This document sets standards of care and foundations for use of animals by Lakehead University. The University will work with the Animal Care Committee (ACC) to ensure that all ACC members, animal users and caregivers are informed of and comply with the institutional animal care and use policies. The University will ensure that all members of the ACC are provided with training opportunities to understand their work and role.
The Terms of Reference for Lakehead University's ACC are prepared in accordance with the Canadian Council on Animal Care (CCAC) guidelines (revised in March 2006) and comply with legislation including the Animals for Research Act (Ontario, 1980). The terms described herein will ensure the humane care and use of animals in Lakehead University programs, both in facilities managed by the University and, insofar as the animals are subject to the control of the University or the investigator, in other facilities or jurisdictions. The ACC is also empowered to make judgments in exceptional situations where individual projects raise issues that fall outside of these terms, in order to ensure that appropriate ethical standards are met.
The Terms of Reference are implemented by the Lakehead University ACC, and its operation is governed by these Terms of Reference.
The Lakehead University ACC is responsible directly to the University President. Its purpose is to fulfill the University's legal and ethical responsibilities (see attachment "Ethics of Animal Investigation") concerning the use of animals in research, teaching and testing.
The University will work with the ACC to ensure that all animal users and caregivers are informed of, and comply with, institutional animal care and use policies and procedures.
The University is supportive of the committee's work and will maintain the appointment of an ACC coordinator who will work part-time for the ACC. The ACC coordinator will support the ACC by ensuring that animal use protocols are well managed, that committee minutes and reports are promptly produced and distributed, that all exchanges between the ACC and animal users are well documented and filed in a timely manner, and that animal users and ACC members are provided with necessary information. The minutes will detail ACC discussions, decisions, and modifications to protocols and must be produced for ACC meetings and forwarded to the President. The Coordinator will also inform the CCAC Secretariat of any important changes to the Animal Care and Use Program, such as membership changes to the ACC, changes in facility management, or changes to the reporting structure.
The University will work with the ACC to ensure that all ACC members, animal users, and caregivers are informed of, and comply with, the University standards for animal care as outlined in the Terms of Reference. It will ensure that ACC members are provided with training opportunities to understand their work and role. These will include a formal orientation session to introduce new ACC members to the institution's animal care and use program, the other ACC members, the CCAC guidelines and policies, the University's policies and procedures, and the University's animal facilities. ACC members are encouraged to access material on the CCAC website (and other relevant websites), such as the 12 Modules on the Core Topics of the Laboratory Animal/Teaching Stream of the CCAC Recommended Syllabus. Ongoing opportunities to better understand animal care and use in science will also be provided, such as time spent with animal caregivers and users, access to relevant journals and materials, and meetings/workshops related to animal care and use, including the CCAC National Workshop.
The President and senior administrators must ensure that the ACC is well respected within the institution, and that all ACC members and the ACC Chair are valued and recognized.
The University will assume full responsibility, including legal and other resulting costs, associated with legal matters and/or litigation involving the University, its animal care facilities, or the ACC.
1. MembershipACC members will be appointed by the President, upon recommendation by the Deans, for terms of no less than two years and no more than four years, renewable only up to a maximum of eight consecutive years of service. The terms should be staggered to ensure continuity of membership. This does not apply to ACC members who must be part of the ACC because of their role within the institution, such as the ACC Coordinator, the veterinarian(s) and the animal facility manager(s).
The complement of the committee will vary and should be determined by the ongoing needs of the University, but should include:
- Faculty or representatives of the University experienced in animal care and use, who may or may not be actively using animals during their term on the ACC; there should be a minimum of three such members, and representation from all the major animal-using divisions of the institution must be ensured, such as Biology, Biochemistry, Professional Schools, Forestry and the Forest Environment, Psychology; and the Northern Ontario School of Medicine.
- A veterinarian, experienced in experimental animal care and use, and laboratory animal medicine;
- A minimum of one faculty or staff whose normal activities, past or present, do not depend on or involve animal use for research, teaching or testing;
- At least one, and preferably two or more, person(s) representing community interests and concerns, who has (have) had no affiliation with the institution, and who has (have) not been involved in animal use for research, teaching or testing; community representation must be ensured for all ACC activities throughout the year;
- One technical staff representative, preferably the manager with overall responsibility, from each animal use facility;
- One graduate student engaged in animal research but preferably not supervised by an ACC member; and
- A representative of Health & Safety;
- The Manager of the Office of Research and representative of senior administration, non-voting member.
