Filling Out Your Human Ethics Application

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FILLING OUT YOUR HUMAN ETHICS APPLICATION
A Guide for Applicants
Please download a fresh application template from our website for each new
application, to ensure you have the updated version.
1.
University of Otago staff member responsible for the project:
All applications submitted to the University of Otago Human Ethics Committee must be
submitted under the name of a University of Otago academic staff member. In the case
of collaborative research only the name of the principal investigator should be given
here. In the case of student research, the application must be submitted in the name of
the student’s supervisor. All correspondence from the Committee will be addressed to
this person. Other researchers, including students, should be listed under section 5.
2.
Department
Indicate the Department of the applicant. All correspondence from the Committee is
automatically copied to the Head of the Department.
3.
Contact details of the staff member responsible:
Please list only the contact details for the staff member listed in section 1. An email
address is essential so that you can receive correspondence by email.
4.
Title of Project:
Give the full title of the project.
(Please consider whether the title is understandable by lay people with no expertise.
The title in the Information Sheet should be amended so that it is easily understood by
your participants).
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5.
Indicate type of project and the names of other investigators and the students;
List all collaborating staff, students, or researchers from outside the University of Otago.
After the application is approved, the Committee will need to be informed if there are
any amendments to the list e.g. if a student replaces another a year into the study.
6.
Is this a repeated class teaching activity?
If the application for ethical approval is being made for a teaching activity, rather than
research, indicate yes. If this is a repeat application, it is helpful to provide the
application reference number for the previous proposal.
7.
Fast-track procedure
In exceptional and unexpected circumstances, a researcher may request that an
application be considered under the fast-track provisions. Please provide a robust
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 protected] and post the original signed application to the Academic
Committees Office (we are located on the ground floor of the Clocktower Building).
8.
Intended start date of recruitment and data collection:
Intended end date of data collection:
Research cannot commence until full ethical approval has been given.
Give the date at which it is expected that participants will become involved in the
project. Many researchers carry out a literature review before starting the recruitment
of participants, but the date to be detailed here is the date that recruitment will begin.
Also give the date that completion of the project is expected. Note that approval of
research projects expires after three years. If the project continues longer than three
years, the applicant should contact the Committee with a request for an extension.
Please note that retrospective approval cannot be given.
9.
Funding of the project:
If the project is externally funded, participants will normally be expected to be made
aware if any commercial use is made of the data or if the data will be shared by any
outside person or organisation. This information should be included on the Information
Sheet. If this information will not be shared with potential participants, please explain
why.
10.
Brief description in lay terms of the purpose of the project
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Please provide a short description of the purpose of the project using terminology
appropriate for non-academic members of the Committee. A more detailed explanation
of the research is asked for in Item 11 below. If the Committee cannot understand your
proposal, it is unlikely that your intended participants will be able to understand either.
11.
Aim and description of project:
Please clearly specify the aims. What is the research question the research will attempt
to answer, and how? Be sure to cite any references included under this section. Outline
the overall implications of the research. What will the researcher and wider community
gain from the research? What are the benefits? Note that a more detailed description
of the methodology as it pertains to participants should be given in section 13.
12.
Researcher or instructor experience and qualifications in this research area
Indicate the relevant experience, expertise and qualifications for undertaking the
research or for supervising the students undertaking the research. This question is
primarily aimed at the staff member listed under question 1, but can include coinvestigators/co-supervisors and the student researcher.
13.
Participants
Participants means any person whose behaviour, actions, or condition, the researcher
proposes to study; or whose personal information the researcher proposes to collect or
use.
13. (a) Population from which participants are drawn:
Specify what sort of participants you will be seeking.
Specify whether participants will be vulnerable, e.g. minors, prisoners, or
anyone whose capacity to give informed consent is compromised in any way.
If your research proposes to recruit patients/consumers of health and disability
services; or proposes to collect the health information of a healthy individual
(not recruited as a patient) (e.g. collecting blood, urine, tissue samples, or
measuring health information or introducing any health intervention); then your
study falls under the University of Otago Human Ethics Committee (Health).
