All staff or student research which involves human participants must receive ethical approval
The University of Otago has a strong tradition in research culture and the institution has very high standards for research excellence. All research involving human participants undertaken by University of Otago staff or students should be reviewed by a research ethics committee. The researcher has the primary responsibility for maintaining the highest ethical standards inherent in a culture of research excellence. An ethics committee should be used as a tool for researchers to help establish, maintain and review those standards. The responsibility of the researcher extends right throughout the life of the research project. It does not begin and end with the ethical review process.
Which Human Ethics Committee should I apply to?
There are three human ethics committees that review research applications from University of Otago staff and students (student applications are to be made in the name of their supervisors). The committee that is most appropriate to review your application will depend on the type of research you are conducting and how your participants are being recruited.
- The Health and Disability Ethics Committee (HDEC) – administered by the Ministry of Health
- The University of Otago Human Ethics Committee (Health)
- The University of Otago Human Ethics Committee (Non-Health)
Seeking ethical approval for health and disability related research?
Before applying to the University of Otago Human Ethics Committee (Health) for ethical approval, researchers involved in health and disability research are asked to look at the HDEC flowchart and if necessary complete the HDEC Scope of Review Form to ascertain whether the study falls within the HDEC jurisdiction. If your study does not fall within the HDEC remit, then please proceed with applying for ethical approval from the University of Otago Human Ethic Committee (Health).
|Research involving:Human participants but which falls outside the jurisdiction of |
the University of Otago Human Ethics Committee (Health) and the Health and Disability Ethics Committee (HDEC) (i.e. is not considered health research, does not involve patients.)
UOHEC – application form (Category A) (DOCX)
Departmental Ethical Approval
Deadlines & meeting dates
Health Research (observational and intervention studies) involving consumers of health and disability services (patients) but deemed exempt from HDEC review (see list below)
Health Research (observational and intervention
studies) involving healthy participants who are not recruited as patients.(This would include methodologies which require blood and other tissue samples.)
UOHEC (Health) – application form (DOCX)
UOHEC(H) Minimal Risk Health Research – Audit and audit related studies (DOCX)
Deadlines & meeting dates
Human participants recruited in their capacity as:
consumers of health and disability support services or relatives or caregivers of such consumers or volunteers in clinical trials.
HDEC – How to apply
Terms of Reference for the University of Otago Human Ethics Committee
- To ensure that all teaching and research within the University, or under the auspices of the University, which involves human participants or the use of personal information is carried out in accordance with the University's guidelines for ethics by:
- considering and, where appropriate, approving proposals
- recognising or noting approvals granted by other bodies accredited by the Health Research Council or the Director-General of Health
- approving departmental procedures and periodically auditing those procedures and any approvals that departments have given
- To consider any matter of ethical concern relating to the involvement of human participants in research or teaching which any student or member of staff of the University raises with the Committee
- To ensure that research or teaching proposals are carried out in accordance with the principles of the Treaty of Waitangi, with the currently applicable National Standard for Ethics Committees, and other relevant professional codes relating to research
- To review at least at three-yearly intervals the policies and procedures for giving ethical approval to teaching or research proposals and to foster an awareness of those procedures and of ethical principles in general within the University
- To modify ethical procedures when required to ensure continued accreditation of the Committee under the currently applicable National Standard for Ethics Committees
- To report annually to the Health Research Council
- To report regularly to the University Council through the Health and Safety and Ethics Compliance Committee and otherwise as necessary.
If submitting to the University of Otago Human Ethics Committee, please consult these guidelines: Ethical Practices in Research and Teaching Involving Human Participants
If submitting to the University of Otago Human Ethics Committee, (Health), please consult the NEAC guidelines below.
