3.1 Human subjects research

While all research comes with its own set of ethical concerns, those associated with research conducted on human subjects vary dramatically from those of research conducted on nonliving entities. The US Department of Health and Human Services (USDHHS) defines a human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (USDHHS, 1993, para. 1).^[1] Many social work researchers prefer the term “participants” to “subjects'” as it acknowledges the agency of people who participate in the study. For our purposes, we will use the term participants except when referring to “human subjects research” or when the term “human subjects” is used in policy.

In some states, human subjects also include deceased individuals and human fetal materials. Nonhuman research subjects, on the other hand, are objects or entities that investigators manipulate or analyze in the process of conducting research. Nonhuman research subjects typically include sources such as newspapers, historical documents, pieces of clothing, television shows, buildings, and even garbage (to name just a few), that are analyzed for unobtrusive research projects. Unsurprisingly, research on human subjects is regulated much more heavily than research on nonhuman subjects. This is why many student research projects use data that is publicly available, rather than recruiting their own study participants. However, there are ethical considerations that all researchers must take into account, regardless of their research subject. We’ll discuss those considerations in addition to concerns that are unique to human subject research.

Why do research participants need protection?

First and foremost, we are professionally bound to engage in the ethical practice of research. This chapter discusses ethical research and will show you how to engage in research that is consistent with the NASW Code of Ethics as well as national and international ethical standards to which all researchers are accountable. Before we begin, we need to understand the historical occurrences that were the catalyst for the formation of the current ethical standards. This chapter will enable you to view ethics from micro, meso, and macro perspectives.

The research process has led to many life-changing discoveries; these have improved life expectancy, improved living conditions, and helped us understand what contributes to certain social problems. That said, not all research has been conducted in respectful, responsible, or humane ways. Unfortunately, some research projects have dramatically marginalized, oppressed, and harmed participants and whole communities.

The sad fact is that not only did all of these occur, in many instances, these travesties continued for years until exposed and halted.

Does it sound as if ethical breaches in research are something that are relegated to the past? Unfortunately, that’s not the case. Take for instance research funded by the U.S. Department of Health & Human Services. Their Office of Research Integrity publishes verified research misconduct from their funded research. You can check out their case summaries to read about the ethical violations and their consequences.

Additionally, these examples have contributed to the formation of a legacy of distrust toward research. Specifically, many historically oppressed groups have a deep distrust of agencies that implement research and are often skeptical of research findings. This has made it difficult for individuals and communities to support and have confidence in medical treatments, advances in social service programs, and evidence-informed policy changes. While the aforementioned unethical examples may have ended, this deep and painful wound on the public’s trust remains. Consequently, we must be vigilant in our commitment to ethical research.

Many of the situations described may seem like extreme historical cases of misuse of power as researchers. However, ethical problems in research aren’t only extreme examples that took place in the past. None of us are immune to making unethical choices and the ethical practice of research requires conscientious mindful attention to what we are asking of our research participants. A few examples of less noticeable ethical issues might include: failing to fully explain to someone in advance what their participation might involve because you are in a rush to recruit a large enough sample; or only presenting findings that support your ideas to help secure a grant that is relevant to your research area. Remember, any time research is conducted with human beings, there is the chance that ethical violations may occur that pose social, emotional, and even physical risks for groups, and this is especially true when vulnerable or oppressed groups are involved.

A brief history of unethical social science research

Research on humans hasn’t always been regulated in the way it is today. The earliest documented cases of research using human subjects are of medical vaccination trials (Rothman, 1987).^[14]  One such case took place in the late 1700s, when scientist Edward Jenner exposed an 8-year-old boy to smallpox in order to identify a vaccine for the devastating disease. Medical research on human subjects continued without much law or policy intervention until the mid-1900s when, at the end of World War II, a number of Nazi doctors and scientists were put on trial for conducting human experimentation during the course of which they tortured and murdered many concentration camp inmates (Faden & Beauchamp, 1986).^[15]

The trials, conducted in Nuremberg, Germany, resulted in the creation of the Nuremberg Code, a 10-point set of research principles designed to guide doctors and scientists who conduct research on human subjects. Today, the Nuremberg Code guides medical and other research conducted on human subjects, including social scientific research.

Medical scientists are not the only researchers who have conducted questionable research on humans. In the 1960s, psychologist Stanley Milgram (1974)^[16] conducted a series of experiments designed to understand obedience to authority in which he tricked subjects into believing they were administering an electric shock to other subjects. In fact, the shocks weren’t real at all, but some, though not many, of Milgram’s research participants experienced extreme emotional distress after the experiment (Ogden, 2008).^[17] A reaction of emotional distress is understandable. The realization that one is willing to administer painful shocks to another human being just because someone who looks authoritative has told you to do so might indeed be traumatizing—even if you later learn that the shocks weren’t real.

