Payment of clinical research subjects

Grady, Christine

doi:10.1172/jci25694

Cited by 292 publications

(363 citation statements)

References 36 publications

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“…Some authors have raised concerns that payments to underserved populations represents coercion, while others have suggested that payments may bias study results obtained or population recruited. [73][74][75][76][77][78][79] Accordingly, payments could potentially have a negative impact on trust, especially in vulnerable populations that might already be distrustful of research.…”

Section: Discussionmentioning

confidence: 99%

Recruiting Vulnerable Populations into Research: A Systematic Review of Recruitment Interventions

2007

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BACKGROUND: Members of vulnerable populations are underrepresented in research studies.OBJECTIVE: To evaluate and synthesize the evidence regarding interventions to enhance enrollment of vulnerable populations into health research studies.DATA SOURCES: Studies were identified by searching MEDLINE, the Web of Science database, personal sources, hand searching of related journals, and article references. Studies that contained data on recruitment interventions for vulnerable populations (minority, underserved, poor, rural, urban, or inner city) and for which the parent study (study for which recruitment was taking place) was an intervention study were included. A total of 2,648 study titles were screened and 48 articles met inclusion criteria, representing 56 parent studies. Two investigators extracted data from each study.RESULTS: African Americans were the most frequently targeted population (82% of the studies), while 46% targeted Hispanics/Latinos. Many studies assessed 2 or more interventions, including social marketing (82% of studies), community outreach (80%), health system recruitment (52%), and referrals (28%). The methodologic rigor varied substantially. Only 40 studies (71%) incorporated a control group and 21% used statistical analysis to compare interventions. Social marketing, health system, and referral recruitment were each found to be the most successful intervention about 35-45% of the studies in which they were attempted, while community outreach was the most successful intervention in only 2 of 16 studies (13%) in which it was employed. People contacted as a result of social marketing were no less likely to enroll than people contacted through other mechanisms. CONCLUSIONS:Further work with greater methodologic rigor is needed to identify evidence-based strategies for increasing minority enrollment in research studies; community outreach, as an isolated strategy, may be less successful than other strategies.

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Section: Discussionmentioning

confidence: 99%

Recruiting Vulnerable Populations into Research: A Systematic Review of Recruitment Interventions

2007

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“…40,62,69 Controversy and contention still exist internationally concerning the ethics of monetary compensation to parents and investigators. 40,70 However, findings from this literature review showed that there are poorer governance structures and greater concerns regarding inducement or coercion in LMICs. More empirical work is needed to guide appropriate and ethical distribution of research benefits in LMICs.…”

Section: Conducting Trials In Children Inmentioning

confidence: 80%

Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review

et al. 2016

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CONTEXT: Clinical trials are necessary to improve the health care of children, but only onequarter are conducted in the low-to middle-income countries (LMICs) in which 98% of the global burden of disease resides. OBJECTIVE:To describe stakeholder beliefs and experiences of conducting trials in children in LMICs.DATA SOURCES: Electronic databases were searched to August 2014. Five themes were identified: centrality of community engagement (mobilizing community, representatives' pivotal role, managing expectations, and retaining involvement); cognizance of vulnerability and poverty (therapeutic opportunity and medical mistrust); contending with power differentials (exploitation, stigmatization, and disempowerment); translating research to local context (cultural beliefs, impoverishment constraints, and ethical pluralism); and advocating fair distribution of benefits (health care, sponsor obligation, and collateral community benefits). LIMITATIONS:Studies not published in English were excluded. CONCLUSIONS:Conducting trials in children in LMICs is complex due to social disadvantage, economic scarcity, idiosyncratic cultural beliefs, and historical disempowerment, all of which contribute to inequity, mistrust, and fears of exploitation. Effective community engagement in recruiting, building research capacities, and designing trials that are pragmatic, ethical, and relevant to the health care needs of children in LMICs may help to improve the equity and health outcomes of this vulnerable population.

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“…The lack of animal models that can reliably predict vaccine efficacy means that development still unavoidably relies on testing of novel vaccines in healthy individuals. Given the often unquantifiable risks to the recipients of vaccines in early stages of development, clinical trials have traditionally relied on informed and consenting volunteers who appreciate the potential risks but still choose to participate for altruistic reasons [6,7]. But relying on altruism alone to facilitate clinical trials is potentially unsustainable and ethically contentious.…”

mentioning

confidence: 99%

“…To date, the relatively meagre compensation that participants often receive could be seen to belittle and undervalue the contribution of these individuals to global health. The modest financial remuneration commonly provided often means that students and the unemployed make up the bulk of volunteers [6,8,9]. As a result, the risks of developing a health intervention that would benefit the whole population are carried disproportionately by some of society's most poor and vulnerable.…”

mentioning

confidence: 99%

“…However it is hard to increase volunteer payment without creating financial incentives. "Danger money" is frowned upon as an inducement that inevitably clouds an individual's appreciation of risk, limiting the likelihood that consent is informed [6,7]. As a result, consensus has generally dictated that payment for volunteers' trial involvement be modest and limited to compensation for travel, time, and inconvenience only.…”

mentioning

confidence: 99%

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