This section is specifically for studies that require some form of contractual relationship with the Auckland DHB in order to undertake a research project.
The documents for contractual relationship take many names for example, a clinical trial agreement, a research contract, a memorandum of agreement or a head agreement (see sub-headings below).
The key element is that it is a document that sets out the obligations for both parties with respect to the undertaking of a research project. Except for the memorandum of agreement, these documents are binding agreements that are enforceable by law.
In some instances a research project may not involve a contract but because it may not be an Ethics Committee ACC certified study it is likely that it will require an Indemnity and Compensation agreement [DOC, 64 KB] with the Auckland DHB.
A certificate of insurance (see below) is also required when it is a non-ACC accredited study.
If your research does not require a contractual relationship with the Auckland DHB and it is an Ethics Committee approved ACC certified study then this legal section does not apply to your research. Please contact the Research Office if you are unsure.
If your research does require a contractual document, please read the sections below to help you meet the Auckland DHB requirements.
All contractual documents such as the contract/agreement, the indemnity and compensation statements, insurance certificates, and confidentiality agreement, need to be approved by the Research Office and Auckland DHB Legal Counsel PRIOR TO signing.
For all legal documents EXCEPT the insurance certificate and confidentiality agreement, a minimum of three (one for each signatory) original legal documents for signing are required i.e. three contracts, three indemnity and compensation agreement.
A contract is a legal document which will commit the resources and services of Auckland DHB and the principal investigator(s) and research team. All contracts are to be reviewed by the Research Office and Auckland DHB Legal Council before being agreed or signed.
It is recommended that an electronic version of the contract is forwarded to the Research Office for initial legal review if possible. This enables easy "track changes" to be used to convey comments or negotiations quickly and clearly.
Auckland DHB research funds are managed by the Auckland DHB Charitable Trust, a trust formed by Auckland DHB and with a board that currently comprises senior Auckland DHB clinicians and executives. The principal investigators and research staff are employees of Auckland DHB and Auckland DHB is the host institution in relation to research.
As a consequence, the contractual agreement is between the Auckland DHB Charitable Trust and the sponsor, thus Auckland DHB Charitable Trust is the party to be named on contractual agreements.
In most circumstances the contractual agreement contains both the institution and sponsor obligations and the payment amounts and schedule for service details.
However, in some circumstances there are two parts: the clinical trial agreement and the financial agreement. The clinical trial agreement spells out the obligations and expectations of both parties in relation to undertaking the research. The financial agreement states the funding that will be supplied to the institution in order for the research to be undertaken.
The account payment details for all research are:
Name: Auckland DHB Charitable Trust
Address: PO Box 26417, Epsom, Auckland 1051, New Zealand
Account Number: 03-1509-0022063-00
Bank Address: Physical: Britomart Branch, 53 Galway Street, CBD, Auckland 1010, NZ
Postal: PO Box 934, Auckland, New Zealand
Swift Code: WPACNZ2W
ABA/BSB: 03 1509
GST Number: 66-934-136
Is a less formal document than a contract and is often utilised between institutions collaborating on a research project to set out who is responsible for what. The purpose of the memorandum of agreement is to define the expectations, terms and conditions of the working relationship between parties.
ACC does not cover clinical trials that are for the benefit of the sponsor. As such a statement by a sponsoring company which details the compensation offered to patients (participants) in their trials is required.
Most sponsoring companies adhere to ABPI or NZRMI guidelines in this regard. This information should also appear in the National Ethics Application and Participant Information Sheet. Please refer to the National Guidelines for Applicants(external link).
In addition to this statement in the ethics application, an indemnity and compensation agreement from the sponsoring company is required. This document protects both the participant and the Auckland DHB, its employees and agents, and the researcher from civil liability.
It is recommended that the Auckland DHB Standard Indemnity and Compensation Agreement is utilised. All other variations require review by the legal team. Auckland DHB should be specifically named as the host institution in the Indemnity Agreement provided by the sponsor.
Indemnity and compensation agreements must accompany all research applications that are "conducted principally for the benefit of the manufacturer or distributor of the medicine or item in respect of which the trial is carried out" (Accident, Rehabilitation Compensation Insurance Act 1992).
It is recommended that indemnity and compensation agreements are provided on sponsoring company letterhead and dated and signed by a representative.
For all non-ACC research studies it is essential that the sponsor provide an insurance certificate; sometimes called a certificate of currency.
The purpose of an insurance certificate is for the Auckland DHB to be assured that the sponsor has sufficient cover to protect research participants in the event of a complication resulting from participating in the research. The insurance certificate is proof of liability insurance.
Often insurance certificates are annually renewed and it is the responsibility of the researcher to check expiry dates and request a new certificate before the old one has expired. A copy of the certificate should be sent to the Research Office to ensure that it: