The Ethics of Inducing Paranoia in an Experimental Setting

The Ethics of Inducing Paranoia in an Experimental SettingAuthor(s): Melvin LewisSource: IRB: Ethics and Human Research, Vol. 3, No. 10 (Dec., 1981), pp. 9-11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564505 .

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December 1981

assurance to every one that indicated disfavor. We have begun negotiating with those institutions that have ex- pressed criticism, and some that were originally critical have withdrawn their objections.

Perhaps it is worthwhile to reiterate the nature and purpose of the assurance of compliance with the Depart- ment of Health and Human Services (HHS) regulations for the protection of human subjects involved in research (45 CFR 46).

Sec. 46.103 of the regulations states that "research covered by these regulations shall provide written assurance satisfactory to the Secretary that it will comply with the requirements set forth in these regulations." Sec. 46.103 also contains a series of requirements, which call for institutions to provide (1) a statement of principles under which the institution will govern itself in pro- tecting the rights and welfare of human subjects; (2) designation of one or more IRBs with provision for adequate space and staff; (3) a list of IRB members in- cluding their qualifications to serve on the IRB and their affiliation with the institution (if any); and (4) written procedures governing the institution's ad- ministration of the review process.

An acceptable assurance must, there- fore, contain sufficient information to enable the Department to make a rea- sonable determination that the institution has established all of the adminis- trative procedures necessary to comply with the regulations. The sample assurance offers some examples of procedures that meet the requirements of Sec. 46.103. No doubt many other ad- ministrative procedures will also be acceptable to the Department. The sample could only provide one set of examples.

The assurance mechanism has been adopted by the Department (1) in lieu of a routine inspection system; (2) to allow institutions to follow the regulations by adapting existing administra- tive structures rather than creating new structures; (3) to allow institutions to develop their own policies for the protection of human research subjects so long as these include, as a minimum, conformity with HHS regulations; and (4) to serve as an educational tool since the institution is expected to circulate copies of the assurance to investigators and staff who carry out research involving human subjects.

In some respects the sample assurance suggests procedures that go beyond that which is stated in the regulations. These procedures are included because the regulations, in establishing minimal standards for the protection

of research subjects, do not include suggestions of how to implement the regulations. Most institutions have indicated that they welcome suggestions that illustrate ways to implement the requirements of the regulations. The assurance suggests, but does not require, some procedures that exceed minimal requirements. In all major in- stances where the assurance suggests a procedure beyond that which is required, a footnote is included calling to the attention of the institution that the suggested addition is not a require- ment of the regulations.

Large portions of the regulations that directly affect investigators are re- printed in the sample assurance. This is done because experience has shown that investigators often do not read the regulations carefully. It is hoped that, at very least, they will read the assurance, which will provide them with information necessary to adequately protect human subjects.

Dr. Pool has stated that the sample assurance would "incur thousands of dollars a year of expense." We believe that it can be executed by an institution with little change in cost from past procedures, providing that the institution was functioning in compliance with the former regulations. Our belief has already been confirmed by many research administrators throughout the country. In fact, most expect a sig- nificant reduction in workload.

Dr. Pool has indicated that subse- quent changes in procedure will have to be approved by HHS. Such approval will be easily obtained, provided that the changes are consistent with the regulations:'

Dr. Pool suggests that HHS is at- tempting to control the rights of other funding agencies. In fact, some 22 other agencies have already independently chosen to follow HHS regulations. Dr. Pool sems to believe that diversity is preferable to uniformity. In fact, diversity would rapidly increase the cost and complexity of doing business with the federal government.

Dr. Pool's First Amendment arguments have found little favor with the legal profession or the President's Com- mission for the Study of Ethical Prob- lems in Medicine and Biomedical and Behavioral Research. The First Amend- ment does not require institutions to abdicate control over research carried out under their auspices. Dr. Pool's arguments seem to overlook the fact that IRBs are created by and carry out review on behalf of institutions dedi- cated to research.

Dr. Pool is correct in suggesting that some institutions are developing as-

surances that differ markedly from the OPRR sample. This is permissible and expected. Each submitted assurance will be evaluated for acceptability by the Department. The standards for judgment will be (1) conformity with HHS regulations; (2) adequate protec- tions for human subjects; and (3) a statement of acceptable ethical principles to be applied to all research involving humans under the auspices of the institution.

The Ethics of Inducing Paranoia in an Experimental Setting

In a paper entitled "Induced hearing deficit generates experimental paranoia"' Zimbardo, Anderson and Kabat perhaps unwittingly raise a question that deserves some thought.

The authors carried out an experiment on 18 college males. Six partici- pants, after having "completed consent and medical history forms," were hyp- notized, given a post-hynoptic suggestion of partial deafness without being aware of its source, and placed in an experimental social situation. Each subject was subsequently debriefed and rehypnotized with the suggestion to recall all the events experienced. The important finding was that the subjects in the experimental deafness-without- awareness group became significantly more paranoid, and experienced them- selves (and were so experienced by oth- ers) as more irritated, agitated, hostile and unfriendly than the control group.

