Ethics Office

About Ethics Office
The Ethics Office in the SAMRC serves as Secretariat to the Human Research Ethics Committee (HREC) and the Ethics Committee for Research on Animals (ECRA).

Human Research Ethics Committee (HREC)

The mandate of the HREC

All intramural and extramural research conducted by the SAMRC on humans has to be reviewed by the Ethics Committee. Collaborative research projects also have to be reviewed and approved by the SAMRC HREC and any other institutions that are involved, e.g. universities (locally and internationally).

The South African Medical Research Council Human Research Ethics Committee is registered by the National Health Research Ethics Council.. Registration number: REC-130312-011 valid until 30 November 2023

Federal-wide assurance (FWA) number of the SAMRC Ethics Committee
The SAMRC Ethics Committee is registered as an institutional review board (IRB) with the Office for Human Research Protections (OHRP) of the USA Dept of Health and Human Services; IRB organisation identifier: IRB00001569. The Medical Research Council's unique Assurance Number is FWA00002753, and the unique Organisation Number is IORG0001163 as well as OLAWA5726-01.
Terms of Reference for HREC

The South African Medical Research Council (SAMRC) was established in 1969 with a mandate to improve the health of the country’s population, through research, development and technology transfer, so that people can enjoy a better quality of life. The vison of the SAMRC is “building a healthy nation through research and innovation” with a mission “to improve the nation's health and quality of life through promoting and conducting relevant and responsive health research”.

The SAMRC Human Research Ethics Committee (hereinafter referred to as the HREC/Committee) was established in terms of the SAMRC Research Ethics Policy (REP) with the primary purpose of reviewing and monitoring research in the intramural units of the SAMRC from an ethical perspective. This includes protecting participant rights in research, as well as promoting ethical values and research integrity within the SAMRC.

All research conducted by a Principal Investigator (PI) or Co-Principal Investigator (Co-PI) who is an SAMRC employee must be of the highest ethical standard and must be undertaken with prior written approval from the SAMRC HREC.

View the complete Human Research Ethics Committee (HREC) Charter and Terms of Reference

Ethics Committee for Research on Animals (ECRA)

Mandate of ECRA

The safety and efficiency testing of vaccines, medicine, medical appliances and materials, agricultural remedies, vaccines, nutritional supplements pesticides and other consumer products is mandated by various Statutes in South African Law. These laws are intended to promote the concept of preventative medicine which requires such substances to be tested for safety and efficiency before they may be approved and registered for public use.

The South African Medical Research Council Ethics Committee for Research on Animals is registered by the National Health Research Ethics Council. Registration number: AREC- 190312-0011 valid until 28 June 2021.

This mandate for animal studies is, however, not absolute since progress is constantly being made in the development of methods for replacing animals in the safety testing of consumer products and medicines.

Any proposed use of animals for product safety testing must be preceded by a rigorous search for a validated animal replacement method. If such a method does not exist, then the proposed must be supported by a specific statement explaining why an animal experiment is necessary.

The Board of the SAMRC requires that an ethical review process be established and maintained both within the SAMRC and at every institution where SAMRC-supported animal studies are undertaken.

The performance of this institutional ethical review process is a precondition of SAMRC support, collaboration and co-operation.

Terms of Reference for ECRA

These guidelines apply to the use of sentient animals for research, teaching and testing within the South African Medical Research Council.

They are applicable to all Medical Research Council (SAMRC) staff that are occupationally involved with the production, care and use of laboratory animals, and to scientists and educators whose research, teaching and testing on animals is done in collaboration with SAMRC staff or with financial or other support from the SAMRC and its employees.

Studies that may result in severe or chronic pain or significant alterations in the animals’ ability to maintain normal physiology, or adequately respond to stressors, should include descriptions of appropriate humane endpoints or provide science-based justification for not using a particular, commonly accepted humane endpoint.   Veterinary consultation must occur when pain or distress is beyond the level anticipated in the protocol description or when interventional control is not possible. The “three R” principles of Russell and Burch, Replacement, Reduction and Refinement should be applied.   The values of these principles are as follows:  

Replacement refers to methods that avoid using animals.  The term includes absolute replacements (i.e. replacing animals with inanimate systems such as computer programs) as well as relative replacements (i.e. replacing animals such as vertebrates with animals that are lower on the phylogenetic scale).

Reduction involves strategies for obtaining comparable levels of information from the use of fewer animals or for maximizing the information obtained from a given number of animals (without increasing pain or distress) so that in the long run fewer animals are needed to acquire the same scientific information.

Refinement refers to modifications of husbandry or experimental procedures to enhance animal well-being and minimize or eliminate pain and distress.

Researchers should guard against any tendency to under-rate or ignore the potential discomfort or suffering of animal subjects, and may not attempt to achieve cost savings by compromising the quality of care-afforded to them.