List of Ethical Principles (2)
Informed and Voluntary Consent (2.1)
Respect for Rights of Privacy and Confidentiality (2.2)
Minimisation of Risk (2.3)
Limitation of Deception (2.4)
Social and Cultural Sensitivity including commitment to the principles of the Treaty of Waitangi (2.5)
Research Adequacy (2.6)
Avoidance of Conflict of Interest (2.7)
Respect for Vulnerability of Some Participants (2.8)
Respect for Property (2.9)
Terms of Reference for AUTEC (3)
Further AUTEC Membership Guidelines (4)
Committee Decision Making Processes (5)
Exceptions to Activities requiring AUTEC approval (6)
Compensation for Researchers and Participants (7)
Approval of Class Research Projects (8.2)
Approval of Health Research (8.3)
Reporting and Monitoring Requirements for Researchers (9)
General Approval Provisions (10)
Responsibilities of Researchers and Teachers (11)
Guidelines for Research with Children as Participants (12)
Principles Relating to the Treatment of Human Remains (13)
Translation of Research Instruments (14)
Legal Opinion (16)
Final Storage of Data and Consent Forms (18)
Appendix A: Glossary
Appendix B: AUTEC Application and Approval Procedures
Appendix C: Form EA1 Application for Ethics Approval
Appendix D: The Information Sheet: A Guide
Appendix E: Consent and Assent Form Exemplars
Appendix F: Confidentiality Agreement Exemplars
Appendix G: Form EA: Progress Report
Appendix H: Form EA3 Completion Report
Appendix I: Information Privacy Principles
Appendix K: Form EA5 Notification to AUTEC of External Approval
Appendix L: Form EA6 Application for Ethics Approval of Class Research Projects
Appendix M: Form EA7 Annual Ethical Report on Class Research Projects
Appendix N: Guidelines for Health Research with Children
Appendix O: The Code of Health and Disability Services Consumers' Rights - A Summary
Appendix P: Guidelines for Researchers on Health Research involving Maori
Appendix Q: Referral of Research Studies to a Health and Disability Ethics Committee
Appendix R: Policy on Access by External Researchers
Appendix S: Action Research Project Procedures
Appendix T: Reconsideration, Appeals and Complaints Procedures
Appendix U: Intellectual Property Rights Policy
Appendix X: Form EA9 Application for Access by External Researcher
1.1. Research and teaching are integral to the mission of the University. In pursuit of these aims Auckland University of Technology Ethics Committee (AUTEC) recognises the need for studies in which human participants may serve as research or teaching subjects. The role of AUTEC is to promote excellence in research and teaching, while upholding the University’s responsibility to ensure that the privacy, safety, health, social sensitivities and welfare of human participants are adequately protected.
1.2. AUTEC recognises that individual researchers and teachers, working in and familiar with their own disciplines, are generally in the best position to assess their proposed activity. Nevertheless, to ensure consistency and impartiality in considering the interests of potential participants, as well as to provide a degree of protection for the researcher or teacher, it is important that certain categories of research and teaching activities be approved in accordance with these Guidelines before the research or teaching is undertaken. Approval by an accredited ethics Committee (as is AUTEC) is also a requirement for many funding agencies and for publication.
1.3. It is the policy of the University that all staff or student research and teaching sessions involving human subjects (with the exception of special cases mentioned under Section 6) must receive approval from AUTEC prior to commencement.
1.4. Whether they are teachers or students, all members of the University whose teaching or research involves human participants or human tissue or otherwise affects people’s privacy, rights and freedoms, are required to consider whether their work requires ethical approval in accordance with these Guidelines. If researchers or teachers are in any doubt about the need for ethical approval they should discuss the matter with a member of AUTEC.
1.5. It is the policy of the University that staff or student teaching or research involving animals must receive ethical approval from The University of Auckland Animal Ethics Committee prior to commencement of the research.
Note: The University of Auckland Animal Ethics Committee can be contacted by email at email@example.com
The Ethics Committee will be guided by the following key principles in considering applications for ethical approval:
OTHER RELEVANT PRINCIPLES:
2.1. Informed and Voluntary Consent
2.1.1. Participation of a human subject in any research project or teaching session must be voluntary and based on understanding of adequate or appropriate information about what such participation will involve. Information provided should be in simple, clear language appropriate to the potential participants.
2.1.2. All prospective participants must know:
2.1.3. In general, this information will be provided in written form through the Information Sheet (Refer to Appendix D1 for the exemplar) and the Consent Form which will need to be signed by each participant (Refer to Appendix E for the exemplar). These forms should be adapted appropriately to the particular research.
2.1.4. Points for applicants to consider:
2.2. Respect for Rights of Privacy and Confidentiality
2.2.1. Privacy and confidentiality must be respected. The identity of participants is to be protected at all stages of a project unless prior consent has been obtained from each participant. The confidentiality of information obtained incidentally during research must also be respected except where disclosure is necessary to avoid grave harm.
2.2.2. The distinction between anonymity and confidentiality must be appreciated (Refer to Appendix A). It may not be possible to guarantee anonymity in all situations and this should be acknowledged by researchers.
2.2.3. Researchers should remain aware of the possibility of inadvertent disclosure of identities, for example when reflecting on their research experiences in focus group discussions.
2.2.4. Researchers are responsible for keeping information (including the identity of participants) confidential and secure from interception or appropriation by unauthorised persons, or for purposes other than the approved research. This will often require coding of data and removal of identifying material from documentation. Anonymity is not always assured when this is done.
2.2.5. Researchers and supervisors are responsible for the safekeeping and confidentiality of signed consent forms. These must be stored separately from the data.
2.2.6. Teaching or research participation by a health consumer requires compliance with the Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996 (Refer to Appendix O).
2.2.7. The Privacy Act (1993) must be complied with. Participants have a right to access all personal information held by researchers. Information must be used only for the purpose for which it was gathered (Refer to Appendix I).
2.2.8. Where the health information of participants is being gathered, applicants must consult the Health Information Privacy Code.
2.3. Minimisation of Risk
2.3.1. It is not acceptable to expose participants to unacceptable levels of risk or harm. Risks may be physical, psychological or social and may include such things as pain, stress, emotional distress, fatigue, embarrassment, cultural dissonance and exploitation.
2.3.2. Researchers should make every attempt to identify, disclose and minimise any risks which may be involved for individuals or groups in a research project. It should be acknowledged that risk cannot be completely eliminated in many fields of investigation. Considerations of public good may justify an element of risk under certain circumstances, provided participants are aware of the risks. It may be helpful to consult potential participants to see what concerns or risks they are worried about. Unavoidable risks, including inconvenience and discomfort, must be balanced against possible benefit to participants or the community and the benefits for the public good in judging the ethical acceptability of research.
2.3.3. Elements of psychological risk are greatest in research which involves dealing with persons who are undergoing or have undergone trauma. In such cases, AUTEC will only give approval where the researcher or a nominated person is a professional person with suitable training and experience or where appropriate supervision and safeguards are provided for. Adequate information on that training and experience must be provided to AUTEC as part of the application.
2.3.4. Research or teaching involving risks to participants must be supervised by appropriately qualified persons.
2.4. Limitation of Deception
2.4.1. Deception of participants in research may involve deception, concealment or covert observation. Deception of participants conflicts with the principle of informed consent, but in some areas of research it may sometimes be justified to withhold information about the purposes and procedures of the research. Researchers must make clear the precise nature and extent of any deception and why it is thought necessary. Emphasis on the need for consent does not mean that covert research can never be approved. Any departure from the standard of properly informed consent must be acceptable when measured against possible benefit to the participants and the importance of the knowledge to be gained as a result of the project or teaching session. This must be addressed in all applications.
2.4.2. The threshold of justification is in general higher for research involving concealment or deception of participants than for research involving covert observation only.
2.4.3. The following matters will be taken into account by AUTEC when considering research involving covert elements:
184.108.40.206. Whether there are suitable alternatives involving less or no deception, concealment or covert observation, by which the aims of the research can be achieved;
220.127.116.11. Whether the precise nature and extent of the deception, concealment or covert observation have been defined;
18.104.22.168. Normally, only adults with independent capacity should be included as participants in research involving deception. A special case must be made to justify inclusion of other participants;
22.214.171.124. Whether the intrinsic harm of the deception, concealment or covert observation, combined with any risk of eroding community trust in research and with any other risks of harm to participants, is outweighed by the benefits likely to result from the research;
126.96.36.199. In general, in research involving deception, concealment or covert observation, adequate and prompt disclosure must be made and ‘debriefing’, including a sufficient explanation of the approach followed, provided to each participant as soon as practicable after the participant’s involvement is completed. The more significant the deception or concealment, the more thorough the ‘debriefing’ should be;
188.8.131.52. Where minimal covert observation only is involved, a researcher may submit that subsequent disclosure is not ethically required;
184.108.40.206. Where observation is conducted in a public place, the information available to the researcher is presumed to be in the public domain., although ethical limitations may apply to the use of such data.
