OBJECTIVE
This SOP is to ensure quality, a more effective and consistent ethical review mechanism of the Institutional Animal care and Use Committee (IACUC) protocol that will be dealt with so to prevent infliction of unnecessary pain and injury before, during and after experiment on animal subjects.

GENERAL POLICY
• The Council for Scientific and Industrial research (CSIR) recognizes the moral dilemma posed by the use of sentient animals (i.e. animal which can feel sensations and experience emotions) for research, teaching or testing. It subscribes to the ethics of only supporting studies which promise to contribute to the understanding of biology and environmental principles to the acquisition of knowledge that can reasonably be expected to benefit humans, animals and the environment.
• It recognizes that all vertebrate animals are protected by law and that it may be an offense to kill or interfere with the well-being of the animals for scientific and educational purpose without justification which is ratified by a formal process ethical review.
• It insists that animal may only be used when researcher’s best effort to find a non-sentient alternatives have been unsuccessful.
• It requires optimal standards of animal health and care to be observed to provide good quality that enhance credibility and productivity.
• It requires the ‘three R’ principles of reduction, replacement and refinement’ to be adhered to in the conduct and planning of animals studies. These uphold the principles and practice of using the most humane method of the smallest number of animal that will permit valid scientific information to be acquired.

FOR WHOM THE GUIDELINE ARE INTENDED
These guidelines apply to the use of sentient animal for research teaching and testing within CSIR and Ghana. They are applicable to all CSIR staff who are occupationally involved in the production, care and use of laboratory animal and to scientists and educators whose research, teaching and testing on is done in collaboration with CSIR or with financial other support from CSIR and its employees.


• It is accepted sentient and non-human animals have the capacity to experience a range of physical sensations and emotions and are therefore subjects of moral concern.
• Laboratory animals should be able to live, grow, produce and interact under conditions and circumstances in which their species specific needs are met. Special considerations should be given to the needs of social animals and animals which have adapted to special circumstances or environment (e.g. nocturnal animals, marine animals etc).
• Experimental procedures which may cause hunger, thirst, injury, disease, discomfort, fear, distress, deprivation or pain must be design to keep exposure of animals of those conditions minimal.
• Replacement of sentient animal or non-sentient research model or system in order to eliminate the use of animals that can experience sensations.
• Reduction of the numbers in animals in experiment by design strategies that facilitates the use of smallest number that will allow valid information to be obtained from the studies.
• Refinement of animal sourcing, animal care practices and experimental procedures to minimized or remove physical and psychological distress within the limitations imposed by the requirements of the research.
The IACUC of the CSIR will have oversight responsibility on the welfare of animals used in research and ensure the protection of research animal care and use. The committee would also have an oversight responsibility over investigators, whose research activities involve the use and care of vertebrate animals and also promote the humane care and use of animals in biomedical and behavioral research as well as product testing and to ensure that these institutions and organization evaluate their animal facilities in regard to the maintenance of acceptable standards for the care, use and treatment of such animals.

PRIMARY FUNCTION OF THE CSIR-IACUC
• The IACUC’s will be responsible for reviewing and approving protocols relating to research involving the use and care of animal.
• Independent reviews at specified time intervals the research facility’s program for the humane care and use of animals.
• The IACUC will conduct program evaluations as a means of overseeing the animal care and use programs.
• Monitor and Inspect at specified periods, the institutional animal facilities (including satellite facilities) to ensure that they adhere to standard regulations.
• Ensure that experiments on animals are avoided whenever it is possible to do so and propagate the principles of 3Rs (Reduce, Refine & Replace the use of animals in experiments).
• Ensure that experiments on larger animals are avoided when it is possible to achieve the same results by experiments upon small laboratory animals like guinea-pigs, rabbits, frogs, rats, mice and pottery.
• Ensure that required records are maintained with respect to experiments performed on animals.
• Ensure that as far as possible experiments are not performed merely for the purpose of acquiring manual skill.
• Ensure that animals intended for the performance of experiments are properly looked after both before and after experiments

• Veterinarian
• Animal Breeding
• Medical Parasitologist and Molecular Epidemiologist
• Legal practitioner
• Health Policy
• Health Planning and Sociologist
• Social Worker
• Community member
• Bioethicist

