Ethical Conduct in Human Research and Related Activities Regulations

1. Title
   These are the Ethical Conduct in Human Research and Related Activities Regulations 2008.
2. Purpose
   Ethical issues arise when University research and/or related activities involve the interests and rights of others. The purpose of these regulations is to facilitate ethical conduct which respects the rights of people, communities, companies, trusts, and other organisations. These regulations explain the standards of ethical conduct and the procedures that apply for the maintenance and monitoring of these standards. All applications to the University’s human research ethics review committees will be reviewed for approval on the basis of their compliance with these regulations.
3. Date of effect
   These regulations are effective from 1 July 2008.
4. Scope
   1. These regulations apply to all
      1. staff of the University of Waikato
      2. students of the University of Waikato, and
      3. any other person authorised to undertake research and/or a related activity on behalf of the University of Waikato, including those employed or contracted in wholly-owned subsidiary entities.
   2. Research collaborators or partners are expected to apply for approval of their research and/or related activities from their organisation and must also apply to the relevant University of Waikato Divisional or Faculty of Māori and Indigenous Studies committee.
   3. Under these regulations, all research and/or related activities are required to have formal ethics review and approval.
   4. Applications for approval are not required for normal teaching activities; but are required for specific teaching that involves the participation of a student or students and has the potential for harm (see section 13 of these regulations), or that involves collection of data from students.
   5. Applications are not required for University teaching evaluations or for University reviews and quality assurance activities; however, such activities do have ethical implications and should be conducted in a professional way consistent with the University Staff Code of Conduct and should be consistent with the spirit of these regulations.
5. Definitions
   In these regulations

research means an inquiry of an investigative, experimental, or critical nature which is driven by a question, hypothesis, or intellectual position capable of rigorous assessment, and the findings of which are open to scrutiny and formal evaluation. It may include any intellectual or creative work published, exhibited, presented, or performed in a written, spoken, electronic, broadcasting, visual, performance, or other medium
related activities may include teaching, consulting, evaluation, and publication when these activities involve collecting data about and from people and organisations. These activities are defined as follows:
teaching means teaching in lectures, tutorials, demonstrations, and related educational research
consulting means the provision of advice to a client, such advice being based upon the pre-existing professional knowledge and skills of the consultant
evaluation means the systematic collection and analysis of information to make judgements, usually about the effectiveness, efficiency, and/or appropriateness of the research and/or related activity
publication means any intellectual or creative work published, exhibited, presented, or performed in a written, spoken, electronic, broadcasting, visual, performance, or other medium
participant means a live human being or group of live human beings who participate in research and/or related activities whether by observation, questioning, participation in an experiment, provision of specimens or human tissue samples, or by any other means
organisation means a social unit of people systematically arranged and managed to meet a need or to pursue collective goals on a continuing basis. Examples include firms, iwi groupings, schools, and professional societies
researcher means the person undertaking research and/or related activities
harm includes physical, psychological, social, economic, or cultural harm to participants
field research means research conducted in person in a natural setting outside of a laboratory.

