Please note that this document is currently under review. For current documents and processes please visit the University of Otago Human Ethics Committees' webpage.
The University requires that any research involving human participants is conducted in accordance with the highest ethical standards. The University seeks to promote ethical practices in research and teaching and to ensure that all researchers and teachers are aware of ethical issues concerning research and teaching activities that involve human participants. There are prescribed principles and procedures for determining whether teaching and research proposals involving human participants meet appropriate ethical standards.
Researchers, teachers and other members of the University should always consider whether their work requires ethical approval.
If you are undertaking research using human subjects then you will normally be required to gain ethical approval.
The University of Otago Human Ethics Committee is an Institutional Ethics Committee accredited by the Health Research Council (HRC). All applications for ethical approval submitted to the Committee are entered onto a database and applications are archived indefinitely. Details related to applications (both Category A and Category B) are submitted to the HRC as part of the Annual Report which is required for accreditation.
It is important to note that some research undertaken by Otago staff and students falls outside the jurisdiction of the University of Otago Human Ethics Committee.
If you have a health related proposal which involves Health Authority patients, the records of patients, or any Health Providers employed by the Health Authority, you should apply to a Health and Disability Ethics Committee (HDEC) (refer to www.ethics.health.govt.nz). The University Committee and the HDEC are independent from one another with each having its own application template and administration processes. Most proposals from the Faculty of Medicine, the Faculty of Dentistry, the School of Pharmacy and the School of Physiotherapy which could be deemed to be clinical in nature should be submitted to an Health and Disability Ethics Committee (HDEC).
You should apply to the University of Otago Human Ethics Committee when teaching or research proposals involving human participants do not come within the terms of reference of the HDEC as set out above.
Also, you should apply to the University Committee with:
- Proposals from, especially, Physical Education and Pharmacy which are not clinical but are essentially class teaching practicals;
- Proposals from, especially, Physical Education which may well involve physical stress and or (mildly) invasive techniques but do not fall under the terms of reference of the HDEC.
D. Research and teaching proposals that require ethical approval
Any research proposal in the University which:
- involves individuals or groups as the subject of experimentation or study;
- involves human tissue or samples; or
- otherwise concerns individuals' personal information, rights and freedoms requires ethical approval.
Research means any research involving human participants or human tissue:
- conducted by any student or employee of the University of Otago while in the course of his or her study or employment with the University, including research projects carried out by students as part of course requirements and surveys or questionnaires undertaken by the University administration or student services concerning organisational practices; or
- conducted within the precincts of the University; or
- conducted by an outside agency at the request or under the auspices of the University; but does not include the analysis of data collected elsewhere.
Teaching includes any teaching activity undertaken by any employee of the University of Otago while in the course of employment with the University.
A participant is any person:
- whose behaviour, actions, condition, state of health or other characteristics the researcher proposes to study; or
- whose personal information the researcher proposes to collect or use; or
- other than an instructor, who participates in a teaching activity that requires ethical clearance;
- including subjects, clients, informants, students and patients.
Personal information means 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.
E. 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 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. The Committee normally does not comment on Category B Reporting Sheets unless it sees a misunderstanding of the criteria between Category A and Category B or there is a point of clarification or query about the research.
1. Proposals which require approval from the University Ethics Committee (Category A)
Any proposal which involves any of the following matters or issues may not commence without approval from the University of Otago Human Ethics Committee, unless another ethics committee accredited by the HRC or the Director-General of Health has already approved the proposal. In such a case, the researcher or teacher must provide the University Ethics Committee with a copy of the approval given by that other committee before the project commences.
A research or teaching proposal is within Category A if it involves:
- 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 from 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;
- Any form of physical or psychological stress;
- Situations which might place the safety of 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 or other vulnerable individuals;
- Any form of deception which might threaten an individual's emotional or psychological well-being.
- The research is being undertaken overseas by students.
Category A Application Form
Filling out your Category A Application Form - Important Notes/Guidelines for Applicants
2. Proposals which departments may approve (Category B)
If a proposal does not involve any of the issues raised in Category A, a Head of Department or departmental ethical review body may evaluate the proposal using the principles set out in this document. Processes that departments establish for this purpose must ensure that only persons with an appropriate degree of independence and expertise evaluate proposals. Departments may only consider proposals that do not fall within the jurisdiction of the Ethics Committee.
Every department which considers proposals under this policy must report its decisions, as soon as they have been made, to the Ethics Committee using the Category B Reporting Sheets form ).
3. Repeated teaching activities
Activities that are routinely undertaken on an annual or more frequent basis with classes enrolled for specific papers require approval under whichever category above is appropriate. A further approval is required every three years from the date the activity first received approval or if the procedures change from those originally approved.
