For University of Otago staff and students seeking ethics approval to conduct health science studies involving human participants, there are three different ethics committees to choose from:
- The Health and Disability Ethics Committee (HDEC)
- The University of Otago Human Ethics Committee (UOHEC)
- The University of Otago Human Ethics Committee (UOHEC) - Health
The nature of your study, the characteristics of your participants, and the context in which you are conducting the research are key factors in deciding which committee should review your application. General information about the type the studies that each committee will consider are available on the University’s Human Ethics Committee webpage, but for detailed information on this topic, a closer look at the criteria for review by each committee is required.
Note: UOHEC is an Institutional Ethics Committee that has been approved by the Health Research Council Ethics Committee. UOHEC (Health) is a subcommittee of UOHEC.
Not all studies meet the conditions for HDEC, and the HDEC online submission process takes you through a set of questions to determine whether or not your study needs to be reviewed by one of the HDEC committees. This online submission process includes questions to identify applications that only need expedited review as opposed to full review. The same web-based application form is used for both expedited and full ethics review.
The HDEC website provides information on how to apply using an online process. One useful tip for finding out more about the HDEC process is to create an HDEC account and then begin to write a mock-ethics application. This allows you to look through the online submission process – just avoid clicking the ‘Proceed to Submission’ button on the last section of the online form until you are actually ready to submit an application.
Other useful information can be found in the HDEC Standard Operating Procedures and the National Ethics Advisory Committee’s (NEAC) Ethical Guidelines. These guidelines cover intervention studies and observational studies (include audits, qualitative research, and other related methods).
PLEASE NOTE: The University of Otago’s Academic Committees Office must to be informed about all studies being undertaken by University researchers and research students that have been approved by HDEC. The Academic Committees Office is required to report on these approvals to the University Risk Management, Ethics & Statutory Compliance Committee and for insurance requirements. Send copies of all HDEC approval letters to: Jo Farron de Diaz, Research Ethics Administrator, Academic Services, Clocktower Building, Leith Street, University of Otago, Dunedin.
According the HDEC Standard Operating Procedures, the HDECs are required to reach a decision about an application within 35 calendar days for a full review and within 15 days for an expedited review. However, for full reviews the HDECs can choose to suspend this timeframe once for up to 90 calendar days where they required additional information in order to make a final decision.
Note: The calendar days from 25 December to 15 January inclusive do not count for the purposes of these review time frames.
All of the four HDECs can act as multi-regional ethics committees. There is no specific committee to send these applications to – just follow the standard online application process as for all HDEC applications.
All applications to HDEC for ethical approval need to be accompanied by documented evidence of scientific review (also referred to as ‘peer review’ in HDEC documents).
Documented evidence of scientific peer review needs to be uploaded onto the HDEC website as part of the online submission process. Information about what constitutes scientific peer review can be found in the “Scientific peer review submissions – guidance.”
As part of a HDEC application you will need to provide evidence of locality authorisation.
When the HDEC processes were revised in July 2012, review of governance issues were separated from ‘ethical review’, resulting in replacement of Locality Assessment Form with online evidence of having received ‘locality authorisation’.
According the HDEC Standard Operating Procedures, a ‘locality’ is ‘an organisation responsible for a hospital, health centre, surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be conducted’ (p. 38). This might be a DHB, private hospital, private clinical practice, or other health and disability organisation. If the study is being conducted on a University of Otago campus, the University of Otago is the locality, and locality authorisation must be provided by the University.
Locality authorisation is provided online by the ‘locality’ in question, by having an authorised person sign your application electronically via the HDEC website. (There is no Locality Approval Form as there was for the old ethics application process prior to July 2012). Under the new HDEC process, locality authorisation does not have to be obtained prior to HDEC review, and does not have to be checked or ratified by HDEC once it has been obtained. However, HDEC does state that locality authorisation must be obtained before the study commences at a locality, and that to not do so is a breach of HDEC approval. This includes all HDEC approved studies that are conducted on a UOW campus as well as those conducted in a DHB or elsewhere.
