14 March 2019
Important Reminder: Muscle biopsies may only be performed by a Health Practitioner
Performing a muscle biopsy is considered to be a “Restricted Procedure” under the Health Practitioners Competence Assurance Act 2003 and the Health Practitioners Competence Assurance (Restricted Activities) Order 2005.
This means that muscle biopsies can only be performed by health practitioner who is registered with the appropriate authority under the Health Practitioners Competence Assurance Act 2003, and is permitted by his or her scope of practice to perform a muscle biopsy.
The Ministry will update its guidance on restricted procedures and its guidance for ethics committees, to clarify that muscle biopsies are a "restricted activity." (See Ministry of Health website “restricted activities under the Act”).
A breach of this provision is punishable by a fine of up to $30,000 (see section 9 of the Health Practitioners Competence Assurance Act 2003).
08 March 2019
CENTRAL HDEC meeting is moving from 23 April 2019-Tuesday to 26 April 2019 - Friday. The agenda closing date remains unchanged.
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12 December 2018
The Ethics Secretariat at the Ministry of Health will closed for the Christmas period on December 21 at 3pm and will not reopen until Monday 07 January 2019.
All the Health and Disability Ethics Committees will be closed from 21 December at 3pm and will not reopen until Tuesday 15 January.
For urgent study safety concerns or research participant complaints during this time please email firstname.lastname@example.org.
The HDECs and the Ethics Secretariat would like to wish you all a very safe and happy Christmas period, and we look forward to working with you in 2019!
The HDEC Team
21 November 2018
Due to a high volume of applications recently received, the five remaining meetings for this year are likely to be full well in advance of their agenda close dates.
Additionally, the HDEC Secretariat will be closed for the year from 21 December 2018 and the HDEC review clock will be paused from 25 December to 15 January inclusive.
We are in the process of working with Committee members to hold an additional meeting before the 21st December 2018. We will update this announcement once arrangements are confirmed.
The first meeting scheduled for 2019 will be the Central HDEC meeting on 22 January 2019. Agenda close date for this meeting is 10 January 2019.
In the meantime please feel free to contact the Secretariat by email at: email@example.com or by phone: 0800 4 38442.
21 August 2018
We are currently experiencing a high level of demand for the services of the HDEC Secretariat. Please be patient, due to a delay in resources it is taking longer than usual to respond.
If your matter is an urgent ethics or patient enquiry, then please contact the Ethics Team on 0800 4 ETHIC (08004 38442 or +64 4 819 6877 from outside New Zealand).
THE HDEC TEAM
30 July 2018
The HDEC Newsletter - Winter Edition 2018 - is now live
This Newsletter will give you an update on changes to HDECs standards and expectations, as well as pointing you in the direction of new guidance that has been created to help you through the application process.
15 May 2018
It is your responsibility to ensure that the file name to attachments (eg Protocols, Surveys and PISF) that are submitted with Applications and Post Approval Forms, are correctly labelled with the most current version number and date. Please check that these are all correct before submitting your application. Due to our increasing workload, the Secretariat will place a low priority on administrative decision letter changes.
22 November 2017
CLOSING DATES OVER CHRISTMAS AND NEW YEARS 2017/2018
Kia Ora Koutou. The Health and Disability Ethics Committee formally close between 25 December 2017 and 15 January 2018.
The calendar days between 25 December 2017 and 15 January 2018 will not count towards the review clock. Review recommences on 16 January 2018.
25 November 2016
Notice for Researchers
The last scheduled HDEC meeting for full review is Southern HDEC on 13 December 2016 in Christchurch. The agenda is full for this meeting.
You may still submit applications for expedited review up until 23 December 2016. We will assign validated applications for full review to the next available HDEC meeting in 2017.
The next scheduled meeting for full HDEC review is 24 January 2017. Southern HDEC in Christchurch.
If you have an urgent application for review please contact the HDEC Secretariat to discuss the matter.
The HDEC Secretariat will be on leave from the afternoon of 23 December until 4 January 2017.
18 August 2016
Online Form users, please be advised we are currently experiencing some difficulties with the phone lines. Please email the Helpdesk on firstname.lastname@example.org with your technical issues. [RESOLVED - Online form users can now call the Infonetica Helpdesk for technical issue.]
8 July 2016
A lay and non-lay role are advertised for recruitment. Applications due 20 July 2016.
Please pass the message on to any qualified and interested groups.
