Scientific Response to Deadly Novel Epidemics: The Role of Good Clinical Practice

  • Francis K. Kombe
  • Jennyfer Ambe
  • Gibril Ndow
  • Korlia Bonarwolo


Good Clinical Practice (GCP), has grown to be a widely accepted international quality standard that guides the regulation and conduct of clinical trials involving human subjects. The overall aim of GCP is to protect the welfare and well-being of human research projects by providing a stepwise approach to planning, conducting and monitoring of clinical trials. The International Conference on Harmonization of GCP guidelines provides a strict checklist, which researchers and their nominees must follow when conducting clinical research. Unfortunately, these stringent checklists often fall short of appreciating the complex ground realities usually experienced in their application. This chapter uses an African case study to outline the shortcoming of using the GCP guidelines during a deadly novel epidemic. Using the case study as an example of how GCP can fail to protect research participants at a time when they are highly vulnerable, we highlight important considerations for enhancing research subjects’ protection during a deadly epidemic, especially in an African context.



All names used in this chapter are fictitious and therefore do not belong to any particular individuals. They are however common Mijikenda names, hence some people may relate to them within the Mijikenda community context. Obtaining consent from such individual is therefore not applicable.


  1. Department of Health. (2014). The Belmont report. Ethical principles and guidelines for the protection of human subjects of research. The Journal of the American College of Dentists, 81(3), 4.Google Scholar
  2. Dickens, B. M., & Cook, R. J. (2003). Challenges of ethical research in resource-poor settings. International Journal of Gynecology & Obstetrics, 80(1), 79–86.CrossRefGoogle Scholar
  3. Dixon, J. R. (1999). The international conference on harmonization good clinical practice guideline. Quality Assurance, 6(2), 65–74.CrossRefGoogle Scholar
  4. Folayan, M. O., Peterson, K., & Kombe, F. (2015). Ethics, emergencies and Ebola clinical trials: The role of governments and communities in offshored research. The Pan African Medical Journal, 22.
  5. Grant, R. W., & Sugarman, J. (2004). Ethics in human subjects research: Do incentives matter? Journal of Medicine and Philosophy, 29(6), 717–738.CrossRefGoogle Scholar
  6. Guerra, S. Á. (2011). Harmonization of quality standards for clinical trials. ISO-9001 standard and guide of good clinical practice. Armonización de Estándares de Calidad Para Ensayos Clínicos. Norma ISO 9001-Guía de Buena Práctica Clínica.Google Scholar
  7. ICH. (2016). E6 (R2) Guideline for good clinical practice. Guidance. Scholar
  8. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use. (1996). ICH E6 guideline for good clinical practice. ICH Harmonised Tripartite Guideline. Scholar
  9. Macrae, D. J. (2007). The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials. Proceedings of the American Thoracic Society, 4(2), 176–179.CrossRefGoogle Scholar
  10. Marsh, V., Kamuya, D., Rowa, Y., Gikonyo, C., & Molyneux, S. (2008). Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust research programme, Kilifi, Kenya. Social Science & Medicine, 67(5), 721–733.CrossRefGoogle Scholar
  11. Nelson, R. M., Beauchamp, T., Miller, V. A., Reynolds, W., Ittenbach, R. F., & Luce, M. F. (2011). The concept of voluntary consent. The American Journal of Bioethics, 11(8), 6–16.CrossRefGoogle Scholar
  12. Odom, S. L., Brantlinger, E., Gersten, R., Horner, R. H., Thompson, B., & Harris, K. R. (2005). Research in special education: Scientific methods and evidence-based practices. Exceptional Children, 71(2), 137–148.Google Scholar
  13. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A. (2009). The obligation to participate in biomedical research. JAMA, 302(1), 67–72.CrossRefGoogle Scholar
  14. Victora, C. G., Habicht, J.-P., & Bryce, J. (2004). Evidence-based public health: Moving beyond randomized trials. American Journal of Public Health, 94(3), 400–405.CrossRefGoogle Scholar
  15. Weijer, C., & Emanuel, E. J. (2000). Protecting communities in biomedical research. Science, 289(5482), 1142–1144.CrossRefGoogle Scholar
  16. World Health Organization. (2005). Handbook for good clinical research practice (GCP): Guidance for implementation.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Francis K. Kombe
    • 1
  • Jennyfer Ambe
    • 2
    • 3
  • Gibril Ndow
    • 4
    • 5
  • Korlia Bonarwolo
    • 2
  1. 1.African Research Integrity Network (ARIN)KilifiKenya
  2. 2.Global Emerging Pathogens Treatment InitiativeMainland HospitalLagosNigeria
  3. 3.Department of Public Health, School of Nursing and Health SciencesCapella UniversityMinneapolisUSA
  4. 4.Medical Research Council Unit The Gambia at London School of Hygiene & Tropical MedicineBanjulThe Gambia
  5. 5.Institute of Global Health Innovation, Division of Integrative Systems Medicine & Digestive Diseases, Faculty of MedicineImperial College LondonLondonUK

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