Patients’ Perspectives of Enrollment in Research Without Consent

Abstract

Objective Research in acute illness often requires an exception from informed consent (EFIC). Few studies have assessed the views of patients enrolled in EFIC trials. This study was designed to assess the views of patients and their surrogates of EFIC enrollment in a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury. Design Interactive interview study. Setting Nested within the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III) trial, a Phase III randomized controlled trial in acute traumatic brain injury (TBI). Participants Patients and surrogates (for patients incapable of being interviewed) enrolled in ProTECT III under EFIC at 12 sites. Measurements Interviews focused on respondents’ acceptance of EFIC enrollment in ProTECT, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Main Results 85 individuals were interviewed. 84% had positive attitudes toward ProTECT III inclusion. 78% found their inclusion under EFIC acceptable, and 72% found use of EFIC in ProTECT III acceptable in general. Only 2 respondents clearly disagreed with both personal and general EFIC enrollment. The most common concerns (26%) related to absence of consent. 80% and 92% were accepting of placebo use and randomization, respectively. Though there were few black respondents (n=11), they were less accepting of personal EFIC enrollment than white respondents (55% vs 83%, p= 0.0494). Conclusions Acceptance of EFIC in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. EFIC enrollment appears generally consistent with patients’ preferences.

Understanding preferences regarding consent for pragmatic trials in acute care

“…The distinction between making a recommendation for others and stating personal preferences has been observed in other contexts, including emergency research conducted under the exception from informed consent. 29–31 While some individuals “crossed over” in both directions, these data demonstrate a tendency to recommend more extensive consent processes when making decisions for others in the IRB role. This tendency is understandable and well-intentioned.…”

An Alternative Consent Process for Minimal Risk Research in the ICU*

“…With only a one-line description of a future, hypothetical study, participants may have been less comfortable supporting deferred consent. Previous studies have also found discrepancies between support for specific versus open-ended or hypothetical research studies [16, 17]. Second, in the description of the future, hypothetical study, we did not specify that the option for deferred consent would apply only to subjects who lack capacity.…”

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

“…An important consideration is that studies assessing attitudes towards deferred consent often fail to distinguish views of patients and surrogates. For example, the finding that there is less acceptability from ethnic minority groups incorporates both surrogate-decision makers and previously incapacitated patients (an under-served group) with no distinction between them [42,43]. The lack of clarity between these groups risks inaccurately over-representing minority views, further raising the issue of intersectionality whereby incapacitated patients are already likely to be under-served in deferred consent research.…”