• The members are appointed by the DG, CSIR.
• The members are drawn from different Institutes, and specialties to give a multi sectorial, multidimensional structure.
• The duration of appointment is initially for a period of 5 years.
• Board members are required to submit their curriculum vitae to the administrator after nomination.
• A member can be replaced in the event of death or long-term assignments outside the country or for any misconduct deemed unfit for a member.
• A member can tender resignation from the committee with proper reasons to do so, which should be acceptable to the DG, CSIR.
• All members should maintain absolute confidentiality of all discussions during the meeting.

• All proposals should be submitted in the prescribed application form, copies of which will be available with the Administrator assistant.
• All relevant documents should be enclosed with application.
• The duration of appointment is initially for a period of 5 years.
• The required number of copies of the proposal along with the application and documents in prescribed format duly signed by the PI and Co-investigators/Collaborators should be submitted to the Administrator assistant.
• A member can be replaced in the event of death or long-term assignments outside the country or for any misconduct deemed unfit for a member.
• The date of meeting will be communicated to the PI who should be available to offer clarifications if necessary.
• The decision of IACUC will be communicated in writing. If revision is to be made, the revised document in required number of copies should be submitted within a stipulated period of time as specified in the communication.

• A Maximum of five meetings to be held per annum.
• All members to be notified of meetings.
• Agenda, Previous Minutes and Application forms to be circulated to the committee two weeks prior to the meeting.
• Minutes of the meeting to be recorded.
• All meetings must consist of at least a quorum.
• Not more than 10 protocols will be reviewed at any one meeting

The minimum of 50% + 1 member are required to compose a quorum. All decisions should be taken in meetings and not by circulation of project proposals. The Administrator will keep a record of attendance, indicating which members were present for the discussion of each application. IACUC members are expected to attend the majority of scheduled meetings each year and are required to attend at least half of such meetings. Members may attend using video-conferencing facilities.

DEPENDENT CONSULTANTS/CO-OPTED REVIEWER

IACUC may call upon subject experts as consultants for review of selected research protocols. These experts may be specialists in ethical or legal aspects, specific subjects or methodologies. They will not take part in the decision making process.


• A Maximum of five meetings to be held per annum.
• All members to be notified of meetings.
• Agenda, Previous Minutes and Application forms to be circulated to the committee two weeks prior to the meeting.
• Minutes of the meeting to be recorded.
• All meetings must consist of at least a quorum.
• Not more than 10 protocols will be reviewed at any one meeting


• Meetings of IACUC shall be held on scheduled intervals as prescribed, at least 5 meetings per annum. Additional meetings will be held as and when necessary.
• The proposals will be sent to members at least 2 weeks in advance.
• PI/Co-investigator will be invited during meetings to offer clarifications if need be.
• Independent consultants/Experts may be invited to offer their opinion on specific research proposals if the need arises.
• The decisions of the meeting shall be recorded in the minute’s book and shall be confirmed during the next meeting with signature of Chairperson at each page.

• Scientific design and conduct of the study.
• Approval of scientific review committee and regulatory agencies.
• Assessment of predictable risks/harms to the animals.
• Protocol and proforma of the study.
• The decisions of the meeting shall be recorded in the minute’s book and shall be confirmed during the next meeting with signature of Chairperson at each page.

• Decision of IAEC would normally be taken by consensus. If divergent views are expressed by the members, these may be recorded in the minutes and a broad consensus be recorded as per understanding of the Chair.
• A member shall withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises. This shall be indicated to the chairperson prior to the review of the application and recorded in the minutes.
• Only members will make the decision. The decisions shall be taken in the absence of investigators & consultants.
• Decision may be to approve, reject or revise the proposals. Specific suggestions for
• Modifications and reasons for rejection should be given.

• Curriculum Vitae (CV) of all members of IACUC.
• Minutes of all meetings duly signed by the Chairperson. Copy of all
• Correspondence with members, researchers and other regulatory bodies.
• Copy of existing relevant national and international guidelines on research ethics and laws along with amendments.
• All study related documents (study projects with enclosed documents) should be archived for minimum of five years after the completion of study. A copy of filled information related to the projects shall remain with the PI for minimum of five years.

