Faculty of Health Sciences



Prof EJ Ndebia


Deputy Chairperson - Basic Sciences

Dr YY Yako


Deputy Chairperson - Clinical Dr AO Usenbo ausenbo@wsu.ac.za
  • National Health Research Ethics Council : REC- 102209-020

  • Federalwide Assurance (FWA) for the Protection of Human Subjects with the FWA number FWA00015171

  • US Department of Health and Human Services (HHS) as an Institutional Review Board (Research Ethics Committee in South Africa) with the Office for Human Research Protections (OHRP) and the registration number is IORG0009382

  1. The Faculty of Health Sciences Research Ethics & Biosafety Committee (hereafter referred to as REC) is mandated to fulfil its function by the Senate of Walter Sisulu University through the Faculty of Health Sciences Board to which REC will report annually in writing.
  1. The essential purpose of REC is to protect the dignity, rights, safety, and well-being of all human participants in health-related research. REC will do this through independent, prospective and ongoing ethics review of all health research projects undertaken by members of staff, registered students and affiliates of the University.
  1. The definition of health research used by REC is in accordance with the South African National Health Act No 61. 2003.
  1. REC may accept for review research protocols involving human participants in the Eastern Cape province submitted to it by researchers from other institutions who are not WSU staff members, students or affiliates.
  1. FHS REC functions in compliance with, but not limited to, the following documents and guidelines:
    • The SA National Health Act. No. 61 of 2003.
    • The SA Department of Health (2015) Ethics in health research: Principles, Processes and Structures (2nd ed). Department of Health: Pretoria, South Africa; The SA Department of Health (2020) South African Clinical Trial Guidelines: Good Practice for clinical trials with human participants (3rd ed). Department of Health: Pretoria, South Africa.
    • Declaration of Helsinki.
    • The Belmont Report.
    • The US Office of Human Research Protections 45 CFR 461 (for non-exempt research with human participants conducted or supported by the US Department of Health and Human Services.
  1. The REC will not consider research for approval if it has already been conducted. Ethical approval must be obtained before a study commences.
  1. The REC, when necessary, will appoint a standing or ad hoc subcommittee to investigate or finalize certain matters under its jurisdiction, in compliance with applicable rules and regulations of conducting research with human participants.
  1. The REC is accountable and reports to the Faculty Board of the Faculty of Health Sciences, Walter Sisulu University.
  1. The REC functions within the transcripts of the Walter Sisulu University Ethics Policy (2020) and other related research development policies and guidelines.
  1. The REC will continue to register with NHREC and meet all the necessary compliance and auditory requirements.
  1. The REC provides oversight and guidance to the functions and responsibilities of the secretariat.
  1. REC members affiliated to WSU will not be remunerated for their work and activities conducted for and on behalf of the REC unless costs (travel expense, loss of income due to REC responsibilities, etc.) were incurred as a result.
  1. The REC has established an EXCO to deal with matters between meetings of the full committee. The EXCO is composed of the REC Chairperson and the two Deputy Chairpersons. The EXCO membership may increase in numbers on an adhoc basis to deal with specific tasks as mandated or required by the full committee.
  1. Subcommittees and task teams may be dissolved as soon as specific tasks are completed to the satisfaction of the full committee.
  1. The REC will review and approve all proposed health related research to be conducted in the WSU teaching and learning platform of the Eastern Cape Province.
  • To promote high ethical standards in health research .

  • To protect potential health research participants from harm which may result from a particular research.

  • To ensure that health research benefits communities and/ or participants while respecting their dignity, rights, safety and well-being.

  • To develop and review guidelines, policies and procedures related to ethics for health research conducted in the Eastern Cape Province.

  • Review proposed health research to identify ethical issues especially with research involving human participants.

  • Advise on resolution of identified ethical concerns by suggesting means to modify the proposed research without compromising scientific merit of the study.

  • Ensure that researchers are accountable for their research activities.

  • Monitor approved research.

  • Establish and maintain relationships with other National Health Research Ethics Council (NHREC) registered RECs for purposes of mutual reciprocal reviews of health research.

  • Update policies and procedures that guide ethical reviews of health research.

  • Maintain registration with the NHREC.