Please apply using the Health application form located on our website at:
http://www.otago.ac.nz/administration/committees/HumanEthicsCommittees.
html .
13. (b) Specify inclusion and exclusion criteria:
Specify what type of participant you are seeking. Careful consideration should
be given to setting the inclusion criteria (those participants you wish to attract
to the project) and the exclusion criteria (those you wish to prohibit from
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participating), taking into account the purpose of the research and also the
safety of the potential participants.
The inclusion and exclusion criteria, as listed here, should also be set out on the
Information Sheet for Participants, and any other Information Sheets that may
be necessary for other interest groups, such as parents/guardians.
13. (c) Estimated number of participants:
Specify the range in the number of participants that will be recruited. What is
the minimum number of participants required to make the research viable in
addressing the research questions? What is the maximum number of
participants? Where a sample size calculation is appropriate i.e., for quantitative
research, it should be provided.
Provide a brief justification for the number of participants. Please note that this
information is expected for both quantitative and qualitative research projects.
13. (d) Age range of participants
Specify the age of the youngest and oldest participants that will be recruited.
Applicants should note the following points if they intend to recruit young
people:
- The legal definition of a minor is usually 20, but varies according to specific
legislation;
- That the Children and Young Persons legislation defines a ‘child’ as a person
under 14 and a ‘young person’ as a person between the ages of 14 and 16;
- That 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 16
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
nature of the research.
13. (e) Method of Recruitment
Explain in detail how participants will be contacted and recruited. If
advertisements will be used, explain where they will be posted or published.
Please attach the advertisement to be used to recruit participants at the end of
the application. A template for the development of an advertisement for the
recruitment of participants is provided with the application form.
Will any other organisation be involved in the recruitment of participants? If so,
please include details of how this process will be managed. Please attach any
relevant agreements or MOUs with organisations.
13. (f) Please specify any payment or reward to be offered:
Specify whether or not a payment will be made to participants. Payments made
to participants to cover costs associated with participating in the research, such
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as compensation for travel, are appropriate. It is considered that payments
offered as inducements are not appropriate. Where a koha is to be offered,
please be specific about what you are giving to the participants and its value.
Please note that care needs to be taken with wording when preparing 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 incurred, and this payment is tax free.
14.
Methods and Procedures
Describe the design of the study, and in particular the nature of the tasks required of
participants. The various precautionary measures to be taken to avoid harm or
discomfort should be described (up to two pages; any questionnaire or survey form, or
line of questioning to be used must be attached). Will there be control conditions? Will
there be differing levels of participation? If so, please describe.
15.
The Privacy Act 1993 and the Health Information Privacy Code 1994 imposes strict
requirements concerning the collection, use and disclosure of personal information.
The following questions allow the Committee to assess compliance.
15. (a) Are you collecting and storing personal information directly from the
individual concerned that could identify the individual?
YES / NO
15. (b) Are you collecting information about individuals from another source? Please
explain.
If information about individuals is being collected from another source, please explain
which source, and reasons for this collection method.
15. (c) If you are collecting personal information directly from the individual
concerned, specify the steps taken to make participants aware of the
following points:
You should make participants aware of these points in an Information Sheet for
Participants (a suggested template is attached):
 the fact that you are collecting the information
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the purpose for which you are collecting the information and the uses you
propose to make of it
who will receive the information
the consequences, if any, of not supplying the information
the individual's rights of access to and correction of personal information
If you are not informing them of the points above, please explain why.
15. (d) Please outline your data storage and security procedures.
The University requires original data of published material to be archived for at
least five years after publication for possible future scrutiny. The University is
responsible for providing data storage space, data relating to projects should be
kept in secure storage within the University Department concerned [rather than
at the home of the researcher] unless a case based on special circumstances is
submitted and approved by the University of Otago Human Ethics Committee.