Terms of Reference for the University of Otago Human Ethics Committee (Health)
- To advise the University Council, Senate, Deputy Vice-Chancellor (Research & Enterprise) and other University staff as appropriate on issues relevant to health research involving human participants including but not limited to the following:
- mitigating the risk to the University in response to the changes being made to the HDECs
- Procedures for the peer review of research involving research participants being undertaken by Otago staff
- Procedures for “locality review”
- Changes to functions, procedures and membership of the University of Otago Human Ethics Committee (Health)
- Collaboration with organisations outside of the University with regard to the ethical review of research applications involving human participants
- To ensure that research conducted by staff and students under the supervision of staff which involves people as participants is conducted with the highest appropriate standards and to review research protocols and their supporting documents based on internationally accepted ethical principles including scientific validity, an acceptable ratio of potential benefits to risks of harm, the minimisation of risks, adequate informed consent procedures, social and cultural sensitivity (including consistencies with the Treaty of Waitangi), measures to ensure the protection of vulnerable populations, and the treatment of participants with respect and dignity
- To protect the interests of participants, researchers and the University of Otago
- To provide advice and assistance in regard to ethical principles to researchers and to the University of Otago
- To review research applications in accordance with the established ethical standards set out in the guidelines from the National Ethics Advisory Committee (NEAC), National Ethical Standards
- To review research applications in accordance with internationally recognised ethical standards deemed to be appropriate by the University
- To review health and disability research applications involving human participants including those that are outside the jurisdiction of Health and Disability Ethics Committees (HDECs)
- To review both observational and intervention or invasive studies on healthy participants who are not recruited as patients
- To review research applications involving health information not publicly available
- To consider changes to research protocols previously approved and when appropriate to monitor ongoing studies.
- To report annually to the Health Research Council
- To report regularly to the University Council through the Health and Safety and Ethics Compliance Committee and otherwise as necessary.
Does your research require University of Otago Human Ethics Committee (Health) approval?
The University of Otago Human Ethics Committee (Health) will review health and disability research that is considered outside of the jurisdiction of the Health and Disability Ethics Committees, namely studies that:
- Involve participants recruited in their capacity as consumers of health and disability services (patients)
- Involve participants recruited other than in their capacity as consumers of health and disability services (patients), their relatives, or volunteers in early-phase clinical trials (for instance, health professionals or members of the general public)
- Involve the use of existing anonymised human tissue samples with consent
- Involves any electrophysiological recordings, such as EEG
- Involve low-risk (class I) medical devices
- Are audits or related studies (except where HDEC review is required by law)
- Are observational studies that do not involve more than minimal risk
- Are to be conducted wholly or principally for the purposes of an educational qualification, in some circumstances.
Does your research require Peer Review?
Peer Review in the context of human research refers to the scientific validity of the research project and is a vital step in research project development. Peer review can enhance research project development in a variety of ways through providing an objective perspective from an informed reader. From an ethical perspective it is important that research done with human participants is scientifically valid.
University of Otago Human Ethics Committee (Health) Peer Review expectations
Prior to submission of the Research Ethics (Health) application to the University of Otago Human Ethics Committee (Health) the expectation is that:
- the proposal will have been appropriately peer reviewed
- comments made by the reviewer will be appended to the application
- where the reviewer has made specific recommendations the committee expects to see a response by the Principal Investigator to the peer review comments also appended to the application
There may be occasions where no review has been undertaken, where this is the case, a clear justification for not doing so must be detailed in section 6.2 of the application form.
Administering peer review
It is understood that currently each department has different approaches for conducting peer review. For the purposes of ethical review, the committee requests the following to be recorded at a minimum as part of the peer review:
- Name of researcher
- Name of project
- Reviewer's name/s and contact details
- Date reviewed
Peer Review Guidelines
(The following have been adapted from the guidelines for Dunedin School of Medicine Departments and covers the general principles and standards for peer review.)
Principles for Peer Review
- A peer review process should be commensurate with the type of proposal; the potential risk to participants and where the research will be undertaken
- The type of peer review process that is used must be fit for purpose, efficient and justifiable
- Peer review should involve a process that would ideally lead to a consensus opinion about the quality of the research
Research requires peer review of scientific validity but the level of review should reflect the risk and intended purpose.
