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Human Research Ethics Regulations



Preamble
Any member of the University community who undertakes research is expected to conduct the research in a manner that conforms with ethical standards set down by the University, by relevant professional bodies nationally and internationally, and in many cases by the law of the country in which the research is undertaken.
These regulations apply to all human research undertaken in the name of the University of Waikato. Students are referred also to the University’s Student Discipline Regulations 2004. Staff are referred also to the University’s Staff Code of Conduct and Code of Ethics for Academic Staff.

Human Research Ethics Regulations

1.   Title
  These are the Human Research Ethics Regulations 2005.
2.   Purpose
  The purpose of these regulations is to explain the standards of ethical conduct required in University research involving human participants, and the procedures that apply for the maintenance and monitoring of those standards.
3.   Date of effect
  These regulations are effective from 8 March 2005.
4.   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 includes any intellectual or creative work published, exhibited, presented or performed in a written, spoken, electronic, broadcasting, visual, performance or other medium
  research refers specifically to human research, which means an activity in which a live human being or a group of live human beings participates in the research, whether by observation, questioning, participation in an experiment, or by other means; it includes teaching that involves the participation of a human being or group of human beings for the demonstration of procedures or phenomena; (ethical aspects of research using live animals is covered by the University’s Code of Ethical Conduct for the Use of Animals for Teaching and Research)
  researcher means the person conducting the research.
5.   Application
  These regulations apply to
  (a)   staff of the University of Waikato,
  (b)   students of the University of Waikato, and
  (c)   any other person authorised to undertake research in association with the University of Waikato.
6.   Responsibility for ethics in human research
  (1)   A researcher is responsible for identifying a research project as human research and, if it is identified as human research, for ensuring that it complies 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.
7.   Value of research and public interest
  (1)   A researcher must be able to justify to his or her peers the goals and methodology of the research in terms of its reasonably anticipated benefits balanced against any foreseeable risk to the participants.
  (2)   A researcher must not refuse to make available the findings of the research in the public domain unless this has been agreed in writing by the Deputy Vice-Chancellor (Research) or by a person to whom authority is delegated in writing by the Deputy Vice-Chancellor (Research), and notified to the chairperson of the Human Research Ethics Committee.
8.   Informed consent of participants
  (1)   A researcher must not involve a person in research unless the person has understood the nature of his or her involvement and freely agreed to it in accordance with the principles outlined in this section.
  (2)   A researcher must not use coercion to obtain the agreement, and must not use inducement to obtain the agreement except in accordance with section 16 of these regulations.
  (3)   A researcher must be able to justify the research on the basis of an explicitly formulated principle of trust between the researcher and the participant that is capable of peer review by a relevant professional body.
  (4)   Unless section 9 of these regulations applies, a researcher must adhere to the following principles with respect to informed consent of participants:
  (a)   A researcher must inform participants of their right to complain if they feel that their trust has been abused, and must also inform them of the process for making a complaint.
  (b)   If the research involves manipulation of, or intervention in, the physical or psychological state of a participant, the participant’s consent, or, if subsection (d) applies, the consent of the person with legal responsibility for the participant, must be recorded in writing or on tape.
  (c)   Because much social science research involves 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, in spite 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.
  (d)   If a prospective participant is, because of age or infirmity, judged incapable of giving informed consent, the researcher must obtain the consent from the person who has legal 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 him or her and the person whose consent is required.
  (e)   A researcher who seeks the consent of another person on behalf of a prospective participant under subsection (d) must make all reasonable effort to involve the prospective participant him or herself in the process and the decision about consent.
  (f)   A researcher must inform prospective participants of their right to
  (i)   decline to participate in the research
  (ii)   decline to answer particular questions or engage in particular activities
  (iii)   withdraw completely from the research at any time
  (iv)   withdraw any information they have provided at any time before completion of data collection.
  (g)   Where research participants are asked to answer questionnaires that might identify them, answer questions in a formal interview, or 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 on tape.
  (h)   Where the research methods and consent process are to be formal, the researcher must, before inviting prospective participants to participate
  (i)   make them aware of the nature of the research
  (ii)   make them aware of the form in which the findings will be published
  (iii)   provide them with all information relevant to the decision to participate.
  (i)   A researcher must provide the information under subsection (h) plainly and in the language that is appropriate for the prospective participants.
