ethical and legal aspects of behavioral instrumentation

BEHAVIOR THERAPY (1970) 1, 498-509

Ethical and Legal Aspects of Behavioral Instrumentation

RALPH K. SCHWITZGEBEl~

Harvard University

Informed consent, avoidance of unnecessary, harmful effects, and protection of privacy appear to be three major ethical principles to be followed during experimentation with behavioral devices. At present, no preclearance or approval prior to the marketing of a behavioral device is required by the Food and Drug Administra- tion. But increasing concern in Congress and a rapidly expanding definition of "drugs" by the courts which includes devices makes it advisable for the potential producer of a device to consult appropriate state and federal agencies.

Independent of government regulation, the manufacturer, seller, and perhaps therapist, may be liable for harm produced by a device, based upon a private legal action by the patient. Within the past few years, the scope of product liability has rapidly expanded, but several doctrines for limiting this liability are now emerging. The public welfare may require the use of some dangerous devices. These devices should provide adequate warnings and safeguards for the users.

Principles for directing the development and use of behavioral devices are not well developed. The field is a new one and guidance, therefore, comes primarily by analogy to related disciplines. Also, because the field is new, concern is generally directed toward the research and develop- mental aspects of new devices rather than the manufacturing and sale of devices already developed. Although the following discussion will consider both aspects, primary emphasis will be placed upon problems in the area of research and development. Because of limited space, issues can be presented here in only very broad outline. It might also be pointed out that, although written primarily with the American reader in mind, the issues raised have general relevance for all behavior researchers and therapists.

E X P E R I M E N T A T I O N WITH DEVICES

The ethical and legal considerations in experimentation with new behavioral devices are, in broad outline, similar to those found more gen-

i Requests for reprints should be sent to Ralph K. Schwitzgebel, Department of Social Relations, William James Hall, Harvard University, Cambridge, Mass. 02138.

498

BEHAVIORAL INSTRUMENTATION AND THE LAW 499

erally in psychological research and medical investigations. Many of the principles now applied in psychological research were originally derived from standards proposed by medical organizations. This medical orientation can be seen in both the traditional Nuremberg Code (U. S. Adjutant General 's Department , 1947) and in the more recent Declaration of Hel- sinki adapted by the World Medical Association (1964). These and related codes contain substantial areas of agreement and provide a suitable starting point for the consideration of basic principlesY

Near ly all of the major codes governing the ethical aspects of experimentation with human subjects mention the informed consent of the subject as a prerequisite to the conduct of an experiment. In addition, the Food and Drug Administration and the Public Health Service also require consent. The Food and Drug Administration (FDA) regulations (1967) emphasize the nature of the information that must be given to the subject so that his consent is informed (although the term "consent" is used rather than "informed consent"). The Public Health Service (1966a), on the other hand, allows the research institution to determine the "appropria teness" of the " informed consent" obtained by the experimenter. Thus, the Food and Drug Administration provides a substantive definition of consent while the National Institutes of Health rely more on local institutions to develop appropriate concepts of consent by following procedural directives, z

Generally, the requirement of informed consent is more rigorous when there is some risk to the subject together with little or no therapeutic potential for him. When there is little or no risk to the subject, the requirement of consent may be relaxed somewhat (Lipsitt, 1967; Public Health Service, 1966b). The use of electronic devices to observe or elicit information could presumably be included among those procedures that do not require fully informed consent. If, however, the device alters the status of the subject and involves risk to him, informed consent generally would be required.

Consent should be voluntary and should not involve duress. "Volun- tariness" assumes that the potential subject has a basic understanding of potential risks and benefits, although, of course, he probably cannot know all of the risks and benefits because some uncertainty is usually involved in experimentation. It has sometimes been suggested that the potential subject should be informed of alternative procedures that might be used to

It may be noted, however, that behavioral research is not a mere extension of medical research. Assumptions and procedures may be markedly different, requiring at times a different interpretation of those ethical codes used in medical contexts (Schwitzgebel, 1968).

a Curran (1969) has prepared an excellent discussion of the development of the consent regulations in these two agencies.

500 RALPH K. S C H W I T Z G E B E L

benefit him so that he can weigh the possible alternatives. This assumes a therape:~dcally oriented experiment. In such a situation, this seems reasonable, particularly if the experimenter is also the subject's therapist.

