Ethics protocol committee operational process

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)

Standard Operating Procedures

Protocol Submission Process

Rapid Review and Approvals

Expedited Review and Approvals

Obtaining Informed Consent and Informed Consent Documents

Research involving minors and  vulnerable persons

Processing of an appeal against a resolution made by the FHS REC

Processing of complaints against the FHS REC and/or its resolutions

Processing of complaints and “whistle-blowing” regarding research or a researcher

Active monitoring of ethically approved studies

Risk and Vulnerability Assessments 

Succession Planning for the REC Executive Committee

HOW TO LOGIN TO THE PEOPLESOFT ETHICS APPLICATION & APPROVAL SYSTEM 

Guides to assist with the electronic submission:

A. UP Student / UP Staff

B. External Persons (Non-UP Staff or Students)

Which documents?

Templates available (choose as appropriate)

Timeline of Review Process

2025 Ethics Submission Dates

Click here for more information regarding the Research Ethics Committee process.

 

- Author Nicoleen Smit

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