M. Rivlin & P. Michael Timpane, eds., Ethical and Legal Issues of Social Experimentation (Washington, D.C.: The Brookings Institution, 1975). For a discussion of the legal aspects of research on human subjects, see, e.g., Comment, Non-therapeutic Medical Research Involving Human Subjects, 24 Syracuse L. Rev. 1067 (1973); Note, Experimentation on Human Beings, 20 Stan. L. Rev. 99 (1967).Google Scholar

2 5 U.S.C.A. sec. 552a(i) (Supp. 1976). See text at notes 94-97 infra.Google Scholar

3 For some other types of research the risk of criminal or quasi-criminal sanctions is more real. An investigation of street crime in which the investigator witnesses the criminal conduct may expose the investigator to liability as an accessory if he fails to report the crime. See Marvin Wolfgang, Ethical Issues of Research in Criminology, in Social Research, supra note 1, 25, 30. Although I am aware of no instances in which a researcher has been prosecuted for failure to disclose knowledge of criminal conduct gained through research, there is a significant risk that the researcher may be subpoenaed and imprisoned if he refuses to disclose what he has learned. See Paul Nejelski & Kurt Finsterbusch, The Prosecutor and the Researcher: Present and Prospective Variations on the Supreme Court's Branzburg Decision, 21 Soc. Prob. 3 (1973); see generally James D. Carroll & Charles R. Knerr, Progress Report, Confidentiality of Social Science Research Sources and Data (Feb. 25, 1975). Medical research may lead to proceedings to revoke the certification of the doctor or, conceivably, to prosecution for manslaughter. See Katz, supra note 1, at 9-65 (discussing proceedings against two physicians arising from injection of live cancer cells); cf. Commonwealth v. Edelin, 359 N.E.2d 4 (Mass. 1976) (manslaughter conviction for performing abortion overturned); Fetal Research Continued Despite Hysteria, Med. Tribune, Feb. 2, 1977, at 1, col. 2 (describing impact of prosecution on research).Google Scholar

4 E.g., Mohr v. Williams, 95 Minn. 261, 104 N.W. 12 (1905) (operation skillfully performed but defendant liable in absence of consent); Corn v. French, 71 Nev. 280, 289 P.2d 173 (1955). See Marcus L. Plant, An Analysis of “Informed Consent,” 36 Fordham L. Rev. 639, 650 (1968).Google Scholar

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8 Karp v. Cooley, 493 F.2d 408, 423-24 (5th Cir. 1974), cert. denied, 419 U.S. 845 (1974). See also, e.g., Fried, supra note 1, at 28-29; Note, Medical Experiment Insurance, 70 Colum. L. Rev. 965, 966-67 (1970); Note, supra note 1, at 99, 113. While some early cases contain language suggestive of strict liability for experimentation, the practices involved in those cases fell below those of the profession and in some instances amounted to quackery. E.g., Owens v. McCleary, 281 S.W. 682 (Mo. 1926); Fortner v. Koch, 272 Mich. 273, 261 N.W. 762 (1935); Kershaw v. Tilbury, 214 Cal. 679, 8 P.2d 109 (1932). These were not cases in which the use of an experimental drug would be recognized in the profession (or within a specialty) as an appropriate treatment. For a detailed analysis of the early cases, see Irving Ladimer, Ethical and Legal Aspects of Medical Research on Human Beings, 3 J. Pub. L. 467, 475-82, 510 (1954).Google Scholar

9 E.g., Fried, supra note 1, at 27-28; Note, supra note 1, at 115; cf. Note, Medical Experiment Insurance, supra note 8, at 968 (strict liability only a first step–urges federal insurance).Google Scholar

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11 Prosser, supra note 7, at 330-33.Google Scholar

12 See note 35 infra and accompanying text.Google Scholar

13 See, e.g., Ver Hagen v. Gibbons, 47 Wis. 2d 220, 177 N.W.2d 83 (1970); Owens v. Childrens Memorial Hosp., 480 F.2d 465 (8th Cir. 1973); Prosser, supra note 7, at 327-39. There has been a trend toward increased recognition of the interest in emotional tranquility. Most courts will now award damages for negligently caused emotional distress that results in physical injury. The concept of physical injury has been stretched, in some cases, to include a serious emotional reaction that has physical symptoms and requires medical or psychiatric treatment. In Leong v. Takasaki, 55 Haw. 398, 520 P.2d 758 (1974), Hawaii became the first state to hold that a plaintiff could recover for negligently inflicted emotional distress in the absence of any resulting physical injury or objective manifestations of the emotional distress. See also Comment, Negligently Inflicted Mental Distress: The Case for an Independent Tort, 59 Geo. L.J. 1237 (1971) (arguing for recognition of an independent cause of action for the negligent infliction of severe mental distress).Google Scholar

14 Restatement (Second) of Torts sec. 46 (1965). See Prosser, supra note 7, at 49-60.Google Scholar

15 Savage v. Boies, 77 Ariz. 355, 272 P.2d 349 (1954).Google Scholar

16 Blakely v. Shortal's Estate, 236 Iowa 787, 20 N.W.2d 28 (1945).Google Scholar

17 Grimsby v. Samson, 85 Wash. 2d 52, 530 P.2d 291, 292 (1975).CrossRefGoogle Scholar

18 Id. at 295.Google Scholar

19 Id. For other examples of conduct held sufficiently outrageous, see, e.g., Bennett v. City Nat'l Bank & Trust Co., 549 P.2d 393 (Ct. App. Okla. 1976); Samms v. Eccles, 11 Utah 2d 289, 358 P.2d 344 (1961); Anderson v. Knox, 297 F.2d 702 (9th Cir. 1961), cert. denied, 370 U.S. 915 (1962); Hanke v. Global Van Lines, Inc., 533 F.2d 396 (8th Cir. 1976).Google Scholar

20 See, e.g., Hughes v. Moore, 214 Va. 27, 197 S.E.2d 214 (1973); Daley v. LaCroix, 384 Mich. 4, 179 N.W.2d 390, 396 (1970) (loss of weight, extreme nervousness and irritability, inability to perform ordinary household tasks); Okrina v. Midwestern Corp., 282 Minn. 400, 165 N.W.2d 259, 262-63 (1969) (plaintiff became “sick and numb” and “moody and introspective”); First Nat'l Bank v. Langley, 314 So. 2d 324 (Miss. 1975) (anxiety neurosis with depression and paranoia and such physical § symptoms as muscular tension, shaking, nightmares, vomiting, swelling of the lip and tongue); Prosser, supra note 7, at 329 n.43; Note, Torts-Expanding the Concept of Recovery for Mental and Emotional Injury, 76 W. Va. L. Rev. 176, 185 (1974). Cf. Wallace v. Coca-Cola Bottling Plants, Inc., 269 A.2d 117, 121 (Me. 1970) (recovery may be had for negligently inflicted emotional suffering if “substantial and manifested by objective symptomatology”).Google Scholar

21 214 Va. 27, 197 S.E.2d 214, 219 (1973).CrossRefGoogle Scholar

22 The report described, for example, whether the mother looked directly into the infant's face, what her tone of voice was, and whether she listened to the infant. These reports were combined with mental development tests to determine whether there was a relationship between the behavior of the mother toward the child and the child's performance on the standardized test. Ira J. Gordon & R. Emile Jester, Techniques of Observing Teaching in Early Childhood and Outcomes of Particular Procedures, in Robert M. W. Travers, ed., Second Handbook of Research on Teaching 184, 190-92 (Chicago: Rand McNally & Co., 1973) [hereinafter cited as Handbook].Google Scholar

23 Cf. James G. Holland & Judith Doran, Instrumentation of Research in Teaching, in Handbook, supra note 22, 286, 311-12.Google Scholar

24 See Barak Rosenshine & Norma Furst, The Use of Direct Observation to Study Teaching, in Handbook, supra note 22, at 122.Google Scholar

25 Id.; Arthur R. Miller, The Assault on Privacy: Computers, Data Banks, and Dossiers 100-101 (Ann Arbor: University of Michigan Press, 1971).Google Scholar

