Promoting Informed Consent of Women in Labor DONNA J. VAN LIER, RN, CNM, PHD, AND JOYCE E. ROBERTS, RN, CNM, PHD, FAAN Laboring women are increasingly being asked to participate in perinatal research. These women should be considered captive or special subjects who deserve greater protection of their rights. Essential elements of informed consent are reviewed. Specific guidelines are suggested for promoting informed consent for women in labor participating in clinical research.
Consumers and health-care professionals are focusing attention on protecting the rights of human subjects involved in research. The exposure of human rights violations such as the World War 11 nazi atrocities and the United States Public Health Servicesponsored Tuskegee syphilis study precipitated a significant national and international response. Subjects were not informed adequately about the nature, risks, and benefits of the research in which they were participating.' In reaction to the disclosures of the Nuremberg war trials, the World Medical Association formulated the Nuremburg Code in 1947. This document constituted the first code of ethics that declared the rights of subjects and included guidelines for human experimentation. Since 1947, at least 35 additional codes have been formulated for the protection of human rights.' In 1974 in the United States, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission was charged with identification of the basic ethical principles that should underlie all research involving humans. The final regulations were a result of a study of the problems involved in the use of human subjects as well as recommendations generated by public ~ o n c e r n . ~ These regulations defined the elements of informed consent, set standards for protection of special groups Accepted: July 1984. Updated: March 1986.
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such as prisoners, children, and pregnant women, and delineated research that is exempt from review. Institutional review boards were established in all facilities applying for or using federal monies for research to provide systematic review and monitoring of all protocols involving human subjects. FEDERAL GUIDELINES The federal guidelines have established that the informed consent procedure shall 1. include a reasonable opportunity for the subject
to consider participation; 2. be expressed in understandable language; 3. exclude exculpatory language; 4. contain a reasonable explanation of the research, its purpose, and duration of participation; 5. describe any benefits; 6. describe appropriate alternative procedures; 7. describe the extent to which confidentiality of records will be maintained; 8. explain the availability of compensation and the availability of treatment if injury occurs; 9. contain instructions concerning who may be contacted for answers to pertinent questions; and 10. state the conditions of voluntary parti~ipation.~ When appropriate, one or more of the following elements shall also be provided. The informed consent procedure shall
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1. state that the procedure may involve unforeseeable risks; 2. state circumstances for termination of a subject’s participation by the investigator; 3. state possible additional costs to the subject; 4. describe consequences of a subject’s withdrawal from participation: 5. state that significant new findings will be provided to the subject; and 6. state the approximate number of subjects in the study.3
SPECIAL OR CAPTIVE SUBJECTS All human subjects deserve informed consent procedures as well as protection of rights, but some individuals need greater protection. These individuals are considered special or captive s ~ b j e c t sA. ~captive subject is one who feels compelled to participate in a study for economic reasons or from a perceived or actual negative threat if one refuses. Both positive and negative pressures can adversely influence the right of self-determinati~n.~ Special or captive subjects for research purposes are children, prisoners, and mentally incompetent and dying or seriously ill patients. In certain circumstances, university students required to participate as subjects in faculty’s research activity can be viewed as captive subject^.^^^ Subjects from low socioeconomic groups are considered to be more at risk for lack of the informed consent process because of increased communication problems between the investigator and subject. In Gray’s investigation, 40% of the women who had signed a consent form did not know that they were involved in a research study.6 The unaware women in the study were less educated and were more often black. Gray argued that the data supported the hypothesis that “the problem becomes more serious as the social distance between physician and prospective subject increases.” Laboring women should also be considered as special subjects for purposes of the informed consent process. Patients who are in active labor are more vulnerable and need special considerations by the researcher when obtaining informed, written consent. First, laboring patients are often in pain, and their attention is focused primarily on coping with the physical events of labor. Most laboring women find thinking about extraneous information difficult, and thus, their ability to consent voluntarily to participation is questioned. For example, an active laboring patient admitted to a labor unit was asked to participate in a study contrasting two positions in a birthing chair. A consent form was given to the patient, and
