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Ethical approval

The University requires that any research involving human participants and/or animals is conducted in accordance with the highest ethical standards. Supervisors must ensure that the student's research project complies with all of the requirements of the University's ethics policy. Where appropriate, compliance includes ethical approval from the relevant ethics committee.

Research Involving Human Participants

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 Ethics Committee do I need to submit an application to?

There are three ethics committees that review research applications from University of Otago staff. 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.
1) The University of Otago Human Ethics Committee
2) The University of Otago Human Ethics Committee (Health)
3) The Health and Disability Ethics Committee (administered by the Ministry of Health)


1) The University of Otago Human Ethics Committee

The University of Otago Human Ethics Committee reviews applications for research involving human participants that is not considered health research and does not involve patients and which falls outside the jurisdiction of the University of Otago Human Ethics Committee (Health) and the Health and Disabilities Ethics Committee (HDEC).

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)
• 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 University of Otago Human Ethics Committee (Health))
• Any form of deception which might threaten an individual's emotional or psychological well-being
• The research is being undertaken overseas by students.
For further information and guidance on submitting applications, please visit the University of Otago Human Ethics Committees’ web site:
http://www.otago.ac.nz/administration/committees/HumanEthicsCommittees.html

2) The University of Otago Human Ethics Committee (Health)

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:
o involve participants recruited in their capacity as consumers of health and disability services (patients)
o 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)
o involve the use of existing anonymised human tissue samples with consent
o involve low-risk (class I) medical devices
o are audits or related studies (except where HDEC review is required by law)
o are observational studies that do not involve more than minimal risk
o are to be conducted wholly or principally for the purposes of an educational qualification, in some circumstances.
The University of Otago Human Ethics Committee (Health) also has a separate application process for low risk studies which allows Departmental Approval of Projects using Health Information (Low Risk Studies or Audits).

The Departmental approval of projects using health information form is intended for low risk health studies or audits where the researcher intends to 1) use unidentified data and can confirm that the study only uses information that cannot be linked to an identifiable individual OR 2) if the researcher is using identifiable data that compiles with the definitions as specified in the Health Information Privacy Code.
‘Departmental approval of projects using health information’ applications are considered to have ethical approval once the appropriate Head of Department has signed off on the proposal however these forms are also audited by a sub-committee of the University of Otago Human Ethics (Health) committee each month. If the committee raise any specific issues with the research then the Principal Investigator will be notified following the sub-committee meeting.

For further information and guidance on submitting applications, please visit the University of Otago Human Ethics Committees’ web site:
http://www.otago.ac.nz/administration/committees/HumanEthicsCommittees.html

3) Health and Disability Ethics Committees (HDECs)

The Health and Disability Ethics Committee will review studies that:

Involve human participants recruited in their capacity as:
o consumers of health or disability support services (patients), or
o relatives or caregivers of consumers of health or disability support services, or
o volunteers in clinical trials
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. For further information and guidance on HDEC applications, please visit the HDEC web site http://ethics.health.govt.nz/home

Contact details:
Manager, Academic Committees: Gary Witte
Tel: 64 3 479 8256
Email: gary.witte@otago.ac.nz
Room: G22 Clocktower Building

Academic Committees Administrator: Jane Hinkley
Tel: 64 3 479 6531
Email: jane.hinkley@otago.ac.nz
Room G24 Clocktower Building

Research Ethics Administrator: Jo Farron de Diaz
Tel: 64 3 479 8956
Email:jo.farrondediaz@otago.ac.nz
Room: G23 Clocktower Building

Research Involving Animals

The Animal Welfare Act 1999 Part 6 provides for the use of animals* in research, testing and teaching. To comply with this legislation, any research that involves the use of any animals must be approved by the Animal Ethics Committee.

Further information, including the appropriate forms, is available from the Director of Animal Welfare, telephone 64 3 479 5976 or from one of the following secretarial staff of the Animal Ethics Committee:
• in Christchurch: tel 64 3 364 0237
• in Dunedin: tel 64 3 479 7422
• in Wellington: tel 64 4 385 5576

The Animal Welfare Office was established in 2001 to assist scientists with their use of animals in research, testing and teaching. The Director of Animal Welfare is a veterinarian with specialist qualifications in laboratory animal medicine. Researchers are encouraged to discuss their proposed animal model with the veterinarian, prior to submitting an Animal Ethics Committee application form.

For further details please visit the website: http://awo.otago.ac.nz.
*Animals are defined to include mammals, birds, reptiles, amphibians, fishes, crabs, squid, octopus, lobster and crayfish, and embryos of mammals, birds and reptiles in the second half of their gestation or incubation period, and marsupial pouch young.

Importation or Development of New Organisms

Any importation or development of new organisms, including all organisms or cell lines modified through the use of recombinant DNA techniques (GMOs), requires approval under the Hazardous Substances and New Organisms (HSNO) Act 1996.
All applications for the importation or development of new organisms must be considered by the Institutional Biological Safety Committee (IBSC) in the first instance. For the importation of new organisms, approval from the Environmental Protection Authority (EPA) is then required, as is an import permit from the Ministry of Primary Industries (MPI).

Further information is available from the Secretary of the Institutional Biological Safety Committee, telephone 64 3 479 5628 or the Biological Compliance website. (ask your supervisor for the username and password).

For information about University Health and Safety policies and procedures, including Hazardous Substances and New Organisms (HSNO), please consult the following website:
http://www.otago.ac.nz/healthandsafety/

Notes:
• It is the responsibility of the Departments and supervisors to advise candidates on ethical matters and to ensure that any required approvals are granted before the research proceeds in earnest.
• The process of obtaining ethical approval may include consultation with Māori when appropriate.
• If a substantial and/or significant change in research direction and/or thesis title occurs, candidates may need to seek new ethical approval. In this respect, candidates are also referred to in Changes to admission details.
• International candidates are alerted to the fact that ethical approval policies and procedures in New Zealand are different to those in other countries.

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