Online Research Ethics Course for Investigators

Welcome to the Online Research Ethics Course 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 and the European and Developing Countries Clinical Trials Partnership Program supported by the European Union.

Background

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

Duration

The estimated time commitment for this course is between 6-8 hours.

Certification

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.

Format

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:

  Topic Facilitator
Module 1 Introduction to Research Ethics 

Objectives:

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.

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Dr.  Shaza Abass
Module 2 Ethical Review System in Sudan

Objectives:

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

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Dr. Sumaia Alfadil 
Module 3 Categories of Ethical Review

Objectives

1.     Describe the what is human subjects research
2.     Describe categories/levels of research review

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Dr. Sara -Lavinia Brair
Module 4 Risks and Benefits

Objectives

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

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Dr. Shaza Abass
Module 5  The Informed Consent Process      

Objectives

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

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Dr. Shahd Osman
Module 6 Understanding Vulnerability

Objectives:

1.     Identify vulnerability issues
2.     Explain coercion and undue inducement

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Dr. Tahra Alsadig
Module 7 Ethical issues in Clinical Trials

Objectives

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

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Prof. Dyeldin Elsayed
Module 8 Therapeutic Misconception

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Prof. Henry J. Silverman

Module 9

 

Research Misconduct

Objectives:

1.     Define plagiarism, falsification and fabrication.
2.     Describe questionable research practices
3.     Discuss authorship.

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 Prof. Mohamed Elshiekh