5.1 Research on humans

Learning Objectives

  • Define human subjects research
  • Describe and provide examples of nonhuman subjects that researchers might examine
  • Define institutional review boards and describe their purpose
  • Distinguish between the different levels of review conducted by institutional review boards


In 1998, actor Jim Carey starred in the movie The Truman Show. [1] At first glance, the film appears to depict a perfect research experiment. Just imagine the possibilities if we could control every aspect of a person’s life, from where that person lives, to where they work, their lifestyle, and whom they marry. Of course, keeping someone in a bubble of your creation and sitting back to watch how they fare would be highly unethical, not to mention illegal. However, the movie clearly inspires thoughts about the differences between scientific research and research on nonhumans. One of the most exciting, albeit challenging, aspects of conducting social work research is that most of our studies involve human subjects. The free will and human rights of the people we study will always have an impact on what we are able to research and how we are able to conduct that research.

Human research versus nonhuman 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). [2] Some researchers prefer to use the term “participants” as opposed to “subjects,” as it acknowledges the agency of the people who participate in the study. For our purposes, we will use the two terms interchangeably.

In some states, human subjects also include deceased individuals and human fetal materials. On the other hand, nonhuman research subjects are objects or entities that investigators manipulate or analyze in the process of conducting unobtrusive research projects. Nonhuman research subjects can include sources such as newspapers, historical documents, clinical notes, television shows, buildings, and even garbage. Unsurprisingly, research on human subjects is regulated much more heavily than research on nonhuman subjects. However, there are ethical considerations that all researchers must consider regardless of their research subject. We’ll discuss those considerations in addition to concerns that are unique to research on human subjects.


road sign with two arrows pointing towards right and wrong

A historical look at research on humans

Research on humans hasn’t always been regulated in the way that it is today. The earliest documented cases of research using human subjects are of medical vaccination trials (Rothman, 1987). [3] 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 end of World War II, when 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). [4] 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) [5] 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. The electric shocks were not real at all, however some of Milgram’s research participants experienced extreme emotional distress after the experiment (Ogden, 2008). [6] A reaction of emotional distress is understandable. The realization that you are willing to administer painful shocks to another human being, just because someone who looked authoritative told you to do so, might indeed be traumatizing. This can be true even after you learn that the chocks you administered were not real.

Around the same time that Milgram conducted his experiments, sociology graduate student Laud Humphreys (1970) [7] was collecting data for his dissertation research 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,” the person who watches for police and gets to watch the sexual encounters, in a local park restroom where the tearoom trade was known to occur. What Humphreys did not do was identify himself as a researcher to his subjects. Instead, he watched them for several months, getting to know them while learning more about the tearoom trade practice. And, without the knowledge of his research subjects, he would jot down their license plate numbers as they entered and exited the parking lot near the restroom.

After participating as a watch queen, Humphreys utilized the license plate numbers and his insider connections with the local motor vehicle registry 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. [8]

When Humphreys’ work became public, he was met with much controversy from his home university, fellow scientists, and the entire public, as his study raised many concerns about the purpose and conduct of social science research. His work was so ethically problematic that the chancellor of his university even tried to have his degree revoked. In addition, the Washington Post journalist Nicholas von Hoffman wrote the following warning about “sociological snoopers”:

We’re 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). [9]

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. [10] In his written reflections on his research and its resulting fallout, 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). [10]

With the increased regulation of social scientific research, it is unlikely that researchers would be permitted to conduct projects like Humphreys’ in today’s world. 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). [11] 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). [12] What do you think, and why?

These and other studies (Reverby, 2009) [13] led to increasing public awareness and concern regarding research on human subjects. 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. 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). [14] The National Research Act (1974) [15] also required that all institutions receiving federal support establish institutional review boards (IRBs) to protect the rights of human research subjects. Since that time, many private research organizations that do not receive federal support have also established their own review boards to evaluate the ethics of the research that they conduct.


seven people sitting around a table talking and taking notes

Institutional Review Boards (IRBs)

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 sociology, economics, education, social work, and communications. 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 ensures that the complex ethical issues of human subjects research will be considered fully by a knowledgeable, 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. Even students who conduct research on human subjects must have their proposed work reviewed and approved by the IRB before beginning any research (though, on some campuses, some exceptions are made for classroom 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. Exempt studies expose participants to the least potential for harm and often involve little participation by the 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. 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. Full board proposals 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 pregnant women, prisoners, 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’s approval to study.

It may surprise you to hear that IRBs are not always popular or appreciated by researchers. Sometimes, researchers are concerned that the IRBs are well-versed in biomedical and experimental research and less familiar with the qualitative, open-ended nature of social work research. The members of IRBs often want specific details about your study. They may require you to describe aspects of your study, including but not limited to: the specific population you will be studying, observation methods, potential interview questions for participants, and any predictions you have about your findings. For example, it would be extraordinarily frustrating or nearly impossible to provide this level of detail for a large-scale group participant observation study.