Around the same time that Milgram conducted his experiments, sociology graduate student Laud Humphreys (1970)^[18] was collecting data for his dissertation on the tearoom trade, which was the practice of men engaging in anonymous sexual encounters in public restrooms. Humphreys wished to understand who these men were and why they participated in the trade. To conduct his research, Humphreys offered to serve as a “watch queen,” in a local park restroom where the tearoom trade was known to occur. His role would be to keep an eye out for police while also getting the benefit of being able to watch the sexual encounters. What Humphreys did not do was identify himself as a researcher to his research subjects. Instead, he watched his subjects for several months, getting to know several of them, learning more about the tearoom trade practice, and without the knowledge of his research subjects, jotting down their license plate numbers as they pulled into or out of the parking lot near the restroom.

After participating as a watch queen, with the help of several insiders who had access to motor vehicle registration information, Humphreys used those license plate numbers to obtain the names and home addresses of his research subjects. Then, disguised as a public health researcher, Humphreys visited his subjects in their homes and interviewed them about their lives and their health. Humphreys’ research dispelled a good number of myths and stereotypes about the tearoom trade and its participants. He learned, for example, that over half of his subjects were married to women and many of them did not identify as gay or bisexual.^[19]

Once Humphreys’ work became public, there was some major controversy at his home university where the chancellor tried to have his degree revoked. Some scientists and members of the public, as it raised public concerns about the purpose and conduct of how  about how social science research was conducted and for what purpose. In addition, the Washington Post journalist Nicholas von Hoffman wrote the following warning about “sociological snoopers”:

We are so preoccupied with defending our privacy against insurance investigators, dope sleuths, counterespionage men, divorce detectives and credit checkers, that we overlook the social scientists behind the hunting blinds who’re also peeping into what we thought were our most private and secret lives. But they are there, studying us, taking notes, getting to know us, as indifferent as everybody else to the feeling that to be a complete human involves having an aspect of ourselves that’s unknown (von Hoffman, 1970).^[20]

In the original version of his report, Humphreys defended the ethics of his actions. In 2008, years after Humphreys’ death, his book was reprinted with the addition of a retrospect on the ethical implications of his work. In his written reflections on his research and the fallout from it, Humphreys maintained that his tearoom observations constituted ethical research on the grounds that those interactions occurred in public places. But Humphreys added that he would conduct the second part of his research differently. Rather than trace license numbers and interview unwitting tearoom participants in their homes under the guise of public health research, Humphreys instead would spend more time in the field and work to cultivate a pool of informants. Those informants would know that he was a researcher and would be able to fully consent to being interviewed. In the end, Humphreys concluded “there is no reason to believe that any research subjects have suffered because of my efforts, or that the resultant demystification of impersonal sex has harmed society” (Humphreys, 2008, p. 231).^[21]

Today, given increasing regulation of social scientific research, chances are slim that a researcher would be allowed to conduct a project similar to Humphreys’. Some argue that Humphreys’ research was deceptive, put his subjects at risk of losing their families and their positions in society, and was therefore unethical (Warwick, 1973; Warwick, 1982).^[22] Others suggest that Humphreys’ research “did not violate any premise of either beneficence or the sociological interest in social justice” and that the benefits of Humphreys’ research, namely the dissolution of myths about the tearoom trade specifically and human sexual practice more generally, outweigh the potential risks associated with the work (Lenza, 2004, p. 23).^[23] What do you think, and why?

These and other studies led to increasing public awareness of and concern about research on human subjects.

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One such study is the Tuskegee Syphilis Experiment, conducted in Alabama from the 1930s to the 1970s. The goal of the study was to understand the natural progression of syphilis in human beings. Investigators working for the Public Health Service enrolled hundreds of poor African American men in the study, some of whom had been diagnosed with syphilis and others who had not. Even after effective syphilis treatment was identified in the 1940s, research participants were denied treatment so that researchers could continue to observe the progression of the disease. The study came to an end in 1972 after knowledge of the experiment became public. In 1997, President Clinton publicly apologized on behalf of the American people for the study (http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html).