• Experiments shall be performed under supervision of a qualified person (Veterinary/ Medicine/Post graduate above in life sciences/Pharmaceutical sciences/Lab animal
Science) and under the responsibility of the person performing the experiment.
• Experiment shall be performed with due care and humanity.
• Animals intended for the performance of experiments shall be properly looked after both
before and after experiments.
• Personnel using experimental animal(s) shall be responsible for the welfare of animal(s) during their use in experiments.
• Investigators shall be responsible for the aftercare and rehabilitation of animal(s) after
• Experimentation, and shall not euthanize animal(s) except in situations as defined.
• The following parameters shall be adopted for application of euthanasia. Namely;

(a) When the animal is paralyzed and is not able to perform its natural functions or it
becomes incapable of independent locomotion or it can no longer perceive the environment in an intelligible manner.
(b) If during the course of experimental procedure the animal has been left with a
recurring pain wherein the animal exhibits obvious signs of pain and suffering.
(c) Where the non-termination of the life of the experimental animal will be life
threatening to human beings or other animals.
• Rehabilitation treatment of an animal after experimentation shall extend till the point the animal is able to resume a normal existence and will involve providing a lump-sum amount as costs for rehabilitation and care of such animal to cover its entire statistical expected life span. It is mandatory that the cost of after care and rehabilitation should be met from the contingency of the project.
• Experiments involving operative procedures shall be performed under anesthesia to be administered by a veterinary surgeon/scientist/technician so trained for the purpose.
• Animals which in course of experiments under the influence of anesthesia are so injured that their recovery would involve pain or suffering shall be destroyed humanely.
• Experiments shall not be performed by way of an illustration.
• Experiments shall not be performed as a public demonstration.
• No experiment the result of which is already conclusively known shall be repeated without justification.


LABORATORY ANIMAL ETHICS


All scientists working with laboratory animals must have a deep ethical consideration for the
animals they are dealing with. From the ethical point of view it is important that such
considerations are taken care of at the individual level, at institutional level and finally at the national level.

INSTITUTIONAL BIO-SAFETY COMMITTEE (IBSC)

Institutional Bio-safety Committee (IBSC) is to be constituted in all centers engaged in genetic
engineering research & production activities. The committee will constitute the following.
• Head of Institution/his nominee
• 3 or more scientists engaged in DNA work/molecular biology with an external expert in the relevant discipline
• A member with Medical Qualification (Bio-safety Officer) in case of work with pathogenic agent
• One member nominee by DMB

The Institutional Bio-safety Committee shall be the point for interaction within institution for
implementation of the guidelines. Any research project which is likely to have bio-hazard potential (as envisaged by the guidelines) during the execution stage or which involve the production of either micro-organisms or biologically active molecules that might cause bio-hazard should be notified to ISBC. ISBC will allow genetic engineering activity on classified organisms only at places where such work should be performed as per guidelines. Provision of suitable safe storage facility of donor, vectors, recipients and other materials involved in experimental work should be made and may be subjected to inspection on accountability.

The bio-safety functions and activity include the following:
(i) Registration of Bio-safety Committee membership composition and submission of report.
(ii) Review and clearance of project proposals failing under restricted category that meets the requirements under the guidelines on accidents, risks and on deviations if any. IACUC would make efforts to issue clearance certificate quickly on receiving the research proposals from investigators.
(iii) Tailoring bio-safety program to the level of risk assessment
(iv) Training of personnel on bio safety

PENALTIES
If any person/institution contravenes any order made by IACUC/commits a breach any
conditions imposed by committee punishable accordingly: He/She may be punishable with fine which may extended to /- and when the contravention or breach of conditions has taken place in any institutions, the person, In charge of institution shall be deemed to be guilty of the offence and shall be punishable accordingly.

CONTRACT ANIMAL EXPERIMENTS
Amendment of Rule-12, in the breeding and experiments on animal Rule 1998, this rule has been amended to allow to establishment to undertake contract research as per provision of PCA-Act 1980, and the rules made their under.

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