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Purpose: Individuals who struggle to provide substitute judgment for the critically ill often find it challenging to engage in decision making for therapeutic interventions. Although essential to the conduct of research, how these individuals respond to requests for clinical trial participation is poorly understood., Methods: Survey data collected to examine surrogate attitudes toward research provided the conceptual framework to explore influences on decision making. Path analysis was used to derive the final model (nonlatent, fully recursive, 1 indicator/variable)., Results: Surrogates with list-wise complete records (406) were analyzed. The following variables were not retained in the final model: education, income, religiosity, decision-making experience, discussion of patient's wishes, number of individuals assisting with decision making, trust in care providers, difficulty making decisions, and responsibility for decision making. Being white and having experience making treatment decisions for the patient during the current intensive care unit encounter affected the likelihood the surrogate would permit participation in research positively (parameter estimates, 0.281 and 0.06, respectively). No variable reflecting difficulty functioning in the surrogate role was associated with permitting research participation., Conclusions: We were unable to demonstrate a relationship between perceived difficulty in decision making in the surrogate role and receptivity to clinical trial participation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: We undertook the current investigation to explore how the pressures of serving as a surrogate decision-maker (SDM) for an acutely ill family member influence attitudes regarding clinical investigation., Methods: We conducted a prospective study involving SDMs for critically ill patients cared for in the ICUs of two urban hospitals. Measurements included participation in focus groups designed to explore perceptions of ICU care and clinical research. Audiotapes were transcribed and analyzed to identify common patterns and themes using grounded theory. Demographic and clinical data were summarized using standard statistical methods., Results: Seventy-four SDMs (corresponding to 24% of eligible patients) participated. Most SDMs were women and described long-term relationships with the patients represented. SDMs described their role as "overwhelming," their emotions were accentuated by the fatigue of the ICU experience, and they relied on family members, social contacts, and religion as sources of support. Altruism was reported as a common motivation for potential study participation, a sentiment often strengthened by the critical illness episode. Although research was viewed as optional, some SDMs perceived invitation for research participation as tacit acknowledgment of therapeutic failure. SDMs expressed a preference for observational studies (perceived as low risk) over interventional designs (perceived as higher risk). Trust in the ICU team and the research enterprise seemed tightly linked., Conclusions: Despite significant emotional duress, SDMs expressed interest in investigation and described multiple factors motivating participation. Consent processes that minimize the effects of anxiety may be one strategy to enhance recruitment.

Critical illness trials involving genetic data collection are increasingly commonplace and pose challenges not encountered in less acute settings, related in part to the precipitous, severe and incapacitating nature of the diseases involved. We performed a systematic literature review to understand the nature of such studies conducted to date, and to consider, from an ethical perspective, potential barriers to future investigations. We identified 79 trials enrolling 24 499 subjects. Median (interquartile range) number of participants per study was 263 (116.75-430.75). Of these individuals, 16 269 (66.4%) were Caucasian, 1327 (5.4%) were African American, 1707 (7.0%) were Asian Pacific Islanders and 139 (0.6%) were Latino. For 5020 participants (20.5%), ethnicity was not reported. Forty-eight studies (60.8%) recruited subjects from single centers and all studies examined a relatively small number of genetic markers. Technological advances have rendered it feasible to conduct clinical studies using high-density genome-wide scanning. It will be necessary for future critical illness trials using these approaches to be of greater scope and complexity than those so far reported. Empirical research into issues related to greater ethnic inclusivity, accuracy of substituted judgment and specimen stewardship may be essential for enabling the conduct of such trials.

Relationships between academic researchers and industry have received considerable attention in the past twenty years. However, current data on the prevalence, magnitude, and trends in such relationships are rare. In a mailed survey of 3,080 academic life science researchers conducted in 2007, we found that 52.8 percent have some form of relationship with industry. Life science faculty with industry research support were more productive than faculty without such support on virtually every measure. However, we also found a significant decrease in industry support of university research, which could have major consequences for the academic life science research sector.