This course places informed consent within its historical context and outlines the regulations, guidelines and processes which arose from this background. The primary aims of informed consent are to protect the research participant from misinformation, exploitation and coercion. This course offers an introduction to the processes and wider factors which need to be taken into consideration when involving participants in clinical research. The course is aimed at everyone involved in clinical research.

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Duration:
The course should take on average 30-40 minutes to complete.

Certification:
A certificate is issued once a minimum of 80% is achieved in the final quiz section.

Languages:
Français

Related Resources:
MRC Clinical Trials Unit | Global Health Trials Hub | Study Cycle Main Resources | Process Map

QUESTION SETTING AND STUDY DESIGN 

STUDY IMPLEMENTATION AND OPERATIONS 

RESEARCH MANAGEMENT AND GOVERNANCE 

Objectives

Upon completion of the course you will have gained an understanding of:

  1. The events that lead to the development of universal research ethics
  2. Why informed consent is necessary and the guidelines that brought it about
  3. What is involved in taking informed consent from a potential study participant and the information they should be provided with
  4. Who is, and is not, eligible to sign a consent form
  5. Language that should not be used when asking an individual to enrol in a study
  6. The options that are available for non-paper based communities
  7. Points to be taken into account when taking consent

Acknowledgements

The Global Health Training Centre is built through the support and partnership of the  World-Wide Antimalarial Resistance Network and the East African Consortium for Clinical Research.  

Editor:

  • Mary Logan - Global Health Network Training Manager

Reviewers:

  • Steve Wandiga - Kenya Medical Research Institute (KEMRI)/Centers for Disease Prevention and Control (CDC) - KEMRI/CDC Research and Public Health Collaboration, Kisumu, Kenya.
  • Andy Burke - CTSU, University of Oxford

Funders:

This course has been funded by the WorldWide Antimalarial Resistance Network (WWARN)

Source Material:

Material for this course is taken from material very kindly supplied by the The MRC, Gambia from their taught course ‘Informed Consent’.

Use and reproduction of these e-learning materials:

These e-learning materials are owned by The Global Health Network. You are free to share or adapt this material but you must attribute it to The Global Health Network using the link www.theglobalhealthnetwork.org.

For further information please see our FAQ page.

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This course was produced by The Global Health Network in collaboration with The University of Oxford.

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