Research - Approval process

This section is specifically for studies that require some form of contractual relationship with Te Whatu Ora | Te Toka Tumai Auckland in order to undertake a research project.

Documents describing contractual relationships take various names, for example, a clinical trial agreement, a research contract, or an amendment. The key features of these documents are that they set out the obligations for both parties with respect to the undertaking of a research project and are enforceable by law.

In some instances, a research project may not need a contract but may require an Indemnity and Compensation agreement with Te Whatu Ora | Te Toka Tumai Auckland and a current insurance certificate. This will be the case when a study is deemed to be principally for the benefit of its sponsor organisation

If your research does not require a contractual relationship with the Te Whatu Ora | Te Toka Tumai Auckland and it is an Ethics Committee approved ACC certified study then this legal section does not apply to your research.

If your research does require a contractual document, please read the sections below to help you meet the Te Whatu Ora | Te Toka Tumai Auckland requirements.

General legal 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 Te Whatu Ora | Te Toka Tumai Auckland Legal Counsel PRIOR TO signing.

Contract/agreement

A contract is a legal document which will commit the resources and services of Te Whatu Ora | Te Toka Tumai Auckland and the principal investigator(s) and research team. All contracts are to be reviewed by the Research Office and Te Whatu Ora | Te Toka Tumai Auckland Legal Council before being agreed or signed.

Electronic versions of draft contracts must be forwarded to the Research Office for initial legal review. This format enables easy "track changes" to be used to convey comments or negotiations quickly and clearly.

Party to be named on contractual agreements updated 2022 07 13

The establishment of Te Whatu Ora - Health New Zealand has not resulted in the creation of one central agency that will directly engage with external parties in substitution for every former District Health Board. Instead, it is essentially ‘business as usual’, with same individuals who were the employees of what were DHBs continuing to engage on behalf of their districts. For example, trials at Auckland City Hospital are now entered into by the Charitable Trust (Auckland Hospitals Research and Endowment Fund) on behalf of Te Whatu Ora | Te Toka Tumai Auckland. Payments will continue to be made to the same bank account.

Thus, Auckland Hospitals Research and Endowment Fund is the party to be named on contractual agreements.

The below recital must appear on all research contracts.

"The Auckland Hospitals Research and Endowment Fund (AHREF) has delegated authority to enter into contracts with third parties on behalf of and as agent for Te Whatu Ora | Te Toka Tumai Auckland and to accept obligations for Te Whatu Ora in relation to clinical trials for studies to be undertaken at Te Whatu Ora | Te Toka Tumai Auckland facilities and by Te Whatu Ora | Te Toka Tumai Auckland employees."

Te Whatu Ora | Te Toka Tumai Auckland is the host locality in relation to research and the party to be named on indemnity and compensation agreements (see below)

Some useful information for sponsors

As of 1st July 2022, all New Zealand District Health Boards (DHBs) have been replaced by Te Whatu Ora - Health New Zealand (HNZ) via the enactment of the Pae Ora (Healthy Futures) Act 2022. Section 11 of that Act establishes Health New Zealand as a Crown agent; Schedule 1 Subpart – 4 deals with the disestablishment of DHBs (clause 8), the transfer of all assets, rights, liabilities, contracts, entitlements, undertakings and engagements of DHBs to HNZ (clause 10) and notes that (clause 14) “the transfer of a contract or an engagement of a DHB under clause 10 does not affect the scope of the contract or engagement or the application of the terms and conditions of the contract or engagement.”

Authorised signatures required on contracts are:

• Principal investigator.
• The appropriate Auckland Hospitals Research and Endowment Fund representative. 
• Sponsor representative(s).

Financial agreement and payment details

In most circumstances, the contractual agreement contains both the institution and sponsor obligations and the payment amounts and schedule for service details.

The account payment details for all research are:

Name: Auckland Hospitals Research and Endowment Fund
Address: PO Box 26417, Epsom, Auckland 1051, New Zealand
Bank: WESTPAC
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

Indemnity and compensation agreements

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.

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 Te Whatu Ora | Te Toka Tumai Auckland, its employees and agents, and the researcher from civil liability.

It is recommended that the Te Whatu Ora | Te Toka Tumai Auckland Standard Indemnity and Compensation Agreement is utilised. All other variations require review by the legal team. Te Whatu Ora | Te Toka Tumai Auckland should be specifically named as the host locality 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).

The Auckland DHB Standard Indemnity and Compensation Agreement.

