Site authorisation and access request

Site Specific Assessment is required for sites under the control of a NSW public health organisation, even if the project has low or negligible risk to participants, if the project involves one or more of the following activities:

• enrolling participants into research (e.g. obtaining informed consent, screening)
• carrying out protocol-specific research procedures with or on participants
• managing and analysing data, tissue, and responses from surveys and questionnaires collected for or from research.

Site Specific Assessment involves consideration of such matters as resources, staff, insurance and indemnity requirements etc.

The Site Specific Assessment and Human Research Ethics Committee ethical and scientific review may occur in parallel, however the decision to authorise or not authorise the commencement of a research project is only made by the public health organisation when the responsible Human Research Ethics Committee has granted approval and the Site Specific Assessment has been satisfactorily completed.

All applications for Site Specific Assessment must be made on the standard Site Specific Assessment Form in REGIS (Research Ethics and Governance Information System), and submitted to the relevant Research Governance Officer within the public health organisation.

Applications for Site Specific Assessment must be submitted using the Site Specific Assessment Form regardless of project risk level (e.g. greater than low risk or low or negligible risk research). For Instructions on how to complete the REGIS Site Specific Assessment, please see the Quick Reference Guide: Completing a Site Specific Assessment.

Application for Site Specific Assessment must be submitted by the Principal Investigator. The Principal Investigator is also responsible for obtaining signatures from the relevant:

• heads of department (or divisional directors or other authorities) to whom each investigator at the site is responsible
• heads of supporting department(s), whose departments will be involved in the research, including the nominated authorities for data provision the data custodians for a data set required to be accessed as a part of the research
• student supervisors for participating investigators.

AHOs are Organisations that have a legal definition under the Health Services Act 1997 – section 13 but put simply
they are Hospitals that are not for profit and treated as part of the public system.
In the context of Research an AHO can be approved as a NSW Health Site by any Lead HREC

AHO’s that are active in REGIS should have all applications submitted, reviewed and monitored through REGIS.

AHO that are not active in REGIS should be treated like any other site not listed in REGIS.

Info Sheet – AHO

Requests for access request review should be made by the Coordinating Principal Investigator to the Research Governance Officer. The Coordinating Principal Investigator is also responsible for obtaining written agreement from relevant heads of the facilities, locations and services that will provide the access required.

A written request (e.g. letter, public health organisation form or NSW Health form) must be submitted requesting access to participants, tissue and/or data. In the request, the applicant should provide the following information, at a minimum:

• Project title and short title
• Relevant project identifiers
• Coordinating Principal Investigator name and contact information
• Name of study sponsor, if applicable
• Name of Human Research Ethics Committee reviewing the research project
• The resources/services being requested
• The proposed process for accessing those resources/services
• Attached letters or emails confirming the support of each facility, location or service (written evidence of support).

Only one access request per Research Governance Officer is required for each research project, even if the project requires access from a number of facilities, locations or services covered by that Research Governance Officer.

Each externally-sponsored clinical trial conducted at a NSW public health organisation, whether that be by a commercial entity or a not-for-profit organisation (such as a collaborative research group), must be governed by a clinical trial research agreement. The agreement is reviewed by the public health organisation during the site specific assessment process.

NSW Ministry of Health, in collaboration with key stakeholder organisations, has developed a set of standard clinical trial research agreements:

• Standard Medicines Australia Clinical Trial Research Agreement for Commercially Sponsored Trials (Commercially Sponsored CTRA)
• Standard Medicines Australia Clinical Trial Research Agreement for Contract Research Organisations acting as the Local Sponsor (CRO Sponsored CTRA)
• Standard Collaborative or Cooperative Research Groups Clinical Trial Research Agreement (CRG Sponsored CTRA)
• Phase IV Clinical Trial Clinical Trial Research Agreement for Medicines.

The current versions of the four Medicines Australia clinical trial research agreements approved for use by NSW Health can be accessed from Medicines Australia.