- The ACC coordinator (the institutional employee who provides support to the ACC), non-voting member.
Other persons may be appointed to the ACC by the President as the need arises.
A quorum for meetings will be a majority of the members, and the quorum must include the Chair, community members and veterinarian.
2. AuthorityThe ACC is authorized by the President to review each research, teaching or testing protocol that proposes to use living, non-human vertebrate animals, including both living animals used in experiments and field research, and animals that arrived live on University property and from which tissue was taken after application of humane methods of euthanasia.
The ACC has the authority, on behalf of the President, to:
- Stop any objectionable procedure if it considers that unnecessary distress or pain is being experienced by an animal;
- Stop immediately any use of animals which deviates from the approved use, any non approved procedure, or any procedure causing unforeseen pain or distress to animals; and
- Have an animal killed humanely if pain or distress caused to the animal is not part of the approved protocol and cannot be alleviated.
To ensure effective post-approval monitoring, the committee must work with the members of the veterinary and animal care staff to ensure compliance with its decisions and with the conditions set out in approved Animal Use Protocols. The veterinary and animal care staff must work in a collegial manner with animal users and attempt to correct deficiencies collaboratively.
To this end, it is imperative that the ACC obtains timely feedback on all Animal Use Protocols (AUPs) in the form post approval monitoring (see Research Post Approval Monitoring Form), renewal requests, and regular reporting from the veterinary staff (see Research Post Approval Monitoring Form).
Working collaboratively, the ACC, with assistance from the veterinarian, facility managers, and researchers, will monitor all animal use activities. This monitoring aims to prevent unanticipated distress and/or to quickly and properly address unanticipated distress. The ACC will also seek to ensure that, where necessary, AUPs Standard Operating Procedures (SOPs) are revised accordingly.
A manager of an animal facility shall:
i. Visit the facility, at his or her discretion but sufficiently often to ensure that all CCAC & OMAFRA guidelines are being carried out; unlimited access will be provided;At bi-monthly ACC meetings, the veterinarian(s) and facility manager(s) will report compliance issues, welfare issues, and any unexpected protocol events. The technicians will always report, in a timely fashion, any animal illness or welfare problems to the facility manager(s) and veterinarian(s).
ii. Report to the ACC issues relating to health or welfare of animals; and, undertake and ensure that the policies of the Canadian Association of Laboratory Animal Medicine are followed in the animal use and care program;
iii. Regularly review detailed mortality, incident reports, and treatment logs that are maintained by ACC technician(s);
iv. Be involved in the review and establishment of SOPs related to Lakehead University 's animal care and use program;
v. Be involved in the definition, monitoring and application of appropriate endpoints as per the CCAC Endpoint guideline;
vi. Have a visible presence in the animal care and use program;
vii. Make a progress report at each ACC meeting.
Where there are persistent breaches of compliance or threats to the health and safety of personnel or animals, these must be reported to the Chair of the ACC. The ACC must promptly address these issues through communications with the animal users, meetings and site visits and eventually communications with the President as necessary.
Breaches of compliance shall be dealt with in accordance with section 6 of this policy.
The ACC delegates to the veterinarian(s) the authority to treat, remove from a study or euthanize, if necessary, an animal according to the veterinarian's professional judgment. The veterinarian must attempt to contact the animal user whose animal is in poor condition before beginning any treatment that has not previously been agreed upon, and must also attempt to contact the ACC Chair. However, the veterinarian has the authority to proceed with any necessary emergency measures, whether or not the animal user and ACC Chair are available. A written report will be sent by the veterinarian to the animal user and to the ACC following any such event.
The veterinarian and ACC may, in some circumstances, delegate certain responsibilities to one or more senior animal care staff member(s).
3. ResponsibilityIt is the responsibility of the ACC to:
a. Ensure that no research or testing project or teaching program (including field studies) involving animals be commenced without prior ACC approval of a written use protocol; further to this, that no animals be acquired or used before such approval; it will also ensure that the procurement, care, and use of animals under its jurisdiction follow the guidelines and policy statements established by CCAC, and the Animals for Research Act (Ontario). This includes internally funded projects;
b. Ensure that no animals be held for display or breeding purposes, or for eventual use in research, teaching or testing projects, without prior ACC approval of a written animal use protocol, except where current CCAC guidelines provide for exemptions. The ACC should also be aware of other animal-based activities, such as commercial or recreational activities, within the institution, and should work with the persons responsible for these activities to ensure that animal care and use is undertaken according to appropriate procedures;
c. Require all animal users to complete an animal use protocol form and ensure that the information therein is clearly presented in a form that all members of the ACC can readily understand. To facilitate the work of both protocol authors and ACC members, appropriate SOPs should be referred to as much as possible. Approved protocols and SOPs should be readily available for all researchers and teachers in the areas where animal-based work is taking place, and on the institutional Animal Care website (See protocol forms for teaching and research);
d. Ensure that each research project has been found to have scientific merit through independent peer review before approving the project; if the review is not carried out by an external, peer review agency, the institution should require that it be obtained according to the CCAC policy statement on: the importance of independent peer review of the scientific merit of animal based research projects, 2000.