22 June 2016
HDEC Chairperson Update
The HDEC Chairs would like to advise all applicants who have supervisors that the HDEC strongly recommends supervisors attend and support their students both through the completion of an HDEC application as well as when attending full committee meetings. Student led research is important in terms of new researchers gaining valuable experience however conversely they must be well supported due to their lack of experience.
It is also advisable for student research to have the tertiary institution be noted as a Sponsor of the programme of study. Students are encouraged to approach their Head of Department to discuss this. In the case of funded research it may be appropriate to discuss the matter of sponsorship with the Institutional Research Office.
16 May 2016
Note about upcoming HDEC meeting (7 June)
7 June NTB HDEC - the agenda for this meeting closes on 25th May. This means the agenda is open for 2 weeks. This is because there is no meeting on 31st May.
Therefore, you are more likely to get onto the 7 June agenda if you submit earlier. Feel free to contact the Secretariat for an update on agenda availability.
2 May 2016
There will be a planned outage from Tuesday 3rd May 2016 from 6pm through to Wednesday 4th May 2016 9am NZT.
Kia ora koutou,
There have been some improvements to the Online Forms website.
Post approval forms:
From 4 May 2016 the annual progress report and the protocol deviation and or violation form will have new fields for you to complete. The new fields assist the HDEC in monitoring approved HDEC applications. Please contact the HDEC Secretariat if you have any questions about how to complete the new fields.
Please remember to submit your progress report each year. You may contact the Secretariat if you want to confirm when you report is due, or if you need help submitting your report.
HDEC consulted with sponsors and localities and as a result have added some new and useful fields to the ‘request for authorisations’ feature of Online Forms. This means that local sites and sponsors can have more detail and information when getting locality authorisations in Online Forms.
These new fields also populate in the authorisations report.
Modification to the Submission History tab to always display documents.
Modification to the post approval form number. The online forms reference number for post approval items will now update to reflect the HDEC reference number, i.e. 12/CEN/599/AM06
12 April 2016
Please see http://ethics.health.govt.nz/ for New HDEC Guidance for Researchers on Expected Standard for Responses to Questions in On-Line Forms: Benefits to Maori of Health and Disability Research"
8 March 2016
Close of Agenda Update's for Upcoming Northern B Meetings are as follows:
Northern B - Tuesday 5th April 2016 the close of agenda is Wednesday 23rd March 2016 at 12noon (due to Good Friday and Easter Monday)
Northern B - Tuesday 3 May 2016 the close of agenda is Wednesday 20 April 2016 at 12noon (due to Anzac Day)
Northern B - Tuesday 07 June 2016 the close of agenda is Wednesday 25 May 2016 at 12 noon (due to Queens Birthday)
14 October 2015
The HDEC Secretariat would like to advise researchers that full meeting agendas are filling up 5-7 days prior to the agenda close date. If you are submitting on a specific agenda close date it is unlikely you will be assigned to that agenda.
Two additional HDEC meetings have been held to manage the demand.
As of this message (2pm 14 October) the NTB 3 November meeting (agenda close date 22 October) has 6 applications already, with 12 applications being the maximum.
Please submit early if you are seeking a specific agenda close date. Alternatively, contact HDEC to confirm what meeting your application will be heard at.
29 April 2015
We have implemented speed increases for Online Forms in response to requests from researchers. We hope that this change makes it a little easier for you to submit your applications.
The website address for Online Forms will change after this maintenance. If you type in the old web site address it will re-direct you to the new one but please update your bookmarks to ensure you have the updated address.
The new address is:
If you have any questions before then, please do not hesitate to contact us.
28 April 2015
There will be a planned outage from Tuesday 28th April 2015 6pm through to Wednesday 29th April 2015 9am NZT. (ACTIONED)
27 February 2015
Reminder of obligations around coverage of injuries sustained on clinical trials
Dear General Manager/Clinical research organisation/sponsor
The Health and Disability Secretariat would like to pass on the following message from Medicines New Zealand. Please pass this advice around
It has been brought to Medicines New Zealand’s attention that the process for finalising any compensation for injuries sustained by subjects while on clinical trials is variable and sometimes protracted in New Zealand.
We are conscious of the responsibility that companies have to provide cover that is equivalent to that provided by ACC, depending on the injury being related to the trial medicine and would encourage companies to review their processes to ensure a satisfactory resolution of any claim in a reasonable timeframe.
