Terms of reference for the Ethics and Regulatory Issues

 Working Group


This working group will discuss and, where appropriate, develop recommendations on ethical and regulatory issues that Consortium members may face in their research. It is important to note that the protocols and communities for each study are different, and therefore that such recommendations may not be appropriate for all studies.

The issues that were raised by the Steering Committee for discussion by the working group includes:

  • Community engagement strategies
  • Consent that will be aligned with the H3Africa vision
  • Intellectual property topics related to data and sample sharing
  • Return of results
  • Cultural issues
  • Participant safety
  • National policies on ethics and regulatory issues
  • Examine material transfer agreements collected by the Biorepository working group


Final Documents

H3Africa Guidelines for Informed Consent

H3Africa Guidelines for Community Engagement

First Ethics Consultation Meeting (June 2014) 

- Background document to First H3Africa Ethics Consultation Meeting (2014)
- H3Africa internal Proceedings of the First H3Africa Ethics Consultation Meeting (2014)
- Proceedings of the H3Africa Ethics Consultation Meeting published in The Hugo Journal, 2015 (9:1)

Second Ethics Consultation Meeting (May 2015)

- Background document to Second H3Africa Ethics Consultation Meeting (2015)