RELATED DOCUMENTS: 

Research Integrity Policy, European directive Number 86/609/CEE; The principle of 3Rs. University Laboratory Animal Occupational Health Program; Office of Laboratory Animal Welfare Health Research Extension Act of 1985, P.L. 99-158, November 20, 1985 “Animals in Research.; Animal Welfare Act Regulations, Title 9 CFR, Chapter 1, Subchapter A, §2.32.  

SECTION 1: POLICY STATEMENT 

1.1. University Mohammed VI Polytechnic (UM6P) complies with applicable national and international laws and regulations regarding animal care and use in research and education. 

1.2. Researchers conducting their work using animals at UM6P need to comply with ethical principles, legal considerations, and scientific necessity.  

1.3. The Ethics Committee’s approval for use of animals is required before the purchase of animals for research, husbandry, or any animal use for UM6P purposes. 

SECTION 2: SCOPE AND APPLICABILITY 

2.1. This policy applies to all UM6P faculty, staff, and students as well as other individuals engaged in teaching and/or research involving live vertebrate animals conducted at UM6P. 

2.2. This policy is applied in animal use in fundamental research, human medical research and research and development in collaboration with pharmaceutical groups. This policy applies to research projects undertaken on any UM6P campus location or site, even if the investigator is not affiliated with UM6P. 

2.3. This policy is applicable to all animal use, regardless of whether the project has received prior review through the ACUC followed by the final UM6P Ethics Committee decision. 

2.4. This policy is not applicable to dead animals, as in use of tissue. However, it applies to animal use requiring antemortem manipulation for data or tissue collection for UM6P purposes. This is the case even if the animal is neither purchased by nor brought to a UM6P facility.  

2.5. The provisions of this policy are submitted to laws of Morocco and norms applicable in Morocco (hereafter referred to as “Legal Provisions”. If any Legal Provision sets a legal framework more restrictive than the principles set out in this Policy or is mandatory, then such Legal Provision shall prevail. 

SECTION 3: PURPOSE 

3.1. This policy defines and outlines UM6P’s regulations with regards to the use of laboratory animals. 

3.2. This policy ensures that animal use is carried out in compliance with national and international standards, laws, and regulations. 

SECTION 4: DEFINITIONS 

The following definition(s) apply to this policy document: 

4.1.  Agent: include all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility for UM6P or its subsidiaries or governed sites. Agents include students and other trainees enrolled in UM6P educational programs performing activities in connection with their roles and responsibilities as students or trainees. 

4.2. Animal: Any live vertebrate animal used or intended for use in research, training, experimentation, biological testing, or related purposes excluding fœtal and embryonic forms. 

4.3. Employees: include individuals employed by UM6P and all on-site subsidiaries as well as those off-site governed by UM6P policies and procedures.  

4.4. Husbandry: The care and housing of animals, in this case kept captive for UM6P purposes. It may include breeding of those animals for UM6P purposes, but this is not a requirement.  

4.5. Replacement: The avoidance of using animals. In some cases, a complete replacement or relative replacement of animals in experiments. 

4.6. Refinement: The enhance of animal well-being and minimize or eliminate pain in experiments, the researcher must take all measures to reduce pain and distress from certain types of experiments.  

4.7. Reduction: Obtaining comparable or same levels of results from the use of fewer animals or/and maximizing the results obtained from a limited number of animals without increasing pain or distress. 

4.8. Procedure: Any experimental use that could cause lasting harm, pain, suffering, or distress to an animal. 

4.9. Euthanasia: The human termination of an animal’s life that minimizes pain, distress, and anxiety experienced by the animal before loss of consciousness.  

SECTION 5: PROVISIONS AND GUIDELINES 

5.1. University Mohammed VI Polytechnic (UM6P): 

5.1.1. Establishes an institutional culture of respect for animal subjects; 

5.1.2. Ensures effective institution-wide communication and guidance on animal research issues; 

5.1.3. Establishes an Animal Care and Use Committee (ACUC) with necessary resources.  

5.1.4. UM6P supports the authority and decisions of the Ethics Committee and the ACUC.  

5.1.5. Ensures that investigations fulfill their responsibilities; 

5.1.6. Facilitates participation in animal research education activities; 

5.1.7.Serves as a knowledgeable point of contact; 

5.2.Researchers conducting research using animals at UM6P are required to prioritize the welfare of animals in their care. All research must adhere to the 3Rs: Replacement, Refinement, and Reduction. Moreover, researchers must have the required training and the necessary certification to conduct their research in UM6P facilities.  

