Ethical Issues in Research and Ethical Considerations

Chapter 4 Examining Ethics in Nursing Research Learning Outcomes After completing this chapter, you should be able to: 1.Identify the historical events influencing the development of ethical codes and regulations for nursing and biomedical research. • 2.Describe the ethical principles that are important in conducting research on human subjects. • 3.Describe the human rights that require protection in research. • 4.Identify the essential elements of the informed consent process in research. • 5.Describe the role of a nurse in the institutional review of research in an agency. • 6.Examine the benefit-risk ratio of published studies and studies proposed for conduct in clinical agencies. • 7.Describe the types of possible scientific misconduct in the conduct, reporting, and publication of healthcare research. • 8.Critically appraise the protection of human rights and the informed consent and institutional review processes in published studies. • 9.Critically appraise the treatment of animals reported in published studies. • Key Terms Anonymity, p. 106 Assent to participate in research, p. 102 Autonomous agents, p. 101 Benefit-risk ratio, p. 119 Breach of confidentiality, p. 107 Coercion, p. 101 Confidentiality, p. 107 Consent form, p. 112 Covered entities, p. 105 Covert data collection, p. 101 Data use agreement, p. 106 Deception, p. 101 Diminished autonomy, p. 101 Discomfort and harm, p. 108 Ethical principles, p. 98 Principle of beneficence, p. 98 Principle of justice, p. 98 Principle of respect for person(s), p. 98 Fabrication in research, p. 122 Falsification of research, p. 122 Health Insurance Portability and Accountability Act (HIPAA), p. 99 Human rights, p. 100 Individually identifiable health information, p. 105 Informed consent, p. 111 Institutional review, p. 117 Complete review, p. 118 Exempt from review, p. 117 Expedited review, p. 118 Institutional review board (IRB), p. 117 Invasion of privacy, p. 105 Minimal risk, p. 118 Nontherapeutic research, p. 96 Permission to participate in research, p. 102 Plagiarism, p. 122 Privacy, p. 105 Research misconduct, p. 122 Therapeutic research, p. 96 Voluntary consent, p. 113 Ethical research is essential for generating sound empirical knowledge for evidence-based practice, but what does ethical conduct of research involve? This is a question that researchers, philosophers, lawyers, and politicians have debated for many years. The debate continues, probably because of the complexity of human rights issues, the focus of research in new and challenging arenas of technology and genetics, the complex ethical codes and regulations governing research, and the various interpretations of these codes and regulations. This chapter introduces you to the national and international codes and regulations developed to promote the ethical conduct of research. You might think that unethical studies that violate subjects’ rights are a thing of the past, but this is not the case. There are still situations in which researchers do not protect the subjects’ privacy adequately or the study participants are treated unfairly or harmed during a study. Another serious ethical problem that has increased over the last 20 years is research misconduct. Research misconduct includes incidences of fabrication, falsification, or plagiarism in the process of conducting and reporting research in nursing and other healthcare disciplines (Office of Research Integrity [ORI], 2013). Ethical Issues in Research and Ethical Considerations

 You need to be able to appraise the ethical aspects of published studies and of research conducted in clinical agencies critically. Most published studies include ethical information about subject selection and treatment during data collection in the methods section of the report. Institutional review boards (IRBs) in universities and clinical agencies have been organized to examine the ethical aspects of studies before they are conducted. Nurses often are members of IRBs and participate in the review of research for conduct in clinical agencies. To provide you with a background for examining ethical aspects of studies, this chapter describes the ethical codes and regulations that currently guide the conduct of biomedical and behavioral research. The following elements of ethical research are detailed: (1) protecting human rights; (2) understanding informed consent; (3) understanding institutional review of research; and (4) examining the balance of benefits and risks in a study. This chapter also provides critical appraisal guidelines for examining the ethical aspects of studies. The chapter concludes with a discussion of two additional important ethical issues, research misconduct and the use of animals in research. Historical Events Influencing the Development of Ethical Codes and Regulations Since the 1940s, four experimental projects have been highly publicized for their unethical treatment of human subjects: the Nazi medical experiments, the Tuskegee Syphilis Study, the Willowbrook Study, and the Jewish Chronic Disease Hospital Study (Berger, 1990, Levine, 1986). Ethical Issues in Research and Ethical Considerations

Although these were biomedical studies and the primary investigators were physicians, the evidence suggests that nurses understood the nature of the research, identified potential research subjects, delivered treatments to the subjects, and served as data collectors. These unethical studies demonstrate the importance of ethical conduct for nurses while they are reviewing or participating in nursing or biomedical research (Fry, Veatch, & Taylor, 2011, Havens, 2004). These studies also influenced the formulation of ethical codes and regulations that currently direct the conduct of research. Nazi Medical Experiments From 1933 to 1945, the Third Reich in Europe was engaged in atrocious and unethical medical activities. The programs of the Nazi regime included sterilization, euthanasia, and medical experimentation for the purpose of producing a population of “racially pure” Germans who were destined to rule the world. The medical experiments were conducted on prisoners of war and persons considered to be racially valueless, such as Jews, who were confined in concentration camps. The experiments involved exposing subjects to high altitudes, freezing temperatures, malaria, poisons, spotted fever (typhus), or untested drugs and performing surgical procedures, usually without any form of anesthesia for the subjects. Extensive examination of the records from some of these studies indicated that they were poorly conceived and conducted. Therefore this research was not only unethical but also generated little if any useful scientific knowledge (Berger, 1990, Steinfels & Levine, 1976).