4. "Generic" proposals (Category A)
In cases where the requirements of a taught paper require each of the students to undertake a project of a particular generic type which involves human participants, and which falls within the criteria of Category A, the department may submit to the Ethics Committee a single proposal seeking ethical approval for the generic project.
Once approved, such generic projects are regarded as repeated teaching activities and the approval is for three years providing no substantive change is made to the protocol in the interim.
Individual student examples of the generic project may be considered and approved at departmental level during the three year period, providing they fall clearly within the parameters of the generic approval and are reported to the Committee using the standard Reporting Sheet.
5. Exempt proposals
Proposals involving existing publicly available documents or data (for example, analysis of archival records which are publicly available) do not require approval under this policy, unless they otherwise fall within Category A.
F. Principles and policies governing ethical approval
The following principles are consistent with the University's obligations to maintain the highest ethical standards in the exercise of academic freedom. They apply to teaching and research proposals that require ethical approval.
There must be:
- Research or teaching merit;
- Participants' informed consent which is given free from any form of coercion;
- Respect for participants' rights of privacy and confidentiality;
- Minimisation of the risk of harm to participants;
- Special care for vulnerable participants;
- Limitation of, and justification for, any deception;
- Appropriately qualified supervision;
- Avoidance of any conflict of interest;
- Respect for societies and cultures of participants;
- Freedom to publish the results of research, while maintaining the anonymity of individuals.
The University's policies develop from these principles and the University expects researchers and, where applicable, teachers to comply with them.
1. Research or teaching merit
Good research design is critical. Poor design and inadequate safeguards have implications for the safety of participants.
Heads of departments have a duty to assess or have assessed the methodology of proposals either directly or through obtaining knowledge elsewhere. The Ethics Committee will interpret the signature of a head of department on an application for a research or teaching proposal as an assurance that the methodology is sound. Where the head of department is an applicant, this duty falls on the appropriate Assistant Vice-Chancellor.
The Ethics Committee may, however, seek independent verification of methodology or scientific validity.
For studies that carry no risk to participants and do not involve a significant intrusion on privacy, the provisions of these paragraphs may be relaxed.
Researchers should note the following extract from the national Operational Standard for Ethics Committees regarding the validity of research proposals.
Proposals for research and innovative practice must be methodologically valid to ensure that consumers of research participants are not needlessly exposed to risks or inconveniences. Proposals must therefore be able to demonstrate that:
i. the proposed research has the potential to address a significant issue, has the potential to advance knowledge, and that it may contribute to improved outcomes.
ii. The rationale for the research is well made (the aims and, where appropriate, hypotheses are acceptable; original findings may result or previous research will be replicated or validated)
iii. The research design, methods and proposed analyses are adequate and appropriate (awareness of the relevant technical issues is clearly demonstrated; risks and limitations of the proposed research are understood; where appropriate, the statistical basis of the research and the proposed methods of analysis are well developed and sufficient to ensure a definitive outcome. Where appropriate, sample size and methods of analysis should be sufficient to provide information about Māori health)
iv. The research team collectively have the academic qualifications, time and facilities, topic-based knowledge, research and, where relevant, clinical experience to undertake the proposed research (this may include consideration of the track record of publication in peer-reviewed scientific or medical journals and other professional publications, and whether or not the researchers have good networks for dissemination of results).
2. Informed consent
Participation of humans in research projects or Category A teaching activities must be voluntary and obtained through informed consent.
The information provided to gain the consent of the participant must:
- be adequate and appropriate, using language that prospective participants can understand.
- describe any attendant discomforts or material risk.
- explain the purpose of the research and include a description of any benefits that the researcher expects.
- disclose all financial implications for participants including payment of expenses or fees, and explain all compensation or indemnity arrangements.
- include an offer to answer any questions and the name, university phone number, e-mail and fax addresses (as applicable) of the person from whom further information can be obtained during the course of the research, and a summary of the results when the project is complete.
- include an offer of assistance in case of distress, and provide contact details.
Consent must be voluntary and therefore obtained without duress, undue influence, or disproportionate financial inducements. There must be a statement to the effect that:
- potential participants who decline to participate will suffer no adverse effect;
- participants are free to withdraw their consent and discontinue participation in the research or teaching activity at any time without disadvantage.
Consent in writing is mandatory, except in minimally intrusive research (eg questionnaires eliciting non-personal information) or where the researcher can provide the Ethics Committee with good reason.
