A O R N J O U R N A L MAY 198.5, VOL 41, NO 5

OR Nursing Law Protecting human

subjects involved in research

esearch is knowledge R to provide

necessary to extend the base of a practice profession

better care to all clients. Research in nursing or in medicine frequently requires the use of humans as experimental subjects. This column discusses the legal protection afforded human subjects in nursing and medical research.

Historical abuses of human subjects will be briefly examined and the National Research Act and its implications for nurses engaged in nursing research or providing care to clients who are subjects of medical research will be discussed.

Horror stories of the abuse of human subjects in biomedical experimentation are numerous and have contributed to the public’s concern for protection of human subjects, as well as to the negative perception of the use of humans as guinea pigs. The atrocities of Nazi Germany experimentation revealed in the trial of Karl Brandt at Nuremberg revulsed the public worldwide.’ The resulting Nuremberg Code included the following points:

that voluntary consent is essential experiments should be so designed that the anticipated results will justify the experiment the anticipated risk should never exceed the humanitarian importance of the problem to be solved the highest degree of skill and care should be required through all stages of the experiment, and the experiment should be conducted by qualified investigators the subject should be at liberty to bring the experiment to an end at any time during its course

the investigator must be prepared to bring the experiment to an end if at any time the continuation of the experiment is likely to result in injury, disability, or death to the subject.*

In 1964, the World Health Association issued a set of basic principles, called the Declaration of Helsinki, for the conduct of human research. Among those principles are: (1) clinical research must conform to moral and scientific principles and should be based on laboratory and animal experiments or other scientifically established facts; (2) clinical research should be conducted only by scientifically qualified persons and under the supervision of a qualified medical man; (3) clinical research cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject; (4) every clinical research project should be preceded by careful assessment of inherent risks in comparison to forseeable benefits to the subject and to others; (5) special caution should be exercised by the physician in performing clinical research in which the personality of the subject is liable to be altered by drugs or experimental procedure; (6) in the case of therapeutic research (research involving the investigation of a therapy that can reasonably be anticipated to treat the patient’s condition), the physician can combine clinical research with professional care only to the extent that the clinical research is justified by its therapeutic value for the patient; (7) in nontherapeutic research (the investigation is not related to treatment of the patient’s condition), clinical research cannot be undertaken without the patient’s free consent and the subject should be free to withdraw permission

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Even after penicillin became available and generally accepted as a treatment for syphilis,

it was withheld from those in the study.

for the research to be continued at any time during the course of the experiment; and (8) the investigators should discontinue the research if, in their judgment, it may be harmful to the indi~idual.~

Despite these major international declarations, reports of abuse of human subjects continued. In the United States, those reports included the injection of live cancer cells into chronically ill and debilitated patients, attempts to infect mentally retarded children with hepatitis for experimental purposes, and the testing of oral contraceptives without the understanding of what was involved by the women subjects?

The Tuskegee Study shocked the American public and ultimately led to passage of federal legislation to prevent abuses in experimentation with human subjects. Begun under the auspices of the US Public Health Service in the 193Os, the purpose of the Tuskegee Study was to investigate the long-term effects of syphilis. The 40-year study used two groups of males: one with syphilis and a disease-free control group. The Public Health Service continued to monitor the health status of these subjects throughout their lives and provided health care services to them for all conditions except syphilis. Even after penicillin became available and generally accepted as a treatment for syphilis in the 195Os, it was withheld from those in the study. Reportedly, steps were taken to keep the subjects from obtaining treatment for syphilis from other source^.^ The Tuskegee Study was widely publicized in the early 197Os, and litigation was initiated on behalf of survivors and families of deceased subjects. The suit was settled out of court, but the resulting social outrage led Congress to pass Public Act 93-348, the National Research Act, in 1974.6

The National Research Act requires all institutions and persons applying for federal research grants and contracts to provide documentation that the research protocol complies

with federal guidelines and has been reviewed by an institutional review board (IRB). An IRB is a decentralized, interdisciplinary body established by individual institutions that conduct or sponsor research funded by federal monies. Its purpose is to review the research protocol to assure protection of human subjects. The IRB determines the degree of risk incurred by the subject who participates in the study. Minimum risk to the subject is defined as risks ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. If more than minimal risk is involved, the IRB determines if the benefits to. the subject outweigh the risk incurred. If the population under study involves minors, mentally retarded or disabled persons, pregnant women or prisoners, or the proposed activity involves new drugs or clinical devices, or such sensitive areas as fetuses, illegal behavior, or deception, the IRB considers additional guidelines specific to these concerns.