6. Application procedures
   1. A staff member, student, or authorised person must not commence research or a related activity until it has been approved by the appropriate authority and in accordance with these regulations.
   2. Researchers must submit applications for approval for their research or related activity to one of the delegated relevant Divisional or Faculty of Māori and Indigenous Studies committees (see section 22 of and Appendix 2 to these regulations) within the University.
   3. Where applications are made to an external ethics committee, an application must also be submitted to, and approved by, the relevant delegated committee within the University (see section 22(3) of and Appendix 5 to these regulations).
   4. Applications for approval of research and/or related activities must be submitted in the form prescribed for the relevant Division or the Faculty of Māori and Indigenous Studies (see Appendix 3 to these regulations).
   5. If an ethical issue relating to the research and/or related activity that was not envisaged at the beginning arises during its course, the researcher must stop the research and/or related activity, consult the appropriate authority, and apply for approval. The researcher must not begin the research and/or related activity again until the necessary approval has been obtained.
   6. For situations where prior, free, express, and informed consent from participants may not be possible, see sections 10 and 11 of these regulations for guidance in making application for approval of the research or a related activity.
7. Responsibility for ethics in research and related activities
   1. Individual staff, students, and authorised persons are responsible for ensuring their research and/or related activities comply with these regulations.
   2. If a researcher is a student, the staff member responsible for supervising the student's research must take all reasonable steps to ensure that the student complies with these regulations.
   3. Paper convenors may apply for ethics approval for an entire paper if it involves students in that paper engaging in research or related activities. Such applications must cover all anticipated research or related activities the student may engage in, and the convenor’s, lecturers’ and/or tutors’ responsibilities. Applications must identify ethical issues and describe practices for addressing them.
8. Value of research or related activities and the public interest
   1. A researcher must be able to justify to their peers the goals and methodology of the research and/or related activity in terms of its reasonably anticipated benefits balanced against any foreseeable risk of harm to the participants.
   2. A researcher must normally make available the findings of research in the public domain. Any exception to this must be approved in writing by the Senior Deputy Vice-Chancellor, or by a person to whom authority is delegated in writing by the Senior Deputy Vice-Chancellor (see section 12 of the Dissertations and Theses Regulations 2020).
9. Informed consent of participants
   1. Researchers must gain participants’ prior, free, express, and informed consent in a culturally and socially appropriate manner, unless in the case of approved exceptions. For proxy consent from authorised representatives, see subsection (4)(e) and (4)(f) of this section of these regulations. Exceptions regarding large sample surveys and similar research methods, some cases of field research, and the possibility of gaining informed consent after data collection are dealt with in sections 10, 11 and 14 of these regulations.
   2. A researcher must establish explicit processes for reaching agreement with participants. A researcher must not involve a participant in any research and/or related activities unless the researcher is satisfied that the participant has understood the nature of their involvement and freely agreed to it in accordance with the principles outlined in this section.
   3. A researcher must not use explicit or implicit coercion to obtain the agreement, and must not use inducement to obtain the agreement except in accordance with section 18 of these regulations.
   4. Unless sections 10, 11 or 14 of these regulations apply, a researcher must adhere to the following principles with respect to informed consent of participants:
      1. A researcher must inform prospective participants of all information relevant to the decision to participate including
         1. their right to decline to participate in the research and/or related activities or any portion or any part of these
         2. the form in which the findings will be published
         3. duration and security of data storage
         4. their right to withdraw any information they have provided up until analysis has commenced on their data
         5. their right to access and correct personal information
         6. the process for withdrawing information they have provided.
      2. The more readily identifiable the participants may be, the more formal the consent should be. Where participants are asked to answer questionnaires that might identify them, answer questions in a formal interview, undergo formal tests, or where they are subjected to formal observation and recording procedures, the process for obtaining informed consent, and the form of the consent, should be similarly formal and recorded in writing or some other reproducible form. Where the participation is more anonymous the consent may be less personalised and less explicit (see section 10 of these regulations).
      3. If the research or related activity involves manipulation of, or intervention in, the physical or psychological state of a participant, the participant's consent, or, if subsection (e) of this section applies, the consent of the person with authorised responsibility for the participant, must be recorded in writing or some other reproducible form.
      4. Because some research and/or related activities involve collectives, a researcher must recognise the complexities of relationships between individuals and collectives. In some cultures it is common for the leader of a collective to make a decision in respect of participation on behalf of its members. If an individual in a collective wishes to participate or not to participate in the research and/or related activity, regardless of a decision taken on behalf of the collective, the individual's wishes must be respected and all reasonable care taken to ensure that those wishes are also respected by other members of the collective.
