UP Ethics



UP Ethics

UP Ethics,



The Faculty of Health Sciences Research Ethics Committee is tasked with the ethics of all health research and operates in terms of the National Health Act (2003), the Code of Ethics for Research of the University of Pretoria, and the National Health Research Ethics Council. 
It is accredited nationally and internationally as follows:



  • National Health Research Ethics Council of the South African Department of Health. REC-120208-018
  • Office of Human Research Protection of the USA Department of Health & Human Services’
    • Federalwide Assurance FWA 00002567,  Approved dd 22 May 2002 and Expires 03/20/2022.
    • IRB 0000 2235 IORG0001762 Approved dd 22/04/2014 and Expires 03/14/2020.

It is a legal imperative that all health research must be reviewed by the Research Ethics Committee in terms of the National Health Act as well as the policy (Rt 429/99) of the University of Pretoria
The National Health Act (Act 61 of 2003) states in section 73(2):

A health research ethics committee must –



(a) review research proposals and protocols in order to ensure that research conducted by the relevant institution, agency or establishment will promote health, contribute to the prevention of communicable or non-communicable diseases or disability or result in cures for communicable or non-communicable

(b) grant approval for research by the relevant institution, agency or establishment in instances where research proposals and protocol meet the ethical standards of that health research ethics committee.

All health research must be considered by the Research Ethics Committee, where the section of the National Health Act defines health research as:

any research which contributes to knowledge of-

(a) the biological, clinical, psychological or social processes in human beings;

(b) improved methods for the provision of health services;

(c) human pathology;

(d) causes of the diseases;

(e) the effects of the environment on the human body;

(f) the development or new application of pharmaceuticals, medicines and

(g) the development of new applications of health technology.

 

What constitutes ‘health research’ that must be considered by the Research Ethics Committee?

All research that may be health related

  • All research using human participants
  • Research not using human participants (e.g. research on chemicals or instruments)
  • Clinical audits and surveys
  • Laboratory research
  • In vitro and ex vivo research
  • Research on data already collected for clinical or educational purposes
  • Secondary research on data already collected as part of another research project
  • Case series for publication purposes
  • Service delivery “statistics” for research, scientific reports, degree or publication purposes
  • Reports and publications of health surveilance
  • 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 as research participants
  • All research involving personnel of the Faculty of Health Sciences as research participants

 
Letter – Important Notice regarding Ethics approval of research studies
 



Scope of Ethics Review

The 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

 

Contact us



Physical address:
University of Pretoria
Faculty of Health Sciences
Tswelopele Building, Level 4, Rooms 4-59 and 4-60 (opposite the BMS Building)
Dr Savage Road, Gezina, Pretoria
 
Postal address:
Private Bag X323
ARCADIA, 0007
Chairperson to the Faculty of Health Sciences Research Ethics Committee:
Professor Werdie (CW) Van Staden
Deputy-Chairpersons to the Faculty of Health Sciences Research Ethics Committee:
Dr R Sommers; Prof T Rosouw and Prof A Nienaber
Enquiries
The Research Ethics Office:
Tel: 012 356 3084 or 012 356 3085
E Mail: manda.smith@up.ac.za   /   E Mail: deepeka.behari@up.ac.za   /   E Mail: fhsethics@up.ac.za