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A particularly tragic example is the Tuskegee syphilis study conducted by the U.S. Public Health Service from 1932 to 1972 (Reverby, 2009). The participants in this study were poor African American men in the vicinity of Tuskegee, Alabama, who were told that they were being treated for “bad blood.” Although they were given some free medical care, they were not treated for their syphilis. Instead, they were observed to see how the disease developed in untreated patients. Even after the use of penicillin became the standard treatment for syphilis in the 1940s, these men continued to be denied treatment without being given an opportunity to leave the study. The study was eventually discontinued only after details were made known to the general public by journalists and activists. It is now widely recognized that researchers need to consider issues of justice and fairness at the societal level.

In 1997—65 years after the Tuskegee Syphilis Study began and 25 years after it ended—President Bill Clinton formally apologized on behalf of the US government to those who were affected. Here is an excerpt from the apology:

So today America does remember the hundreds of men used in research without their knowledge and consent. We remember them and their family members. Men who were poor and African American, without resources and with few alternatives, they believed they had found hope when they were offered free medical care by the United States Public Health Service. They were betrayed.

Researchers must respect people’s rights and dignity as human beings. One element of this is respecting their autonomy—their right to make their own choices and take their own actions free from coercion. Of fundamental importance here is the concept of informed consent. This means that researchers obtain and document people’s agreement to participate in a study after having informed them of everything that might reasonably be expected to affect their decision. Consider the participants in the Tuskegee study. Although they agreed to participate in the study, they were not told that they had syphilis but would be denied treatment for it. Had they been told this basic fact about the study, it seems likely that they would not have agreed to participate. Likewise, had participants in Milgram’s study been told that they might be “reduced to a twitching, stuttering wreck,” it seems likely that many of them would not have agreed to participate. In neither of these studies did participants give true informed consent.

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In 1974, the US Congress enacted the National Research Act, which created the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. In 1979, the commission produced The Belmont Report, a document outlining basic ethical principles for research on human subjects (National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, 1979).^[24] The National Research Act (1974)^[25] also required that all institutions receiving federally funded research money establish institutional review boards (IRBs) to protect the rights of human research subjects. Since that time, many organizations that do not receive federal support but where research is conducted have also established review boards to evaluate the ethics of the research that they conduct. The federal Office of Human Research Protections oversees IRBs Office of Human Research Protections.

The Belmont Report

As mentioned above, The Belmont Report is a federal document that outlines the foundational principles that guide the ethical practice of research in the United States. These ethical principles include: respect for persons, beneficence, and justice. Each of these terms has specific implications as they are applied to the practice of research. These three principles arose as a response to many of the mistreatment and abuses that have been previously discussed and provide important guidance as researchers consider how they will construct and conduct their research studies. As researchers are crafting their research proposals, they should be mindful of these important ethical guidelines.

Respect for Persons

As social workers, our professional code of ethics requires that we recognize and respect the “inherent dignity and worth of the person” (NASW, 2017).^[26] This is very similar to the ethical research principle of respect for persons. According to this principle, as researchers, we need to treat all research participants with respect, dignity and inherent autonomy. This is reflected by ensuring that participants have self-determination to make informed decisions about their participation in research, that they have a clear understanding of what they will be asked to do and any risks involved, and that their participation is voluntary and can be stopped at any time. Furthermore, for those persons who may have diminished autonomy (e.g. children, people who are incarcerated), extra protections must be built in to these research studies to ensure that respect for persons continues to be demonstrated towards these groups, as they may be especially vulnerable to exploitation and coercion through the research process. A critical tool in establishing respect for persons in your research is the informed consent process, which will be discussed in more detail below.

Beneficence

As researchers, to accomplish this, we seek to maximize benefits and minimize risks. Benefits may be something good or advantageous directly received by the research participant, or they may represent a broader good to a wider group of people or the scientific community at large (such as increasing knowledge about the topic or social problem that you are studying). Risks are potential physical, social, or emotional harm that may come about as a response to participation in a study. These risks may be more immediate (e.g. risk of identifying information about a participant being shared, or a participant being upset or triggered by a particular question), or long-term (e.g. some aspect about the person could be shared that could lead to long-term stigmatization). As researchers, we need to think about risk that might be experienced by the individual, but also risks that might be directed towards the community or population(s) the individual may represent. For instance, if our study is specifically focused on surveying single parents, we need to consider how the sharing of our findings might impact this group and how they are perceived. It is a very rare study in which there is no risk to participants. However, a well-designed and ethically sound study will seek to minimize these risks, provide resources to anticipate and address them, explore unintended consequences, and maximize the benefits that are gained through the study.

