issues in clinical research in global health

Question 1

What issues are there

Answer 1

1. capacity building
2. Adapt procedures to context e..g SOPs easy to read.
3. protect and engage the communities (dont just paternalize them, but also teach them and be careful around certain things e.g. engaging trhough compensensation, is that coercion?
4. the consent procedures: very big problem = humanitarian misconception! they think that something is wrong and that they HAVE to cooperate, but that is not true! also high levels of illiteracy and not understanding the language, so everyhting has to be translated.
5. Benefit sharing: Results of research should be fairly shared with
   participants and their communities. e.g. access for the community to interventions developed by research, data sharing, sample ownership
6. Invest in the supply chain, e.g. deliver high quality drugs, pre-select service providers for maintenance
7. Invest in project management: poor management in contracts results in ethical breaches and harm, e.g. material transfer agreements to have clear rules on ownership

Question 2

Some returning issues in ebola management

Answer 2

Some returning issues :
– how to obtain truly informed consent of patients facing death, in a high-safety environment?
– “humanitarian misconception”?
– community engagement?

Question 3

What went wrong in ebola management?

Answer 3

Samples were exported (lack of local lab facilities), but …
* many without consent, ethics approval, transfer
agreement
* No coownership → no benefit for the communities