26 Rosenshine & Furst, supra note 24, at 173-74.Google Scholar

27 The seminal event in the development of a common law right to privacy was the publication in 1890 by Samuel D. Warren and Louis D. Brandeis of their article urging the recognition of such a right. Samuel D. Warren & Louis D. Brandeis, The Right to Privacy, 4 Harv. L. Rev. 193 (1890). See Miller, supra note 25, at 169-72 (tracing the development of the right).CrossRefGoogle Scholar

28 See Dietemann v. Time, Inc., 284 F. Supp. 925 (C.D. Cal. 1968), aff'd on other grounds, 449 F.2d 245 (9th Cir. 1971) (awarding damages); York v. Story, 324 F.2d 450 (9th Cir. 1963), cert. denied, 376 U.S. 939 (1964) (complaint states a claim for damages); Griswold v. Connecticut, 381 U.S. 479, 484-85 (1965) (reversing conviction); Roe v. Wade, 410 U.S. 113, 152-53 (1973) (declaring criminal abortion statute unconstitutional). Although the constitutional right to privacy is not confined by limitations on the right as defined by state law, several recent decisions have viewed the federal right as narrower than the common law right. E.g., Rosenberg v. Martin, 478 F.2d 520 (2d Cir. 1973), cert. denied, 414 U.S. 872 (1973) (jury verdict awarding damages reversed); Dixon v. Pennsylvania Crime Comm'n, 67 F.R.D. 425 (M.D. Pa. 1975) (dismissing action for damages and injunctive relief); McNally v. Pulitzer Publishing Co., 532 F.2d 69 (8th Cir. 1976), cert. denied, 97 S. Ct. 150 (1976) (affirming dismissal of action for damages for invasion of constitutional and common law right to privacy); Mimms v. Philadelphia Newspapers, Inc., 352 F. Supp. 862, 865 (E.D. Pa. 1972) (dismissing action for damages for invasion of constitutional right to privacy); Morris v. Danna, 411 F. Supp. 1300 (D. Minn. 1976) (dismissing action for damages and injunctive relief for violation of constitutional right to privacy). In several cases it has been suggested that the constitutional right to privacy extends only to the most intimate phases of an individual's life. McNally v. Pulitzer Publishing Co., supra. Accord, Dixon v. Pennsylvania Crime Comm'n, supra; Rosenberg v. Martin, supra. In Morris, supra, the court appeared to suggest that the constitutional right of privacy was limited to government intrusion in a private area. Moreover, it was only a “gross abuse” of privacy that reached constitutional proportions. It should be noted, however, that these cases involved for the most part the publication of information concerning persons charged with the commission of a crime. In McNally the court found there was a legitimate interest in the material and that, moreover, the material published contained little that was not in the public record. In Dixon the adverse publicity on which the privacy claim was based concerned alleged irregularities in the bidding, award, execution, and interpretation of state contracts, clearly a matter of great public interest. It is questionable whether the publications involved in these cases would have been–or constitutionally could have been–made actionable under state law. The current Restatement draft declares that the publicizing of private facts is actionable only if “not of legitimate concern to the public” and comments that “[tl hose who commit crime, or are accused of it, may not only not seek publicity but may make every possible effort to avoid it, but they are nevertheless persons of public interest, concerning whom the public is entitled to be informed.” Restatement (Second) of Torts sec. 652D & comment f (Tent. Draft No. 22, 1976). See also Prosser, supra note 7, at 823-26. Moreover, as the Supreme Court recognized in Cox Broadcasting Corp. v. Cohn, 420 U.S. 469, 489 (1975), “[b]ecause the gravamen of the claimed injury [from the tort of public disclosure is the publication of information, whether true or not, the dissemination of which is embarrassing or otherwise painful to an individual, it is here that claims of privacy most directly confront the constitutional freedoms of speech and press.” In Cohn the Court held that a state may not, consistent with the First Amendment, impose liability on the press for truthfully publishing information contained in court records open to the public, and both the reasoning of that case and of the court's decision in Time, Inc. v. Hill, 385 U.S. 374 (1967) (a false-light case) suggest that liability cannot be imposed for truthfully publicizing information on matters of public interest.Google Scholar

29 Prosser, supra note 7, at 804-14. This classification has also been adopted by the restaters and by Professor Miller as reflecting the approach of the courts. Restatement (Second) of Torts sec. 652A (Tent. Draft No. 22, 1976) (Dean Prosser was reporter for the Restatement during the drafting of this section); Miller, supra note 25, at 173. See also Edward J. Bloustein, Privacy as an Aspect of Human Dignity: An Answer to Dean Prosser, 39 N.Y.U.L. Rev. 962 (1964) (arguing that the four types of cases differ only in the means used to threaten a single protected interest).Google Scholar

30 Prosser, supra note 7, at 805.Google Scholar

31 Eick v. Perk Dog Food Co., 347 Ill. App. 293, 106 N.E.2d 742 (1952).Google Scholar

32 Dietemann v. Time, Inc., 449 F.2d 245 (9th Cir. 1971) (covert photographing and taping); Thompson v. City of Jacksonville, 130 So. 2d 105 (Fla. Dist. Ct. App. 1961) (unlawful search); Billings v. Atkinson, 489 S.W.2d 858 (Tex. 1973) (wiretapping). Prosser, supra note 7, at 807-8.Google Scholar

33 Lambert v. Dow Chem. Co., 215 So. 2d 673 (Ct. App. La. 1968).Google Scholar

34 Cf. Bennett v. Norban, 396 Pa. 94, 151 A.2d 476, 478 (1959) (false allegation of shoplifting conveyed by defendant's actions).Google Scholar

35 “Damages for mental suffering are recoverable without the necessity of showing actual physical injury in a case of willful invasion of the right of privacy because the injury is essentially mental and subjective ….” Billings v. Atkinson, 489 S.W.2d 858, 861 (Tex. 1973). See, e.g., Dietemann v. Time, Inc., 284 F. Supp. 925, 932 (C.D. Calif. 1968), aff'd, 449 F.2d 245 (9th Cir. 1971); Eick v. Perk Dog Food Co., 347 Ill. App. 293, 106 N.E.2d 742, 745 (1952).Google Scholar

36 E.g., Hamberger v. Eastman, 106 N.H. 107, 206 A.2d 239 (1964) (publicity not an essential element); Dietemann v. Time, Inc., 449 F.2d 245, 247 (9th Cir. 1971) (same).Google Scholar

37 See Virgil v. Time, Inc., 527 F.2d 1122, 1126 (9th Cir. 1975), cert. denied, 425 U.S. 998 (1976); McNally v. Pulitzer Publishing Co., 532 F.2d 69, 79 (8th Cir. 1976), cert. denied, 97 S. Ct. 150 (1976); Pearson v. Dodd, 410 F.2d 701 (D.C. Cir. 1969), cert. denied, 395 U.S. 947 (1969).Google Scholar

38 See Geoffrey R. Stone, The Scope of the Fourth Amendment: Privacy and the Police Use of Spies, Secret Agents, and Informers, 1976 A.B.F. Res. J. 1193, 1216-17, 1257-58 (discussing the Fourth Amendment's protection of privacy).CrossRefGoogle Scholar

39 Merriken v. Cressman, 364 F. Supp. 913, 918 (E.D. Pa. 1973); see Pierce v. Society of Sisters, 268 U.S. 510, 534-35 (1925); Prince v. Massachusetts, 321 U.S. 158, 166 (1974) (dictum); Griswold v. Connecticut, 381 U.S. 479, 495 (1965) (Goldberg, J., concurring) (“As this Court said in Prince v. Massachusetts, … the Meyer and Pierce decisions ‘have respected the realm of family life which the state cannot enter.'”)Google Scholar

40 See Schneckloth v. Bustamonte, 412 U.S. 218 (1973) (consent to search and seizure). Indeed, an absence of consent is implicit in the concept of invasion of privacy. See note 128 infra and accompanying text. See also Stone, supra note 38, at 1217-19 (knowing exposure of information to the police operates to estop the individual from claiming that his privacy interests have been invaded).Google Scholar