While the expectation of the Committee is to retain original data for at least 5
years in secure storage, it is also expected that any personal information which
generally refers to the information the researcher may hold on the participants
such as contact details, audio or video tapes, after they have been transcribed
etc, will be destroyed (the data derived from the research will in most cases be
kept for much longer or possibly indefinitely). The paramount issue for the
researcher is to ensure that the participant is fully aware of exactly what will be
done with the data and the personal information prior to consenting to take
part in the research.
The storage of any sensitive or personal information regarding research
participants on storage systems outside of the control of the University of Otago
is inappropriate. It is recommended that a University controlled data centre be
used for the purpose. Information Technology Services provide such a service
and the Committee recommends that you contact Mark Borrie (ITS Security
Manager) to discuss your needs. Please provide the Committee with the details
of the data storage and access and security arrangements once they have been
made.
Some more information about cloud computing can be found at:
http://www.otago.ac.nz/its/about/publications/otago030292.html
15. (e) Who will have access to personal information, under what conditions, and
subject to what safeguards?
Personal information includes video and audio recordings, transcripts of
interviews etc. Although individuals do not need to be named, the positions of
those with access to the data and their relationship to the research need to be
listed.
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Will participants have access to this information?
Will participants be given access to the data in its raw format? Will the results of
the research be provided or be made available to participants when the project
is completed? This should also be made clear to participants before they
consent to the project.
15. (f) Do you intend to publish any personal information and in what form do you
intend to do this?
Explain the format the data will take in the final write up. If participants are to
be identified, the Information Sheet and/or Consent Form should reflect this.
15. (g) Do you propose to collect demographic information to describe your sample?
For example: gender, age, ethnicity, education level, etc.
The Committee recommends that you use the question format used in the
Census for collecting ethnicity data. The following link discusses the ethnicity
question;
http://www.stats.govt.nz/Census/2013-census/info-about-2013census-data/information-by-variable/ethnicity.aspx
The question allows a range of options and ends in other to allow participants to
self-identify. The question looks like this:
15. (h) Have you, or do you propose to undertake Māori consultation? If not, please
provide a brief outline of reasons why not.
We would refer you to the University of Otago Research Consultation with
Maori Policy (found on http://www.otago.ac.nz/research/maoriconsultation ).
Under the Purpose of the Policy it states those areas of research affected and
expectations of timing and submission dates. You can attach a copy of any
automated response acknowledging receipt. If this process has already been
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undertaken please attach a copy of the letter you will have received from the
Ngāi Tahu Research Consultation Committee.
16.
Does the research or teaching project involve any form of deception?
Where participants have not been informed fully of the nature and purpose of the
research, or where in the course of the project some degree of deception is involved,
the researcher must provide participants with an explanation of the research goals and
procedures when the procedure is completed. Researchers also have an obligation to
be available after participants have participated in the project, should any stress, harm,
or related concerns arise. Participants should normally have the opportunity to obtain
information relating to the outcome of the project if they wish. Where relevant, explain
how these matters will be dealt with in the proposed research.
17.
Please disclose and discuss any potential problems
The applicant should discuss potential issues or concerns that might arise as a result of
the research and strategies for avoiding or mitigating potential problems. Such issues
may include, but not be restricted to the following:
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Physical harm, discomfort or inconvenience to participants;
Mental or emotional distress or anxiety prompted by the research;
Legal complications (examples may include the disclosure of illegal activity by
participants to researchers)
Community or media concerns with the research (e.g., topic might strain community
relations, touch upon sensitive issues, or attract media attention);
Conflict of interest (examples may include situations where the researcher may have an
additional role to that of a researcher, i.e., an employee of an organisation being
studied, using participants that are also students (and thus) will be marked by the
researcher);
Threats to anonymity (e.g., the population sample might be small and therefore difficult
to maintain participants’ anonymity);
Potential risk to researcher (examples include research involving potentially violent
participants, students undertaking interviews alone or in an unsafe setting, sensitive or
emotionally distressing issues, student researchers travelling overseas).
Ethical approval does not override the University of Otago’s Travel Policy and Fieldwork
Policy. These policies must be reviewed and complied with. The Committee will expect
a risk assessment for any overseas travel. Has the University’s Travel Insurer provided
cover?
