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Health and Disability Ethics Committees

General frequently asked questions

This FAQ is not a substitute for information provided in the Standard Operating Procedures for Health and Disability Ethics Committees(external link) or the National Ethical Standards(external link), but can be helpful for expanding on or clarifying points. More information and an FAQ for ETHICS RM can be found in the user manual.

Submitting to HDEC and the review process

I am unsure if my study needs HDEC review. How can I check?
  • If you have looked at Chapter 3 of our Standard Operating Procedures for Health and Disability Ethics Committees(external link) and are still unsure, you can create an application in Ethics RM(external link) and answer the screening questions for immediate feedback.
  • Alternatively, you can email the following information to the HDECs Secretariat (hdecs@health.govt.nz):
    • description of how participants are recruited, or if there are no active participants, in what form will data be made available to researchers (identifiable, de-identified, etc.) before it is handled by the study team
    • whether it is an Intervention or Observational study
    • anything else you are uncertain of from the Standard Operating Procedures
    • additional supporting documents such as a Protocol for the advisors to look at.
What makes a project an audit/quality improvement, and are they always out of scope?
  • Audits/quality improvements are undertaken primarily for the purpose of evaluating current or slightly new practices, and the primary aim is to inform current care in a localised scope, rather than generate generalisable information. Some Observational research may be misattributed to being an audit/quality improvement activity.
  • As per paragraph 30 of the Standard Operating Procedures, audits/quality improvement related activities are out of scope, except for cases of audits that involve use, collection, or storage of tissue without consent, other than in accordance with a statutory exception (set out at section 20(f)(external link) of the Human Tissue Act 2008 and Right 7(10)(c)(external link) of the Code of Health and Disability Services Consumers' Rights 1996).
  • The National Ethical Standards(external link) describes this in more detail.
Is my study health and disability research?
  • The definition is broad, but studies that aim to generate knowledge for the purpose of improving health and health/disability independence outcomes are always considered health and disability research.
  • As per the National Ethical Standards(external link), health and disability research should broadly:
    • aim to answer a question or solve a problem and therefore generate new knowledge to prevent, identify, and treat illness and disease
    • have the ultimate purpose of maintaining and improving people’s health – in the sense of a state of physical, mental and spiritual wellbeing, rather than simply the absence of disease or infirmity
    • support disabled people to be included, participate more, exercise choice and control, and be more independent
    • address health and disability disparities
    • contribute to whānau ora.
  • The Standards further outline what should not be considered health and disability research. If you are still unsure, you can contact the HDECs Secretariat for advice (hdecs@health.govt.nz)
I only found out after finishing my study that I need HDEC review. Can I apply even though my study is finished?
  • The HDECs cannot provide review for studies that have already happened.
  • HDEC review must be obtained prior to commencement, which includes recruitment, analysis, or publication.
  • If this situation pertains to you and you require further assistance, please email the HDEC Secretariat for further discussion.
I am doing a study that does not involve participants, just their information. Do I still need HDEC review?
I am out of scope of HDEC review, where can I get an alternative ethics review?
  • If you are part of an institution like a University or Te Whatu Ora District, you should seek ethics review from an internal committee at your institution.
  • Alternatively, there are committees not administered by the Health Research Council (HRC) that offer ethical approval, but you may wish to seek out clarification with your intended publication whether they are acceptable.
The journal I intend to publish results in requires ethics review, but my study is out of scope for HDEC review.
  • The HDECs can only determine whether something requires HDEC review. Being out of scope for HDEC does not exclude any study from ethics review.
  • Alternative ethics review will need to be arranged and can be provided by institutional ethics committees or independent committee.
  • If your journal of choice has stipulated explicitly that only HDEC review is what they will accept for submission, please email the Secretariat for further discussion.
My Institutional Ethics Committee requires proof that HDEC review is not required for my project. How can I get this?
  • Finishing the screening questions in the application form in Ethics RM(external link) will return an automated email outlining that your project is out of scope for HDEC review if questions are answered correctly.
  • If you are unable to find this email, please check your Spam or Junk folder.
  • More information on completing this form can be found in the Ethics RM manual.
When conducting research in New Zealand, should researchers from abroad be required to obtain ethics approval in New Zealand?
  • Any research conducted in New Zealand (i.e., at least one site located in New Zealand) requires ethics approval from a New Zealand committee.
  • If your study is in scope for HDEC review, a locally based Co-ordinating Investigator (CI) must be nominated and listed in the HDEC application.
Can there be more than one Co-ordinating Investigator (CI) (for example, Co-CIs) on a single trial for a New Zealand site?
  • While there can be, the HDECs require only one to be listed and the application form can only accept one.