41 Dietemann v. Time, Inc., 284 F. Supp. 925 (C.D. Cal. 1968), aff'd, 449 F.2d 245 (9th Cir. 1971).Google Scholar

42 “Plaintiff … was engaged in the practice of healing with clay, minerals, and herbs–as practiced, simply quackery.” 284 F. Supp. at 926.Google Scholar

One of the pictures … [showed] plaintiff with his hand on the upper portion of … [the reporter's] breast while he was looking at some gadgets and holding what appeared to be a wand in his right hand. [The reporter] had told plaintiff that she had a lump in her breast. Plaintiff concluded that she had eaten some rancid butter 11 years, 9 months, and 7 days prior to that time. 284 F. Supp. at 927.Google Scholar

43 Id. at 929-30.Google Scholar

44 449 F.2d at 249.Google Scholar

45 385 U.S. 293 (1966). Although only one justice dissented from the judgment, only five justices joined in the Court's opinion. Mr. Justice Douglas, although concurring in the result, maintained that while one necessarily takes the risk that a friend might prove untrustworthy, the case is different when the government plants an agent in one's living room or uses fraud or deception in getting him there. “In the one case the government has merely been the willing recipient of information supplied by a fickle friend. In the other, the government has actively encouraged and participated in a breach of privacy by sending in an undercover agent.” 385 U.S. at 347.Google Scholar

46 Id. at 303.Google Scholar

47 373 U.S. 427 (1963) (Harlan, J.).Google Scholar

48 401 U.S. 745 (1971).Google Scholar

49 Id. at 787.Google Scholar

50 Id. at 787-88.Google Scholar

51 Professor Stone has recently criticized this line of authority. He contends that the risk that a confidant may prove untrustworthy is of an entirely different order from the risk that he is in reality a secret agent since “[i]n the latter situation we are no longer dealing with a risk of misplaced confidence inherent in the nature of human relationships” but “with government action designed explicitly to end in deceit,” and that “the notion that our willingness to assume one risk means that we must also necessarily assume the other is conclusory at best.” Stone, supra note 38, at 1240. He acknowledges, however, that as yet the Court has held the use of secret agents and informers to fall outside the scope of the Fourth Amendment.Google Scholar

52 401 U.S. at 752.Google Scholar

53 Id. at 753.Google Scholar

54 Nader v. General Motors Corp., 25 N.Y.2d 560, 255 N.E.2d 765 (1970).Google Scholar

55 255 N.E.2d at 769.Google Scholar

56 Id. at 771.Google Scholar

58 215 So. 2d 673 (Ct. App. La. 1968). See Restatement (Second) of Torts, Illustration 1, sec. 652B (Tent. Draft No. 22, 1976). Cf. Barber v. Time, Inc., 348 Mo. 1199, 159 S.W.2d 291 (1942) (publication of plaintiff's photograph taken while she was in the hospital and of plaintiff's name in a national magazine in connection with story describing her medical ailment).Google Scholar

59 215 So. 2d at 675.Google Scholar

60 The opinion does not clearly distinguish between intrusion into a zone of privacy and the publication of private facts. Although the court bases liability upon the use of the photographs in such a manner as to disclose the identity of the plaintiff, it also stressed that the taking of the photographs was wrongful. The significant point, however, is that although plaintiff was in a semipublic place he retained a zone of privacy. Although plaintiff's wounds could be viewed by doctors, nurses, and interns, he was not subject to being photographed without his consent.Google Scholar

61 215 So. 2d at 675.Google Scholar

62 Cf. White v. Davis, 13 Cal. 3d 757, 120 Cal. Rptr. 94, 533 P.2d 222 (1975) (complaint alleging use of undercover police officers in university classes and organizational meetings held to state a prima facie violation of state constitutional right to privacy).Google Scholar

63 See Miller, supra note 25, at 94-96, 100-101; John P. Robinson & Phillip R. Shaver, Measures of Social Psychological Attitudes, ch. 10 (religious attitudes) (Ann Arbor, Mich.: Institute for Social Research, 1973); Comment, Protecting the Privacy of School Children and Their Families Through the Family Educational Rights and Privacy Act of 1974, 14 J. Fam. L. 255, 257-58 (1975). Professor Miller, while agreeing that achievement and intelligence tests present fewer privacy problems, asserts that “the need for safeguarding test data against inaccuracies, misuse and inappropriate dissemination is as important as protecting other types of personal information that we consider far more sensitive.” Miller, supra note 25, at 94.Google Scholar

64 Professor Miller compiled the following list of questions from widely used personality tests:Google Scholar

Have you ever engaged in sexual activities with another man or boy? (asked of male subjects)Google Scholar

When you were a youngster, did you engage in petty thievery?Google Scholar

Are you troubled by the idea that people on the street are watching you?Google Scholar

Do you think something is wrong with your sex organs?Google Scholar

Do you think that Jesus Christ was greater than Lincoln or Washington?Google Scholar

Once in a while do you think of things too bad to talk about?Google Scholar

Are you a special agent of God?Google Scholar

Miller, supra note 25, at 95. See also Comment, supra note 62, at 257-58.Google Scholar

65 364 F. Supp. 913 (E.D. Pa. 1973).Google Scholar

66 Id. at 916.Google Scholar

67 Id. at 918.Google Scholar

70 Id. at 920.Google Scholar

71 Id. at 915.Google Scholar

73 Id. at 920.Google Scholar

74 Id. at 921.Google Scholar

75 At least one state by statute requires parental consent before a questionnaire may be administered containing any questions about the pupil's or his family's beliefs or practices in sex, family life, morality, and religion. Cal. Educ. Code sec. 10901 (West 1975). Although a comprehensive survey of state education statutes has not been attempted, such restrictions appear to be rare.Google Scholar

76 Identification of the plaintiff is central to those aspects of the right of privacy that are based on publicity or appropriation. In Rawls v. Conde Nast Publications, Inc., 446 F.2d 313 (5th Cit. 1971), cert. denied, 404 U.S. 1038 (1972), a photograph of plaintiff's home, so retouched as to remove any identifying features, was published in a national magazine as part of a fashion layout. The court rejected plaintiff's claim that the publication invaded her right of privacy. The court held that the plaintiff “has the burden … to prove that she has been publicly identified as a prerequisite to recovery for invasion of privacy” and had failed to meet this burden. The court stated:Google Scholar

In our case the absence of public identification of the plaintiff's home or possessions (as already indicated, all possibility of identification was carefully obliterated before publication) precludes recovery …. Very simply put, the plaintiff may not recover for invasion of privacy when, as here, her privacy remains inviolate.Google Scholar

446 F.2d at 318. In Young v. That Was the Week That Was, 312 F. Supp. 1337, 1338 (N.D. Ohio 1969), the relatives of Katherine Young alleged that a statement on a telecast that “Mrs. Katherine Young of Syracuse, New York, who died at 99 leaving 5 sons, 5 daughters, 67 grandchildren, 72 great-grandchildren, and 73 great-great-grandchildren, gets our First Annual Booby Prize in the Birth Control Sweepstakes” had invaded their right to privacy. The court argued that “[t]o sustain an action for invasion of privacy based on the publication of a person's private affairs, one necessary element is the identification of the plaintiff in the publication.” 312 F. Supp. at 1341. Since plaintiffs “were not publicized or identified in the broadcast in any way,” the court concluded that their right to privacy had not been invaded. Id. And see, e.g., Brauer v. Globe Newspaper Co., 351 Mass. 53, 217 N.E.2d 736, 740 (1966) (publication alleged to place plaintiff in a false light did not identify plaintiff); Bayer v. Ralston Purina Co., 484 S.W.2d 473 (Mo. 1972) (photograph of plaintiff's horse in defendant's advertisement did not identify plaintiff); Branson v. Fawcett Publications, 124 F. Supp. 429 (E.D. Ill. 1954) (photograph of racing accident in which plaintiff was involved used to illustrate fictional story that made no reference to plaintiff).Google Scholar