The President, with the assistance of the Office of Research, will ensure that peer reviews are conducted. Reviews should be conducted by at least two independent experts with no links to the researcher, at least one of whom will not sit on the ACC. Reviewers will be selected based on their expertise in their field and the nature of the AUP to be reviewed. This requirement exists for past protocols which have not been adequately reviewed and will be required at the time of renewal. The ACC will generally accept peer reviews provided by funding agencies (i.e. Tri-Council reviews) though, in some cases, may require additional peer review.
Teaching courses involving live animals require departmental pedagogical and scientific review only (2 members or a departmental committee attesting to the values of pedagogical and scientific merit). The ACC discourages the use of live animals in situations where there are viable alternatives and investigators are asked to substantiate the use of live animals. Undergraduate student projects require similar departmental review. The ACC discourages undergraduate student projects past level C invasiveness unless they are very well justified, closely monitored and subject to a full independent peer review.
e. Review and assess all animal use protocols, with particular emphasis on the CCAC policy statement on: ethics of animal investigation and CCAC guidelines on: animal use protocol review as well as on all other relevant CCAC guidelines and policy statements and, where necessary, require further supportive information from the investigator/teacher or meet with the investigator/teacher to ensure that all members of the committee understand the procedures to be used on the animal.
Information exchanges and ACC discussions with protocol authors can be very useful, but protocol authors and members of their teams must always clearly remove themselves from ACC decision-making on their own protocols.
Ensure that all procedures comply with CCAC guidelines, and, if at variance with those guidelines, require justification for the variance on scientific grounds. The ACC should discuss protocols and make decisions on them during full committee meetings, rather than through individual reviews, and should attempt to reach decisions by consensus.
The ACC may delegate the responsibility of interim approvals to an interim approval subcommittee, which must include at least one scientific member, one veterinarian and one community representative, one of which should preferably be the Chair of the ACC. However, such interim approvals should only be used infrequently, and the interim review process, including exchanges between the ACC and protocol authors, must be documented and must then be subject to discussion and final approval at a full meeting of the committee.
Before any research or teaching concerning animals is initiated (including ordering of animals) the animal use protocol must be reviewed and approved by the ACC. The basic philosophical principle is that total responsibility and accountability is the price the individual researcher pays for the privilege of animal experimentation. The protocol review process is as follows:
i. The protocol must address the issues that are stated the University AUP forms that are and based on CCAC guidelines on: animal use protocol review (1997 )and the Canadian Council on Animal Care (CCAC) guidelines (revised in March 2006);f. Ensure that animal users update their protocols. Minor modifications to an AUP must be written on the AUP Modification Form and approved before they are implemented. Minor modifications (e.g., 1 or 2 animal users added or removed, a small number of animals added, etc.), as defined by the ACC, can be approved by the Chair of the ACC or a delegate.