The question to be considered here is the advisability of inducing paranoid behavior in a previously healthy individual. Aside from the other ethical questions (the subjects were not told that they would become deaf, were expected to become paranoid, and that there was an unknown here in terms of possible long-term effects) there is the questionable act of inducing a state about which we do not know a great deal. In short, we do not know enough in developmental psychiatry to be con- fident that an episode of induced paranoia will have no sequelae.

I raise this question now because of our heightened awareness of developmental psychiatry2 and the need for more information before we expose previously healthy individuals to risks that while they are presently unknown, are not necessarily unlikely.

Melvin Lewis, M.D.

Professor of Pediatrics and Psychiatry Yale University

9



1o

REFERENCES 'Zimbardo, P.G., Anderson, S.M., and Kabat,

L.G.: Induced hearing deficit generates experimental paranoia. Science 212: 1529-1531, 1981.

2Rutter, M.: Ed. Scientific Foundations of Devel- opmental Psychiatry. London, William Heinemann, 1980.

Philip G. Zimnbardo replies: Any research in the area of experi-

mental psychopathology certainly re- quires close scrutiny of its procedural safeguards for minimizing risks to the subject population-before, during and following the study. Our recent research relating induced hearing defi- cits to experimental paranoia' raises both ethical questions about the treatment of human subjects and clinical questions about unknown long-term psychiatric consequences that I wish to address.

I hope that the research we have reported in Science will be only the first in a program of related studies I am de- signing to understand better a phe- nomenon that neither psychiatry nor psychology has much knowledge about-the process by which previously normal people first begin to develop pathological cognitive, affective, or behavioral states. The traditional approach of reconstructing likely causal mechanisms after someone has been identified as a "mental patient" (in therapy or committed to an institution) is inadequate, and may have given us a faulty analysis of the signifi- cant variables involved, thereby obscuring possible treatment alterna- tives. Thus the practical goal of my projected research is to learn how to in- tervene more effectively in the early stages of an incipient pathological state by understanding how such states start to develop. Experimentally creating conditions that may (on the basis of conceptual analysis) trigger such states is one methodological approach suited to providing the needed knowledge.

Indeed, it can be argued that it is pre- cisely such an approach that may provide the kind of information about developmental psychiatry which Dr. Lewis says is needed. How can we ever get information about the long-term risks of exposing an individual to an experimental treatment in the absence of any information about the efficacy of that treatment? I maintain that one function of a scientific approach to clinical phenomena is to make known the presently unknown conditions that give rise to both transient and chronic pathological states.

However, acknowledging the theoretical and practical benefits such research might have can be only part of

the justification for allowing such research to be conducted. The researchers, as well as disinterested parties concerned foremost with the rights and needs of the subjects, must be sensitive to any potential distress to the subjects, and insist upon procedures to keep those risks minimal.

The research reported in Science involved all the following features of con- cern for the welfare of our subjects (those required by the Stanford Human Subjects Panel, plus some we ini- tiated):

1. Exploratory pretesting with a small number of subjects (n=10) in which physiological arousal was monitored, while verbal/behavioral reactions were videotaped for independent evaluation. The treatment con- sisted of hypnotically inducing anomalous perceptions of unexplained arousal with suggestions for possible (biased) sources of that arousal (social, environmental, biological, spiritual). Our year-long follow-ups revealed no negative after effects of this experience, nor any that persisted beyond the experimental situation itself.

2. I personally conducted all the hypnosis training and testing sessions and directly supervised the actual conduct of each experimental session in the final, reported study. (I have been for- mally trained and certified in the use of hypnosis, and for over a decade have done research utilizing hypnosis.)

3. Arrangements were made to have a clinical psychologist on call during each experimental session in case we encountered any extreme reactions (there were none).

4. Lengthy process debriefing sessions were conducted by a trained therapist who followed techniques other research has reported to be most effective in attenuating induced experimental effects.

5. At the end of the debriefing session each subject was given the office and

home phone numbers of two of the researchers to contact at any time if they experienced any unusual feelings or thoughts, and strongly encouraged to contact us in such a case (none did).

6. The duration of the induced state (of experiencing the anomalous event) was made as brief as possible (less than 30 minutes) and experienced under highly controlled laboratory circum- stances, under surveillance by several observers.

7. During the earlier training sessions, subjects did experience hypnotically induced arousal, amnesia, and deafness in the presence of other people-the basic treatments they were to receive in the experiment proper. They were informed that in the experiment they would be exposed to some similar experiences.

8. On the basis of individual subject selection (for theoretical and ethical reasons) via personality tests, back- ground data, interviews and observa- tions, we retained only those young men who were judged to be functioning in the normal range, with a history of mental and physical health.

9. Follow-up interviews and retesting during the two weeks after the experimental sessions revealed that every subject who had changed in a pathological direction during the experiment had returned to his normal baselevel scores-several even having lower MMPI paranoia scores than initially.

10. We utilized the smallest number of subjects per cell needed to establish statistical significance (n=6), so that any negative effects would be re- stricted to a limited sample.