77 E.g., Yoder v. Smith, 253 Iowa 505, 112 N.W.2d 862 (1962); Timperley v. Chase Collection Serv., 272 Cal. App. 2d 697, 77 Cal. Rptr. 782 (1969); French v. Safeway Stores, Inc., 247 Or. 554, 430 P.2d 1021 (1967); Prosser, supra note 7, at 810; Miller, supra note 25, at 177; Restatement (Second) of Torts sec. 652D, comment a (Tent. Draft No. 22, 1976). Although the rule has been stated broadly, a number of the cases so holding appear to rely in part on the existence of a legitimate interest in the communication of the information to the particular recipient. Thus, in Harrison v. Humble Oil & Ref. Co., 264 F. Supp. 89 (D.S.C. 1967), where the court held that disclosure of the indebtedness by creditor to the debtor's employer was not an actionable invasion of the debtor's right to privacy, the court argued that (1) the right of the debtor to privacy was subject to the right of the creditor to take reasonable steps to collect and that (2) in contrast to the general public the employer had a legitimate interest in his employees' debts. As the restaters note, “[w]hile the cases to date allowing recovery for the type of invasion of privacy covered by this section have been confined to the giving of publicity to the private matter, the courts may decide to extend the coverage to a simple disclosure.” Restatement (Second) of Torts, supra.Google Scholar

78 Brents v. Morgan, 221 Ky. 765, 299 S.W. 967 (1927).Google Scholar

79 E.g., Yoder v. Smith, 253 Iowa 505, 112 N.W.2d 862 (1962); Timperley v. Chase Collection Serv., 272 Cal. App. 2d 697, 77 Cal. Rptr. 782 (1969).Google Scholar

80 Moreover, the members of a research team perhaps to an even greater extent than the creditor and the debtor's employer have a mutual interest in the exchange of the information.Google Scholar

81 Charles W. Sherrer & Ronald A. Roston, Some Legal and Psychological Concerns About Personality Testing in the Public Schools, 30 Fed. B.J. 111, 116 (1971). See Miller, supra note 25, at 93-94, 101-102, 115-16. Although the questions on aptitude and achievement tests do not go to an individual's family life, politics, religion, or personal behavior and hence are less likely to be found to invade a legally protected zone of privacy, the disclosure of the results of such tests may also result in harm to the individual. See Miller, supra note 25, at 93-84.Google Scholar

82 In Porten v. University of San Francisco, 64 Cal. App. 3d 825, 134 Cal. Rptr. 839 (1976), the complaint alleged that defendant university had disclosed to the State Scholarship and Loan Commission the grades plaintiff had earned at Columbia University in violation of an assurance that the grades would be used solely for the purpose of evaluating his application for admission and would not be disclosed without plaintiff's authorization. The court held that since the disclosure to the commission was “not a communication to the public in general or to a large number of persons” the complaint did not allege a violation of the common law right to privacy. The court also found, however, that the alleged conduct constituted a prima facie violation of the state constitutional right to privacy, noting that the constitutional amendment on privacy had been intended to expand the privacy right recognized at common law. The court stated that at trial the university may show some compelling interest justifying the transmittal of the transcript to the commission.Google Scholar

83 Act of Aug. 21, 1974, Pub. L. No. 93-380, sec. 513, 88 Stat. 484.Google Scholar

84 Act of Dec. 31, 1974, Pub. L. No. 93-579, 88 Stat. 1896.Google Scholar

85 The Act applies to “any public or private agency or institution which is the recipient of funds under any applicable program.” 20 U.S.C.A. sec. 1232g(a)(3) (Supp. 1976). An applicable program is defined as one “for which the Commissioner [of Education] has administrative responsibility ….” 20 U.S.C.A. sec. 1230 (Supp. 1976). For a detailed analysis of the Act, see Note, Federal Genesis of Comprehensive Protection of Student Educational Record Rights: The Family Educational Rights and Privacy Act of 1974, 61 Iowa L. Rev. 74 (1975).Google Scholar

86 20 U.S.C.A. sec. 1232g (Supp. 1976). In addition, the Act accords the parents the right to inspect the educational records of their children, to challenge the content of these records, to correct or delete inaccurate, misleading, or otherwise inappropriate data, and to insert a written explanation. 20 U.S.C.A. sec. 1232g (a)(2) (Supp. 1976). Parents are given the right to inspect all instructional material used in connection with a research or experimentation program. 20 U.S.C.A. sec. 1232h (Supp. 1976). Some states place limits on the disclosure of educational records by statute, but a recent study found that most do not. See Project, Government Information and the Rights of Citizens, 73 Mich. L. Rev. 971, 1262 (1975). The passage of the Family Educational Rights and Privacy Act of 1974 is likely to lead, and to some extent already has led, to additional state legislation on this topic as well as to the revision of existing statutory restrictions. See Ill. Ann. Stat., ch. 122, sec. 50-6 (Smith-Hurd Supp. 1977); Cal. Educ. Code sec. 10947 (West Supp. 1977); Me. Rev. Stat. Ann., tit. 20, sec. 805 (West Supp. 1976-77). These statutes are directed against the disclosure of school records rather than data gathered by researchers and thus affect researchers only indirectly by limiting their access to information on students contained in school files.Google Scholar

87 20 U.S.C.A. sec. 1232g(d) (Supp. 1976).Google Scholar

88 The Act purports to exempt “directory information” from the general prohibition. Directory information is defined as including “the student's name, address, telephone listing, date and place of birth, major field of study, participation in officially recognized activities and sports, weight and height of members of athletic teams, dates of attendance, degrees and awards received, and the most recent previous educational agency or institution attended by the student.” 20 U.S.C.A. sec. 1232g(a)(5)(A) (Supp. 1976). An institution wishing to make directory information public, however, is required to give public notice of the categories of information it has designated as directory information and to allow a reasonable period of time for a parent to inform the institution that the information should not be released without the parent's prior consent. 20 U.S.C.A. 1232g(a)(5)(B) (Supp. 1976). Thus, even such relatively innocuous information as that discussed above may not be released over parental objection.Google Scholar

89 20 U.S.C.A. sec. 1232g(b)(1)(F) (Supp. 1976). The Act also exempts disclosures to:Google Scholar

90 Other school officials, including teachers within the institution who have been determined by the educational institution or agency to have legitimate educational interests;Google Scholar

91 Officials of other schools or school systems in which the student seeks or intends to enroll, provided that the student's parents are notified, receive a copy of the record if they desire, and have an opportunity for a hearing where they can challenge the content of the record;Google Scholar

92 Authorized representatives of the Comptroller General of the United States, the Secretary of the Department of Health, Education, and Welfare, an administrative head of an education agency, or state educational authorities, in connection with the audit and evaluation of a federally supported education program or in the enforcement of the legal requirements of such a program;Google Scholar

93 State or local officials to whom such information must be disclosed pursuant to a state statute adopted prior to November 19, 1974;Google Scholar

94 Accrediting organizations for use in accreditation;Google Scholar

95 Parents of a dependent student;Google Scholar

96 To appropriate persons in an emergency when necessary to protect the health or safety of the student or others.Google Scholar

20 U.S.C.A. sec. 1232g(b)(1) (Supp. 1976). Information may also be furnished in connection with a student's application for or receipt of financial aid and in response to judicial order or subpoena. 20 U.S.C.A. sec. 1232g(b)(2)(A)(B) (Supp. 1976). Most state statutes mandating the confidentiality of student records do not contain a research purpose exemption. E.g., Colo. Rev. Stat. Ann. sec. 24-72-204 (1973); Del. Code Ann., tit. 14, sec. 4111(a) (1974); Neb. Rev. Stat. sec. 79-4, 157 (Supp. 1976). But see Tenn. Code Ann. sec. 15-305(2) (Supp. 1976); Cal. Educ. Code sec. 10947(b)(4) (West Supp. 1977). The Illinois statute provides an exception for disclosure of student records with the permission of the State Board of Education or an authorized representative “provided that no student or parent can be identified from the information released.” Ill. Ann. Stat. ch. 122, sec. 50-6(4) (Smith-Hurd Supp. 1977).Google Scholar

