Research Ethics Committee: Human (REC-H)

The primary purpose of the Nelson Mandela University REC-H is to protect the dignity, rights, safety and wellbeing of all human participants in research, and to ensure the safety, health and wellbeing of humans affected by environmental related research. The REC-H will do this through independent, prospective and ongoing ethics review of all research projects submitted to this committee for review..

A secondary purpose of the REC-H is to protect the dignity, rights, safety and wellbeing of University researchers conducting research on human participants, at the same time affording due consideration to the interests of the community from where participants are recruited and the reputation of the University during the course of conducting the research.

 

 

Applications for ethics approvals must be submitted online on MEOS, the Mandela Ethics Online System, through meos-apply.mandela.ac.za using your Mandela username and password. Applications must be submitted in English. Where information will be provided in translated form, both translated and English version must be uploaded where requested.

MEOS userguides/video:

Researchers should familiarise themselves with these documents prior to the completion and submission of an application form.

  • Nelson Mandela University Research Ethics Policy - aims to promote awareness of fundamental ethical standards, principles and practices when conducting research with human participants.
  • Nelson Mandela University Code of Conduct for Researchers - gives expression to the values that apply at the Nelson Mandela University and to which all researchers (students, academic and support staff) commit themselves in their research activities.
  • REC-H Terms of Reference - defines the purpose, structure, scope and limitation of REC-H.
  • REC-H Standard Operating Procedures, with emphasis on the section on the responsibilities of the PRP and PI. This document serves as a guide for all stakeholders (researchers and reviewers, amongst others) to achieve efficiency, quality output and uniformity of performance in the carrying out of their tasks in the context of research with human participants.
  • National Department of Health Research Ethics Guidelines (2024), with emphasis on consideration for the mental and physical well-being of all human participants. This document provides the minimum national benchmark of norms and standards for conducting responsible and ethical research.
  • Summary of Protection of Personal Information Act (POPIA) - summarises the most important aspects of the Protection of Personal Information Act, a legal requirement for all studies collecting personal data from human participants.
  • Belmont Report - propagates the 3 ethics principles of beneficence, justice and respect for persons. The purpose of the report is to protect subjects and participants in research studies.
  • Declaration of Helsinki, 2013: The World Medical Association's statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
  • The Singapore Statement on Research Integrity: The principles and professional responsibilities that are fundamental to the integrity of research.

 

Does my study require ethics approval?

  • Research studies making use of human participants must apply for ethics approval through the relevant faculty structures.
  • For research studies making use of secondary data, the risk should be assessed using the guidelines on the RECH Risk Assessment webpage.
  • Certain journals require ethics approval for publication purposes. It is the responsibility of the researcher to ensure that they consult the journal's publishing policies before commencing a study without ethics approval, as retrospective approval cannot be granted.
  • Some faculties have their own guidelines with regards to the application for ethics approval. If you are in doubt, please engage with your faculty administrator and/or supervisor.
  • Failure to apply for ethics approval, when ethics approval is required, is in breach of the University's Research Ethics Policy.

An overview of the review process

  • All applications to conduct research with human participants must first be submitted to the relevant Faculty Postgraduate Study Committee (FPGSC) for the scientific review and approval of the project proposal and guidance on ethical considerations. Proposals for studies for non-degree purposes from applicants in a faculty must submit their proposals and ethics applications through a peer review process at Faculty level. Those applicants that are affiliated to support service departments/centres (e.g., Library Services, CriSHET, CANRAD, etc.) must identify a relevant faculty committee to submit the proposal/ethics application for review.
  • All applications for ethics approval are first subjected to an initial review at faculty level. Thereafter all applications are transferred to the Research Ethics Committee (Human) (REC-H) for final review and approval. Negligible/low risk studies are subject to expedited review, whilst medium/high risk studies are subject to full REC-H committee review.
  • The REC-H process overview provides further information.

Ethics training

  • It is advised that applicants for ethics approval (both students and supervisors) complete ethics training. 
  • Various online courses can be found on the Ethics Training page.

New umbrella and/or Undergraduate Honours group projects application

  • An umbrella project is a broad research project under which a number of smaller, independent research projects fall. It can be a project in which a number of individual Masters (treatise and research) and Doctoral students collaborate, with each individual student conducting research to realise at least one objective of the umbrella research project. It is also advised for groups of undergraduate, PGDip and/or Honours students undertaking small research projects.
  • Apply for ethics approval for an umbrella project. (Please note that applications for umbrella projects cannot be submitted through MEOS).

Request for an ethics waiver

  • Researchers may request an ethics waiver when a formal ethics review is not considered necessary, but evidence of ethics review is still required. For instance, when submitting to a journal or applying for funding.

External parties wishing to conduct research using Mandela Staff/Students

  • Researchers external to Mandela University wishing to conduct research using University staff and/or students must apply for approval PRIOR to initiating contact with staff and/or students. Retrospective approval of such requests is not permitted.
  • Please note that these applications cannot be submitted through MEOS.

Amendment to a study

  • Amendments to a study must be approved PRIOR to the implementation thereof. Retrospective approval of amendments cannot be granted; failure to receive approval may result in the immediate suspension or termination of all data collection activities linked to the study.
  • Apply for an amendment.

Extension of a study

  • Ethics approval for a research study is granted for one year only.
  • Researchers requiring an extension of data collection activities must submit an application for extension 4-6 weeks before the current ethics approval lapses.
  • An extension cannot be granted on a lapsed protocol. If approval has lapsed, a NEW application must be submitted via the relevant faculty structure.
  • Data collection may not commence or continue if ethics approval has lapsed.
  • Any data collected without ethics approval may not be used for research purposes.
  • Apply for an extension.

Study progress report

  • Researchers of currently active studies are required to submit a progress report on an annual basis. 
  • Failure to do so may result in the immediate suspension or termination of all data collection activities linked to the study.
  • For protocols approved on MEOS (Mandela Ethics Online System), reminders will be sent when the report is due.
  • For all other protocols, a progress report must be submitted in response to the Call in November of each year.
  • Submit a study progress report.

Adverse events

  • An adverse event is an an event defined as any untoward or unfavourable experience or response. The adverse event may be physical, emotional, psychological or physiological in nature. It does not necessarily have a causal relationship with the research, or any risk associated with the research.
  • Read more about adverse events / Report an adverse event.

Study Violations/Deviations/

  • A study violation/deviation is an unplanned or unforeseen failure of the research team to follow the specified procedures approved in the original ethics application.
  • Protocol deviations differ from amendments because they usually apply to a single incident or participant and are not intended at the time to change the study.
  • Read more about study violations/deviations / Report a study violation/deviation.

Closure/discontinuation of a study

  • A closure report may be submitted on conclusion of data collection activities as long as it is known that no further interaction with participants will be conducted.
  • For the discontinuation of a study and therefore the data collection for which ethics approval was granted, a discontinuation/closure report should be submitted no later than 1 month after reaching such a conclusion.
  • Submit a closure/discontinuation of data collection report.

Report Research Misconduct

  • The University has a responsibility to investigate allegations of research misconduct fully and expeditiously. It also has a responsibility to protect researchers from malicious, mischievous, or frivolous allegations.
  • Report Research Misconduct.