Ethics in Research and Clinical Practice (ETHIMED)

About the project

Project lead is the Centre of Medical Ethics (CME) at the University of Oslo. CME collaborates with the College of Medicine and Health Sciences, University of Rwanda (UR), and the Department of Philosophy and Religious Studies (P-RS), University of Dar es Salaam (UDSM), Tanzania.

Background

The Rwandan National Health Research Committee (RNEC) lacks contextualised guidelines to guide ethics review processes. Although the Rwanda Food and Drug Authority (RFDA) regulates clinical trials, it lacks adequate capacity in regulating clinical trials. Additionally, there is no undergraduate or postgraduate bioethics training at the UR Rwanda. Tanzania lacks clinical ethics committees; healthcare providers face complex ethical issues in care provision with minimal resources to address them. The medical students at UiO are only taken through a 3-hour course on research ethics that does not adequately prepare them for research activities. In addition, there is no established research ethics training of research ethics committee (REC) members in Norway.

Across all institutions, staff are not mandated to undertake research ethics (RE) /research integrity (RI) training. In all three institutions, there is need to improve ethics training. Therefore, ETHIMED will:

1. create mutual learning opportunities on RE/ RI and clinical ethics for the three institutions through staff and student exchange programs
2. train staff, undergraduate and postgraduate students, and Research ethics committee and regulatory board members on RE/RI in Rwanda, Tanzania, and Norway
3. train health practitioners and students in Rwanda and Tanzania on the moral deliberation model
4. establish a clinical ethics committee in Tanzania

Objectives

1. Establish and strengthen mobility partnerships for ethics education in research and clinical practice at both undergraduate and postgraduate levels at all 3 universities
2. Develop RE courses/modules for students and staff at the partner universities
3. Create train-the-trainer (TtT) programmes on RE/RI and clinical ethics to enable participants to train other persons
4.  Collaborate with the Ministry of Health in Tanzania to establish a clinical ethics committee in one major hospital
5. Develop standard operating procedures for ethical review for Rwandan RECs and a clinical ethics manual for Tanzanian clinical ethics committees
6. Train members/staff of RECs and drug regulatory authorities in the partner countries on RE/RI.

Expected impact

1. Increased student and faculty mobility will be an opportunity for professional development in an international, nurturing, collaborative, and dynamic setting.
2. UR and UDSM will build their international reputation following the training of postgraduate students and the yearly organisation of RE/RI and clinical ethics courses.
3. The training of faculty staff, RNEC and RFDA members, and researchers will improve RE/RI knowledge and skills and ensure that ethically sound research is conducted in the partners’ countries.
4. The project will develop a mandatory course on RE/RI for undergraduate and postgraduate students at UR, UDSM, and UiO. Joint course development will improve the quality of the course, promote internationalisation, and foster key knowledge and competencies.
5. The training on post-trial access will be conducted with RNEC, RFDA, and RECs in Tanzania to facilitate better ethics review and ethical conduct of research. This will also contribute to capacity building of REC members.
6. Clinical ethics training will support a systematic approach in dealing with difficult cases by the clinical ethics committee. The training will also strengthen clinical ethics education in the region.
7. A Masters curriculum will be developed on Clinical and RE for UDSM. The roll out of the course will create a platform for scholars to learn clinical and RE in Tanzania and possibly other parts of Sub-Saharan Africa.

Cooperation

The College of Medicine and Health Sciences, University of Rwanda

The Department of Philosophy and Religious Studies, University of Dar es Salaam, Tanzania

Financing

The project is financed by The Norwegian Directorate For Higher Education and Skills, through the Norwegian Partnership Programme for Global Academic Cooperation (NORPART) NORPART-2021/10586

Project start and finish

2022-2026