Many problems with a broad principle of informed consent remain unresolved. Particularly sensitive areas where no generally accepted guidelines have been formulated involve the consent of minors and men- tally incompetent persons, the administration of placeba and the use of related control procedures, and the employment of life-saving but high-risk procedures. Exceptions to the general principle of consent are few, but the 1962 amendments to the Federal Food, Drug, and Cosmetic Act do not require consent when the experimenters "deem it not feasible or, in their professional judgement, contrary to the best interests of such human beings." The exact nature and limits of these exceptions are not clear but they appear to be related to emergencies or serious disease situations.

There is considerable agreement among the major codes that all unnecessary, harmful effects of experimentation are to be avoided. But not all risks can be known before the experiment is conducted. Wolfensberger (1967) has usefully suggested a distinction between intrinsic and extrinsic risk in experimentation. Intrinsic risk arises from the experimental procedure itself, e.g., an allergic reaction to a drug. Extrinsic risk arises from factors other than the experimental procedure. Intrinsic risks are assumed to lie within the special competence of the experimenter. Although all of these risks cannot be known, the experimenter should be familiar with those that are commonly known among experimenters doing related, similar work. The experimenter should take precautions to avoid all risks of this type that are not necessary.

Those persons developing and studying new behavioral devices should be aware of those risks, such as electric shock or malfunction, that may be intrinsically associated with a device. Such risks are to be eliminated; or, if this is not possible, these risks should be minimized as much as possible, with the subject knowingly and voluntarily assuming the residual risk. If neither of these alternatives is available, then the experimenter should seriously question whether the experiment ought to be conducted.

Increasing emphasis has recently been placed on the protection of the subject's privacy so that information obtained from him or about him during the course of an experiment will not be used subsequently to harm him (Ruebhausen & Brim, 1965). Some states provide special statutes that may be used to safeguard the confidentiality of research information given in confidence to the investigator (Schwitzgebel, 1969). These statutes generally relate to subject matter within the purview of public health. Within the judicial view, confidential records about the subjects may be open for inspection by the administrator of the institution responsible for


the research if the confidentiality is maintained by procedures such as striking out the subjects' names. 4

F D A R E G U L A T I O N

The procedures used by the Food and Drug Administration to regulate the sale and use of drugs and cosmetics are considerably more detailed and well developed than those used by the FDA to regulate medical devices. However, as concern regarding the potential harmfulness of devices increases, legislation is being proposed that would regulate devices in much the same manner as drugs. For this reason, it may be useful to consider very briefly some of the procedures currently being used for the regulation of drugs as they may apply to devices. 5

Procedures

The original Pure Food and Drug Act of 1906 was aimed primarily at preventing interstate commerce in harmful drugs. In 1938, the Federal Food, Drug, and Cosmetic Act was passed which required that new drugs be cleared by the FDA for safety prior to their sale in interstate commerce. In 1962, after the thalidomide crisis, amendments were passed by Congress which required drug manufacturers to demonstrate not only the safety but also the effectiveness of a new drug prior to its approval.

In the 1906 Act, devices were not mentioned. In the 1938 Act, devices that produced harmful results or which were accompanied by false or misleading claims could not be marketed in interstate commerce. 6 At present, devices may be marketed without any preclearance or approval by the FDA. Once they are sold in interstate commerce, however, the FDA may examine the devices and related data and make a determination as to their safety or labeling. Unsuitable devices may be seized and their manufacturers and agents prosecuted.

Some relevant sections of the Federal Food, Drug, and Cosmetic Act read in part as follows:

"The term "device" . . . of this title means instruments, apparatus, and contriv- ances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other

animals; or (2) to affect the structure or any function of the body of man or other animals. ''7

4 See Hyman v. Jewish Chronic Disease Hospital, 15 N. Y. 2d 317,206 N. E. 2d 338,258 N. Y. S. 2d 397 (1965).

5 There are also statutes in many states that deal with drugs, cosmetics, and devices. These statutes, like the Federal Food, Drug, and Cosmetic Act, are often criminal or quasi-criminal in nature and violations may be misdemeanors. Investigators should become aware of the statutes of the state in which they conduct their studies.

e Relevant sections of the Federal Food, Drug, and Cosmetic Act can be found generally

in 21 U.S.C.A. 321,331-337, 351-357, 371-392. 7 Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. 321 (6).

