Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

Kamalo, Patrick; Manda-Taylor, Lucinda; Rennie, Stuart

doi:10.1136/medethics-2014-102246

“…This is a regulatory requirement for high-risk research in Malawi. No-fault insurance for clinical trial research is a regulatory requirement that aims to assert the legal notion of responsibility in research and reflect the ethical thinking of solidarity to remind public health researchers in LMICs like Malawi that "an injury to one is an injury to all" 28 . Besides, the duty of care is a universal moral obligation for research, especially in HIS, where the possibility to cause harm could have severe legal and financially costly implications.…”

Section: Discussionmentioning

confidence: 99%

“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

Toto

¹

,

Gooding

²

,

Kapumba

³

et al. 2021

Self Cite

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Background: Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. HIS research is expanding to many low and middle-income settings to accelerate vaccine development. Given the implementation of the first HIS research to establish the experimental human pneumococcal carriage model’s feasibility, we sought to understand the participant’s opinions and experiences. Methods: We used a qualitative, descriptive approach to understand participants perceptions and experiences on HIS participation. Sixteen healthy adult participants were invited to participate in in-depth exit interviews to discuss their experiences, motivations and concerns. Results: Our findings showed that the likelihood of participation in HIS research rests on three essential conditions: motivation to participate, compensation and advocacy. The motivation and decision to participate was based on reasons including altruism, patriotism, monetary and material incentives, and while compensation was deemed appropriate, concerns about unanticipated research-related risks were raised. Participant advocate groups were recommended for increasing awareness and educating others in the broader community about HIS research. Conclusions: Participants’ experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted.

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“…Although not a research-related injury compensation system per se, in Sub-Saharan African culture the Ubuntu ethical framework for dispute resolution focuses on consensus-building, reconciliation, and “collective responsibility without blame.” 101 Injury to one member of society translates to injury to the whole society. Likewise, blame is shared by the whole society, and there is a norm that everyone should contribute to reparation for the injury.…”

Section: Demonstration Of the Feasibility Of Compensation Systems In Other Countriesmentioning

confidence: 99%

The Quest for Compensation for Research-Related Injury in the United States: A New Proposal

Chapman¹,

Sukumaran²,

Tsegaye³

et al. 2019

J. Law. Med. Ethics

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In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.

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“…It reflects the ethical commitment to establish justice and fairness in research. It serves as a reminder to CHIM researchers in LMICs like Malawi that "an injury to one is an injury to all"31 . The payment of risk model would help build public trust by demonstrating a commitment to the value of life, which is consistent with the duty of care, especially in CHIM research, where the possibility to cause harm could have severe implications for public support and willingness to participate.…”

mentioning

confidence: 99%

“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

Toto

¹

,

Gooding

²

,

Kapumba

³

et al. 2021

Self Cite

View full text Add to dashboard Cite

Background: Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. HIS research is expanding to many low and middle-income settings to accelerate vaccine development. Given the implementation of the first HIS research to establish the experimental human pneumococcal carriage model’s feasibility, we sought to understand the participant’s opinions and experiences. Methods: We used a qualitative, descriptive approach to understand participants perceptions and experiences on HIS participation. Sixteen healthy adult participants were invited to participate in in-depth exit interviews to discuss their experiences, motivations and concerns. Results: Our findings showed that the likelihood of participation in HIS research rests on three essential conditions: motivation to participate, compensation and advocacy. The motivation and decision to participate was based on reasons including altruism, patriotism, monetary and material incentives, and while compensation was deemed appropriate, concerns about unanticipated research-related risks were raised. Participant advocate groups were recommended for increasing awareness and educating others in the broader community about HIS research. Conclusions: Participants’ experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted.

show abstract

Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

Cited by 5 publications

References 28 publications

“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

The Quest for Compensation for Research-Related Injury in the United States: A New Proposal

“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

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