unconsented touching' and the autonomy-absolute

'Unconsented Touching' and the Autonomy-AbsoluteAuthor(s): Paul RamseySource: IRB: Ethics and Human Research, Vol. 2, No. 10 (Dec., 1980), pp. 9-10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563990 .

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December 1980

'Unconsented Touching' and the Autonomy-Absolute by Paul Ramsey

Thomas A. Shannon's case study "Consent in a Neonatal Screening Pro- gram," which concerns the obtaining of written consent from parents before a single urine sample could be taken from infants in a neofiatal intensive care unit to determine the prevalence of infection with cytomegalic inclusion virus (CMV), needs further analysis.' This case seems an astonishing outcome of our recent concern to protect human subjects in medical research merely by proxy consent. A whole web of regulations and IRB decisions now surrounds an investigation. In this commentary, I wish to address the confusion in the conceptual foundation that undergirds the ethics of experi- mentation with voiceless subjects.

On the one hand, we have in this case a research protocol involving no conceivable risk to the infant subjects. Yet the IRB rules that parents of each infant must sign consent forms. (I will not discuss here the impact of the regulations and the legalities that may have led to the IRB's ruling.) On the other hand, the IRB has presumed that parents can morally give proxy consent to research presenting what is called "minimal risk" to their children. Signed consents are required for research presenting no conceivable risk to the voiceless subjects. Similar consents are presumed to excuse research that places one's well child at risk-if "minimal." This is paradoxical enough to require some conceptual analysis and explanation.

Insofar as the IRB's decision in this case (and Shannon's defense of it) rests upon a moral warrant, this was an ap- peal to the child's "autonomy" or "privacy." The promotion of such abso- lutes, combined with the medical research community's resolve to go for- ward with research involving children under cover of minimal risk, resulted in a trammeling of the investigators in this case. This would be laughable if it were not so lamentable.

I have sometimes pointed out that an "unconsented touching" is at law a battery no less than a "harmful touching." This standard is not pertinent in this case. No touching was planned, let alone any conceivable harm. The urine samples were to be obtained by wringing out the diapers!

Paul Ramsey, Ph.D., is Harrington Spear Paine Professor of Religion at Princeton University.

What is the difference between wringing out diapers for the purpose of washing them better and doing so for the purpose of researching viral conditions in the intensive care nursery? I see none sufficient to warrant the web of regulations and consent forms or the IRB's ruling. Moreover, involvement in this research protocol was possibly to the benefit of each and every subject, including the staff. The situation may be compared to epidemic conditions, in which we do not ask public health authorities to obtain written consents, not even for invasive vaccinations. Also, there is no indication that the knowledge obtained from the samples would stereotype the subjects and so harm them later in life. There was no real privacy-interest in this case for parental consent to represent.

Only a routinized autonomy-absolute sustained this decision. This time, proxy consent representing the exercise of an as yet nonexistent autonomy was supposed to protect the small, voiceless subjects. It should not pass unnoticed that the increasing use of such substitute judgments (by courts, or by parents with their physician) can lead to negligence that brings death. In some neonatal cases (and in the Saikewicz case), parties other than the one chiefly concerned presume to exercise the patient/subjects' decision for them. Hereby, it is claimed, the voiceless patient's privacy decision is exer- cised in his or her stead; others decide as they decide the patient would decide, if competent.

In the case of proxy consent to urine samples, the outcome was supposed to be protection from a violation of privacy; and in the latter case, it is supposed to assure for another an exercise of that privacy. Neither claim can withstand examination. Both out- comes are fruits of the autonomy-absolute. From a moral point of view, whether the outcome is court-ordered or parental consent to negligent homi- cide or to an indefensible trammeling of medical research, both results are lamentable.

All the researchers proposed to do in this case was to wring out diapers, at some risk of damaging the diapers! Whether they would have said "no discernible risk" or "minimal" or "negligible risk" of damaging them, I do not know. Or perhaps they meant to say that conscious consent was substituted for what the babies (or the diapers)

would consent to (because they should) if they were lucid and could consent to anything; or, at least, that it was a consent that neither babies nor diapers could "reasonably" object to! One of these propositions is as sensible (or nonsensical) as the other. But we are responsible to the babies only to protect them from any possible harm.

