Health research has made spectacular strides over the past few decades. The value of health research is obvious and irrefutable. What is not so apparent is that people who participate in research may be harmed during the process. Africa prides itself in having some of the most respected universities globally. It is a continent of immense research potential. At the same time, Africa suffers from many of the health burdens of low-income regions. While it affords many research opportunities, this creates the potential for the misuse of power on vulnerable individuals and populations. 

This book explores why participants in health research require protection. It also explains how ethical principles and the law can assist inter alia research ethics committees, researchers, funders and institutions at which research is conducted, to safeguard the rights and dignity of individuals contributing to the research enterprise. It engages with this imbalance and examines how well-intentioned aims of ethical health research can be achieved while simultaneously maximising the protection of research participants. It draws on local and international documents and expertise to inform the resolution of many ethical dilemmas and complexities that inevitably arise in health research. 

Health Research Ethics: Safeguarding the Interests of Research Participants provides a solid understanding of the normative values for protecting research participants against exploitation, harm and wrong. Since research ethics is multidisciplinary, this book will be of value to a range of professionals and academics inter alia those from the health sciences, social sciences, and legal disciplines. 

Key features:

• An overview of the norms and values of human conduct and their application in the health research context. 
• Comprehensive coverage of current and emerging themes in research ethics. 
• The most recent developments in health research, namely biobanks and genetic/genomic research.
• Examples and case studies which support the concepts and enable the reader to apply the theory to practice.
• Discussion of pertinent international research ethics policies and guidelines. 
• Ethical aspects of health research in South Africa, the African continent and internationally. 
• Discussion of pertinent South African law.

• Part 1: Ethics in Health Research: General Considerations
  • Chapter 1: Understanding ethics with specific reference to health research
  • Chapter 2: Research ethics: An overview with specific reference to Africa
  • Chapter 3: Guiding principles of ethical research
  • Chapter 4: Informed consent and confidentiality in health research
  • Chapter 5: Research vulnerabilities
  • Chapter 6: Researcher responsibilities
  • Chapter 7: Answers and discussion on case studies and quiz questions
• Part 2: Special Issues: Genetics, Genomics, Biobanks and Health Databases
  • Chapter 8: Special issues: Genetics, genomics, biobanks and health databases in the context of health research
• Part 3: Guidelines and Templates
  • Appendix 1: Template: Ethics application form
  • Appendix 2: Template: Information sheet
  • Appendix 3: Template: Consent document
  • Appendix 4: Guideline for reviewers
  • Appendix 5: HREC biobanks policy
  • Appendix 6: Application for BEC approval of biobank/databank (BEC1)
  • Appendix 7: BEC1 biobank/databank checklist 2019
  • Appendix 8: Application for storage/retrieval/transfer of samples from biobank (BEC2)
  • Appendix 9: Nuremberg Code
  • Appendix 10: World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research involving Human Subjects 
  • Appendix 11: World Medical Association Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks 
  • Appendix 12: The Singapore Statement on Research Integrity 
  • Appendix 13: San Code of Research Ethics

Post graduate students, researchers, ethics committee members, scientists, lawyers, health practitioners, social scientists, LLB students completing a bioethics module and those working in health law.