» Articles » PMID: 19537430

Why Do Individuals Agree to Enrol in Clinical Trials? A Qualitative Study of Health Research Participation in Blantyre, Malawi

Overview
Journal Malawi Med J
Specialty General Medicine
Date 2009 Jun 23
PMID 19537430
Citations 32
Authors
Affiliations
Soon will be listed here.
Abstract

Current literature suggests that therapeutic misconception a belief by participants in a clinical trial that they are in fact simply being given clinical care is common, especially among illiterate populations in developing countries. Therapeutic misconception reects problems in informed consent, as people agree to participate in clinical trials without being aware that the trial procedures and test products may not in fact benet them. In this study of Malawian adults who had participated in research projects of various kinds during the preceding years, we found that the majority participated in research for the sake of obtaining better quality treatment made available through the clinical trials as ancillary care. Their consent to participate was not due to a belief that the actual procedures of the trial would directly benet their health. Respondents indicated that, government hospitals being crowded and commonly lacking drugs, they agreed to take part in research projects in the hope of obtaining access to ancillary care provided by clinical trials. We conclude that in this environment, possibly owing to inadequacy of routine health services, people make rational decisions to participate in research. We question whether the term therapeutic misconception accurately describes participants motivation under conditions of limited resources. We also discuss the relevance of these ndings for understanding undue inducement in clinical trials.

Citing Articles

Traditional medicine regulation status and challenges in Malawi and Nigeria.

Mponda J, Muula A, Choko A, Ajuwon A, Moody J BMC Complement Med Ther. 2025; 25(1):53.

PMID: 39953523 PMC: 11829355. DOI: 10.1186/s12906-025-04812-2.


"When selling anything to an audience, visible publicity is key:" experiences, barriers, and enablers to participate in a COVID-19 study in Malawi.

Mdala V, Nyirenda D, Mpinganjira S, Mwapasa V, Nyondo-Mipando A BMC Med Res Methodol. 2024; 24(1):207.

PMID: 39285321 PMC: 11403996. DOI: 10.1186/s12874-024-02329-9.


Women's motivations for participating in the dapivirine vaginal ring open label extension study.

Naidoo K, Montgomery E, Katz A, Garcia M, Naidoo S, Mansoor L AIDS Care. 2023; 36(3):326-342.

PMID: 37734338 PMC: 10922482. DOI: 10.1080/09540121.2023.2260145.


Culturally responsive research ethics: How the socio-ethical norms of Arr-nar/Kreng-jai inform research participation at the Thai-Myanmar border.

Khirikoekkong N, Asarath S, Nosten S, Hanboonkunupakarn B, Jatupornpimol N, Roest J PLOS Glob Public Health. 2023; 3(5):e0001875.

PMID: 37141207 PMC: 10159138. DOI: 10.1371/journal.pgph.0001875.


'Guidance should have been there 15 years ago' research stakeholders' perspectives on ancillary care in the global south: a case study of Malawi.

Kapumba B, Nyirenda D, Desmond N, Seeley J BMC Med Ethics. 2023; 24(1):8.

PMID: 36765406 PMC: 9912595. DOI: 10.1186/s12910-023-00889-x.


References
1.
Kass N, Maman S, Atkinson J . Motivations, understanding, and voluntariness in international randomized trials. IRB. 2006; 27(6):1-8. PMC: 3099429. View

2.
Rothman K, Michels K . The continuing unethical use of placebo controls. N Engl J Med. 1994; 331(6):394-8. DOI: 10.1056/NEJM199408113310611. View

3.
Molyneux C, Peshu N, Marsh K . Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast. Soc Sci Med. 2004; 59(12):2547-59. DOI: 10.1016/j.socscimed.2004.03.037. View

4.
Onvomaha Tindana P, Kass N, Akweongo P . The informed consent process in a rural African setting: a case study of the Kassena-Nankana district of Northern Ghana. IRB. 2006; 28(3):1-6. PMC: 3099424. View

5.
Featherstone K, Donovan J . Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ. 1998; 317(7167):1177-80. PMC: 28698. DOI: 10.1136/bmj.317.7167.1177. View