Applying for Ethical Approval
Staff and students in the Faculty of Medical and Health Science undertaking research involving human participants, or the personal information of individuals,
require
ethical approval from the appropriate ethics committee. There are two pathways for ethical approval:
- the Health and Disability Ethics Committees (HDECs), run by the Ministry of
Health
- or the University of Auckland Human Participants Ethics Committee (UAHPEC)
Your study is likely to require HDEC review if it involves:
- Human participants recruited in their capacity as: consumers of health or
disability support services, or relatives or caregivers of such consumers, or
volunteers in clinical trials
- Human tissue
- Or health information
The summary flow chart linked to below describes the scope of research reviewed
by the HDECs.
HDEC eligibility flowchart(173.6KB FILE)
If you are still ensure whether your project requires HDEC review for further
consultation and advice please contact
HDEC.
All applications outside of the HDEC scope should be directed to UAHPEC for
ethical approval. If ADHB patients, facilities, or staff are involved in the
study, you should also contact Auckland District Health Board (ADHB) Research Office.
Similar arrangements should be made if other DHBs are involved.
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Applying to an HDEC
In July 2012, the Ministry of Health HDECs changed radically. The old committees
(Northern X and Y, Central, Upper South A and B, Lower South, and Multi-Region)
were disestablished, and replaced with four new ones (Northern A and B, Central,
and Southern).
Online application process
The application process to HDEC is now fully electronic through the Online Forms
system. Online forms is a secure, password-protected system that allows
researchers to electronically submit manage and share applications and
“post-approval items” for HDEC review.
Health
and Disability Ethics Committees - How do I apply?
Online forms users can:
- create new applications
- upload study documents, such as protocols and information sheets
- obtain authorisations/approvals from other users
- transfer applications to other users
- check draft applications for completeness
- indicate a review preference and submit applications for review
- submit amendments, progress reports and other “post-approval items” for approved
studies
- track all submitted items through the review process
- view correspondence from HDECs about their applications
This system requires that all the listed co-investigators and everybody who you
need approval from (localities, sponsors, etc.) have an account on the system.
Within the application you will be asked to provide evidence of peer review. As
proof of this we recommend that you complete the old Dean's coversheet,
obtaining your Head of Department’s (HoD) signature. This will indicate the
approval of your HoD and account for the internal requirement of having HoD
sign-off on all applications to bodies external to the University.
Dean's cover sheet(154.0KB DOC)
Gaining University / Faculty approval
The approval of the Dean or delegate is handled through the Online Forms system.
To gain approval from the Faculty, and thus the University, please list the
Faculty as a sponsor (in the person of Prof Louise Nicholson) and request
sponsor sign-off from the FMHS account at
healthresearch@auckland.ac.nzz.
FMHS Administration Details for HDEC Applications(64.0KB FILE)
The faculty will automatically receive an email asking us to review and approve
the application. Therefore no paper submission to the Faculty Research Office is
necessary.
2013 HDEC submission deadlines and meeting dates
2013 HDEC meeting dates and venues(168.5KB DOC)
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Applying to UAHPEC
Staff and students in the Faculty of Medical and Health Sciences conducting
research that isn't covered by HDEC review should apply for ethical approval
from the University of Auckland Human Participants Ethics Committee (UAHPEC).
Routes of review
There are 2 routes for UAHPEC approval, low risk and full review. A low risk
research project is one where there is no risk of physical harm, psychological
harm, exploitation or other potential adverse effect. Participants must give
full informed consent and must have the right to choose anonymity in all
reporting. The choice of route will be determined by the committee upon
evaluation of risks of participation and the impediments to clear understanding
by the participants.
When an application is considered as low risk, it will be
pre-screened and reviewed and an outcome provided to the applicant within three
weeks. If the application is not deemed low risk, it will be automatically put
into the next agenda for Full Review.
Only in exceptional circumstances will
UAHPEC consider a request for Expedited Review, that is, for a review outside
normal committee meeting dates. Upon written request from the Principal
Investigator, the Chair of UAHPEC will consider whether such a review can be
undertaken.
- Application forms and guidelines can be found on the
UAHPEC website [Univeristy of Auckland staff intranet]
-
Applicants manual(DOC)
[Univeristy of Auckland staff intranet]
Human Ethics Module – Electronic Submission Process
From 1 January 2013 all applications to UAHPEC must be made electronically
through the Human Ethics Module. This replaces the need for any paper copy
submissions to the Research Office with the Deans coversheet no longer required.
Once you have submitted your application sign off is now obtained electronically
from your Head of Department (HoD).
Human Ethics Module:
https://researchmanagement.auckland.ac.nz
- Click on ‘My Human Ethics’ in the left hand menu to see the Human Ethics
navigation menu. Whilst off Campus you are able to access the system through
The University of Auckland Virtual Private Network (VPN).
- To prepare a new application, click on ‘Create New’ and select ‘New Human
Protocol in Human Ethics Development’
- You may still like to draft your application using a word version of the
application form and copy and paste your final version into the online eform.
Applications form(261.5KB DOC)
Please note that your application must be submitted and then approved by your
HoD by the submission deadline for inclusion on the meeting agenda. Please allow
time for this process to complete when aiming to meet the deadline. You can
track the progress of your application within the module as described in section
6 of the Full User Guide.
Human Ethics Module Full user guide(PDF)
[Univeristy of Auckland staff intranet]
Reviewer sign off guide(PDF)
[Univeristy of Auckland staff intranet]
2013 UAHPEC submission deadlines and meeting dates
Please note that the submission deadline is the last date you can submit your
application for a particular round. UAHPEC meetings are scheduled for three
weeks after the closing date.
2013 closing dates(18.2KB DOC)
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Further advice
Schools and high user departments have designated Ethics Advisors who can assist
you with your application:
Ethics Advisors 2012(PDF)
[Univeristy of Auckland staff intranet]
For any other information or procedural advice please contact the Faculty
Research Facilitator:
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