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the study was explained. Because t h e patient did not seem to understand the nature of the research, the investigator did not include the patient in the study. The following day, the patient stopped the investigator on the postpartum ward and volunteered that s h e came to the hospital specifically t o use the birthing chair for delivery. The patient said, however, that thinking about anything but the pain of labor and other procedures at the time of admission was impossible. Further questions or decisions seemed overwhelming to the patient at that time, despite interest in the research protocol and desire to use the birthing chair. Second, women fear being abandoned o r treated poorly during labor and delivery should they refuse to participate in the study. The desire for personal support can be an overwhelming motivating factor that, in some circumstances, could constitute coercion. For example, a laboring patient who presented as a potential research subject did not have an accompanying support person. As her participation in a research study was discussed, the patient explained that she would agree to any reasonable procedure if someone would stay with her during labor. Third, women fear for the safety, physical health, and welfare of the infant. The stress of labor exaggerates these fears and influences a patient t o consent to procedures that she might not consent to under less stressful circumstances. Fourth, patients may consent to procedures or protocols that offer any hope of relief of pain or may improve the progress of labor, irrespective of a given study’s or procedure’s merit. Researchers can unknowingly abuse the vulnerable state of laboring patients. Most nurse researchers a r e clinicians and believe their research ultimately will benefit patient care. But in their zeal for a researchbased practice, nurse researchers may compromise the individual’s rights. Research involving human subjects needs to be reviewed by committees that consider the subject’s best interest. Some researchers view these committees as cumbersome a n d as bureaucratic red tape, but an institutional review board is an asset to the researcher in two ways. First, even with best intentions, a researcher may be blind to the ways in which privacy is invaded in some aspect of the research. The judgment of an unbiased interdisciplinary group will help ensure that the major considerations-consent, anonymity, and confidentiality-are properly handled.7 Second, review committees give an additional element of protection of all participants-subjects, investigators, sponsoring agency, and those responsible for t h e subject’s welfare in the research: Even after approval of review committees is ob-
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tained, the danger of subtle pressure on captive subjects still exists. Hayter suggests, “Be sensitive to the possibility of such pressures, alert to their existence, and use all reasonable procedures to avoid undue influen~e.”~ RECOMMENDATIONS ~~
These guidelines are proposed for obtaining informed consent from laboring women 1. Provide the potential subject with information about the research, including procedures, risks,
and benefits, before labor, preferably in the third trimester. 2. When obtaining consent for a study before labor is not possible, the patient’s participation should be sought in early labor (less than 4 cm dilatation). Most patients are relatively comfortable during early labor, and the intervals between contractions allow adequate explanation and discussion. 3. When informed consent is sought during active labor (4 to 10 cm dilatation), provide information between contractions, and avoid other distractions so that the patient can focus on the request. 4. Discuss the research with the patient’s significant other who may be present. Frequently, couples have discussed preferences about procedures before labor. The family can help weigh the risks and benefits more objectively. 5. If the patient must be identified during labor for follow-up study but part of the data is not collected until the postpartum period, elicit the written consent during labor, and then explain the study again after delivery, with more information as nece~sary.~ Postpartum, the patient can think about the study and reaffirm participation with optimal information and opportunity to ask questions. 6. If the nurse is functioning as the principal investigator or data collector for a study, the nurse should be represented as a researcher, not as a care provider. The public is uninformed about nurse researchers and may assume that the nurse only provides patient care in the patient’s best interest. Patients need to understand clearly that they are research subjects, and nurses must be aware that their “positive public image may work against the patient’s best interest.”” 7. The researcher must take the responsibility to eliminate communication barriers.‘ Consent forms must be written in nontechnical terms at a level appropriate for the targeted subjects. After explaining the study, the researcher can ask the subject to explain in the subject’s own words the essence of the participation.
