In early 2014, PRIM&R explored the topic of what we call individuals who volunteer for research in a post titled What’s in a name? Research “participant” versus research “subject.” In this post, PRIM&R concludes that, on the whole, “subject” is the most appropriate title for those involved in research studies (recognizing, however, that in some instances “participant ” may be appropriate; for example, in community-based participatory and participant-led research).
While we respect the very thorough argument presented, herein we present the contrasting points of view of three individuals: Jeff Taylor, a 35-year HIV survivor who is an HIV research advocate and has participated in many research trials and who prefers the term “volunteer;” Karine Dubé, a social scientist who has led HIV research activities and prefers the term “participant;” and Brandon Brown, an epidemiologist who has also led HIV research and argues that the term “subject” is not respectful of their contribution, though he does not have a strong preference between “volunteer” and “participant”.
As a starting point for our discussion on terminology, the Oxford dictionary defines the proposed terms as follows:
- volunteer: a person who freely offers to take part in an enterprise or undertake a task
- participant: a person who takes part in something
- subject: a person or thing that is being discussed, described, or dealt with
We also outline the two most common arguments for the use of the term “subjects” as:
- The term “participant” is not found in federal regulations governing human subjects research.
- Without agency, people who join research should not be called participants, or else we glorify unethical studies.
In response to the first argument, we point out that there many examples of laws/guidelines that were once in place but deemed unacceptable over time and subsequently modified. We recognize that changing a term in the federal guidelines could be an administrative and political nightmare, but this does not mean that it should not be changed if a need for change is determined—especially if the research community comes to a consensus.
The second argument , meanwhile, may actually expose an underling issue that leads us to use the term “subject”—”subject” assumes that people who join research do not have agency in that research. In other words, they don’t necessarily have a voice in the research being done. But perhaps studies taking place without “community voice” or the opportunity for participants to provide input are inherently unethical. And in fact, many funding agencies, including the National Institutes of Health, require involvement of communities (or at least a community advisor) when community engagement is relevant to the study.
Community voice (as there are various levels of participation) might include participants advocating for funds to undertake the project, helping plan and coordinate the project (community-based participatory research), or simply actively choosing to volunteer for the project. In recent years especially, the role of volunteers in research projects has expanded; they might serve as stakeholders, advisors, consultants, peer educators, and even act as researchers themselves. For example, in high risk/low benefit studies like HIV cure research, people living with the condition being studied can become true partners in that research—and one could argue that research should leave space for their input.
People should have a choice of participating in a study; a person is not a thing to be acted upon. We believe everyone can get on board with this statement, but how does it provide further argument against using the term subject? For an answer on that, we should ask people who participate in research, since they are the ones we are referring to in this debate. Perhaps we should practice the ethical principles of respect and autonomy, and allow them to decide what they want to be called.
In a study of 400 people living with HIV in 2015, we did just that, asking study participants the following question (348 responded, with 87% response rate):
‘If you were to participate in an HIV cure-related study, how would you describe yourself’?
Figure 1: Response from n = 348 people living with HIV to the question: “If you were to participate in an HIV cure-related study, how would you describe yourself’?
While the question may have been biased slightly towards the term “participant”, respondents were given 8 different options of what they preferred to be called, ranging from “participant” to “guinea pig”. Nearly half of all people surveyed preferred to be called “study participants”, a quarter preferred to be called “partner”, and just 8% “research subject”. (Surprisingly, some preferred the term “guinea pig”, and we might ask ourselves what this says about their views and experience participating in research). In addition to this survey, there have been several requests from community members to use the term “participant”, including from individuals on community advisory boards who are insulted by the use of the term subject, which they say has a negative connotation and may hinder participation in research.
This is just a small snapshot of what research subjects themselves prefer—and this is only the people who were given an opportunity to speak on this topic. It is time we use more participatory methods in research, and provide people who participate in research the opportunity to be heard. Let’s ask people what they want to be called, and let’s ask them what research priorities they would like explored in their community. Without community participation, there will be no sustainability and maybe no community buy-in for research, and that’s just unethical. Lack of community input may also lead to bad study designs where people may not enroll in or be retained in research, making it a costly failure.
Critics of our argument may point out the fact that we are concentrating on HIV research, which may be very different from other types of research. We agree, but considering its well-known commitment to human rights and its history of activism, the HIV research community is ideally suited to lead the way. Plus, there are plenty of other examples where the shift from “subject” to “participant” is already happening. The NIH sponsored HIV networks (HPTN, MTN, HVTN) mandated the use of the term “participant” in their protocols and informed consent forms years ago. Other non-HIV focused sources are also moving in this direction. ClinicalTrials.gov, which reports broad clinical research, refers to people as participants, not subjects. The New England Journal of Medicine, American Journal of Public Health, and International Committee of Medical Journal Editors all use the term participant exclusively. NIH Director Francis Collins is quoted as saying, “Medical advances would not be possible without participants in clinical trials.”
With increased emphasis on patient-centered care and shared decision-making in the United States, clinical researchers need to start appreciating patients as willingly donating their time in research, instead of being “subjected” to experiments.
Bromley E, Mikesell L, Jones F, Khodyakov D. ‘From Subject to Participant: Ethics and the Evolving Role of Community in Health Research’. American Journal of Public Health 2015; 105(5): 900 – 908. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/25790380
Brandon Brown is an assistant professor of medicine at the University of California, Riverside. Karine Dubé is an assistant professor of public health at the University of North Carolina, Chapel Hill, Gillings School of Global Public Health. Jeff Taylor is the Director of the Coachella Valley Community Research Initiative in Palm Springs, California.