The ability to engage in clinical trials in New Zealand brings with it an obligation to ensure that any risks posed to the subjects are adequately mitigated by good clinical processes, but also by a robust insurance process. Ethics committees carry the responsibility of ensuring that investigators and sponsors have ensured that ACC-equivalent compensation arrangements will be in place for participants. By way of example, ACC coverage can include a range of entitlements such as compensation for lost earnings, lump sum compensation and independence allowance, home-based care and rehabilitation.
We refer you to the Medicines New Zealand Guidelines on clinical trials compensation for injury resulting from participation in an industry sponsored clinical trial http://www.medicinesnz.co.nz/clinical-trials/
3 February 2015
Progress reports/notifications of conclusion of study/final reports
Please make sure that you are submitting progress reports annually. If your study has finished, please complete first a notification of conclusion of study, followed by a final report within one year.
3 February 2015
Unclear about whether your study is an observational study needing review or exempt from review?
We have developed a short form that you can email to us to determine whether your observational study needs review. This means that you won't have to complete the full form unless you absolutely need to. The form can be found on http://ethics.health.govt.nz/.
17 November 2014
IMPORTANT UPDATE: Change of address from Monday 8 December 2014.
New physical address is:
Ministry of Health
20 Aitken Street
5 November 2014
IMPORTANT TO NOTE! An issue has been identified
whereby Post Approval Applications are not being submitted to the reviewing committee. The NZ Forms system allows the user to submit however the status continues to display IN PROGRESS. Please refrain from submitting any Post Approvals while we are working to resolved this issue. Thank you for your patience. (Resolved 5 November 2014 - PAFs that had a submission code but were marked as IN PROGRESS have been submitted successfully)
10 October 2014
There will be a planned outage on the 13 October and 28 October. The outage will be for 3-5 minutes between 12-6pm NZDST. You should experience little or no effect and can carry on using the system. At the time of the outage you may experience a longer page load or a timeout for a few seconds.
29 August 2014
IMPORTANT TO NOTE! An issue has been identified whereby electronic signatures are invalidating HDEC/SCOTT applications (generated before 28 August), that are opened to the authorisations tab. PLEASE DO NOT OPEN THE AUTHORISATION TAB until this issue has been resolved as this will invalidate the electronic signatures. Thank you for your patience. (Resolved 3 September 2014)
28 August 2014
The multi document upload allows you to upload more than one supporting document on the application's Documents tab. This is compatible with Firefox, Safari, Chrome, Opera and Internet Explorer 10 and above. You can select multiple documents in the one folder and enter the version, document date and description for the selected documents and upload the files at the one time. For more guidance click on the (i) information icon on the documents upload tab.
For browsers Internet Explorer 9 or below, you will need to upload documents one at a time.
31 July 2014
Customising Online Forms categories
After approval it can be useful to organise your approved studies by their HDEC Reference number. We have prepared some instructions on how to customise your online forms categories, and how to group similar studies, eg by Co-ordinating Investigator, study type, or sponsor. You can also use this function to easily find the HDEC reference on the ‘My Projects’ without having to enter into a study. Please check out the instructions and screenshots on our HDEC website at http://ethics.health.govt.nz/home and view the Latest News and Updates section for the instructions.
30 July 2014
Proposal to drop valid letters
At the moment the HDEC team sends you a letter confirming that your application has been processed and assigned to a meeting. These letters do not constitute review and replicate information that is available on online forms.
We plan to stop sending these “valid letters” from 1 September 2014. This will give us more time to spend on processing incoming applications and actioning items that have been approved, ie activities that contribute to faster approval times.
What if my application is out of scope or going to a full meeting?
We would still send confirmation letters for applications that will be heard in a full meeting, and applications/PAFs that are deemed not to require HDEC review
How can I check that my application has been received?
You can view when your application or post approval form has been validated and assigned for review by logging into your online forms account, clicking my project and choosing the study you want to check, then go to the e-submissions tab and click the + sign on submission history. This will tell you whether it has been validated and that it has been assigned to a meeting. The same process works for post approval forms, but you must make sure you have selected the relevant post approval form on the left hand side of the screen.
You will see that items reviewed via expedited review (expedited applications, amendments, progress reports etc) have been assigned to an online meeting. DON’T PANIC! Your items will be reviewed within the time periods set out in the SOPs.
How do I find out about my review?
You will receive a letter via email as well as being uploaded to your online forms account, this letter will detail the decision the committee made and if there are any requests for further information it will state what these are and how to submit them.
If you have any questions please give us a call on 0800 4 ETHICS.