Standards for Peer Review
The following are adapted from the “Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the scientific validity of research, 2012.” While not strictly standards, they nevertheless describe the key areas of focus for determining scientific validity and provide a nationally recognised framework for scientific peer review
- The relative merit of the research: consideration of whether the proposed work is important, worthwhile and justifiable. The research should address a health issue that is important for health and/or society. The aims, research questions and hypotheses should build on and address gaps in existing knowledge.
- The design and methods: consideration of the quality of study design and the robustness of the methods used. This might include study methodology, a description of sample recruitment and characteristics (including number, gender and ethnicity where relevant and proposed methods of data analysis), study power. An indication of timelines for the research should be included.
- The feasibility of the research: consideration of whether the overall strategy, methodology and analyses are well reasoned and appropriate to achieve the specific aims of the project. The review will determine whether the research has the likelihood, on balance, of improving scientific knowledge, concepts, technical capacity or methods in the research field, or of contributing to better treatments, services, health outcomes or preventive interventions. The research should be achievable within the specified timeframe and the researcher/research team must have the appropriate experience and expertise to undertake the research.
- The presentation of the application: consideration of the overall presentation, including structure, 'understandability', clarity and readability of the research application. While not directly about the research, the way in which the application reads and gets the message across often reflects how well the research has been planned and conceived. Presentation is a strong determinant of whether the research will be understood, fundable and therefore whether it will be done at all.
Can researchers attend the ethics meeting?
The University of Otago Human Ethics Committee (Health) recognises that researchers may wish to attend the ethics meeting to discuss their proposal under review. If you would like to attend the meeting please advise the academic committee's office at the time of submission by either sending an email or enclosing a note with your application.
Please note, upon receipt of the agenda, the Committee also may invite researchers to attend. In such cases, the researcher will be contacted and a time scheduled by mutual agreement.
Does your research require HDEC approval?
Applying to the HDEC – the application process for the HDEC is fully electronic. The online form is secure and allows the researcher to modify and edit prior to submission.
Use the HDECs webpage How do I apply? to register and create an account.
Summary of the type of studies the HDEC will review
The Health and Disability Ethics Committee will review studies that:
Involve human participants recruited in their capacity as:
- consumers of health or disability support services (patients), or
- relatives or caregivers of consumers of health or disability support services, or
- volunteers in clinical trials (including, for the avoidance of doubt, bioequivalence and bioavailability studies)
Involve the use, collection or storage of human tissue (as defined by the Human Tissue Act 2008), unless:
- informed consent (which may include informed consent to future unspecified research) has been obtained for such use, and tissue will not be made available to researchers in a form that could reasonably be expected to identify the individual(s) concerned, or
- one or more of the statutory exceptions to the need to gain informed consent set out at section 20(f) of the Human Tissue Act 2008 (or Right 7(10)(c) of the Code of Health and Disability Services Consumers' Rights 1996) applies
Involve the use or disclosure of health information (as defined by the Health Information Privacy Code 2020), unless:
- this use or disclosure has been authorised by the individual(s) concerned, or
- health information will not be disclosed to researchers in a form that:
- could identify, or could reasonably be expected to identify, the individual(s) concerned, or
- would allow for the information to be matched with other data sets (for example, through the use of non-encrypted identifiers such as National Health Index numbers).
Exemptions to main criteria
Studies on low-risk devices: A study involving a medical device does not require HDEC review if the device is (or would be) classified as a low-risk (class I) medical device by Australia's Therapeutic Goods Administration (TGA).
Minimal-risk observational studies: An observational study requires HDEC review only if the study involves more than minimal risk (that is, potential participants could reasonably be expected to regard the probability and magnitude of possible harms resulting from their participation in the study to be greater than those encountered in those aspects of their everyday life that relate to the study).
For the avoidance of doubt, an observational study always involves more than minimal risk if it involves one or more of the following:
- one or more participants who will not have given informed consent to participate, or
- one or more participants who are vulnerable (that is, who have restricted capability to make independent decisions about their participation in the study), or
- standard treatment being withheld from one or more participants, or
- the storage, preservation or use of human tissue without consent, or
- the disclosure of health information without authorisation.
