PRIM&R reexamined this issue in 2019; read that piece here.
by Ali Hall, Educational Programs Assistant
At a recent discussion at one of PRIM&R’s staff meetings, we took up the issue of how to refer to those who volunteer to participate in research. More specifically, our conversation started with the fact that PRIM&R uses the term “research subject,” rather than the term “research participant.” The significance of this very conscious choice of language had previously managed to escape me, and so I found the ensuing discussion incredibly enlightening.
While research “subject” is the more traditional of the two terms, there has been a shift over the past 25 years or so to use research “participant” when referring to individuals who take part in research, because, many argue, it is more respectful of research volunteers. This shift can be directly traced to the work of the HIV/AIDS activist and cancer survivor communities in the 1980s and 1990s, who demanded not only access to clinical trials, but participation in setting research agendas. I saw first-hand evidence of this shift recently when I received a request from a conference faculty member to change the title of a session at PRIM&R’s 2013 Advancing Ethical Research Conference—specifically, to replace the word “subject” with the word “participant.” In making the request, the individual expressed to me that the term “subject” tends to perpetuate an unhelpful view of the research enterprise and is most likely part of why only 5% of individuals participate in clinical trials nationwide. This person felt strongly that, because it emphasizes the passivity of the individual who is taking part in research, using the term “subject” discourages people from taking part in research and thereby slows the rate of scientific discovery.
I must admit, I found this argument compelling. So why does PRIM&R continue to refer to volunteers as “subjects,” I wondered. Well, what I learned during our staff meeting is that PRIM&R uses “subject” rather than “participant” for a number of carefully considered reasons. For one, the term “participant” is not found anywhere in the federal regulations governing human subjects research, known as the “Common Rule.” For another, and more substantively, PRIM&R’s view is that the term “subject,” far from being disrespectful of those who volunteer for research, much more accurately and honestly represents the true nature of the research enterprise, including the fact that there is always a power and knowledge differential between those conducting the research and those on whom the research is conducted. In addition, using the term “subject” to refer to those who volunteer to take part in research makes salient the fact that, due to their position of relative vulnerability within the research enterprise, there need to be independent mechanisms to ensure the individuals who volunteer for research are respected and protected. We do not, of course, wish to diminish or ignore the potential for exploitation of research subjects (especially since that is something PRIM&R actively works hard to prevent); indeed, we believe that use of the term “participant” to refer to research volunteers may leave them more vulnerable to exploitation, since it may obscure the need for formal protections.
Now, this doesn’t mean, I also learned, that PRIM&R believes that the term “participant” is never appropriate when referring to those who volunteer for research. In the context of community-based participatory research, for instance, where communities who will be the subjects of the research are integrally involved in both designing the research study and in carrying it out, it seems appropriate to refer to those individuals as “participants” in the research. In addition, we’re currently seeing a rise in “participant-led” and “participant-centered” research, where those being studied act as a driving force behind the research. Examples include self-surveillance, analyses of genomic data, and genome-wide association studies, to name a few, all of which represent a more bottom-up approach to research, as opposed to the more top-down approach favored by traditional scientists.
While I can see why people may think the term “subject” is disrespectful, or even pejorative, when describing people who take part in research, I now understand and appreciate PRIM&R’s choice to stand by it. Being forced to stop and consider the potential implications of using one term over another, has also raised a series of questions relating to human research subjects and the part they play in the overarching research apparatus for me. For instance, are there additional arguments for using one term over the other? Do most researchers think the choice of terminology has significant bearing on the decision of the average individual to participate in research? Please share your thoughts.
I would like Prim&r's input on subject vs patient.
Thank you for your question, Sue! While the term “patient” may be accurate when referring to an individual being recruited for a trial, it is PRIM&R’s view that once an individual is enrolled in a research study, the term “subject” is more appropriate.
In clinical research, decisions about an individual’s care are made according to a pre-established protocol. The primary goal of clinical research is to develop generalizable knowledge that can be applied in the future; any immediate therapeutic benefit to an individual is secondary. In contrast, the chief aim of clinical care is to address a person’s individual and immediate health needs. If potential research subjects do not clearly understand the difference between clinical care and clinical research, therapeutic misconception can result.
To foster a potential subject’s understanding of the differences between clinical care and clinical research and reduce the potential for therapeutic misconception, attention should be paid to using appropriate language during the informed consent process and throughout course of the trial. Careful language choices, such as the use of the term “subject” or “experiment,” can serve to reinforce this distinction for patients and healthy volunteers as they consider research participation.