2.5. SOCIAL AND CULTURAL SENSITIVITY INCLUDING COMMITMENT TO THE PRINCIPLES OF THE TREATY OF WAITANGI: Appropriate research practices for diverse social and cultural groups.
2.5.1. In any research, particular consideration must be given to the principles of the Treaty of Waitangi in planning for appropriate consultation and research processes.
220.127.116.11. The three key principles of partnership, participation and protection apply to all research and particularly to research targeting specific cultures or social groups (e.g. Chinese mothers, paraplegics).
2.5.2. The ethics of research and the way knowledge is shared and gained incorporates these three principles. Researchers may not always be able to identify whether definitive issues in this regard will arise, but must be receptive and prepared for the eventuality.
2.5.3. Research procedures should be appropriate to the participants. Researchers have a responsibility to inform themselves of, and take the steps necessary to respect, the values, practices and beliefs of the cultures and social groups of all participants.
2.5.4. Where a research project targets persons from another cultural, social or language group, consideration must be given to the preferences of the potential participants as far as consultation, language and documentation are concerned. Particular consideration must be given to the translation of documentation if appropriate in particular cases (refer to section 14 on Translation).
2.5.5. Researchers should also be cognisant of potential implications or interest that the process and outcomes of the research might have for other cultures or groups.
2.5.6. The purpose of any consultation is to ensure that research practices are appropriate and acceptable. Consultation should begin as early as possible in the project and should continue throughout its duration.
All researchers, whether their research is health related or not, are referred to the HRC Guidelines for Researchers on Health Research Involving Maori (Appendix P) and to the Frequently Asked Questions.
2.6. Research Adequacy
2.6.1. Research is considered ethical only if it meets appropriate standards of adequacy.
2.6.2. AUTEC recognises that different research paradigms may inform the conception and design of projects. It adopts the following minimal criteria of adequacy:
Note that in the case of student projects, it is appropriate to take into account the contribution of the work to the student’s own education.
2.6.3. Quantitative research
18.104.22.168. In deciding the number of participants required for a quantitative study there must be a balance between:
22.214.171.124. In quantitative research, the hypothesis must be clearly stated and be specific about what variables are being measured and the units of measurement.
126.96.36.199. How the power calculation was done must be described fully so that it can be verified. i.e.
e.g. it is known (see reference below) that without treatment the mean and standard deviation of a waist measurement in a previously studied group is 108±2cm. The lifestyle intervention will be considered successful if after treatment the waist measurement difference between a control and treatment group is 2cm. The question is “How many should be in each group to be able to distinguish this difference with 90% power and a probability (P) of 0.05?”
The test to be applied is an unpaired t test.
The answer is that there should be 23 in each group i.e. 46 total.
Racette SB, Weiss EP, Obert KA, Kohrt WM, Holloszy JO. Modest lifestyle intervention and glucose Obes Res. 2001 Jun;9(6):348-55.
i.e. measurement description
actual value and units of measurement and standard deviation
the change expected
Test to be used
And the final number
Reference or pilot study where information came from Action research: For guidance on action research projects, please refer to Appendix S.
2.7. Avoidance of Conflict of Interest
2.7.1. Researchers have a responsibility to ensure that there is no conflict between their responsibilities as a researcher and other duties or responsibilities they have towards participants or others. For example, academic staff members who propose to involve their students as participants in research need to ensure that no conflict arises between their roles as teacher and researcher, particularly in view of the dependent relationship between student and teacher, and of the need to preserve integrity in assessment processes.
2.7.2. It is important that researchers identify any potential conflicts of interest and specify measures proposed to deal with them.
2.7.3. Any sponsorship, funding or commercial support of a research project must not compromise the adequacy or ethical integrity of the research.
2.8. Respect for Vulnerability of Some Participants
2.8.1. It is important to recognise that some potential participants may be particularly vulnerable because of age, disability, health status or for other reasons. Where this is the case, researchers should give special consideration to their needs, especially with respect to informed consent and minimisation of risk. All practicable steps should be taken to address the particular needs of vulnerable groups or individuals.
2.8.2. Researchers should refer particularly to Section 12, concerning research with children as participants.
2.9. Respect for Property (Including University Property and Intellectual Property Rights)
2.9.1. Teachers and researchers must ensure that processes do not violate or infringe legal or culturally determined property rights. These may include factors such as land and goods, works of art and craft, spiritual treasures and information.
2.9.2. Particular attention should be paid to the legal and ethical dimensions of intellectual property. Care must be taken to acknowledge and reference the ideas of all contributors and others and to obtain any necessary permissions to use the intellectual property of others. Teachers and researchers are referred to AUT’s Intellectual Property Policy for further guidance (Refer to Appendix U). The abuse or misuse of University property is not acceptable in research or teaching activities. It is also considered unethical for members of AUT to publish false, misleading or inaccurate information or interpretation which diminishes the public image of the University.
3. TERMS OF REFERENCE - AUCKLAND UNIVERSITY OF TECHNOLOGY ETHICS COMMITTEE (AUTEC)
AUTEC is an institutional ethics committee which is approved by the Health Research Council of New Zealand. AUTEC reports annually to Council and to the Health Research Council Ethics Committee. A copy of the annual report is forwarded to Academic Board for information. The following are the objectives and membership of AUTEC:
3.1.1 To review or provide for the review of all proposed research and teaching projects being undertaken by staff or students at the University and involving human participants.
3.1.2 To provide advice and assistance with regard to ethical principles to anyone undertaking such research or teaching projects.
3.1.3 To provide an avenue for handling complaints or queries regarding ethical standards of research and teaching.
3.1.4 To provide comment and guidance on all aspects of institutional ethics, including the public image of the University, the use of assets of the University, ethical aspects of institutional research and other matters referred to AUTEC from time to time.
Note: Any research or teaching at the University that involves the use of animals is to be referred for ethical review to The University of Auckland Animal Ethics Committee via the Research Ethics Advisor.
AUTEC shall be comprised of not more than seventeen members including:
3.2.1 A chairperson appointed by Council on the recommendation of the Academic Board.
3.2.2 An appointee of each faculty.
3.2.3 An appointee of Council.
3.2.4 An appointee of the Auckland Student Movement at Auckland University of Technology (AUTSA).
3.2.5 An appointee of the Pro-Vice Chancellor, Maori Advancement.
3.2.6 An appointee of the Pro-Vice Chancellor (Research)
3.2.7 Four to six other members appointed by the Chair, the Executive Secretary and the Council’s representative, the majority of whom shall be from outside the University to provide expertise and balance as required by the Health Research Council’s Guidelines for the Approval of Ethics Committees and as AUTEC considers necessary.
The Executive Secretary is an ex officio member of AUTEC.
Membership shall be for a term of three years with the right of
re-appointment with the exception of the Executive Secretary whose membership is ex officio.
AUTEC shall function in accordance with the Health Research Council’s Guidelines for the Approval of Ethics Committees and the procedures given in AUTEC’s Applying for Ethics Approval: Guidelines and Procedures.
4. FURTHER MEMBERSHIP GUIDELINES
AUTEC’s membership is determined in accordance with the Terms of Reference given in the previous section. It is also guided by the following:
4.1. Accreditation Membership Requirements
AUTEC is accredited to the Health Research Council. It is the responsibility of the Chair and the Committee to ensure that the following accreditation requirements of the Health Research Council are met each time the composition of the Committee is changed:
4.2. Term of Appointment
4.2.2. No member shall serve on the Committee for more than two consecutive terms or six successive years. The Chair may have a term as Chair after any other consecutive terms in another capacity. The Executive Secretary, as an ex officio member, is exempt from this requirement.
Each meeting is to be chaired by the Chair or their nominee. The Chair shall be recommended by Academic Board and appointed by Council from the lay membership of the Committee.
5. COMMITTEE DECISION MAKING PROCESSES
5.1. All decisions of AUTEC are by consensus. Where AUTEC cannot reach consensus, an application will be deferred for further discussion. Further information may be sought from the applicant.
