Ethics and Regulatory Issues

Terms of reference for the Ethics and Regulatory Issues


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

First Ethics Consultation Meeting (June 2014)

Second Ethics Consultation Meeting (May 2015)

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