Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research

Grady, Christine; Bedarida, Gabriella; Sinaii, Ninet; Gregorio, Mark Anthony; Emanuel, Ezekiel J.

doi:10.1177/1740774517722130

Cited by 48 publications

(48 citation statements)

References 15 publications

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“…Phase I participants. As noted in previous studies (Fisher and Kalbaugh 2011; Grady et al 2017), healthy volunteers tend to be lower-income, minority men. Our sample reflected these trends with 73.6% of our participants being men and 68.0% being members of minority groups (40.4% black; 21.3% Hispanic) (see Table 1).…”

Section: Methodssupporting

confidence: 63%

“…Specifically, Phase I participants in the United States are overwhelmingly represented by black men from low socioeconomic positions (Cottingham and Fisher 2016;. Healthy volunteers have been a largely understudied population, and researchers who have empirically examined these types of trial participants typically do not focus on the intersection of financial motivation to participate and the social context of profound racial and economic inequality in the United States (e.g., Grady et al 2017;Kass et al 2007).…”

Section: Introductionmentioning

confidence: 99%

“…Healthy volunteers have been a largely understudied population, and researchers who have empirically examined these types of trial participants typically do not focus on the intersection of financial motivation to participate and the social context of profound racial and economic inequality in the U.S. (e.g., Grady et al 2017; Kass et al 2007). …”

mentioning

confidence: 99%

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Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Williams

Fisher

2018

Sociological Inquiry

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This article develops the concept of temporal total institutions to describe how and why individuals voluntarily submit to highly-controlled and often dehumanizing environments. We focus empirically on Phase I clinical trials, which offer compensation to healthy people in exchange for testing investigational pharmaceuticals. Analyzing the experiences of 67 U.S. healthy volunteers, we illustrate how comparisons between Phase I trials and prison are salient to participants as they reflect on their confinement in research facilities and their interactions with other participants and research staff. We argue that conditions of contemporary economic insecurity and/or poverty facilitate the existence of coercive temporal total institutions by undermining voluntariness. Phase I clinics take advantage of the steady supply of individuals who will submit to the organization’s demands out of hope that the income gained will be transformative for their lives.

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Section: Methodssupporting

confidence: 63%

Section: Introductionmentioning

confidence: 99%

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Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Williams

Fisher

2018

Sociological Inquiry

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“…assessment time, cost of transportation, childcare, etc. ), and evidence suggests that adequate remuneration may be critical to incentivize study participation [5][6][7][8] and retention [9]. Remuneration schedule, which refers to the system of dispersal of funds to participants throughout a study, varies across studies [10].…”

Section: Introductionmentioning

confidence: 99%

The effect of remuneration schedule on data completion and retention in the Pregnancy Eating Attributes Study (PEAS)

Terry

Lipsky

Siega‐Riz

et al. 2019

Preprint

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Background: Maximizing data completion and study retention is essential in population research. There is scant research to inform how remuneration schedules and data collection modality in uence participant data completion and retention. Purpose: We examined the effect of remuneration schedule and data collection modality on data completion and retention in the Pregnancy Eating Attributes Study (PEAS) cohort. Methods: Participants (n=458) completed self-administered surveys and diet recalls online and attended six study visits. Initially, remuneration was a prespeci ed amount per visit (lump sum). The remuneration schedule was changed mid-study to be based on the number of forms completed (prorated). Survey data collection modality was changed to in-person at the 1-year postpartum visit.Remuneration schedule as a predictor of withdrawal by visit was modeled using Poisson regression; differences in retention at 1-year postpartum were examined by t-test. Differences in survey and diet record completion were determined by t-test, analysis of covariance, and logistic regression. Results:There was no signi cant difference in the time to withdrawal and no interaction of visit with remuneration schedule on withdrawal. Survey and diet recall completion were signi cantly lower under prorated remuneration at the rst visit but did not signi cantly differ at subsequent visits. Survey completion at 1year postpartum was signi cantly higher for in-person versus online completion. Conclusions: Findings suggest that remuneration schedule and data collection modality can impact completion of self-reported assessments. Further research is needed to understand how remuneration and data collection practices intersect with diverse populations to in uence data completion and retention.

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“…Garza et al, (2017);Grady et al, (2017);Simon et al, (2011);Perez et al, (2016);Chin et al, (2015);Devine et al, (2015);Edelblute & Fisher, (2015) Application to other scenariosGrady, et al, (2017);Simon et al, (2011);Perez et al, (2016). ;Devine, et al, (2015) DependabilityDetailed description of methodsGarza, et al, (2017); Grady, et al, (2017); Simon, et al, (2011); Perez et al, (2016); Chin et al, (2015); Devine et al, ., (2017); Grady et al, (2017); Simon et al,.…”

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confidence: 99%

Academic researcher decision making processes for research participant compensation

Beck¹

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ii To my daughters, for their unwavering support.iii ACKNOWLEDGEMENTS Many people have guided and supported my academic journey that I would like to acknowledge. Their support and guidance were an integral part of my personal and professional growth as a scholar and researcher.I would like to thank the members of my dissertation committee, John appreciate their support and guidance throughout the dissertation process. I am grateful for the assistance Heidi Arbisi-Kelm, my Interdisciplinary Studies Academic Advisor, provided me through the final stages of my graduate studies. I appreciate the guidance provided by Christian Simon during the initial dissertation development and pilot study. Other individuals who had a profound influence on my academic journey include professors of courses I have taken and other faculty and staff whom I have interacted with in my academic and professional roles. The support of family and friends throughout my academic journey has helped me throughout the successes and challenges I faced. I am appreciative for the constant encouragement and support from my daughters when I made the decision to return to graduate school. Thank you to all who have supported me during this journey. iv ABSTRACT The purpose of this study was to explore the academic researcher decisionmaking processes related to participant compensation. Three interlocking questions guided this exploratory study: RQ 1 : When electing to compensate or not compensate research participants for a study, what factors do academic researchers consider? RQ 2 : What are the ethical challenges faced by academic researchers when determining research compensation for their studies? RQ 3 : How, from the perspective of academic researchers, can compensation practices be improved?Both slippery slope theory and complexity theory grounded this research study.The researcher applied slippery slope to specific interactions and relationships between researchers and the IRB. The researcher also applied complexity theory to analyze the broader, systems approach, essentially to the human subjects research program at one R01 institution, the research setting.Compensation for research participants is a complex issue nested within human subjects research, involving potential ethical pitfalls like undue influence and coercion.Regulations require researchers possess sufficient understanding of their subject population to make informed decisions with respect to compensation issues. Despite the key role compensation practices play in the research process, few researchers have considered these practices from the perspective of the academic researcher.The researcher used a purposive selection method to recruit diverse participants.The study participants spanned multiple disciplines, conducting both biomedical and v behavioral-social science-based research. The final N for this study was 16. This qualitative study had a small N, but nevertheless attempted to recruit participants that would provide a variation in research experiences. The participant perspec...

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Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research

Cited by 48 publications

References 15 publications

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

The effect of remuneration schedule on data completion and retention in the Pregnancy Eating Attributes Study (PEAS)

Academic researcher decision making processes for research participant compensation

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