This brings me to the claim that proxy consent can morally warrant research that places well children at risk. This assumption has not been effec- tively challenged during the current concern to protect human subjects from harm, even while our concern to find someone to represent and protect a voiceless subject's (as yet) nonexistent autonomy has grown over our heads (as in the present case).

There is a difference between "discernibly no risk" and "no discernible risk"; and between "no conceivable risk" and "conceivably no risk." The first expressions in these pairs accu- rately describe the urine-sample case. If investigators say "negligible risk," it is proper to ask, why negligible? or how negligible? The standard expression, of course, is "minimal risk."

By speaking of minimal risk, we obtain the conditions supposed sufficient for fiduciary agents (physicians and parents) to provide in their protocols and consents less than full protection from all possible harm. In the urine- sample case, where there is no conceivable harm and discernibly no harm, we don't have a case to argue about or to call for a meeting of the IRB-unless we add in the weight of an as yet nonexistent (and so imputed) privacy or autonomy for the fiduciary agent to protect. The latter notion leads to more outrageous consequences than trammeled research. Conscious consent substituted for an ascribed autonomy or exercise of privacy or substituted for a voiceless subject's consent to be exposed to risk remains an unexamined notion.

To confirm one side of this conten- tion, I cite exchanges from the Tran- script of the Sixth Meeting (April 25-26, 1975) of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. What was said is applicable beyond the topic of fetal research.

Commissioner Karen Lebacqz called attention to the evaluative nature of terms such as "minimal risk," suggest- ing that the Commission at least note that they were aware that it is a "judg- mental term" (p. 19). "Non-invasive" (p. 36) and "no additional risk" were mentioned as possible meanings; and also "so minimal as to be immaterial"

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(A. Jonsen, p. 267) and "no conceivable harm" (K. Ryan, p. 268).

Lebacqz spoke up again (p. 331): "Just a question, I hope. I notice that the term 'minimal risk' has been used. I would like to know," she said, "if that term has been defined in the document. If not, I am going to have problems with it"-and she observed that "I find the term 'minimal risk' to be almost a void term" (p. 354). Robert Cooke re- plied in effect that "whether it is minimal is what is commonly accepted" (p. 404); and others that it is standard language. Jonsen still felt that although "we are using standard language," "Somebody is going to have to spell it out a little bit more in the body of the report" (p. 405; see also p. 412ff). No one ever did.

There are some who assert that the ground for parental consent to nontherapeutic research on their children is the decision that the children would (if competent) do what they should do because of the inherent sociability of acting to aid other children. That ground soon shifts to what the child "cannot reasonably object to." So whose reasonableness? becomes the question. This still goes in a circle, as- suming what has to be proved. In any case, reasonableness is ascribed, not found because of a discovery of the child's interests. Only the latter is con- sistent with full parental protection from all possible harm.

Thus do we enlarge the range of op- tions by saying "minimal risk." Or- for those who make autonomy or privacy an absolute-what the voiceless subject would agree to if he or she were competent. Both grounds, sooner or later, turn into judgments by adults or courts concerning what the child would consent to or object to in the exercise of privacy or social propensities, or what the child could not reasonably object to.

Later the Commission attempted to avoid the crux of the distinction between therapeutic and nontherapeutic research with incompetent subjects. It largely voided that distinction, instead of filling in the "void" term "minimal risk." This it did by defining "research" as a process that goes on largely in a scientist's head, not primarily consist- ing in anything done with experimental subjects. Coincident with this, our culture (of which researchers are a part) supplied them with something ethical still to worry about in their heads, namely, an infant's autonomy or exercises of privacy for which substituted consent must always be obtained from surrogates.2 This is the genesis of the urine-sample case.

