After reviewing the course textbook (attached), summarize the history of nursing research. Discuss the importance of nursing research as it relates to appl

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1. History and Process of Nursing Research, Evidence- Based Nursing Practice, and Quantitative and Qualitative Research Process

“If we knew what we were doing, it would not be called research, would it?” —Albert Einstein (WorkingMinds.com,

n.d., para. 53).

By June Helbig

Essential Questions

What is the history of human subject testing, and what has been its impact on current practices and informed consent? Why is it important for nurses to use evidence-based practices? Why is it important for nurses to perform research and contribute to generalizable knowledge?

Introduction Nurses strive to provide the best possible care to diverse clients under consistently changing conditions. From the medications administered to the type of dressing used to heal a wound, nurses apply procedures that have been tested through research and deemed appropriate according to evidence-based standards of practice. Through foundational knowledge related to research methods, translation of research data is used to improve nursing practice and, ultimately, patient outcomes. Therefore, nurses must become familiar with the specific language of scientific research and the research process.

Many historical events have shaped research practices, and guidelines have been developed to protect human subjects from inadvertent harm. Many nurses and physicians conduct research studies, but to do so, they must adhere to research practices that address ethical considerations for participants, ensure the integrity of the research process, and safeguard the public. This chapter outlines the historical events that have shaped modern research, providing a framework to introduce novice researchers to the foundations of research design and implementation.

History of Research As health care professionals, nurses seek to provide their patients with the best possible health care. To determine which approaches to care result in the best

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possible care, the effectiveness of each approach specific to a chosen population must be investigated. The pursuit of knowledge is the basis for research. Researchers seek to find answers to various scientific questions, but there are the boundaries associated with the pursuit of knowledge.

Nazi Medical Experiments (1933-1945)

During World War II, German physicians conducted unethical experiments on thousands of human prisoners at the Nazi concentration camps. These experiments were performed without consent and many times without anesthesia. The most notorious of these experiments occurred at the hands of Dr. Josef Mengele. Mengele worked at the Auschwitz concentration camp, called the killing center. Auschwitz, the largest of the concentration camps, was operational from 1940-1945. It was the site of medical experiments and various forms of research that were performed on infants, twins, and dwarfs. Forced sterilization and castration of adults occurred as well (U.S. Holocaust Memorial Museum [USHMM], n.d.-a.).

According to the United States Holocaust Memorial Museum (USHMM, n.d.-b), there were three categories of unethical medical experimentation, including “facilitating the survival of Axis military personnel,” (para. 2), testing different medications for illnesses and injuries, and advancing “the racial and ideological tenets of the Nazi worldview” (para. 4). The first category of experiments conducted at Dachau, another Nazi camp in nearby Germany, included high altitude experiments using low-pressure chambers, freezing experiments to find treatments for hypothermia, and various seawater experiments. Experiments for the second category involved injecting patients with various compounds to test treatments for contagious diseases, such as malaria, typhus, tuberculosis, typhoid fever, yellow fever, and infectious hepatitis. Prisoners were also exposed to deadly gases such as phosgene and mustard gas. The third category of experiments included the “mass sterilization of Jews, Roma, and other groups Nazi leaders considered to be racially or genetically undesirable” (USHMM, n.d.-b., para. 5). By the end of World War II, 6 million European Jews were murdered, and thousands of prisoners were forced to endure incredible pain and suffering without giving their consent for the acquisition of knowledge.

The Nazi physicians performed brutal medical experiments upon helpless concentration camp inmates. These acts of torture were characterized by several shocking features: (1) persons were forced to become subjects in very dangerous studies against their will; (2) nearly all subjects endured incredible suffering, mutilation, and indescribable pain; and (3) the experiments often were deliberately designed to terminate in a fatal outcome for their victims. (Cohen, n.d., para. 11)

The Nazi physicians were brought to justice before a military tribunal held in Nuremberg, Germany. Knowledge generated by the Nazi physicians exists today and can be used to generate new knowledge in several fields, but considerable debate surrounds the use of this information. Physicians and scientists who “have sought to use the Nazi research have … [examined at length] the social responsibility and

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potential abuses of science” (Cohen, n.d., para. 3). Researchers today must ask themselves whether it is appropriate to use the data.

