--- title: "Legal and contracts" canonical: "https://research.refined.site/space/Research/48333417/Legal%20and%20contracts" format: markdown --- ### Research agreements Health New Zealand | Te Whatu Ora - Waitematā District legal review and approval of the entire contract is **mandatory **for all legal contractual agreements between Health NZ - Waitematā District and a research sponsor/funder. The term 'contract' refers to the main body and all the schedules. “Agreements” refers to any contract, subcontract, Letter of Agreement, Memorandum of Understanding, CTRA. Contract is used on this page to refer to all of the above. In contracts we are described as (Party): **Health New Zealand**, a Crown agent established by section 11 of the Pae Ora (Healthy Futures) Act 2022 trading as Health New Zealand | Te Whatu Ora NZBN: 9429050678402 having its business address care of Health NZ - Waitematā, at Level 2, 15 Shea Terrace, Takapuna, Auckland 0622 **(Health NZ)** ### Agreement templates for **Waitematā-awarded** research grant funding There are Waitematā District-specific templates for research funding (subcontracts for HRC and for other research funding, and Service Level Agreements for either HRC or other funders). Who the other party is will determine whether a subcontract or a SLA is used. Contact [waitemataresearch@tewhatuora.govt.nz](mailto:waitemataresearch@tewhatuora.govt.nz) for templates. Other organisations may use either their own or the NZACRes templates (see below “Other agreement templates”). ### Pathway for legal review & execution | | | | | --- | --- | --- | | 1 | - [ ] | Before a contract can be executed, the **Health Research Agreement Master Signature Sheet **must be completed. Complete section 1. | | 2 | - [ ] | If applicable, following budget review, obtain Finance endorsement in section 2. | | 3 | - [ ] | Lodge request for contract review to the Health NZ - Waitematā legal advisor [Jane Wright](mailto:Jane.Wright2@waitematadhb.govt.nz) and copy (cc) [waitemataresearch@tewhatuora.govt.nz](mailto:waitemataresearch@tewhatuora.govt.nz). Contracts must be provided electronically in MSWord format (not paper or PDF). Once the legal review of the contract (including all schedules) is complete, obtain Legal endorsement in section 3. | | 4 | - [ ] | Once Sections 1–3 have been completed, send to the [Research & Knowledge Centre](mailto:waitemataresearch@tewhatuora.govt.nz) team. Endorsement will be provided in section 4 on receipt of all Waitematā host site approval requirements including a copy of the contract (signed first by the Waitematā lead researcher, if required in contract). | | 5 | - [ ] | The Research & Knowledge Centre team will coordinate completion of Section 5 and arrange for contract execution. | > ℹ️ The delegated signatory for all research revenue contracts at Health NZ - Waitematā District is the Executive Regional Director (ERD) who is Andrew Brant. For all other research contracts please liaise with the [Research & Knowledge Centre](mailto:waitemataresearch@tewhatuora.govt.nz) team. | | | | | --- | --- | --- | | 6 | - [ ] | Contract is ‘wet’ signed by delegated signatories and every page is initialled by the delegated signatory. | | 7 | - [ ] | The signed and initialled contract is scanned in high quality and emailed to the Sponsor (hold onto the physical copy which has been signed by Waitematā and file it somewhere safe). | | 8 | - [ ] | The Sponsor prints the scanned contract, 'wet' signs, scans in high quality and emails research team or alternatively signs using electronic signature (eg. DocuSign). An image of a signature that is simply inserted into the document is not acceptable. | > ℹ️ Research contract/indemnity signed by a clinical trial sponsor using Electronic Signature are accepted with a certificate of completion to authenticate signee. A certificate of completion is created during the electronic signing process and provides a permanent audit trail of each sender, signer, approver, or recipient of the form. Please forward copy of signed contract plus certificate of completion to Research and Knowledge Centre. ### Other agreement templates Also see above “Agreement templates for **Waitematā-awarded** research grant funding”. Health NZ -Waitematā supports the use of the NZ Standard Clinical Trial Research Agreement (sCTRA), the NZ Standard Indemnity and Compensation Agreement (sICA) and the Contract Addendum Template. Download these contract templates directly from the New Zealand Association of Clinical Research [NZACRes website](https://www.nzacres.org.nz/contract_templates/). To clarify, the purpose of the sICA: - The sICA should be used for clinical trials/studies sponsored by pharmaceutical or medical device companies. The sICA is between the DHB and the trial Sponsor or clinical research organisation (CRO) acting on the Sponsors behalf. - The sICA should be used for clinical trials conducted principally for the benefit of the manufacturer or distributor of the medicine or items (device) being trialled. - The sICA is not required for clinical trials that are approved by an ethics committee as not conducted principally for the benefit of the manufacturer or distributor. Compensation for injuries caused to participants as a result of their participation in these clinical trials are covered by ACC or its replacement ### Master non-disclosure agreements (NDA) Health NZ -Waitematā has a number of NDAs with sponsor organisations. These facilitate sharing of confidential protocols with Health NZ -Waitematā researchers who are considering becoming a Locality Site for a clinical trial. Sponsors **must still notify** the [research office](mailto:waitemataresearch@tewhatuora.govt.nz) when contacting a Health NZ -Waitematā researchers about new studies. Local investigators **must** request a copy of the Master NDA from the research office before proceeding with confidential protocol reviews. | | | --- | | - AbbVie Limited (2022) - Apellis Pharmaceuticals (2020) - AstraZeneca (2021) - Avance Pty (2019) - Beigene NZ Unlimited (2023) - Fisher and Paykel Healthcare (2019) - IQVIA RDS Pty. Limited (2022) - Optimal Clinical Trials (2019, maternity and paediatrics only) - Pfizer (2023) - Pharmasol/Pharmaceutical Solutions (2021) - Novotech (2023) | ### Three Harbours Health Foundation (THHF) The primary contact for all THHF research-related queries is [Janice Buenaflor](mailto:Janice.Buenaflor@waitematadhb.govt.nz), Senior Financial Analyst, Corporate Finance. If you are required in a CTRA to describe the relationship between Three Harbours Health Foundation and Health NZ-Waitematā use the following wording: > *Three Harbours Health Foundation (THHF) Trust is a registered charitable trust that holds and administers funds for charitable health-related purposes in the Waitematā region. Health New Zealand | Te Whatu Ora (Health NZ) is the settlor of the THHF Trust and, through its Regional Director (Northern), Health NZ has the power to appoint and remove trustees. The THHF Trust operates to receive, administer and apply funds for charitable health purposes, including research and education, within the Waitematā area. The THHF trustees exercise independent discretion in managing and applying the THHF Trust Fund, in accordance with the terms of the Trust Deed. THHF Trust’s purposes include supporting health services, education, training and research, and improving outcomes for people residing in the Waitematā area. The THHF trustees may apply surplus or accumulated funds, at their discretion, toward initiatives such as research, workforce development, and other activities that enhance health services for the benefit of the community.* --- ###### Last reviewed June 2026 Author: Victoria Andersen & Kathryn Tennant