Please refer to Appendix B – Students Conducting Research Overseas.
If research is to be conducted anywhere in the Pacific region, the Committee seeks
assurance that the researcher has read and considered the Pacific Research Protocols
regarding the research. All University of Otago staff and students need to comply with
the principles set out in the Protocols, which can be found at the following website:
http://www.otago.ac.nz/research/otago028670.html
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If the research is being carried out by a student researcher, the supervisor has the
responsibility of ensuring the student is aware of the Protocols and complies with them.
Please provide the Committee with confirmation as to whether or not a research permit
is required to conduct research in the relevant Pacific location, and if so, please provide
the Committee with evidence that a permit has been obtained.
Researchers also have an obligation to be available after participants have participated
in the project, should any stress, harm, or related concerns arise. If it is anticipated that
professional services are appropriate, these services for the participants should be
clarified.
Participants should also be made aware of risks, limitations and obligations inherent in
the research.
Participants normally should have the opportunity to obtain information relating to the
outcome of the project if they wish.
18.
Applicant’s signature
Please ensure that the person signing the application is the applicant (the staff member
responsible for the research as listed in section 1) rather than the student researcher.
The applicant should sign off their application prior to submitting it to their HOD.
19.
Departmental approval
The Head of Department’s signature on the application is confirmation that the
research project is valid and ethically sound. The signature is an endorsement of
the methodology the research employs.
If the person responsible for the project is the HoD then it is inappropriate for them to
sign here as HoD. Ideally the appropriate Dean or Pro-Vice-Chancellor should sign
instead,. Alternatively a senior member of the academic staff from the department who
is knowledgeable in the subject area or is familiar with the research methodology can
sign off.
Please get the original signed before copying the application for the Committee. Each
Committee member needs to have a fully signed off copy.
Please note that the Committee expects to review the finalised documentation that will
be provided to participants, as opposed to a draft; therefore writing style, spelling and
formatting should be of the highest standards and should be free of any errors or
ambiguity. If the application is for student research, it is the responsibility of the
supervisor to proofread and correct documentation that will be distributed to research
participants.
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APPENDICES TO THE APPLICATION
Please attach the Information Sheet, the Consent Form and the Advertisement to
Recruit Participants to this application. The Information Sheet and Consent Form must
be separate documents, as the participant keeps the Information Sheet but returns the
Consent Form.
Information Sheet
Consider whether a simplified title is required for your participants. At a minimum the
Information Sheet must describe (using wording and terms that ordinary people can
comprehend):
 the nature and purpose of the research
 the procedure and how long it will take
 any risk or discomfort involved
 who will have access and under what conditions to any personal information
 the eventual disposal of data collected
 the name and contact details of the staff member responsible for the project and an
invitation to contact that person over any matter associated with the project
 details of reimbursement offered for participation and compensation payable in the
event of harm
 exclusion criteria for the project, if applicable,. (If exclusion include a clear
statement to the effect that: “People who meet one or more of the exclusion
criteria set out above may not participate in this project, because it involves
unacceptable risk to them.”) and any other relevant matters.
The Information Sheet must conclude with the statement: “This study has been
approved by the University of Otago Human Ethics Committee. If you have any
concerns about the ethical conduct of the research you may contact the
Committee through the Human Ethics Committee Administrator (ph +643 479
8256 or [email protected]). Any issues you raise will be treated in
confidence and investigated and you will be informed of the outcome.”
Consent Form
The Consent Form must make it clear that a participant:
 understands the nature of the proposal;
 has had all questions satisfactorily answered;
 is aware of what will become of the data (including video or audio tapes and data
held electronically) at the conclusion of the project;
 knows that he or she is free to withdraw from the project at any time without
disadvantage;
 is aware of risks, remuneration and compensation;
 is aware that the data may be published;
 is aware that a third party (i.e. transcriber) may have access to the data;
 is aware that every effort will be made to preserve the anonymity of the participant
unless the participant gives an express waiver, which must be in addition to and
separate from this consent form.