  (j)   Where less formal research methods are involved or where the participation is more collective or anonymous, informed consent may be less personalised and less explicit (see section 9 of these regulations).
  (k)   A researcher must inform participants of their right of access to any data that may have been collected from or about them.
9.   Large random sample surveys and similar research instruments
  (1)   A researcher who intends to conduct structured interviews involving large numbers of people sampled randomly and anonymously is not required to adhere to all the principles concerning informed consent outlined in section 8(4) of these regulations if the research instrument 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 maximise the response rate in order to generate reliable information.
  (2)   However, the researcher must declare and justify an intention not to adhere to the principles in section 8(4) of these regulations in the application for approval submitted under section 21 of these regulations, and must provide the following information, as a minimum, to a participant before the interview:
  (a)   the anticipated length of the interview
  (b)   the general purpose of the research
  (c)   an assurance that the participant will not be identified in any publication or dissemination of research findings.
10.   Archiving of data and privacy and storage of personal information
  (1)   All data used for published research must be archived indefinitely and made available for secondary analysis, unless an intention to do otherwise is declared and justified in the application for approval submitted under section 21 of these regulations.
  (2)   Where the research 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:
  (a)   Participants and informants must not be publicly identified or identifiable without their explicit consent
  (b)   Participants must be informed (unless section 9 of these regulations applies) that they will not be identified in any publication or dissemination of the research findings without their explicit consent
  (c)   Researchers must take all reasonable precautions to prevent unauthorised use, access, modification or disclosure of personal information
  (d)   Data identifying participants must not be kept for longer than required for the purpose for which it is collected (see subsection (1))
  (e)   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 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 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 21 of these regulations a statement about the conditions under which, and the period for which, any personal information collected for the research is to be stored.
11.   Minimisation of risk
  (1)   A researcher must make particular effort to identify physical, psychological, social or cultural risk to participants before seeking their consent to participation in research.
  (2)   A researcher must minimise both the risk to a participant and the potential for negative consequences of the risk.
  (3)   ‘Risk’ in this context includes pain, stress, emotional distress, fatigue, embarrassment, cultural dissonance and exploitation.
  (4)   Unless it would be impractical or undesirable to do so in the terms described in section 9 of these regulations, a researcher must consult participants to ascertain any risk that they themselves may identify or concerns that they themselves may have.
  (5)   If, during the course of the research, it is apparent to the researcher that the risk to the participant is greater than originally envisaged, the researcher must inform the participant and re-evaluate the research in terms of the principles outlined in this section.
12.   Limitation of deception
  (1)   Deception of participants conflicts with the principle of informed consent, but in some areas of research it may be necessary to withhold information about the purpose of the research or the procedures involved.
  (2)   Research involving deception of participants will be approved only if the researcher demonstrates, through the approval procedures explained in section 21 of these regulations, that the deception is absolutely essential to the goals of the research.
  (3)   A researcher who undertakes research involving deception of a participant must ensure that the participant is provided with an explanation of the true purpose of the research and the reason for the deception as soon as practicable after the participation.
13.   Social and cultural sensitivity
  (1)   A researcher must respect the cultural, social and language preferences and sensitivities of the participant.
  (2)   Where the research is aimed at individuals or groups who are significantly different in culture from the researcher, the researcher must consult a qualified person before the research begins about appropriate procedures and approaches to the research, and about informing the participant or community concerned of the research findings.
14.   Exploitation of relationships
  (1)   A researcher must not exploit the relationship between researcher and participant.
  (2)   A researcher must prevent or terminate 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 aims or data gathering.
  (4)   Where a researcher is a staff member and the prospective participant a student, the researcher must ensure that the student is not disadvantaged through his or her participation or refusal to participate, academically, professionally or otherwise.
15.   Respect for property rights
  (1)   A researcher must ensure that procedures or publications associated with the research do not infringe legally or culturally determined property rights.
  (2)   Property rights in this context may apply to land, goods, works of art and craft, spiritual treasures, information and intellectual property.
  (3)   A researcher must identify and address any issues associated with property rights and ownership of data at the time he or she seeks informed consent.
16.   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, either directly or indirectly, unless the payment is approved by the appropriate approving authority under section 21 of these regulations.
17.   Professional codes of ethics
