Ethics in Research

Discuss the historical background that led to the creation of various codes of ethics

Understand the potential for ethical dilemmas stemming from conflicts between ethics and research demands

Identify the three primary ethical principles articulated in the Belmont Report and the important dimensions encompassed by each

Identify procedures for adhering to ethical principles and protecting study participants

Given sufficient information, evaluate the ethical dimensions of a research report

Define new terms in the chapter

Key Terms

Anonymity

Assent

Belmont Report

Beneficence

Certificate of Confidentiality

Code of ethics

Confidentiality

Consent form

Debriefing

Ethical dilemma

Full disclosure

Informed consent

Institutional Review Board (IRB)

Minimal risk

Risk/benefit assessment

Stipend

Vulnerable group

ETHICS AND RESEARCH

In any research with human beings or animals, researchers must address ethical issues. Ethical concerns are especially prominent in nursing research because the line between what constitutes the expected practice of nursing and the collection of research data sometimes gets blurred. This chapter discusses ethical principles that should be kept in mind when reading a study.

Historical Background

We might like to think that violations of moral principles among researchers occurred centuries ago rather than recently, but this is not the case. The Nazi medical experiments of the 1930s and 1940s are the most famous example of recent disregard for ethical conduct. The Nazi program of research involved using prisoners of war and “racial enemies” in medical experiments. The studies were unethical not only because they exposed people to harm but also because subjects could not refuse participation.

There are more recent examples. For instance, between 1932 and 1972, the Tuskegee Syphilis Study, sponsored by the U.S. Public Health Service, investigated the effects of syphilis among 400 poor African American men. Medical treatment was deliberately withheld to study the course of the untreated disease. It was revealed in 1993 that U.S. federal agencies had sponsored radiation experiments since the 1940s on hundreds of people, many of them prisoners or elderly hospital patients. And, in 2010, it was revealed that a U.S. doctor who worked on the Tuskegee study inoculated prisoners in Guatemala with syphilis in the 1940s. Other examples of studies with ethical transgressions have emerged to give ethical concerns the high visibility they have today.

Codes of Ethics

In response to human rights violations, various codes of ethics have been developed. The ethical standards known as the Nuremberg Code were developed in 1949 in response to the Nazi atrocities. Several other international standards have been developed, including the Declaration of Helsinki, which was adopted in 1964 by the World Medical Association and was most recently revised in 2013.

Most disciplines, such as medicine and nursing, have established their own code of ethics. In the United States, the American Nurses Association (ANA) issued Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research in 1995 (Silva, 1995). The ANA, which declared 2015 the Year of Ethics, published a revised Code of Ethics for Nurses with Interpretive Statements, a document that not only covers ethical issues for practicing nurses primarily but also includes principles that apply to nurse researchers. In Canada, the Canadian Nurses Association published the third edition of its Ethical Research Guidelines for Registered Nurses in 2002. And, the International Council of Nurses (ICN) developed the ICN Code of Ethics for Nurses, which was updated in 2012.

TIP Many useful websites are devoted to ethics and research, links to some of which are listed in the Internet Resources for this chapter on website.

Government Regulations for Protecting Study Participants

Governments throughout the world fund research and establish rules for adhering to ethical principles. In the United States, an important code of ethics was adopted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission issued a report in 1978, known as the Belmont Report, which provided a model for many guidelines adopted by disciplinary organizations in the United States. The Belmont Report also served as the basis for regulations affecting research sponsored by the U.S. government, including studies supported by the National Institute of Nursing Research (NINR). The U.S. ethical regulations have been codified at Title 45 Part 46 of the Code of Federal Regulations and were revised most recently in 2005.

Ethical Dilemmas in Conducting Research

Research that violates ethical principles typically occurs because a researcher believes that knowledge is potentially beneficial in the long run. For research problems, participants’ rights and study quality are put in direct conflict, posing ethical dilemmas for researchers. Here are examples of research problems in which the desire for rigor conflicts with ethical considerations:

1. Research question: Does a new medication prolong life in patients with AIDS?

Ethical dilemma: The best way to test the effectiveness of an intervention is to administer the intervention to some participants but withhold it from others to see if the groups have different outcomes. However, if the intervention is untested (e.g., a new drug), the group receiving the intervention may be exposed to potentially hazardous side effects. On the other hand, the group not receiving the drug may be denied a beneficial treatment.

