1.0 Purpose

This policy provides principles and guidelines for the ethical use of animals in all research funded directly or indirectly by the Science for Africa Foundation (SFA Foundation). In realising its mission of utilising science, technology and innovation to transform lives, SFA Foundation recognises that improving human and animal health may require the involvement of animals as subjects in biomedical research. SFA Foundation believes that involving animals as research subjects is central in understanding the factors that underpin health and disease in both humans, and animals, and is also important in evaluating the safety and effectiveness of biomedical and social interventions. Accordingly, SFA Foundation supports such research as a key part of its mission. In conducting research that involves animal subjects, the first priority for researchers should always be the humane treatment and protection of the rights, interests and safety of animals. The SFA Foundation requires grantees to maximise animal welfare, and further expects that research involving animals should follow, at a minimum, the regulations set out in International Guiding Principles for Biomedical Research Involving Animals (1985), the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products Guidelines  and prevailing best practice.

SFA Foundation funded researchers are therefore responsible for ensuring they are aware of the issues, comply with relevant national and international legislation where necessary, and follow best practice on the use of animals in medical and veterinary research.

2.0 Scope

This policy applies to all SFA Foundation grantees, their collaborators and Contract Research Organisation (CRO) contracted by the grantee, undertaking research that involves animal subjects, animal derived tissue or analysis of pre-existing data collected on research using animals. This applies regardless of the species used or where in the world the research is conducted.

3.0 Definition

The definitions in this section are adopted from Ethics of Medical Research with Animals glossary terms.

Alternative

This word in different contexts can refer to:

1. Non-animal models (that is, an alternative to animals);
2. Another, less objectionable animal model (an alternative to the original animal);
3. Any approach that reduces, refines, or replaces research methods using animals (an alternative to the original research method).

Animal

Any vertebrate.

Distress

Pain or suffering affecting the body, a bodily part, or the mind.

Enrichment

Modifications to an animal's environment that promote psychological and physiological well-being by facilitating species-typical behaviours.

Humane

Minimum requirements with respect to handling, housing, feeding, watering, sanitation, ventilation, shelter from extremes of weather and temperatures, adequate veterinary care, including the appropriate use of anaesthetic, analgesic or tranquilizing drugs and separation by species. This definition excludes enrichment and other efforts to meet species-specific needs, such as companionship.

Necessary

In the context of biomedical research, “necessary” refers to what is needed to carry out an experiment and what is needed for the humane handling, care, or treatment of laboratory animals. The word sometimes also refers to whether an experiment is itself needed to attain some medical or scientific goal.

Pain

According to the International Association for the Study of Pain, pain is “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.”

Reduction

Means using as few animals as possible. Improvements in statistical techniques, more sensitive recording and better management of animals bred for research means that the number of animals bred and used for research can be minimised. It is important, however, not to use too few animals in an experiment as this may invalidate the results, thus making the experiment meaningless, or cause additional suffering to the animals through their repeated use.

Refinement

Means the improvement of experimental techniques to minimise pain, distress or other adverse effects and/or the enhancement of the animals' well-being, for example, by improving housing, husbandry and transportation practices.

Replacement

Means the replacement of animals with methods or tools that do not require animal use, for example the use of tissue cultures and the use of computer modelling. Where possible, experiments on animals should be replaced by experiments not requiring animals. The whole animal, however, reacts differently in comparison to isolated cells, and some work on whole animals remains necessary.

Welfare

Animal welfare is concerned with assuring humane treatment of animals: maintaining good health, minimizing negative states such as pain, enhancing positive states, and giving animals the freedom to behave in ways that are natural to the species.

4.0 Policy Statement

4.1 Research Using Animals

Research using animals is an important part of medical and veterinary research. Animals may be used in research if there are no alternative develop drugs and therapies to treat disease, or check the safety of the treatments for humans, animals and the environment or study the processes that can cause disease in animals and humans.

SFA Foundation therefore supports the use of animals in research where the potential benefits to humans and animals outweighs the risks and concerns of such research. In all research using animals supported by SFA Foundation, the principles of the 3Rs (replacement, reduction and refinement) will apply.

Grantees, subgrantees and partners using animals in their research must conform to local regulations and standards for the humane care and treatment of animals at the site where the research is being conducted and as outlined in this policy. These processes must meet internationally recognized standards. In the absence of a relevant national standard, research should, at a minimum, conform to the International Guiding Principles for Biomedical Research Involving Animals (1985).