5.2. AUTEC may request the attendance of the applicant at a meeting where it would assist the decision-making process.
5.3. AUTEC may delegate authority to approve as follows, subject to the endorsement of such approvals at the following meeting:
5.3.1. The Chair or the Executive Secretary may exercise delegated authority to approve, or to approve subject to conditions, the following:
188.8.131.52. minor amendments to previously approved applications where the amendments, in the view of the Chair or Executive Secretary, pose minimal risk;
184.108.40.206. applications requesting only an extension of time for a previously approved project, where a time extension is necessary to complete the project, provided that the extension shall be for no more than one year;
220.127.116.11. applications where amendments have been required as a condition of approval by AUTEC, or by the Chair and the Executive Secretary in accordance with section 5.3.2 below, and those amendments have been submitted for AUTEC’s consideration;
18.104.22.168. amendments of previously approved projects involving only a change of supervisor;
5.3.2. The Chair and the Executive Secretary together, forming a subcommittee of AUTEC, may exercise delegated authority to approve, or to approve subject to conditions, applications not previously considered by AUTEC, where:
22.214.171.124. there are exceptional circumstances which mean that, in the opinion of the Chair and the Executive Secretary, it would be inequitable for the applicant to be required to apply to the next meeting of AUTEC; or
126.96.36.199. the ethics approval for research being undertaken by AUT staff or students has been granted by a Health and Disability Ethics Committee in accordance with the Health Research Council's Guidance Notes on Research Ethics, or
188.8.131.52. the application, in the opinion of the Chair and the Executive Secretary, poses no more than minimal ethical risk, and
184.108.40.206.1 all participants are able to give an informed consent, and are not vulnerable to the research or in a dependent situation e.g. people with learning difficulties, over-researched groups, people in care facilities, or patients highly dependent on medical care, and
220.127.116.11.2 there is no reasonable expectation of causing participants physical pain beyond mild discomfort, or such pain as is experienced by the participants on an every-day basis, or any emotional discomfort embarrassment, psychological or spiritual harm, and
18.104.22.168.3 there is no possibility of eliciting information about any participant’s involvement in illegal activities, or activities that represent a risk to themselves or others, and
22.214.171.124.4 there is no collection of human tissue, blood or other samples, or invasive or intrusive physical examination or testing, and
126.96.36.199.5 there is no administration of any drugs, medicines, supplements, placebo or non-food substances, and
188.8.131.52.6 there is no intervention of any form of exercise, or other physical regime that is different to the participants’ normal activities, and
184.108.40.206.7 there are no participants who are being asked to give information of a personal nature about their colleagues, employers, teachers, or coaches (or any other person who is in a power relationship with them), and the identity of participants or their organisation may be inferred, and
220.127.116.11.8 there is no situation which may put the researcher at risk of harm, and
18.104.22.168.9 there is no use of previously collected biological samples or identifiable personal information for which there was no explicit consent for the research outlined in the application, and
22.214.171.124.10 there are no matters of commercially sensitive information, and
126.96.36.199.11 there is no financial interest in the outcome of the research by any member(s) of the research team, and
188.8.131.52.12 there is no deception, partial disclosure or concealment, or any covert observation in non-public places (including social media), and
184.108.40.206.13 there are no participants who are in a dependent or unequal relationship with any member(s) of the research team e.g. where the researcher is a lecturer/ teacher/ health care provider/ coach/ employer/ manager/ or relative etc. of any of the participants.
5.3.3. Either the Chair or the Executive Secretary and an AUTEC Faculty Representative together, forming a subcommittee of AUTEC, may exercise delegated authority to approve, or to approve subject to conditions, applications not previously considered by AUTEC, where
220.127.116.11 the application, in the opinion of either the Chair or the Executive Secretary and the AUTEC Faculty Representative, poses no more than minimal ethical risk, and
18.104.22.168 the application is only for the collection of anonymous (no identifying information is being collected), un-linked and non-sensitive survey/questionnaire data from adult participants.
5.4. Advice and information may be sought from experts and professional advisors from time to time as AUTEC considers appropriate.
5.5. Where AUTEC deems it necessary, applications may be sent to appropriate experts chosen by AUTEC for confidential comment and advice.
5.6. Applicants will be advised formally of AUTEC’s decision once the Minutes are approved by the Chair and Executive Secretary. Where a supervisor is the applicant, the student concerned will also be advised.
For Information on Ethics Approval Procedures, refer to Appendix B.
6. EXCEPTIONS TO ACTIVITIES REQUIRING AUTEC APPROVAL
The following activities do not require AUTEC approval:
6.1. Evaluations or surveys conducted within the University for the specific purpose of reviewing and improving education practices and University processes, (for example. teacher, module or programme evaluations, overall pass/fail statistics, performance data of broad groups such as mature students, international students, staff and student surveys etc.). Such evaluations or surveys must meet AUTEC’s ethical standards and must be used only for the purpose specified above. Where they are reported or published as academic research, this exception does not apply. (Refer also to Appendix Q).
6.2. Research and teaching involving existing publicly available documents or data (for example analysis of archival records which are publicly available).
6.3. Preliminary interaction or discussion where the exact research aims have not yet been formulated. This does not include pilot studies. Action research is in a special category. Refer to Appendix S for further guidance.
6.4. Research and teaching in which a single investigator is the subject of his/her own research and where no physically or psychologically hazardous procedure is involved.
6.5. A one-off interview where the object is to seek non-sensitive factual information and no opinions are sought.
6.6. A one-off interview of limited scope and depth with professional persons, authorities or public figures, (for example. politicians, scholars, prominent authors) in the area of their expertise. Such an interview must not comprise a major study.
6.7. Where a professional or expert opinion is sought, except where this is part of a study of the profession or area of expertise.
6.8. Observational studies in public places in which the identity of the participants remains anonymous (i.e. where the data by its nature cannot be used to identify individuals) and compilation of the data does not involve any harmful or objectionable activity.
Researchers who are uncertain whether their proposal fits into one of the exemption categories should contact the AUTEC Secretariat or their AUTEC Faculty Representative for advice.
7. COMPENSATION FOR RESEARCHERS AND PARTICIPANTS
7.1. Both staff and students of AUT are covered for personal liability as researchers under the insurance policies held by the University, providing ethical approval has been gained where necessary and the research carried out according to the terms of the approval.
7.2. If clinical trials are being conducted by AUT staff or students, then additional declarations are required to be submitted as part of the ethics application to the appropriate Health and Disability Ethics Committee to determine the eligibility of the research for Accident Rehabilitation and Insurance Corporation coverage of participants. Chapter 8 of the National Ethics Advisory Council's Ethical Guidelines for Intervention Studies should be referred to for further detail about the process and criteria relating to compensation for participants.
8. SPECIAL APPROVAL PROVISIONS
8.1. This process has been discontinued.
8.2. APPROVAL OF CLASS RESEARCH PROJECTS
8.2.1. Where students are required to undertake research of a standardised nature as part of their coursework for a paper, application for approval must be made by the teacher responsible, using Form EA6 Application Form for Ethics Approval for Class Research Projects (Appendix L).
Approval may be obtained for up to a three year period if the assessment requirements do not change in that time.
8.2.2. The application should provide details of all anticipated types of research tools and methodologies, the nature of the planned projects, plus exemplars of the Information Sheet(s) and Consent Form(s).
8.2.3. The teacher is responsible for ensuring that students understand and observe the principles and requirements of AUTEC.
8.2.4. The teacher is responsible for providing a report to AUTEC at the end of the class with the names of the student, titles of their projects, the nature of the project and note of any issues arose during the research, using Form EA7 Annual Ethical Report on Class Research Projects (Appendix M).
8.3. APPROVAL OF HEALTH RESEARCH
8.3.1. Certain health research proposals require ethical approval by a Health and Disability Ethics Committee. As an Institutional Ethics Committee approved by the Health Research Council Ethics Committee, AUTEC is able to hear some health research proposals. More information may be found using the flow chart titled 'Do I need Ethics Approval' on the front page of this Research Ethics website.
8.3.2. Any application which is required to be submitted to a Health and Disability Ethics Committee will not be reviewed for institutional purposes by AUTEC until the HDEC review has taken place.
8.3.3. Applicants must complete the HDEC Application Form which is available through the links to the left. Where a locality assessment is required for the HDEC approval, applicants should use the EA5 form.
8.3.4. Applicants will advise AUTEC of the Health and Disability Ethics Committee approval and provide required details before the research begins on Form EA5 Application to AUTEC of External Ethics Committee Approval and Locality Authorisation for a Health and Disability Committee (Refer Appendix K) within two months of approval or before data gathering begins, whichever is earlier. AUTEC reserves the right to comment on the approved application and to require further information or action if, in AUTEC’s opinion, AUT’s interests are at issue.
8.3.5. Summary regional application data will be recorded in the AUTEC database and reported as part of the Annual Report.
8.3.6. Applicants are required to keep AUTEC informed of all changes approved by the Regional Ethics Committee and to send a copy of all reports to maintain accurate records.
9. REPORTING AND MONITORING REQUIREMENTS FOR RESEARCHERS
9.1. AUTEC may, as part of the conditions of approving a proposal, require an independent review or audit of approved research or innovative practice at any time.
