Guide to the Preparation of Codes of Ethical Conduct

Transcription

1 ANIMAL WELFARE National Animal Ethics Advisory Committee Guide to the Preparation of Codes of Ethical Conduct NAEAC National Animal Ethics Advisory Committee Guide to the Preparation of Codes of Ethical Conduct 1

2 The purpose of this document is to give guidance to applicants on the preparation of a code of ethical conduct. Applicants are requested to consider carefully the relevant provisions under Part 6 of the Animal Welfare Act 1999 and Animal Welfare Amendment Act (No 2) 2015 and seek independent advice or legal assistance if necessary. Disclaimer While every effort has been made to ensure the information in this guide is accurate, MPI and NAEAC, their employees and consultants expressly disclaim all and any liability to any person in respect of anything, and the consequences of anything, done or omitted to be done in reliance, whether wholly or partly, upon the whole or any part of the contents of this publication. National Animal Ethics Advisory Committee C/- Ministry for Primary Industries P O Box 2526 Wellington 6140 New Zealand ISBN (online) October 2017

3 Contents A. Introduction 3 1. The Guide 3 2. What is a code of ethical conduct? 4 3. Role of the Director-General of MPI 4 4. What does a code of ethical conduct look like? 4 5. Proposed code of ethical conduct 5 6. Public access to AEC meetings 5 B. Format of applications for a CEC 6 C. The application: documentation checklist 6 1 Application form 6 2 Qualifications and references 7 3 Draft code of ethical conduct 7 Appendix 1: Application form 8 Application for a Code of Ethical Conduct 8 Appendix 2: Guidance for CEC Template 10 Cover Page Introduction & Background on the Activities of the Applicant Establishment, Functions, Powers and Membership of the Animal Ethics Committee AEC Procedures Consideration and approval of projects by the AEC Responsibilities Animal Facilities Monitoring of Projects Arrangements for External Parties to Use the Code and AEC Complaints Procedure Amendments, Suspension or Revocation of the CEC 20 Appendix 3: CEC Template 21 Appendix 4: Animal Welfare Act 1999 sections 87 to Codes of Ethical Conduct 21 Animal Ethics Committees 25 Appendix 5: Animal Welfare Amendment Act (No 2) Appendix 6: Checklist for Code of Ethical Conduct 31 Guide to the Preparation of Codes of Ethical Conduct 1

4 2 Guide to the Preparation of Codes of Ethical Conduct

5 A. Introduction 1. The Guide 1.1 This guide is designed to assist persons wishing to apply for, or renew, a code of ethical conduct under section 87 of the Animal Welfare Act 1999 (the Act) and gives additional information on what is to be contained in such codes. Any person who engages in research, testing, or teaching and wishes to use animals for such purposes shall have an approved code of ethical conduct, or work for a person who holds such a code or have a formal arrangement to use another person s code pursuant to section 84 of the Act. Codes must be approved by the Director-General of the Ministry for Primary Industries (MPI) prior to commencing research, testing or teaching activities. 1.2 The requirement to have a code of ethical conduct is set out in Part 6 of the Act which deals with the use of animals in research, testing and teaching. 1.3 The relevant sections of the Animal Welfare Act 1999 and Animal Welfare Amendment Act (No 2) 2015 are set out in full in Appendix 4 and Appendix 5 (respectively) to this document and should be consulted when preparing an application for a code of ethical conduct. These sections cover codes of ethical conduct and animal ethics committees. Sections of the Animal Welfare Amendment Act (No 2) 2015 come into force at various times as detailed below: Sections 41(1), (2), and (4) come into force on 1 January 2018; Section 41(3) came into force on 9 November 2015; Section 46(1) came into force on 9 August 2015; The rest of this Act came into force on 9 May This guidance includes the changes made under the Animal Welfare Amendment Act (No 2) Cosmetic Testing Use of animals for the purpose of cosmetic testing is prohibited under the Act. Section 84A Prohibition on use of animals in research, testing, and teaching for making cosmetic (1) A person must not use an animal in any research, testing, or teaching that is for the purpose of (a) (b) developing, making, or testing a cosmetic; or developing, making, or testing an ingredient that is intended exclusively for use in a cosmetic. (2) Subsection (1)(b) does not apply to research, testing, or teaching in relation to an ingredient that is carried out for a purpose unrelated to the intended use of the ingredient in a cosmetic. (3) A person commits an offence who contravenes subsection (1). (4) In a prosecution for an offence against this section, it is not necessary for the prosecution to prove that the defendant intended to commit the offence. Guide to the Preparation of Codes of Ethical Conduct 3