- Audits and related activities: An audit or related activity requires HDEC review only if it involves the use, collection or storage of human tissue without consent, other than in accordance with a statutory exception (set out at section 20(f) of the Human Tissue Act 2008 and Right 7(10)(c) of the Code of Health and Disability Services Consumers' Rights 1996).
- Student-led research: From 1 January 2013, a study conducted wholly or principally for the purposes of an educational qualification requires HDEC review only if it:
- is an intervention study, or
- is not conducted at or below Master's level.
National Ethical Standards for Health and Disability Research and Quality Improvement
The University of Otago Human Ethics Committee (Health) expects that all applications for ethical approval will comply with the established National Ethical Standards set out in the National Ethics Advisory Committee (NEAC), 'Ethical Standards for Health and Disability Research and Quality Improvement'.
Composition of the University of Otago Human Ethics Committee
- 1 lay person appointed by the University Council (Convenor)
- The Deputy Vice-Chancellor (Research & Enterprise)
- The Director (or nominee) of the Bioethics Research Centre
- 1 member of the academic staff of the Department of Psychology nominated by the Head of Department
- 1 member of the academic staff of the College of Education nominated by the Dean, with expertise in research involving children or young people
- 1 member of the academic staff of the Faculty of Law nominated by the Dean of the Faculty
- 2 Māori members nominated by the Treaty of Waitangi Committee
- 1 Pacific Knowledge Researcher nominated by the Pro-Vice-Chancellor, Humanities
- 2 lay members nominated by the Convenor of the Senate
- 1 student member nominated by the Executive of the Students' Association
- (With power to co-opt up to two further members)
- (Members of the Committee shall be chosen not only because of the area of their expertise but also for their personal qualities. The Committee's membership shall at any time reflect an appropriate diversity of knowledge and experience in ethics, philosophy, law, health sciences, research design and tikanga Māori.)
Composition of the University of Otago Human Ethics Committee (Health)
- 1 lay person appointed by the University Council (Convener)
- The Deputy Vice-Chancellor (Research & Enterprise), ex officio
- The Director (or nominee) of the University of Otago Bioethics Centre
- The Dean (or nominee) of the University of Otago Faculty of Law
- 1 lay member of the community to represent health consumer perspective
- 2 health researchers from the Division of Health Sciences or the Division of Sciences appointed by the Deputy Vice-Chancellor (Research & Enterprise)
- A member of the academic staff of the School of Pharmacy or the Department of Pharmacology appointed by the Dean of the School of Pharmacy
- A biostatistician from the Division of Health Sciences appointed by the Pro-Vice-Chancellor (Health Sciences)
- 2 health practitioners (eg, paediatrician, mental health expert, physician or general practitioner) appointed by the Pro-Vice-Chancellor(Health Sciences), after consultation with the Te Whatu Ora New Zealand –Southern
- 2 members from the Māori community appointed by the Director, Office of Maori Development
- 1 student nominated by the Convenor
- With power to co-opt members with appropriate expertise as needed.
Meeting dates and deadlines for submission
The deadline for both committees is on the same day each month. Please note that the meetings for the committees are held on separate consecutive days.