11. An additional six experimental subjects (not reported in the Science ar- ticle) were given a treatment of unexplained physical arousal-heart rate and respiration increase-with hypnotic amnesia for the suggestion, along with an induced cognitive bias toward social explanations for this anomalous

CALENDAR

FEBRUARY 15, 1982:Deadline for submissions to the 1982 competition for the Nellie Westerman Prize in Ethics, sponsored by the American Federation for Clinical Research. Manuscripts should focus on an issue involving human research. Either general discussions or descriptions of specific problems that have arisen together with the manner in which they were solved may serve as the subject of the papers. Papers are submitted with the understanding that the award-winning paper will be published in the journal Clinical Research. Further details regarding the Nellie Westerman Prize competition will be found in an announcement in Clinical Research or may be obtained by writing the Chairperson of the Committee, Dale H. Cowan, M.D., J.D., Saint Luke's Hospital, 11311 Shaker Blvd., Cleveland, Ohio 44104. Papers should be submitted to Dr. Cowan.



OVERVIEW OF FDA, IRBs AND REGULATIONS (Continued from page 3)

large part this difference stems from the traditional roles that each agency has played: NIH supports research, while FDA regulates research. For the most part, NIH has established a close working relationship with the institutions and scientists associated with the programs it funds. It is basically a col- legial relationship with a great deal of peer interaction. FDA, on the other hand, is primarily interested in whether the research data it receives are reliable and valid, and whether those data support the marketing of the products that it regulates.

The difference in mission is reflected in FDA's emphasis on compliance with regulations through inspections and audits. The question that needs to be addressed in the area of protection of human subjects is whether or not it is possible for the IRB system to be han- dled by the federal government in a uniform manner in an atmosphere of trust and support. This is a question that the Commissioner has been con- sidering seriously, and one that has

concerned a great many people over the past several years. As difficult as it may be, it is extremely important for FDA to move ahead with a re-examina- tion of its basic regulatory philosophy for IRBs, and to link its activities more closely with those of NIH. That process is now under way, and with the continued interest in the IRB area of both the President's Commission and the new Congressional Commission on the Federal Drug Approval Process, I am hopeful that ultimately a uniform pol- icy based on philosophy of basic trust will emerge.

REFERENCES 'Federal Register 46:8366 (January 26, 1981). 2Federal Register 46:8942 (January 27, 1981). 3Federal Register 43:35186 (August 8, 1978). 4Federal Register 43:56174 (November 30, 1978). -Federal Register 44:46799 (August 14, 1979). 'Federal Food, Drug, and Cosmetic Act, Sec-

tion 520(g)(3)(A)(i). 7Federal Register 41:35282 (August 20, 1976). 'Federal Register 46:45539 (September 11, 1981). 'Federal Food, Drug, and Cosmetic Act, Sec-

tion 520 (g)(3)(D). "OFederal Register 46:36332 (July 14, 1981).

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December 1981

experience. They too reacted on most measures like the deaf-without-awareness subjects, i.e., became more paranoid. Follow-ups of these subjects also revealed complete post-experimental reversal of the induced effect.

12. In earlier, large-scale studies (under my supervision) of affect arousal via injections of epinephrine2 and by hypnotic induction of unexplained arousal3 no post-experimental negative consequences were found in follow-ups even a year later.

13. The subjects were not informed in advance that we expected them to experience paranoid thinking for two reasons. First, we did not know until the study was completed whether paranoid reactions would be elicited from the condition of being deaf without awareness of it in the context of a social situation. Second, to give the experimental subjects that expectation would create a demand characteristic likely to confound the interpretation of the process by which the independent variables may result in paranoid reactions.

It is my considered opinion (after 20 years of related research)4 that the experimental induction of atypical experiences, thoughts, feelings and behav- iors in normal, healthy, mature research volunteers is highly constrained to the specific time and place of the experimental setting--when process debriefing is carefully conducted. Such an opinion obviously encourages me to pursue questions of developmental psychiatry using an experimental psychopathology model. The risks to the subjects appear to be quite transient while the potential benefits hold sub- stantial promise. Nevertheless, because any particular individual subject may overreact within the study or continue to respond atypically afterwards, ex- tensive precautions and routine checks have been, and will continue to be, an essential feature of such research in my laboratory.

REFERENCES 'Zimbardo, P. G., Andersen, S.M., and Kabat, L.

G.: Induced hearing deficit generates experimental paranoia. Science: 212, 1529-1531, 1981.

2Marshall, G., and Zimbardo, P.: The affective consequences of inadequately explained physiological arousal. Journal of Personality and Social Psychology, 37: 970-988, 1979.

3Maslach, C.: Negative emotional biasing of un-

explained arousal. Journal of Personality and Social Psychology, 37: 953-969, 1979.

4Maslach, C., Zimbardo, P. G., and Marshall, G.: Hypnosis as a means of studying cognitive and behavioral control. In E. Fromm and R. Shor, eds. Hypnosis: Research developments and perspectives. (2nd Edition). Chicago, Ill.: Aldine-Atherton, 1979, pp. 539-571.



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The Ethics of Inducing Paranoia in an Experimental Setting