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Research or teaching involving children or young persons may require written consent
from both the child or young person AND the parent/guardian unless an adequate
justification is provided. Ensure that the parent/guardian’s consent form is linked to the
child, as surnames may differ.
Advertisement for Recruitment of Participants
The Advertisements should include the following:
 description of the project;
 criteria for eligibility;
 benefits to participants (if any);
 time commitment for participants.
Applicants should use the pro forma Information Sheet and Consent Form provided by
the University of Otago Human Ethics Committee, with appropriate adaptation, unless a
case is made and approved that these formats would be inappropriate for the specific
project.
Refer to Appendix A: Common Problems with the Information Sheet and/or Consent
Form
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Appendix A: Common Problems with the Information Sheet and/or Consent Form
raised by the Committee
The Committee expects to see the finalised versions that will be given to Participants
under the University’s name. When they review your documentation, they will pick up
any errors and note them, as they want to assist researchers to provide the best
possible information to participants. The following are common issues that arise:
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The need to reword text into lay terms for participants (being user-friendly), and
tailoring the information sheet and consent form appropriately for children and
young people.
More information being required under the Aims section, including noting the
implications of the research and its benefits.
The need to include the Human Ethics Committee contact statement.
The Writing style, spelling and formatting should be of the highest standards and
should be free of any errors or ambiguity. If the application is for student research,
it is the responsibility of the supervisor to proofread and correct documentation
that will be distributed to research participants.
Numbering errors in the Consent Form.
The use of personal pronouns in the Consent Form (ie the Consent Form needs to be
worded from the participant’s point of view).
Neglecting to provide advice about the time commitment involved in the project.
Neglecting to provide details around what clothing may need to be worn, and what
participants will experience.
Checking that anonymity options are available, and ensuring the Information Sheet
and Consent Form relate to each other regarding anonymity.
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Appendix B – Students Conducting Research Overseas
University of Otago staff conducting or supervising research involving human
participants in a country other than New Zealand should be aware of the ethical issues
that this type of research entails. Every effort should be made to identify and mitigate
any potential risk to participants and to the researcher(s). Ethical approval does not
override the University of Otago’s Fieldwork Policy and Travel Policy. Such policies
should be reviewed and complied with.
Safeguarding Participants
The University of Otago Human Ethics Committee asks you to be aware of the issues set
out below and to address any appropriate issues in the application for ethical approval.
If research is being conducted in a country where there might be a relative lack of
educational or health infrastructure or where relatively weak socio-economic conditions
exist, the participants would normally be considered vulnerable. In these circumstances
care should be taken to apply the same ethical standards in the host country as would
be expected in New Zealand.
Care should also be taken to apply the universally accepted fundamental ethical
principles and to be aware that the application of those principles might not be as
straight forward as it would be if the research were being conducted in New Zealand.
In an application for ethical approval for research being undertaken overseas, the
researcher, or research supervisor, must demonstrate that attention has been paid to
the political, cultural, social, linguistic and other relevant contextual issues.
Researchers and supervisors should be mindful that the research must comply with any
requirements of the host country. This may involve local ethical review or Governmental
approval. Confirmation of such approval should be included in the application to the
University of Otago Human Ethics Committee (UOHEC) if it has been obtained. If it has
not, the intention to do so should be explicitly stated in the application. In these cases
the UOHEC would normally conditionally approve the application subject to the
research being approved in the host country. If there is an absence of any ethical review
mechanism in the host country, an effort should be made to solicit the support of a local
“sponsor” of the research. Such a sponsor might vary depending on the local
circumstances but might be an academic from a university in the country or a
community leader.
Information
Will the participants be fully informed of not only the aims of the research but also of
exactly what they will be asked to do, how long it will take and what will happen to the
data once it has been gathered. They should be informed of all the information in a
format that is appropriate to them i.e., it should be free of jargon, if the information is
written, it should be in the language of the participants.
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Informed Consent
Once participants are fully informed, written consent is normally the universal standard.
Having said this, there may be cases where less formalized consent may be appropriate.
