BOX 1-2The Imperative for Participant-Centered Research in Name and Action
Historically, the role of patients and community members in research has been as passive “subjects”—a term connoting individuals on whom research was to be conducted and thus to be seen as representatives of some group or class of humans under study and not as individuals with personal needs, interests, and preferences. Given this state of affairs, investigators had little expectation that those who volunteered to take part in research should have a voice in its design or execution. Moreover, the research “subject” construct suggests a power and knowledge differential between the investigator and subject along with an associated vulnerability in the subject, the implications of which are that investigators have an ethical responsibility to ensure the wellbeing of human subjects and that protective mechanisms are needed to prevent their exploitation (Bromley et al., 2015). While cases of egregious human experimentation in the past demonstrated the need for protections for research participants and prompted the establishment of cornerstone ethical principles for human research, such as those laid out in the Nuremburg code, the Declaration of Helsinki, and the Belmont Report, dissatisfaction has been growing with the notion of research participants as subjects—a characterization that many find demeaning (Corrigan and Tutton, 2006) and reflective of research policies and regulatory systems that are paternalistic (Miller and Wertheimer, 2007). The role of subject is associated with passivity and, for some, exploitation (Bromley et al., 2015), a perception that may contribute to public distrust in the research enterprise and to the challenges that many investigators face in the recruitment and retention of research participants. High-profile historical examples of research participants and their families pushing back on this dynamic and demanding a more active role in research involving their biospecimens include the Henrietta Lacks story and the gene patent legal suit (Skloot, 2010),a which both resulted in public controversy and litigation (Colaianni et al., 2010). Consequently, a national movement is reframing the role of research participants in such a way that they are not the objects of research, but rather collaborators in the research process.
The degree of appropriate participant engagement in research can be thought of as a continuum. In some cases, the appropriate action may simply be to keep participants informed—for example, by explaining research protocols and providing aggregate study results. In other cases, it may be the case that participants should play a more active role, which could take the form of providing input and feedback to investigators or even working collaboratively with them in the design and conduct of research. Throughout this report, and consistent with use in the broader research community (American Psychological Association, 1973; Boynton, 1998; Bromley et al., 2015), the committee refers to human research volunteers as “research participants” rather than “research subjects,” in accordance with the ethical principles of autonomy and respect for persons and to reflect their changing role in the research enterprise.
- a
Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064, 2003 U.S. Dist. LEXIS 8959, 121 A.L.R.5th 687, 16 Fla. L. Weekly Fed. D 417 (S.D. Fla. May 29, 2003).
