Literature DB >> 30585505

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

Stephanie A Kraft1,2, Devan M Duenas1, James G Kublin3, Kelly J Shipman1,3, Sean C Murphy4, Seema K Shah5,6,7.   

Abstract

Controlled human malaria infection (CHMI) studies deliberately infect healthy participants with malaria to test interventions faster and more efficiently. Some argue the study design and high payments offered raise ethical concerns about participants' understanding of risks and undue inducement. We conducted baseline and exit interviews with 16 CHMI study participants to explore these concerns. Participants described themes including decision-making tension with friends and family, mixed motivations for participating, low study risks but high burdens, fair compensation, sacrificing values, deceiving researchers, and perceived benefits. Our findings do not support concerns that high payments limit understanding of study risks, but suggest participants may lack appreciation of study burdens, withhold information or engage in deception, and experience conflict with others regarding study participation.

Entities:  

Keywords:  deception; healthy volunteers; human infection challenge studies; payment for research participation; research ethics; undue influence; volunteer infection studies

Mesh:

Year:  2018        PMID: 30585505     DOI: 10.1177/1556264618820219

Source DB:  PubMed          Journal:  J Empir Res Hum Res Ethics        ISSN: 1556-2646            Impact factor:   1.742


  15 in total

Review 1.  Controlled Human Infection Models To Accelerate Vaccine Development.

Authors:  Robert K M Choy; A Louis Bourgeois; Christian F Ockenhouse; Richard I Walker; Rebecca L Sheets; Jorge Flores
Journal:  Clin Microbiol Rev       Date:  2022-07-06       Impact factor: 50.129

Review 2.  Systems biology of malaria explored with nonhuman primates.

Authors:  Mary R Galinski
Journal:  Malar J       Date:  2022-06-07       Impact factor: 3.469

3.  Ethical and practical considerations arising from community consultation on implementing controlled human infection studies using Schistosoma mansoni in Uganda.

Authors:  Moses Egesa; Agnes Ssali; Edward Tumwesige; Moses Kizza; Emmanuella Driciru; Fiona Luboga; Meta Roestenberg; Janet Seeley; Alison M Elliott
Journal:  Glob Bioeth       Date:  2022-07-04

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

Authors:  Marie-Astrid Hoogerwerf; Martine de Vries; Meta Roestenberg
Journal:  BMJ Open       Date:  2020-07-26       Impact factor: 2.692

Review 5.  Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy.

Authors:  Euzebiusz Jamrozik; Michael J Selgelid
Journal:  J Med Ethics       Date:  2020-05-07       Impact factor: 2.903

6.  When could human challenge trials be deployed to combat emerging infectious diseases? Lessons from the case of a Zika virus human challenge trial.

Authors:  Ricardo Palacios; Seema K Shah
Journal:  Trials       Date:  2019-12-19       Impact factor: 2.279

7.  Typhoidal Salmonella human challenge studies: ethical and practical challenges and considerations for low-resource settings.

Authors:  Meriel Raymond; Malick M Gibani; Nicholas P J Day; Phaik Yeong Cheah
Journal:  Trials       Date:  2019-12-19       Impact factor: 2.279

8.  Towards a fair and transparent research participant compensation and reimbursement framework in Vietnam.

Authors:  Lucy J Sansom; Trang Pham Nguyen Minh; Iona E Hill; Quyen Nguyen Than Ha; Thuan Dang Trong; Celine Vidaillac; Nhu Dong Quynh; Hugo C Turner; Jennifer Ilo Van Nuil; Dung Nguyen Thi Phuong; Evelyne Kestelyn
Journal:  Int Health       Date:  2020-11-09       Impact factor: 2.473

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

Authors:  Olivia Grimwade; Julian Savulescu; Alberto Giubilini; Justin Oakley; Joshua Osowicki; Andrew J Pollard; Anne-Marie Nussberger
Journal:  J Med Ethics       Date:  2020-09-25       Impact factor: 2.903

10.  Exploring willingness to participate in future Human Infection Studies in Lusaka, Zambia: A nested qualitative exploratory study.

Authors:  Evelyn Muleba Kunda-Ngándu; Masuzyo Chirwa-Chobe; Chanda Mwamba; Jenala Chipungu; Esnart Ng'andu; Hope Mwanyungwi Chinganya; Michelo Simuyandi; Roma Chilengi; Anjali Sharma
Journal:  PLoS One       Date:  2021-07-09       Impact factor: 3.240

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