3. Vulnerable participants
Research involving participants at particular risk requires researchers to take special care. These include minors, prisoners, and mentally infirm or unconscious persons. Where the vulnerable participant is not competent to give consent, the researcher must seek a proxy consent from a person legally representing the person's interests. Where the vulnerable participant can understand his or her interests, the researcher must seek the individual's informed consent. In the case of children, however, the researcher or teacher must in any event obtain the consent of the child's legal guardian (not simply the consent of a caregiver). Where either the child or the legal guardian declines consent, the child cannot participate in the project. The vulnerable person's decision not to participate has priority over any other valid proxy consent (e.g., by legal guardians or representatives).
The Committee considers children to be vulnerable participants and as such, requires extra care. If your proposed study involves working with children please note the following points:
(i) The legal definition of the term minor is people under the age of 20;
(ii) The Children and Young Persons legislation, however, defines a "Child" as a person under 14 and a "Young person" as a person between the ages of 14 and 17;
(iii) For the purposes of requiring parental consent it might be appropriate to expect such consent to be obtained for participants up to the age of 17 but that, in some circumstances or for some proposals, this requirement might be able to be lowered to 14 years and younger depending on the kind of information being gathered;
(iv) The Committee retains some degree of flexibility in this regard depending upon the exact nature of any proposal and the practicalities involved.
It is recommended that when children are involved in a research study, the Consent Form and Information Sheet for children should be tailored for that particular age group, using language that is appropriate for the age group.
Researchers must protect participants' personal information at all stages of a research project unless the participant has given a prior written consent for disclosure. Researchers must conform to the requirements of the Privacy Act 1993 and any applicable code of practice that the Privacy Commissioner has issued under the Act (such as the Health Information Privacy Code 1994). In particular, researchers should:
- note that it is preferable to collect personal information directly from the individual concerned;
- take steps to ensure that participants know that the researcher is collecting information, why he or she is collecting it, who will receive the information, and what consequences there are, if any, of not supplying the information;
- ensure participants know of their rights of access to and correction of personal information;
- ensure that they collect only that personal information which is relevant, accurate, up to date, complete, and not misleading;
- keep personal information secure and for only as long as is required, but, if it constitutes original data for the purposes of the research project, for at least five years;
- use personal information only for the purpose for which they acquired it, unless they obtain the authorisation of the individuals concerned.
5. Minimisation of harm
The researcher must balance inconvenience and discomfort to participants against the benefit to the participant or to society and the importance of the knowledge to be gained.
6. Limitation of deception
Deception of participants in research projects is justified only where the impact of the deception on the participant is minimal, the potential knowledge to be gained is significant, and no less deceptive means is reasonably available. Wherever possible, projects involving a measure of deception must incorporate an appropriate debriefing of the participants at the end of the project. The researcher must provide the participants with an explanation of the research goals and procedures. Researchers also have an obligation to be available after participants have participated in the project should any stress, harm or other concerns arise.
7. Appropriately qualified supervision
Appropriately qualified personnel must supervise research or teaching involving human participants.
8. Conflict of interest
Generally, applicants must avoid any project that puts them in a position where their activities as a researcher, clinician or teacher might come in conflict with their interests as a professional or private individual. Applicants must explain to the Ethics Committee the nature of any potential conflict, and what actions if any they propose to take to minimise, avoid or resolve the conflict.
9. Cultural and social sensitivity
Researchers and teachers must ensure that their actions are appropriately sensitive to participants' cultural and social frameworks. Researchers must discuss any issues relating to Māori cultural and ethical values by consultation with the whanau, hapu or iwi concerned.
10. Publication of results
Participants may not attempt to prevent or limit the researcher's right to publish the results of the research. This right of publication is qualified by the need to ensure appropriate preservation of participants' anonymity and to report results accurately. Where possible, researchers must convey findings to participants in a form comprehensible to them.
G. Compliance with other standards
1. Treaty of Waitangi
Research proposals must incorporate, where appropriate, the spirit of the Treaty of Waitangi. This means that all parties involved in the research project must respect the principles of partnership and sharing implicit in the Treaty.
The University's Policy for Research Consultation with Māori provides the framework for an appropriate and mandated consultation process with Māori for research. It ensures a mechanism for managing the consultation process while acknowledging the needs and aspirations of Ngai Tahu for Māori development.
If researchers are drawing comparisons between Māori and non-Māori or if the nature of the project is such that there are clear potential implications of direct interest to Māori the Human Ethics Committee asks researchers to provide evidence that the consultation process has been undertaken by submitting a copy of the completed Māori Consultation Form. This form is available at the following web site http://www.otago.ac.nz/research/maoriconsultation/
2. Codes established by professional associations
Research proposals must also conform to any other relevant professional codes relating to research. Where there is any inconsistency between the University policy and a professional code, the researcher must advise the Committee of the inconsistency, and the Committee shall determine what is to apply.