6 2. What is a code of ethical conduct? 2.1 A code of ethical conduct (CEC) is a document that details the policies to be adopted and procedures to be undertaken by the code holder and the animal ethics committee (AEC) appointed by the code holder to ensure that the use of animals in research, testing and teaching is regulated according to the requirements of the Animal Welfare Act 1999 and Animal Welfare Amendment Act (No 2) The person making the application on behalf of the organisation would normally be the chief executive as a representative of the organisation that is covered by the code. The CEC lists the responsibilities of the code holder, the steps to be undertaken in setting up an AEC, and the policies and procedures to be adopted and followed by the code holder and the AEC. The Director-General of MPI may approve a CEC for a maximum of five years. 2.2 The details of what is required in a CEC are set out in the Act. A standardised format of a CEC provides consistency in outcomes for organisations writing a CEC, the National Animal Ethics Advisory Committee (NAEAC) in reviewing CECs and MPI when approving CECs. Section B of this document provides a template within which the specific needs and circumstances of each applicant and NAEAC can be accommodated. 2.3 The term organisation refers to any individual, company, institution or organisation that might apply for approval of a code. It should be noted that in the case of an organisation, the code holder is the organisation, not a person such as a chief executive. The code is not transferable to another organisation if companies are sold or merge, unless the Director-General of MPI gives specific approval to the transfer prior to the sale or merger. 3. Role of the Director-General of MPI 3.1 The Director-General is required to consult with, and invite comments from NAEAC on each application for a CEC. The Director-General will be guided by the comments received from NAEAC. The Director-General is required to notify the applicant of the decision within 40 working days of the application being lodged. This can be extended to 80 working days if the Director-General requires more information or needs to consult with the applicant. If the Director-General does not notify the applicant of the decision within the required time period, the Director-General is deemed to have refused to approve the proposed code. 4. What does a code of ethical conduct look like? 4.1 While it is accepted that all CECs will not be identical, a template is provided as guidance in section B of this guide. The contents that should be inserted into each section are presented as a checklist in section C. To facilitate compliance, and review of the code, it is highly recommended that CECs follow the standardised format in section C. The style should be such that it can be approved by the Director-General as a statement of how the organisation in general, and the AEC in particular, will meet the requirements of the Act when deciding whether animals are used in research, testing or teaching. 4 Guide to the Preparation of Codes of Ethical Conduct

7 5. Proposed code of ethical conduct 5.1 The details of the CEC are described in the recommended format on the following pages. It is emphasised that, in following this format and checklist, the application should describe the in-house rules that will ensure that all manipulations, as defined in section 3 of the Act, are in accordance with the purpose of Part 6 of the Act (under section 80), and carried out by appropriately trained personnel. 5.2 It is important that any proposed code must incorporate, as a minimum, the requirements specified in section 88 of the Act. A system of keeping records and monitoring all activities involving animal use and husbandry is essential. This must be to a standard that is acceptable to the reviewer at the time of the mandatory five-yearly review of the ethical system set up under each CEC. There may be conditions or extra instructions that apply to an individual code holder that are not in the Act but are specific to the organisation. In such cases these should be clearly stated and separated from those sections that reflect the mandatory requirements of the Act. 5.3 Every code holder must also comply with the Animal Welfare (Records and Statistics) Regulations Public access to AEC meetings 6.1 Some public organisations undertaking research, testing and teaching may be subject to the Local Government Official Information and Meetings Act Where this is the case, committee deliberations must take place in meetings that are open to the public unless there is good reason for excluding the public. The committee must apply section 48(1)(a)(ii) of the Local Government Official Information and Meetings Act. This means sections 6, 7 and 9 of the Official Information Act 1982 apply including commercial sensitivity and legal professional privilege. However, section 9(2) (g)(i) of the Official Information Act (which relates to free and frank expression of opinion between members of an organisation) is not available. Guide to the Preparation of Codes of Ethical Conduct 5

8 B. Format of applications for a CEC 1. Part 6 of the Act contains information relevant to the use of animals in research, testing, and teaching. New applicants and those renewing their CECs must submit applications to the Director- General that are consistent with the Act. 2. The detailed contents of each section are summarised in the checklist in section C of this guide. The checklist can be used by both the applicant and the Director-General (with the advice of MPI and NAEAC) to assist in ensuring that the CEC contains the appropriate policies and procedures. This approach can then accommodate the diversity of code holders. Applicants can vary the content of the CEC to suit their organisation and at the same time maintain a format that is consistent to all applications, without diverging from the requirements of the Animal Welfare Act Such consistency will assist the Director-General and NAEAC when processing applications. The final structure of the application will comprise several documents. 3. The mandatory review of code holders and AECs, in sections of the Act, makes it highly desirable for the code holder and the AEC to document their policies and procedures. This will also help new AEC members to understand their roles. Any review would require the AEC to account for its procedures and verify that these have been followed carefully and minuted appropriately. Similarly, the allocation of responsibilities regarding the distribution of information on the regulation of animal use in the organisation should also be set out clearly. 4. Every application to the Director-General should include: the draft CEC itself; an application form incorporating the information required by section 89(1) of the Act; independent references as specified in section 89(2)(b) of the Act; where the application is for a renewal of the CEC, a satisfactory report from an accredited reviewer. (Both MPI and NAEAC will have been supplied with a copy of the accredited reviewer s report as required by section 115 of the Act). C. The application: documentation checklist 1 Application form The application form must include: the full legal name of the person or organisation applying for approval of a code; the applicant s contact details. Note: If the applicant is an organisation, the name, contact details and role within the organisation of the individual completing the application form should be provided; a description of the type and range of work in which the applicant is/will be engaged see section 89(1) (a); the period for which the approval is sought see section 89(1)(b); particulars of any convictions against certain Acts see section 89(1)(c); See Appendix 1 for a sample form. 6 Guide to the Preparation of Codes of Ethical Conduct

