Welcome to the Online Research Ethics Course for Investigators developed by the Program for Improving Ethical Review System in Sudan a collaborative program between the University of Khartoum, Al–Neelain University, the Federal Ministry oh Health and the European and Developing Countries Clinical Trials Partnership Program supported by the European Union.
In compliance with national regulations that govern human subjects in research in Sudan “Guidelines for Ethical Conduct of Research Involving Human Subjects” , it is recommended that investigators conducting human subjects’ research should have training in research ethics. This course is intended to provide a foundation for investigators in conducting human subjects’ research. The course is divided into nine modules that cover the major topics in research ethics. Each module includes a power point audio presentation
The estimated time commitment for this course is between 6-8 hours.
A certificate is issued once a minimum of 80% is achieved in the final test. Two attempts are allowed. Once you have successfully completed the test, you may print out a certificate of completion. Further attempts are allowed after at least two weeks duration.
The course consists of nine modules that offer comprehensive training exploring the wide range of ethical issues faced by investigators dealing with human subjects in their research. This course is funded by the European and Developing Countries Clinical Trial Partnership Grant (EDCTP-Ethics 2015-873).
We recommend that you navigate the course in the order defined below. Each module varies in length but no module should take longer 30 minutes to complete. Additional recourses are also attached to each module for further readings. When you have finished the nine modules you will have the option to complete the course by taking a test consisting of 40 best answer questions.
Some of the content for this course were adopted from the Middle Eastern Research Ethics Training Initiative (MERETI)
Course Contents and Objectives:
|Module 1||Introduction to Research Ethics
1. Define what research is, what is ethics, and what is research ethics.
2. Discuss the evolution of guidelines that govern human subject’s research.
|Dr. Shaza Abass|
|Module 2||Ethical Review System in Sudan
1. Recognize the role of the National and Institutional Research Ethics Committees
2. Describe the constitution and functions of RECs
3. Describe the ethical review system in Sudan
|Dr. Sumaia Alfadil|
|Module 3||Categories of Ethical Review
1. Describe the what is human subjects research
2. Describe categories/levels of research review
|Dr. Sara -Lavinia Brair|
|Module 4||Risks and Benefits
1. Evaluate the potential risks and benefits to the research participant in a research protocol
2. Discuss how to minimize identified risks and enhance identified benefits
|Dr. Shaza Abass|
|Module 5|| The Informed Consent Process
1. Identify the critical elements of informed consent that must be provided to potential participants
2. Identity the alternative elements of informed consent that must be provided to participants in specific situations
3. Describe different strategies for implementing informed consent
|Dr. Shahd Osman|
|Module 6||Understanding Vulnerability
1. Identify vulnerability issues
2. Explain coercion and undue inducement
|Dr. Tahra Alsadig|
|Module 7||Ethical issues in Clinical Trials
1. Describe the difference between the different phases of clinical trials
2. Discuss controversial ethical issues relating to human subject research that may occur in different phases of clinical trials including concept of equipoise
|Prof. Dyeldin Elsayed|
|Module 8||Therapeutic Misconception|
1. Define plagiarism, falsification and fabrication.
2. Describe questionable research practices
3. Discuss authorship.
|Prof. Mohamed Elshiekh|