5.3 ACUC provides the university with oversight regarding compliance with regulations, adequacy of facilities, animal husbandry and the appropriate use of animals in education programs and research. 

5.4 The Ethics Committee, with the technical support of the ACUC, and in accordance with its relevant procedures, supports, reviews, communicates approvals of animal use and provides training, monitoring and renewals for research projects involving laboratory animals.  

5.5. An animal database would be set up to identify each animal present at the animal movements in the laboratories. The database is managed by the ACUC, but it is the animal keepers (researchers/experimenter) who are responsible for recording daily entries and exits in a computerized register dedicated to each zone.  

5.6. Animal laboratories are operated under strict sanitary and regulatory control. All researchers must be aware of the requirements under which they carry out their duties and are obliged to comply with them. In case of neglect and recklessness, the responsible researchers could face consequences. (for more detail see University Laboratory Animal Occupational Health Program) 

The composition of the Animal Care and Use Committee (ACUC): 

5.7. The ACUC comprises multidisciplinary members, with the objective of ensuring compliance with the international charter on the ethics of animal experimentation, and adherence to the principles of ethical evaluation.  

5.8. To preserve the impartial and the independence of the ACUC, the unit would be composed of:  

5.8.1. An expert with proven competence in the design of projects or experimental procedures on animals. 

5.8.2. An expert with proven expertise in the performance of experimental procedures on animals. 

5.8.3. A veterinarian responsible for the well-being and clinical management of live vertebrate animals used in research and teaching. 

5.8.4. An Expert not specializing in questions relating to the use of animals for scientific purposes. 

5.8.5. One person with proven skills in Animal care and/or termination of animal’s life. 

ACUC Role 

5.9. The ACUC oversees, evaluates, review and provides technical assessment on all research involving animals before the final approval of the Ethics Committee.  

5.10. The ACUC has a mission of review and participates in the approval of animal use protocols for the animal use at UM6P. This includes animal facilities inspection and a semi-annual evaluation of the overall program for the care and use of laboratory animals.  

5.11. Activities involving animals must be reviewed by the ACUC when: 

5.11.1 Employees or agents of UM6P and/or their respective affiliated entities, in connection with their institutional responsibilities, use animals for research, education, or other activities; 

5.11.2 The activity is conducted under the direction of employees or agents of UM6P and/or their respective affiliated entities; 

5.11.3 The activity involves the use of any property or services of UM6P and/or UM6P receives a direct award to conduct the activity, even where all activities involving animals are carried out by a subcontractor or collaborator; and/or the activity is sponsored by UM6P. 

5.12. The ACUC shall report the cases of misconduct of using UM6P animal facility to the Head of the Department of the Medical Sciences who reserves the right to suspend or terminate approval or place restrictions on active studies.  The researcher must stop all research activities until a final decision is made by the Ethics Committee.  

5.13. Research on inquiries from the Ethics Committee and/or the ACUC about regulations or common practices are conducted.  

5.14. The Ethics Committee, under the recommendation of the ACUC, may request modifications or disapprove a study due to cultural inappropriateness.

Procedure for the approval for Animal Use and Care

5.15. By definition, the use of an animal in any capacity at UM6P involves animal use and care approval and is subject to this policy and related procedures. The request application form must be submitted electronically to the ACUC, and approval is required from the Ethics Committee prior to using such animal(s).

5.15.1. The Ethics Committee and/or ACUC, may require modifications to a proposed use to approve it.

5.15.2. Researchers would have to justify for the need and availability of facilities, as well as their description, must be provided with the application, along with any personnel arrangements or contracting for animal husbandry.

5.15.3. The duration of the approval is determined on a project basis and shall not exceed five (5) years. Furthermore, a review of the protocol must take place whenever a significant change occurs.

5.15.4. Modifications to a study design, methods of animal use, change in the timeline or method of animal disposal, change to the project title, change of the participating investigators or the source of funding must be submitted to the ACUC for review before continuation of work.

5.16. First, researchers must submit to the ACUC for recommendation. The ACUC will review the proposal, taking into account ethical implications, the level of distress caused to animals, and compliance with UM6P policies and standards. All the recommendations will be sent to UM6P Ethic Committee for the final decision.

5.17. ACUC works together with the Ethics Committee to facilitate the approval process. The ACUC reviews and evaluates the technical aspects of the research proposal within 10 days. The Ethics Committee then makes a final decision on the proposal based on the ACUC’s recommendation within 30 days of receiving the proposa

5.18. To reject a research project on animals, the UM6P Ethic Committee has the obligation to justify its decision and notify the researcher via the ACUC. The researcher has the right to appeal the decision of the UM6P Ethic Committee in front of a special joint committee composed of the members of the Ethics Committee and the ACUC that emits a final decision.