We often get asked whether a study has a sponsor or not. A sponsor is different from a funder and different from the locality. This is how we differentiate:
· A funder is a person or organisation that provides funding for the study (eg HRC, Marsden Fund)
· A sponsor is a person (or entity) who controls the design, running, and funding of a study (eg an industry-funded clinical drug trial).
· The locality authorisation ensures that the host organisation is aware of the proposed research and has assessed whether (in light of staff, resources and other governance matters) it is safe and appropriate for the study to be conducted.
Please don’t declare your funder or locality as a sponsor unless they are in fact designing, controlling or directing the conduct of your research. If your research is researcher-initiated, don’t tick sponsor, but do ensure that locality issues are covered off.
13 June 2014
UPDATE: Changes to Online Forms
We have made some changes to Online Forms from 13 June 2014. The user manuals have been updated to explain how to use these features. Please consult the revised user manuals for more detailed information about the changes. Key changes include:
Provisional Approvals - You will be able to submit responses to provisional approvals via Online Forms.
Navigating Forms – We have modified the project filter tab to make it clearer where within the project tree you are working.
Transferring Forms – We have improved the transfer forms functionality to more clearly differentiate between transferring a form temporarily and transferring project ownership.
Authorisations – The authorisations report tab will include details of cancelled authorisations.
04 July 2013
For users using IE 10:
When using the Print Draft or Generate PDF feature from Online Forms, the webpage is currently experiencing an issue whereby the
page will refresh but the PDF will not be generated. Those users experiencing this issue are advised to use an alternate
Internet browser (e.g. Google Chrome) or switch Internet Explorer 10 into compatibility mode (instructions on how to do this are available
This workaround will allow the user to print from Online Forms whilst this issue is being resolved. (Resolved 6 July 2013)
26 April 2013
The Online Forms website has been updated. This includes the following changes:
- The status field in the Project Information Bar now shows if the application is either submitted or not submitted.
- Once submitted an application and its supporting documents becomes read-only.
- The document description field is now viewable in the Documents - List tab.
- Some information text changes have been made to the forms (questions have not been changed).
- Word limits have been replaced with character limits.
01 November 2012
A new Online Forms User Manual has been released. Please go to the Help tab to download the Online Forms User Manual in PDF format.
01 November 2012
SCOTT now available on Online Forms
The SCOTT form is now available in Online Forms electronic application system.
For step-by-step guidance on creating and submitting these forms, please click here. Don't hesitate to contact us if you need a hand.
04 October 2012
"The SCOTT form will now be available in Online Forms from 1 November 2012. We apologise for this delay, and thank you for your patience as we finalise this form."
26 September 2012
The SCOTT form will now be available in Online Forms from 8 October 2012. We apologise for this delay, and thank you for your patience as we finalise this form.
03 September 2012
MDF and PAF now available on Online Forms
Two new forms are now available in Online Forms electronic application system. The Minimal Dataset Form (MDF) allows you to log applications submitted in hard-copy before 30 June 2012 into Online Forms. The Post Approval Form (PAF) allows you to submit amendments, annual progress reports, and other items once a study is approved.
For step-by-step guidance on creating and submitting these forms, please click here. Don't hesitate to contact us if you need a hand.
20 August 2012
Revised release date for Minimal Dataset and Post Approval Forms.
Online Forms users will be able to log existing studies into Online Forms, and to submit post-approval items (including progress reports and substantial amendments), from Monday 3 September 2012.
We appreciate that you may need to submit a post-approval item for HDEC review before this date. If so, please contact us for advice on doing so.
We apologise again for this delay, and thank you in advance for your patience and understanding as we continue to roll out Online Forms.
16 August 2012
Unfortunately the release of the Minimal Dataset Form and Post Approval Form, due for today, has been furthered delayed. A revised release date will be posted on this site by the end of the day.
The Ministry of Health apologises on behalf of its supplier, Infonetica, for the inconvenience this delay will cause.
If you have inquiries about this update please contact:
Manager, Ethics Committees
Ministry of Health
(04) 816 2053
31 July 2012
Delays in introduction of new form types in Online Forms
Unfortunately the introduction of new form types in Online Forms will be slightly delayed. We now expect that you will be able to:
- Log applications submitted prior to 1 July 2012 using the Minimal Dataset Form (MDF) from Friday 17 August 2012
- Submit amendments, progress reports, and other post-approval items using the Post-Approval Form (PAF) from Friday 17 August 2012
- Use Online Forms to submit new applications to SCOTT from Friday 31 August 2012.
We apologise for the inconvenience these delays will cause, and thank you again for your patience as we roll out the new application system.
24 May 2012
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