Insurance certificate

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 Te Whatu Ora | Te Toka Tumai Auckland 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:

• Provides adequate cover.
• Covers clinical trials.
• Covers research undertaken in New Zealand.

At Te Whatu Ora | Te Toka Tumai Auckland the various clinical disciplines, departments, services and units may have different conventions for developing, presenting and approving the undertaking of research amongst their population groups. In some areas, such as National Women's Health, there is a formal research group that meets regularly and strategically to think about what research to support and what not to support.

Once an idea has been agreed upon for further development by the staff who will be supporting the study, it is the principal investigator’s responsibility to ensure that the proposal is scientifically and methodologically sound, operationally and financially feasible and ethical.

It is important that any proposed research considers the likely impact on standard care of patients, access to care and other resources (human, logistic and financial).

In addition, it is important to consider whether the research is likely to impact on other areas, for example, nursing, allied health, laboratory, radiology, pharmacy and medical records. It is recommended, when relevant, that these groups are consulted with early to ensure that they are able to assist in the way the research proposes. 

Once these steps have been followed formal agreement to proceed to submit your research to the Research Office should be obtained from the clinical director/leader or director of nursing, depending on the area of research. How this is obtained is up to the respective people. 

Access to patient information for the purpose of research requires the Te Whatu Ora | Te Toka Tumai Auckland research approval processes (see below) and ethics approval to be obtained the same way as other research activities do.

When a research project is being led by an external researcher and there is not a Te Whatu Ora | Te Toka Tumai Auckland co-investigator then the external researcher must enlist a relevant Te Whatu Ora | Te Toka Tumai Auckland employee as either a supervisor or clinical partner or contact. This person will ensure that your research is ethically approved (where relevant), that you are aware of all the relevant policies and procedures for the Te Whatu Ora | Te Toka Tumai Auckland, and will endeavour to ensure that you adhere to them.

Who can be a research supervisor or clinical partner or Te Whatu Ora | Te Toka Tumai Auckland contact?

Any Te Whatu Ora | Te Toka Tumai Auckland employee with subject matter expertise in relation to the proposed study and with access to or professional responsibility for the patient population.

It is expected that having agreed to act as supervisor/partner/contact that this person assists the researcher to negotiate sign off/authorisation from the clinical director of the service or nurse leader or equivalent. Evidence of this sign-off/authorisation must be sent to the Research Office along with the other study documents for approval.

Non-staff (e.g. students) as part of the research team

If you are not a Te Whatu Ora | Te Toka Tumai Auckland staff member but are part of the research team and will be accessing hospital facilities or patients, you need to organise with the principal investigator to complete an ID and parking name badge form and a confidentiality form from the RAC site.

Once all the documents have been signed and processed, the HR department will contact the relevant person with instructions on how you can collect or obtain your identity card.

Responsibilities

It is important that non-Health New Zealand | Te Toka Tumai Auckland researchers are made aware of the relevant policies and procedures when undertaking research within our organisation.

The role of a research supervisor or clinical partner is to:

• Provide oversight of the researcher/s while they undertake the research within Te Whatu Ora | Te Toka Tumai Auckland.
• Be familiar with the research project and are confident in the appropriateness of the study design and methodology.
• Provide adequate information to the researcher/s on the relevant policies and procedures and guidance to ensure those processes are followed.
• Ensure that appropriate ID badges are obtained and confidentiality agreements are signed before the research has begun.
• Make sure that ID badges are returned at the completion of the research.

The steps for obtaining an ID badge and completing a confidentiality agreement:

Obtain the appropriate confidentiality and card and parking permit forms to be completed. (copy and paste into your folder drive on your work computer)

• • \\ahsl6\main\GROUPS\INTRANET\HR\Confidentiality Form.doc
  • \\ahsl6\main\GROUPS\INTRANET\HR\ID Card & Parking Permit Form.pdf

1. Review the screening policy to check for what steps need to be followed for health screening for the researcher. The level of screening depends on the place, level, and extent of patient interaction.
2. Complete the appropriate forms.
3. The confidentiality agreement needs to be signed by the principal investigator. The researcher needs to make a copy and send to the Research Office. Please write on the form or attach a note which has the Te Whatu Ora | Te Toka Tumai Auckland number, ethics number or the title of the study.
4. The completed ID form needs to be signed off by the relevant Service Manager. This form is then mailed or faxed to HR. HR will then contact the relevant person about how to obtain their ID card.
5. At the completion of the research, the  researcher/s must return the ID card to the contact, supervisor or clinical partner.