9 2 Qualifications and references The purpose of this legal requirement is to ensure that the applicant has or the applicant s staff have the appropriate qualifications and expertise to carry out the type of research, testing or teaching intended to be undertaken. In the case of organisations, qualifications and references relating to the senior member of staff undertaking or overseeing animal research, testing and teaching will suffice, although a brief description of the types of staff employed by the organisation is useful. 3 Draft code of ethical conduct The guidance in Appendix 2 contains items for possible inclusion in a CEC. Detailed information should be provided under each part of the CEC. The code holder must be satisfied that procedures are in place to enable the AEC to exercise its powers and functions. Once it has been established, an AEC is required to set in place its own procedures. The code should differentiate clearly between those procedures that are to be established by the code holder and those to be set in place by the AEC once it has been established. The code may also contain any additional information that is relevant but is not a statutory requirement under the Act. Guide to the Preparation of Codes of Ethical Conduct 7

10 Appendix 1: Application form Application for a Code of Ethical Conduct (1) Full legal name of applicant (person or organisation): (2) Name of individual completing form on behalf of organisation: (3) Designation: (4) Site/location of company/institution where activity is to take place: (5) Postal address: telephone: (6) Does the applicant or senior staff of the organisation have any convictions against the Acts specified in section 89(1)(c) of the Act? Yes/No If yes, please give particulars: (7) A brief summary of the general nature and extent of the research, testing, or teaching in which the applicant will be engaged: (8) Statement of the period in respect of which the approval is sought (maximum 5 years): [Note: Independent references and appropriate academic qualifications should be attached to this form section 89(2)(b) In the case of organisations, a description of the types and qualifications of staff employed is helpful.] 8 Guide to the Preparation of Codes of Ethical Conduct

11 Signature page An example of final page with signatures and other details to be included with CEC application. A blank form for this will be available on request from the Secretary of NAEAC. This is to certify that the code holder undertakes to conform to all the requirements of the Animal Welfare Act 1999 and will ensure that all persons involved in the animal manipulations and carrying out of these activities are appropriate persons according to that Act. It is accepted that the code holder is also responsible for distributing information on the requirements of the Act to the animal ethics committee to help ensure that the animal ethics committee follows the requirements of the law. Signature of applicant: Date: Guide to the Preparation of Codes of Ethical Conduct 9

12 Appendix 2: Guidance for CEC Template This is guidance for the CEC Template (which is available as a separate Word document) that covers the essential components of a CEC. More elaborate codes may specify greater detail and have additional sections that are designed to help the functioning of the AEC and the staff conducting manipulations. Cover Page NAEAC recommends that the preparation date of the code be inserted somewhere (for example CEC cover page or footer) so that users know they are referencing the current version. NAEAC recommends, that as legal provisions can change during the life of a code, applicants refrain from inserting legal definitions and just refer directly to the Act. [A glossary table is recommended, particularly where acronyms are widely used in the code]. 1. Introduction & Background on the Activities of the Applicant Describe the scope and general nature of the research, testing or teaching activities of the organisation and species of animals used. It is helpful to provide a statement of the organisation s philosophy towards research, testing and teaching and the Three R s. Describe the persons in the organisation who will be responsible for administering the code. 2. Establishment, Functions, Powers and Membership of the Animal Ethics Committee 2.1 Functions, Duties and Powers of the Committee The code must describe the functions, duties and powers of the committee. The code should reflect that a function of the AEC is to ensure that the highest ethical standards are observed by all persons associated with it in relation to the manipulation and use of animals. 2.2 Membership This part should contain a description of the number and categories of persons constituting the members of the AEC. This should specify: the number and classification of persons on the AEC; appointment, reappointment and replacement details; training of new members and expectations of AEC members. NAEAC suggests wording to include reference to the NAEAC new member s induction pack; remuneration of external members, that is, those not employed by the code holder; procedures that ensure external members will have effective input into the work of the AEC Organisational members The Act requires that one member of the AEC be a senior member of the organisation capable of evaluating the application, the qualifications and experience of the applicant, and the scientific or teaching value of the project. This does not preclude other members also contributing as well and bringing additional skills. 10 Guide to the Preparation of Codes of Ethical Conduct