Meetings of the University of Otago Human Ethics Committee 2023
|Deadlines for Applications (5pm)|
|5pm, Monday 16 January||(for meeting of 26 January)|
|5pm, Monday 13 February||(for meeting of 23 February)|
|5pm, Monday 13 March||(for meeting of 23 March)|
|5pm, Monday 17 April||(for meeting of 27 April)|
|5pm, Monday 8 May||(for meeting of 18 May)|
|5pm, Tuesday 12 June||(for meeting of 22 June)|
|5pm, Monday 17 July||(for meeting of 27 July)|
|5pm, Monday 14 August||(for meeting of 24 August)|
|5pm, Monday 11 September||(for meeting of 21 September)|
|5pm, Monday 9 October||(for meeting of 19 October)|
|5pm, Monday 6 November||(for meeting of 16 November)|
|5pm, Monday 27 November||(for meeting of 7 December)|
Meetings of the University of Otago Human Ethics Committee (Health) 2023
|Deadlines for Applications (5pm)|
|5pm, Monday 16 January||(for meeting of 27 January)|
|5pm, Monday 13 February||(for meeting of 24 February)|
|5pm, Monday 13 March||(for meeting of 24 March)|
|5pm, Monday 17 April||(for meeting of 28 April)|
|5pm, Monday 8 May||(for meeting of 19 May)|
|5pm, Tuesday 12 June||(for meeting of 23 June)|
|5pm, Monday 17 July||(for meeting of 28 July)|
|5pm, Monday 14 August||(for meeting of 25 August)|
|5pm, Monday 11 September||(for meeting of 22 September)|
|5pm, Monday 9 October||(for meeting of 20 October)|
|5pm, Monday 6 November||(for meeting of 17 November)|
|5pm, Monday 27 November||(for meeting of 8 December)|
Submitting your application
For Both Committees
Paper copies of any application type are no longer accepted. Once fully signed by the Principal Investigator and Head of Department, the application and all required attachments must be compiled as one PDF and emailed by the deadline to email@example.com.
University of Otago Human Ethics Committee - (for studies not considered to be health research and do not involve patients)
In exceptional and unexpected circumstances, a researcher may request that an application be considered under the Fast-Track provisions. Please provide a justification for Fast-Track consideration. To apply for Fast-Track please email your completed Fast-Track application following Head of Department approval to Jo Farron de Diaz (Specialist, Research Ethics) (Extension 8956) email: firstname.lastname@example.org or Paulette Milnes (Senior Administrator) email: email@example.com and post the original signed application to the Academic Committees and Services Office.
Category A vs Category B
The University of Otago Human Ethics Committee has two categories of application; Category A and Category B. Category A applications are considered and approved by the Committee; whereas Category B Reporting Sheets are audited by the Committee after having been approved by the Head of Department on the Committee's behalf. The Human Ethics Committee has delegated authority to Heads of Department to approve low risk research involving human participants who are NOT recruited in their capacity as patients. Research falling under Category B is considered to be approved once the relevant Head of Department has signed it. However, the Category B form should be sent to the Human Ethics Committee immediately after the Head of Department approves it and before research commences. You are welcome to scan in the fully signed and approved application and send this to us by email.
A proposal can only be classified as Category B if NONE of the following is involved:
- Personal information - any information about an individual who may be identifiable from the data once it has been recorded in some lasting and usable format, or from any completed research (Note: this does not include information such as names, addresses, telephone numbers, or other contact details needed for a limited time for practical purposes but which is unlinked to research data and destroyed once the details are no longer needed).*See note below.
- The taking or handling of any form of tissue or fluid sample from humans or cadavers (refer to University of Otago Human Ethics Committee (Health))
- Any form of physical or psychological stress
- Situations which might place the safety of either participants or researchers at any risk
- The administration or restriction of food, fluid or a drug to a participant
- A potential conflict between the applicant's activities as a researcher, clinician or teacher and their interests as a professional or private individual
- The participation of minors (children and young people)
- The participation of any other vulnerable individuals, in particular patients (refer to UOHEC (Health))
- Any form of deception
- A student is travelling overseas from New Zealand in order to undertake human participant research.
If your research involves patient information, for example an audit of patient data, and/or access to any health information/data obtained from the Ministry of Health, District Health Boards, or Pharmac etc, please refer to the University of Otago Human Ethics Committee (Health) Minimal Risk Health Research - Audit and audit related studies
*Exception: Please note that Category B applications can be used where you are interviewing a public figure (s) about their work/profession (e.g. a writer, artist, musician, politician, government official). Public figures can expect to be interviewed and quoted about their professional practice, so this is considered minimal risk. However the public figure needs to be offered the opportunity to give informed consent to be interviewed, named and quoted.
University of Otago Human Ethics Committee (Health)
Research Ethics (Health) Application Form
From January 2020 no paper copies of any University of Otago Human Ethics Committee application type will be required. Once fully signed by the Principal Investigator and Head of Department, the application and all required attachments must be compiled as one PDF and emailed by the deadline to firstname.lastname@example.org.