In societies before ours men and women have sacrificed their children to the gods. The gods today are medical progress in pediatric research. We don't dance around, but still we meld one child with another under the ban- ner of benefits. A sibling's "donation" (that is, the parents' donation) of bone marrow presents a risk of one death in 20,000 from the extraction-procedure: that is "negligible risk." So is the far greater incidence of risk of death or brain damage, from human error, if the well child must undergo general anes- thesia. Still, common sense tells us that a mathematically remote incidence of a serious injury is a serious risk of grave damage. Our medical way of talking about minimal risk does not fully hide this from us.

Is it possible that the growth of well- meant regulations is some sort of penitential system with "absolution" by proxy consent-givers administered by priestly IRBs? And that this vast penitential system now holds the consciences of researchers captive in cases where there is no conceivable risk to

the subjects? We may need a Martin Luther to convince us that a penitential system afflicts consciences by man- ufacturing nonexistent sins, and ex- cuses actions that only God can forgive.

REFERENCES

'Shannon, T.A.: Consent in a neonatal screening program. IRB: A Review of Human Subjects Research 1 (No. 3): 5-6, May, 1979.

2Lebacqz, K., and Levine, R.J.: Respect for persons and informed consent to participate in research. Clinical Research 25: 101-107, 1977. "Because we see overprotection as a form of disrespect for persons, we favor an approach that emphasizes the autonomy of prospective subjects" (p. 107). The Commission's Belmont Report used "respect for persons" as the carrier of "autonomy" (DHEW Publica- tion No. (OS) 78-0012). See also the separate articles by Lebacqz and Levine in the sym- posium on fetal research in the Villanova Law Review 22 (No. 2) 357-383, 1976-77. The hope was that, by avoiding or minimizing the distinction therapeutic/nontherapeutic, the neglect to give precise meaning to minimal risk would seem less of a flaw, and that over-regulation could be avoided. The urine- sample case shows that judgments substituted for a subject's "autonomy" require as much or more regulation. Moreover, in the case of voiceless subjects, possible harm is real, while their autonomy is not actual.

Ramsey on Research: Conceptual Confusion by Karen A. Lebacqz

Is it necessary to obtain parental consent to take urine specimens from the diapers of newborn infants in order to screen for prevalence and risk of viral infection? One IRB answered "yes," largely on legal grounds. Paul Ramsey differs, on ethical grounds. Un- der the cloak of this case, he argues:

* That signed parental consent was

tnot necessary here because there was no risk (indeed, there was potential benefit) to the children and they were not to be "touched";

* That children are to be protected "from all possible harm." Hence, even parents may accept no risks for a child unless that child will benefit;

* That the term "minimal risk" obscures important value judgments, since it includes a small chance of a great harm. Even "minimal risk" research is not permissible unlesss it is "therapeutic";

* That the distinction between therapeutic and nontherapeutic research should not be eschewed, as the Com- mission did in its later work.

Many share Ramsey's concern about the "iweb of regulations" woven around research. Many will share his judgment

Karen Lebacqz, Ph.D., is associate professor of Christian ethics at the Pacific School of Religion.

that consent was not (morally) necessary in this case. But such concurrence must not obscure fundamental dis- agreements. Ramsey's argument suf- fers much conceptual confusion. In- deed, his outrage is sadly ironic, for his own previous arguments fueled the fire of restrictive regulations. Let us turn the clock back ten years.

In The Patient as Person, Ramsey contended that the consent require- ment ensures that the (prospective) subject is not simply "used" by the re- searcher, but is respected as a person with a will. By adopting the re- searcher's ends as his or her own, the subject becomes a partner. Since children cannot choose ends and become full "partners" in research, they can be used only where the research furthers their own ends-i.e., where it is directed toward their well-being. It is not the harm to the child that makes research wrong where it is not directed toward the child's recovery, but simply the fact that a human being is then used for someone else's ends.'

From this it would seem to follow that it is not only risky "experimental" (nonvalidated) interventions that cannot be performed unless they are directed to the child's own good, but also noninvasive, nonrisk research involv-



unconsented touching' and the autonomy-absolute

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