13 2.2.2 External members There must be a policy in place to ensure that persons who are members of the AEC, but who are not employed by the code holder, have input into the working of the committee. These members include the person nominated by an approved animal welfare organisation 1, the person nominated by a territorial authority or regional council, and the person nominated by the New Zealand Veterinary Association. Codes are required (by the Act) to contain policies and procedures to ensure that external AEC members have an effective input into the working of the committee. NAEAC assumes that external members receive some remuneration as well as expenses and reference should be made to this. While it is commendable to state that external members will be remunerated, there is no need to specify the precise amount (as this would mean any increase in remuneration over the next five years would require an amendment of the code). NAEAC suggests wording such as External members will be appropriately remunerated Additional members The code must detail the circumstances under which any additional members may be appointed. 2.3 Appointment Procedures NAEAC recommends the code describes how the appointment of the AEC members is performed, and the maximum term of appointment. It is useful to include the eligibility criteria for the reappointment of members. NAEAC recognises it is the code holder s prerogative to determine whom the Chairperson and Deputy Chairperson should be, and who should make this decision (i.e. the code holder, or the AEC). NAEAC recommends the code describes how the appointment of the Chairperson and Deputy Chairperson is performed, and the term of appointment. It is useful to include the eligibility criteria for the reappointment of the Chairperson and Deputy Chairperson. NAEAC recommends codes outline how replacement or reappointment of external members at the expiry of their term will be managed, through a formal nomination by the relevant body. This should make clear that when the terms of the statutory external members expire, how nominations must be sought from the nominating bodies. NAEAC recommends if applicants wish to have additional members participate on their AECs, the code will describe how these additional members (external or internal) are appointed or reappointed. 2.4 Vacancies The code must detail how vacancies and unexpected/prolonged absences are managed. While it appreciates the difficulties that lack of a quorum can pose, NAEAC requires codes to detail how vacancies and unexpected/prolonged absences are managed. If there are insufficient members present to constitute a meeting then NAEAC considers that those members present could, in effect, act as a subcommittee under the provisions of section 56 of the code. If vacancies rendered the AEC inquorate this would invalidate its actions. 2.5 Induction of new members NAEAC recommends the process for induction and training of new members should be described in the code. In addition, the code should specify what information and documentation will be supplied as 1 The Royal New Zealand Society for the Prevention of Cruelty to Animals is the only approved organisation in New Zealand. Guide to the Preparation of Codes of Ethical Conduct 11

14 part of the induction process for new members. It is expected that all AEC members will have read and understood the code to enable them to perform their duties. NAEAC considers the ability and competency of the external members to participate fully in the AEC process to be a critical component of the integrity of the regulatory management of research, testing and teaching in New Zealand. NAEAC also recommends new AEC members should be provided with the NAEAC induction pack. Members should also be encouraged and supported to attend NAEAC workshops, conferences and/or training courses during their term on the AEC. 2.6 The term of appointment The code must specify the terms, conditions and duration of appointment under which members of each AEC hold office. NAEAC recognises that it is the organisation s prerogative to decide on frequency of appointment. However, NAEAC has concerns that annual appointment risks loss of institutional knowledge and for the external members places an unnecessary burden on nominating bodies. Similarly, NAEAC also believes that AEC members should not be reappointed indefinitely. 3. AEC Procedures The Act requires that the AEC be able to function effectively. The following items, although not statutory requirements, will enable effective functioning and can be separated into those to be established by the code holder and those to be set up by the AEC once it has been appointed. This includes any criteria that will be used by the AEC to approve the protocols but are not a requirement of the Act; and are, additional to powers, functions, and criteria under sections 99 and 100 of the Act, such as: how meetings will be run; frequency of and attendance at meetings; preparation and distribution of agenda including timing; what constitutes a quorum; method of decision making e.g. consensus, majority (NAEAC strongly recommends consensus as the preferred method of approval); management of possible conflict of interest by AEC members; ensuring effective input of external members; confidentiality and the treatment of commercially sensitive information; policy on the use of tele/videoconferencing; policy on consideration between meetings and the use of subcommittees (including terms of reference and mechanisms for set up); public attendance at AEC meetings and possible application of Local Government Official Information and Meetings Act 1987; how presence (or not) of the applicant at meetings is managed; secretarial support; record keeping, including minute staking and information management; reporting of statistics to MPI; process to amend the CEC. 3.1 How meetings will be run NAEAC recommends AEC meeting scope and process is stated. 12 Guide to the Preparation of Codes of Ethical Conduct