Freezing Experiments

In another series of experiments, prisoners were placed into sub-zero water tanks to investigate how long pilots would survive if shot down over freezing waters. The Nazi physicians recorded data as prisoners were immersed and kept in frozen water for hours. “The Nazis meticulously recorded the changes in body temperature, heart rate, muscle response, and urine” (Cohen, n.d., para. 28). The data obtained described end-stage hypothermia in humans. Many years later, hypothermia research was performed involving cold-water survival suits to protect people from boating accidents in frigid waters and rewarming frozen victims of the cold. The scientists looking to save lives from hypothermia had concerns about whether or not they should use the data generated by the Nazi experiments. The only data currently available regarding extreme hypothermia is the data collected by Nazi physicians

High-Altitude Experiments

To simulate high altitude conditions, Nazi physicians used decompression chambers. The chambers simulated altitudes as high as 68,000 feet. The physicians monitored the subjects’ physiological responses as they succumbed to death. The victims’ brains were dissected while they were still alive to demonstrate that high-altitude sickness consisted of the formation of tiny air bubbles in the blood vessels of the brain. After death, the brains were studied, and additional data was obtained (Cohen, n.d.).

Experiments on Twins

Twins were studied extensively in the concentration camps. Mengele studied identical twins by injecting substances into one twin and when that twin died, he would kill the other twin and look for differences upon autopsy. Mengele was obsessed with “the Nazi ideology of racial purity and Aryanism led him to believe that he could unlock the secrets of human reproduction and multiple births” (Cohen, n.d., para. 24) through his research.

Whether the data gathered from these studies will help save lives in the present is unknown. The experiments cannot be replicated, and the integrity of the data itself may be in question. Applying data obtained in unethical studies also warrants consideration toward the victims and their families. As a direct result of these atrocities, regulations guiding research practice have been written.

Nuremberg Code

On October 18, 1945, 22 of Nazi Germany’s political, military, and economic leaders were brought to trial in Nuremberg, Germany for war crimes, and crimes against humanity. For the first time in history, an international military tribunal (IMT),

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composed of representatives from the Allied countries as well as representatives from Nazi-occupied countries, united to seek justice for victims.

The Nuremberg trials (see Figure 1.1) lasted from October 18, 1945 through October 1, 1946. All judgments against the Nazi leaders were completed on October 1, 1946. Of the 22 Nazi leaders placed on trial, “twelve were sentenced to death, three to life imprisonment, four to imprisonment ranging from 10 to 20 years, and three were acquitted” (USHMM, n.d.-c., para. 3). Through the course of the trial, the IMT was able to define the criminality of war, war crimes, and crimes against humanity. In a series of 12 additional trials, more than 100 defendants were tried for war crimes.

Figure 1.1

Defendants at the Nuremberg, Germany War Crimes Trial

Photo credit: National Archives and Records Administration.

The doctors’ trial followed the trial of the Nazi leaders. The question of medical experimentation on human beings was discussed. At the time, no rules or guidelines existed to govern research on human subjects. In April of 1947, a list of guidelines discussing voluntary consent as well as the rights, safety, and well-being of those

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participating in research studies was prepared and submitted to the United States Counsel for War Crimes. Initially, this list was called Permissible Medical Experiments, and it contained six points defining legitimate research. Shortly thereafter, the six points were expanded to 10 and was given the title the Nuremberg Code.

The Nuremberg Code was a landmark document and the first internationally accepted code to govern scientific research. Among the key tenants was informed consent and voluntary participation, which forms the basis for ethical conduct of research today. According to the principle of informed consent, human subjects must be informed of the purposes of the study, the possible risks and benefits associated with the study, and maintain the right of refusal at any time even after a study has been initiated. All forms of research must be conducted with integrity, transparency, confidentiality, and minimal risk to participants.

Nuremberg Code 1. The voluntary consent of the human subject is absolutely essential. 2. 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.

3. 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.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. 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.

6. 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.

7. Proper preparations should be made, and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. 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.

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9. 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.

10. 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 (USHMM, n.d.-d).

Declaration of Helsinki (1964)

In June of 1964, the “World Medical Association developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects” (World Health Organization, 2001, p. 373). The Declaration of Helsinki assured that protections of basic rights were extended to all groups, regardless of whether the group consisted of vulnerable populations. Historically, vulnerable populations included minority groups, prisoners, women, and children. Since the Declaration of Helsinki, the requirement is to state why any group, including vulnerable populations, were to be excluded from the research trial. Transparency is important to conducting ethical research. With the advancement of biomedical research, the public, as well as the human subject, must be knowledgeable of available research trials as well as the results of human subject research.

The Declaration of Helsinki continues to be an important document for research oversight. It mandates that not only are the successes discussed, but the failures are acknowledged as well. People have the right to know the inconclusive results. “The scientific enterprise must openly acknowledge that science improves through both failure and success” (Ndebele, 2013, para. 6). Researchers must be transparent with human subjects regarding the possible risks and benefits of the study, so the human subject can make an informed decision on whether to participate in the study. Part of the informed consent process involves giving the human subject sufficient information in a nonthreatening environment. The human subject must not be coerced or intimidated to participate in the research trial and must be given adequate time to make a decision. The researchers must respect the subject’s autonomy, ensuring that participation in the study is a choice. Informed consent is not only about signing a consent document, but it is a process that lasts from the beginning until the end of the study. The human subject can leave the study at any time without having any obligation to the person conducting the research study.