ii. Copies of the protocols for each member of the committee must be sent to the coordinator or ACC chair at least 15 days before the next bi-monthly ACC meeting. Providing it is completed properly, a copy of each protocol will be sent from that office to each member of the committee. If the protocol is not received by each member of the committee ten days before the meeting, the committee may under exceptional circumstances consider the protocol under interim approval. The ACC reviews and assesses all animal use protocols, with emphasis on the CCAC's Guide to the Care and Use of Experimental Animals, Ethics of Animal Investigation, Animal Use Protocol Review, and their Terms of Reference for Animal Care Committees;
iii. AUPs are considered during bi-monthly meetings. The decision for approval or non-approval is determined by the ACC giving consideration to CCAC guidelines and OMAF regulations and by the clarity of the protocol. The researcher can be invited to answer specific questions and help clarify aspects of the AUP but not be present during the final discussion and voting to avoid conflicts of interest;
iv. Committee members shall not participate in the review of their own AUPs or the AUPs submitted by persons with whom they are in direct academic collaboration or conflict. If a Committee member is unsure whether a conflict of interest exists, he/she must disclose the nature of the potential conflict to the Committee and abide by the Committee's decision as to whether he/she should participate in the proposal review;
v. Every effort will be exercised to obtain a consensus. If a protocol is not accepted unanimously, discussions of the concerns will focus upon solutions;
vi. Approval of a protocol is defined by simple majority at the meeting where quorum is met. If more than one meeting elapses when quorum is not met, a special meeting may be called by the Chair for interim approval by a sub-committee of the veterinarian, community representative, the coordinator and the Chair. An interim approval would then need subsequent approval at the next full meeting of the ACC. AUP's always require all content to be acceptable according to current veterinary standards;
vii. When an AUP is approved it is signed by the chair and a protocol number is assigned by the coordinator. Where animals are held at an animal use facility, this number must appear within the room, or on every enclosure of animals, involved with this AUP. The signed AUP is returned to the coordinator for filing and a second copy of the protocol is sent to the researcher, a third copy is retained by the Facility manager and a final copy is retained by the Office of Research. Correspondence, clarifications and additional protocol information should be kept with the protocol file;
viii. If approval of an AUP is postponed, the Chair will communicate the concerns of the ACC to the researcher. The researcher can submit an addendum to the original protocol in order to address specific issues as well as attend the following meeting;
ix. It is recommended that AUPs be first sent to the university veterinarian for content review prior to the ACC meeting in order to expedite the process. A meeting or email/phone interaction can be held to discuss veterinary details and procedures involved in the experiment and assist with overall planning of the project. After AUP approval, further meetings with the veterinarian and/or the facility manager are encouraged in order to facilitate implementation details.
Major changes to a protocol require that a new one be submitted. See explanations on the appropriate AUP forms and the AUP Modification Form for guidance on differences between minor or major changes.
Ensure that animal users report any unanticipated problems or complications, as well as on the steps they have taken to address the problem(s), to the ACC.
It is recommended that modification forms be first sent to the university veterinarian for content review prior to the ACC meeting
g. Review all protocols annually, i.e., within a year of commencement of the project; researchers must request the renewal of ongoing protocols on an annual basis in writing to the coordinator; annual renewals should be approved by at least a scientist, a veterinarian and a community representative and should be brought to the attention of the full ACC for its information. Renewal information must contain (See AUP Renewal Form):
i. A brief description of the protocol, and a new termination date;Require the submission of a new protocol after a maximum of three consecutive renewals.
ii. The number of animals used in the preceding year;
ii. The number of animals needed for the year to come, with a justification;
iii. a brief progress report, describing any complications encountered relative to animal use (unpredicted outcomes, and any animal pain, distress or mortality), and steps taken by the investigator to address the problem; any amendments to the original protocol; and, any progress made with respect to the Three Rs of replacement, reduction and refinement of animal use;
iv. brief report on the adequacy of the endpoints for the protocol, and on any complications encountered or refinements made relative to protecting animals from pain, distress or mortality; and
v. any other changes from the original protocol.
It is recommended that renewal forms be first sent to the university veterinarian for content review prior to the ACC meeting.
h. Document all ACC discussions and decisions in the committee minutes and on attachments to the protocol forms;
i. Ensure that AUP authors can appeal decisions in the event that proposed animal use is not approved by the ACC. This mechanism involves:
i. An oral presentation to the committee by the applicant; if issues are not resolved then;j. Ensure that all ACC members and animal users have the opportunity to become familiar with the CCAC Guide and CCAC policy statement on: ethics of animal investigation and all other CCAC guidelines and policy statements, federal, provincial or municipal statutes that may apply, as well as institutional requirements;
ii. A review by an appeals committee established by the President. Members of this committee should have appropriate expertise and ensure an appropriately separate, fair, and impartial process that is overseen by the President. Individual(s) with expertise from outside of the ACC may be assigned to the appeals committee;
iii. The CCAC may be called upon for information purpose; however, appeals cannot be directed to the CCAC.