15 3.2 Frequency of and attendance at meetings NAEAC recommends AEC meeting frequency is stated (at least specifying a minimum, which must be at least one per year). While acknowledging the practicalities of being able to cancel some meetings, NAEAC suggests that as a minimum, one face to face meeting a year should be held to maintain continuity and the relationships between AEC members. Even if there are no applications to consider, there may be monitoring reports to consider or monitoring visits that could be scheduled. A statement should be provided describing how remote meetings (e.g. phone/video conference) will be managed if they are required. 3.3 Timing for circulation of agenda items NAEAC recommends the timing for circulation of agenda items is specified (i.e. minimum number of days/weeks prior to the meeting). Phrases such as well in advance are vague and are inconsistent with providing clarity to all involved. 3.4 Quorum NAEAC also seeks clarification regarding the quorum. The quorum should include the Chairperson and at least two of the external members. NAEAC is strongly of the view that for the purposes of establishing a quorum, the definition of external member should include statutory external members only. NAEAC also recommends that the minimum number to constitute a quorum be 50% plus one of the current members of the committee. 3.5 Decision process NAEAC strongly recommends consensus, with revisions or changes to protocols being made until all members are satisfied (NAEAC Newsletter 8 November 2013). If decisions are made by majority vote, NAEAC is of the view that the code should specify that this majority must include at least two of the three statutory external members. 3.6 Conflict of interest AEC members are likely to err on the side of caution in declaring possible conflicts of interest and there could be situations where the AEC decides there is no need for the member concerned to withdraw. It is suggested that codes include direction as to how all conflicts of interest are declared, managed and recorded. NAEAC has a policy on conflict of interest at the following link: document-vault/ Ensuring effective input of external members Codes should describe mechanisms that ensure that all committee members have effective input into the working of the committee (as required by the Act). 3.8 Confidentiality Codes should describe how confidentiality will be managed. Commercially sensitive information may be included in applications to the AEC. Applications must contain sufficient information so the AEC can ensure that the review criteria set out in the Act is met. Guide to the Preparation of Codes of Ethical Conduct 13

16 3.9 Use of teleconferencing NAEAC has a guideline on the use of teleconferencing to assess protocols at the following link: NAEAC does not consider it appropriate to make some types of decisions by teleconference or and prefers to see some restrictions on the use of these. It considers teleconferences could be used for new applications so long as they are graded only A or B or for modifications to approved projects. NAEAC s preference is that teleconferencing should not be used routinely to assess protocols, and not at all for those protocols graded C, D or E Consideration between meetings and the use of subcommittees Refer to the NAEAC Policy on the formation and use of subcommittees by AECs at the following link: NAEAC states in this guideline that the use of subcommittees to give temporary consent should be restricted to instances where there is a legitimate requirement for urgency so this section should be amended to reflect that. NAEAC considers that the procedures for the appointment of subcommittees and/or fast-tracking applications are of sufficient importance to be included in the code itself. Any fast-tracking provisions or considerations between meetings must be included in the code Public presence at meetings If applicable, the code can describe whether meetings are open or closed to the public Applicant presence at meetings The code should describe whether the applicant may be present or not Secretarial support The code should describe how the AEC is supported with secretarial functions Record keeping and information management The code holder is required to make provision for collecting information and maintaining records relevant to its decisions, operations and functions under the Animal Welfare (Records and Statistics) Regulations Policies and procedures relating to the collection, storage (including duration), security and access to information and records should be clearly set out. These should include policies and procedures for grading the impact of animal manipulations including the possible regrading of estimated grades following the actual manipulations. The code should describe the scope of the information/records/documentation requiring management (e.g. project approvals, applications, policies, procedures, standard operating procedures, site visits, independent review reports, complaints log, convictions) and how they are managed and stored Reporting of statistics to MPI NAEAC has a guidance document Animal Use Statistics Guidance for Completing Statistical Returns (June 2013), detailing how to complete animal use statistics at the following link: 14 Guide to the Preparation of Codes of Ethical Conduct

17 The code must describe how animal use statistics are reported to MPI in accordance with the Act Process to amend the CEC There must be procedures in place to enable the AEC to recommend to the code holder that the CEC be amended (see section 11 Amendments, Suspension or Revocation of the CEC). 4. Consideration and approval of projects by the AEC The key principle underlying the application/approval process is that the benefits that are likely to be derived from using animals in research, testing and teaching must be considered by AECs to outweigh any foreseeable harm to those animals (section 80). Codes should therefore contain policies and procedures to ensure that relevant criteria, specified in the Act (section 100), are considered both by project applicants in writing applications, and by the AEC in evaluating applications. The (section 100) criteria relate to the proposed aims and methodology, and the animal welfare aspects of the work. This information forms the basis for assessing likely benefit: harm of the work. To meet other requirements of the Act relating to the approval process, codes should also contain policies and procedures to ensure that: the proposed work has not been conducted previously (section 100 (j)) unless: previous work was flawed; there is a need for statistical replication of an experiment; there is a need for repeated batch-testing of products; the work is part of a repeated teaching course; See Occasional Paper No 7 Avoiding duplication of research involving animals for further information at the following link: the AEC sets conditions of approval, and to vary or revoke such conditions (section 99(1)(c)). Such conditions may include matters such as: the time period for which approval is granted; reporting requirements of project applicants to the AEC; evaluation of reports by the AEC; other monitoring of the approved project to be undertaken by the AEC; See Occasional Paper No 5 Monitoring methods for animal ethics committees and Occasional Paper No 4 Compliance monitoring: The University of Auckland approach for further information at the following links: the AEC is empowered to renew project approvals (section 99(1)(f)) or to suspend or revoke approvals where necessary (section 99(1)(g)). In addition, it may be appropriate for codes to include a policy relating to the use of animals that may have special interest to Maori. In some circumstances, this may influence the approval of a project. NAEAC has a policy regarding which AEC should be assume the approval role, in cases where researchers and/or animals from more than one organisation are involved in a common research, teaching and testing application. This policy can be found at the following link: Guide to the Preparation of Codes of Ethical Conduct 15