97 120 Cong. Rec. S21,491 (daily ed. Dec. 13, 1974) (Joint Statement in Explanation of Buckley/Pell Amendment).Google Scholar

98 Id. at S21,489.Google Scholar

99 Con. Rep. No. 93-1409, 93d Cong., 2d Sess. in [1974] U.S. Code Cong. & Ad. News 6793, 6795-96.Google Scholar

100 Cf. Clay v. Martin, 509 F.2d 109 (2d Cir. 1975), where in overturning the dismissal of a complaint brought by a prisoner under the Federal Tort Claims Act alleging that he had suffered a heart attack as a result of his participation in a drug experiment, the court stressed the enactment of legislation creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The court stated:Google Scholar

The legislative history of the Act indicates that it was passed in reaction to reports of abuses similar to those alleged here …. In view of these expressions of public policy, a court should not be quick to dismiss on pleading technicalities an action involving experimentation on humans.Google Scholar

509 F.2d at 113. Violation of a statutory duty has long been recognized as a basis for the imposition of liability in a negligence action. Prosser, supra note 7, at 190-202.Google Scholar

101 For a critical analysis of the Act, see Project, supra note 86, at 1303-40; Note, The Privacy Act of 1974: An Overview, 1976 Duke L.J. 301.CrossRefGoogle Scholar

102 Although the Act applies principally to federal agencies when an agency “provides by a contract for the operation by or on behalf of the agency of a system of records to accomplish an agency function,” it is required to “cause the requirements of this section to be applied to such system.” 5 U.S.C.A. sec. 552a(m) (Supp. 1976). Guidelines issued by the Office of Management and Budget implementing this provision state that “‘[c]ontract’ covers any contract, written or oral, subject to the Federal Procurement Regulations (FPR's) or Armed Services Procurement Regulations (ASPR's)” which provides for the operation of a system of records to accomplish an agency function. 40 Fed. Reg. 28,976 (1975). Grants, as distinguished from contracts, are not referred to in the Act and clearly fall outside the scope of “contract,” as defined in the OMB guidelines. HEW regulations confirm what is implicit in the Act and the OMB guidelines, stating that the Privacy Act requirements do not “[alpply to grantees, including state and local governments or subdivisions thereof, administering federally funded programs.” 45 C.F.R. sec. 5b.2(e)(4) (1976). Moreover, even contractors are covered only if the system is maintained “to accomplish an agency function.” The Office of Management and Budget construes this language as “intended to limit the scope of the coverage to those systems actually taking the place of a Federal system which, but for the contract, would have been performed by an agency and covered by the Privacy Act.” 40 Fed. Reg. 28,976 (1975). It is unclear whether records developed in research performed under contract would fall within this provision. The examples of covered records listed by the OMB are of records relating to the operations of federal agencies:Google Scholar

The determinations on benefits … made by Federal agencies;Google Scholar

The records … maintained for administrative functions of the Federal agency such as personnel, payroll, etc; orGoogle Scholar

Health records being maintained by an outside contractor engaged to provide health services to agency personnel.Google Scholar

Id. Records maintained solely for the purposes of research obviously differ markedly from the foregoing “typical” cases of agency records and will be covered only if conducting the research is regarded as an agency function.Google Scholar

The Act directs the Privacy Protection Study Commission to consider the desirability of applying the restrictions of the Act to record systems maintained by state and local governments and private organizations. 5 U.S.C.A. sec. 552a (note) (Supp. 1976).Google Scholar

103 5 U.S.C.A. sec. 552a(b) (Supp. 1976).Google Scholar

The purpose of this Act is to provide certain safeguards for an individual against an invasion of personal privacy by requiring Federal agencies, except as otherwise provided by law to–Google Scholar

….Google Scholar

(2) permit an individual to prevent records pertaining to him obtained by such agencies for a particular purpose from being used or made available for another purpose without his consent.Google Scholar

5 U.S.C.A. sec. 552a (note) (Supp. 1976). The record may be disclosed without consentGoogle Scholar

104 To employees of the agency who need the record in the performance of their duties;Google Scholar

105 If required by the Freedom of Information Act;Google Scholar

106 For a purpose specified by the agency in the Federal Register that is consistent with the purpose for which the record was collected;Google Scholar

107 To the Bureau of the Census;Google Scholar

108 For statistical research or reporting purposes and transferred in a form that is not individually identifiable;Google Scholar

109 To the National Archives;Google Scholar

110 For civil or criminal law enforcement activity;Google Scholar

111 Upon a showing of compelling circumstances affecting the health or safety of an individual;Google Scholar

112 To either House of Congress;Google Scholar

113 To the Comptroller General of the United States; orGoogle Scholar

114 Pursuant to court order.Google Scholar

5 U.S.C.A. sec. 552a(b) (Supp. 1976). These exceptions obviously leave considerable room for disclosure without consent. Indeed, one writer has questioned whether the consent provision “provides a real limitation upon agency activity.” Note, supra note 94, at 311.Google Scholar

115 5 U.S.C.A. sec. 522a(b)(5) (Supp. 1976). Draft recommendations of the Privacy Protection Study Commission would substantially liberalize the research purpose exception. 41 Fed. Reg. 55,007-11 (1976). The draft recommendations distinguish between information gathered for research and information collected for some other purpose. When information is collected for research, the recommendations require that (absent an explicit statutory provision to the contrary) the individual be informed of the fact that participation in the research is voluntary, of the purposes for which the data are being collected, and of the conditions under which information so collected may be disclosed in an identifiable form. Information so collected may be disclosed in an identifiable form to another researcher for a different research purpose provided that certain conditions are met:Google Scholar

116 The disclosure must not violate any of the limitations under which the information was collected. This presumably includes the statement of the conditions under which the information may be disclosed.Google Scholar

117 The importance of the research must be such as to justify the additional risk to the individual.Google Scholar

118 Disclosure in identifiable form must be necessary to accomplish the research purpose.Google Scholar

119 The recipient must agree not to disclose the information in identifiable form.Google Scholar

120 The recipient must establish adequate safeguards for the protection of the information against unauthorized disclosure.Google Scholar

When information is collected by a federal agency for a purpose other than research, the recommendations permit the disclosure of the information for a research purpose irrespective of the wishes of the person from whom the information was obtained if an institutional review process determines that the needs and importance of the research justify the disclosure in identifiable form, if redisclosure of the information by the researcher is prohibited, and if adequate safeguards are established to prevent the unauthorized disclosure of the information.Google Scholar

121 The subjective nature of the damages and the difficulty in measuring them does not preclude recovery since in a privacy action plaintiff may recover general damages without showing any specific loss and since the trier of the fact is accorded a wide discretion in fixing the amount of damages. See, e.g., Fairfield v. American Photocopy Equip. Co., 138 Cal. App. 2d 82, 291 P.2d 194 (1955); Prosser, supra note 7, at 815. The amount of damages awarded, however, will depend on the jury's perception of the seriousness of the harm to the plaintiff, and the absence of any dramatic harm will pose an obstacle to a large recovery.Google Scholar

122 42 U.S.C.A. sec. 2891-3(a) (1976). The institutional review board (under other names) antedates this enactment by approximately a decade. For a discussion of the genesis and development of the review board see Bernard Barber et al., Research on Human Subjects 145-48 (New York: Russell Sage Foundation, 1973).Google Scholar

123 45 C.F.R. sec. 46.102 (1976). Despite the encompassing language of the regulations, the jurisdiction of institutional review boards over educational research is probably for the most part indirect. Authority to administer federal education programs (including programs for educational research) is entrusted by statute to the Commissioner of Education and the Director of the National Institute of Education–not to the Secretary of the Department of Health, Education, and Welfare. 20 U.S.C.A. sec.1121e–3 (Supp. 1976); see S. Rep. No. 94-882, 94th Gong., 2d Sess. 104-105 (1976) (history of organization of Education Division). Rules and regulations promulgated by them take effect only after transmission to Congress and a lapse of 45 days, during which period Congress may by concurrent resolution disapprove the regulation. 20 U.S.C.A. sec. 1232 (Supp. 1976). Although the subject protection regulations are written as if they cover research funded by the Office of Education and National Institute of Education, when the regulations were promulgated it was provided that they were to become effective for programs administered by these agencies only “upon adoption or implementation in regulations issued by, respectively, the Commissioner of Education and the Director of the National Institute of Education….” 39 Fed. Reg. 18,917 (1974). Neither official has adopted the regulations.Google Scholar

