Training overview for RECs

 

Training in Research Ethics for Research Ethical Committee Members

 

  1. Training overview

This training program is intended to provide an intensive training course for members of Institutional and Research Ethics Committees. The workshop will focus on research ethics, reviewing protocols and problems that can be encountered while reviewing different protocols.

  1. Trainers:

Professor Mohamed Ahmed El Sheikh, MBBS, FRCOG, Chairman, UNESCO Chair in Bioethics

 

Professor  Dyaaeldin Elsayed, Professor of Community Medicine, Al-Azahari University, Fellowship in Bioethics, John Hopkins, USA

 

Proffessor Suad Suliman,  Proffeser of Parasitology, and member of the Technical Advisory &  National Ethical Research committee, Federal Ministry of Health

 

Dr. Sumia Alfadil, Associate Professor of Community Medicine, Nile College, Certificate in Research ethics, the MERETI program, USA

 

Dr. Shaza Abass, BDS, MSc, PhD.Associate Professor of Orthodontics, University of Khartoum, Certificate in Research ethics, University of Maryland and the MERETI program, USA

 

Dr. Sara-Lavinia Brair, MBBS, MD., Associate Professor of Community Medicine, Dean Scientific Research Deanship,Al Neelain University, Certificate in Research ethics, University of Maryland and the MERETI program, USA

 

Dr. Shahd Osman, MBBS, MSc. Epidemiologist, Federal Ministry of Health, Certificate in Research ethics, University of Maryland and the MERETI program, USA

 

Dr. Tahra Alsadig Alsidig, Vice Dean , and Director of Educational Development Centre, Ahfad University , Faculty of Medicine, Certificate in Research ethics, University of Maryland and the MERETI program, USA

 

 

  1. Objectives:
    • Knowledge:

The knowledge domain will be addressed using formal sessions in the form of large group teaching using power point presentation as well as small group discussions.  In addition, selected articles will be distributed one week before the workshop with the dates when they will be discussed on. These articles will form the basis of the small group discussion. By the end of the workshop the participants should be able to 

  1. Recognize the importance of research ethics in human subject
  2. Recognize the importance of international and national guidelines in protecting human subjects
  3. Identify risks and benefits
  4. Describe all the components of informed consent
  5. Describe different categories for research review
  6. Recognize roles of research ethics committees
  7. Explain therapeutic misconception
  8. Identify vulnerability issues while reviewing protocols
  9. Explain coercion and undue inducement

  

3.2 Skills:

Participants will be provided with protocols for reviewing using a provided checklist, reviewing informed consent form for a provided protocol (one case) and developing an informed consent form for a provided protocol. These exercises will be done in small groups. By the end of the workshop participants should have the skills of:

  1. Analyze different protocols using provided checklist
  2. Write an informed consent form for a provided protocol

 

3.3 Attitudes:

By the end of the course, members should adopt the following attitudes:

  1. Willingness to participate actively in a team with other Institutional Review Members for reviewing protocols
  2. Willingness to accept different point of views while reviewing protocols in an Intuitional Review Board meeting

 

The content of the workshop will be spread over four weeks including an initial face to face component (4 days) followed by a three weeks component as described in the following timetable.

 

 

  1. Tentative Timetable

Day 1

Time

Topic

08:30-09:00

 Registration & Inauguration

09:00-09:30

Ice Breaking Session

09:30-10:00

Pre-test

10:00-10:30

Introduction to Research Ethics

Objectives

1.     Discuss the history and evolution of ethics in research involving human participants.

2.     Define human subjects research

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

10:30-11:00

What makes Research Ethical?

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

11:00-11:30

Coffee Break

11:30-12:00

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

12:00-12:30

Case Study on Risks and Benefits

Group Work

12:30-01:00

Categories of Research Review

Objectives

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

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

01:00- 01:30

Exercise  of Categories of Research Review

Group Work

01:30- 02:00

Break

02:00-02:30

Protocol I Review

Group Work

02:30-0:00

Discussion

       

 

Day 2

Time

Topic

09:00-09:30

The Informed Consent Process

Objectives

1.     Identify the critical elements of informed consent that must be provided to potential participants

2.     Identity  alternative elements of informed consent that must be provided to participants

3.      Describe different strategies for implementing informed consent

09:30-10:00

Case study on informed consent

Group Work

10:00-10:30

Waiver of informed Consent

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

10:30-11:00

Protocol II review

Group Work

11:00-11:30

Coffee Break

11:30-12:00

Research Designs

Objectives

1.     Identify the different types of study designs

2.     Select the appropriate study design for a given research question

12:00-12:30

Vulnerability, Coercion and Undue Inducement 

Objectives

1.     Identify vulnerability issues s and extra protections that may be needed.

2.     Learn about coercion and undue inducement and how to elicit there possible existence in research

12:30-01:00

Case Study

Group Work

01:00- 1:30

Research Ethics Committees, Constitution   and review process

Objectives

1.     Describe the constitution of research ethics committees

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

01:30- 02:00

Break

02:30-0:00

Protocol I Review

Group Work

 

Discussion

       

Home work:  Construct an informed consent form for protocol III and submit on day 2 of the workshop

 

Day 3

Time

Topic

09:00-09:30

Phases of 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

3.     Highlight the importance of clinical trials registry

09:30-10:00

Ethics of Social sciences and Behavioral Research involving Children Research 

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.

10:00-10:30

Ethics of research involving Children Research

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.

10:30-11:00

Protocol VI review

Group Work

11:00-11:30

Break

11:30-12:00

Therapeutic Misconception

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

12:00- 12:30

Responsible Conduct of Research

Objectives

1.     Define some key terms in Responsible conduct of research

2.     Identify different situations of Research misconduct

3.     Recognize the consequences associated with research misconduct including quality of research, harm to participants and effects on the researcher.

12:30- 01:00

Prevalence of Research misconduct in Sudan (Research study)

01:00-01:30

Break

01:30-02:00

Research on Human Tissue samples and Genetic Research

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

02:00- 02:30

Case Study

Group Work

02:30- 03:00

Discussion

 

Day 4

Time

Topic

Facilitator

09:00-09:30

Protocol  V Review

Group Work

09:30-10:00

Ethics of Globalization  of Research 

Objectives

1.     Learn about 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 to 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.

10:00-10:30

Introduction to online Training

10:30-11:00

The Ethical Review System in Sudan  and role of Institutional  and State RECs

Objectives

1.     Describe the ethical review system in Sudan

2.     Recognize the role of the National and Institutional research ethics committees

11:00-11:30

Break

11:30-12:00

The accreditation process for RECs

Objectives

1.     Define the accreditation and its periodicity 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

12:00- 12:30

Post-test

12:30- 1:00

Break  and group photo

1:00- 2:30

Individual Presentations

All

02:30- 3:00

 Wrap up and Discussion

 

Online Training (3 weeks)

Week 1            Levels of Ethical Review

Week 2            Ethical Issues in International Research

Week 3            Monitoring of Clinical Trials

 

 

  1. Books and References

 

  1. International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. Geneva. Council for International Organizations of Medical Sciences (CIOMS); 2016.
  2. Guidelines for Ethical Conduct of Research Involving Human Subjects in Sudan, The Federal Ministry of Health , 2008
  3. Developing Accreditation Guidelines for Research Ethics Committees In Sudan, The Federal Ministry of Health, 2017
  4. International Conference on Harmonization, Guideline for Good Clinical Practice