2. Research question: Are nurses equally empathic in their treatment of male and female patients in the intensive care unit (ICU)?

Ethical dilemma: Ethics require that participants be aware of their role in a study. Yet, if the researcher informs nurse participants that their empathy in treating male and female ICU patients will be scrutinized, will their behavior be “normal”? If the nurses’ usual behavior is altered because of the known presence of research observers, then the findings will be inaccurate.

3. Research question: How do parents cope when their children have a terminal illness?

Ethical dilemma: To answer this question, the researcher may need to probe into parents’ psychological state at a vulnerable time, yet knowledge of the parents’ coping mechanisms might help to design effective ways of addressing parents’ grief and stress.

4. Research question: What is the process by which adult children adapt to the day-to-day stress of caring for a parent with Alzheimer’s disease?

Ethical dilemma: Sometimes, especially in qualitative studies, a researcher may get so close to participants that they become willing to share “secrets” and privileged information. Interviews can become confessions—sometimes of unseemly or illegal behavior. In this example, suppose a woman admitted to physically abusing her mother—how does the researcher respond to that information without undermining a pledge of confidentiality? And, if the researcher divulges the information to authorities, how can a pledge of confidentiality be given in good faith to other participants?

As these examples suggest, researchers are sometimes in a bind. Their goal is to develop high-quality evidence for practice, but they must also adhere to rules for protecting human rights. Another type of dilemma may arise if nurse researchers face conflict-of-interest situations, in which their expected behavior as nurses conflicts with standard research behavior (e.g., deviating from a research protocol to assist a patient). It is precisely because of such dilemmas that codes of ethics are needed to guide researchers’ efforts.

ETHICAL PRINCIPLES FOR PROTECTING STUDY PARTICIPANTS

The Belmont Report articulated three primary ethical principles on which standards of ethical research conduct are based: beneficence, respect for human dignity, and justice. We briefly discuss these principles and then describe methods researchers use to comply with them.

Beneficence

Beneficence imposes a duty on researchers to minimize harm and maximize benefits. Human research should be intended to produce benefits for participants or, more typically, for others. This principle covers multiple aspects.

The Right to Freedom From Harm and Discomfort

Researchers have an obligation to prevent or minimize harm in studies with humans. Participants must not be subjected to unnecessary risks of harm or discomfort, and their participation in research must be necessary for achieving societally important aims. In research with humans, harm and discomfort can be physical (e.g., injury), emotional (e.g., stress), social (e.g., loss of social support), or financial (e.g., loss of wages). Ethical researchers must use strategies to minimize all types of harms and discomforts, even ones that are temporary.

Protecting human beings from physical harm is often straightforward, but it may be more difficult to address psychological issues. For example, participants may be asked questions about their personal lives. Such queries might lead people to reveal deeply personal information. The need for sensitivity may be greater in qualitative studies, which often involve in-depth exploration into highly personal areas. Researchers need to be aware of the nature of the intrusion on people’s psyches.

The Right to Protection From Exploitation

Involvement in a study should not place participants at a disadvantage. Participants need to be assured that their participation, or information they provide, will not be used against them. For example, people describing their economic situation should not risk loss of public health benefits; people reporting drug abuse should not fear being reported for a crime.

Study participants enter into a special relationship with researchers, and this relationship should not be exploited. Because nurse researchers may have a nurse–patient (in addition to a researcher–participant) relationship, special care may be needed to avoid exploiting that bond. Patients’ consent to participate in a study may result from their understanding of the researcher’s role as nurse, not as researcher.

In qualitative research, psychological distance between researchers and participants often declines as the study progresses. The emergence of a pseudotherapeutic relationship is not uncommon, which could create additional risks that exploitation could inadvertently occur. On the other hand, qualitative researchers often are in a better position than quantitative researchers to do good, rather than just to avoid doing harm, because of the close relationships they develop with participants.

Example of therapeutic research experiences

Beck et al. (2015) found that some participants in their study on secondary traumatic stress among certified nurse-midwives told the researchers that writing about the traumatic births they had attended was therapeutic for them. One participant wrote, “I think it’s fascinating how little respect our patients and coworkers give to the traumatic experiences we suffer. It is healing to be able to write out my experiences in this study and actually have researchers interested in studying this topic.”

