Notes from the PCOR Field: Is it Still Patient-Centered When We Say Human Subjects?

As we’ve engaged in research partnerships over the past few years, our team has learned many lessons along the way. We’ve launched this new blog series, Notes from the PCOR Field, that focuses on how partnerships with patients, caregivers, family members, and other stakeholders have changed the way we think about and conduct research. Our second post is from Patient Advisory Network Director Danielle Lavallee on the use of the term “human subjects” to describe people who participate in research studies.

Words matter. This is one of many lessons I have learned through patient-centered outcomes research. The common challenge faced is the jargon used in research. The terms used by researchers are often technical and not self-descriptive. Acronyms, ever abundant, are even worse. On occasion, however, a term or phrase comes up that, in the spirit of patient-centricity, borders on offensive. For me, that term is human subject.

In research, a human subject is defined as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about whom includes a subject’s opinion on a given topic.” (source: US Department of Health and Human Services) Interestingly, it is most often referenced in the context of informed consent for research participation.

I find the term subject falls short as we push towards patient-centered research. As defined, the term “subject” indicates “a person or thing that is being discussed or described; a person or thing that is being dealt with in a particular way.” Placing person and thing in the same context, in my opinion, dehumanizes the person participating in the research process. It is a stark contrast to the true partnership that we strive for in patient-centered research.

The premise of patient-centered outcomes research (PCOR) is to “help people and their care partners communicate and make informed health care decisions, allowing their voices to be heard and valued in assessing the relevant health care options. PCOR promotes partnership with patients and caregivers throughout the research process to ensure that what researchers seek to study is important and informative to people grappling with often difficult and complex decisions about health.” (source: Patient-Centered Outcomes Research Institute)

It is contrary to the mission of PCOR then to view the focus of our research as merely a subject or thing rather than as a person with interests, preferences, and needs in healthcare. Humanizing our definition of who participates in research is critical. In doing so, we shift focus from what we think is interesting to research to what is important to improve patient care; we think not only about what we can measure, but what is meaningful to measure; we strive for transparency in our work; and we seek effective mechanisms to disseminate our findings to transform patient care.

But most importantly, we recognize that research is only possible with the participation of each individual who contributes time, data, experience, tissue, blood, etc., to help us all learn and advance healthcare.

At CERTAIN, we’re working to change our terminology. The term we use for people who agree to participate in our research studies is study participant – a simple but important change. Although perhaps not a perfect term, we vastly prefer it to research or study subject, as the term study participant acknowledges the willingness to contribute and gives people more agency than referring to them merely as subjects.

What do you think about the term human subjects? What other research terms do you feel need updating? We would love to hear from you in the comments below!

Do you have a lesson you’ve learned, a challenge you’ve overcome, or simply thoughts on PCOR partnerships you would like to share for a future Notes from the PCOR Field post? We would love to feature you! Contact Sarah Lawrence to discuss further.

Dear Jessie, I am finally taking your advice.

by Danielle Lavallee

CERTAIN Patient Advisory Network Director Danielle Lavallee introduces a new blog series that focuses on sharing tips, tools, and lessons learned through learning how to engage patients over the years.

“You need a blog.” This advice came from Jessie Gruman, founder of the Center for Advancing Health, when I asked her what peer-reviewed journal to target for a manuscript. Jessie was my first mentor in the world of patient engagement in research. She knew from her own experience as a cancer survivor that patient engagement in healthcare served as the key ingredient for successful health outcomes. A prolific and articulate writer, she focused her work on connecting with people to share actionable tips, tools, and resources for being a prepared and engaged patient. While Jessie believed patient engagement a necessity to improving research, she knew much needed to change in the research culture to reap the benefits – starting with communication.

Jessie’s point in telling me to blog was simple. Academic attempts at communicating to the masses in fact misses the masses. Research jargon, “the publish or perish” thought process, and academic journal paywalls limit, if not eliminate, the ability for patients to access critical information that can support their decision-making about their health. In the present era of smartphones and social media, our ability to communicate and connect are becoming limitless, and the research world is not keeping up.

Jessie offered her advice over 5 years ago and, despite thinking about it often, I am only now taking up her challenge. What took so long? Fear, mostly. In academia, rejection is not uncommon, but it happens through peer review and scripted letters gently informing you that more work is necessary or the fit isn’t right. Blogs require the writer to be succinct and engaging. It also requires a willingness to be vulnerable by putting forth your ideas and experiences. Have you ever read the comments section of a blog? Yikes!

Why now? Because timing is everything. Our resources for research are finite and threatened, yet our need for scientific discovery grows. Now more than ever, researchers need patients and caregivers as partners to improve the quality and efficiency of research and to help spread research results beyond traditional academic circles. Evidence about how partnership improves all aspects of research is growing, but it is still not standard practice. We need to communicate more about our experiences. That means pushing past our academic comfort zones. Through this blog series, I hope to connect with people to share actionable tips, tools, and resources for partnering based on the lessons I have learned along the way. I look forward to inviting discussion on a range of topics. Among them – how my patient partner Mary made me think differently about informed consent, my loathing of the phrase “human subjects,” and that time I realized how research writing can ruin relationships.

Crafting this blog is bittersweet. Jessie lost her fight with cancer in 2014. Revisiting archives of her blog as I prepared to write this reminded me of her intensity and passion for making healthcare better for all. In a tribute to Jessie’s legacy a colleague stated, “She created all of us as her spokesperson. She imbued us with the need and desire to be communicators. Her legacy is actually leaving a part of herself in all of us that we are her voice moving forward.” I am so thankful and honored that Jessie, and so many other patients, caregivers, and family members have shared with me their stories, their time, and their partnership over the years. I am a better researcher because of what they have taught me. I hope this blog will spur discussion and discourse about the journey forward. I look forward to continuing the conversation.