Seriously now: taking post-trial obligations in developing countries seriously

Multinational clinical trials are increasingly being held in developing countries and in relation to it, international ethics guidelines have proposed post-trial access (PTA) as a form of compensation. This requires sponsors, investigators, and governmental agencies to make the product or the knowledge gained through the clinical trial available to the participants, the research community, or the host country. However, PTA has not trickled down to actual clinical trials. This is largely because what PTA is has never been concretized. To address this issue, I wish to examine and ethically reflect on what post-trial access is a requirement of, from whom, and on whose oversight it falls.

To effectively address this objective, both empirical research and ethical reflection shall be used. Focus group discussions and a stakeholder meeting in Norway and the Philippines, representing the sponsor and the host countries respectively. This will be followed by a more systematic ethical reflection on the questions of what PTA is a requirement of and what the duties are of duty-bearers within the context of an ethics of human rights. At the end, I aim to develop an integrative guidance document on the provision of PTA in developing countries.