Justice

The final ethical principle we need to cover is justice. For the purposes of research, justice is the idea that the benefits and the burdens of research are distributed fairly across populations and groups. To help illustrate the concept of justice in research, research in the area of mental health and psychology has historically been critiqued as failing to adequately represent women and people of diverse racial and ethnic groups in their samples (Cundiff, 2012).^[27] This has created a body of knowledge that is overly representative of the white male experience, further reinforcing systems of power and privilege. In addition, consider the influence of language as it relates to research justice. If we create studies that only recruit participants fluent in English, which many studies do, we are often failing to satisfy the ethical principle of justice as it applies to people who don’t speak English. It is unrealistic to think that we can represent all people in all studies. However, we do need to thoughtfully acknowledge voices that might not be reflected in our samples and attempt to recruit diverse and representative samples whenever possible.

These three principles provide the foundation for the oversight work that is carried out by Institutional Review Boards, our next topic.

Institutional review boards

Institutional review boards, or IRBs, are tasked with ensuring that the rights and welfare of human research subjects will be protected at all institutions, including universities, hospitals, nonprofit research institutions, and other organizations, that receive federal support for research. IRBs typically consist of members from a variety of disciplines, such as nursing, sports medicine, sociology, economics, education, social work, and communications (to name a few). Most IRBs also include representatives from the community in which they reside. For example, representatives from nearby prisons, hospitals, or treatment centers might sit on the IRBs of university campuses near them. The diversity of membership helps to ensure that the many and complex ethical issues that may arise from human subjects research will be considered fully and by a knowledgeable and experienced panel. Investigators conducting research on human subjects are required to submit proposals outlining their research plans to IRBs for review and approval prior to beginning their research. Everyone who conducts research on human subjects must have their proposed work reviewed and approved by the IRB before beginning any research (though, on some campuses, exceptions are made for student projects that will not be shared outside of the classroom).

The IRB has three levels of review, defined in statute by the USDHHS. Exempt review is the lowest level of review. Studies that are considered exempt expose participants to the least potential for harm and often involve little participation by human subjects. In social work, exempt studies often examine data that is publicly available or secondary data from another researcher that has been de-identified by the person who collected it.

Expedited review is the middle level of review. Studies considered under expedited review do not have to go before the full IRB board because they expose participants to minimal risk. However, the studies must be thoroughly reviewed by a member of the IRB committee. While there are many types of studies that qualify for expedited review, the most relevant to social workers include the use of existing medical records, recordings (such as interviews) gathered for research purposes, and research on individual group characteristics or behavior.

Finally, the highest level of review is called a full board review. A full board review will involve multiple members of the IRB evaluating your proposal. When researchers submit a proposal under full board review, the full IRB board will meet, discuss any questions or concerns with the study, invite the researcher to answer questions and defend their proposal, and vote to approve the study or send it back for revision. Proposals that require full board review pose greater than minimal risk to participants. They may also involve the participation of vulnerable populations, or people who need additional protection from the IRB. Vulnerable populations include imprisoned people, children, people with cognitive impairments, people with physical disabilities, employees, and students. While some of these populations can fall under expedited review in some cases, they will often require the full IRB to approve their study.

It may surprise you to hear that IRBs are not always popular or appreciated by researchers. Who wouldn’t want to conduct ethical research, you ask? While most researchers are not actively trying to do harm to research participants, those who hold power over others sometimes unwittingly do so anyway. IRBs are valuable in the research process because of the diverse set of experiences that each member has. IRB members may see something that the researcher never would, not because the researcher is “bad,” but because the researcher may hold power and privileges that may not have allowed them to see.

In some cases, the concern is that IRBs are most well-versed in reviewing biomedical and experimental research, neither of which is particularly common within social work. Much social work research, especially qualitative research, is open-ended in nature, a fact that can be problematic for IRBs. The members of IRBs often want to know in advance exactly who will be observed, where, when, and for how long, whether and how they will be approached, exactly what questions they will be asked, and what predictions the researcher has for their findings. Providing this level of detail for a year-long participant observation within an activist group of 200-plus members, for example, would be extraordinarily frustrating for the researcher in the best case and most likely would prove to be impossible. Of course, IRBs do not intend to have researchers avoid studying controversial topics or avoid using certain methodologically sound data collection techniques, but unfortunately, that is sometimes the result. The solution is not to eradicate review boards, which serve a necessary and important function, but instead to help educate IRB members about the variety of social scientific research methods and topics covered by social workers and other social scientists.

What we have provided here is only a short summary of federal regulations and international agreements that provide the boundaries between ethical and unethical research.