Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience
2011

Improving Informed Consent in Health Research

Sample size: 90 publication Evidence: moderate

Author Information

Author(s): Boga Mwanamvua, Davies Alun, Kamuya Dorcas, Kinyanjui Samson M., Kivaya Ester, Kombe Francis, Lang Trudie, Marsh Vicki, Mbete Bibi, Mlamba Albert, Molyneux Sassy, Mulupi Stephen, Mwalukore Salim

Primary Institution: KEMRI-Wellcome Trust Research Programme

Hypothesis

How can informed consent processes be strengthened in low-resource settings?

Conclusion

The study found that contextualizing informed consent processes significantly improves understanding and compliance among participants.

Supporting Evidence

  • Informed consent is crucial for ethical health research.
  • Challenges in obtaining consent are particularly pronounced in low-resource settings.
  • Community engagement can enhance the informed consent process.

Takeaway

This study shows that making consent forms easier to understand helps people agree to participate in health research.

Methodology

The study involved developing and implementing contextualized informed consent form templates and standard operating procedures for health research.

Potential Biases

Potential biases may arise from the reliance on community engagement and the varying levels of understanding among participants.

Limitations

The study did not systematically assess the long-term impact of the new consent processes.

Participant Demographics

Participants were from low-resource settings in Kilifi, Kenya.

Digital Object Identifier (DOI)

10.1371/journal.pmed.1001089

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