This course was developed for training of members of Research Ethics Committees (RECs) on emerging and complex research study designs. The overarching goals of this course are; 1) to provide a brief but detailed overview of the study design; and 2) to identify areas of study designs that REC members need to pay critical attention to during the review and monitoring of research studies. Successful completion of training on this course will to ensure that members of RECs are equipped with skills and tools to provide thorough ethical reviews of research protocols with emerging and complex study designs in compliance to international ethical standards. It is noteworthy that training on this curriculum is not intended to produce a scientific area content expert on any given study design therein, but to inform and sensitize REC members on the vital aspects of the included study designs and to point out areas of focus during the REC review. This will enable REC members to conduct efficient and effective review of research protocols with the study designs covered herein and providing researchers with timely and high-quality responses.

Purpose of the course

The course aims to equip members of Research Ethics Committees with skills and tools to provide thorough ethical reviews of research protocols with conventional complex and emerging study designs in compliance to local and international ethical standards.

Course objectives:

  • To describe the basic principles of different emerging and complex study designs
  • To understand the key design issues with each of the emerging and complex study designs
  • To understand ethics considerations for each of the emerging and complex study designs
  • To objectively review protocols with emerging and complex study designs
Trainers’ description: Trainers will include a team of experts from Infectious Diseases Institute, Makerere University, Makerere University Joint AIDs Program and Uganda Virus Research Institute. The videos included in this course are derived from the live zoom class sessions that were held in May and July for the REC members from Makerere University RECs, Uganda Cancer Institute, Mulago Hospital and Infectious Diseases Institute REC.

Course Roadmap

This is an online self-paced training. There are 10 sessions to be covered. Each session has reflection prompts to assess understanding of the content covered.

Course Evaluation

  • Pre-training and post training assessments will be used to evaluate the impact of the training.

Certification

Certificates of completion will be awarded to trainees who participate in the course and have a final score of 60% or more in the post test assessments.

Sessions

Session 0

Welcome and Introduction

Session 1

Introduction to Randomized Controlled trials and clinical trials phase I-IV

Session 2

Adaptive study design

Session 3

Cluster Randomized controlled trials

Session 4

Stepped Wedged trial design

Session 5

Ecological study design

Session 6

Reverse pharmacology design

Session 7

Controlled Human Infection Model

Session 8

Implementation science research

Session 9

Evaluation of new technologies and digital health intervention

Session 10

Ethical, legal and social issues in genetic research

Acknowledgements and History

The complex and emerging study design Training Program have been developed with funding from the National Institutes of Health (NIH #1G11TW011309-01, PI Pauline Byakika). It has been modified into the online format by the e-Learning team of Infectious Diseases Institute’s Training and Capacity Development department.

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