Tuskegee Syphilis Study (1932–1972)

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The Tuskegee Syphilis Study, officially titled the “Tuskegee Study of the Untreated Syphilis in the Negro Male” involved 600 African American men (Centers for Disease Control and Prevention [CDC], 2017).

Figure 1.2

Physician with Tuskegee Study Participant

Photo credit: Centers for Disease Control and Prevention

Researchers told the men they were being treated for “bad blood,” a local term used to describe several ailments, including syphilis, anemia, and fatigue. In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years. (CDC, 2017, para 2)

In 1972, the Associated Press reported on the Tuskegee Study, leading to public outcry. A review of the study was done by an advisory panel appointed by the assistant secretary for Health and Scientific Affairs. The panel found the men who had participated in the study had done so voluntarily; however, the panel found that the researchers never informed the men of the real purpose of the study, and the men were never given the appropriate treatment for syphilis even though one existed. In 1973, a lawsuit was filed for the participants and their families, and a year later, the parties reached $10 million settlement. By 1975, the men and their descendants were promised lifetime medical benefits and burial services. In 1997,

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President Bill Clinton offered a public apology to all the men and their families for the horrible treatment they received by the United States government (CDC, 2017).

Figure 1.3

President Bill Clinton and Tuskegee Study Patient Herman Shaw

Photo credit: Centers for Disease Control and Prevention

Willowbrook Study (mid 1950s to early 1970s)

In 1942, the Willowbrook School, a state school for the mentally disabled, was built on Staten Island, New York. The school housed 6,000 mentally handicapped children in a facility built to house 4,000 children. Many of the residents were orphaned with no one to speak for them or oversee the care they received. Hepatitis ran rampant at the overcrowded facility. In addition to poor conditions, medical researchers Saul Krugman and Robert McCollum carried out their own experiments there from the late 1950s to the 1970s, injecting hepatitis into the children identified as “mentally defective” to observe the natural course of the illness. “The children were deliberately infected with hepatitis in order to test the effects of gamma globulin, a practice justified by the researchers on the grounds that the children would probably contract the disease in any case” (Bence, 2011, para. 5). The study continued for 15 years and was officially closed in 1987 following public investigations of the mistreatment of children residing at the Willowbrook School. One of the most important consequences of the study was the development of the National Research Act of

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1974, which requires all research institutions receiving federal support to establish institutional review boards (IRBs) to review and approve research.

Brooklyn’s Jewish Chronic Disease Hospital (1960s)

Brooklyn’s Jewish Chronic Disease Hospital (JCDH) in New York, was the site of another unethical research trial. Elderly patients and those in need of long-term care were the primary patient population of JCDH. Dr. Chester Southam had suggested to physicians associated with JCDH “a collaborative research project with the JCDH. Southam hoped to initiate an evaluation of the immunologic status of patients with chronic non-neoplastic diseases, as revealed by promptness of rejection of subcutaneous cancer-cell homografts” (Hornblum, 2013, para. 5). Without informed consent, Southam injected live cancer cells into 22 elderly and long-term patients of JCDH to study how those patients reacted to the injections. Southam wanted to research if healthy patients would react the same way as those that were ill. Southam told the human subjects in the study they were receiving live human cells that were growing in a test tube. Southam conducted the study, but he asked three of his colleagues, Dr. Avir Kagan, Dr., David Leichter, and Dr. Perry Frersko, to join him in his research (Hornblum, 2013). Kagan, Leichter, and Frersko all refused to take part in the experiment and complained to the New York State Board of Regents. The three doctors thought Southam was acting like a Nazi physician by using human beings as guinea pigs. In 1963, the New York State Board of Regents found Southam guilty of fraud and unprofessional conduct (Hornblum, 2013).

Protection of Human Participants The research experiments described in this chapter demonstrate the potential for harm when research is practiced without consideration to human protections, in particular the protection of vulnerable groups. In 1962, Congress passed the Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic Act that required new drugs to be evaluated for safety and required informed consent when testing investigational drugs (National Academies Press, 2004b). Informed consent is not only a document the research subject signs; it is an ongoing process. The informed consent process remains ongoing for as long as the subject is participating in the study. The informed consent document must contain the purpose of the study, the risks and possible benefits of the study, the length of time participation is expected, and alternative treatments the subject can choose. Informed consent is ongoing, meaning the participant can withdraw from the study at any time.

Belmont Report (1978)

In 1974, the National Research Act was established, which brought about the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission provides ethical and policy analysis related to human research, including the Belmont Report (National Academies Press, 2004a). The Belmont Report “identified three fundamental ethical principles applicable to

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research with humans—respect for persons, beneficence, and justice—which translated respectively into provisions for informed consent, assessment of risk and potential benefits, and selection of participants” (National Academies Press, 2004a, p. 6).