18 4.1 Criteria for consideration The code should describe the criteria used in the consideration of applications to the AEC. 4.2 Outcomes of consideration The code should state how various outcomes of the consideration process are described and captured. 4.3 Maximum approval period The code should set the maximum approval periods for all types of AEC approvals. The code should specify that after expiry of an approval, if a project is to be continued a new application must be submitted for consideration and describe how this will be managed. 4.4 Power to suspend/revoke/vary approvals The code should state that the AEC has the power to set, vary or revoke conditions of project approval and to suspend, or revoke approvals if required. The code should specify grounds for how these decisions may be made and how the processes are managed. 4.5 Changes to approved applications The code should state how changes to approved applications are managed. NAEAC is of the view that any proposed modifications to approved projects must be communicated to and approved by the AEC. In the case of minor modifications this could be done by an AEC subcommittee with more significant modifications approved by the whole AEC. 4.6 Protection of members Section 104 of the Act states no member of an AEC is personally liable for any act done or omitted by the member or the committee in good faith in the course of the operations of the committee. The CEC should reflect this. 5. Responsibilities 5.1 Compliance The code holder must: ensure that any research involving the manipulation of any animal is carried out in accordance with this code; ensure that all research proposals are brought to the attention of the AEC for prior consideration, and what form these applications will take; comply with all Acts of Parliament, regulations or bylaws pertaining to the care and treatment of animals. 5.2 Appropriate qualifications The Act requires suitably qualified persons will be engaged in supervising and undertaking the research, testing, or teaching. The Act requires any research, testing or teaching involving the manipulation of an animal is carried out in accordance with a CEC. Persons conducting these activities must comply with 16 Guide to the Preparation of Codes of Ethical Conduct

19 all Acts of Parliament, regulations or bylaws pertaining to the care and treatment of animals. Particular attention should be given to sections 80 and 100 of the Act. 5.3 Transportation of Animals The code should require that animals are transported under humane and hygienic conditions at all times. The Transport within New Zealand code of welfare can be found at the following link: govt.nz/document-vault/ Housing of Animals The code should require that when animals are housed, their health is safeguarded and that undue stress is avoided. Sufficient space should be allocated and environmental needs should be consistent with the needs of the species concerned. Animals must receive free access to water and adequate feed to meet their nutritional requirements. 5.5 Sick or injured animals Sick and injured animals must receive appropriate veterinary care and/or be humanely killed. 5.6 Development of Standard Operating Procedures (SOPs) NAEAC considers that the AEC should have a role in reviewing and accepting SOPs relating to animal and facility management and manipulations. SOPs should exist for animal husbandry processes and routine procedures that relate to the manipulation of animals in research, testing and teaching. 5.7 Adverse event reporting NAEAC requires comprehensive policy on adverse event reporting and actions. This should cover when these events should be reported. The expectation is adverse events will be dealt with promptly and reported to the AEC as soon as practicable. Adverse events should be discussed at the next AEC meeting if the adverse event requires change to an approved manipulation this must be communicated to the AEC, along with a request for a modification approval, as soon as possible. If the AEC believes the adverse event was preventable, procedures may be developed to preclude the same or a similar event happening in future manipulations. Note it is NAEAC s view that adverse events occurring under approved protocols should be reported to the AEC at the time, not at the end of the study report. AEC members may feel that such an incident requires a change to the protocol or some other action to prevent another such incident (NAEAC Newsletter 8 November 2013). 5.8 Grading The code should specify how the AEC will consider impact grading of proposed and approved projects and how they will approve them. 5.9 Euthanasia for tissue collection/dissection NAEAC recommends AECs refer to the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. NAEAC has published its policy on Killing as a Manipulation at the following link: Guide to the Preparation of Codes of Ethical Conduct 17

