Exploring Ethical Concerns About Human Challenge Studies: A Qualitative Study of Controlled Human Malaria Infection Study Participants’ Motivations and Attitudes

Kraft, Stephanie A.; Duenas, Devan M.; Kublin, James G.; Shipman, Kelly J.; Murphy, Sean C.; Shah, Seema K.

doi:10.1177/1556264618820219

Cited by 36 publications

(51 citation statements)

References 33 publications

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“…Research into the attitudes of CHIM participants has found that the physical requirements of participation can be 'more significant or more painful than expected'. 59 This may indicate that more effort is needed to both accurately describe the expected level of pain in a CHIM and to provide adequate compensation for the pain. However, the elusive and subjective nature of pain makes it extremely difficult to accurately quantify, describe and hence determine payment for.…”

Section: Augmentation For Risk and Painmentioning

confidence: 99%

Payment in challenge studies: ethics, attitudes and a new payment for risk model

et al. 2020

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Controlled Human Infection Model (CHIM) research involves the infection of otherwise healthy participants with disease often for the sake of vaccine development. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clear ethical guidance for their conduct. The payment of CHIM participants is a controversial issue involving stakeholders across ethics, medicine and policymaking with allegations circulating suggesting exploitation, coercion and other violations of ethical principles. There are multiple approaches to payment: reimbursement, wage payment and unlimited payment. We introduce a new Payment for Risk Model, which involves paying for time, pain and inconvenience and for risk associated with participation. We give philosophical arguments based on utility, fairness and avoidance of exploitation to support this. We also examine a cross-section of the UK public and CHIM experts. We found that CHIM participants are currently paid variable amounts. A representative sample of the UK public believes CHIM participants should be paid approximately triple the UK minimum wage and should be paid for the risk they endure throughout participation. CHIM experts believe CHIM participants should be paid more than double the UK minimum wage but are divided on the payment for risk. The Payment for Risk Model allows risk and pain to be accounted for in payment and could be used to determine ethically justifiable payment for CHIM participants.Although many research guidelines warn against paying large amounts or paying for risk, our empirical findings provide empirical support to the growing number of ethical arguments challenging this status quo. We close by suggesting two ways (value of statistical life or consistency with risk in other employment) by which payment for risk could be calculated.

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Section: Augmentation For Risk and Painmentioning

confidence: 99%

Payment in challenge studies: ethics, attitudes and a new payment for risk model

et al. 2020

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“…Research participation can involve a range of burdens; and some HCS designs entail relatively high levels of burdens for participants (eg, studies involving higher risk pathogens and/ or long periods of inpatient isolation and/or close monitoring of participants), especially in comparison with other studies involving healthy volunteers. 32 Here, we use 'burdens' to capture all potential compromises of individuals' interests that occur due to research participation, including exposure to risk, privacy infringements, restrictions of freedom of movement, loss of time, other reductions in well-being, etc. 33 The following sections summarise the findings of our project regarding (i) upper limits to risks to participants in HCS in general, (ii) risks to participants in (LMIC) HCS in particular, (iii) other burdens of participation, (iv) the right to withdraw and (v) risks to third parties.…”

Section: Risks and Other Burdensmentioning

confidence: 99%

Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy

Jamrozik¹,

Selgelid

2020

J Med Ethics

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Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/ or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19.

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“…Participants from both countries, however, showed little concern about trial risks and showed high levels of trust in the study team. In a qualitative study among US CHMI participants, 17 the participants similarly describe little concerns about the risks, trust in the study team as important and mixed motivations for participation. The differences between the American, Kenyan and Dutch CHI participants illustrate the influence of cultural differences and healthcare organisation that remain important to address and separately investigate.…”

Section: Open Accessmentioning

confidence: 99%

Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials

2020

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ObjectiveTo quantitatively investigate the motivations, decision-making and experience of participants in controlled human infection (CHI) studies.DesignCross-sectional descriptive survey study.SettingPrevious participants of CHI studies at the Leiden Controlled Human Infection Center, control group of students from Leiden University.Participants61 previous participants and 156 controls.MeasurementsRanking of motivational and decisional factors, risk propensity score and multiple-choice questions on experience of trial participation and ethical aspects of CHI studies.ResultsMotivating factors for participants were contributing to science (81%), contributing to research that may benefit developing countries (72%) and the financial compensation (63%). For 51% of participants, a reason other than financial compensation was the most important motivational factor. Participants considered trust in the study team (70%), time investment (63%), severity of symptoms (54%), chance of developing symptoms (54%) and whether it is an easy way to make money (54%) in their decision to participate. Most CHI participants (84%) were proud of their participation, would advise others to participate (89%) and would participate in a similar trial again (85%). CHI participants had a higher risk propensity score than students (estimated difference 0.9, p<0.001).ConclusionAlthough financial compensation is important, the motivations for participants in a CHI study are diverse and participants make a balanced appraisal of risks and burden before participating.

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Exploring Ethical Concerns About Human Challenge Studies: A Qualitative Study of Controlled Human Malaria Infection Study Participants’ Motivations and Attitudes

Cited by 36 publications

References 33 publications

Payment in challenge studies: ethics, attitudes and a new payment for risk model

Payment in challenge studies: ethics, attitudes and a new payment for risk model

Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy

Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials

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