These guiding principles provide a framework for more specific national or institutional provisions. They apply not only to biomedical research but also to all users of vertebrate animals for other biomedical purposes, including the production and testing of therapeutic, prophylactic, and diagnostic substances, the diagnosis of infections and intoxications in man and animals, and any other procedures involving the use of intact live vertebrates.

4.2 The 3R’s – Replacement, Reduction and Refinement

SFA Foundation funded researchers are required to consider alternatives to the use of animals in medical research as far as this is practicable. The development of alternatives to animals continues on many fronts. However, there are currently no methods which can satisfactorily replace animals in all cases, therefore the use of animals in research will need to continue in order to make advances in human and animal health. SFA Foundation acknowledges that development of new techniques - such as cell lines, tissue cultures or imaging and computer modelling - will reduce the need for use of animals in research in some areas.

All SFA Foundation grants are assessed by independent experts from the scientific community, a process known as peer review. These experts are asked to ensure that the use of animals in the research is necessary and relevant.

In all research using animals supported by SFA Foundation, the principles of the 3Rs (replacement, reduction and refinement) will apply.  Applicants must include in their proposals details of how they have considered replacing, reducing and refining the use of animals in their research.  This should be initiated at the earliest stage of research design.

4.3 Peer Review

All research involving the use of animals should be rigorously assessed by appropriately qualified independent peer reviewers to assess specifically their compliance to international consensus of animal welfare, in the case of absence of national regulation. All panels and panel members, including independent peer reviewers should consider whether the principles of the 3Rs have been followed by the applicant in their application.

4.4 Requirement for Ethical Approval of Research and Compliance with Local Legislation

All research funded by SFA Foundation that requires the use of animals must comply fully with applicable local laws and ethical review procedures. This includes collaborations with other laboratories or where a third party such as a Contract Research Organisation is used, for example, to contract out animal research, and is regardless of the species used or where in the world the research is conducted. In certain cases, steps will be taken by SFA Foundation to ensure compliance through visits to research facilities/sites.

All SFA Foundation funded research requiring the use of animals has to obtain ethical approval from an appropriate local institutional ethical review committee based at the host institution or a national ethical review committee.  SFA Foundation further requires that the ethics committee reviewing the proposal includes non-scientists and members who are independent of the institution. The committee provides independent ethical advice to help ensure that:

1. All use of animals in the proposed research is carefully considered and justified;
2. Proper account is taken of all possibilities for reduction, refinement and replacement (the 3Rs);
3. Standards of accommodation and welfare are species appropriate and are achieved as outlined in the Guide for the Care and Use of Laboratory Animals, 8th edition.

​​​​​​​4.5 Government Permits and Activities in Foreign Countries

• Principal Investigators of SFA Foundation-funded research are required to obtain any required permits prior to undertaking research that includes activities requiring permits from appropriate national, state, or local government authorities in the foreign country where the research is taking place.
• SFA Foundation does not assume responsibility for grantee compliance with the laws and regulations of the country in which the work is to be conducted.

​​​​​​​​​​​​​​4.6 General Animal Welfare Requirements

1. The grantee is responsible for the humane care and treatment of any animal used or intended for use in such activities as field or laboratory research, development, training, experiments, biological testing or for related purposes supported by SFA Foundation grants;
2. During the life of an SFA Foundation grant, additional ethics review committee approval must be obtained if the protocols for use of animals have been changed substantively from those originally proposed and approved, or if the previous approval is more than three years old;
3. In the event the grantee’s ethics approval is cancelled or lapses, the grantee must immediately notify SFA Foundation;
4. Research facilities intending to use live animals in research and who receive SFA Foundation funding are required to register the facility with any relevant and accredited International Animal and Plant Health Inspection Service as a pre-award condition. 
5. In the context of animal welfare, euthanasia means killing animals as painlessly as possible. SFA Foundation adopts the guidance on euthanasia provided by the National Centre for the Replacement, Refinement and Reduction of Animals in Research.
6. Researchers should provide adequate veterinary care with the appropriate use of anaesthetic, analgesic, tranquilizing drugs, or euthanasia to reduce pain and distress to animals.