  • If your study has more than one CI, it is the responsibility of the study team to select who is the CI for the purpose of the HDEC application and has the oversight required to maintain ethics approval.
What is required as part of Independent Scientific Peer Review?
  • Please see the guidance on our website(external link) for what constitutes Independent Scientific Peer Review. This page outlines what is or is not appropriate to submit as a peer review.
  • Independent Scientific Peer Review is required for any study in scope for HDEC review, and failure to submit an adequate peer review will result in your submission being invalidated.
My study has already been reviewed and approved by another ethics committee overseas/at my institution. Can I submit this as scientific peer review?
  • This does not meet the requirements as per the guidance on our website(external link). The purpose of the peer review is to ensure a study is scientifically valid, which the HDECs do not review.
  • Discussion of ethical aspects by other committees is not a substitute for this document, nor is it a substitute for HDEC review and approval overall if the study is conducted in part in New Zealand.
When is evidence of professional indemnity held by the Co-ordinating Investigator required?
Can I request to be reviewed by a specific HDEC?
  • There are various reasons why you can request a specific HDEC. These reasons commonly include (but are not limited to):
    • your submission was previously Declined by an HDEC and they are familiar with your study
    • you have had similar studies approved by an HDEC and they are familiar with your studies
    • there is a known conflict of interest between you and a member in a particular HDEC, so you may request a different one to avoid this.
  • There is an option in the application form to do this and provide justification. It is important to note that if the HDECs Secretariat are unable to accommodate your request to be reviewed by a specific HDEC, they will contact you with details of this either via email or the ‘Correspondence’ tab on Ethics RM.
I am only available during a certain time to attend my application’s review. How can I request a specific time? Can I change my application time?
  • If ahead of your application submission you know what times that you are available for, please provide detail of this in a cover letter for your application, or email the HDECs Secretariat (hdecs@health.govt.nz). Alternatively, the application form has a free-text field where you may request a specific 30-minute timeslot. These three methods are checked during agenda assignment and are considered before it is finalized. Please note that if multiple applicants request the same/similar time slots, it may not be possible to honour all requests.
  • You may request a different time after you have received your validation letter outlining your time slot, but it may not be possible to arrange an alternative time for you.
  • Please check the start time(external link) of meetings before you request a timeslot to ensure your request is workable. The first 30 minutes of any meeting is reserved for HDEC business and cannot be requested.
When is my submission being reviewed?
  • If your submission is a Full application, this will be reviewed at the next available full HDEC meeting. A schedule of when these take place can be found on our website(external link). The clock for Full applications is 35 days and are validated on the agenda closing date it was submitted by.
  • If you have a full application and selected a specific HDEC, it will be reviewed at the next available meeting for that Committee.
  • If your submission is an Expedited application or a post-approval form (Amendment, Progress Report, etc.), then unless otherwise told, your application is reviewed online by a Subcommittee and not at a full meeting. The clock for these submissions is 15 days.
  • If you have submitted your response to Provisional Approval, all submissions are reviewed online by the lead reviewers (unless you are otherwise notified).
What can I expect following submission of my full application?
  • Applications submitted by 12pm of the agenda closing date will be validated (if valid) and assigned to the next available meeting. You will receive a valid letter confirming the date and time of your review within a few working days of this.
  • During your allocated timeslot, the Committee will ask questions and raise ethical issues. Some matters may be resolved during the meeting, and some may require document amendments that will need to be sent back to the Committee. You will be advised of your decision via a letter on Ethics RM.
  • Our website contains further information on the process here(external link).
Do I need to prepare/bring anything to the (full review) HDEC meeting?
  • No prior preparation is required; however, it can be helpful for researchers to have their study documents and application form on hand (electronically or printed) as the Committee may refer to pages directly with their questions.
  • Our website contains further information on HDEC Full meetings here(external link).
Do I have to attend the review of my application if it has gone to a full meeting?
  • It is preferable for researchers to attend so that issues raised could be resolved within the meeting.
  • An application is always reviewed at the meeting it is assigned to even if no one on the research team makes it to the timeslot.
  • Regardless of attendance, researchers are provided with a decision letter following the review of their full application.
When can I expect to receive my letter from the full meeting?
  • The minutes following the meeting can take up to 2 weeks or more for the HDECs Secretariat to complete. Letters are sent following the completion of the minutes by the HDECs Secretariat.
  • If a letter is taking longer than usual/more than 2 weeks after the meeting, please contact the HDECs Secretariat (hdecs@health.govt.nz) to check if there are any expected delays or for expected timeframes. We will endeavour to provide updates in advance.
When can I start my study?
  • You can start your study once you have received an Approval letter for your application and you have completed all Standard and any Non-standard conditions (if any) listed in the letter.

