Module 4: Lesson 13 – Clinical Research and Genetic Epidemiology


Name: Elize Pietersen
Affiliation: University of Cape Town
Location: Cape Town, South Africa

Elize is a registered nurse with work experience as a clinical nurse, educator and researcher. She worked in hospitals in rural and urban areas and in the private sector. Her experiences include general nursing, midwifery, oncology and intensive cardio-thoracic care. Elize was a lecturer psychiatric nursing at university level, taught community health at college level and general nursing at private nursing schools. Her research career started in 1996. She was involved in human genetic research related to bi-polar disease and hereditary non-polypotic cancer. Since 2009 to date her research focus is on extensive drug-resistant TB. In April 2017 she was appointed as the coordinator of the Global Research Nurses. Her vision is to establish a formailised career pathway for clinical research nurses.

Name: Dr Anita Ghansah
Affiliation: Noguchi Memorial Institute for Medical Research
Location: Accra, Ghana

Anita was awarded her PhD in Genetic Epidemiology from the London School of Hygiene and Tropical Medicine (LSHTM) in 2009. During the course of her PhD programme, she spent part of her time at the Wellcome Trust Centre for Human Genetics (Oxford University) to complement her epidemiology training at the LSHTM with genetics and genomics training. Her PhD project was based on a severe malaria case-control study conducted in Navrongo (Upper East Region of Ghana). She conducted a detailed genetic association analysis of resistance and susceptibility to severe malaria, focusing particularly on the beta-globin gene region. As a PhD student Anita also coordinated the Noguchi Memorial Institute’s involvement as a key partner in the Malaria Genomic Network (MalariaGEN), and proved to be highly effective in building successful working relationship between research teams and in establishing strong scientific collaborations. In 2010-2011, Anita was an Exxon Mobil leadership training scholar for 2010-2011, part of which provided six month training at the Harvard School of Public Health. Anita has also acquired knowledge in using statistical packages, population genetics/genomics analysis software and various Bioinformatics tools. Anita is a Co-PI of the NMIMR noded and is involved in organizing workshops to introduce Bioinformatics to the University of Ghana community.

This session aims to give participant a background to clinical research and genetic epidemiology such that they can a) understand the ‘bigger picture’ of clinical studies in which their own role is situated or will be situated in the future b) introduce them to some basic research skills and the field of genetic epidemiology should they decide to pursue their own research within further academic studies. For this course, this session will allow for participants to develop their own research projects for this course.

Learning Outcomes

  • Describe how to frame an achievable research question and match it to an appropriate study design
  • Distinguish between observational and interventional research, quantitative and qualitative methods
  • Select potential study end points and determine how these could be measured and/or achieved
  • Develop a plan for selecting and recruiting study subjects
  • Define genetic epidemiology and its relationship to other disciplines

Class Videos

Assessments – Pre-class Exercise
Increased genomic research in Africa has led to a higher demand of research nurse positions. Please read the interview below, the interview is based on a research nurse working in the UK, please reflect on this article and if possible point out areas which might be of concern in Africa. When you can, respond to other participants’ reflections.

Assessments – Class Exercise
1) Describe an idea or problem you would like to work on? You are also welcome to please pick an idea from the list suggested in the following document click to see draft proposals you can expand on
2) Turn your idea problem into a research question
3) Describe the study design you would choose for this research study: observational and interventional research, quantitative and qualitative methods
4) Select potential study end points and determine how these could be measured and/or achieved
5) Develop a plan for selecting and recruiting study subjects if these are required
6) Discuss some ethical concerns that might crop up during or after your research
7) Explain how findings from your research question might be useful to the wider community
8) Define the approvals and clearance you might need to get this research question approved in your area. (We already have ethical clearance from the University of Cape Town, as long as your study participants are not from outside of this course)
9) Literature review of your research questions. Identify 5 key research articles to be included in your literature review.
10) Identify experts within your institute you might consider partnering/collaborating with and why? These experts might have some skills you do not have.

Class Evaluation
See course evaluations section.

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Additional Readings & Exercises
1) Access and complete The Global Health Network’s eLearning modules. “Introduction to clinical research”:  Click here for access
2) The Global Health Network’s The Process Map: Click here for access 
3) The Global Health Network’s eLearning modules “The study protocol: Part 1”, “The study protocol: Part 2” : Click here for access 
4) The Global Health Network’s Social Science Sessions:  Click here for access 
5) Chandler, C.I.R., Reynolds, J., Palmer, J., & Hutchinson, E. Qualitative methods for international health intervention research: Click here for access
6) Genetic Epidemiology Basics Click here for access
7) Study Designs in Epidemiology