Although the subject protection regulations are not directly applicable to most educational research, educational research at institutions with institutional review boards will generally be subject to review irrespective of the source of funding. The statutory requirement that any institution receiving funding under the Public Health Service Act establish an institutional review board “to review biomedical and behavioral research involving human subjects conducted at or sponsored by” the institution has been construed by HEW to require that the board review research conducted at or sponsored by the institution regardless of whether the research is funded by HEW. See Director, Office for Protection from Research Risks, NIH, DHEW, Memorandum to Grantee and Contractor Research Officers Responsible for Implementing DHEW Policies and Regulations on Protection of Human Subjects at Institutions with General Assurances, at 2 (May 22, 1975). In addition, while declining to adopt the subject protection regulations pending further study, the Director of the National Institute of Education has issued regulations requiring adherence to HEW policies and procedures on the treatment of human subjects as set forth in the DHEW Grant Administration Manual–including review by an institutional review board. See 45 C.F.R. sec. 1410.2 (1976); 41 C.F.R. subpart 3-4.55 (1976).Google Scholar

124 45 C.F.R. sec. 46.102(b) (1976).CrossRefGoogle Scholar

125 More detailed guidelines have been created to regulate research involving fetuses, pregnant women, and human in vitro fertilization. 45 C.F.R. secs. 46.201-.211 (1976). Special regulations have been proposed but not as yet adopted for research involving prisoners, the mentally disabled, and children. See 42 Fed. Reg. 3,076 (1977) (report of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on research involving prisoners); 39 Fed. Reg. 30,648-57 (1974); 38 Fed. Reg. 31,73849 (1973).Google Scholar

126 The regulations provide that the Board shall be composed of not less than five persons “with varying backgrounds to assure complete and adequate review of activities commonly conducted by the institution,” that the “maturity, experience, and expertise of its membership” must be such as “to insure respect for its advice and counsel,” and that [i]n addition to possessing the professional competence necessary to review specific activities,” the membership of the Board must be such as to enable it “to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes.” 45 C.F.R. sec. 46.106(b)(1) (1976). The regulations thus contemplate that the Board possess expertise as to both the scientific and the legal aspects of the proposals it reviews.Google Scholar

127 Dr. Veatch of the Hastings Institute criticizes the jury analogy, rightly pointing out that committees are dominated by scientists from the institution. Robert M. Veatch, Human Experimentation Committees: Professional or Representative? Hastings Center Rep., Oct. 1975, at 31. Although a number of review boards contain an unrelated minister or attorney, and less often a business executive or “housewife,” and while the regulations mandate some outside participation, most members of committees are employees. While very reflective of the academic and scientific community, such boards are not drawn from the broader community affected by research.CrossRefGoogle Scholar

128 45 C.F.R. sec. 46.101(a) (1976).Google Scholar

129 Research in instructional methods is a matter of doing systematically (and, one hopes, in a scientific fashion) what teachers do, and have always done informally. Teaching is a process of trial and error–of finding out what works. It is doubtful whether even the most wooden of teachers ever teaches a course twice in precisely the same manner; certainly a good teacher does not. See generally John Dewey, Democracy and Education 200-202 (New York: Macmillan Co., 1916).Google Scholar

130 45 C.F.R. sec. 46.102(b) (1976).CrossRefGoogle Scholar

131 45 C.F.R. sec. 46.103.Google Scholar

132 Some commentators have suggested that a total failure to educate may be actionable. See Comment, Educational Malpractice, 124 U. Pa. L. Rev. 755 (1976); Stephen R. Ripps, The Tort Liability of the Classroom Teacher, 9 Akron L. Rev. 19, 28 (1975);. Richard S. Vacca, Teacher Malpractice, 8 U. Rich. L. Rev. 447, 452 (1974). In a careful and detailed analysis of the issue, the author of the University of Pennsylvania student comment acknowledges that “[n]o reported case has allowed public school students to recover for the loss of educational benefits because of teacher negligence or incompetence” but contends that “[t]raditional legal principles … provide ample guidance for fashioning a viable cause of action.” Comment, supra at 766, 803. If this theory is adopted, use of innovative techniques that resulted in a less good education might also give rise to an action for damages. The practical difficulties, however, in establishing that the innovative techniques had resulted in an inferior education and that the researcher should have known that they would do so are forbidding.Google Scholar

133 U.S. Department of Health, Education, and Welfare, The Institutional Guide to DHEW Policy on Protection of Human Subjects 6 (Washington, D.C.: U.S. Government Printing Office, 1971) [hereinafter cited as Institutional Guide].Google Scholar

134 section 46.119 of the regulations provides that “[e]xcept as otherwise provided by law information in the records or possession of an institution acquired in connection with an activity covered by this part, which information refers to or can be identified with a particular subject, may not be disclosed except: (1) With the consent of the subject or his legally authorized representative; or (2) As may be necessary for the Secretary to carry out his responsibilities under this part.” This provision is construed in one commentary as prohibiting investigators from disclosing, without the subject's consent, any data that can be identified with the subject. Nathan Hershey & Robert D. Miller, Human Experimentation and the Law 56 (German-town, Md.: Aspen Systems Corp., 1976). Both the text of the regulation and its history indicate that this was not the intent. The regulation refers to information in the possession of the institution, not information in the possession of the investigator. The provision was added in the May 30, 1974, version of the regulations in response to comments indicating a concern over the confidentiality of information that the regulations required to be maintained by the institution for HEW inspection: copies of documents presented for initial or continuing review by the institutional review board such as board minutes, records of subject's consent, transmittals on actions, instructions, and conditions resulting from board deliberations addressed to the investigator. See 39 Fed. Reg. 18,916 (1974).Google Scholar

135 45 C.F.R. secs. 100a.263, 1410.1 (1976). Instruments that deal solely with “(1) Functions of technical proficiency, such as scholastic aptitude, school achievement, and vocational proficiency; (2) routine demographic information; or routine instructional information” are not covered by the regulations. 45 C.F.R. secs. 100a.263(b), 1410.1(b) (1976).Google Scholar

136 45 C.F.R. secs. 100a.263(c)(1), 1410.1(c) (1976).Google Scholar

137 45 C.F.R. secs. 100a.263(f), 1410.1(f) (1976). The National Institute of Education regulations permit the director to waive the consent requirement on written request. In issuing the regulations the director noted that even in the case of instruments excepted from the requirement of informed consent, the “DREW policy on treatment of human subjects … may require informed parental consent ….” 39 Fed. Reg. 38,995 (1974).Google Scholar

138 45 C.F.R. sec. 100a.263(c)(2) (1976).Google Scholar

139 45 C.F.R. secs. 100a.263(f), 1410.1(f) (1976).CrossRefGoogle Scholar

140 The instrument need not be submitted for review unless the grant or contract so provides. 45 C.F.R. secs. 100a.263(d), 1410.1(d) (1976).Google Scholar

141 Nor do they absolve review boards of their responsibility to determine whether the rights and welfare of subjects are adequately protected. This point was expressly recognized by the Director at the time the regulations were issued.Google Scholar

[W]hile procedures for the protection of human subjects and those for the clearance of data-collection plans may occasionally overlap in the case of some data-collection activities, these represent in fact two distinct sets of procedures accomplishing separate purposes. When a data-collection plan is a part of an activity or project involving risk to human subjects, that plan may have to be designed in accordance with the project sponsor's assurances on file with NIH/DHEW.Google Scholar

39 Fed. Reg. 38,994 (1974).Google Scholar

142 For a general discussion of the law of informed consent to medical treatment, see, e.g., Theodore J. Schneyer, Informed Consent and the Danger of Bias in the Formation of Medical Disclosure Practices, 1976 Wis. L. Rev. 124; Jon R. Waltz & Thomas W. Scheuneman, Informed Consent to Therapy, 64 Nw. U.L. Rev. 628 (1970); Plant, supra note 4. See generally Katz, supra note 1, at 521-724.Google Scholar

