The NIH policy released 16 September 2016 requires training on the protections for human research participants in addition to GCP training.
The NDoH Ethics Guideline (2024), Section 5.4, also stipulates that health research ethics training is additional to discipline- or profession-specific and GCP training for anyone who wants to undertake research with human participants, before conducting research, to ensure they have the appropriate knowledge, skills, expertise, competence, including discipline-appropriate scientific background and research ethics training to conduct studies involving human participants.
This course will teach you all you need to know about the ethical conduct of health research in humans! Covering USA, EU and SA regulations (South African Ethics in Health Research Guidelines: Principles, Processes and Structures, NDoH 2024, 3rd Edition), ethics guidelines, research methodologies, expectations for Research Ethics Committees (RECs) and descriptions of the research ethics infrastructure and regulatory framework in South Africa, USA and EU, principles, key standards and norms as well as the ethical considerations, role, responsibilities and reporting requirements from ethics committees when conducting health research.
We also discuss the sensitive issues around fraud and misconduct and uncover conflict of interest as well as ethical tensions and dilemmas when conducting research with placebos, human biological materials, enrolling intensive care and terminal care patients and a look at ethics in genetic research highlighting advancements in health care infrastructure as well as addressing emerging areas like data science, generative artificial intelligence, and the protection of personal information.
