Risk Assessment

PLEASE NOTE THAT:

• Information is not always collected for research purposes.
• Not all research projects will require formal ethics review and approval.
• Decisions on whether a project requires ethics approval are determined according to its ethics risk classification.
• The RECH does not give retrospective ethical approval to any project that has already been completed. Thus, it is essential that researchers clarify whether ethical approval for a specific project is required, or not, prior to beginning the data collection.

 

NMU RISK ASSESSMENT PROCEDURES:

Procedures for ethics approval are routed according to the level of risk. The Nelson Mandela University RECH system functions according to the ethical risk classification REGARDLESS of the researcher’s level of study. Even undergraduate student projects will require prior review and approval by the RECH. The level of ethics review is determined by the ethical risks presented by the research project, not the level of degree. The higher the risk, the more in-depth the ethical review process should be. If a less-experienced researcher (e.g., a student at undergraduate or Honours level) chooses a topic that is particularly sensitive, a higher level of scrutiny is required to ensure that the risks to participants and the institution are reduced as far as possible.

Risk is a function of the magnitude of harm and the probability that it will occur.

• Low risk research – where the only foreseeable risk is one of inconvenience or discomfort, or where the probability and magnitude of possible harms implied by participation are no greater than those posed by everyday life in a stable society
• Medium risk research – research involving vulnerable groups, sensitive or potentially sensitive topics, access to private information, and in which there is a potential risk of harm or discomfort, but where appropriate steps can be taken to mitigate or reduce overall risk.
• High risk research poses a real and foreseeable risk of harm or serious adverse consequences to participants and researchers if not managed in a responsible manner.

 

FORMAL ETHICS REVIEW IS NOT REQUIRED WHEN:

• the study does not involve humans or use data or biological materials belonging to humans.
• the research relies exclusively on information that is publicly available (i.e., involves the analysis of information in the public domain) or that is accessible in terms of legislation or regulation, and:
  • does NOT require gatekeeper, site, or platform permission,
  • does NOT involve sensitive or potentially sensitive information,
  • AND uncontroversial topics are being investigated,
  • AND participants are not from vulnerable populations,
  • AND data collection and dissemination of research findings will not identify individuals or groups and does not create the possibility of re-identification.
• the research involves the observation of people in public spaces (including virtual public spaces) and natural environments, provided that:
  • the researcher does not interact directly with individuals or groups,
  • the researcher does not stage any intervention,
  • the individuals or groups do not have a reasonable expectation of privacy, and
  • dissemination of research findings does not identify individuals or groups and does not create the possibility of re-identification.
• research that is exclusively for quality assurance, quality improvement (audits), programme evaluation activities, performance reviews, and consumer surveys.

 

Please also refer to  the document below that will assist in the determination of risk:

• National Department of Health Research Ethics Guidelines (2024) - this document provides the minimum national benchmark of norms and standards for conducting responsible and ethical research that uses human participants. The REC-H ethics application process assumes that the researcher is familiar with this document

 

Students are advised to discuss their research studies with their supervisors in determining the need for ethics review.