Respect for Human Dignity

Respect for human dignity is the second ethical principle in the Belmont Report. This principle includes the right to self-determination and the right to full disclosure.

The Right to Self-Determination

The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking prejudicial treatment. It also means that people have the right to ask questions, refuse answering questions, and drop out of the study.

A person’s right to self-determination includes freedom from coercion. Coercion involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate. The issue of coercion requires careful thought when researchers are in a position of authority or influence over potential participants, as might be the case in a nurse–patient relationship. Coercion can be subtle. For example, a generous monetary incentive (or stipend) to encourage the participation of a low-income group (e.g., the homeless) might be considered mildly coercive because such incentives may be seen as a form of pressure.

The Right to Full Disclosure

Respect for human dignity encompasses people’s right to make informed decisions about study participation, which requires full disclosure. Full disclosure means that the researcher has fully described the study, the person’s right to refuse participation, and potential risks and benefits. The right to self-determination and the right to full disclosure are the two elements on which informed consent (discussed later in this chapter) is based.

Full disclosure is not always straightforward because it can create biases and sample recruitment problems. Suppose we were testing the hypothesis that high school students with a high absentee rate are more likely to be substance abusers than students with good attendance. If we approached potential participants and fully explained the study’s purpose, some students might refuse to participate, and nonparticipation would be selective; students who are substance abusers—the group of primary interest—might be least likely to participate. Moreover, by knowing the study purpose, those who participate might not give candid responses. In such a situation, full disclosure could undermine the study.

In such situations, researchers sometimes use covert data collection (concealment), which is collecting data without participants’ knowledge and thus without their consent. This might happen if a researcher wanted to observe people’s behavior and was worried that doing so openly would change the behavior of interest. Researchers might choose to obtain needed information through concealed methods, such as observing while pretending to be engaged in other activities.

A more controversial technique is the use of deception, which can involve deliberately withholding information about the study or providing participants with false information. For example, in studying high school students’ use of drugs, we might describe the research as a study of students’ health practices, which is a mild form of misinformation.

Deception and concealment are problematic ethically because they interfere with people’s right to make truly informed decisions about personal costs and benefits of participation. Some people think that deception is never justified, but others believe that if the study involves minimal risk yet offers benefits to society, then deception may be acceptable.

Full disclosure has emerged as a concern in connection with data collected over the Internet (e.g., analyzing the content of messages posted to blogs or social media sites). The issue is whether such messages can be used as data without the authors’ consent. Some researchers believe that anything posted electronically is in the public domain, but others feel that the same ethical standards must apply in cyberspace research and that researchers must carefully protect the rights of individuals who are participants in “virtual” communities.

Justice

The third principle articulated in the Belmont Report concerns justice, which includes participants’ right to fair treatment and their right to privacy.

The Right to Fair Treatment

One aspect of justice concerns the equitable distribution of benefits and burdens of research. The selection of participants should be based on research requirements and not on people’s vulnerabilities. For example, groups with lower social standing (e.g., prisoners) have sometimes been selected as study participants, raising ethical concerns.

Potential discrimination is another aspect of distributive justice. During the 1990s, it was found that women and minorities were being excluded from many clinical studies. In the United States, this led to regulations requiring that researchers who seek funding from the National Institutes of Health (including NINR) include women and minorities as study participants.

The right to fair treatment encompasses other obligations. For example, researchers must treat people who decline to participate in a study in a nonprejudicial manner, they must honor all agreements made with participants, they must show respect for the beliefs of people from different backgrounds, and they must treat participants courteously and tactfully at all times.

The Right to Privacy

Research with humans involves intrusions into people’s lives. Researchers should ensure that their research is not more intrusive than it needs to be and that privacy is maintained. Participants have the right to expect that any data they provide will be kept in strict confidence.

Privacy issues have become even more salient in the U.S. health care community since the passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which articulates federal standards to protect patients’ medical records and health information. For health care providers who transmit health information electronically, compliance with HIPAA regulations (the Privacy Rule) has been required since 2003.

PROCEDURES FOR PROTECTING STUDY PARTICIPANTS

Now that you are familiar with ethical principles for conducting research, you need to understand the procedures researchers use to adhere to them. It is these procedures that should be evaluated in critiquing the ethical aspects of a study.

TIP Information about ethical considerations is usually presented in the method section of a research report, often in a subsection labeled “Procedures.”

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