k. Ensure appropriate care of animals in all stages of their life and in all experimental situations. Veterinary care must be available on an ongoing basis. Formal arrangements must be made to obtain the services of a veterinarian. These formal arrangements must be based on the elements contained in the CALAM/ACMAL Standards of Veterinary Care of the Canadian Association for Laboratory Animal Medicine (2004), which define the roles and responsibilities of veterinarians involved in scientific animal care and use programs;
l. Establish procedures, commensurate with current veterinary standards, to ensure that:
i. unnecessary pain or distress is avoided, and animal stress and injuries are avoided, whether during transfers of animals or in their normal quarters;m. Ensure that policies to provide for a system of animal care that will meet the needs of the institution are established and implemented, and include:
ii. anesthesia and analgesia are properly and effectively used; the only exception to this may be when agents must be withheld as a scientifically justified requirement of the study, and that this has been approved by the ACC. Painful studies requiring exemption from the use of either anesthetics or analgesia must be subject to particular scrutiny, not only prior to approval, but also during the experiment;
iii. appropriate post-operative care is provided;
iv. all due consideration is given to animal welfare, including environmental enrichment;
i. the requirement that all animal care and animal experimentation are conducted according to CCAC guidelines and policies, and to any federal, provincial and institutional regulations that may be in effect;n. Encourage the use of pilot studies with few animals when new approaches, methods or products are being tried, before approving new, large scale protocols. Ensure that animal users report on the results of any pilot studies, no matter whether they wish to pursue the study immediately or not, in order to preserve important data on various approaches to animal-based studies, whether they work well or not; and
ii. ensuring adequate animal care and management of the animal facilities, in particular by verifying that there is a person clearly designated to be in charge of animal care and management of the animal facilities, who should be a member of the ACC (see Section 1), and who should keep the other ACC members updated on the activities within the animal facilities;
iii. the training and qualifications of animal users and animal care personnel; veterinarians and animal care staff must receive continuing education in their field, and animal users (scientists/study directors, post-doctoral fellows, graduate students and research technicians) must receive appropriate training according to the CCAC guidelines on: institutional animal user training, 1999, either within the institution or through the programs of other institutions. The ACC will be involved in reviewing training programs;
iv. an occupational health and safety program for those involved in animal care and use, in collaboration with the institutional authorities on occupational health and safety, that will appropriately protect all those who may be affected by animal-based work, according to CCAC guidelines (see Chapter VIII of Volume 1 (2nd Edn, 1993) of the CCAC Guide or the most recent CCAC guidance on occupational health and safety);
v. standards of husbandry, facilities and equipment;
vi. standard operating procedures (SOPs) for all activities and procedures that involve animals, including animal care and facility management SOPs (typically produced by the veterinary and animal care staff), and animal use SOPs (typically produced by animal users, in collaboration with veterinary/animal care staff as needed); the ACC should receive all SOPs and ensure that all necessary SOPs are produced and regularly reviewed (see also Section 5a)iii); SOP's are to be readily available through the Office of Research, the University website, and in animal care facilities; researchers should refer to SOPs them as much as possible when filling out the AUPs. These SOP's need to meet current appropriate veterinary and animal health standards to ensure that:
vii. procedures for euthanasia;
- Unnecessary pain or distress is avoided;
- Anesthesia and analgesia are properly and effectively used. Painful studies requiring exemption from the use of analgesia must be subject to particular scrutiny prior to approval and during the experiment;
- Appropriate post operative care is provided.
o. In the case of projects involving proprietary or patentable research or testing, ensure that as much information as possible is provided to the ACC in terms of what effects to expect on animal health and welfare, and insist on close monitoring of animals in order to respect the elements outlined in 3 (l).
4. MeetingsAnimal care committee meetings will normally be held bi-monthly and more frequently if necessary to fulfill their Guidelines and be satisfied that all animal use within their jurisdiction is in compliance with institutional, municipal, federal and provincial regulations, and CCAC guidelines. Minutes detailing ACC discussions, decisions and modifications to protocols will be produced for each meeting, and will be forwarded to the President.
In addition, the ACC should have the opportunity to visit all animal care facilities and areas in which animals are used every 6 months, in order to better understand the work being conducted within the institution, to meet with those working in the animal facilities and animal use areas and discuss their needs, to ensure that facilities are within CCAC standards, to monitor animal-based work according to approved protocols and SOPs, to consider cleanliness and animal health, that all necessary records are in compliance as required by the CCAC and to ensure continuous registration under the Animals for Research Act, to assess any weaknesses in the facilities (ageing facilities, overcrowding, insufficient staffing and any other concerns) and to forward any recommendations or commendations to the person(s) responsible for the facilities and for animal use.
Visits of the animal facilities should be conducted at least once a year, and should be documented through the ACC minutes and written reports to the President that outline findings. The ACC shall, when appropriate, make recommendations to the President relating to the development, maintenance, and use of the animal facilities in their charge.