The Nazi experiments violated numerous rights of the research subjects. The selection of subjects for these studies was racially based and unfair, and the subjects had no choice—they were prisoners who were forced to participate. As a result of these experiments, subjects frequently were killed or they sustained permanent physical, mental, and social damage (Levine, 1986). Nuremberg Code Those involved in the Nazi experiments were brought to trial before the Nuremberg Tribunals, and their unethical research received international attention. The mistreatment of human subjects in Box 4-1 The Nuremberg Code The voluntary consent of the human subject is absolutely essential. …

The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur, except, perhaps, in those experiments where the experimental physicians also serve as subjects. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. From U.S. Department of Health and Human Services, Office of Human Research Protection (OHRP). 2013. The Nuremberg Code (1949). Retrieved June 9, 2013 from,  Ethical Issues in Research and Ethical Considerations http://www.hhs.gov/ohrp/archive/nurcode.html. these studies led to the development of the Nuremberg Code in 1949. Box 4-1 presents this code. The code includes guidelines that should help you evaluate the consent process, protection of subjects from harm, and balance of benefits and risks in a study (U.S. Department of Health and Human Services [U.S. DHHS], Office of Human Research Protection [OHRP], 2013). Declaration of Helsinki The Nuremberg Code provided the basis for the development of the Declaration of Helsinki, which was adopted in 1964 and revised most recently in 2008 by the World Medical Association (WMA, 2008). A major focus of the initial document was the differentiation of therapeutic research from nontherapeutic research. Therapeutic research provides patients with an opportunity to receive an experimental treatment that might have beneficial results. Nontherapeutic research is conducted to generate knowledge for a discipline; the results of the study might benefit future patients but probably will not benefit those acting as research participants. The Declaration of Helsinki includes the following ethical principles: (1) the investigator should protect the life, health, privacy, and dignity of human subjects; (2) the investigator should exercise greater care to protect subjects from harm in nontherapeutic research; and (3) the investigator should conduct research only when the importance of the objective outweighs the inherent risks and burdens to the subjects. The most recent addition to the Declaration of Helsinki is that researchers must use extreme caution in studies in which participants receive a placebo or sham treatment. For example, in studies testing the effectiveness of a drug, the placebo group would receive a pill with no medication and the experimental group would receive a pill with the drug. Ethical Issues in Research and Ethical Considerations

Researchers must provide the participants in the placebo group with access to proven diagnostic and therapeutic procedures after the study (WMA, 2008). The ethical principles of the Declaration of Helsinki are available online at http://www.wma.net/en/30publications/10policies/b3. Most institutions in which clinical research is conducted adopted the Nuremberg Code and Declaration of Helsinki; however, episodes of unethical research continued to occur in biomedical and behavioral studies. Tuskegee Syphilis Study In 1932 the U.S. Public Health Service initiated a study of syphilis in African American men in the small rural town of Tuskegee, Alabama (Rothman, 1982). The study, which continued for 40 years, was conducted to determine the natural course of syphilis in African American men. Many of the subjects who consented to participate in the study were not informed about the purpose and procedures of the research. Some were unaware that they were subjects in a study. By 1936 it was apparent that the men with syphilis had developed more complications than the men in the control group. Ten years later the death rate among those with syphilis was twice as high as it was for the control group. The subjects were examined periodically but were not treated for syphilis, even when penicillin was determined to be an effective treatment for the disease in the 1940s. Information about an effective treatment for syphilis was withheld from the subjects, and deliberate steps were taken to deprive them of treatment (Brandt, 1978). Published reports of the Tuskegee Syphilis Study started appearing in 1936, and additional papers were published every 4 to 6 years. No effort was made to stop the study; in fact, in 1969 the Centers for Disease Control and Prevention (then called the Center for Disease Control) decided that the study should continue. In 1972, an account of the study in the Washington Star sparked public outrage; only then did the U.S. Department of Health, Education, and Welfare (DHEW) stop the study. The study was investigated and found to be ethically unjustified (Brandt, 1978). vEthical Issues in Research and Ethical Considerations