9.2. Researchers are required to submit annual progress reports (Refer to Form EA2, Appendix G) to AUTEC as a condition of ethical approval. Reports may be required more frequently. Researchers will be advised in the approval letter of such a requirement.
9.3. Researchers are required to immediately report any serious or unanticipated adverse events to the Committee.
9.4. Researchers are required to advise participants if new information relating to the safety or integrity of the study becomes available.
9.5. Researchers are required, on the completion of an approved and implemented proposal, to report on the findings of the research or the outcomes of the treatment (refer also Section 10 General Provisions Relating to Approval).
9.6. Where an approved application has been abandoned, researchers are required to report on the reasons for its abandonment.
9.7. As part of the conditions of approving a proposal, AUTEC requires researchers to provide a summary of the research findings or treatment outcomes to all participants (refer to Form EA3, Appendix H).
NOTE: Reference should also be made to Section 11 Responsibilities of Researchers .
10. GENERAL APPROVAL PROVISIONS
10.1. Approval of individual applications is normally granted for a period of three years from the date of notification.
10.2. Where the research has been completed, a final report on the findings of the research or the outcomes of the treatment should be submitted to the Committee (refer to Form EA3, Appendix H).
10.3. Where the research has not been commenced within a 12 month period from the approval date, a new application must be submitted, making reference to the previous application.
10.4. Where conditions have not been met within 12 months of the date of notification to the applicant of those conditions and the researcher wishes to continue with the project, a new application must be submitted, making reference to the previous application.
10.5. Where it appears that the project will not be completed before the expiry of the approval date, the applicant must submit a request to the Committee for an extension, providing justification for the extension. The length of requested extension must be clearly identified.
10.6. Applicants are responsible for informing AUTEC if their project changes during the period for which approval has been given. In such cases applicants are required to write to AUTEC, providing details of the proposed changes and copies of any revised Consent Forms, Questionnaires, Information Sheets, etc.
11. RESPONSIBILITIES OF RESEARCHERS AND TEACHERS
11.1. Persons undertaking research or teaching involving human participants are responsible for obtaining approval as required by AUTEC and for complying with the requirements of AUTEC. The attention of persons undertaking health research is drawn to Section 8.3 above.
11.2. The academic responsibilities of supervisors and their student researchers with respect to the requirements for ethical approval are as follows:
11.2.1. Academic Responsibilities of Supervisors:
22.214.171.124. Ensure students apply for appropriate ethics approval where human participants are involved. Requirements for ethics approval need to be addressed with students within an appropriate time-frame that does not compromise their research (at least two months prior to commencement of participant research);
126.96.36.199. Read, edit and provide feedback on the ethics application. Sign off the ethics application forms for low risk ethics approval and EA1 full ethics approval as appropriate;
188.8.131.52. Ensure Head of School or delegated authority signature has been obtained for all ethics applications;
184.108.40.206. Assist students in corrections and responses to unsuccessful applications or conditional approvals;
220.127.116.11. Supervise the ethical conduct as outlined in the approved ethics application;
18.104.22.168. Ensure any amendments to approved research projects are put forward to AUTEC for approval prior to implementation of the change;
22.214.171.124. Ensure AUTEC is provided with the required progress and completion reports.
11.2.2. Students’ Responsibilities:
126.96.36.199. Fully discuss any research involving human participants with their supervisor;
188.8.131.52. Become cognisant of AUTEC guidelines and application procedures (for example, by attending a postgraduate seminar on the topic);
184.108.40.206. Prepare application in consultation with their supervisor and, where appropriate, an AUTEC faculty representative;
220.127.116.11. Ensure their supervisor reads, edits and comments on the ethics application;
18.104.22.168. Ensure application is signed off by supervisor and Head of School;
22.214.171.124. Respond to AUTEC feedback as appropriate in consultation with their supervisor;
126.96.36.199. To undertake research in an ethical manner and according to the frameworks outlined in the approved ethics application;
188.8.131.52. Work with their supervisors to ensure any amendments to approved research projects are put forward to AUTEC for approval prior to implementation of the change and to prepare the required progress and completion reports.
11.3. Where students are required to undertake research as part of their coursework for a paper, the teacher responsible must obtain the necessary ethical approval, using Form EA6 Application Form for Ethics Approval for Class Research Projects (Appendix L - refer also to section 8.2).
11.4. STAFF UNDERTAKING RESEARCH
11.4.1. AUT staff undertaking research involving human participants as a student either at AUT or at another institution must obtain the necessary ethical approval before the research begins.
11.4.2. If the research is to be conducted with AUT staff and/or students, ethical approval must be gained through AUTEC whether or not other ethical approval is required (such as by another qualification-conferring institution). Applications may be submitted concurrently on the other institution’s form, along with a completed EA5 form.
11.4.3. If the research involves human participants but does not involve students and/or staff of AUT as participants and is not carried out at AUT, ethical approval should be gained from another appropriate ethics committee. A copy of the letter of approval and application must be forwarded to AUTEC for noting using Form EA5 Notification to AUTEC of External Ethics Committee Approval (Refer Appendix K) within two months of approval or before data gathering begins, whichever is earlier. AUTEC reserves the right to comment on the approved application and to require further information or action if, in AUTEC’s opinion, AUT’s interests are at issue.
11.4.4. If the research involves human participants but does not involve staff and/or students of AUT and there is no other relevant ethics committee, or that other relevant committee does not require approval, ethical approval must be obtained from AUTEC.
11.5. Where a researcher seeks access to records for participant selection for research purposes, AUTEC will generally require the researcher to ensure that the holders of those records (rather than the researcher) identify potential research subjects and approach them directly on behalf of the researcher.
11.6. Staff in charge of teaching or laboratory classes involving participants, including classes where students are used as experimental subjects, are responsible for obtaining AUTEC approval and for ensuring compliance with any Committee requirements.
11.7. All applications for AUTEC approval are required to be signed by a senior person in the appropriate centre or faculty (e.g. head of department, programme leader, supervisor, academic group leader).
11.8. COLLABORATIVE RESEARCH
11.8.1. Where an AUT staff member or student proposes to undertake collaborative research with organisations or individuals external to AUT, either in New Zealand or overseas, the researcher(s) concerned must ensure that if the research is to be conducted with AUT staff and students, ethical approval is obtained through AUTEC irrespective of any other ethical approval granted, provided that if the research is health-related, approval by the appropriate regional committee only is sufficient. Applications may be submitted concurrently.
11.8.2. If the collaborative research is to be conducted only with participants other than AUT staff and/or students, that any necessary ethical approval is obtained from an appropriate accredited committee(s), either in New Zealand or overseas. In such cases, project details and evidence of ethical approval shall be provided to AUTEC for noting. If no other accredited ethics committee is available to provide ethical review, an application must be made to AUTEC.
11.8.3. Where approval is gained from another ethics committee, a copy of the full application, accompanying documentation and letter of approval must be sent to AUTEC for noting, using Form EA5 (Appendix K).
11.9. Members of AUTEC will respond to requests for advice on ethical matters before, during and after the research process. Researchers should, however, recognise the advantages of planning ahead and approaching faculty representatives well in advance of Committee agenda closing dates.
11.10. Where a member of AUTEC is involved in an application being considered by AUTEC, that member shall withdraw from AUTEC when that application is under consideration.
11.11. Where a researcher or teacher fails to carry out the responsibilities set out in Section 11, AUTEC may require compliance with them and may take other reasonable and appropriate steps to address breaches of the Guidelines.
12. GUIDELINES FOR RESEARCH WITH CHILDREN AS PARTICIPANTS
12.1. The Committee will make appropriate reference to the ethical guidelines developed by Nicola Peart and David Holloway on health research with children. Applicants planning research with children as participants are required to consult these guidelines which are also relevant to research other than health research. The guidelines should be read together with the broad principles which follow below.
12.2. The particular vulnerability of children makes consideration of the ethical issues surrounding their involvement in research particularly important. To safeguard their interests and to protect them from harm, special consideration will be given to such ethical issues.
12.3. Well-conducted and appropriate research involving children is important for the benefit of all children and should be supported and encouraged.
12.4. Requirements which apply to research involving children as participants will be additional to those routinely applying to adult participants.
12.5. Research involving children as participants should only be undertaken if comparable research with adults could not answer the same question and if the purpose of the research is to obtain knowledge relevant to the needs of children.
12.6. Children are not small adults; they have their own unique set of interests.
12.7. A prime consideration in any research involving children is that it is not against the interests of any individual child participant. However, research which is not intended directly to benefit a child participant is not necessarily unethical.