20 6. Animal Facilities The code holder must specify policies and procedures relating to the animal management practices and facilities to be undertaken to ensure that owners or persons in charge of animals used in research, testing and teaching attend properly to the welfare of those animals. These should be in accordance with the NAEAC publication Good Practice Guide for the Use of Animals in Research, Testing and Teaching at the following link: NAEAC recommends investigators use an owner consent form when animals not owned by the organisation are used. If these animals are also to be housed by the owner during the project the owner should be provided with detailed management expectations, and should also sign and hold a copy of the AEC application. 6.1 Management of animal facilities NAEAC recommends that all facility visits are to be reported back to the AEC. NAEAC also recommends that code holders have emergency management protocols and procedures in place for their animal facilities, to manage any impacts on animal welfare caused by emergency events. NAEAC has provided guidance on emergency management at the following link: Development of SOPs NAEAC considers the AEC should have a role in reviewing and accepting animal facility SOPs, including protocols and procedures for emergency management. 6.3 Monitoring of animal facilities Monitoring of facilities should involve an inspection by the AEC or its nominee (this could be an animal welfare officer or, in the case of an external parented organisation someone independent of that organisation but located close by) at least annually. In addition, with regard to best practice, NAEAC considers that some reference should be made to the provisions of its Good Practice Guide for the Use of Animals in Research, Testing and Teaching. When the AEC veterinarian has an on-going oversight role in evaluating practices and facilities, NAEAC suggests that the frequency (or a minimum frequency) should be specified. NAEAC regards monitoring as an extremely important function of AECs. While members should be able to inspect whenever they wish, NAEAC is strongly of the view that a minimum programme of monitoring should be specified in the code and that biennial facility inspection is not sufficiently frequent. It should also be clear who carries out those inspections. 7. Monitoring of Projects 7.1 Powers of the AEC This will include policies and procedures for: monitoring approved protocols; requiring animal users to report back to the AEC; monitoring of adherence to specific operating procedures; monitoring of animal facilities, routine animal husbandry and animal welfare (including parented organisations). These policies should also cover external organisations using the AEC, where relevant. 18 Guide to the Preparation of Codes of Ethical Conduct

21 The AEC has the power to inspect animals, their accommodation, and related experimental records at any time to satisfy itself that approved procedures are being properly carried out. NAEAC has provided guidance to AECs on adequate monitoring at the following link: Frequency of monitoring of approved projects One of the monitoring mechanisms referred to, includes visits by AEC members and this is something in which AEC members are expected to be actively involved. NAEAC considers that codes should specify a minimum frequency of monitoring visits to be undertaken by the AEC. NAEAC recommends annual inspections of, say, 10% of approved projects. While noting that the AEC can undertake monitoring of projects at any time, a minimum number of monitoring activities should be specified. All monitoring visits should be documented and outcomes recorded in the minutes of the AEC meeting following the visit. 7.3 Monitoring of manipulations graded C-E NAEAC would recommend annual inspections of all projects graded C-E. 7.4 Monitoring by nominated veterinarians When the AEC or a nominated veterinarian has an on-going oversight role in evaluating practices and facilities, NAEAC suggest that the frequency (or a minimum frequency) should be specified. 7.5 End of approval reports The AEC must be informed of the outcome of all approved projects at the completion of the project. This information should be supplied before the first AEC meeting after completion of the project. If the AEC does not meet frequently then a deadline for end of approval reports should be specified. NAEAC considers that final reports to AECs are important but adverse events arising during a trial should be reported to the AEC at the time. 7.6 End of approval grading The AEC must be informed of the impact gradings of approved projects at the completion of the project. This information will enable the AEC to compare the actual gradings from the manipulations performed, against those proposed in the initial application. This information should be supplied before the first AEC meeting after completion of the project or at the deadline set by the AEC. It should be explicit that if the impact on an animal or animals is greater than the expected impact that was approved it should be reported to the AEC immediately. If the impact was lower than that approved, this should be identified, and an explanation included in reporting at the end of the project. 7.7 End of approval statistics The AEC must be informed of the animal use statistics at the completion of the project. This information should be supplied in a timely manner to ensure correct reporting of animal usage to MPI. NAEAC recommends all completed projects must have a statistics form provided showing the numbers of animals and observed impact gradings. Guide to the Preparation of Codes of Ethical Conduct 19

22 8 Arrangements for External Parties to Use the Code and AEC Organisations or individuals without their own CEC may make arrangements to use the code and AEC of an organisation which does have them. It is the code holder s decision as to whether external parties will be allowed to do this. If the code holder intends to allow use by external parties, the CEC must stipulate policies and procedures in respect of such arrangements should this occur. Policies should include the process and information required and differentiate between local and distant supervision. The code holder must be satisfied that the members of the AEC are suitably qualified to evaluate all projects submitted by a parented organisation. The code holder must further be satisfied that the personnel who will manipulate animals on behalf of that parented organisation are appropriately qualified, and the AEC must review and accept all SOPs that the parented organisation operates under. The code holder may wish to appoint a nominee of the parented organisation to the AEC. Note: It is the code holder s legal responsibility to notify MPI in writing of the arrangement before the external party begins any research, testing and teaching using animals. NAEAC recommends that those code holders that enter into parenting arrangements with external parties, have policies in place regarding how the monitoring requirements under the Act will be met. NAEAC recommends where code holders do not permit parenting arrangements, they state this in their code. In some cases, employees of an approved code holder may undertake RTT involving the manipulation of animals and facilities owned by another code holder. NAEAC has a policy statement on what AEC should assume the approval role, for projects where individuals from more than one organisation are involved in a research, testing or teaching project, at the following link: 9 Complaints Procedure The Act requires the code holder to ensure that any complaints from members of AECs are dealt with promptly and fairly either by the AEC or by the code holder. The CEC should identify policies and procedures for dealing with such complaints. The complaints procedure should also cover complaints from staff members or members of the public, as well as AEC members. There should also be procedures in place for complaints against the Chairperson. The code should also specify how complaints and the outcomes of the complaints process are recorded and archived by the code holder. 10 Amendments, Suspension or Revocation of the CEC There must be a procedure in place to enable the AEC to recommend to the code holder that the CEC be amended. NB Minor amendments must be notified to MPI. Any amendments to the code which are not minor must be approved by MPI. NAEAC advises there should be a provision in the code to enable the AEC to recommend to the code holder that the CEC be amended. (Obviously if the code is to be amended, the requirements of the Animal Welfare Act in terms of approval or notification, as the case may be, must still be met.) While minor amendments are notified to MPI, the Act requires MPI approval of amendments that are not minor. It is helpful to make this distinction. 20 Guide to the Preparation of Codes of Ethical Conduct