- For locality authorisation provided by an external agency such as a DHB or other organisation, you will need to follow whatever process those organisations have for locality authorisation. As part of the review process you give access to your online ethics application to the nominated person for locality authorisation, who signs your application electronically if authorisation is given.
- For locality authorisation provided by any University of Otago campus, you need to follow the University’s process for locality authorisation. This requires you to fill out the University’s locality authorisation form. The UOW Campus HDEC Manager/Advisor referred to on this form is Dr Sara Filocheck, Associate Dean Research.
If you are a staff member or student of the University of Otago, you must add the University of Otago as sponsor (see below) and request authorisation.
The University of Otago is registered as a sponsor for studies of staff and students with the HDECs.
What is a Sponsor?
An individual, company, institution or organisation that is responsible for initiating, managing and/or financing a study. This excludes an individual company, institution or organisation that has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
(National Ethics Advisory Committee, 2019, p. 250)
Interim Process for UO as a Sponsor
There is currently an interim process for the University of Otago as a Sponsor for studies meeting HDEC requirements.
- The Principal Investigator (PI) adds R & E as a Sponsor on the HDEC application (via Online Forms).
- PI adds the Director (R & E) as the contact and uses the email: firstname.lastname@example.org
- A Research Advisor will be able to review ethics Main Form and protocol documentation.
- A Research Advisor will authorise the sponsor request on the HDEC portal.
UOHEC (Health) will review any application for health research (observational and intervention studies) involving consumers of health and disability services (patients) but deemed exempt from HDEC review (see above). This includes health research involving healthy participants who are not recruited as patients (e.g. studies which require blood and other tissue samples.) It also includes studies conducted for the purposes of an educational qualification at Master’s level or lower and a number of low risk non-intervention studies (e.g. many qualitative studies involving non-vulnerable populations).
Visit the University of Otago Human Ethics Committee website for more information about the UOHEC (Health) review process and to download the UOHEC (Health) application form. Like HDEC, the UOHEC (Health) decisions are based on the National Ethics Advisory Committee’s Ethical Guidelines for interventional and observational studies.
UOHEC (Health) meets monthly. Deadlines for submission of applications and dates for these meeting can be found on the UOHEC website.
UOHEC (Health) usually responds to each application within two weeks of the meeting in which it was discussed. This response may include requirements for the researchers to provide more information however.
Is there a shorter/easier application process for UOHEC (Health) approval if I am undertaking a low-risk study?
Yes. For low-risk research (e.g. audits and some observational studies) there are the options of either an expedited review process (for studies that need to be urgently considered outside the normal meeting cycle) and a process for conditional approval of a study by a Head of Department or Head of Clinical Services. For information on both of these options, please refer to information on the UOHEC website.
At this stage, peer review of the scientific quality of your study is not an absolute requirement before submitting to UOHEC (Health), however it is (increasingly) expected. The UOHEC (Health) application form includes space for information about what peer review has been completed and documentation around this must be provided if it is available. Researchers have the option of indicating that they do not intend to seek peer review, but must provide an good explanation why this is not provided.
The UOHEC (Health) do not specifically require locality authorisation for all studies submitted to them, but will require some form of authorisation for any study when organisations or services involved are external to the University. As for HDEC applications, you will need to follow whatever process these external organisations require from you in order to secure locality authorisation. For DHBs this may well be the exact same process as required for HDEC applications.
The standard (non-health) University of Otago Human Ethics Committee will review ethics applications for studies involving human participants that otherwise fall outside the jurisdiction of both UOHEC (Health) and HDEC. This would apply to studies that are not health research and do not involve patients (e.g. some research involved the general public or healthy people with disabilities in the community might fall into this category) Most research conducted within the Division of Health Science will need to be submitted to UOHEC (Health), but if you require further details about applying to the standard (non-health) UOHEC, please visit the UOHEC website.
If you have questions about the new processes for ethical approval that are not answered above, or if you spot errors in the information provided above, please contact Dr Sara Filoche.