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.
The HDEC provides a summary flowchart for deciding whether your study requires HDEC review. However, the online submission process for HDEC also 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. This includes a link to a document covering a number of Frequently Asked Questions. 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).
When the HDEC processes were revised in July 2012, ‘scientific review’ was separated from ‘ethical review’. Now scientific review of a research study is not included as part of the ethics review, although the HDECs do required evidence of such a peer review having been conducted prior to approving studies.
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 Standard Operating Procedures for Health and Disability Committees. Furthermore, Appendix 1 of the NEAC's Ethical Guidelines for Intervention Studies: Revised edition presents the “Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the scientific validity of research.” The NEAC is not prescriptive about what does or does not count as peer review, but rather indicates that this is context-specific and provides a set of principles for seeking and undertaking peer review. NEAC defines peer review as “the process by which an applicant can assure an HDEC that a proposal has an appropriate degree of scientific merit, feasibility and likelihood of impact.” Regarding the independence of peer reviewers, NEAC states that:
"Those acting in the capacity of reviewers are charged with delivering a balanced and considered analysis of the research. Generally, the success of the peer review process is determined by the extent to which these evaluations can be considered free of bias, equitable and fair. Objectivity can be compromised if peer reviewers have conflicts of interest, and so appropriate peer reviewers typically will not be materially connected to the researcher(s) in a way that might undermine objectivity, and be free from either positive or negative inducements." (NEAC, 2012, p.45)
Given the NEAC’s guidelines, it seems reasonable to assume that in many cases peer review completed as part of receiving a research grant (e.g. via a successful HRC Project Grant, University of Otago Research Grant or similar) would be sufficient for HDEC purposes. If a study hasn’t been subject to scientific peer review during its development or funding, then this will have to be sought in addition to ethics approval and locality authorisation. Please refer to the NEAC guidelines referred to above for further information on what constitutes a peer review.
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 William Levack, Associate Dean Research & Postgraduate Studies.
Applications to HDEC also include the option of providing sign-off by a 'sponsor' for the research project. The definition of a 'sponsor' according to the HDEC Standard Operating Procedures is: "The person or organisation with responsibility for the initiation, management and financing arrangements of a study."
- For commercially-funded studies being conducted through the University, sponsor sign-off will be required by the organisation providing the funding for the project. A similar process to locality authorisation is followed whereby as part of the review process you give access to your online ethics application to the named sponsor, who signs your application electronically if authorisation is given.
- For University studies that are not commercially funded (which includes most PhD projects and HRC-funded studies for instance) the 'person with responsibility for the initiation, management and financing arrangements for the study' is the primary investigator - usually the named Co-ordinating Investigator (CI) on the HDEC application. In this case, no sponsor sign off is required and HDEC will accept the application without one. Thus, where the HDEC Standard Operating Procedures and NEAC Ethics Guidelines make reference to activities of a 'sponsor' such as: "Researchers and sponsors must ensure that the scientific validity of proposed research has been peer-reviewed before an application is made to an HDEC..."; "Researchers and sponsors are responsible for ensuring that their health and disability research is conducted lawfully..."; "It is the responsibility of the CI and study sponsor to ensure that applicants meet all standard and minor conditions of HDEC approval before the study commences"; "...responsibility for proactively monitoring a study remains at all times with the CI and sponsor of that study..."; "Where a protocol deviation/violation is necessary due to errors, omissions or inadequacies in the protocol or other study documents, the sponsor and CI are responsible for making appropriate amendments...", all of these activities and roles are primarily the responsibility of the study CI to proactively monitor and manage, not the University.
NOTE: Sponsor sign-off is different from locality authorisation for HDEC ethics applications. The University has a separate process for managing locality authorisation for studies conducted on or via a University-owned research site (see above).
If you need to contact to HDEC for any reason regarding a study approved prior to 31 July 2012 (e.g. to ask them a question about your ethical approval, to request approval of a significant revision of your study, to inform them of any minor changes to your protocol, or for any other reason) you should write directly to the HDEC secretariat at the Ministry of Health, who will forward your letter to one of the new HDECs. HDEC secretariat’s contact details are:
Phone: (04) 816 2053
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 William Levack for amendments.