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LEGAL REVIEW |
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Introduction |
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This section is specifically for studies that require some form of
contractual relationship with the ADHB 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. 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 a
binding agreement that is enforceable by law. |
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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
with the ADHB. A Certificate of Insurance is also required when it
is a non-ACC accredited study. |
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If your research does not require a contractual relationship with
the ADHB 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. |
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If your research does require a contractual document please read the
sections below to help you meet the ADHB requirements. |
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A Confidentiality Agreement is a legal document through which
enables funders of research to discuss a particular research
proposal with a researcher with the legal protection that their
intellectual property can be disclosed safely as the researcher
agrees that this will be kept in confidence. The Research Office
recommends that these are reviewed but this is not essential as it
does not commit the researcher or the ADHB to undertaking the
research only to review the details in order to determine if it can
be undertaken. |
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General Legal Requirements |
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All contractual documents such as the Contract/Agreement, the
Indemnity and Compensation statements, and Insurance Certificates,
Confidentiality Agreement, need to be approved by the Research
Office and ADHB Legal Counsel PRIOR TO signing. |
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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. |
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Contract/Agreement |
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A contract is a legal document which will commit the resources and
services of Auckland District Health Board 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. |
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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. |
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Party to be Named
on Contractual Agreements |
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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
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between the Auckland DHB Charitable Trust and the Sponsor, thus Auckland DHB Charitable Trust
is the party to be named on contractual
agreements. |
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Authorised signatures required on each contract are:
• the Principal Investigator, and
• the appropriate Auckland DHB Charitable Trust representative
• the Sponsor Representative(s) |
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go
to Contract
/ Indemnity
/ Insurance
/ Confidentiality
Agreement /
Memorandum of Agreement |
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Financial Agreement and Payment Details |
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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. |
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The account payment details for all research are:
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Name: |
Auckland DHB Charitable Trust |
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Address: |
PO Box
26417, Epsom, Auckland 1051, New Zealand |
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Bank: |
ASB Bank Limited |
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Account: |
12-3113-0000668-00 |
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Bank Address: |
PO Box
35, Shortland St, Auckland 1140, New Zealand |
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Swift Code: |
ASBBNZ2A |
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ABA/BSB: |
123113 |
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GST Number: |
66-934-136 |
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Memorandum of Agreement / Head Agreement |
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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 Memorandum of Agreement is to define the expectations, terms and conditions of the working relationship between parties. |
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go to Contract / Insurance / Confidentiality Agreement / Payment Details |
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Indemnity and Compensation Agreements |
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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". |
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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. |
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It is recommended that the ADHB standard Indemnity and Compensation Agreement is utilised. All other variations require review by the legal team. |
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Auckland DHB should be specifically named as the host institution in the Indemnity Agreement provided by the sponsor. |
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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) |
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It is recommended that Indemnity and Compensation Agreements are provided on sponsoring company letterhead and be dated and signed by a representative of the company. |
The Auckland DHB Standard Indemnity and Compensation Agreement: Download (V.2 Uploaded 25/7/11)
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go to Contract / Indemnity / Memorandum of Agreement / Confidentiality Agreement / Payment Details |
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Insurance Certificate |
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For all non-ACC research studies it is essential that the Sponsor provide an Insurance Certificate; sometimes called a Certificate of Currency. |
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The purpose of an insurance certificate is for the ADHB 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. |
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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
• provides adequate cover,
• covers clinical trials
• covers research undertaken in NZ |
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ADHB Research Office - July 2011
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Ministry of Health
