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    3. Ethics Committee (EC) / Institutional Review Board (IRB)
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    3. Ethics Committee (EC) / Institutional Review Board (IRB)

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    3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. 

    To complete the application, applicants will need to create an account and log in to the Ethics Review Manager (Ethics RM).

    HDEC application will need to be completed online. The below links are relevant to completing the application to the HDEC.

    1. HDEC Application Form

    https://ethics.health.govt.nz/assets/Uploads/HDEC/HDEC-Application-Form-Final.pdf

    2. Submission of Amendment

    https://ethics.health.govt.nz/assets/Uploads/HDEC/HDEC-Amendment.pdf

    3. Protocol Deviation

    https://ethics.health.govt.nz/assets/Uploads/HDEC/HDEC-Protocol-Deviation.pdf

    4. Annual Progress Report

    https://ethics.health.govt.nz/assets/Uploads/HDEC/HDEC-Annual-Progres-Report.pdf 

    5. Notification of Conclusion of Study

    https://ethics.health.govt.nz/assets/Uploads/HDEC/HDEC-Notification-of-Conclusion-v2.pdf

    6. Final Report

    https://ethics.health.govt.nz/assets/Uploads/HDEC/HDEC-Final-Report.pdf

    7. Forms and templates

    Templates may be adapted and used. They are not mandatory but help understand the amount of detail required by the HDECs as outlined in the National Ethical Standards.

    3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.

    • Under the standard review process, HDECs must make a final decision within 35 calendar days. They may suspend this timeframe once for up to 90 calendar days where they require additional information in order to make a final decision. 
    • Calendar days from 25 December to 15 January inclusive do not count for the purposes of the 35-day review clock.

    Standard Operating Procedures for HRECs

    3.3 Does EC/IRB have any fast-track or expedited review process?

    Yes, an expedited review process exists where approval may be gained within 15 calendar days. 

    The expedited review pathway applies to: 

    1. All new applications for which full review is not required (including studies of class IIa medical devices, where none of the other features making full review appropriate are present)
    2. All substantial amendments to approved studies that were reviewed through the expedited review pathway
    3. Any substantial amendments to other studies, at the discretion of the chair
    4. All annual progress reports and final reports 
    5. All protocol deviations or violations
    6. All notifications of the conclusion or early termination of a study

    Under the expedited review process:

    • There are no physical meetings of the HDEC.
    • HDECs must give a final opinion within 15 calendar days. They may suspend this timeframe once in the case of provisional approval of an application or substantial amendment. 
    • The 15-day review clock begins on the working day following the submission of the application or substantial amendment. 
    • Calendar days from 25 December to 15 January inclusive do not count for the purposes of the 15-day review clock.

    Standard Operating Procedures for HRECs

    3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?

    All ethics committees reviewing health and disability research in New Zealand should be approved to the requirements of the Operational Standard by the Director-General of Health or the Health Research Council (HRC) to ensure the attainment of appropriate standards and best practices.

    Institutional Ethics Committees (IECs) and other human ethics committees

    IECs are established and supported by the institution to which they belong, usually a university, and they review research that’s occurring within their institution, which can span a broad range of research applications involving human participants. The HRCEC currently approves 13 IECS:

    1. Auckland Health Research Ethics Committee
    2. Auckland University of Technology Ethics Committee
    3. Lincoln University Human Ethics Committee
    4. Massey University Human Ethics Committee: Northern
    5. Massey University Human Ethics Committee: Southern A
    6. Massey University Human Ethics Committee: Southern B
    7. University of Auckland Human Participants Ethics Committee
    8. University of Otago Human Ethics Committee
    9. University of Otago Human Ethics Committee (Health)
    10. University of Waikato Human Research Ethics Committee (Health)
    11. Unitec Research Ethics Committee
    12. Victoria University of Wellington Human Ethics Committee
    13. Wintec Human Ethics in Research Group

    3.5 How frequently do EC/IRB meet?

    HDEC has four committees: Central, Northern B, Southern, and Northern A. Each committee meets once a month.

    Each meeting has a maximum capacity of 12 applications. Agendas close 12 pm on the close date and will only accept submissions made prior to this deadline. Observers for the meetings are welcome and can email the Secretariat ahead of the meeting to request the Zoom information to attend. The first 30 minutes of a meeting is reserved for Committee administrative business. Public holidays that may interfere with Committee business are noted. 

    3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

    No additional approval apart from EC/IRB is required prior to GTAC/EPA approval for GMOs.

    3.7 Please describe the process of the EC/IRB submission for clinical trial approval.

    An online application for clinical trial approval is made using the NZ Online Forms at https://nz.forms.ethicalreviewmanager.com.

    The applicant must first create an account to get access to SCOTT / GTAC and HDEC application forms. Instructions for creating an account and how to prepare and submit applications electronically are on this website. 

    The Online Forms User Manual provides guidance on this process. 

    The applicant should use the SCOTT Online Form for applications to either SCOTT or GTAC. Applicants should note that an application to the Health and Disability Ethics Committees for ethics approval should be made on the separate HDEC Online Form. 