5 0 2 R AL P H K. S C H W I T Z G E B E L

" A drug or device shall be deemed to be misbranded (a) if its labeling is false or misleading in any particular . . . (f) unless its labeling bears (1) adequate direc- t ions for use, and (2) such adequate warnings against use in those pathological con- ditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or durat ion of administrat ion or application, in such manne r and form, as are necessary for the protection of users . . . . ,,a

Although a device does not have to be precleared before marketing, the FDA has often been willing to give manufacturers advice and recommen- dations concerning their devices when schematic diagrams, the results of experimentation, and perhaps a prototype can be made available. Trends in Congress and in the courts appear to be moving toward preclearance for new devices.

Some current thinking on the regulation of devices by the FDA is embodied in medical device bills now before Congress. Similar bills have been introduced in the past without passing, but impetus is mounting with the rapid increase in the use of critical medical devices such as cardiac pace makers and artificial organs. The Senate bill, S.2107, provides in part as follows:

"A device shall, with respect to any particular use or intended u se thereof, be deemed unsafe, unreliable, or ineffective . . . if (1) its composit ion, construct ion, or propert ies are such that such device is not generally recognized, among exper ts qualified by scientific training and exper ience to evaluate the safety, reliability, and effectiveness of such device, to be safe, reliable, and effective for use under the condit ions prescribed, recommended , or suggested in the labeling t h e r e o f . . . . , , 9

From the judicial viewpoint, there seems to be a similar extension of FDA regulatory procedures to cover devices. This has occurred in part by extending the definition of "new drugs" to include certain new devices, thus requiring their preclearance. 1°

In an extensive study of the legislative history of FDA device legislation, Weitzman (1969a,b) has suggested that the courts may be moving toward distinguishing drugs from devices on the basis of the physical, mechanical action of devices in contrast to the physiological action of drugs. He notes:

"Such a method dist inguishing drugs from devices would allow the F D A to classify radiation or electromagnetic forces as drugs even though the machines that emit them are devices. U n d e r the definition of new drugs, these devices could be required to be precleared if they are part of a new method of administer ing the drug to the patient . . . . Articles which do not present the same dangers, such as surgical ins t ruments , prosthetic devices and others intended to be covered by the "Medical Device Safety Act , " would cont inue to remain outside the preclearance requirement until Congress acts ." (1969b, p. 341)

8 Federal Food, Drug, and Cosmet ic Act, 21 U.S .C.A. 352. 9 Senate bill no. S.2107, sec. 514 (a), 91st Congress , May 8, 1969 (Nelson). 10 U. S. v. An Article of Drug *** Bacto-Unidisk, 89 S. Ct. 1410 (1969), rev 'g 392 F. 2d

21 (Sixth Cir. 1968).

BEHAVIORAL I N S T R U M E N T A T I O N AND THE L A W 503

In view of the present confusion about the classification of drugs and devices, it might be useful for the researcher or manufacturer in the area of behavioral devices to obtain, if possible, some determination from the FDA as to the classification of the article if he is not certain. This might preclude legal liability which could arise should the article become labeled by the FDA as a drug while in interstate commerce without having been precleared.

It is recognized that new drugs cannot be approved without data from prior investigations and experiments. In the area of new drugs, the FDA permits human testing and the shipment of a drug across state lines if the investigator has claimed an investigational exemption for a new drug (IND) and it has been approved. The proposed investigation must be properly designed and must not expose the subjects to undue hazard. Information may also be required as to the investigator's competence and background, institutional facilities, experimental procedure, and the consent of the subjects. Of course, detailed records of results must be kept. The investigation of new devices categorized as new drugs would probably have to follow these same procedures. At present, however, most behavioral devices do not appear to fit within this "new drug" category, and thus these procedures would not be required during preliminary investigation. Also, as most devices do not now require preclearance, suddenly to require approval by the FDA even to investigate these new devices would seem to be a marked departure from customary practice and to be most appropriately mandated by Congress rather than by administrative or judicial action.