      5. If a prospective participant is reasonably judged incapable of giving informed consent, the researcher must obtain the proxy consent from the person who has responsibility for the prospective participant's welfare, taking particular care to protect the participant's interests and also taking into account any potential conflict of interest between them and the person whose consent is required.
      6. A researcher who seeks the proxy consent of another person on behalf of a prospective participant under subsection (e) of this section must make all reasonable effort to involve the prospective participant themselves in the process and the decision about consent.
      7. Staff, students, and other approved persons must obtain informed consent when recording images of participants, participants’ possessions, or research and/or related activity in which participants are involved, unless the recording of images is of lawful activity occurring in a public place and is culturally appropriate.
      8. A researcher must provide the information under subsection (a) of this section plainly and in the language and medium that is appropriate for the prospective participants.
      9. A researcher must inform participants of their right of access to any data that may have been collected from or about them.
      10. A researcher must inform participants of their right to complain about the conduct of the research and/or related activity and must also inform them of the process for making a complaint.
10. Large random sample surveys and informed consent
    1. A researcher who intends to collect data involving large numbers of people is not required to adhere to all the principles concerning informed consent outlined in section 9(4) of these regulations if the research method makes adherence to all these principles impractical or undesirable and if such a requirement is likely to impact adversely on the researcher's ability to generate reliable information.
    2. However, the researcher must declare and justify an intention not to adhere to the principles in section 9(4) of these regulations in the application for approval submitted under section 6 of these regulations.
    3. In these situations the researcher must provide the following information, as a minimum, to a participant before the research or related activity begins
       1. the anticipated length of the research or related activity
       2. the general purpose of the research or related activity
       3. the forms in which the data might be published
       4. an assurance that the participant will not be identified in any publication or dissemination of research findings.
11. Field research and informed consent
    1. ‘Field’ research in this context means research conducted in person in a natural setting outside of a laboratory.
    2. In field research situations, prior, free, express, and informed consent must be gained in a culturally and socially appropriate manner from participants.
    3. In some forms of field research using such methods as participant observation, participatory research and action research, where obtaining prior, free, express, and informed consent from all participants would be inappropriately intrusive or impractical for social, cultural, or methodological reasons, it is acceptable not to gain such consent.
    4. However, the researcher must take care to apply other ethical principles, especially minimising the risk of harm to participants and maintaining the anonymity of participants. It may also be appropriate in such cases that informed consent be sought afterwards but prior to the publication of research findings, from people who have in the course of information collection come to the attention of the researcher.
12. Archiving of data, privacy, storage, and use of information
    1. All non-identifying data (eg data sets and transcripts) used for publication must be securely kept long enough to allow for academic examination, challenge, or peer review. This period would normally be at least five years. Identifying data such as consent forms, photographs, and videos will be securely stored consistent with agreements made under section 9(4)(a) of these regulations. The responsibility for data storage lies with the department or other equivalent academic unit.
    2. Where the research and/or related activity is conducted in New Zealand, the researcher must comply with the Privacy Act 1993 and the Official Information Act 1982, and must adhere to the following principles consistent with that legislation
       1. participants and informants must not be publicly identified or identifiable without their explicit consent
       2. participants must be informed (unless sections 10, 11 and 14 of these regulations apply) that they will not be identified in any publication or dissemination of the research findings without their explicit consent
       3. researchers must take all reasonable precautions to prevent unauthorised use, access, modification, or disclosure of personal information
       4. data identifying participants must not be kept for longer than required for the purpose for which it is collected (see subsection (1) of this section)
       5. except in circumstances specified in the relevant legislation, personal information may be used only for the purpose for which it is collected.
    3. Where the research and/or related activity is conducted in a country other than New Zealand, the researcher must comply with any legislation that applies in that country with respect to privacy and storage of personal information.
    4. Even where the research and/or related activity is conducted in a country other than New Zealand, the researcher must comply as far as possible with the spirit of the Privacy Act 1993 and the Official Information Act 1982; however, if there are contradictions between the legislation of New Zealand and the other country, the legislation of the other country must prevail
    5. A researcher must include in an application submitted under section 4(3) of these regulations a statement about the conditions under which, and the period for which, any personal information collected for the research and/or related activity is to be stored.