Figure 1.4

Fundamental Principles of the Belmont Report

Consent should be obtained from fully informed participants and special consideration should be given to vulnerable persons. Vulnerable populations are groups of people who may lack the capacity to give consent or lack the capacity to understand. The informed consent must fully explain the study, and the participant should be given the opportunity to ask the researcher questions. Giving informed consent to participate is totally voluntary, and the participant can withdraw from the study without explanation at any time. All human beings have right to autonomy. There are vulnerable populations that, at times, must be excluded from participating in a research study. Those who are incapable of consent could have the informed consent of their legal guardian. All approvals for research studies are obtained from an IRB or ethics board to include vulnerable populations, such as:

Racial or ethnic minorities; Children; Pregnant women; Human fetuses; Neonates;

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Human in vitro fertilization; Employees; Military persons and students in hierarchical organizations; Terminally ill, comatose, and physically and intellectually challenged individuals; Institutionalized, elderly individuals, and visual or hearing impaired; Socioeconomically disadvantaged; Underinsured; Immigrants; Prisoners; and LGBTQI persons (Waisel, 2013).

Belmont Report: Basic Ethical Principles Respect for Persons

Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. (U.S. Department of Health & Human Services [HHS], n.d., para. 14)

Beneficence

Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. (HHS, n.d., para. 19)

Justice

Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is

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entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. (HHS, n.d., para. 23)

Institutional Review Board

An IRB or ethics board is an “appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research” (U.S. Food and Drug Administration [USDA], 2018, para. 2). Their role is to ensure that the rights of research participants are protected and that the investigator has complied with the rules and regulations of conducting research within the United States. The IRB is composed of at least five men and women with varying backgrounds and expertise, one of whom must not have a scientific background.

Code of Federal Regulations

The Federal Register, which is part of the National Archives and Records Administration, published a set of general rules and regulations, called the Code of Federal Regulations (CFRs). There are 50 titles, representing areas of federal regulation. The first set of CFRs was published in 1938. The titles of interest in research for the protection of human subjects include:

45 CFR 46, Protection of Human Subjects 21 CFR 50, Informed Consent 21 CFR 56, Institutional Review Boards

Table 1.1

Code of Federal Regulations

Code Title Description

45 CFR 46 Protection of Human Subjects

Offers basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by U.S. Department of Health & Human Services (HHS); risks to subjects are minimized; selection of

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subjects is equitable (HHS, 2009)

21 CFR 50 Informed Consent “No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative” (USDA, 2017a, para. 1)

21 CFR 56 Institutional Review Boards

IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications, or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects (USDA, 2018, para. 2).

The Office for Human Research Protections (OHRP) was established in 2000 to “protect human subjects in biomedical and behavioral research and to provide leadership for all federal agencies that conduct or support human subjects research under the Federal Policy for the Protection of Human Subjects, also known as the Common Rule” (HHS, 2016a, para. 1). The Common Rule is the U.S. policy for the protection of human subjects and was published in 1991. “The Common Rule outlines the basic provisions for Institutional Review Boards, informed consent, and Assurances of Compliance” (HHS, 2016b, para. 2).

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Health Insurance Portability and Accountability Act of 1996

Health Insurance Portability and Accountability Act of 1996 (HIPAA) was legislation passed to protect patient data and included security provisions for safeguarding medical information. This federal law or privacy rule provides people with rights over their health information and sets rules and limits on who can look at or use this information. “The Privacy Rule applies to all forms of individuals' protected health information, whether electronic, written, or oral. The Security Rule is a Federal law that requires security for health information in electronic form” (HHS, 2017b, para. 1).

History of Nursing Research Florence Nightingale was the first nurse researcher. Her first research study took place during the Crimean War in 1854. The war took place on the outskirts of Constantinople, Turkey. Nightingale started collecting data about the injured soldiers, including information about their injuries and whether they died. She took what she learned, applied her knowledge of statistics to the data she collected, and came up with some very significant results. The statistics showed that hundreds of the soldiers were dying from communicable and infectious diseases. She took her knowledge about cleanliness and the importance of a clean environment and applied it to current war environment. Nightingale believed if the environment was kept clean, the soldiers would not be exposed to infection or communicable diseases (Karimi & Alavi, 2015). With the knowledge gained from collecting data on the soldiers and their causes of death, Nightingale saved the lives of many men and women. In 1859, Florence Nightingale published Notes on Nursing, which described how environment can affect and promote health. This was basically the first nursing research article ever published. It took many years before any more nursing research was performed. Twenty years later, the committee for the Study of Nursing Education issued the Gol

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