In most protocols, the IRB also serves to protect subject autonomy by requiring the investigator to obtain the subject’s informed consent. The informed consent required of research subjects is similar to the informed consent to surgery in that both require disclosure of the general procedure, its risks, benefits, and alternatives. The research subject, however, must also be told that he or she can withdraw from continuing the experiment at any time without fear of retribution. If there are no anticipated benefits to the research subject, the subject must be so informed and the investigator must expressly offer to answer any questions the subject may have.

Although the National Research Act applies only to researchers and institutions receiving or applying for federal funds, many other institutions are adopting and applying these guidelines. Individual states have also passed statutes that apply to all research conducted in that state. These statutes frequently create special responsibilities for

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the investigator when conducting experiments in controversial areas such as psychosurgery and fetal research.

Operating room nurses are involved with research in a variety of capacities. They may be the principal investigators or they may participate by collecting data or by delivering care to patients who are undergoing experimental therapies. For example, most nurses working in ophthalmic surgery are familiar with the extensive additional consent form that is required because post-cataract extraction implants are still considered experimental devices.

As an investigator, the OR nurse must make every effort to design and conduct the study with constant concern for the protection of the subjects, and to work with the institutional review board in the institution in which the study is conducted. As a data collector or care giver, the OR nurse should ascertain whether the research the nurse is asked to support has received the approval of the institution’s IRB, or if the institution does not have an IRB, to seek administrative clarificationn of the status of the study in that setting. After clarifying that the research has been approved, the nurse must take care to adhere to the protocol to assure both valid data and the protection of human subjects.

There have been no publicized cases of abuses by nurse researchers. It is imperative that this record continue for the protection of human subjects, as well as for the continued development of nursing knowledge through research.

ELLEN K. MURPHY, MS, JD, CNOR MILWAUKEE, WIS

Notes 1. Jay Katz, Experimentation with Human Beings:

The Authority of the Investigator, Subject, Professions, & State in the Human Experimentation Process (New York Russell Sage Foundation, 1972) 292-305.

2. Helen Creighton, “Legal concerns of nursing research,” Nursing Research 26 (September-October 1977) 337.

3. Zbid, 338. 4. Katz, Experimentation with Human Beings, 9-44,

5. Creighton, “Legal concerns of nursing research.” 6. L W Standridge, “Experimentation on humans

739, 1007.

in biomedical research,” Case and Comment 83 (February-March 1978) 3.

The above information is intended for general informational purposes on&. Spectjic situations should be reviewed by legal counsel

If you have any questions on OR nursing law you would like answered please send them to Ellen K. Murphy, JD, c/o AORN Journal, I01 70 E Mississippi Ave, Denver, CO 80231. Questions of general interest will be selected for replies in thb column

Injection Effective for Eye Muscle Spasm An eye-muscle condition that leads to involuntary eyelid closure can be treated with an injection of botulin toxin, according to the March issue of Archives of Ophthalmology.

The condition, blepharospasm, is caused by spasm of an eye muscle, making pursuit of ordi- nary occupations impossible. The problem has previously been treated surgically. But in a study of patients treated with injections of botulinum A toxin into the eyelid and brow, Alan B. Scott, MD, Smith-Kettlewell Eye Research Founda- tion, San Francisco, and his colleagues, reported 39 patients gained relief from abnormal eye movement for up to 170 days.

Kidney Screening Test for Children A new screening test can be used to detect under- lying kidney problems in hypertensive children, according to the February issue of the American Journal of Dkeases of Children.

Kidney abnormalities such as asymmetry of function, size, or shape were identified with an accuracy of 96% in a study of 80 children by Paul R. Rosen, MD, and colleagues from Child- ren’s Hospital, Boston. The method uses renal scintigraphy with technetium Tc 99m succimer and technetium Tc 99m pentetate.

tion of pediatric and adolescent patients with hypertension,” said the researchers.

The test should be used “in the initial examina-

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