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Ensuring informed consent of subjects is essential for the continued credibility of the nursing profession. Even in seemingly innocuous studies, patients deserve the right to know they are involved in research. If individuals discover that they were unknowingly a research subject, they will be less likely to trust health-care providers. Uninformed consent in research negatively affects nursing’s public image and the cooperation of subjects for later studies. One might want to avoid human subject research in order to minimize dilemmas; however, maternalchild nurses are increasingly confronted with issues of informed consent.” More perinatal research is being conducted; more nurses are principal investigators or data collectors; nurses are using human subject research findings in their practice; and consumers are actively involved in the decision-making Nursing is moving toward a researchbased practice and needs to direct and assist in research that will promote better patient care scientifically. The American Nurses’ Association Human Rights Guidelines for Nurses in Clinical and Other Research state, “Just as nurses have an obligation to protect the human rights of patients so do they also have an obligation to support the accrual of knowledge that broadens the scientific underpinnings of nursing practice and the delivery of nursing ~ e r v i c e . ” ’ ~ If pregnant women do not participate in research, little progress can be made toward the goals of improved diagnosis of health needs, prevention of health problems, and provision of effective care to pregnant women and their infants. SUMMARY
The concern for human research subjects has progressed from the discovery of abuses of human subjects to the refinement of ethical standards and guidelines for vulnerable subjects. A s nurses become more directly involved in research as investigators or as professionals providing care to potential subjects, nurses are more aware of their professional and ethical responsibilities. Nurses are more often in the unique dual role of care provider and re~earcher.’~ The standards of patient care as well as the ethical and rigorous standards of research must be combined and preserved. The presented guidelines reflect an awareness of the nurse’s influence as a care provider and a sensitivity to the needs and vulnerability of laboring patients. In the process of refining knowledge about the effectiveness of various care practices that accompany childbirth, the dignity and rights of the patient-subjects who participate in the research must be preserved.
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ACKNOWLEDGMENT This work was partially funded by HHS Public Health Service, National Research Service Award, Nurse Research Predoctoral Fellowship, Division of Nursing, #5637-01 2-2-16080.
REFERENCES 1. Informed consent and human experimentation. In: Fromer MJ, ed. Ethical issues in health care. St. Louis: Mosby, 1981:268-311. 2. Beecher HK. Research and the individual, Appendix A. Boston: Little Brown, 1970. 3. US Department of Health and Human Services. Final regulations amending basic HHS policy for the protection of human research subjects. Federal Register 46(16):8366-89, January 26, 1981. 4. Lasagna L. Special subjects in human experimentation. In: Freund PA, ed. Experimentation with Human Subjects. New York George Braziller, 1970. 5. Hayter J. Issues related to human subjects. In: Downs FS, Fleming JW, eds. Issues in nursing research. New York: Appleton-Century-Crofts, 1979. 6. Gray BH. Human subjects in medical experimentation. New York: John Wiley & Sons, 1975. 7. Notter LE. Editorial: Protecting the rights of research subjects. Nurs Res 196918:483. 8. Creighton H. Legal concerns of nursing research. Nurs Res 1977;26377-40.
9. Diers D. Research in nursing practice. Philadelphia: Lippincott, 1979. 10. May KA. The nurse as researcher: impediment to informed consent? Nurs Outlook 1979;27:36-9. 11. Elsea SB. Ethics in maternal-child nursing. MCN 1985;lO: 303-5. 12. Ellis R. The nurse as investigator and member of the research team. Ann NY Acad Sci 1970;169:435-41. 13. Benoliel JO, Berthold JS. ANA’s human rights guidelines for nurses in clinical and other research. Kansas City: ANA, 1975. 14. Shatter MK, Pfeiffer IL. Nursing research and patients’ rights. AJN 1986;86:23-4.
Address for correspondence: Donna J. van Lier, 1079 Brittney Way, Norcross, GA 30093.
Donna van Lier is a nurse midwife at Grady Memorial Hospital and assistant professor at Neil Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia. She is a member of NAACOG, ACNM, and Sigma Theta Tau. Joyce Roberts is director and associate professor of the Graduate Nurse-Midwifery Program, School of Nursing, University of Colorado, Health Sciences, Denver, Colorado. She is a member of NAACOG, ACNM, and Sigma Theta Tau.
I MARCH OF DIMES TELECONFERENCE SCHEDULED The March of Dimes Birth Defects Foundation is sponsoring a two-hour live interactive teleconference “Environmental Risks and Pregnancy: What We Know, What We Don’t Know, and How to Answer Questions in Clinical Practice.” The teleconference is scheduled November 19, 1986, at 12:30 P.M. (EST). It will originate from Stamford, Connecticut, and will be transmitted by satellite to Washington, DC; Indianapolis, Indiana; Minneapolis, Minnesota; Valhalla, New York; Cleveland, Ohio; and Memphis, Tennessee. For details, contact Sue Greene, Conference Manager, March of Dimes Birth Defects Foundation, 1275 Mamaroneck Ave., White Plains, NY 10605; (914)428-7100. I
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