143 45 C.F.R. sec. 46.109 (1976).Google Scholar

144 As originally proposed the regulation did not contain the words “legally effective.” See 38 Fed. Reg. 27,883 sec. 46.8 (1973). The insertion of the phrase was suggested in comments on the proposed rule. 39 Fed. Reg. 18,914 (1974). No explanation of the significance of the addition was given.Google Scholar

145 45 C.F.R. sec. 46.103(c) (1976).Google Scholar

146 46 C.F.R. sec. 46.109 (1976).Google Scholar

147 45 C.F.R. sec. 46.103(c) (1976).Google Scholar

148 Disclosure of the nature of the contemplated procedure is basic to securing consent. Put simply, for a physician to obtain the necessary consent for the amputation of a limb he must disclose to the patient that he seeks the patient's consent to amputation. Beyond this the focus of both the cases and the commentary has been upon the disclosure of risks associated with the contemplated treatment and the standards to be employed in determining the necessity for disclosure. See, e.g., Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972) (failure to disclose 1 percent risk of paralysis); Wilkinson v. Vesey, 110 R.I. 606, 295 A.2d 676 (1972) (lack of expert testimony regarding what risks a reasonable practitioner would have disclosed does not bar recovery); Karp v. Cooley, 493 F.2d 408, 419-22 (9th Cir. 1974), cert. denied, 419 U.S. 845 (1974) (lack of expert testimony barred recovery based on failure to disclose risks and experimental nature of treatment); Schneyer, supra note 119; Waltz & Scheuneman, supra note 119; Plant, supra note 4. According to Professor Capron, “The cases frequently take a view of what needs to be communicated that goes well beyond solely ‘risks,' but it has apparently never been the point at issue in litigation.” Alexander Morgan Capron, Informed Consent in Catastrophic Disease Research and Treatment, 123 U. Pa. L. Rev. 340, 421 n.198 (1974). Other items of information that have been mentioned are: (1) the benefits to be anticipated from the proposed treatment; (2) any alternative forms of treatment; (3) the innovative nature of the procedure; and (4) when the procedure is innovative, the possibility of unknown risks. See, e.g., Canterbury v. Spence, supra (alternate treatment); Congrove v. Holmes, 37 Ohio Misc. 95, 101, 308 N.E.2d 765, 769 (C.P. Ross County 1973) (benefits); Fiorentino v. Wenger, 26 App. Div. 2d 693, 272 N.Y.S.2d 557 (1966) (experimental character of treatment); Waltz & Scheuneman, supra note 106, at 629, 632-34 (alternatives, innovative nature of treatment).Google Scholar

149 See, e.g., Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093, 1100 (1960); Smith v. Yohe, 412 Pa. 94, 194 A.2d 167, 174-75 (1963); Perin v. Hayne, 210 N.W.2d 609, 616-18 (Iowa 1973).Google Scholar

150 E.g., Rawls v. Conde Nast Publications, Inc., 446 F.2d 313, 316-17 (5th Cir. 1971), cert. denied, 404 U.S. 1038 (1972) (intrusion into home acquiesced to by plaintiff); Volk v. Auto-Dine Corp., 177 N.W.2d 525, 529 (N.D. 1970) (publication consented to by plaintiff). Prosser, supra note 7, at 817.Google Scholar

151 Professor Miller criticizes the consent-waiver defense, arguing that waiver is often merely a conclusory label and that “consent” may be the product of coercion. Miller, supra note 25, at 185-87. He maintains that “[t]he propriety of a waiver or consent defense to a privacy action should be assessed in terms of whether there is an overriding public interest in the free dissemination of information about the event in question, rather than on the basis of a fictive assertion about the injured person's intent at the time of the invasion.”Id. at 186. Obviously privacy issues ought not to be determined on the basis of a “fictive” consent. The problem, however, is in finding an invasion of privacy when an individual has given a voluntary informed consent to the disclosure. To speak of invasion of a zone of privacy in such a case is itself fictive. When in the context of social research a questionnaire recipient completes and returns the questionnaire after having been informed of the purpose of the study, of the use that will be made of the data, and of any substantial risks in responding, it is hard to see how his action in responding is to be viewed as an invasion of his privacy. It is only when the data are used for some other purpose to which he has not consented–e.g., his suitability for government employment–that a privacy issue arises.Google Scholar

152 See Rosenshine & Furst, supra note 24, at 169; Holland & Doran. supra note 23, at 311; Ad Hoc Committee on Ethical Standards, supra note 1, at 30-35.Google Scholar

153 Supra p. 509.Google Scholar

154 45 C.F.R. sec. 46.110 (1976).Google Scholar

155 45 C.F.R. sec. 46.110(c) (1976).Google Scholar

156 Institutional Guide, supra note 110, at 7.Google Scholar

157 Id. at 8 (emphasis added).Google Scholar

158 See Note, Parental Consent Requirements and Privacy Rights of Minors: The Contraceptive Controversy, 88 Harv. L. Rev 1001 (1975).CrossRefGoogle Scholar

159 20 U.S.C.A. sec. 1232g(d) (Supp. 1976); 45 C.F.R. sec. 100a.263(f) (1976).Google Scholar

160 See Robert Bennett, Allocation of Child Medical Care Decision-Making Authority: A Suggested Interest Analysis, 62 Va. L. Rev. 285 (1976); Note, supra note 135, at 1004 n.17.CrossRefGoogle Scholar

161 Younts v. St. Francis Hosp., Inc., 205 Kan. 292, 469 P.2d 330 (1970); Lacey v. Laird, 166 Ohio St. 12, 139 N.E.2d 25 (1956); Smith v. Seibly, 72 Wash. 2d 16, 431 P.2d 719 (1967); Bakker v. Welsh, 144 Mich. 632, 108 N.W. 94 (1906). According to Professor Bennett, “the oldest child allowed to recover damages in a reported case for an operation to which he personally consented was fifteen years old,” while many over that age have been denied recovery. Bennett, supra note 137, at 289. By 1975 two states had codified the “mature minor” exception and numerous others had by statute conferred a power to consent to medical treatment upon emancipated minors. See Lawrence P. Wilkins, Children's Rights: Removing the Parental Consent Barrier t o Medical Treatment of Minors, 1975 Ariz. St. L.J. 31, 58-61.Google Scholar

162 205 Kan. at 292, 469 P.2d at 337.Google Scholar

163 205 Kan. at 292, 469 P.2d at 338. In Lacey v. Laird, 166 Ohio St. 12, 139 N.E.2d 25 (1956), the court stressed that the child was 18 years old and that the operation, which the jury could have found to be a simple one, was for the child's benefit. In Bakker v. Welsh, 144 Mich. 632, 108 N.W. 94, 96 (1906), the court notes that the operation was “of a not very dangerous character.” In Smith v. Seibly, 72 Wash. 2d 16, 431 P.2d 719, 723-24 (1967), the court stressed plaintiff's emancipation in concluding that he was “sufficiently intelligent, educated and knowledgeable” to give a legally binding consent to a vasectomy.Google Scholar

164 Bonner v. Moran, 126 F.2d 121 (D.C. Cir. 1941).Google Scholar

165 Id. at 123.Google Scholar

167 45 C.F.R. sec. 46.103(c) (1976).Google Scholar

168 See, e.g., Note, supra note 135; Prosser, supra note 7, at 103. Regulations of the National Institute of Education and the Office of Education require that parental consent be obtained for the use of data collection instruments when the respondent is under the age of consent. 45 C.F.R. secs. 100a.263(0, 1410.1(a), 1410.1(f) (1976). The regulations do not expressly consider whether parental consent is sufficient to authorize use of the instrument.Google Scholar

169 38 Fed. Reg. 31,746, sec. 46.27(a) (1973).Google Scholar

170 The plan, as originally proposed, provided for obtaining parental consent through a “book of the month club” approach under which the failure of the parents to object is construed as consent, Memken v. Cressman, 364 F. Supp. 913, 914 (E.D. Pa. 1973).Google Scholar