5.19. To receive the recommendation from the ACUC and the final approval from Ethics Committee, each researcher willing to conduct research in a UM6P facility, must present a summary of the project and a detailed experimental protocol.

5.20. Both Procurement and Facilities will require receipt of ACUC favorable opinion before purchasing or facilitating animal arrivals or housing at UM6P. Procurement and Facilities require proof of ACUC approval before arranging contracting for husbandry or other animal services on behalf of UM6P for the purposes of teaching, research, exhibition, or

5.21. Principal Investigators (PIs) must take responsibility for the appropriate training of their agents, associates, and staff, and to make sure that their research programs are in compliance with all regulations and policies governing the care and use of animals in the human care and use of laboratory animals, ensuring that they are qualified to perform their duties, and that they understand their obligations to comply with all specifics of the approved protocol.

5.22. The PI is required to conduct a risk assessment for all research activities he/she supervises. A risk assessment is a systematic review of potential injury causes, illness, or damage in the workplace, so that he/she can assess the level of precautions to take. All these points must be communicated to ACUC and to UM6P Ethics committee (See University Laboratory Animal Occupational Health Program)

Educational use of animals

5.23. The use of either live or deceased vertebrate animals for solely instructional purposes is permitted when:

5.23.1. The cognizant instructor(s) judges that the educational goals of the program or course will be best achieved by such usage.

5.23.2. The Ethics Committee determines that such usage is humane, proper, and appropriate, consistent with national regulations for the utilization and care of vertebrate animals used in teaching and research. Only the minimum number of animals essential to instructional objectives should be used. Instructors should be encouraged to use alternatives to animals whenever possible.

5.24. Academic departments and programs should alert prospective students if any courses which are required for a major or degree involve the use of animals. This requirement may be met by a statement to the effect that some required courses for certain degrees may involve use of animal tissue, and that interested students should seek further information about such requirements from the department. Normally this statement should appear in the course catalog.

5.25. Instructors must inform their students during the first week of class if animals or animal tissue will or may be used as part of that course. Students who have concerns about the use of animals may then choose whether or not to take the class. Students should feel free to discuss their concerns with the instructor but should be aware that instructors and departments are not obligated to alter course requirements which are consistent with university policies.

5.26. Any faculty member who intends to use vertebrate animals for teaching purposes must submit a request in accordance with the ACUC standards and requirements. Reuse of previously approved preserved material does not require renewal of approval if the courses taught each year do not involve significant changes in animal usage. The request must include information about the source from which animals are procured. In addition, the request must explain why animals are needed to achieve the goals of the course and justify the species and the number of animals to be used. If the ACUC questions the species of animal chosen, the procurement process, the number of animals to be used or other related matters, such questions need to be resolved before the animals may be ordered.

5.27. In order for students to carry out research on animals they must be accompanied by a supervisor. The supervisor takes all the necessary steps to ensure the research is carried with the recognized standards and in line with UM6P policies.

Reporting non-compliance and concerns

5.28. Any person may contact (anonymously, if they wish) the ACUC or the Attending Veterinarian if there are concerns regarding the human care and use of laboratory animals at UM6P.

5.29. In the event of violation of this policy and/or the instructions of the ACUC and/or the Ethics Committee, or disregard for the welfare of the animals, the researcher may be subject to sanctions depending on the gravity of his/her actions, after review by the ACUC and evaluation by the UM6P Ethic Committee:

5.29.1. Warning

5.29.2. Temporary or permanent ban from using the animal facility.

5.29.3. Suspension of the researcher.

End of research on animals

5.30. If at the end of research on animals, it is established that it will leave a big distress at the end of the research project, the researcher is allowed to proceed to a euthanasia to avoid an additional level of pain for the animal.

SECTION 6: RESPONSIBILITIES

6.1. The ACUC is responsible for the compliance team further provides any required support with regards to regulatory research and clarifications requested by the researchers.

6.2. The Ethics Committee ensures transparency by disclosing the purpose and the conduct of research on animals.

6.3. ACUC is responsible for equipment maintenance and repair of all the laboratories and the husbandry.

6.4. The ACUC is required to keep detailed records of each experiment and animal at the disposal of UM6P. The record keeping must include detailed records of each experiment.

6.5. The ACUC is responsible for maintaining and making available all necessary forms and traceability for animal use at UM6P.

6.6. The Researchers using animal in their research are responsible for maintaining the animal use records for UM6P.