Preface
The Interim Constitution of the Republic of Sudan, established in 2005, laid down the foundation for governance in Sudan following a period of civil war and political transition. While it focused on broader political and constitutional matters, it did include provisions related to scientific research and the protection of participants in such research.
One of the key aspects of the Interim Constitution was its encouragement of scientific research as a means to promote development and progress in Sudan. This encouragement was aimed at fostering innovation, knowledge creation, and technological advancement within the country.
However, this encouragement was conditioned by the requirement to protect and promote the lives of research participants. This reflects a recognition of the importance of ethical considerations in research, particularly within times and areas of areas of conflict, where participants may be vulnerable and require special protections.
In addition to the Interim Constitution, other legal instruments such as the Public Health Act of 2008 and subsequent presidential decrees have further emphasized that the National Research Committee in collaboration with the National Drug and Poisons Board shares the responsibility of safeguarding the lives of Sudanese people, including those who participate in research.
These legal frameworks collectively underscore the importance of ethical standards, informed consent, privacy protections, and overall respect for the rights and well-being of research participants in Sudan. They aim to ensure that scientific research is conducted responsibly and ethically, contributing positively to the advancement of knowledge and the improvement of public health outcomes in the country.
All research involving human subjects, from planning and approval to conduct, recording, and reporting, must adhere to a comprehensive set of ethical standards and legal requirements in Sudan. These requirements include compliance with the principles outlined in the Helsinki Declaration on medical research involving human subjects from 1964, as well as specific provisions laid out in the Public Health Act of 2008 (PHA, 2008), particularly in Chapters 6, Article 29, and Article 30. Furthermore, researchers and institutions must follow the National Guidelines for Ethical Conduct of Research Involving Human Subjects. These guidelines, last updated in 2017, align with international standards and encompass key principles such as informed consent, protection of vulnerable populations, ethical review by independent committees, and data privacy. The Helsinki declaration built on principles first stated in 1947 in the Nuremberg Code and further incorporated elements from the Declaration of Geneva. The guiding principles include protecting health, wellbeing, dignity, integrity, confidentiality and self-autonomy of participants. The Uppsala Codex from 1984 also natural science, technology, law, and social sciences. The Oviedo convention from 1997 for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine is the only international legally binding instrument on the protection of human rights in the biomedical field. In addition to these guidelines, the National Research Ethics Committee periodically publishes regulations and guidelines that further augment the ethical framework for research involving human subjects. Researchers and institutions are mandated to stay abreast of these evolving regulations and guidelines to ensure the ethical integrity of their research endeavors.
This course (and additional training manual) has been developed to orient researchers with a systematic understanding of a wide range of ethical issues faced by investigators dealing with human subjects in their research. It is based on the accordance with the principles of the Guidelines for Conduct of Research Involving Human Subjects, Second Edition (2017) and the curriculum of the Middle Eastern Research Ethics Training Initiative (MERETI) developed by Henry Silverman. The training provides a basic level of training to be considered in research involving human subjects.
The training is divided into 10 modules covering the major research ethics topics. Each module includes educational videos and cases for discussions/reflection.
This course (and additional training manual) has been developed with financial support from the Norwegian Embassy in Sudan through the Sudan-Norway Academic Collaboration (SNAC) Project.
Shaza Abass, PhD
Research Ethics Training Coordinator