Willowbrook Study From the mid-1950s to the early 1970s, Dr. Saul Krugman conducted research on hepatitis at Willowbrook, an institution for the mentally retarded in Staten Island, New York (Rothman, 1982). The subjects were children who were deliberately infected with the hepatitis virus. During the 20-year study, Willowbrook closed its doors to new inmates because of overcrowded conditions. However, the research ward continued to admit new inmates, and parents had to give permission for their child to be in the study to gain admission to the institution. From the late 1950s to the early 1970s, Krugman’s research team published several articles describing the study protocol and findings. In 1966 Beecher cited the Willowbrook Study in the New England Journal of Medicine as an example of unethical research. The investigators defended injecting the children with the hepatitis virus because they believed that most of the children would acquire the infection on admission to the institution. They also stressed the benefits the subjects received, which were a cleaner environment, better supervision, and a higher nurse-to-patient ratio on the research ward (Rothman, 1982). Despite the controversy, this unethical study continued until the early 1970s. Jewish Chronic Disease Hospital Study Another highly publicized unethical study was conducted at the Jewish Chronic Disease Hospital in New York in the 1960s. The purpose of this study was to determine patients’ rejection responses to live cancer cells. A suspension containing live cancer cells that had been generated from human cancer tissue was injected into 22 patients (Levine, 1986). Because researchers did not inform these patients that they were taking part in a study or that the injections they received were live cancer cells, their rights were not protected. In addition, the study was never presented for review to the research committee of the Jewish Chronic Disease Hospital, and the physicians caring for the patients were unaware that the study was being conducted. The physician directing the research was an employee of the Sloan-Kettering Institute for Cancer Research; there was no indication that this institution had conducted a review of the research project (Hershey & Miller, 1976). This unethical study was conducted without the informed consent of the subjects and without institutional review and had the potential to injure, disable, or cause the death of the human subjects. The study was stopped immediately and steps were taken to ensure proper care for the patients exposed to the cancer cells and to review all future research to be conducted by this agency. Department of Health, Education, and Welfare, 1973: Regulations for the Protection of Human Research Subjects The continued conduct of harmful, unethical research from the 1960s to the 1970s made additional controls necessary. In 1973 the DHEW published its first set of regulations for the protection of human research subjects. These regulations also provided protection for persons having limited capacity to consent, such as those who are ill, mentally impaired, or dying (Levine, 1986). According to the DHEW regulations, all research involving human subjects had to undergo full institutional review, which increased the protection of human subjects. However, reviewing all studies without regard for the degree of risk involved greatly increased the time for study approval and reduced the number of studies conducted. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Because the DHEW regulations did not resolve the issue of protecting human subjects in research, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed in 1978. This commission was established by the National Research Act (Public Law 93-348), which was passed in 1974.

The commission identified three ethical principles relevant to the conduct of research involving human subjects: respect for persons, beneficence, and justice. The principle of respect for persons indicates that people should be treated as autonomous agents, with the right to self-determination and the freedom to participate or not participate in research. Those persons with diminished autonomy, such as children, people who are terminally or mentally ill, and prisoners, are entitled to additional protection. The principle of beneficence encourages the researcher to do good and “above all, do no harm.” The principle of justice states that human subjects should be treated fairly in terms of the benefits and the risks of research. Before it was dissolved in 1978, the commission developed ethical research guidelines based on these three principles and made recommendations to the U.S. DHHS in the Belmont Report. (Information on this report and the three ethical principles—respect for persons, beneficence, and justice—are available online at http://or.org/pdf/BelmontReport.pdf). Greaney and colleagues (2012)studied these ethical principles and provided guidelines for applying them in reviewing and conducting nursing research. Regretfully, violations of human subjects’ rights continue to occur, as evident in letters written by the Office of Human Research Protection (http://www.hhs.gov/ohrp/index.html). Ethical Issues in Research and Ethical Considerations

These violations include omitting required information from informed consent documents, failing to update the consent document when additional information was available about potential risks, and beginning data collection prior to having the study approved by the IRB. In December 2011, the Presidential Commission for the Study of Bioethics Issues released its report, Moral Science: Protecting Participants in Human Subjects Research, which included recommendations for enhancing the protection of human subjects. Current Federal Regulations for the Protection of Human Subjects In response to the recommendations presented in the Belmont Report, the U.S. DHHS developed a set of federal regulations for the protection of human research subjects in 1981, which have been revised over the years; the most current regulations were approved in 2009. The 2009 regulations are part of the Code of Federal Regulations (CFR), Title 45, Part 46, Protection of Human Subjects (U.S. DHHS, 2009). These regulations provide direction for the (1) protection of human subjects in research, with additional protection for pregnant women, human fetuses, neonates, children, and prisoners; (2) documentation of informed consent; and (3) implementation of the IRB process. You can access these reg … Ethical Issues in Research and Ethical Considerations