Published online by Cambridge University Press: 27 September 2018
1. Title of the Study: ‘Advancing Access to Opioid Analgesics’
2. Principle Investigator: M.E.C. (Marie Elske) Gispen, LLM, Ph.D. Researcher at the Netherlands Institute of Human Rights (SIM), Utrecht University. Ph. +31(0)6 43 43 99 18; E-mail: firstname.lastname@example.org
3. Context and Justification
You are asked to participate in a research, which sets out to analyse a human-rights based model of drug-control to advance access to opioid analgesics such as morphine in resource poor countries. This research is carried out under the supervision of Professor J.E. (Jenny) Goldschmidt (Director of the Netherlands Institute of Human Rights, Utrecht University) and Professor M. (Marcus) Düwell (Director of the Ethics Institute, Utrecht University), by Ms. M.E.C. (Marie Elske) Gispen, LLM. Before you decide, you can talk to anyone you would feel comfortable with about the research. This consent form may contain words you do not understand. Please ask me to stop as we go through all the information and I will take the time to explain anything you do not clearly understand. If you have questions later, you can ask me at any time.
The purpose of the study is to get insight in Uganda's reform process and present regulatory system of controlled substances applying to morphine, and to map the link between the regulatory demands of the procedural obligations anchored in international drug control treaties and morphine availability. In doing so, the study will also compare access to morphine with an uncontrolled medicine necessary for pain treatment. We believe that you can help us better understand the regulatory chain of morphine in Uganda by telling your experience as one of the actors in the system.
4. Research participation and procedures
Your participation will comprise of one, one-on-one interview lasting for approximately one hour, with the possibility of a follow-up interview for clarification purposes if mutually agreed upon between the PI and the participant. You are being invited to take part in this research because the African Palliative Care Association (APCA) has recommended you as relevant actor in the regulatory chain of morphine.
If you decide to participate you will be asked questions about your role in the regulatory chain of morphine, the pros and cons of the present system and the way it affects delivering adequate standards of palliative care and pain treatment in particular.