Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials

Abstract

Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)—particularly those that may alter or waive informed consent—remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.

Patient priorities for fulfilling the principle of respect in research: findings from a modified Delphi study

“…The high ranking of these items may reflect the fact that these interactions are often the most visible parts of a research study from a participant’s perspective, and thus a key locus for participants to experience respect, but it is also important for researchers to be aware how systems-focused approaches may shape these and other research experiences. Other highly ranked items on our survey may be particularly critical for showing respect in studies where consent and/or personal interactions are not feasible—for example, in some pragmatic clinical trials where varied considerations have been proposed that could, individually and/or collectively, contribute to respectful research [ 26 ]. Our findings also highlight a need for further work examining perceptions of respect among individuals who use languages other than English, as well as to support the development of respect-promoting interventions.…”

“…Lower-ranked items from our final survey round may also reveal approaches to showing respect outside of the consent process or any interpersonal interactions, for example through providing high-quality information in the participant’s language, individual or overall study results, and/or other follow-ups. These may be particularly important to implement in the setting of pragmatic trials or other settings where consent is not feasible [ 26 ]. Given respondents’ comments that many of these approaches are seen as basic requirements, it may be important to strive to fulfill as many as possible within a study’s constraints.…”

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials

“…Notification demonstrates respect for persons, recognizing them as individuals who should be offered information about activities that affect them-a practice that has ethical value independent of whether individuals are offered a choice about participation. 2 Transparency about research is also important for promoting both participant understanding of their contributions and researcher and institutional trustworthiness. Notwithstanding these ethical reasons, ePCT investigators (and their institutional review boards) too rarely consider whether and how to promote transparency about trials conducted under a waiver of consent.…”

What do health care professionals, students, and laypeople in Greece believe about informed consent for research on medical practices? Unleashing Pandora's box

“…5,9 So far, eight dimensions have been proposed of demonstrating respect in pragmatic clinical trials: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. 10 Although previous research in Greece has emphasized on the role of the patient-physician relationship, the time spent by the physician to inform the patient, the patient's comprehension of informed consent, and the alternatives to therapy, 11 there are no data about research and more specifically about research on medical practice in individuals who are not patients. Research in Greece is scarce and out of date and focuses only on nurses (a group of health care professionals who are not primarily linked to medical research but who are of secondary importance) as well as on surgical patients.…”