Those responsible for the animal facilities should respond to any ACC recommendations in writing, and site visit reports should always be followed up on jointly by the President and the ACC.
Each member of the ACC should participate in some of the facility visit(s) on an annual basis.
More frequent ACC site visits should be made as necessary to follow up on any protocols that have raised significant concern during the protocol review process, or where problems have been encountered with a protocol being carried out in practice or with other aspects of animal facility operations; these visits may be carried out by the Chair of the ACC or delegate, accompanied or not by other members or animal care staff.
5. GeneralThe animal care committee:
a. Will regularly review (at least every three years):
i. its Terms of Reference to meet new CCAC guidelines or policies and changing needs within the institution, the scientific community, the animal welfare community and society as a whole, and expand its Terms of Reference to meet the requirements of each institution;b. Will maintain liaison with the CCAC Secretariat, and inform the Secretariat of any changes to their program: to the senior administrator responsible for animal care and use, the chairperson of the ACC, or the veterinary or senior animal care personnel;
ii. the security of the animals and research facilities;
iii. standard operating procedures and institutional animal care and use policies; SOP review may be delegated to ACC members with the appropriate expertise, but SOPs should be accessible to all ACC members, and the full ACC should review all SOPs that involve procedures that may result in deleterious effects to animal health or welfare; and
iv. policies and procedures for monitoring animal care and experimental procedures within the institution, including the identification of the persons responsible for monitoring animal health and welfare, and the procedures carried out by the ACC to conduct monitoring;
c. Will submit complete and accurate animal use information in the CCAC Animal Use Data Form (AUDF) format for all protocols annually (animal use information for each calendar year must be submitted by March 31 of the following year) and also in pre-assessment documentation; and will report animal use numbers to OMAFRA as required annually by March 1 of the following year.
d. Will develop a crisis management program for the animal facilities and for the animal care and use program, in conjunction with any general institutional crisis management plan(s). This program must detail plans in the event of power outages (short and prolonged), work stoppages, fires, natural disasters, large chemical spills and other similar crises, and must include a communications plan for addressing public and media inquiries on concerns related to animal use;
e. Will, from time to time, sponsor seminars or workshops on the use of animals in science and the ethics of animal experimentation, and encourage as many animal users, animal caregivers, students, ACC members and other interested parties to attend as possible;
f. Will try to achieve and maintain a high profile within the institution and in the community in order to demonstrate the institution's efforts in promoting animal welfare and to allay some of the public concerns regarding animal experimentation; and
g. Will be open to developing and maintaining communication with animal welfare organizations.
6. Non-Compliance with this policya. The ACC is responsible for post-approval monitoring of animal use protocols, and for determining and working to correct breaches of compliance. Breaches of compliance that cannot be corrected by the ACC working with the concerned animal users and veterinary animal care staff will be referred to the President, who must inform all members of the animal care and use program about sanctions that will be taken by the administration in the event of serious breaches of compliance.
b. When an allegation of non-compliance is made, the Chair shall investigate the matter, and determine whether the allegation is valid. This may involve comparing the approved protocol or standard operating procedures approved by the ACC to the alleged activities.
c. If a problem is found, the Chair will inform the individual(s) involved in writing that an allegation has been made, and allow time to respond. In the meantime, an emergency meeting of the ACC will be scheduled. The written response of the individual must be received prior to the emergency meeting.
d. In the event of an emergency where a meeting cannot be held within an appropriate amount of time, the Chair and one (1) other designated individual from the Committee can recommend immediate action to the President. The recommendation can include the immediate suspension of the related activity.
e. The allegation and the response of the individual(s) involved will be communicated by the Chair to the committee. The committee must then make one of the following determinations:
i) The response to the allegation is adequate. No further action is required.f. The decisions of the committee shall be documented in writing. All correspondence directed to the individual(s) involved in the allegation will be copied to both the Chair of the department and the appropriate Dean.
ii) The response to the allegation is inadequate, and the allegation involves minimal risk (as determined by the committee). Recommendations must then be sent to the Principal Investigator/Instructor, and a specified time period will be set for the issue to be resolved.
iii) The response to the allegation is inadequate, and the allegation involves, or could potentially involve, significant risk. Recommendations to suspend activities will be sent immediately to the President by the committee.
g. Recommendations to the President shall be made in a formal letter detailing the following:
i. The issue
ii. The alleged infraction
iii. Steps taken to resolve the issue
iv. Recommendations of the committee
v. Time period for response to be made to the committee.