You should be aware of appropriate adaptations of the mechanisms of consent. For
example, it might be appropriate to get consent from community leaders or from
spouses.
Scientific validity
Ethical research requires methodology that results in valid data. Participants should not
be expected to give up their time if the results of the research are not fruitful.
Risks and Benefits
The potential benefits of the research should outweigh any risks to participants. Does
the research potentially benefit the population from which the participants have been
drawn? Ideally, it should.
Supervision of students
Care needs to be taken in supervising students conducting research overseas. While it is
acknowledged that research students are adults and have responsibility for their own
safety, the UOHEC wishes to ensure that the University, through the research
supervisor, has taken due care in the oversight of their students.
Travelling overseas, away from the oversight and guidance of a supervisor, carries some
vulnerability to risks for the student. In an effort to minimise that risk, the Committee
asks that both students and supervisors are familiar with and comply with the guidelines
set out below.
Course Related Student Travel Overseas
1. Departments and Supervisors, together with their students, are asked to assess the
level of risk associated with students conducting research overseas. Determination of
the level of risk should include an assessment of the following factors:
(a) Method of travel – any risk associated with the means of travel to and from the
destination.
(b) Risks associated with the travel destination – including remoteness, climate,
geopolitical climate and potential civil unrest, disease and access to health care and
communication. Travel destination risk is assessed by International SOS (ISOS) which is
a security and medical alert advisory service available to University of Otago staff
members.
(c) Risks associated with course-related activity – this includes research activity.
Students may not be automatically covered by University Liability Insurance Cover and
accordingly risks which create any potential liability for the University must be clearly
identified and steps taken to mitigate the risks.
(d) Fitness for travel – conditions that may affect the ability of the student to travel
should be addressed. Particular attention should be paid to the need for all appropriate
vaccinations.
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2. Departments, supervisors and students must ensure that risks have been identified
and minimised as appropriate before travel commences and must be able to
demonstrate the precautions that have been undertaken.
Procedures for Course Related Student Travel Overseas
Determine the ISOS risk rating of the country or countries the student is travelling to, i.e.
low, medium, high or extreme.
Refer to: http://www.internationalsos.com/private/UOtago_MS
number: 25ACPA000012.
Membership
For travel to high risk countries an application should be made by the department to the
relevant Pro-Vice-Chancellor (PVC). The application should include the security advice
recommended by ISOS together with an explanation of how those risks will be
mitigated. Such factors as the student’s familiarity of the country being visited should
be taken into account. Travel to high risk destinations must be approved by the relevant
PVC.
Travel will not be approved by the UOHEC to countries identified as being extreme risk.
Research undertaken overseas involving human participants must have ethical approval
from the appropriate ethics committee.
Information/documentation/contact details
The department must ensure that the student has a valid passport, necessary visas and
any other relevant travel documentation (be aware that it is the requirement of some
governments that a passport needs to have at least 6 months’ validity remaining after
the date of intended departure from the country being visited).
The department should hold a copy of a detailed travel itinerary of the student. The
itinerary should include flight details (airline, arrival/departure dates and times), dates
and contact details of accommodation. It should also include names and contact details
of any relevant embassy, consulate, sponsor, organisation, institution, family or friend
that can be contacted in the case of an emergency.
The student must hold contact details (phone, text, email) of the department and
supervisor, including after hours contact details in case of an emergency.
Medical Preparation
The department, supervisor and student should assess the medical risks associated with
visiting the country by ISOS. Student Health Services provides travel clinics which are
open to all students who attend Otago University. An appointment at the travel clinic
needs to be booked as soon as the student is aware of their travel destination as some
vaccinations courses take several weeks to complete. Please refer to the Student Health
website for detailed information and costs. www.otago.ac/nz/studenthealth
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Insurance
All students travelling overseas on University study / business should arrange travel
insurance which will cover their course-related activities Please note: Students are
covered by the Professional Indemnity Policy when under the direction or control of the
University; and when employed by, or placed with third parties where such employment
or placement is in connection with their studies).
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