Scope of Ethics Review


It is a legal imperative that all health related research must be reviewed by an independent ethics committee. The Research Ethics Committee that undertakes the review must be accredited by the National Health Research Ethics Council. In the evaluation of study protocols and related documents, the Research Ethics Committee looks after the interests of all potentailly affected parties, including people subjected to research procedures, in accordance with international research and ethics standards and guidelines.


The Research Ethics Committee consider among other things the following aspects when reviewing a proposal for a study: 

  •  the scientific relevance, quality and integrity of the study. The WHO-guidelines consider scientific integrity as the basis for the ethics approval of a study (WHO Research Ethics Committees)
  •  the suitability of the investigator(s) for the proposed study in terms of his/her availability,
  • qualifications, experience, supporting personnel, and available facilities;
  • the study rationale and the appropriateness of the inclusion/exclusion criteria in the South African context;
  • the suitability of the study methodology in relation to the objectives of the study; i.e. the potential for reaching sound conclusions with the smallest possible exposure to risk of participants, and the justification of predictable risks and inconveniences weighed against the anticipated benefits for the participants and/or others;
  • the suitability of the study population;
  • whether particpants constitute a vulnerable group, and if so whether the study is justified and whether sufficient measures to protect their interests are in place;
  •  that the number of participants to be recruited is appropriate in aswering the research question;
  •  the risk-benefit analysis takes full cognisance of benefits and harms, also after the study itself, especially in relation to chronic life-threatening conditions;
  • if a placebo is used, whether its use is adequately justified;
  • that by their participation in a study the participants or other persons in the establishment or centre are not denied timely access to medical personnel, investigations, equipment or procedures;
  • the means by which initial recruitment is to be conducted;
  • the means and processes by which participants will be informed and informed consent be obtained;
  • the adequacy and completeness of the written information to be given to the participants, their relatives, guardians and, if necessary, legal representatives;
  • that the application allows the participants and/or their representatives adequate time to consider the patient information package before informed consent is sought;
  • the content of any advertisements or public notices which will be used to recruit participants to a study;
  • that the study protects participants' rights to privacy;
  • the provision of compensation/treatment in the case of injury or death of a participant if attributable to a clinical study, and the insurance or indemnity to cover the liability of the investigator and sponsor;
  • the involvement of payments and monetary transactions or financial matters and costs related to the research, researchers and research participants;
  •  whether results of the study are duly publicised and whether restrictions are required on the publication of results; (e.g., ensure there is a written commitment from investigators to publish the results of trials and there is no contractual clause which reserves the right of publication to the sponsor only);
  • the scientific soundness of the study on which to base, among other things, the ethics approval (including for example the adequacy of the statistical methods proposed to evaluate the data generated);
  • whether the study is advancing the body of knowledge on the subject and is worthy of execution considering risks, costs, and benefits

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