12.8. Legally valid consent should be obtained from the child, parent or guardian as appropriate depending on the age of the child. In general, the following guidelines should be observed:
12.9. No inducements should be offered to children, parents or guardians to persuade them to agree to their participation or that of their children in a research project. Small gifts after the completion of the project and/or compensation for expenses incurred in participation may be offered.
12.10. Potential child participants must be provided with full information about the research in a form which they can readily understand. The style and content of information must both inform fully and be appropriate to the participants’ level of understanding.
12.11. Pressure must not be placed on a child to agree to participate in a research project. This is particularly important given the power imbalance between adult researchers and children.
13. PRINCIPLES RELATING TO TREATMENT OF HUMAN REMAINS
13.1. All human remains shall be treated with respect, irrespective of age, condition, origin, ethnicity, religion, sex or nationality.
13.2. The relevant law and regulations shall be complied with at all times.
13.3. For any research proposal involving human remains, tissue or body fluids (other than standardised testing procedures such as blood sample tests), application must normally be made to the appropriate Health and Disability Ethics Committee. (refer also to Appendix O).
13.4. Arrangement and agreements about the treatment and disposal of human remains, tissue and/or body fluids must be stated in the application for ethical approval.
13.5. The wishes of the local community and relatives or guardians with respect to investigation, storage, and/or disposal shall be complied with wherever possible and reasonable.
13.6. Account shall be taken of the value of skeletal, mummified or other human remains, including fossil hominids, for scientific and other scholarly research. The potential value of remains should be demonstrable in the light of either current knowledge or foreseeable investigatory techniques.
13.7. Fossil, skeletal, mummified or other human remains shall be disposed of after negotiated agreement. Any agreement shall take into account the legitimate concerns of communities for the proper treatment of their ancestors and the legitimate requirements of science, education and other scholarship.
13.8. The concerns of various ethnic groups as well as those of science, education and of other scholarship and research shall be expressly recognised.
14. TRANSLATION OF RESEARCH INSTRUMENTS
14.1. When either the researcher or AUTEC considers that some or all of the research instruments or participant documentation (e.g. questionnaires, interview schedules, information sheets, consent forms, confidentiality agreements, etc.) need to be translated into a language other than English, then:
14.1.1. The ethics application is to contain an account of the relevant circumstances;
14.1.2. A true and accurate translation in the appropriate languages is to accompany the English version and the application, along with details of the translator’s/ translators’ expertise and/or professional qualifications;
14.1.3. Translators are to sign a Confidentiality Agreement when translation of confidential participant information or responses is involved and a copy of the Confidentiality Agreement is to accompany the application.
14.2. AUTEC reserves the right to require a verified translation where appropriate (Refer to the Glossary - Appendix A for a definition of ‘Verified Translation’).
14.3. Given their status as official languages of New Zealand, the appropriate use of Te Reo Maori and New Zealand Sign Language by researchers is encouraged;
14.4. Researchers are advised to consider the following matters when deciding whether or not to use languages other than English in research projects:
14.4.1. The preferred language of the participants;
14.4.2. The impact upon the ability of the participants to provide fully informed consent when they are given information in a language of which they have limited understanding;
14.4.3. The impact upon the quality of the data if the research is conducted in a language of which participants have limited understanding;
14.4.4. The need to ensure the accuracy and compositional quality of the translations, which should be undertaken by qualified and competent persons;
14.4.5. The need to provide translation services for focus groups and interviews as well as for the written documentation.
Many procedures are potentially hazardous in terms of the equipment used (for example, electrical), the environment in which a study is conducted, or the methodology used. Applicants should take account of the health and safety implications of proposed studies for participants and the wider AUT community. AUTEC may refer proposals to appropriate safety experts, including the relevant health and safety committee, as it deems necessary.
15.2. HAZARDOUS SUBSTANCES
Applications for approval for research or teaching classes involving hazardous substances should be accompanied by a statement outlining compliance with the Hazardous Substances and New Organisms Act 1996, especially with respect to safe use, handling, transportation and storage, Applicants must provide a risk assessment that outlines controls and an emergency plan. This shall be prepared in consultation with the AUT Health and Safety Advisors.To determine whether substances are hazardous or do not fit within the legislative definition, you are advised to visit the Hazardous Substances and New Organisms website.
16. LEGAL OPINION
In some circumstances AUTEC may require that the applicant seek a legal opinion. Before such an opinion is sought, the applicant should consult the General Manager. The General Manager will decide whether the cost of the opinion is to be paid wholly by the applicant, the University or shared by both. If the cost is to be shared the General Manager will decide the appropriate apportionment. Neither departments nor faculties will be liable for the costs of legal opinions unless the head of department, or the dean, has given written permission prior to the seeking of that opinion.
17.1. Concerns about the conduct or nature of a research project or teaching exercise may be raised confidentially and informally, in the first instance, with the Chair of AUTEC, or any Committee member.
17.2. No complaint will be proceeded with unless a written and signed complaint is received by the Executive Secretary of AUTEC.
17.3. The procedures set out in Appendix T: Reconsideration, Appeals and Complaints Procedures will be followed to address the matters raised in the complaint.
17.4. AUTEC retains the right, where appropriate, to withdraw ethical approval previously given.
18. FINAL STORAGE OF DATA AND CONSENT FORMS
18.1. Information, which may take the form of documents, tapes, disks, videos, computer files etc., is to be handled in a manner that ensures its safekeeping (1) and protects the confidentiality of participants.
18.2. Particular matters which need to be considered at the beginning of the research process include:
18.2.2. the need to gain the consent of participants and subjects for the return of creative works which are part of an assessed research project to the artist or creator once the marking is completed;
18.2.3. the desirability of storing tapes or film separately from transcripts or other identifying material;
18.2.4. the provision of full information about the use of the data and the duration and general nature of data storage to potential participants. Researchers should be aware that they are unable legally to use or store the information in a manner to which the participants have not consented.
18.3. The storage location of data and consent forms is to be as follows:
18.3.2. The data must be stored in a separate location from the Consent Forms. Details of the storage locations must be specifically provided in the appropriate sections of part H of the EA1 Application Form.
18.4. The storage duration of data and consent forms is to be as follows:
18.4.2. When the data is health related, it must be stored for at least ten years as required by section 5 of the Health (Retention of Health Information) Regulations 1996;
18.4.3. When a participant withdraws from a research project, all data relating to them is to be destroyed whenever possible, with the exception of their Consent Form, a notification of their withdrawal from the project, and a note detailing how and when the data was destroyed, which are to be stored with the other Consent Forms for that project and destroyed along with them at the approved time.
18.4.4. In exceptional circumstances, AUTEC may approve the destruction of data within six years of its collection, provided that the data is not health related and is part of routine low risk research;
18.4.5. When required for legal or research reasons (e.g. Public Records legislation or longitudinal studies), AUTEC will approve the storage of data in perpetuity. The applicant is to provide AUTEC with detailed reasons for such storage and to identify the archival facilities in which the data will be stored;
18.4.6. In accordance with section 2.5 of these Guidelines and Procedures, AUTEC requires that appropriate consultation takes place about the storage and destruction of data that may be perceived as forming part of the cultural taonga of the Tangata Whenua.
(1) Safekeeping requires researchers to consider appropriate levels of security for the type of data and duration of storage. For example, it not appropriate for electronic data to be stored on non-secured hard-drives or a student researcher's personal computer or network after analysis has been completed. Electronic data is better secured if (a) transferred to appropriate storage media, e.g. external hard-drives, usb drives, cd's, or dvd's and then stored in a locked cabinet or another secured storage facility or (b) kept in a folder on an AUT network drive accessible through an AUT staff member's login so that destruction may be effected at the approved time.
(2) AUT premises includes offices and contracted archive facilities such as RECALL.
In a research context, anonymity refers to the collection of data. Anonymous data is of an unknown or undeclared source.
Anonymity differs from confidentiality – please refer to the definition of confidentiality.
This term describes the status of an ethics application which has been considered by AUTEC or a delegated authority of AUTEC, but which raises substantial issues or questions which need to be clarified or remedied prior to the research commencing. In this instance, a revised application must be resubmitted to AUTEC. The research can only commence once the revised application has been considered and approved by AUTEC. In these cases, AUTEC arranges for advice and guidance to be available to assist applicants to meet requirements.
This applies to an ethics application which has been considered by AUTEC or under delegated authority from AUTEC, which has been accepted as sound and ethical research and which can proceed.
Approved Subject to
An ethics application which has been considered by AUTEC or a delegated authority of AUTEC and has been accepted as sound and ethical research but which has several points which need to be clarified or remedied prior to the research commencing. The research can only commence once these points have been addressed to AUTEC's satisfaction. If the points have not been addressed to AUTEC's satisfaction within six months, the application will be closed and a new application will be required if the research is to go ahead.