Additionally, it is worth noting that the use of the term “subject” is consistent with language used in the regulatory definitions employed by the Department of Health and Human Services [45 CFR 46.102(f)] and the Food and Drug Administration [21 CFR 50.3(g)].
(1) I have never heard of a person actually declining to take part in research simply because of the terms being used to describe them. So if that claim is true, it seems a rare occurrence or something that happens within a specific study area I am unfamiliar with). (2) I view the term "subject" as a respectful reminder that the researcher is focusing on the individual (like the subject of a sentence, the word refers to a critical component of the message). (3) I have also heard that the argument for distinguishing between the terms is because researchers do not "subject" people to research without their consent (whereas this occurs for non-humans). A distinction that reminds me of the German words for eating (essen vs. fressen). Yet there are studies that collect data from people without their knowledge or consent (observational studies, possibly some aspects of deception studies fit here, etc.). (4) While APA seems strongly in favor of a distinction (participants for humans, subjects for non-humans) it seems that PRIM&R hold almost the opposite view due to perceptions of vulnerability. Is there a way to reconcile these views or do you think this will end up being an "agree to disagree" situation?
Thank you for this thoughtful article.
Thank you for adding to this discussion, Steve. You raise some interesting points, and we appreciate your willingness to share your thoughts.
Where does the word “volunteer” fit in to the lexicon? It is used frequently in the protocols and consent forms that I review, and emphasizes important facets of the enterprise: the freedom of an individual to participate or not participate, and the positive connotations of altruism and contributing to a good cause. I like the term, but have an issue when it is applied to minors, especially small children / infants where verbal assent isn’t even an option. Can the term “volunteer” be appropriately applied to those less than 17 years? To those less than the age of written or verbal assent? Are there any guidances from the FDA, EMA, ICH, etc., about the use of any of these terms (subject, participant, volunteer)?
I prefer the term Participant. It is a more dignified. I don’t know anyone who would like to be referred to as a Subject. I think using the word Subject is degrading and neglects the fact that we are people too, and that we care about how people refer to us, and that we are in fact Participants there on our own free will.
Totally agree on this. Subject may be fine in a scientific context but from a community perspective, it dehumanizes a person. It reminds me of articles I read on war crime experiments
Good discussion and rationale for why PRIM&R decided to use the term “subject” vs. “participant” acknowledging there are reasons to use both terms somewhat interchangeably. But if only one term can be used, “subject” yields the strongest weight in human research protections (HRP), how HRP came about in history, and for securing future Human Research Protections for subjects/participants. Thank you.
Great discussion/thread which I have recently come across. We most certainly agree that words matter. What we also must acknowledge is that we should do better as we learn more; referring to humans as ‘subjects’ psychologically diminshes what we seek to do ~ study factors (whether relating to health behaviors, outcomes, or other matters) or a particular subject in a ‘human’. Even though our leading federal organizations like NIH refer to these protections as ‘human subjects’, that doesn’t mean that referring to individuals in such a manner is respectful, nor does it value or seek to truly engage persons into research. Kings have ‘subjects’ and continuing to use dehumanizing terms like ‘subjects’ (which was initially the intention to detach one from the research conducted to be more “objective”) does not inherently build trust or value. In essence, it actually is easier to refer to individuals as ‘subjects’ since that subconciously provides an easy “out” for the researcher to be objective and not feel (as) guilty as we seek beneficience since tests/research might cause harm or adverse events.
Points regarding the power dynamics are also valid and important so referring to an eligible persn who enrolls in a study as a ‘participant’, ‘respondent’, ‘individual’ or anything but ‘subject’ gets researchers and scientists closer to the true goal of full engagement. I am looking forward to leading organizations becoming more cognizant of the terms we use, which has a deeper meaning to the world of research…what I am called when participating in a research study, and what I choose to call persons I seek to enroll into my translational research studies, matter. Addressing each person in a manner that recognizes his/her role and value while recognizing s/he is a living being I am studying some characteristic of, helps to increase trust especially with underrepresented persons and communities we seek to engage in (and help lead) our research studies and investigations. Just as in some cultures (at least the one I grew up with and currently a member in), I couldn’t call adults or my elders by their first name, the same addage is true regarding how we show respect when seeking to engage all persons into our research.
Just some thoughts to consider…and glad to be a part of the conversation…at least we’re talking about this.
If the big obstacle to changing the language is the regulatory language, we must change the regulatory language.