Policy The discussion has outlined only very briefly some of the procedures

and formalities of present regulatory practice. Much of the complexity, informality, negotiation, and uncertainty has not been discussed. The movement toward the preclearance and investigational supervision of medical devices and equipment likely to be used by behavior therapists is in a very early and tentative period of development. In fact, even the procedures for removing from interstate commerce devices that are so clearly harmful or mislabeled as to constitute quackery are only beginning to be adequately used.

A central objective of present regulatory practice is the protection of the health of the public. But this is to be accomplished in such a way that the availability and development of new devices is not unduly hampered, for, if this should happen, then, in the long run, the public's health would be harmed. To achieve this, the FDA has a very wide range of discretion- ary authority. Also, because most drugs and devices are in some way involved in some aspect of interstate commerce, such as the shipment of

504 RALPH K. SCHWITZGEBEL

components across state lines or the study of patients who travel across state lines, the jurisdiction of the F D A is quite comprehensive.

It is apparent that not all devices and drugs can be absolutely safe. Side effects and hazards are necessarily involved in the use of some therapeu- tically effective articles. But, as a class, behavioral devices are not likely to be as hazardous to the user as are medical devices per se. Also, many behavioral devices would not seem to lie within the purview of the Federal Food, Drug, and Cosmetic Act. Teaching machines, portable transceivers, wrist watches, closed-circuit television, and traffic devices are generally not covered. However , braces, toothbrushes, galvanometers for diagnosis, ultrasonic treatment devices, and phonograph records intended to produce sleep for persons suffering from insomnia have been found by the courts to lie within the jurisdiction of the F D A . A portable shock device worn by a patient would be marginal. I f it presented a serious electrical hazard to the wearer, or were permanently attached, action might be taken by the F D A to prevent its sale in interstate commerce though no action on such a behavioral device has been taken in the past. The Federal Food, Drug, and Cosmetic Act is directed primarily toward health, not behavioral problems. But, if any behavioral devices are developed that present potential hazards to health, policy may quickly change. 11

PRODUCT LIABILITY

Whether a device is approved by the F D A , or lies beyond its jurisdiction, liability may still arise from injury caused by its use. Several theories might be used by the plaintiff to impose liability upon the manufacturer, seller, or user of a device. The area of product liability is presently undergoing rapid change and, therefore, the following discussion is tentative and provides only a very general orientation to this area. Also, because there is so little developed law in regard to behavioral devices, understanding must be derived largely from a study of current trends affecting medical and related articles.

Breach of Warranty and Negligence

The breach of warranty action by the plaintiff is based upon an express or implied assertion (warranty) by the manufacturer or seller that the article is suitable for its intended use. This action generally requires a contract, usually a sale, between the supplier of the article and the person injured. This privity of contract requirement usually means that a patient

1~ This raises many interesting issues and implications when considered in the light of the present trend among many behavior therapists to view their craft in terms of models other than medical.


cannot bring an action against a manufacturer for injury resulting from a defective device used by a physician because the physician was not a manufacturer or seller of the device to the patient. There has, however, been a recent tendency to relax this privity requirement in regard to patients and household members. Perhaps this is because the courts are particularly concerned with articles that directly affect health, 12

In the contract action of breach of warranty, the plaintiff does not need to show that the manufacturer or seller was negligent in the construction or care of the device. Rather, he shows that the article was not suitable for its intended use. Negligence, however, is the basis of a different legal action. The manufacturer and seller have a duty not to provide defective products. I f they are negligent, they may be liable to not only the immedi- ate purchaser but also to any subsequent user. There is no privity of contract requirement. The manufacturer and seller are held to a standard of reasonable, due care. This standard of care may be determined by refer- ence to federal or local statutory requirements or F D A regulations. 13

The manufacturer of a device must also inspect the device for obvious or latent defects. Sellers are often required to inspect for obvious defects. There also appears to be a trend to impose a duty upon a user, such as a physician (and, by inference, perhaps psychologists), to inspect for defects in the device that may harm patients. ~4 The manufacturer and seller should provide proper labeling that includes suitable directions.