    6. Data must not be made available to persons or for purposes that are not named on the application.
13. Minimisation of harm
    1. A researcher must make particular effort to identify physical, psychological, social, economic, or cultural harm to participants before seeking their consent to participation.
    2. A researcher must minimise both the risk of harm to a participant and the potential for negative consequences of the harm.
    3. 'Harm' in this context includes pain, stress, emotional distress, fatigue, embarrassment, and exploitation.
    4. Unless it would be impractical or undesirable to do so in the terms described in section 10 of these regulations, a researcher must consult participants to ascertain any risk of harm that they themselves may identify or concerns that they themselves may have.
    5. If, during the course of the research and/or related activity, it is apparent to the researcher that the risk of harm to the participant is greater than originally envisaged, the researcher must inform the participant and re-evaluate the research and/or related activity in terms of the principles outlined in this section.
14. Limitation of deception
    1. Deception of participants conflicts with the principle of informed consent, but in some research and/or related activities it may be necessary to withhold information about the purpose of the research and/or related activity or the procedures involved.
    2. Research and/or related activities involving deception of participants will be approved only if the researcher demonstrates in the application for ethics review that the deception is absolutely essential to the goals of the research and/or related activity.
    3. A researcher who undertakes research and/or related activities involving deception of a participant must ensure that the participant is provided with an explanation of the true purpose of the research and/or related activity and the reason for the deception as soon as practicable after the participation.
15. Social and cultural sensitivity
    1. A researcher must respect the cultural, social, and language preferences and sensitivities of the participant.
    2. Where the research and/or related activity potentially affects individuals or groups who are significantly different in culture from the researcher, the researcher must consult an appropriate person before the research and/or related activity begins about appropriate cultural procedures and approaches to the research and/or related activity and about informing the participant or community concerned of the research findings.
    3. An application for ethics review under these regulations must demonstrate how the researcher has responded to the advice received from the person consulted.
    4. Appropriate consultation and subsequent responses on matters of social and cultural sensitivity are the responsibility of the researcher.
16. Exploitation of relationships
    1. A researcher must not exploit the relationship between researcher and participant.
    2. A researcher must resist any initiative by a participant to exploit the relationship between researcher and participant.
    3. 'Exploitation' in this context means the seeking or obtaining of money, goods, services, favours, information or relationships that have no direct bearing on the stated research and/or related activity aims or data gathering.
    4. Where a researcher is a staff member and the prospective participant a student, the researcher must not exploit that relationship and must strive to ensure that the student is not disadvantaged through their participation or refusal to participate, academically, professionally, or otherwise.
17. Respect for property rights
    1. A researcher must ensure that procedures or publications associated with the research and/or related activity do not infringe legally determined property rights.
    2. A researcher must ensure that procedures or publications associated with the research and/or related activity do not infringe culturally determined property rights to the extent possible and reasonable in all circumstances.
    3. Property rights in this context may apply to land, goods, works of art and craft, images, and intangible materials such as spiritual treasures, music, information, and intellectual property (see Appendix 4 of these regulations).
    4. A researcher must identify and address any issues associated with property rights and ownership of data at the time they seek informed consent and monitor these issues throughout the research process.
18. Payment for participation
    A researcher must not pay participants for their participation, or arrange for participants to be paid, in money, goods, services, prizes, favours, or in any other form of remuneration or form of hospitality appropriate to the engagement, either directly or indirectly, unless the payment is approved by the appropriate approving authority (see section 22 of and Appendix 2 to these regulations).
19. Professional codes of ethics
    A researcher must ensure that their research or related activity complies with any professional code of ethical practice or standard relevant to the research and/or related activity.
20. University research and/or related activities in schools and early childhood services
    A researcher involved in research and/or related activities in schools or early childhood services must comply with the Guidelines for Observation and Research in Schools and Early Childhood Services (see Appendix 5 to these regulations).
21. Declaration of potential conflict of interest
    1. A researcher must, in an application submitted under section 4 of these regulations, declare any potential conflict of interest.
    2. 'Conflict of interest' occurs where a researcher or related party is, or is reasonably likely to
       1. obtain an unfair, inappropriate, or unethical professional, commercial, or personal advantage as a result of or in connection with the research and/or related activity
       2. be in a position in relation to the activity or the participants that could appear to affect the researcher’s impartiality in the research and/or related activity;
