Key Ethical Issues in CRTs
The article examines two CRTs conducted in LMICs: the PolyIran trial in Iran and the PASTAL trial in Malawi. Both trials underscore the importance of addressing ethical issues such as informed consent, choice of control arm, post-trial access, and the need for ethics education and capacity building.
1. Informed Consent
Obtaining informed consent in CRTs can be particularly challenging in LMICs due to factors like high illiteracy rates and cultural differences in understanding research. The PolyIran trial addressed this by using verbal consent documented by local research staff. However, further guidance is needed on when verbal consent is acceptable and how to ensure accurate communication of study information.
2. Choice of Control Arm
The choice of an ethically appropriate control arm remains contentious. The principle of beneficence requires that the potential benefits and risks of participation stand in reasonable relation. In the PASTAL trial, the usual care arm showed poor results, raising questions about the adequacy of locally available care as a comparator. Researchers must carefully consider whether control groups should receive augmented care, care as defined by national standards, or locally available care.
3. Post-Trial Access
Ensuring post-trial access to effective interventions is crucial, particularly in LMIC settings. The PolyIran trial planned to provide the polypill to participants for five years if proven effective. However, this raises questions about the feasibility and sustainability of long-term access. Clear guidelines are needed to define stakeholder obligations for post-trial access.
4. Ethics Education and Capacity Building
There is a pressing need for ethics education and capacity building regarding CRTs in LMICs. Many researchers and ethics committees in these settings are not familiar with guidelines like the Ottawa Statement. Web-based educational materials, regional workshops, and training fellowships can help build capacity and ensure ethical practices in CRTs.
Implementing Ethical Practices
Practitioners can enhance their ethical practices by:
- Ensuring informed consent procedures are culturally appropriate and understandable.
- Carefully selecting control arms that balance ethical considerations with research needs.
- Planning for post-trial access to interventions and clarifying stakeholder responsibilities.
- Engaging in continuous ethics education and capacity-building activities.
To read the original research paper, please follow this link: Ethical issues in cluster randomized trials conducted in low- and middle-income countries: an analysis of two case studies.