4.7 Use of Non-human Primates for Research

Whenever non-human primates are used for scientific purposes, the investigator must justify their use and weigh the scientific or educational value of the study against the potential effects on the welfare of the animal. Investigators are responsible for using animals humanely and treating them with respect.                                                               

SFA Foundation will only fund research using non-human primates which meets all of the following requirements:

1. No alternative to animal use or other species of animal is suitable for the particular research project and the predicted outcome of the project justifies the use of non-human primates;
2. The most appropriate species of non-human primate is chosen and detailed justification for such use and animal numbers required is provided;
3. The principal investigator and all animal care staff have training and experience specific for the species of non-human primate to be used;
4. The application must state the fate of the non-human primates at the end of the project. In deciding the fate of the animals, their long-term welfare must be taken into account;
5. Investigators should obtain non-human primates from the approved breeding colonies licensed to provide macaques (Macaca nemestrina & Macaca fascicularis), baboons (Papio hamadryas) and marmosets (Callithrix j. jacchus);
6. Investigators must ensure that documentation of the source of each nonhuman primate and assessment of its behaviour, clinical history and health status must accompany the animal throughout its life and must be kept current;
7. Investigators must undertake to uphold animal welfare at the source facility. This should include housing conditions, social grouping, environmental enrichment, diet, fertility and transport conditions between the source colony and the institution;
8. Social interaction between experimental animals must be accommodated. Animals should be held in appropriate social groupings unless individual caging is necessary for a particular project. When individual caging of animals is unavoidable, it is for a minimum time and the singly-housed animal is given auditory and visual contact with other animals in the colony;
9. When social isolation is unavoidable, attempts are made to increase the variety of environmental enrichment beyond that available for socially grouped animals;
10. Daytime access to an outside enclosure is freely available to all non-human primates held for six weeks or longer. It must be ensured that the non-human primates are presented with as many choices of environment as possible;
11. All personnel working with non-human primates are informed about the diseases transmissible between non-human primates and humans and are instructed on the measures needed to prevent disease transmission;
12. When non-human primates are killed for experimental or veterinary reasons, all possible attempts are made to inform other interested investigators of the availability of tissues and organs and their disease status.

For more information pertaining to the welfare of non-human primates and especially if applying for funding from funders accredited to the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3R’s), please visit this site: 3Rs resource library.

4.8 Data and Safety Monitoring Board (DSMB)

A Data and Safety Monitoring Board (DSMB) shall play a critical role in monitoring animal studies, particularly in preclinical research. The primary role of a DSMB in animal studies shall be to ensure that the study protocol is scientifically valid, and the animal subjects are treated humanely and ethically.

The DSMB shall review the study protocol, animal welfare, and monitoring procedures to ensure that the animals are not subjected to unnecessary pain or distress during the experiment. The board shall also review the data generated from the study to assess the safety and effectiveness of the intervention.

In animal studies, the DSMB may recommend modifications or early termination of the study if safety concerns arise or if the intervention is deemed ineffective. The board may also make recommendations on future animal studies based on the data generated from the current study.

Overall, the role of the DSMB in animal studies shall be to ensure that the research is conducted in an ethical and scientifically valid manner and to promote the safety and welfare of the animal subjects involved in the study.

​​​​​​​4.8.1 Conflict of Interest

No member of the DSMB should have direct involvement in the conduct of the study. Furthermore, no member should have financial, proprietary, professional, or other interests that may affect impartial, independent decision-making by the DSMB.

​​​​​​​​​​​​​​4.8.2 Relationship between DSMB’s and IRB’s

DSMBs shall be focused on monitoring the safety and efficacy of the research using animals during the study period, while IRBs shall be responsible for ensuring the ethical conduct of the study as a whole.

​​​​​​​​​​​​​​4.9 Disposal of Animals used in Research

The grantee must put systems in place to ensure that any animal still living after undergoing a series of procedures is kept at their establishment under the supervision of a veterinary surgeon or at a minimum, qualified personnel (Research Assistant, Laboratory Manager etc) with validated qualifications delivered from local or national research authority allow management of animal studies. This is the case until or unless there is authorised and qualified approval for the animal’s transfer to another establishment, its setting free or re-homing, or its re-use in another series of regulated procedures.

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For any queries on this policy, please contact [email protected]