Post-approval submissions

What can be submitted with annual reports?
  • Some studies are only required to fill in the annual progress report form and submit.
  • You can submit any non-substantial updated documents for filing for your progress report.
  • If your study involves a new medicine, you will need to submit a safety report.
  • For more information see the Standard Operating Procedures for Health and Disability Ethics Committees(external link), paragraphs 198 – 205. Please note that the annual reports should not be used to submit substantial amendments and will require separate submission.
Will I get a reminder when my progress report is due?
  • At this stage we are unable to do this in Ethics RM but will hopefully have this feature in the future. 
  • Please ensure you are aware of your reporting period, which is outlined in your application approval letter and any subsequent progress report submissions. Your annual report date is determined by the date of your application approval letter.
I have submitted my application/post-approval form but a document is missing, can you add it to my project for me?
  • Unless the Committee has asked for something to be added or this addition has been discussed with the HDECs Secretariat, we cannot add anything new once the application has been validated. This includes sending documents via the ‘Correspondence’ tab in Ethics RM.

General administrative questions

How do I respond to Provisional Approval?
I will not make the 90-day deadline for responding to Provisional Approval. Can I have an extension?
  • Please email the HDECs Secretariat (hdecs@health.govt.nz) as soon as you are aware that you are unable to meet the deadline.
I was referred to an HDEC template in the list of changes I need to make. Is it mandatory to use HDEC templates?
  • HDEC templates(external link) are not mandatory; however, they were created in consultation with the HDEC members to ensure that they cover all items required under the National Ethical Standards.
  • Templates are often recommended to researchers as guidance to meet all National Ethical Standards and can be used as guides or adapted for each study’s needs.
I went to submit something on Online Forms, but it says that this is no longer in use.
  • The HDECs replaced Online Forms with Ethics RM(external link) on 01 September 2021.
  • If this is your first time logging in on Ethics RM, your login details from Online Forms remain unchanged for Ethics RM.
I have read the Standard Operating Procedures and am still unsure if my updated documents require submission as an amendment.
Can I use documents I have submitted as an amendment while waiting for HDEC approval?
  • Until you have received an Approval letter, anything submitted as an amendment (i.e., recruitment material) cannot be used until then.
What is a locality? What can I expect from locality review?
  • Chapter 10 of the Standard Operating Procedures for Health and Disability Ethics Committees(external link) outlines this in detail.
  • District Health boards, academic institutions (such as universities), private companies (such as clinical trial units), private hospitals or clinical practices, or other health and disability research centres are all considered a locality. What a locality checks is outlined under paragraph 173 of the Standard Operating Procedures.
  • How to document locality review is outlined in the Ethics RM manual
My study was created prior to the release of the National Ethical Standards (2019). Do I need to ensure that my study complies with the new Standards?
  • Yes, all studies that maintain ongoing HDEC approval must be in line with the current National Ethical Standards(external link), regardless of when the study was first approved. It is the responsibility of the CI to ensure that the study remains compliant with the most up-to-date ethical standards.
  • Some studies may be asked when they submit post-approval items to ensure that their study is updated to incorporate the current National Ethical Standards.
Where can I follow the progress of a submission that I have made to HDECs?
  • You can follow the progress of your submission by looking at the ‘History’ tab in Ethics RM.
  • Further information on navigating Ethics RM can be found in the manual
My letter has an error. Can this be corrected?
  • If your letter contains an error caused by the HDEC Secretariat, it can be reissued. Please use the ‘Correspondence’ button to send a message through EthicsRM advising of the error and a team member will be in touch.
  • If it is a result of submitter error (e.g., the wrong version number or date on a document) this cannot be changed as it was the document identifier received by the HDEC at the time of review. Please ensure these are correct before submitting. If you require the correct details to be displayed on an HDEC letter, you can submit these documents as a non-substantial Amendment, indicating minor administrative changes.

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