Oftentimes, social science researchers cannot study controversial topics or use certain data collection techniques due to ethical concerns of the IRB. When important social research is not permitted by review boards, researchers may become frustrated (and rightfully so). The solution is not to do away with review boards, which serve a necessary and important function. Instead, an effort should be made to educate IRB members about the importance of social science research methods and topics.


Key Takeaways

  • When it comes to conducting ethical research, the use of human subjects presents a unique set of challenges and opportunities.
  • Research on human subjects has not always been regulated to the extent that it is today.
  • All institutions receiving federal support for research must have an IRB. Research organizations that do not receive federal support often include IRBs as a part of their organizational structure, although they are not required.
  • Researchers submit studies for IRB review at one of three levels, depending on the potential level of harm that the study may inflict on its subjects.



Exempt review– lowest level of IRB review, used for studies with minimal risk of harm or low levels of human subject involvement

Expedited review– middle level of IRB review, used for studies with minimal risk of harm but greater levels of human subject involvement

Full board review– highest level of IRB review, used for studies with greater than minimal risk of harm to participants

Vulnerable populations– groups of people that may pose an additional risk for harm when studied; may be granted additional protections during an IRB review.


Image attributions

ethics by Tumisu CC-0

roundtable meeting by Debora Cartagena CC-0


  1. You can read a brief synopsis of the film at http://www.imdb.com/title/tt0120382.
  2. US Department of Health and Human Services. (1993). Institutional review board guidebook glossary. Retrieved from https://ori.hhs.gov/education/products/ucla/chapter2/page00b.htm
  3. Rothman, D. J. (1987). Ethics and human experimentation. The New England Journal of Medicine, 317, 1195–1199.
  4. One little-known fact, as described by Faden and Beauchamp in their 1986 book, is that during the time the Nazis conducted their horrendous experiments, Germany had written regulations specifying that human subjects must clearly and willingly consent to their participation in medical research. Obviously these regulations were completely disregarded by the Nazi experimenters, but the fact that they existed suggests that efforts to regulate the ethical conduct of research, while necessary, are certainly not sufficient for ensuring that human subjects’ rights will be honored. Faden, R. R., & Beauchamp, T. L. (1986). A history and theory of informed consent. Oxford, UK: Oxford University Press.
  5. Milgram, S. (1974). Obedience to authority: An experimental view. New York, NY: Harper & Row.
  6. Ogden, R. (2008). Harm. In L. M. Given (Ed.), The sage encyclopedia of qualitative research methods (p. 379–380). Los Angeles, CA: Sage.
  7. Humphreys, L. (1970). Tearoom trade: Impersonal sex in public places. London, UK: Duckworth.
  8. Humphreys’ research is still relevant today, as undercover police operations targeting tearoom activities still occur. For example, in 2007 Idaho Senator Larry Craig was arrested in a public restroom of the Minneapolis-St. Paul airport for engaging in similar activities. Humphreys’ research is also frequently cited by attorneys who represent clients arrested for lewd behavior in public restrooms.
  9. von Hoffman, N. (1970, January 30). Sociological snoopers. The Washington Post, p. B1.
  10. Humphreys, L. (2008). Tearoom trade: Impersonal sex in public places, enlarged edition with a retrospect on ethical issues. New Brunswick, NJ: Aldine Transaction.
  11. Warwick, D. P. (1973). Tearoom trade: Means and ends in social research. Hastings Center Studies, 1, 39–49. See also Warwick, D. P. (1982). Types of harm in social research. In T. L. Beauchamp, R. R. Faden, R. J. Wallace Jr., & L. Walters (Eds.), Ethical issues in social science research. Baltimore, MD: Johns Hopkins University Press.
  12. Lenza, M. (2004). Controversies surrounding Laud Humphreys’ tearoom trade: An unsettling example of politics and power in methodological critiques. International Journal of Sociology and Social Policy, 24, 20–31. See also Nardi, P. M. (1995). “The breastplate of righteousness”: Twenty- five years after Laud Humphreys’ Tearoom trade: Impersonal sex in public places. Journal of Homosexuality, 30, 1–10.
  13. 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). For more on the Tuskegee Syphilis Experiment, see Reverby, S. M. (2009). Examining Tuskegee: The infamous syphilis study and its legacy. Chapel Hill, NC: University of North Carolina Press.
  14.  National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
  15. National Research Act of 1974, Pub. L. no. 93-348 Stat 88. (1974). The act can be read at https://history.nih.gov/research/downloads/PL93-348.pdf


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