Assistant Professor Geisinger College of Health Sciences Malvern, Pennsylvania
Abstract: In the late 1980s and 1990s, scientific and advocacy groups adopted the term “research participants” in place of “human subjects” to emphasize the voluntary, active role participants ought to play in research. Adopting “participant” language, however, can obscure critical distinctions in research relationships. While “participant” suggests active engagement and voluntary consent, this term may overstate agency and overlook the interests of some relevant parties. We argue for a more precise framework, distinguishing between “participants”, who actively engage with researchers and often provide informed consent; “subjects”, who are the focus of the research question and may or may not engage with researchers; “sources”, who provide data, whether actively or passively (e.g., through administrative records or electronic health data), and “bystanders” who may be indirectly affected by research. While the first three categories often overlap in conventional clinical research, they diverge in other study designs. For example, in research on clinician guideline adherence, clinicians are the research subjects, patient records may serve as the data source, and no participants may exist if neither group directly interacts with the researchers. Research regulations and Institutional Review Board (IRB) practices, shaped by the conventional researcher-participant dyad, frequently fail to consider all relevant parties when research designs deviate from the traditional model. This paper examines ethical considerations relevant to participants, subjects, sources, and bystanders. It explores power dynamics, vulnerability, the relevance of risks and benefits, and the interaction between these factors and current regulations and IRB practices.
Keywords: Ethics review and institutional review boards, Research participants or human subjects, Unconventional study designs
Learning Objectives:
After participating in this conference, attendees should be able to:
Distinguish between participants, subjects, sources, and bystanders in unconventional research designs and evaluate ethical considerations for research studies in which subjects, sources and/or bystanders do not directly interact with researchers
Assess the implications of power dynamics, including the relative vulnerability of relevant parties and the role of implicit consent
Propose strategies for IRBs and researchers to ensure ethics review considers all relevant parties in a research study
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