This is the agreement to participate in a project, which has been given by a child who lacks the capacity to give full consent. Where a parent or guardian gives the necessary consent to a project involving a child, the child's assent must be obtained if this is possible.
An investigation into whether an activity meets explicit standards, as defined in an auditing document, for the purpose of checking and improving the activity audited. Audit involves examining practice and outcomes in a particular time and place to see whether they conform with expectations, with a view to informing and improving management rather than adding to general knowledge.
Auckland University of Technology Ethics Committee
The day-to-day activities normally regarded as the regular duties of a body of health practitioners during the course of delivering a health service.
The following definitions are both in use:
"A clinical trial is any systematic research study involving humans, whether they are patients or non-patient volunteers. The objective of the study would be to obtain clinical and scientific information about a pharmaceutical product, medical items, treatment, medical procedures, etc. The study would be limited to a specific time frame and should have been approved by an accredited ethics committee." [ACC booklet: Clinical Trials, September 1996. A copy of this booklet is held by the Secretary of AUTEC]
Any research on human subjects conducted to gain new knowledge into mental and physical health and disease. It would exclude research based on the analysis of secondary sources of health information. Clinical trials involve a wide range of health professionals with different qualifications, skills and expertise and would usually be conducted in hospitals, other health care settings, the community and academic host institutions (Definition from Guidelines for Injuries Caused as a Result of Participation in a Clinical Trial and the Role of Ethics Committees).
In the context of the evaluation of investigational products, a clinical trial means the systematic study of investigational products (medicines or devices) in humans for the collection of information. Studies conducted to discover or verify the effects of and/or identify any adverse reactions to those products; studies of the absorptions, distribution, metabolism and excretion of a product (Phase I/II); studies to ascertain the efficacy and safety of a product (Phase III); and quality of life data and/or pharmacoeconomic studies (Phase IV) all lie within this definition.
Note: All research which is deemed to be a clinical trial must be submitted to a Regional Ethics Committee for ethical review. Please refer to the section titled Approval of Health Research.
Payment or medical care provided to participants injured in research. This does not refer to payment (remuneration) for participation in research.
An ethics application which is being forwarded to another ethics committee at the same time as it is being submitted to AUTEC. This does not apply where an application is submitted to a Regional Ethics Committee.
The obligation on persons to whom private information has been entrusted not to use or divulge the information without permission for any purpose other than that for which it was originally given. This includes protecting the identity of individual research participants in addition to any information they may provide throughout the course of their participation. Confidentiality differs from anonymity. Please refer to the definition of anonymity.
This is an acknowledgement signed by potential participants when they have been fully informed about the research (through an oral explanation and/or through a research participant Information Sheet) and are agreeing to participate in the project. Projects may require more than one type of Consent Form. Consent forms should be stored separately from research data for a period of six years.
Please refer to the Consent Form Exemplar in Appendix E and please note that certain people e.g. legal minors cannot give consent (see Assent above).
This refers to AUTEC's delegation of authority to specified persons to act on its behalf.
Several people in faculties and across the University have the ability to approve research under special conditions. Please refer to the section on Special Approval Provisions. The AUTEC Chair, Executive Secretary and members also have delegated authority in particular circumstances. Please refer to the section on Committee Decision Making Processes.
An external researcher is someone who is not a student or staff member of AUT. Such a person may be working either for another institution or independently.
Includes the substance, structure, and texture of which the human body or any part or organ is composed and which is removed or separated from that human body; includes cells, blood, blood components, waste products, hair or nail clippings, including those from deceased or living people.
Health information includes information:
The gathering and use of health information requires the researcher to consult either the Health and Disability Privacy Information Act or the Privacy Act.
This sheet fully informs research participants about the research they are invited to participate in, using appropriate language. For example, an information sheet for children will differ significantly from one for teachers. It should include an appropriately worded invitation to participate in the research project. (please refer to Appendices D and D1)
A person's voluntary agreement, based on adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure.
Institutional Research is the planning, coordination, collection, organisation, compiling and dissemination of information concerning the characteristics and performance of the institution.
The purpose of Institutional Research is to provide objective, systematic and thorough research that supports the institution's enrolment goals, planning, policy formation and decision making.
"Broadly, 'institutional research' is viewed as a range of activities involving the collection, analysis and interpretation of information descriptive of an institution and its activities, including its students and staff, programmes, management and operations. The findings of such 'institutional research' can assist institutional leaders (in both academic and administrative domains) through informing their planning and decision making."
Zimmer, B; JIR, Vol.4 No.1, May 1995, pg.74, "Achieving quality within funding constraints: the potential contribution of institutional research"
(Acknowledgement is made to the Australasian Association for Institutional Research (AAIR) for this information.)
The general usage and contemporary application of the concept of Koha is as follows:
"It is the offering and presentation of a gift or reward for some work or duty that has been performed by a person, party, group or organisation. It also incurs a mutual obligation"
It involves the three entities the koha, the donor and the recipient. Certain duties and expectations are inherent in the koha concept. The main principle of the koha involves a mutual understanding between the donor and recipient. This in turn leads to an undertaking between the two parties. (This understanding and undertaking is often not written).
Finally, the notion of koha includes an obligation between both parties to adhere to certain procedures.
When a koha (gift or present) is offered or presented to a person, group or organisation implicit in the offering and receipt of the koha is the notion that at some later date (Time can be specified or is unspecified) some reciprocal arrangement will be made. It could be the return, or compensation of a koha.
The koha may be offered in several ways:
If the amount of money or donations given as koha in acknowledgment of duties performed is in excess of actual expenses incurred then that koha is liable for tax. Below is a link to the booklet, "Payments and gifts in the Maori community", on the Inland Revenue Website: http://www.ird.govt.nz/resource/publicat/ir278_apr00.pdf
Please also refer to the definition of payment.
A lay person is defined in the National Standard as a person who is not currently, nor has recently been:
In educational settings, the term is defined more broadly to refer primarily to the last of the criteria specified above.
Risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
Ethics approval must be sought for taught papers which include a student research component. In this case, the teacher needs to submit an ethics application which explains the types of research being proposed by students and the parameters within which all the research will fall, using Form EA6 (Appendix L). Approval can be given for three years. The Teacher must supply AUTEC with a short report of all student projects and their titles at the end of each year using Form EA7 (Appendix M). Any student project deviating from the original paper approval must be submitted to AUTEC as a separate application.
The offering of payment or inducements to potential participants is a practice not normally approved by AUTEC, Such instances need to be identified and justified in the application. Small gifts after the completion of the project and/or compensation for expenses incurred in participation may be offered. Please also refer to the definition of Koha.
This refers to information which is openly (and often freely) available to all members of the public, through libraries, publication, the media and/or the internet.
A participant is any person involved in a research or teaching situation as an experimental subject, as an example of some human characteristic or condition, as a recipient of any physical, psychological, behavioural or social intervention or manipulation, or as a provider of information. Though recognising the variety of descriptions of such persons in different research areas and disciplines, e.g. 'subjects', 'clients', 'patients', 'consumers', 'informants', AUTEC uses the term 'participants' for simplicity and as a reminder of the power differentials inherent in research relationships.
This is information collected directly from "the field", including research participants themselves. Primary data will usually need to be analysed or "treated" in a particular way in order that conclusions or interpretations can be deduced.
Please refer to the definition of payment.
In this document, unless specified otherwise, the term 'research' refers to any investigative activity undertaken by members of the University within, or outside, AUT. This includes any University research, including contract research. Student research, either independent thesis research or as part of course requirements, is also included.
The function of the magnitude of a harm or injury (physical, psychological, social or economic) and the probability of its occurrence as a result of participation in innovative practices or research studies. Both the probability and magnitude of possible harm may vary from minimal to significant.
This usually refers to information and knowledge gained through information already in the public domain e.g. through books, journal articles, statistics etc.
This is research undertaken by staff under the auspices of AUT as part of their employment.
Staff as Student Research
This is research engaged in by AUT staff members while studying as formally enrolled students themselves. They may be enrolled at AUT or at another New Zealand or overseas institution.
This is research engaged in by students enrolled at AUT. The research may be part of a taught module (usually covered by AUTEC paper approval) or an independent research project (dissertation or thesis).
"Teaching refers to any activity which is undertaken by an academic staff member to facilitate learning as part of any course of study prescribed by AUT, and which involves human participants."
The research physician's intent to provide some benefit to improving a participant's condition (for example, prolongation of life, shrinkage of a tumour, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected). This term is sometimes associated with Phase I drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the consumer's condition as well as assessing the safety and pharmacology of a drug.
All research which is deemed to fall under the category of a therapeutic trial must be submitted to a Regional Ethics Committee for ethical review.