23 Appendix 3: CEC Template The CEC template is available as a Word document from the NAEAC secretariat by ing NAEAC@mpi.govt.nz or can be accessed from the MPI website at the following link: govt.nz/protection-and-response/animal-welfare/animals-in-research-testing-teaching/ Appendix 4: Animal Welfare Act 1999 sections 87 to 104 Codes of Ethical Conduct 87 Codes of ethical conduct Any person who (a) (b) Is engaged in, or wishes to be engaged in, research, testing, or teaching; and Wishes to use animals in that research, testing, or teaching, may apply to the Director-General for approval of a code of ethical conduct in relation to the use of animals. 88 Contents of code of ethical conduct (1) Each code of ethical conduct must contain provisions that set out, in relation to the carrying out of the research, testing, or teaching to which the code relates, the policies to be adopted and the procedures to be followed, (a) By the code holder; and (b) By an Animal Ethics Committee appointed by the code holder. (2) The policies and procedures must (a) Enable the Animal Ethics Committee to carry out its functions effectively; and (b) Enable persons who are members of the Animal Ethics Committee but who are not employed by the code holder to have an effective input into the working of the committee; and (c) Make provision for adequate monitoring of compliance with the conditions of project approvals to be carried out; and (d) Make provision for the code holder to collect the information and to maintain the records required by regulations made under this Act; and (e) Specify animal management practices and facilities that are such as to enable the purposes of this Part to be met adequately; and (f) Be such as to ensure that where any member of the Animal Ethics Committee makes a complaint, that complaint may be dealt with fairly and promptly by the Animal Ethics Committee or the code holder; and Guide to the Preparation of Codes of Ethical Conduct 21

24 (g) Include, if necessary, the policies and procedures referred to in section 84(1)(b). (3) The provisions of each code of ethical conduct must (a) Be consistent with this Act and with any standards or policies prescribed by regulations made under this Act; and (b) Be such as to enable any requirements specified in regulations made under this Act to be met. 89 Application for approval (1) Every application under section 87 must be in writing and must contain (a) Information on the general nature and extent of the research, testing, or teaching in which the applicant is engaged or proposes to be engaged; and (b) A statement of the period in respect of which the approval is sought; and (c) Particulars of any convictions against (i) This Act; or (ii) The Animals Protection Act 1960; or (iii) The Agricultural Compounds and Veterinary Medicines Act 1997; or (iv) The Biosecurity Act 1993; or (v) The Companies Act 1993; or (vi) The Crimes Act 1961; or (vii) The Dog Control Act 1996; or (viii) The Serious Fraud Office Act 1990; or (ix) The Trade in Endangered Species Act 1989; or (x) The Veterinarians Act 2005; or (xi) Any Act that was replaced by any of the Acts specified in subparagraphs (ii) to (x); or (xii) Any Act passed in substitution for any of the Acts specified in subparagraphs (iii) to (x). (2) Every application under section 87 must be accompanied by (a) The proposed code of ethical conduct to which the application relates; and (b) Evidence, in the form of independent references and appropriate academic qualifications, that the applicant, or the persons employed or engaged to do the work, have the capability, skills, and experience to carry out the type of research, testing, or teaching to which the application relates; and (c) Where the application relates to a second or subsequent period of research, testing, or teaching, a report (i) Made by an accredited reviewer; and (ii) Showing that the work carried out during the previous period of research, testing, or teaching was satisfactory in terms of section 106(1). (3) The Director-General must refer to the National Animal Ethics Advisory Committee for its comments every application made under section 87 and must consult with that Committee with regard to every such application. (4) Where a person, who is deemed, by section 192(b)(ii), to be a code holder for the purposes of section 105(3), makes an application under section 87, that application is deemed for the purposes of this section to be an application relating to a second or subsequent period of research, testing, or teaching. 90 Changes to proposed code The Director-General may, before deciding whether to approve, or to refuse to approve, a proposed code of ethical conduct, change the contents of the code if the National Animal Ethics Advisory Committee so recommends after consultation with the applicant. 22 Guide to the Preparation of Codes of Ethical Conduct