    Delivery site addresses for the trial medicines should be clearly stated on the application form. These delivery site addresses will be included on the approval letter issued by Medsafe if the trial is approved. Applicants should be aware that Customs will not clear delivery of any investigational medicine to unapproved sites or investigators if these are not on the approval letter. 

    3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)?

    Link to current fee schedule (effective July 2022): https://www.medsafe.govt.nz/regulatory/Fees/FeesScheduleJuly2022.pdf

    Criteria for fee waiver:

    A waiver may be considered for a clinical trial conducted for the public good, or for specific types of bioequivalence studies utilizing new generic medicines. Applications should include the reasons for requesting a waiver. 

    The criteria taken into consideration for granting a fee waiver are as follows:

    • The time reasonably required to consider any application made or notice given under the Medicines Act 1981.
    • The degree of complexity involved in considering any such application or notice.
    • The interests of public health in New Zealand.
    • Any funding that the trial receives.

    3.9 Does EC/IRB accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

    Upon receipt of a clinical trial application, Medsafe will issue an invoice. This invoice can be paid electronically. 

    3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

    The Online Forms User Manual is a PDF guide for opening an account and lodging the application. 

    3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

    It depends on the type of study/materials. All materials should be in English. 

    3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

    HDEC has a checklist for the features that need to be included in the ICF - Features of informed consent – checklist template [DOC, 475 KB].

    3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

    Participants in clinical trials may receive “reasonable reimbursement for their time and travel costs". 

    Participants can receive treatment injury cover for personal injury suffered as a result of treatment given as part of a clinical trial only under two conditions:

    1. An ethics committee, which is approved by the Health Research Council of New Zealand or the Director-General of Health, has approved the trial and was satisfied the trial was not to be conducted principally for the benefit of the manufacturer or distributor of the medicine or item being tried; or
    2. the participant did not agree, in writing, to participate in the trial (e.g. if the participant was unconscious).

    Therefore, consenting participants are excluded from compensation in the event of an injury if it was conducted principally for the benefit of the manufacturer or distributor of the medicine or item being trialed (‘commercially sponsored research’), regardless of whether it has been approved by an ethics committee. 

    Accident Compensation Act 2001(external link)

    https://neac.health.govt.nz/national-ethical-standards/part-two/17-compensation-for-injury-in-commercially-sponsored-intervention-studies/ 

    3.14 Are there any specific local safety reporting requirements for clinical studies?

    Urgent Safety Measures:

    It may sometimes be necessary for investigators to take urgent safety measures in order to protect participants in an intervention study from a significant, immediate hazard to their health or safety. If this occurs the applicant must notify the HDEC immediately and in any case within seven calendar days of taking any such measures.

    Notifications of urgent safety measures are considered to be a type of amendment, and applicants should submit them as such to the HDEC for review.

    Applicants must notify Medsafe of:

    • withdrawal from continued development; 
    • withdrawal from the market in another jurisdiction, for any reason; 
    • termination of an overseas study or a study in New Zealand due to serious or unexpected adverse events. The reasons for halting the study and the arrangements for halting the New Zealand arm of the study are required to be included in the report; or
    • temporary halt for safety reasons to an overseas study also being conducted in New Zealand.

    3.15 Does the EC/IRB require any periodic study reporting?

    Annual Progress Reports:

    • Applicants must submit annual progress reports for all approved studies to the HDEC at least yearly, using HDEC’s electronic submission system. It may be desirable in some cases to submit the first annual progress report early, in order to align with annual reporting cycles for the study in other countries.
    • The HDEC secretariat should send a reminder to the applicant about one month before an annual progress report is due. If it does not receive an annual progress report by the due date, it must send a second reminder as soon as possible. If it does not receive an annual progress report within one month of a second reminder being sent, it may cancel approval for the study. However, the secretariat should make all reasonable efforts to contact the applicant before canceling approval for a study and may extend the due date for an annual progress report for up to 90 calendar days from the date of the second reminder letter.

    Annual Safety Reports:

    An annual safety report must be attached to each annual progress report for an intervention study involving a new medicine. While there is no prescribed format for annual safety reports, they must be no longer than two pages in length, written in lay language, and include:

    • A brief description and analysis of new and relevant findings that may have a significant impact on the safety of participants.
    • A brief analysis of the safety profile of the new medicine and its implications for participants, taking into account all safety data as well as the results of any relevant non-clinical studies.
    • A brief discussion of the implications of safety data to the risk-benefit ratio for the intervention study, and whether study documentation has been or will be updated.
    • A description of any measures taken or proposed to minimize risks. (Where such a proposed measure would be a substantial amendment, it must be submitted to the HDEC for review in the normal way.)

    Final Reports:

    • Applicants should submit a summary of the final report of a study to the HDEC within one year of its conclusion or early termination, through the HDECs’ electronic submission system.
    • There is no standard format for final reports. However, they should include information on whether the study achieved its objectives, the main findings, and arrangements for the publication or dissemination of results. 
    • The secretariat should acknowledge final reports and the HDEC reviews them through the expedited review pathway. No further action is necessary unless the chair wishes to discuss any matter arising from the information contained in a final report at an HDEC meeting.
    • Where an HDEC does not receive a final report within one year of the conclusion or early termination of a study, the secretariat should send a reminder.
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