NSW Health, in collaboration with key stakeholder organisations, has also developed a Clinical Investigation Research Agreement (CIRA) for use when a medical device company sponsors a clinical trial. In keeping with the terminology used in the industry, the research is known as a ‘clinical investigation’ rather than a ‘clinical trial’.

The current version of The Standard MTAA Clinical Investigation Research Agreement can be accessed from the Medical Technology Association of Australia.

The current version of The Multi-Jurisdictional Multi-Party non-Clinical Trial Collaborative Research Agreement can be accessed from the Australian Clinical Trials Website .

Joint review of sponsor specific clauses

The panel reviewing Australian clinical trial agreements (previously known as SEBS) is now a national panel known as the National Clinical Trial Agreement (NaCTA) Panel. The NaCTA Panel is comprised of representatives from all states and territories.

Together with Medicines Australia the NaCTA panel have developed five Clinical Trial Research Agreements (CTRAs) that can be accessed from the Medicines Australia website, that are available for use by any sponsor and/or institution for specific clinical trial scenarios.

For more information on the application process and templates available, please visit the Medicines Australia website.

Medicines Australia, in consultation with NSW Health and other key stakeholders, has developed two standard forms of indemnity in relation to commercially-sponsored clinical trials.

Where the trial is to be conducted at a site under the control of a public health organisation, whether or not the reviewing Human Research Ethics Committee (HREC) is under the auspices of that organisation, the commercial sponsor must provide an indemnity in the form of Medicines Australia’s Form of Indemnity – Standard, in favour of the public health organisation.

Where a lead Human Research Ethics Committee is reviewing a trial and the trial is not being conducted at a site where the lead Human Research Ethics Committee resides, the commercial sponsor must provide an indemnity in the form of Medicines Australia Form of Indemnity for Clinical Trials: Human Research Ethics Committee Review Only in favour of the public health organisation at which the lead Human Research Ethics Committee resides.

It is perfectly acceptable for lead Human Research Ethics Committees to choose to request a Medicines Australia Form of Indemnity for Clinical Trials: Human Research Ethics Committee Review Only up front from a Sponsor in each and every case when they review a multi-centre clinical trial whether their host institution is a site in the trial or not. This is primarily for reasons of procedural convenience; in the event that, if their institution (as a trial site) falls through, the site Research Governance Officer (RGO) will not require a Standard Form of Indemnity, and then the Human Research Ethics Committee will not then need to pursue a sponsor for an outstanding Human Research Ethics Committee Review Only indemnity. However, if the institution does become a trial site, the Research Governance Office will need to obtain a Standard Form of Indemnity in addition to the Human Research Ethics Committee Review Only Indemnity obtained by the Committee.

Both forms of indemnity must be provided by an Australian corporate entity, who is the sponsor of the clinical trial. This may be:

• an Australian company
• an Australian company that is subsidiary of an overseas parent company
• an Australian contract research organisation (CRO) that has been engaged by an overseas or Australian company to conduct the trial in Australia.

It is not acceptable for an indemnity to be provided by any company as an agent of an overseas entity; that is, the commercial sponsor must provide the indemnity in its own right.

Under the Medicines Australia indemnities, the commercial sponsor agrees to compensate injured subjects on a no-fault basis in accordance with Medicines Australia Guidelines for Compensation for Injury Resulting in Participation in a Company-Sponsored Clinical Trial. The entitlement of an injured participant to claim compensation from a sponsor pursuant to the Guidelines does not displace a participant’s right of action against a sponsor at common law.

Medicines Australia Standard Indemnity Forms and Guidelines can be downloaded online.

NSW Health’s Clinical Trials – Insurance and Indemnity (PD2011_006) policy directive sets out the insurance and indemnity requirements for the conduct of clinical trials at sites under the control of NSW public health organisations. Compliance with this policy directive is mandatory.