Strict Liability

The two concepts of breach of warranty and negligence appear to be merging into a theory of strict liability. The doctrine of strict liability is generally interpreted to impose liability upon any person who is in the business of selling a product that is in "a defective condition unreasonably dangerous to the user or consumer . . . . " (The American Law Institute, 1965, p. 347). The seller may be liable even though he has exercised all possible care in the design, manufacture, and sale of the device. The physician or psychologist, as a user of a device for therapeutic purposes with a patient, should not be liable under this doctrine unless he is also the designer, manufacturer, or seller of the device.

There must be limits to this liability if the manufacturer or seller is not to become an insurer against all harm involving the use of the product. Three approaches to limiting liability are being developed. First, the manufacturer and seller are not liable if the device has been substantially

12 See Bernstein v. Lily-Tulip Cup Corp., 177 So. 2d 363 (Fla. Ct. App. 1965). 13 See Orthopedic Equipment Co., Inc., v. Eutsler, 276 F. 2d 455, 79 A.L.R. 2d 390

(1960). 14 See Cohran v. Harper, 115 Ga. App. 2d 277, 154 S. E. 2d 461 (1967).

506 R A L P H K. S C H W I T Z G E B E L

damaged, beyond reasonable use, after being sold. Second, they are not liable for those harms that cannot be reasonably foreseen. Third, they are not liable if the injured party has used the product in a manner which was not intended by the manufacturer and/or seller. 15

Some products, particularly of a medical or therapeutic nature, are inherently dangerous. To preclude their use by attaching strict liability, as in the case of some vaccines, would subject the public to even greater risks of harm. If such a product is properly developed and is accompanied by proper directions, it should not be considered "unreasonably" dangerous. The user must also, of course, be given an adequate warning that describes the risks involved as would be required for a dangerous product. This standard would also seem applicable to new or experimental products or devices used by behavior therapists. 16

Policy The manufacturer, seller, and researcher are to protect the public from

all unnecessary harms produced by their devices. But not all harms can be foreseen and sometimes even foreseeable risks may be necessary, as in the case of overriding therapeutic necessity or the assumption of risk by the person using the product. This assumes that the person is fully informed of the reasonably foreseeable risks. In the product liability area, this obligation on the manufacturer or seller is sometimes known as the duty to warn and is imposed even though the device is properly manufactured and not defective according to generally accepted standards. The label should be explicit as to hazards both within the area of intended use of the article and, to some not very clear extent, beyond the area of intended use. Labels should clearly state known hazards and, if possible, suggest safeguards.

The possible hazards in the use of certain behavioral devices are not only electrical but also chemical (from battery leakage), structural (from the breakage of the device), and psychological. How far the courts should go in awarding damages for psychological harms has always been a trou- blesome issue. Generally, courts have been reluctant to award damages to plaintiffs for mental suffering in the absence of physical harm. However, there is, perhaps, some trend to permit damages in unusual circumstances when the mental suffering is very clear and exceptionally intense.

Finally, some consideration should be given to the design and quality of the device so that it can function safely and reliably over a reasonable period of time. Sometimes this may require additional cost to the manu-

15 Helene Curt is Industr ies, Inc. v. Pruitt, 385 F. 2d 841 (Fifth Cir. 1968). ~ A brief d iscuss ion of hazardous but apparently or potentially useful products can be

found in the Res t a t emen t of Tor t s 2d (The Amer ican Law Inst i tute, 1965, p. 354).

BEHAVIORAL INSTRUMENTATION AND THE LAW 5 0 7

facturer in terms of design, testing, and material. There recently has been some question about the reliability of cardiac pacemakers in regard to poor material, battery failure, and the breakage of electrode connections. Courts have not given much consideration to this aspect of reliability based upon design, but some attention is now being given to it in areas such as automotive engineering. In matters of critical medical or psychological importance, additional consideration should be given to the development of internal warning systems, redundant circuits, and easily inspec- table and replaceable components.

C O N C L U S I O N

This discussion has briefly considered some of the major ethical and legal aspects of behavioral instrumentation as it is related to experimentation, FDA regulation, and product liability. In the area of experimentation, guidance comes primarily from ethical codes, such as the Declaration of Helsinki, that emphasize the informed, voluntary consent of the subject. Some relaxation of this requirement of consent might be permissible in situations that involve no risk to the subject such as when devices are used only to observe or elicit information.

