What constitutes 'health research' that must be considered by the Research Ethics Committee?

Research that requires prior ethics approval at the Faculty of Health Sciences Research Ethics Committee:

• All quantitative and qualitative research related to the health of humans (in all Faculties)
• All quantitative and qualitative research in the Faculty of Health Sciences

This health-related research includes

• That which uses human participants as well as not using human participants (e.g. research on chemicals or instruments)
• Clinical audits and surveys
• Health-related laboratory research
• In vitro and ex vivo health-research
• Research on data already collected for clinical or health educational purposes
• Secondary health-research on data already collected as part of another research project
• Case series for publication purposes
• Health service delivery “statistics” for research, scientific reports, degree or publication purposes
• Reports and publications of health surveillance
• Research on education in the Health Sciences Faculty
• All research involving patients or materials from Steve Biko Academic Hospital, Kalafong Hospital, Tshwane District Hospital, Weskoppies Hospital, or NHLS
• All research involving healthcare workers or other personnel at Steve Biko Academic Hospital, Kalafong Hospital, Tshwane District Hospital, Weskoppies Hospital, and NHLS
• All research involving students of the Faculty of Health Sciences and Oral and Dental Hospital as research participants
• All research involving personnel of the Faculty of Health Sciences and Oral and Dental Hospital as research participants
• Research involving animals should additionally be considered by the Animal Ethics Committee (AEC)

Descriptive clarification:

Prior Research Ethics Committee approval is required for all health-related research as defined by the National Health Act across all Faculties of the University and all quantitative and qualitative research done in the Faculty of Health Sciences. The Faculty of Health Sciences is the only legally accredited ethics committee at UP for approving research related to the health of humans.

Quantitative and qualitative research is defined as all scholarly inquiry that seeks to contribute to knowledge or understanding, using quantitative or qualitative methods descriptively, inferentially or interpretatively. The scope of research for ethics review usually excludes conceptual, comparative texts research, and literature reviews.

Health-related research includes all quantitative and qualitative research done in any of the Faculties at the University of Pretoria that relates to the health of humans. It extends to all quantitative and qualitative research in the Faculty of Health Sciences, research on health services, clinical research, clinical trials, education of students and workers in health matters, health practices, research on health personnel in the Faculty of Health Sciences. This scope is not confined to research on human participants but include research on chemicals or instruments, research using audits and surveys, health related laboratory research, in vitro and ex vivo health research, research on data already collected for clinical or educational purposes, secondary research on data already collected as part of another research project, case reports and case series for publication and conference presentations, and service delivery statistics for degree or publication purposes.

 When a literature review is part of preparations for a degree-related study, no prior ethics approval is required for such literature review. When a literature review (or other “evidence synthesis” research) is of such sophistication that in itself it is sufficient for degree purposes and is presented in its entirety (as a full thesis or dissertation) for a degree, then an ethics application is required. 

 Regarding the issue of students requiring ethics approval for their studies, all masters and doctorate students require ethics approval of their specific study regardless of whether part of an umbrella study. For honours or undergraduate degree studies, students may present to administration the ethics approval for an umbrella study without obtaining ethics approval for their specific component of the umbrella study provided that their study does not exceed the scope of the approved umbrella study. In the absence of an umbrella study, they need to obtain ethics approval for their specific study. (“Degrees” should be understood in the broad sense as to include any qualification-driven study including diplomas – as such studies are also subject to the National Health Act and UP Policy provisions).

Notification - all health related research requires prior Ethics approval