This is a translation (a text converted into another language or languages) by a properly qualified and certified individual. Ideally, this person should be accredited to the equivalent of at least NAATI (National Association of the Accreditation of Translators and Interpreters) Level Three.
Free of coercion, duress, or undue inducement; used in the health and disability care and research contexts to refer to a consumer's or participant's decision to receive health or disability care or to participate (or continue to participate) in a research activity.
APPENDIX B: AUTEC APPLICATION AND APPROVAL PROCEDURES - INFORMATION FOR APPLICANTS
1. AUTEC MEETINGS
1.1. Meetings are normally held twice each month on a Monday.
1.2. The closing date for applications is normally between six to eleven working days prior to the meeting day.
1.3. Agenda closing dates and meeting dates can be viewed here on the website.
In order to ensure that members are able to give adequate consideration to the matters involved, Agenda closing dates will be adhered to strictly.
1.4. Applicants are advised that the application process should be commenced at least two months prior to the commencement of the gathering of data. AUTEC frequently requests clarification and/or amendments and the resubmission may need to go back to the full Committee for consideration.
2. WHO SHOULD APPLY TO AUTEC?
2.1. All AUT staff and students proposing to undertake research with human subjects (apart from those listed in the exceptions in Section 6 of the AUTEC Guidelines) are expected gain ethical approval in the prescribed manner before the collection of data commences (Refer to the Guidelines, Section 11 for full information).
2.2. The categories of research include:
3. HEALTH RESEARCH
3.1. Health research may require review by a Health and Disability Ethics Committee (HDEC). Applicants should check the HDEC flowchart to determine whether or not this is the case.
3.2. If HDEC review is required, then applicants need to apply using the online application process for HDEC's and need to also observe the following:
3.2.1. Where an application to a Health and Disability Ethics Committee is required, AUTEC will not review the application for institutional requirements until HDEC Review has occurred.
3.2.2. When final approval has been granted by the Health and Disability Ethics Committee, the applicant must notify AUTEC by completing an EA5 form, (Application to AUTEC for institutional approval of research approved by an external Ethics Committee and Locality Authorisation for applications to Health & Disability Ethics Committees) and sending it, along with a full copy of the original application, final accompanying documentation and a copy of the final approval letter from the Health and Disability Ethics Committee.
3.2.3. The application will be reviewed for institutional ethical requirements by the Chair and Executive Secretary under delegated authority.
4.1. Downloading the Forms
The AUTEC application form (Form EA1) and Information Sheet and Consent Form exemplars can be downloaded from this website. Download the forms from the website and save them onto the hard disk of your computer or onto a CD-Rom. However, it is necessary to download the forms each time you make an application as changes are made to both the forms and the guidelines from time to time. The web version will always be the most current.
Sometimes there are difficulties experienced in downloading the forms. These may be caused through browser and/or computer settings or variances. Help is available through the following channels:
The AUTEC Secretariat
Telephone: 09 921 9999 ext 8860 or 8316
IT Client Services
Telephone: 09 921 9931
4.2. Filling in the Forms
4.2.1. Please note that AUTEC will not consider incomplete or incorrectly formatted applications.
4.2.2. When completing the form, simply place your cursor at the beginning of the blank line after the question or instruction section and type. To assist the Committee in considering your application and making reference to it, please do not alter the formatting of the form or delete any of the sections. If you consider that a section is not applicable to your research, simply state so as your response to that section. If AUTEC does not agree with you, you will be asked to provide further explanation.
4.2.3. Continue to type in the blank lines until you have completed the form. You can of course stop and save at any time and return to filling in the form later.
4.2.4. Text can be cut from other documents and pasted into the appropriate space in the form.
4.2.5. Applications must be written in plain language and be free of jargon. All categories of information requested should be provided, or their inapplicability explained. As AUTEC does not normally have the applicants attend their meetings, your application will be considered on the basis of the information supplied. Insufficient or inaccurate information may significantly delay the approval process. You are advised to take particular care with grammar and spelling, which needs to be of a high standard, particularly in material that will be distributed to potential participants.
4.3. Submitting Applications
4.3.1. Applications for students must be made in the name of the primary supervisor. Communication of AUTEC decisions will be made through the supervisor and a copy of the letter will be sent to the student where an e-mail address has been supplied.
4.3.2. One fully completed copy (single-sided, clipped not stapled) of the application should be sent addressed to:
4.3.3. Applications can be sent through the following avenues:
4.4. Concurrent Applications
Where the application is being made to an ethics committee other than a Health and Disability Ethics Committee, for example where a staff member is a student at another institution, a concurrent application is to be made to AUTEC. Applicants are required to complete the EA5 application form and to attach a copy of the full application and accompanying documentation. This is to be submitted in the same manner as given above.
The gaining of ethical approval from AUTEC does not imply access to facilities or to participants for research. Independent permission must be obtained from the relevant management authority.
Researchers external to the University wishing to access AUT staff or students as participants should consult the Policy for External Researchers (Appendix R).
Applicants will be advised by letter of the outcome of AUTEC's deliberations. The AUTEC decision will normally be one of the following:
These terms are defined in the Glossary (Appendix A). Applicants are warned that they must not commence recruiting participants or gathering data until they have met any conditions that have been set and they have received the final letter of approval from the Executive Secretary.
This guide is intended to supplement the Information Sheet exemplar which may be accessed through the related articles download in the grey column to the left. AUTEC requires all projects to have a comprehensive Information Sheet which is user friendly and presented in language suitable for all potential participants. More than one Information Sheet may be required, depending on the nature of the research. The experience of many researchers is that a very useful way to present the information is by way of questions and answers. Accordingly, this is the format is used in the AUTEC exemplar.
The following headings may prove useful to applicants, although other headings may of course be incorporated as appropriate.
PROJECT TITLE and DATE of the Information Sheet
This should be a simple description of the research that is neutral in terms of the research question. Researchers should note that their title should be worded so as not to discourage potential participants.
An invitation to take part in the research, emphasising the voluntary nature of participation
WHAT IS THE PURPOSE OF THIS RESEARCH?
A clear explanation of the aim of the study and the procedures to be followed in lay terms. Include reference to being part of a student's research project for a particular degree if this is the case and indicate if any publications or presentations are likely to result from the research.
HOW WAS I IDENTIFIED AND WHY AM I BEING INVITED TO PARTICIPATE IN THIS RESEARCH?
Provide details of the selection process. Identify any exclusion criteria and include a matching statement on the Consent Form.
WHAT WILL HAPPEN IN THIS RESEARCH?
Provide details about all aspects of involvement for participants.
WHAT ARE THE DISCOMFORTS AND RISKS and HOW WILL THESE DISCOMFORTS AND RISKS BE ALLEVIATED?
Identify any possible discomforts and risks (whether physical, psychological or other) which may eventuate as a result of participation, as well as ways of mitigating these. If there are serious risks, a matching statement must be provided in the Consent Form. Thought should also be given here to issues of compensation if relevant and to provision of support if necessary (e.g. counselling).
WHAT ARE THE BENEFITS?
Provide a realistic explanation of what benefits may be realised through this research. Distinguish between benefits to participants and to researcher.
HOW WILL MY PRIVACY BE PROTECTED?
Address any issues of anonymity and/or confidentiality and provide an assurance with regard to participant privacy. If participants are able to be identified through any aspect of the research output, this must be specifically stated here and a matching statement provided in the Consent Form. Note that anonymity is not the same as confidentiality.
WHAT ARE THE COSTS OF PARTICIPATING IN THIS RESEARCH?
Identify any potential costs (time, money etc) which might be incurred through participation, including how much time will be required. Include all relevant financial considerations including payment of expenses or fees to participants.
WHAT OPPORTUNITY DO I HAVE TO CONSIDER THIS INVITATION?
Provide details of the following:
HOW DO I JOIN THE STUDY?
Provide details of participant acceptance process.
WILL I RECEIVE FEEDBACK ON THE RESULTS OF THIS RESEARCH
AUTEC usually requires that participants are given (or given access to) a summary report of the research findings.
WHAT DO I DO IF I HAVE CONCERNS ABOUT THIS RESEARCH?
The following statements must be included in the Information Sheet:
Any concerns regarding the nature of this project should be notified in the first instance to the Project Supervisor, enter name, email address, and a work phone number.
Concerns regarding the conduct of the research should be notified to the Executive Secretary of AUTEC, Kate O’Connor, firstname.lastname@example.org , 921 9999 ext 6038.
AUTEC approval details
Approved by the Auckland University of Technology Ethics Committee on dd mmmm yyyy. (Note that this is the date in the AUTEC letter of FINAL approval, not approval with conditions. The Information Sheet must not be distributed until this has been received).
AUTEC Reference number xx/xxx
For your convenience, an Information Sheet exemplar is provided for use as a template for the Information Sheet.