The policy requires that the insurer issuing the insurance policy is either Australian Prudential Regulation Authority-approved or (if an overseas insurer) has a minimum Standard and Poor’s credit rating of A- or better. To obtain this information from the Standard and Poor’s website, register as a user and then search using the ratings tab. Alternately, you can request the insurer to confirm their rating. Insurers who are listed on the Register of Authorised Insurers approved by the Australian Prudential Regulation Authority are listed on the Authority’s website.

Currently, there is no leeway period for sponsors who do not meet the $20M coverage limit.

There are two options for sponsors who submit annual renewable certificates of currency detailing coverage for their trials that apply from year to year:

1. sponsors can choose to either insure for the total length the clinical trial up front; or
2. take out annual insurance.

If they choose to take out annual insurance, each year they will need to present an annual certificate of currency demonstrating their compliance with the insurance requirements set out in policy directive (PD2011_006).

The NSW Government has established a Legal Services Panel which offers a range of legal services and expertise to meet the external legal needs of NSW Government agencies.

NSW public health organisations may engage the Panel for advice on all legal matters, which may include Clinical Trial Research Agreements (CTRAs) and research governance matters. The Panel Rules require staff to approach their in-house legal team to obtain legal services as only legal staff are permitted to obtain external legal services on behalf of their Agency (subject to any specific rules established by individual LHD).

Contact information is available via Info.buy.nsw.gov.au. Go to ‘Information for buyers’ then ‘How to buy from this scheme’ and follow the instructions to complete the Legal Services Order Form.

As always, for any clarifications on NSW Health policy, please contact the relevant NSW Health Branch contact, such as the Office for Health and Medical Research for Research Policy queries.

Is a site authorisation required for private facilities?

The requirement for site authorisation applies to the NSW public health system only. It is entirely a matter for a private institution to determine the mechanism it will use for authorising the conduct of research within its facilities.

Is the Site Specific Assessment application or Access Request reviewed by the Human Research Ethics Committee?

No. The Human Research Ethics Committee does not see the Site Specific Assessment application form nor Access Requests. The Research Governance Officer undertakes these reviews.

Why is it necessary to complete the Site Specific Assessment application form in addition to the ethics application?

The purpose of the ethics application form is to enable the Human Research Ethics Committee to consider whether the research project is ethically and scientifically acceptable, and whether it meets the requirements of the National Statement on Ethical Conduct in Human Research (2007). The purpose of the Site Specific Assessment application form is to allow NSW public health organisations to elicit information about the research project, thereby enabling it to consider whether the research meets its research governance requirements.

These requirements are additional to the ethical and scientific acceptability of research and include consideration of:

• investigator’s skills, training and experience
• availability and suitability of facilities and resources for the proposed research
• funding for the project;
• insurance and indemnity arrangements
• contractual arrangements
• compliance with legislative requirements.

Why is there some duplication between the ethics and Site Specific Assessment application forms?

Some aspects of research need ethical, scientific and governance considerations (for example, investigator’s skills, training and experience). For this reason, there is some duplication between the two forms.

Can I submit the Site Specific Assessment application form at the same time as I submit my ethics application?

Yes. You should contact the relevant Research Governance Officer(s) and individuals that need to provide a declaration of support, and start to prepare an application for Site Specific Assessment at the earliest possible opportunity. It is not necessary to wait for the outcome of Human Research Ethics Committee approval before preparing and submitting an application for Site Specific Assessment. If the project is a clinical trial, you can submit documentation on insurance and indemnity arrangements and a copy of the Clinical Trial Research Agreement to the Research Governance Officer ahead of making a full Site Specific Assessment application.

However, both Human Research Ethics Committee approval and a satisfactory Site Specific Assessment are required before the Chief Executive or their delegate may grant authorisation for the research to commence at the site.

I’ve received an approval letter from the Human Research Ethics Committee, what do I do now?

Provide a copy to the relevant Research Governance Officer. The Research Governance Officer will attach this to your Site Specific Assessment application form and submit all the documentation to the Chief Executive or their delegate along with a recommendation that the research be authorised, not authorised, or that Chief Executive consideration is required.