Conducting human challenge studies in LMICs: A survey of researchers and ethics committee members in Thailand


Autoři: Jaranit Kaewkungwal aff001;  Pornpimon Adams aff002;  Jetsumon Sattabongkot aff003;  Reidar K. Lie aff004;  David Wendler aff005
Působiště autorů: Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand aff001;  Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand aff002;  Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand aff003;  Department of Philosophy, University of Bergen, Bergen, Norway aff004;  Department of Bioethics, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, Maryland, United States of America aff005
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223619

Souhrn

Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries (LMICs). Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. The target respondents included those who had experience with health-related research at universities, non-university hospitals, and research institutes. A total of 240 respondents completed the on-line survey. In general, the respondents felt that the ethical issues raised by human challenge studies in LMICS do not differ significantly from those in high income countries, including: scientific rationale, safety, appropriate risks, and robust informed consent process. In contrast, issues that have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers in different fields, nor between researchers and REC members. These findings provide an important perspective for assessing existing frameworks for human challenges studies in LMICs.

Klíčová slova:

Clinical research design – Quality assurance – Quality control – Questionnaires – Social research – Survey research – Surveys – Thailand


Zdroje

1. Njue M, Njuguna P, Kapulu MC, Sanga G, Bejon P, Marsh V, et al. Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya. Wellcome Open Res. 2018;3:39. doi: 10.12688/wellcomeopenres.14439.2 29806038

2. Expert Committee on Biological Standardization. Human Challenge Trials for Vaccine Development: regulatory considerations. Geneva: World Health Organization; 2016.

3. Gordon SB, Rylance J, Luck A, Jambo K, Ferreira DM, Manda-Taylor L, et al. A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi. Wellcome Open Res. 2017;2:70. doi: 10.12688/wellcomeopenres.12256.1 29018841

4. World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

5. Darton TC, Blohmke CJ, Moorthy VS, Altmann DM, Hayden FG, Clutterbuck EA, et al. Design, recruitment, and microbiological considerations in human challenge studies. Lancet Infect Dis. 2015;15(7):840–51. doi: 10.1016/S1473-3099(15)00068-7 26026195

6. Bambery B, Selgelid M, Weijer C, Savulescu J, Pollard AJ. Ethical Criteria for Human Challenge Studies in Infectious Diseases. Public Health Ethics. 2016;9(1):92–103. doi: 10.1093/phe/phv026 29731811

7. Pitisuttithum P, Islam D, Chamnanchanunt S, Ruamsap N, Khantapura P, Kaewkungwal J, et al. Clinical Trial of an Oral Live Shigella sonnei Vaccine Candidate, WRSS1, in Thai Adults. Clin Vaccine Immunol. 2016;23(7):564–75. doi: 10.1128/CVI.00665-15 27146000

8. Suntharasamai P, Migasena S, Vongsthongsri U, Supanaranond W, Pitisuttitham P, Supeeranan L, et al. Clinical and bacteriological studies of El Tor cholera after ingestion of known inocula in Thai volunteers. Vaccine. 1992;10(8):502–5. doi: 10.1016/0264-410x(92)90347-m 1621412

9. Spring M, Polhemus M, Ockenhouse C. Controlled Human Malaria Infection. S40 • JID. 2014; 209: Suppl 2, S40.

10. Whitehorn J, Van VC, Simmons CP. Dengue human infection models supporting drug development. J Infect Dis. 2014;209 Suppl 2:S66–70.

11. Oxford JS. Towards a universal influenza vaccine: volunteer virus challenge studies in quarantine to speed the development and subsequent licensing. Br J Clin Pharmacol. 2013;76(2):210–6. doi: 10.1111/bcp.12146 23617282

12. Hodgson SH, Juma E, Salim A, Magiri C, Njenga D, Molyneux S, et al. Lessons learnt from the first controlled human malaria infection study conducted in Nairobi, Kenya. Malar J. 2015;14:182. doi: 10.1186/s12936-015-0671-x 25927522

13. Spring M, Polhemus M, Ockenhouse C. Controlled Human Malaria Infection. J Infect Dis. 2014;209 (Suppl 2):S40–45.

14. Knezevic I. Human Challenge Trials for vaccine development: London: WHO approach; 2018.

15. Shah SK, Kimmelman J, Lynch HF, McChutchan F, Miller FG, Palacios R, et al. Ethical Considerations for Zika Virus Human Challenge Trials Report & Recommendations. 2017. Available from: https://www.niaid.nih.gov/sites/default/files/EthicsZikaHumanChallengeStudiesReport2017.pdf

16. Emerson CI. Ethical Considerations for Human Challenge Studies. Institute on Ethics & Policy for Innovation. London, UK: The Academy of Medical Sciences; 2018. Available from: https://acmedsci.ac.uk/file-download/70768021.

17. Rose A, Sekhar A. Bioethics of establishing a CHIM model for dengue vaccine development. Int J Infect Dis. 2019 Jan 11. pii: S1201-9712(19)30024-4. doi: 10.1016/j.ijid.2019.01.013 30641207

18. Miller FG, Lyerly AD. Navigating Ethics Review of Human Infection Trials With Zika. Published in: Clinical Trials and Human Subjects Research, Global Health, Hastings Bioethics Forum. April 30, 2018 Available from: https://www.thehastingscenter.org/navigating-ethics-review-human-infection-trials-zika/ {Access date: 05/08/19).

19. Kaewkungwal J, Adams P. Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand, Accountability in Research. 2019; 26(3): 176–197, doi: 10.1080/08989621.2019.1608190 30987450

20. European Commission. Research, Risk-Benefit Analyses and Ethical Issues. European Union. 2013. Available from: https://ec.europa.eu/research/swafs/pdf/pub_research_ethics/KI3213113ENC.pdf.

21. Shah SK, Kimmelman J, Lyerly AD, Lynch HF, Miller FG, Palacios R, et al. Bystander risk, social value, and ethics of human research. Science. 2018;360(6385):158–9. doi: 10.1126/science.aaq0917 29650663


Článek vyšel v časopise

PLOS One


2019 Číslo 10

Nejčtenější v tomto čísle

Tomuto tématu se dále věnují…


Kurzy

Zvyšte si kvalifikaci online z pohodlí domova

Léčba bolesti v ordinaci praktického lékaře
nový kurz
Autoři: MUDr. PhDr. Zdeňka Nováková, Ph.D.

Revmatoidní artritida: včas a k cíli
Autoři: MUDr. Heřman Mann

Jistoty a nástrahy antikoagulační léčby aneb kardiolog - neurolog - farmakolog - nefrolog - právník diskutují
Autoři: doc. MUDr. Štěpán Havránek, Ph.D., prof. MUDr. Roman Herzig, Ph.D., doc. MUDr. Karel Urbánek, Ph.D., prim. MUDr. Jan Vachek, MUDr. et Mgr. Jolana Těšínová, Ph.D.

Léčba akutní pooperační bolesti
Autoři: doc. MUDr. Jiří Málek, CSc.

Nové antipsychotikum kariprazin v léčbě schizofrenie
Autoři: prof. MUDr. Cyril Höschl, DrSc., FRCPsych.

Všechny kurzy
Kurzy Doporučená témata Časopisy
Přihlášení
Zapomenuté heslo

Nemáte účet?  Registrujte se

Zapomenuté heslo

Zadejte e-mailovou adresu se kterou jste vytvářel(a) účet, budou Vám na ni zaslány informace k nastavení nového hesla.

Přihlášení

Nemáte účet?  Registrujte se