Elisa A Hurley, PhD, originally discussed this topic in her address at the 2018 Advancing Ethical Research Conference. To read the full article in the Journal of Clinical Research Practices, click here. For more information about the Journal of Clinical Research Practices, click here.
It’s been suggested by some that it is time to jettison the term “research subject” from our research ethics vocabulary—including in the regulations—and exclusively use the term “research participant” to refer to those who enroll in research. Most recently, the National Academies report, “Returning Individual Research Results to Participants,” included a short but compelling articulation of the argument for moving from “subject” to “participant “across the board—in fact, that is what got me thinking more about this issue.
There are a number of compelling arguments for this wholesale move from “subject” to “participant.” “Participant” is more respectful of people’s autonomy. It signals a welcome move away from outdated notions of paternalism and protectionism—the idea that a research subject is someone who is acted upon and in need of protection from manipulation, rather than someone with the agency to actively choose to participate in research for their own reasons. It also signals how far we’ve moved beyond the troubled history of research at its most exploitative—the Nazi experiments, Tuskegee, Willowbrook, Guatemala—episodes in which vulnerable people were treated as passive subjects, as human guinea pigs, for the sake of science. Finally, using the term “participant” reflects a general shift across the research enterprise toward patient engagement and the principles of transparency and reciprocity, and it may help counteract lingering distrust in the research enterprise and in researchers.
There is a lot that’s attractive in these arguments; of course, we want to accomplish all the above goals. And we recognize that people are engaged in research in ways that were unimaginable 40 or 50 years ago, when this terminology was put in place. Research is different now. So should we give up the term “research subject” once and for all?
My answer is no. I believe that such a move would be a mistake, and that we need to keep both “research subject” and “research participant” in our shared vocabulary.
In a nutshell, calling someone a research “participant” signals or suggests a kind of active and ongoing engagement in a shared endeavor. Beyond engagement, it suggests the individual has some ownership or investment in the research project in question, or in its outcomes or findings.
Traditionally, PRIM&R has chosen not to use the word “participant” in the research context, on the grounds that it obscures real power and knowledge asymmetries between researchers and those upon whom research is done. These asymmetries are endemic to just about all research. Using the term “subject” to refer to those who volunteer for research, on the other hand, makes salient these asymmetries and people’s position of relative vulnerability within the research enterprise. It also highlights the need for independent mechanisms to ensure that those who volunteer for research are respected and protected, and that’s been my default position as well.
But, over time, I’ve been persuaded that, as long as we recognize that “participant” doesn’t mean “equal partner,” referring to those who are enrolled in research as “participants,” is probably appropriate for many circumstances. For example, I think about patient-centered outcomes research projects that successfully engage research volunteers in decision making. Or longitudinal observational field work or participatory action research conducted in communities with a high incidence of disease—research methodologies that depend on the establishing long-term, trusting relationships between researchers and those they’re learning from. These scenarios strike me as cases in which using the term “participant” is appropriate because they are characterized by ongoing engagement of the participant in the project. These projects have the characteristics of a shared endeavor.
But I believe we still need the term “subjects” because there are other circumstances in which using the term “participant” might not be fitting, and, in fact, risks understating or even obfuscating important characteristics of the research, thereby providing a false sense of the agency exercised by the subject or lulling us into complacency about the need for protections.
Consider so-called “big data” research—research that uses and analyzes large data sets to understand and predict various aspects of human behavior. (I’m going to set aside the question of which big-data research is actually “human subjects research” under our current regulatory framework and continue my current line of reasoning.) In this context, large quantities of data—sometimes highly sensitive data—are collected by social media sites, search engines, and other applications and are stripped of personal identifiers and made available for other uses, including for academic research.
It is off the mark to call the people whose data is collected, combined, and used in this way—that is, basically, all of us—research “participants.” This is the case regardless of whether we think the terms of service we accept adequately constitute informed consent. If we think about what “participant” connotes—ongoing, active engagement in a shared endeavor, a level of ownership and buy-in—that’s just absent here. Referring to people in these contexts as “research subjects” is not disrespectful. Rather, it importantly indicates that we have little or no agency in these situations and are vulnerable to these risks. It highlights the fact that, in this research domain, people are involved, but are not actively engaged, and that we should, therefore, pay special attention to what protections are needed.
I doubt big data is a unique domain, but in any case, I raise the example because I think it highlights why it would be premature to jettison “subject” from our research ethics vocabulary and framework. The term “subject” has a role to play: It makes salient important features of some research contexts, or more to the point, important features that are missing from these contexts.
I worry that a wholesale move to using research “participant” across the board amounts to a shortcut way to feel satisfied about the level of information, engagement or power granted to individuals who enroll in research. I worry about use of the term “participant” to rationalize skipping the work of actually engaging these individuals as true stakeholders in the project. Maintaining an appropriate sense of responsibility for doing this work is why we need to keep both terms, “subject” and “participant,” in our vocabulary.
We’re all accustomed to being careful about when and where we refer to someone as a “patient,” and when we refer to them as a “subject/participant”. And I imagine we’re all familiar with the reasons for being careful. We know using the word “patient” in the research context would be misleading. It suggests the intervention the person is receiving is designed and delivered for their therapeutic benefit, and that decisions by the physician will be based only on what is best for the patient. But in a research context, neither of these conditions are accurate; decisions about interventions are driven by standardized protocols designed to answer pre-determined scientific questions. Calling the person a “patient” might sound more caring and familiar, but it’s important to communicate, for instance in an informed consent form, that we’re asking the person to enroll in research, and for them to understand what that means for them.
It’s equally important to be careful about our use of research “participant” and “subject” because here, too, each of these words has specific connotations, which may or may not be fitting to what is actually happening in a particular research context, and may or may not be fitting in ways that matter for thinking about research protections.
The question of what specific conditions need to be met for someone properly to be thought of as a research “participant” merits further exploration, beyond what I can do here. I imagine it would vary by project. This question also leads to another question: should we be striving toward a research enterprise where all those involved in research can appropriately be thought of as “participants”? And if that is the goal, what would we have to do to reach it? To start with, we would have to do a much better job educating the public about research as a collective, public good.
These are all questions worth exploring further. But my point here is that the right to use the term “research participant” needs to be earned by making the appropriate efforts to actively engage volunteers in the research. And, thus, I want to make a plea for keeping both research “participant” and research “subject” in our shared vocabulary. The term “research subject” is not one we can just jettison—no matter how well-meaning the desire to do so might be—but one we must grapple with as we reimagine our responsibilities as research ethics professionals.