ETHICS RESOURCES

Publications/Journal Articles

  1. 2018 Edition of International Compilation of Human Research Standards. Washington, D.C: Office for Human Research Protections U.S. Department of Health and Human Services
  2. Aarons, D. Ethical issues surrounding body integrity and research. West Indian Med J. 2015; 63: 2015.235.
  3. Aarons, DE. Research: an ethical answer in addressing our people’s health problems and inequities. West Indian Med J 2015; Suppl 2: 97-100.
  4. Aarons, D. Research in epidemic and emergency situations: A model for collaboration and expediting ethics review in two Caribbean countries. Developing World Bioethics, 2017
  5. WHO guidelines on ethical issues in public health surveillance. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.

Theme: Cluster Randomised Tials and Stepped Wedge Trials:

  1. Gallo A et al. ‘What is the role and authority of gatekeepers in cluster randomized trials in health research?’ Trials 2012;13:116
  2. Prost A ‘Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies’ Trials 2015;16:351
  3. Sim J and Dawson A ‘Informed consent and cluster-randomised trials’ American Journal of Public Health 2012;102(3):480-485
  4. Weijer C et al. ‘Ethical issues posed by cluster randomized trials in health research’ Trials 2011;12: 100

Theme: Adaptive Platforms Research:

  1. Berry, SM et al. ‘A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response’ Clinical Trials 2016;13(1):22-30
  2. Hey SP and Kimmelman J ‘Are outcome-adaptive allocation trials ethical?’ Clin Trials 2015; 12(2):102-6 from PubMed Central Canada
  3. Lanini S et al. ‘Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in West Africa?” Lancet Infectious Diseases 2015;15(6):738–745 accessible through registration at: http://www.thelancet.com/user/register
  4. Woodcock J et al. ‘Master protocols to study multiple therapies, multiple diseases, or both’ N Engl J Med 2017;377:62-70 available for personal use only at: http://www.nejm.org/doi/full/10.1056/NEJMra1510062#trial%20innovations

Theme: Controlled Human Infection Models:

  1. Gordon, SB et al. ‘A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi’ [version1]. Wellcome Open Research 2017; 2:70
  2. Hodgson, S et al. ‘Lessons learnt from the first controlled human malaria infection study conducted in Nairobi, Kenya’ Malaria Journal 2015;14:182
  3. Shah, S et al. “Ethical considerations for Zika Virus Human Challenge Trials. Report and Recommendation” (February 2017)

Theme: Current Guidance and Regulation on Alternative Trial Designs:

  1. Council for International Organizations of Medical Sciences (CIMOS) in collaborations with the World Health Organisation ‘International ethical guidelines for health-related research involving humans’ 2016
  2. Weijer C et al. ‘The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials’ PLoS Med 2012;9(11): e1001346
  3. World Health Organisation ‘Human Challenge Trials for Vaccine Development: regulatory considerations’ Expert Committee on Biological Standardisation Geneva 17 to 21 October 2016