Standard Operating Procedures

Human Research Ethics Committee (HREC)

Standard Operating Procedures

Roles and Responsibilities of the HREC
The SAMRC HREC functions as the official Human Research Ethics Committee of the SAMRC. The objective of the Committee in reviewing research involving human research participants is to contribute to safeguarding the dignity, rights, safety and well-being of all research participants and to ensure that the goals of research do not override the best interests of the research participants.

The HREC is committed to ensuring high-quality scientific and ethical research by the SAMRC, therefore protecting the professional interests of the researchers as well. The SAMRC HREC aims to provide independent, comprehensive and timely review of the ethics of proposed studies conducted by SAMRC intramural units. Monitoring is conducted by annual and ongoing reporting.

HREC Members’ appointment and assurance

  • In keeping with the SAMRC Act (1991) s8 and s17, SAMRC Board delegates processes leading to appointment of HREC members to the SAMRC President.
  • A call will be advertised for HREC members and they will be appointed from among the nominated individuals, and if necessary by co-option.
  • SAMRC Board will review recommended names of potential HREC members in consultation with the SAMRC President and shall make the final appointment of the HREC members, including the Chairperson.
  • During their term of office, HREC members will be indemnified from personal liability against claims that may arise during ordinary business of the SAMRC.

Duration of Membership
HREC members will be appointed for a 3-year term and some member’s appointments may be renewed for continuity purposes at the discretion of the Board, in consultation with the SAMRC President. The term can be renewed twice, after which the person should have a cooling-off period of at least one term.

Election of Chairperson
HREC Chairperson may transition from being an ordinary member, but in her or his capacity as Chair the term can only be renewed once

Administrative Support
The Ethics Office in the Research Integrity Office shall provide Secretariat service to the HREC.

Meetings
The HREC holds ten meetings per year (February-November).

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Scientific Review
Scientific review Standard Operating Procedures

Ethics Committee for Research on Animals (ECRA)

Standard Operating Procedures

AUTHORITY

  • The South African Medical Research Council (SAMRC) Ethics Committee for Research on Animals (ECRA) was established as set out in its Research Ethics Policy and Terms of Reference (ToR).
  • Its authority has been conferred upon it by the SAMRC Board.

TERMS OF REFERENCE

  • These guidelines apply to the use of sentient animals for research, teaching and testing within the SAMRC.
  • They are applicable to all 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, introduced by Russell and Burch (1959)1, of 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 or by cell culture).

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 underrate 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 animals.

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