171 Id. at 919.Google Scholar

172 Id. at 918.Google Scholar

173 Id. See also Note, A Student Right of Privacy: The Developing School Records Controversy, 6 Loy. L. Rev. 430, 443 (1975). The Supreme Court in Planned Parenthood v. Danforth, 428 U.S. 52 (1976), held that a statute requiring parental consent for an unmarried woman under the age of 18 to obtain an abortion violated her right of privacy. The Court noted that “[c]onstitutional rights do not … come into being … only when one attains the state-defined age of majority.” 428 U.S. at 74. While recognizing that “the State has somewhat broader authority to regulate the activities of children than of adults,” the Court found that there was no state interest in conditioning the abortion on the consent of the parent “more weighty than the right of privacy of the competent minor mature enough to have become pregnant.”Id. at 74-75. The Court stressed that it was not saying “that every minor, regardless of age or maturity, may give effective consent for termination of her pregnancy,” but only that a blanket parental consent requirement could not be justified. Id.Google Scholar

Although at first blush Danforth appears to support the claim that parents cannot waive their children's privacy rights, a more careful reading of the opinion in the light of the Court's decision in the companion case of Bellotti v. Baird, 428 U.S. 132 (1976), shows the Court's holding to have been quite narrow. In Baird the Court overturned a district court decision invalidating a statute which provided that if the pregnant woman was unmarried and under 18 both her consent and that of her parents was required. The statute qualified this prohibition, however, both by providing that if the parents refused consent, consent could be obtained by court order and by saving “‘any common law rights of any other person or persons relative to consent….’” 428 U.S. at 135. The state contended that under the statute parental consent could be withheld only to further the interests of the child and that the statute preserved the mature minor rule. The Court noted that “[i]n this case, we are concerned with a statute directed toward minors, as to whom there are unquestionably greater risks of inability to give an informed consent.”Id. at 147. Because “adoption of appellants' [the state's] interpretation would ‘at least materially change the nature of the problem,'” the Court concluded that the district court should have abstained pending construction of the statute by state courts. Id. In contrast in Danforth the statute permitted a parental veto irrespective of the maturity of the minor or the motives of the parents. Even as to mature minors the significance of Danforth for issues other than the right to an abortion is not clear. An abortion is performed to advance the interests of the pregnant woman, is nonexperimental, and is relatively safe. Danforth is, therefore, of little help in determining whether the consent of the child is required to authorize the child's participation in research.Google Scholar

174 Annina M. Mitchell, Experimentation on Minors: Whatever Happened to Prince v. Massachusetts? 13 Duquesne L. Rev. 919, 928 (1975) (footnotes omitted). Dr. Donald T. Chalkley similarly contends that “[a]parent has no legal right to give consent for the involvement of his child in an activity not for the benefit of that child.” Donald T. Chalkley, Developing Guidelines, 21 Clinical Research 777, 779 (1973). See Robert M. Veatch, Ethical Principles in Medical Experimentation, in Rivlin & Timpane, supra note 1, 21, 41; Bennett, supra note 137, at 326 (medical experiments on children that do not benefit them probably should be banned). But see Comment, supra note 1, at 1076 (courts probably would not bar all such research).Google Scholar

175 Mitchell, supra note 151, at 935.Google Scholar

176 38 Fed. Reg. 31,740 (1973).Google Scholar

177 In addition to requiring that the consent of the child be obtained if the child is seven years or older, the draft regulations proposed that committees be created both within HEW and at institutions sponsoring research to provide “a form of supplementary judgment.” 38 Fed. Reg. 31,738-42 (1973).Google Scholar

178 Dr. Chalkley, supra note 151, cites Prince v. Massachusetts, 321 U.S. 158 (1944), as establishing that the parent has no legal right to give consent to an activity not for the benefit of the child. In Prince, however, the only issue before the Court was the constitutionality of a state statute prohibiting minors from selling newspapers, magazines, or other merchandise in a public place and making it unlawful for a parent or guardian to permit a minor t o work in violation of the law. The defendant, a Jehovah's Witness, was convicted under the statute of permitting a child in her custody to distribute religious literature on the public streets. The Court held that, as applied, the statute did not unconstitutionally abridge defendant's or the child's freedom of religion–stressing that the state's authority over the activities of children was broader than its authority over the actions of adults. Prince establishes that the state can restrict the parents' control over their children in the interest of advancing child welfare. The question here, however, is not whether the state can prohibit parents from authorizing their children to participate in research that is not for the child's benefit but whether it has done so. On this issue Prince is of little help.Google Scholar

179 126 F.2d 121, 123 (D.C. Cir. 1941).Google Scholar

181 Strunk v. Strunk, 445 S.W.2d 145 (Ct. App. Ky. 1969); In re Richardson, 284 So. 2d 185 (Ct. App. La. 1973), cert. denied, 284 So. 2d 338 (La. 1973); In re Guardianship of Pescinski, 67 Wis. 2d 4, 226 N.W.2d 180 (1975); see Charles H. Baron, Margot Botsford, & Garrick F. Cole, Live Organ Transplants from Minor Donon in Massachusetts, 55 B.U.L. Rev. 159, 170-71 (1975).Google Scholar

182 In re Guardianship of Pescinski, 67 Wis. 2d 4, 226 N.W.2d 180, 181 (1975); In re Richardson, 284 So. 2d 185, 187 (Ct. App. La. 1973), cert. denied, 284 So. 2d 338 (La. 1973).Google Scholar

183 Hart v. Brown, 29 Conn. Supp. 368, 289 A.2d 386 (1972); see Baron, Botsford & Cole, supra note 158, at 172 n.66. It should be noted that in Hart the court found that the risk to the donor was negligible and that there would be some psychological benefit to the donor.Google Scholar

184 See Baron, Botsford, & Cole, supra note 158, at 160-62. In Hart v. Brown the court held that the parents and guardians ad litem should be permitted to give their consent to the transplant “where there is supervision by this court and other persons in examining their judgment….” 289 A.2d at 391. In Strunk v. Strunk the court held that the chancery court–but not the county committee charged with custody of an incompetent–had the power to authorize the operation. 445 S.W.2d 145, 149 (1969).Google Scholar

185 The situation presented by a transplant involving siblings is a compelling one for taking the power of decision away from the parents of the prospective minor donor. One may seriously question whether an operation to remove an organ or tissue will be in the best interests of the prospective minor donor, and the child's parents assuredly are not in a position in which they are likely to be motivated solely to do what is best for the prospective donor.Google Scholar

In a bone marrow or kidney transplant case involving sibling donor and recipient, the parents necessarily are confronted with a painful dilemma. Although they have a desperately ill child who may die if no transplant is performed, and although they wish to do whatever may save his life, presumably they do not want to injure their healthy child, the prospective donor. Generally, the only possible resolution of this conflict for the parents will be to attempt to save the life of the sick child by consenting to the minor donor's participation because of the comparatively minimal risk to the healthy child.Google Scholar

Baron, Botsford, & cole, supra note 158, at 167 (footnote omitted).Google Scholar

186 See cases cited in note 158 supra.Google Scholar

187 In Pescinski, where the donor was 39 years old with a mental age of 12, the court noted the absence of evidence that the donor consented to the transplant, concluding that “[i]n the absence of real consent on his part, and in a situation where no benefit to him has been established, we fail to find any authority for the county court, or this court, to approve this operation.” 226 N.W.2d at 182. In Richardson the donor was a mongoloid, age 17 but with a mental age of 3 or 4 and no understanding of the procedure. See Roger Stetter, Case Commentary, Kidney Donation from Minors and Incompetents, 35 La. L. Rev. 551, 556 (1975). In Strunk the donor was 27 years old with a mental age of 6 years. As Stetter has observed:Google Scholar

In the case of the mentally incompetent donor, the best interest safeguard serves to protect the donor against disfavored treatment based on a low evaluation of his social worth.Google Scholar

Id. at 560.Google Scholar