The Consent Form and Assent Form Exemplars provide you with forms for use by participants in your research. There are two documents. One is a collection of Consent and Assent Forms for use in a variety of situations and with participants who have normal levels of literacy. The other is a combined Information Sheet and Assent Form specifically designed by Early Childhood Educators for use by parents or guardians with pre-literate children.
You are advised:
The Confidentiality Agreement Exemplars provide researchers with agreements for typists, transcribers, translators, research assistants, interpreters and people other than the researcher who will have access to data.
You are advised:
Collect only the personal information that is necessary for a lawful purpose connected with the business of AUT.
Where an agency collects personal information, the agency will collect it directly from the individual concerned.
Ensure that the person is aware of:
Information is not to be collected by unlawful or unfair means and is not to be an unreasonable intrusion on the personal affairs of the individual.
Protect personal information with reasonable safeguards from loss, misuse, or unauthorised access.
Provide access to an individual's own personal information.
Correct personal information on request by the individual.
Take reasonable steps to ensure that information used is accurate, up to date, relevant, and not misleading.
Ensure that we do not keep personal information for longer than is required for the purpose it was gathered.
Ensure that information gathered for one purpose is not then used for another.
Ensure that personal information is not disclosed to any other person or agency.
Only use unique identifiers if it is necessary for research purposes. Unique identifiers may not be cross-linked for tax purposes.
These ethical guidelines on health research with children were developed by Nicola Peart and David Holdaway (for full references refer to the original article)1 and updated in 2007 by Nicola Peart, and are published by the Health Research Council of New Zealand.
THE CODE OF RIGHTS
The Code of Health and Disability Services Consumers' Rights became law on 1 July 1996 as a regulation under the Health and Disability Commissioner Act. It confers a number of rights on all consumers of health and disability services in New Zealand and places corresponding obligations on providers of those services. Application of the Code is very wide and extends to any person or organisation providing, or holding themselves out as providing, a health service to the public or a section of the public, whether that service is paid for or not. With regard to disability services, it extends to goods, services and facilities provided to people with disabilities for their care or support or to promote their independence, or for related or incidental purposes. Unlike health services, disability services do not have to be provided to the public in order to be covered by this legislation. The Code therefore covers all registered health professionals, such as doctors, nurses, dentists, etc, and in addition brings a level of accountability to all those who might be considered outside the mainstream of medical practice, e.g. naturopaths, homeopaths, acupuncturists etc. As well as applying to individual providers, the Code also applies to hospitals and other health and disability institutions and allows the Commissioner to enquire into systems issues across professional boundaries. It does not extend to purchasing decisions or confer entitlement to any particular service. The obligation under the Code is to take "reasonable actions in the circumstances to give effect to the rights, and comply with the duties" in the Code. The onus is on providers to show that such action has been taken. The Code does not override other legislation, and nothing in the Code requires providers to act in breach of a duty or obligation imposed by any enactment, or prevents a provider doing an act authorised by another enactment.
There are two key documents published by the Health Research Council in relation to research involving Maori. All researchers undertaking research involving Maori or within a context that involves Treaty obligations are obliged to read these documents:
For this information, please refer to the Referral Guidelines and the Operational Standard for Health and Disability Ethics Committees.
If you require greater clarity about when you need to refer research to a Health and Disability Ethics Committee, please contact the Research Ethics Advisor or the AUTEC Faculty Representative for Health and Envirionmental Sciences.
Note: Once approved, a completed EA5 application form, the approval letter, the regional ethics application and associated documentation such as Information Sheets and Consent Forms, is to be submitted to AUTEC.
Key Words: External researchers/AUT staff and students as research subjects/AUT staff and student records
1.1.2. use AUT staff or student records for research purposes.
2.1.2. AUT staff or student records.
2.2. Where a team /group of researchers consists of both AUT staff or students and external researchers, the approval procedures applying to staff research will apply.
3. RELATED POLICIES AND PROCEDURES
3.2. AUT Intellectual Property Policy (See Appendix U)
3.3. Faculty Research Committee Policies and Guidelines
4.1.2. AUT staff and/or student records
4.3. Any necessary ethical approval must be applied for and granted pursuant to procedures set down in the AUTEC guidelines and application forms.
4.4. Application for access approval must be made either before or concurrently with any application for ethical approval.
4.5. An agreement by the relevant Dean, Director, HOD, or Manager for access to their area must accompany the application to the Deputy Vice-Chancellor.
4.6. In considering applications for access, the Deputy Vice-Chancellor (Academic) may take into account (but is not limited to) the following matters:
4.6.2. the impact on staff and students of the proposed research and its dissemination
4.6.3. the impact on AUT of the proposed research and its dissemination
4.6.4. the intended purpose, use and dissemination of the proposed research , including public benefit aspects
4.7. In considering applications under this policy, the Deputy Vice-Chancellor (Academic) may seek the advice of the following as appropriate:
4.7.3. the relevant Dean, Director, HOD or Manager
4.7.4. AUT Research Committee
4.8. Applications for access must be made on the prescribed form.
1. Action research is used here to refer to ways of investigating professional experiences which link to practice, or investigating and improving situations or systems in organisations or communities. The cycle of observation, reflection, planning and action is iterative and the plan of the research evolves over time with input from a range of stakeholders and participants in the research, as the research progresses. There is a continuous and participative research and learning, and action for change and improvement, by a group. Data is collected to inform the group about the context for present practice; generating theory about, in, and for the area of practice; connecting emergent theory to previous theories in that field; and disseminating the theory so that others may benefit from it. In academic research there is often a leader of the research (in the case of a postgraduate student, the writer of the thesis) but at some stages during the research group(s) are involved in designing the research, or collecting the data, or interpreting it, or improving their own practice or learning.
2. Action research which is being led by an AUT staff member or student, or undertaken by a group which includes AUT staff or students, must have:
2.2. ethical approval of a confirmation proposal (or of a series of confirmation proposals for different cycles or stages of the research)
prior to the collection of data from or about human subjects where ethical approval is required by AUTEC. For information on whether ethical approval is needed see Section 6 of AUTEC's Applying for Ethics Approval: Guidelines and Procedures.
2.3. The preliminary proposal should include the proposed topic/question/practice area/problem and the context and intended time-frame within which the research will take place. There should be a statement of the intended improvement to practice(s)/ influences on stakeholders/emancipation of participants /audiences for dissemination of the research. There should also be a statement about how rigour will be attained/maintained, such as the number and type of intended cycles, the initial makeup and credibility of the core research group. This proposal may explain how the research leader or group intends to cope with a variety of possible scenarios.
3. This proposal should also outline the steps which will be taken to make sure that relevant stakeholders have been consulted and have given their approval for the research to proceed; the strategies to be used to encourage participants or community members to influence the research plan or process or tools and yet also allow those who do not wish to participate or who wish to have limited participation to express their views and have them respected; the strategies by which it is intended that the research results will be disseminated or utilised; and the intended roles of research participants or stakeholders in the production of publications or other research outputs for intended audiences.
4. Subsequent confirmation proposal(s) should include details of the selected research questions, subtopics and themes related to improvement and evaluation of practice or a situation as the research evolves; the arrangements for meetings of the research group, practice group or community group; the types of data to be collected and the methods to be used; and the negotiations over obtaining or sharing information or agreements over interpretation, publications and authorship. Changes to the preliminary proposal should be included, with reasons. Appropriate confirmation approvals from AUTEC should be sought for different stages of the research and each may be approved by a subcommittee of AUTEC.
There are two kinds of potential participants - the research group asked to participate by the leading researcher or action research facilitator, and other participants who may be asked to provide data by the research group at any stage during the evolving research process. All must give their informed consent to the relevant aspect of their participation. For the preliminary proposal, the informed consent of the initial research group/ practice group should be sought and included. Action research requires the researcher(s) to follow the primary consent process with a multistage process. For subsequent confirmation proposal(s) the method and documents used to obtain informed consent from others should be included if and when applicable. The process used to obtain consents should be reflected upon and documented.
1. The principles outlined below are to be adhered to when raising any matters of concern with the Auckland University of Technology Ethics Committee (AUTEC):
Procedures for Reconsiderations and Appeals
Applicants who are not satisfied with an AUTEC decision about their application may seek reconsideration of the decision, or subsequently appeal against a decision as outlined in the procedures below. Such actions are to be commenced within four calendar weeks of receipt of the decision.
4. Second Opinion from Health Research Council Ethics Committee (HRCEC)
Procedures for Expressions of Concern and Complaints
5. Expressions of Concern and complaints
6. Expressions of Concern
7. Formal Complaints
8. Additional Right to Second Opinion
9. Complaint about Health Research
Auckland University of Technology's Intellectual Property Rights Policy may be found online in the intranet here.