| 1. |
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Title
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These are the Human Research Ethics
Regulations 2005. |
| 2. |
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Purpose
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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. |
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Date of effect
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These regulations are effective from
8 March 2005. |
| 4. |
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Definitions
|
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In these regulations |
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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 |
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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) |
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researcher means
the person conducting the research. |
| 5. |
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Application
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These regulations apply to |
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(a) |
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staff of the University of
Waikato, |
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(b) |
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students of the University of Waikato,
and |
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(c) |
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any other person authorised to undertake
research in association with the University of Waikato. |
| 6. |
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Responsibility for ethics
in human research
|
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(1) |
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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. |
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(2) |
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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. |
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Value of research and public
interest
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(1) |
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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. |
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(2) |
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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 or
by a person to whom authority is delegated in writing by the Deputy
Vice-Chancellor, and notified to the chairperson of the Human Research
Ethics Committee. |
| 8. |
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Informed consent of participants
|
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(1) |
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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. |
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(2) |
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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. |
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(3) |
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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. |
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(4) |
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Unless section 9 of these regulations
applies, a researcher must adhere to the following principles with
respect to informed consent of participants: |
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(a) |
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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. |
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(b) |
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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. |
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(c) |
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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. |
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(d) |
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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. |
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(e) |
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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. |
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(f) |
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A researcher must inform prospective
participants of their right to |
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(i) |
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decline to participate in the
research |
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(ii) |
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decline to answer particular questions
or engage in particular activities |
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(iii) |
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withdraw completely from the research
at any time |
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(iv) |
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withdraw any information they have provided
at any time before completion of data collection. |
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(g) |
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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. |
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(h) |
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Where the research methods and consent
process are to be formal, the researcher must, before inviting prospective
participants to participate |
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(i) |
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make them aware of the nature
of the research |
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(ii) |
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make them aware of the form in which
the findings will be published |
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(iii) |
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provide them with all information relevant
to the decision to participate. |
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(i) |
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A researcher must provide
the information under subsection (h) plainly and in the language
that is appropriate for the prospective participants. |
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(j) |
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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). |
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(k) |
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A researcher must inform participants
of their right of access to any data that may have been collected
from or about them. |
| 9. |
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Large random sample surveys
and similar research instruments
|
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(1) |
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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. |
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(2) |
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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: |
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(a) |
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the anticipated length of
the interview |
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(b) |
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the general purpose of the research |
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(c) |
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an assurance that the participant
will not be identified in any publication or dissemination of research
findings. |
| 10. |
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Archiving of data and privacy
and storage of personal information
|
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(1) |
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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. |
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(2) |
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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: |
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(a) |
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Participants and informants
must not be publicly identified or identifiable without their explicit
consent |
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(b) |
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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 |
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(c) |
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Researchers must take all reasonable
precautions to prevent unauthorised use, access, modification or
disclosure of personal information |
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(d) |
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Data identifying participants must
not be kept for longer than required for the purpose for which it
is collected (see subsection (1)) |
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(e) |
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Except in circumstances specified
in the relevant legislation, personal information may be used only
for the purpose for which it is collected. |
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(3) |
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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. |
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(4) |
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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. |
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(5) |
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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. |
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Minimisation of risk
|
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(1) |
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A researcher must make particular
effort to identify physical, psychological, social or cultural risk
to participants before seeking their consent to participation in
research. |
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(2) |
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A researcher must minimise both the
risk to a participant and the potential for negative consequences
of the risk. |
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(3) |
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‘Risk’ in this context includes pain,
stress, emotional distress, fatigue, embarrassment, cultural dissonance
and exploitation. |
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(4) |
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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. |
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(5) |
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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. |
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Limitation of deception
|
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(1) |
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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. |
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(2) |
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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. |
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(3) |
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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. |
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Social and cultural sensitivity
|
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(1) |
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A researcher must respect
the cultural, social and language preferences and sensitivities
of the participant. |
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(2) |
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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. |
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Exploitation of relationships
|
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(1) |
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A researcher must not exploit
the relationship between researcher and participant. |
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(2) |
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A researcher must prevent or terminate
any initiative by a participant to exploit the relationship between
researcher and participant. |
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(3) |
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‘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. |
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(4) |
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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. |
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Respect for property rights
|
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(1) |
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A researcher must ensure
that procedures or publications associated with the research do
not infringe legally or culturally determined property rights. |
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(2) |
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Property rights in this context may
apply to land, goods, works of art and craft, spiritual treasures,
information and intellectual property. |
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(3) |
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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. |
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Payment for participation
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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. |
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Professional codes of ethics
|
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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. |
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Observation and research in schools
and early childhood centres
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(1) |
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A researcher involved in
observation and research in a school or early childhood centre must
comply with the guidelines in Appendix 11. |
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(2) |
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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. |
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Declaration of conflict of
interest
|
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(1) |
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A researcher must, in an
application submitted under section 21 of these regulations, declare
any conflict of interest. |
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(2) |
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‘Conflict of interest’ in this context
means |
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(a) |
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unfair professional, commercial
or personal advantage |
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(b) |
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position in relation to the research
or the participants that could appear to affect the researcher’s
impartiality in the research |
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(c) |
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direct or indirect pecuniary interest. |
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(3) |
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If research is commissioned
or sponsored, the researcher must ensure that the commission or
the sponsorship |
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(a) |
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is declared to the participants
and in any published findings |
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(b) |
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does not compromise the standard or
ethics of the research. |
| 20. |
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Authority for approval and
monitoring of human research
|
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(1) |
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Any human research requires
approval. |
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(2) |
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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. |
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(3) |
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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 |
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(a) |
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the approval of human research
activities in the School, Faculty or department |
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(b) |
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compliance with these regulations
in the School, Faculty or department |
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(c) |
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maintaining records of human research
activities in the School, Faculty or department in the form required
by the Human Research Committee |
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(d) |
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reporting to the Human Research Ethics
Committee in the form required by that Committee. |
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(4) |
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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. |
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(5) |
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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: |
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(a) |
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the approval of human research
activities in the unit |
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(b) |
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compliance with these regulations
in the unit |
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(c) |
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maintaining records of human research
activities in the unit in the form required by the Human Research
Committee |
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(d) |
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reporting to the Human Research Ethics
Committee in the form required by that Committee. |
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(6) |
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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. |
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(7) |
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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. |
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Application procedures for
human research
|
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(1) |
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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. |
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(2) |
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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. |
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(3) |
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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. |
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Appeals against decisions
concerning applications |
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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. |
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Complaints and breaches
|
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(1) |
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A dispute or complaint about
a human research project that has ethical implications may be referred
to the Human Research Ethics Committee. |
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(2) |
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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) |
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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. |
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(4) |
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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) |
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if it concerns a student,
as misconduct under the Student Discipline Regulations 2006 |
| |
(b) |
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if it concerns a staff member, as
a breach of the Staff Code of Conduct |
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(c) |
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if it concerns a person other than
a student or staff member, as the Vice-Chancellor thinks fit. |
| 24. |
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Appeal provision
|
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(1) |
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A person may appeal to the
Academic Board against any decision by the Human Research Ethics
Committee under these regulations. |
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(2) |
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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. |
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(3) |
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The decision of the Academic Board
(or delegated authority) on an appeal is final. |
Note:
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1.
|
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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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