H. Research Projects and reimbursement
Reimbursement for participants' out-of pocket expenses, time, and any discomfort or inconvenience is permissible, only to the extent that this constitutes recompense.
The following types or circumstances of remuneration are not permitted:
Remuneration which might operate to induce participation of persons whose circumstances disqualify them from participation in the research.
- Remuneration which, in the circumstances, discriminates improperly between participants and non-participants.
- Remuneration which discriminates improperly between different participants or different classes of participants.
("Improper" in these circumstances means a discrimination on irrelevant grounds such as a remuneration unrelated to the contribution made through participation. Giving participants preferential access to programmes, treatment, or resources would constitute improper discrimination as would discrimination on any of the prohibited grounds set out in the Human Rights Act 1993.)
Where a participant withdraws from a project after it has begun, he or she must receive reimbursement proportional to his or her participation. A participant who withdraws from a research project or Category A teaching activity must in no way suffer any academic disadvantage consequent on withdrawal.
Care needs to be taken with wording when preparing all contracts, advertising material and other documents where research participants will be reimbursed for their participation. The word "remuneration" implies that there is an employment relationship between the study participant and the University. Any mention of hourly rates or time involved with the study also implies that there is an employment relationship between the study participant and the University. This has tax and administrative implications for both the participant (PAYE will need to be deducted from their payment) and the University (the participant will need to fill in personnel forms and be loaded to payroll).
The word "reimbursement", however, implies that we are merely reimbursing the participant for expenses and this payment is tax free.
We suggest researchers phrase contracts and advertisements along the lines of:
- "Participants will be given a $20 petrol voucher as a reimbursement for their costs in travelling to this session", or
- "To recognize the costs involved in participating in this study, all participants will be reimbursed $100 for the two testing sessions."
If you would like to discuss any issues of tax liability, please contact the Financial Service Division's Treasury Accountant (ext 8185) or Senior Accounts Administrator (ext 8226).
I. Powers and procedures of the Ethics Committee
1. No proposal may proceed without approval
No proposal within Category A may begin until the Committee approves the proposal, and notifies the applicant in writing.
2. Method of application
The Committee will consider proposals at scheduled meetings, except in the case of the fast track procedure. Meetings are held monthly. Deadlines for application and meeting dates are listed on the Human Ethics Committee webpage.
The Committee will consider applications only when they are correctly presented on the Committee's standard application form.
An electronic application template is available from the Human Ethics Committee webpage.
Researchers should ensure that they have the latest version of the application form by downloading it from the website. The form is updated periodically and by downloading it each time an application is made it will ensure that the latest version is being used.
The Committee will interpret the signature of the Head of Department on the application as an assurance that the proposal is methodologically and ethically sound.
The Committee may seek expert advice, as it requires on any proposal.
The Committee may approve only those proposals, which comply with the University's principles and policies on ethical practices.
Where a proposal does not comply with the University's principles and policies, the Committee may:-
- Provisionally approve a proposal subject to changes made to the Committee's satisfaction. The Committee will give reasons to the applicant for the changes it requires. The Convener may give final approval after the researcher has made the required amendments;
- Decline a proposal. If it does this, the Committee will give reasons to the researcher.
In most cases a letter will be sent to the applicant informing them of the outcome of the meeting, with a copy to the Head of Department, within three working days after the meeting of the Committee.
4. Fast-track consideration of applications
A researcher or teacher may request fast-track consideration of a proposal where he or she can show valid reasons for the need for urgency. The applicant must state these reasons in a letter accompanying the application.
At the discretion of the Convener, the Committee may consider applications by correspondence in cases where consideration of the application at the next scheduled meeting of the Committee would unnecessarily delay the commencement of the research project.
It should be noted that fast track applications normally take up to ten working days.
A proposal may only be approved under this procedure if a minimum of two thirds of the available members of the Committee indicate their approval.
If any member objects to the proposal, it may not be approved under this procedure, and the Committee must consider it at its next scheduled meeting.
The Secretary will report the result of a fast track consideration of a proposal to the Committee at its next scheduled meeting.
5. Subsequent changes to proposals
If the nature, content, procedures, location, or principal investigator of a research proposal changes after the Committee has approved it, the applicant must seek a further approval from the Committee. Applicants are responsible for informing the Committee if any of these changes occurs.
The Convener of the Committee may approve minor changes without reference to the Committee.
6. Reconsideration and appeals of decisions of the Committee
An applicant who is dissatisfied with the Committee's decision may request the Committee to reconsider the decision.
In reconsidering the original decision, the Ethics Committee may seek and consider additional information.