CLINICAL GUIDELINESWORK AT STARSHIPCONTACTSMY SHORTLIST
Health Professionals

Clinical Research Regulatory Approvals

Auckland Health Research Ethics Committee

(AHREC under the Auckland Health Alliance)

AHREC provides ethical oversight and approval of clinical research that is not eligible for review by a Health and Disability Ethics Committee (HDEC), and is carried out by staff and students of the University of Auckland and staff of the Auckland District Health Board and Counties Manukau District Health Board, when participants are recruited from these two DHBs.

Recommended for low risk, observational studies where single site (local) approval is required.
https://www.auckland.ac.nz/en/research/about-our-research/human-ethics/ahrec.html

Ensure your approval and documents are submitted to the research office for organisational registration.

Contact details for technical issues related to submission of the research application form Infonetica: Shanuki Jayamaha - s.jayamaha@auckland.ac.nz who is the ethics committee co-ordinator. Please also refer to the onboarding information for external users. Applicants from the Auckland DHB or CM Health can get access to Infonetica Ethics RM. The first step is to apply to the University of Auckland for a username and password.

NZ Regulatory Application Forms for Clinical Research

(Health & Disability Research Ethics Committee (HDEC), Standing Committee On Therapeutic Trials (SCOTT))

Information on the ethical standards for observational and for intervention studies.

The Health and Disability Ethics Committees (HDECs) check that proposed health and disability research meets or exceeds established ethical standards determined by the National Ethics Advisory Committee (NEAC). These ethical standards are contained in the National Ethical Standards for Health and Disability Research and Quality Improvement

  • Application Forms

The link below provides access to a single site for NZ Regulatory Forms for permission/s to undertake clinical research. The required permissions will be dependent upon protocol design. You can use this site to submit applications to the health and disability ethics committees (HDECs) and the Standing Committee on Therapeutic Trials (SCOTT).
https://nz.ethicsform.org/SignIn.aspx

  • HDEC review

The HDEC review process is set out in detail in the Standard Operating Procedures for Health and Disability Ethics Committees (SOPs): Please refer to the link below for HDEC SoPs.

  • Full review pathway

Higher-risk applications are reviewed by the full review pathway. This means that a decision is made on the application at an HDEC meeting held in accordance with section 5 of the SOPs for HDECs. Final decisions on full review applications must be made within 35 days.

  • Expedited review pathway

Lower-risk applications are reviewed by the expedited review pathway. This means that a decision is made on the application between meetings, by a sub-committee of HDEC members, including the Chair. Final decisions on applications reviewed by the expedited review pathway, which is described in section 6 of the SOPs for HDECs, must be made within 15 days.

Standard Operating Procedure for NZ Health and Disability Ethics committees (HDEC 2012)

Provides guidelines for the constitution and operation of HDECs accredited to consider proposals for research on human participants and innovative treatment.
Standard Operating Procedure for NZ Health and Disability Ethics Committees (HDEC 2012)
document. [DOCX, 307 KB]

National Ethics Advisory Commitee (NEAC)

The National Ethics Advisory Committee – Kāhui Matatika o te Motu (NEAC) is an independent advisor to the Minister of Health on ethical issues related to health and disability research and services.

The National Ethical Standards were updated in December 2019. The revised standards cover all health and disability research and quality improvement. These expand on previous guidelines issued by the NEAC in 2012 and bring together the Ethical Guidelines for Observational Studies and the Ethical Guidelines for Intervention Studies into one document, and also aims to cover gaps and new ethical issues that have become apparent since the 2012 Guidelines.

The National Ethical Standards will help all researchers including new researchers and in-training researchers, foster awareness of ethical principles and enhance more rapid translation of research into clinical practice and health services delivery.
https://neac.health.govt.nz/publications-and-resources/neac-publications/national-ethical-standards- health-and-disability

Medsafe guidelines for clinical trials

Under section 30 of the Medicines Act, approval from the Director-General of Health is required before a clinical trial using a new medicine may commence in New Zealand. The approval process for clinical trials is administered by Medsafe. The Health and Disability Ethics Committees administer the ethics approval system, which applies to all clinical trials conducted in New Zealand.

Approvals under other legislation may be required for clinical trials using certain types of medicines.

All clinical trials in New Zealand are expected to be conducted in accordance with internationally accepted Good Clinical Practice standards, even those that do not require approval under section 30
https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf

Current ICH-GCP

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Guide to current Good Clinical Practice E6(R2)(external link)

  • To complete an online GCP course and certification go to this website
    http://www.pdexternal-roche.com/

  • For Face to Face Courses - Introductory and Refresher (05 June and 16 October 2020)

To register for a comprehensive 6 hour duration face-to-face course (recommended for
interventional studies) https://glcc.co.nz/training/

Courses may be provided in-house for Starship for research teams wishing to renew ICH-GCP
with a modified presentation to 3 hours.

The cost of these courses may be reimbursed with application to debram@adhb.govt.nz

  • ICH / GCP Introduction Course Content

A comprehensive 6-hour seminar covering the below topics:
✓ Clinical Research
✓ ICH / GCP
✓ Clinical Trial Overview
✓ Ethics Committees
✓ Informed Consent
✓ Regulatory Requirements
✓ Records and Documents

Approval for Clinical Audit at ADHB

The research office will no longer review audit not requiring ethical review.

For Starship audit projects the correct approval process is as follows:

  1. Register the audit with Grafton Medical Records (the organisation then has an audit trail of your access to patient study data for audit or research purposes).

  2. Send your audit protocol with this approval to either your SCD or Starship Director Mike Shepherd for review and approval for Starship. A formal response will be provided as documentation.

Auckland District Health Board Approval to undertake clinical research

All research involving Auckland DHB must receive approval from the Auckland DHB Research Review Committee before commencing. The Research Office will register your project and organise the review process for you. Please refer to the Research Office website for application forms and further information.

Please use the following link to register your study for standards review and research review
committee.
http://www.adhb.health.nz/health-professionals/research/review-committee/std-approvalpathway/

ADHB registration of a new research project 

All research projects requiring approval at Auckland DHB have a unique study number (A+ number) issued by the Research Office (RO). Minimal dataset required for RO to issue an A+ number are;

  • Principal Investigator name

  • Study title

  • Funded or not funded study?

  • Commercial or non-commercial study?

An A+ number is not an RO requirement until the process to coordinate institutional review is initiated by an investigator or their representative.