  A researcher must ensure that the research complies with any ethical or scientific code or standard established by any professional organisation relevant to the research.
18.   Observation and research in schools and early childhood centres
  (1)   A researcher involved in observation and research in a school or early childhood centre must comply with the guidelines in Appendix 11.
  (2)   The Human Research Ethics Committee may amend the guidelines in Appendix 1 on the recommendation of the Board of Studies of the School of Education.
19.   Declaration of conflict of interest
  (1)   A researcher must, in an application submitted under section 21 of these regulations, declare any conflict of interest.
  (2)   ‘Conflict of interest’ in this context means
  (a)   unfair professional, commercial or personal advantage
  (b)   position in relation to the research or the participants that could appear to affect the researcher’s impartiality in the research
  (c)   direct or indirect pecuniary interest.
  (3)   If research is commissioned or sponsored, the researcher must ensure that the commission or the sponsorship
  (a)   is declared to the participants and in any published findings
  (b)   does not compromise the standard or ethics of the research.
20.   Authority for approval and monitoring of human research
  (1)   Any human research requires approval.
  (2)   The Human Research Ethics Committee is responsible to the Academic Board for the promotion, review and monitoring of ethical practice in human research, and for monitoring compliance with these regulations.
  (3)   Each School of Studies and Faculty has one or more committees with responsibility at the School, Faculty or departmental level, delegated by the Human Research Ethics Committee, for
  (a)   the approval of human research activities in the School, Faculty or department
  (b)   compliance with these regulations in the School, Faculty or department
  (c)   maintaining records of human research activities in the School, Faculty or department in the form required by the Human Research Committee
  (d)   reporting to the Human Research Ethics Committee in the form required by that Committee.
  (4)   The Dean of each School or Faculty recommends to the Human Research Ethics Committee for approval the committee structure for the respective School or Faculty under subsection (3), and the constitution, membership and procedures of any committee involved.
  (5)   Responsibility for the following matters in any organisational unit outside a School or Faculty is delegated by the Human Research Ethics Committee to the Director of that unit:
  (a)   the approval of human research activities in the unit
  (b)   compliance with these regulations in the unit
  (c)   maintaining records of human research activities in the unit in the form required by the Human Research Committee
  (d)   reporting to the Human Research Ethics Committee in the form required by that Committee.
  (6)   A Director who delegates any of the responsibilities listed in subsection (5) may determine the terms of the delegation, but retains overall responsibility and accountability to the Human Research Ethics Committee.
  (7)   A committee at the departmental, School or Faculty level, or a Director of a unit outside a School or Faculty, may consult with the Human Research Ethics Committee at any time and may request that the Human Research Ethics Committee review any relevant matter, or review any decision taken under delegated authority.
21.   Application procedures for human research
  (1)   A researcher must not commence a human research project until it has been approved by the appropriate authority (section 20 of these regulations) and in accordance with these regulations.
  (2)   If an ethical issue relating to human research that was not envisaged when the research was originally begun arises during the course of a research project, the researcher must stop the research and apply to the appropriate authority for approval; the researcher must not begin the research again until the necessary approval has been obtained.
  (3)   Applications for approval of human research must be submitted in the form prescribed for the relevant School, Faculty, department or unit; a format suggested by the Human Research Ethics Committee for this purpose is attached as Appendix 2.1
22.   Appeals against decisions concerning applications
  A researcher may appeal to the Human Research Ethics Committee against any decision concerning an application for human research at the departmental, School, Faculty or unit level.
23.   Complaints and breaches
  (1)   A dispute or complaint about a human research project that has ethical implications may be referred to the Human Research Ethics Committee.
  (2)   If a complaint or dispute arises, the Human Research Ethics Committee may require that the relevant activity be discontinued until the complaint or dispute is resolved.
  (3)   If, in its judgement, formal disciplinary action is not required, the Human Research Ethics Committee may take informal action, at its discretion, to deal with the complaint or dispute.
  (4)   If the Human Research Ethics Committee considers that the complaint or dispute is sufficiently serious, it may refer the matter to the Vice-Chancellor who may arrange for it to be dealt with
  (a)   if it concerns a student, as misconduct under the Student Discipline Regulations 2004
  (b)   if it concerns a staff member, as a breach of the Staff Code of Conduct
  (c)   if it concerns a person other than a student or staff member, as the Vice-Chancellor thinks fit.
24.   Appeal provision
  (1)   A person may appeal to the Academic Board against any decision by the Human Research Ethics Committee under these regulations.
  (2)   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.
  (3)   The decision of the Academic Board (or delegated authority) on an appeal is final.

Note:
1.   Appendices 1 and 2 of these regulations are printed in the Handbook on Ethical Conduct in Research. Copies of the appendices can also be obtained on request from Deans’ offices, the Research Office, and members of the Human Research Ethics Committee.

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