Subject, Volunteer, Participant or Patient?
Which term is most appropriate?
A patient is a person who receives medical care. As a registered nurse, I delivered care to patients in the hospital and homecare setting, but there are many other settings in which patients can receive medical care. Some of these include a physician’s office, a school nurse’s office, and closer to home, a clinical research site. I have always believed that good care puts patients at the center, and Clariness espouses this belief as well. That’s why I thought it would be interesting, in this time of patient centricity, to renew the discussion about how we refer to people enrolled in clinical research studies.
Over the years we’ve seen the use of the terms subject, patient, participant and volunteer to describe someone who enrolls in a clinical research study. Which term is most appropriate, providing the most accurate description, while honoring the sacrifice and contribution made by the individual and his or her family? Do any of these terms misrepresent the individual or worse, disrespect him or her?
Let’s first consider the term ‘subject’. The U.S. Department of Health & Human Services defines the role of human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the
individual, or identifiable private information. In spite of its official sanctioned use, I’ve always objected to the term ‘subject’ to describe a person who donates time, effort and bodily fluids to further clinical research. It has a negative connotation for me, conjuring up the image of a cold scientific investigation. I wonder if people considering participating in clinical research studies are dissuaded by this term? Do they feel they will be ‘subject’ed to tests and procedures? Acted upon, rather than participating in their health care?
How about ‘patient’, is this a better term? At Clariness one of the ways we support our clients is through patient research, engagement and enrollment that begins early in clinical development and extends through post-approval stages. We recruit people who meet specific criteria in order to be candidates for enrollment into a clinical trial. But are we recruiting patients, subjects, participants or volunteers? As we know, not all individuals who participate in clinical research are patients; phase I studies often rely on healthy individuals. But for later phase studies, individuals with specific medical conditions, having received a diagnosis and in many cases had some level of treatment, aka patients, are enlisted to enroll. So while it seems the word ‘patient’ is not all encompassing, it fits well for phase II and beyond.
I’m in favor of using the word patient to describe an individual who enrolls in a clinical research study. Others are too. If you look at Clinicaltrials.gov, they provide information “For Patients and Families”. Centerwatch has a section of their website called “Patient Resources”. Even the FDA has a section called, “For Patients”. The term has a soft connotation, one that most of us can relate to since at one time or another, we’ve all been a patient. It implies that as a current or former patient, we may be eligible for clinical research studies. To me, it keeps the door open for greater participation.
How about the terms ‘volunteer’ and ‘participant’? ‘Volunteer’ has a wonderful connotation. Dictionary.com defines a volunteer as a person who voluntarily offers himself or herself for a service or undertaking, or a person who performs a service willingly and without pay. ‘Volunteer’ implies an active choice to become involved, in contrast to ‘subject’ which seems passive and as if you will be acted upon. So ‘volunteer’ could definitely apply to later stage studies and well describes what an individual who enrolls in a clinical research study is doing: performing a service willingly and without pay. ‘Participant’ may work too, since the individual enrolling in a clinical research study must participate. Like ‘volunteer’, it also implies an active choice to do something.
Individuals who enroll in clinical research are patients, volunteers, participants and I suppose subjects, but to honor these people who give of themselves with no guarantee of any value for their efforts, I think we should choose terms that empower. For me, this would mean losing the term ‘subject’ or ‘human subject’ when referring to these medical heroes, as CISCRP calls them. Let’s use words that engage individuals and encourage them to participate in clinical research.
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