final training to be held next week, starting on Sunday the 10th of March 2019

 

The Program for Improving the Ethical Review Process in Sudan

 

Training in Research Ethics for Research Ethical Committee Members

Date: 10/03/2019-13/03/2019                             Venue:  El Tigani Al Mahi Lecture hall,                                                                                                            University of Khartoum, Medical Campus

 

Day 1 Supervision: Dr. Shaza Kamal & Dr. Ehsan Babiker                                  Sunday  10/03/2019

            Time Topic Facilitator
08:30-09:00 Registration & Inauguration All Facilitators
09:00-09:30 Ice Breaking Session All Facilitators
09:30-9:40 Overview on EDCTP grant- Dr. Shaza Abass
9:40-10:00 Pre-test All Facilitators
10:00- 10:40 Introduction to Research Ethics Prof. Mohamed Ahmed Elshiekh
Objectives

1.     Define what is research, what is ethics, what are the different streams of bioethics and what is  research ethics (which is the focus of this training)

2.     Discuss the history and evolution of ethics in research involving human participants with focus on the main historical incidences World War II and Tuskegee.

3.     Discuss the importance of research ethics in protecting human participants in health related research.

10:40-11:00 Break
11:00-11:50 Governance of Health Research Ethics in Sudan and Role of RECs Prof. Suad Suliman
Objectives

1.     Recognize the role of the National and Institutional Research Ethics Committees

2.     Describe the constitution of RECs

3.     Describe the purpose, function, and challenges of RECs

4.     Describe the ethical review system in Sudan

11:50- 12:30 What Makes Research Ethical Dr. Sumaia Al Fadil
Objectives

1.     Utilize a systematic framework for evaluating the ethics of a research protocol.

2.     Discuss the principles of research ethics referring to the international and national guidelines

12:30-1:00 Risks and Benefits Dr. Shahd Osman
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

1:00- 1:30 Break
1:30- 2:30 Case study on Risks and Benefits Dr. Shahd Osman

 

Day 2  Supervision: Prof. Dyaldein ElSayid & Dr.Sara Lavinia                            Monday 11/03/2019     

Time Topic Facilitator
09:00-10:00 Categories of Research Review and Exercise Dr. Sara Lavinia Brair
Objectives

1.     Describe the categories/levels of research review that can be conducted by a REC.

2.     Identify which category of review is most appropriate for a research protocol

3.     Exercise on the Categories of Review.

10:00-10:30 The Informed Consent Process Dr. Sara Lavinia Brair
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

10:30- 11:00 Break

 

11:00-12:00 Protocol (1) Review Dr. Aliaa El Gamri

 

12:00–12:30 Waiver of informed Consent Prof. Dyaeldin ElSayed
Objectives

1.     Describe what is waiver of informed consent and the types of waiver

2.     Assess situations in which a waiver of informed consent can be granted

12:30- 01:00 Break
01:00-01:45 Vulnerability, Coercion and Undue Inducement Dr. Aliaa El Gamri
Objectives

1. Identify vulnerability issues while reviewing research protocols and extra protections that may be needed.

2. Explain coercion and undue inducement and how to elicit there possible existence in research protocols

01:45- 02:45 Case study discussion

Dr. Ehsan Babiker

 

 

 

 

 

Day 3  Supervision Dr. Shahd Osman & Prof. Dyaeldin ElSayid   Tuesday 12/03/2019

Time Topic Facilitator
09:00-10:00 Phases of Clinical Trials Dr. Shahd Osman
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

3.     Highlight the importance of clinical trials registry

10:00-10:30 Therapeutic Misconception Dr. Shaza Abass
Objectives

1.     Explain the difference between research and clinical care

2.     Describe therapeutic misconception and strategies to minimize its occurrence in a clinical research setting

10:30-11:00 Break
11:00-11:30 Ethics of research involving Children Research

 

Dr. Shaza Abbas

 

Objectives

1.     Recognize Ethical Issues in pertinent to children research

2.     Discuss some of the safeguards that need to be assessed to inform ethically appropriate and scientifically sound children research.

 

11:30- 12:30 FEAST Trial

Protocol II review

D, Aliaa AlGamri
12:30- 1:30 Ethics of Social sciences and Behavioral Research Prof. Dyaeldin ElSayed
Objectives

1.     Recognize ethical issues in social sciences and behavioural research

2.     Discuss some of the “up front” considerations that inform ethically appropriate and scientifically sound social and behavioural research.

1:30- 2:00 Break
1:00-1:30 Research on Human Tissue samples and Genetic Research Dr. Ehsan Babiker
Objectives

1.     Recognize Ethical Issues in tissue sample research, research on medical records and genetic research

2.     Discuss some of the “up front” considerations that inform ethically appropriate and

Scientifically sound human tissue samples research.

3.      Discuss issues of transferring tissue samples in international research including material

Transfer agreements.

1:30- 2:00 Break
2:00- 3:00 Responsible Conduct of Research

 

Prof. Mohamed Ahmed El Sheikh

 

 

 

Day 4  Supervision Dr. Shahd Osman & Dr. Shaza Abbas             Wednesday 13/03/2019

Time Topic Facilitator
09:00-10:30 Ethics of Globalization  of Research

Case study on HIV AZT Trial

 

 

Dr. Shahd Osman

 

Objectives

1.            Describe the ethical review processes and the role played by ethical review boards to ensure ethical standards of research in developing countries;

2.            Discuss the significance of collaborative research and highlight the issues concerning such research studies such as exploitation;

3.            Analyze the regional differences in the opinions of researchers from different parts of the world.

 

10:30-11:15 The Accreditation process for RECs Dr. Sumaia Al Fadil
Objectives

 

1.     Define the accreditation and its periodicity in relation to Research ethics committees

2.     Discuss the steps of the accreditation process

3.     Describe what to prepare for accreditation

4.     Discuss the benefits of accreditation

 

11:15- 11:30 Break
11:30-12:00 Introduction to Online Learning Mr. Tarig El Khair
12:00- 01:00 Effective  RECs Meetings Dr. Shaza Abass
1.            Discuss and describe some factors that makes RE meetings more effective including forming groups and giving feedback.
01:00-01:30 Post test All
01:30- 2:00 Break and Group Photo All
02:00- 3:30 Individual Presentations All
3:00-3:30 Discussion and Wrap up All

 

 

Online Training (3 weeks)

 

Week 1            Levels of Ethical Review

Week 2            Ethical Issues in International Research

Week 3            Monitoring of Clinical Trials