       3. obtain a direct or indirect pecuniary benefit or interest as a result of or in connection with the research or related activity.
    3. If the research and/or related activity is commissioned or sponsored, the researcher must ensure that the commission or the sponsorship
       1. is declared to the participants and in any published findings
22. Authority for ethical approval and monitoring
    1. Authority for administering these regulations rests with the University of Waikato Human Research Ethics Committee.
    2. The University of Waikato Human Research Ethics Committee makes recommendations to the Vice-Chancellor through the Academic Board for the promotion, review, and monitoring of ethical practice in University research and/or related activities and for monitoring compliance with these regulations.
    3. Each Division and the Faculty of Māori and Indigenous Studies has one or more committees with responsibility at the Divisional or Faculty of Māori and Indigenous level, delegated by the University of Waikato Human Research Ethics Committee, for
       1. the approval of research and/or related activities with human participants in the relevant Division or the Faculty of Māori and Indigenous Studies (health and disability research involving human participants must also be reviewed by the University of Waikato Human Research Ethics Committee).
       2. compliance with these regulations in the relevant Division or the Faculty of Māori and Indigenous Studies
       3. maintaining records of University research and/or related activity with human participants in the relevant Division or the Faculty of Māori and Indigenous Studies in the form required by the University of Waikato Human Research Ethics Committee
       4. reporting to the University of Waikato Human Research Ethics Committee in the form required by that Committee.
    4. The Pro Vice-Chancellor of the relevant Division or the Dean of Faculty of Māori and Indigenous Studies recommends to the University of Waikato Human Research Ethics Committee for approval the committee structure for the respective area, and the Terms of Reference, constitution, membership, and procedures of any committee involved consistent with these regulations (see Appendix 2 to these regulations).
    5. Responsibility for the following matters in any organisational unit outside a Division or the Faculty of Māori and Indigenous Studies is delegated by the University of Waikato Human Research Ethics Committee to the Director of that unit
       1. ensuring applications for approval of research and/or related activities with human participants in the unit are submitted to the University of Waikato Human Research Ethics Committee
       2. compliance with these regulations in the unit
       3. maintaining records of human research and/or related activities with human participants in the unit in the form required by the University of Waikato Human Research Ethics Committee
       4. reporting to the University of Waikato Human Research Ethics Committee in the form required by that Committee.
    6. A committee at the relevant Division or the Faculty of Māori and Indigenous Studies level, or a Director of a unit outside a Division or the Faculty of Māori and Indigenous Studies, may consult with the University of Waikato Human Research Ethics Committee at any time and may request that the University of Waikato Human Research Ethics Committee review any relevant matter, or review any decision taken under delegated authority.
23. Researcher appeals against decisions concerning applications for approval
    1. Having made an application under these regulations, a researcher may appeal to the University of Waikato Human Research Ethics Committee against any decision taken at the relevant Divisional or the Faculty of Māori and Indigenous Studies level.
    2. A researcher may appeal to the Academic Board against any decision by the University of Waikato Human Research Ethics Committee under these regulations.
    3. The Academic Board may determine its own procedures for hearing and deciding the appeal provided that they conform with the principles of natural justice, and may delegate authority to hear and decide an appeal on its behalf.
    4. The decision of the Academic Board (or delegated authority) on an appeal is final.
24. Addressing concerns and complaints
    1. A concern or complaint about the research and/or related activities to which these regulations apply may be referred to the University of Waikato Human Research Ethics Committee.
    2. If a concern or complaint arises, the University of Waikato Human Research Ethics Committee may require that the relevant research and/or related activity be discontinued until the issue is resolved.
    3. If the University of Waikato Human Research Ethics Committee considers that the issue is sufficiently serious, it may refer the matter to the Vice-Chancellor who may arrange for it to be dealt with as applicable
       1. under the Student Discipline Regulations 2020, as amended from time to time
       2. as a breach of the Staff Code of Conduct
       3. as the Vice-Chancellor thinks fit.
    4. If the University of Waikato Human Research Ethics Committee considers that the issue is not sufficiently serious to be referred to the Vice-Chancellor, it may take informal action, at its discretion, to deal with the complaint or dispute.
25. Appeal provision
    1. A person may appeal to the Academic Board against any matters dealt with under section 23 or section 24 of these regulations by the University of Waikato Human Research Ethics Committee under these regulations.
    2. The Academic Board determines its own procedures for hearing and deciding the appeal conforming with the principles of natural justice, and delegates authority to hear and decide an appeal on its behalf.
    3. The decision of the Academic Board (or delegated authority) on an appeal is final.

Appendix 1

Guidelines for Professional Practice and Community Contact in the Conduct of University Research or Related Activities

Appendix 2

Delegated Ethics Committees

Appendix 3

Application Format

Appendix 4

Intellectual Property in Research

Appendix 5

Guidelines for Observation and Research in Schools and Early Childhood Services (under review)

Appendix 6

Referring Human Ethics Applications to a Health and Disability Ethics Committee (under review)