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.
Should you apply to:
The University of Otago Human Ethics Committee (UOHEC) or
The University of Otago Human Ethics Committee (Health) (UOHEC (Health)) or
The Health and Disability Ethics Committee (HDEC)?
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Please note if applying to the HDEC, it is a requirement of the Deputy Vice Chancellor (Research and Enterprise) that the following document-s must be forwarded to the Academic Committees office:
- 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 annually to the University Council through the Risk Management Ethics and Statutory 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.
- 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), namely:
- Ethical Guidelines for Observational Studies;
Ethical Guidelines for Intervention Studies.
- 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 c onsider changes to research protocols previously approved and when appropriate to monitor ongoing studies.
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 other than in their capacity as consumers of health and disability services, relatives of consumers, 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
- 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.
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, 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 1994), 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.
On 1 July 2012 four new Health and Disabilities Ethics Committees (HDECs) came into operation using the new Standard Operating Procedures (SOPs) and a system of online application for ethics review. Information about this new process is available at www.ethics.health.govt.nz.
Researchers who are uncertain whether HDEC review is required should respond to the Ministry of Health Screening Questionnaire available through the website given above. If HDEC review is required, continue with the online application process. If HDEC review is not required, you will need to submit an application for ethical review to the University of Otago Human Ethics Committee (Health), as your research still requires ethics review.
The University of Otago Human Ethics Committee (Health) expects that all applications for ethical approval will comply with the established ethical standards set out in the guidelines from the National Ethics Advisory Committee (NEAC), namely,
An Intervention Study is a study in which the investigator controls and studies the intervention(s) provided to participants for the purpose of adding to the knowledge of the health effects of the intervention(s). Experimental studies and clinical trials are intervention studies.
NEAC guidelines for Intervention studies
An Observational Study is all health and disability research that is not an intervention study. Observational Studies may involve looking at the health effects of interventions, but the researchers do not control these interventions which would have been provided regardless of participation in the study.
Guidelines for Ethical Practices in Research and Teaching Involving Human Participants (Non-Health Research)
Please use these guidelines when applying to the University of Otago Human Ethics Committee (UOHEC) (Non-Health)
Guidelines for Ethical Practices in Research and Teaching Involving Human Participants
- 1 lay member of the Council appointed by the 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 School of Medical Sciences nominate by the Dean of the School
- 1 member of the academic staff of any Division who has clinical medical qualifications and experience, nominated by the Dean of the Faculty of Medicine
- 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 for the University of Otago Human Ethics Committee (Health)
- 1 lay person appointed by the University Council (Convener);
- 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 Southern District Health Board;
- 2 members from the Māori community appointed by the Director, Office of Maori Development;
- With power to co-opt members with appropriate expertise as needed.
|Receipt of proposals deadline dates|
|24 January||5pm, 14 January|
|21 February||5pm, 11 February|
|21 March||5pm, 11 March|
|18 April||5pm, 8 April|
|16 May||5pm, 6 May|
|20 June||5pm, 10 June|
|18 July||5pm, 8 July|
|22 August||5pm, 12 August|
|19 September||5pm, 9 September|
|17 October||5pm, 7 October|
|21 November||5pm, 11 November|
|12 December||5pm, 2 December|
Meetings for the University of Otago Human Ethics Committee (Health) 2013
|Meeting Dates||Receipt of proposals deadline dates|
|25 January||5 pm, 14 January|
|22 February||5 pm, 11 February|
|22 March||5 pm, 11 March|
|19 April||5 pm, 8 April|
|17 May||5 pm, 6 May|
|21 June||5 pm, 10 June|
|19 July||5 pm, 8 July|
|23 August||5 pm, 12 August|
|20 September||5 pm, 9 September|
|18 October||5 pm, 7 October|
|22 November||5 pm, 11 November|
|13 December||5 pm, 2 December|
Submitting your application
For both committees
Please submit your signed original plus 17 double sided, stapled photocopies by the meeting deadlines listed above. If you face difficulties in meeting a deadline please contact us to discuss this. Please note that late applications are not normally accepted, and please allow sufficient time when posting through the internal mail around the time of a deadline.
University of Otago Human Ethics Committee
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 Jane Hinkley, Academic Committees Administrator (Extension 6531) e-mail: email@example.com and post the original signed application to the Academic Committees Office (we are located on the ground floor of the Clocktower Building).
The University of Otago Human Ethics Committee has two categories of application; Category A and Category B. Category A applications are considered 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. Research falling under Category B is considered to be approved once the relevant Head of Department has signed it but should be sent to the Ethics Committee after the Head of Department approves it but before research commences. You are welcome to scan in the fully signed and approved application and send this to us by email.
University of Otago Human Ethics Committee (Health)
Expedited Review Process
Applicants can request an expedited review process for applications to be considered outside of the normal meeting cycle. The request can be made only for applications for projects with very little risk (eg, audits) and subject to very tight timeframes (eg, 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 firstname.lastname@example.org, Jane Hinkley email@example.com or Joanne Farron de Diaz firstname.lastname@example.org . 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.
University of Otago Human Ethics Committee (UOHEC) Forms
- Category A Application Form for the University of Otago Human Ethics Committee (UOHEC) (Word) (If using Internet Explorer, please right click and save to view)
- Filling Out Your Human Ethics Application - Important Notes/Guidelines for Applicants (PDF)
- Ethical Approval at Departmental Level of a Proposal Involving Human Participants (Category B) (Word) (If using Internet Explorer, please right click and save to view)
University of Otago Human Ethics (Health) Committee Form
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The Academic Committees 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 Ground Floor of the University Clocktower Building in offices G22, G23 and G24.