Expedited Review Process
Applicants can request an expedited review process for applications to be considered outside the normal meeting cycle. The request can be made only for applications for projects with very little risk (e.g. audits) and subject to very tight time frames (e.g. Summer Studentships).
The expedited review process requires considerable extra time and resources and will not be undertaken without good reason. A full application needs to be completed, signed by the applicant, signed by the relevant HoD, scanned and emailed to either Gary Witte email@example.com, Jo Farron de Diaz firstname.lastname@example.org or Paulette Milnes email@example.com. The application must be accompanied by a cover letter or email setting out the justification for requesting the expedited process. A response from the Committee will normally be provided within a week.
This application form is intended for ethics committee review of low risk audit or audit related studies. There are two situations to which this process applies:
- When the previously collected and stored health data is de-identified.Where the study only uses information that cannot be linked to an identifiable individual (see the Health Information Privacy Code, Rule 11 (2) (c) (i))
- When identifiable health information is being used for audit of health provision, process or outcomes. While ethics review may not be required for clinical audit, ethics review should be considered:
- where there is any doubt that the audit also constitutes research;
- when the method of evaluation is beyond usual practice or adds risk for the patient;
- and also may be advisable when it is anticipated or intended that this activity will lead to any publication which has a requirement for ethics approval.
A subcommittee of the University of Otago Human Ethics Committee (Health) reviews Minimal Risk Health Research – audit and audit related studies outside the normal meeting cycle. Submit one copy of your signed form with all required authorisation documents to the Academic Committees office. Upon receipt, a response from the subcommittee will be sent to the Principal Investigator within 5 days.
Forms for both Committees
University of Otago Human Ethics Committee (UOHEC) forms
- Application Form (Category A) (DOCX)
- Ethical Approval at Departmental Level (Category B) (DOCX)
- Deadlines & meeting dates
University of Otago Human Ethics Committee (Health) forms
- Application form for Human Ethics (Health) (DOCX)
- Minimal Risk Health Research – Audit and audit related studies (DOCX)
- Compensation for injury to participants – Form B template (DOCX)
- Deadlines & meeting dates
Decisions for Category A and Research Ethics (Health) submissions are usually given within 3-4 working days following the Ethics Committee meetings. The possible decisions are as follows:
Approved – The study may commence immediately.
Approved – with comments – the study may commence however the Committee expects a written response to the points raised.
Conditional Approval – the study may not commence. The Principal Investigator must respond in writing to the Committee addressing the issues raised. Responses to Conditional Approval are reviewed outside the normal meeting cycle and are accepted at any time. Usually, one electronic copy sent to the Manager, Academic Committees or the Research Ethics Administrator is all that is required. The Principal Investigator can expect a response from the Committee within 3-5 days of receipt.
Deferred – the study may not commence. Additional work will be required on the submission before full consideration can be given. Reasons will be outlined in the Committee's letter.
Declined – the Committee will provide comments outlining the issues raised and invite the PI to re-submit for a future meeting.
If the nature, content, location, procedure (including recruitment of participants) or personnel (including student investigators) of an application approved by the University of Otago Human Ethics Committee or University if Otago Human Ethics Committee (Health) changes, applicants are responsible for informing the Committee of those changes.
It is a requirement for all Category A and Research Ethics (Health) approved studies to submit a Final Report. Please note this does not apply to studies reviewed and approved under the provision of Category B or Minimal Risk Health Research – Audit and audit related studies.
The Academic Committees and Services office has the responsibility for the administration of the University of Otago Human Ethics Committee and the University of Otago Human Ethics Committee (Health). The Academic Committees Office is located on the 1st Floor, Scott/Shand House, 90 St David's Street, Dunedin
Manager, Academic Committees and Services
Tel +64 3 479 8256
Jo Farron de Diaz
Tel +64 3 479 8956
Paulette MilnesTel+64 3 479 6531