Another principle found in many of the ethical codes is the avoidance of all unnecessary, harmful effects of experimentation. Even though subjects may voluntarily assume some risks, the experimenter should seek to prevent those risks intrinsic to the experiment that can be reasonably foreseen by him or by other competent persons similarly situated. Some experimentation that is essential for the advancement of knowledge will, however, probably involve some risks to subjects that cannot be pre- dicted or prevented. Finally, the experimenter should attempt to design the experiment so as to produce socially significant results while safeguarding the rights of the subjects.

At present, the major regulatory activity of the FDA is directed toward preventing the interstate commerce of devices that are very clearly harmful or mislabeled. No preclearance or approval prior to the marketing of a device is now required. There are, however, two trends toward increasing the regulatory scope of the FDA over devices. One is the increasing concern in Congress about the potential risk inherent in devices such as cardiac pacemakers and artificial organs. The second trend is the increasingly broad, or at least changing, definition of "drugs" by the courts. Disks for antibiotic testing and surgical ligatures have been classified by the courts as new drugs. This classification of articles as new drugs makes them subject to preclearance by the FDA before marketing and requires the manufacturers to demonstrate their safety and effectiveness.

508 RALPH K. SCHWITZGEBEL

Most behavioral devices do not currently seem to fall within this new drug category and many of them may lie outside of the jurisdiction of the FDA. But the criteria for classification are not clear. Although teaching machines and portable transceivers are generally not within F D A jurisdiction, hearing aids and phonograph records for the treatment of insomnia are within its jurisdiction as medical devices. For this reason, in questionable situations it may be helpful to obtain an opinion from the F D A about the classification of a device prior to marketing it.

The manufacturer and seller of a device may be liable for injuries caused under various theories of product liability independent of FD A regulation. The traditional doctrines of breach of warranty and negligence are apparently merging into a new theory of strict liability. Within this theory, the seller is liable for harm caused by any device in a defective condition that is unreasonably dangerous to the user or consumer.

This liability may be limited to those harms that the seller could reasonably foresee. Also, the user must not use the device in a manner in which it was not intended. Particular attention should be given to the labeling of the device and the provision of adequate warnings and directions for use. Consideration should also be given to the reliability of devices by designing them so that they can be easily inspected and repaired.

REFERENCES

CURRAN, W. J. Governmental regulation of the use of human subjects in medical research: the approach of two federal agencies. Daedalus, 1969, 542-594.

FOOD AND DRUG ADMINISTRATION, 32 Federal Register 3994, March 11, 1967. LIPSITT, P. D. Medical inquiry and the law. New England Journal of Medicine, 1967, 277,

974-975. PUBLIC HEALTH SERVICE, Investigations involving human subjects, including clinical

research: requirements for review to insure the rights and welfare of individuals, PPO #129, Revised July 1, 1966.(a)

PUBLIC HEALTH SERVICE, Clarification of procedure on clinical research and investigations involving human subjects, December 12, 1966.(b)

RUEBHAUSEN, O. M., & BRIM, O. G. Privacy and behavioral research. Columbia Law Review, 1965, 65, 1184-1211.

SCHWITZGEBEL, R. K. Ethical problems in experimentation with offenders. American Journal of Orthopsychiatry, 1968, 38, 738-748.

SCHWITZGEBEL, R. K. Confidentiality of research information in public health studies. Harvard Legal Commentary, 1969, 6, 187-197.

THE AMERICAN LAW INSTITUTE, Restatement of torts 2d. Voi. 2. Washington, D. C. 1965. U. S. ADJUTANT GENERAL'S DEPARTMENT, Trials of war criminals before Nuremberg mili-

tary tribunals under control council law no. 10, Washington, D. C. 1947. 2, 181-183. WEITZMAN, S. Drug, device, cosmetic? Part 1. Food Drug Cosmetic Journal, 1969, 24,

226-249.(a)


WEITZMAN, S. Drug, device, cosmetic? Part 1I. Food Drug Cosmetic Journal, 1969, 24, 320-341 .(b)

WOLFENSBERGER, W. Ethical issues in research with human subjects. Science, 1967, 155, 47-51.

WORLD MEDICAL ASSOCIATION, Declaration ofHelsinki. Helsinki, 1964.

ethical and legal aspects of behavioral instrumentation

Documents