The following document templates and legal agreements are available for use in a research project. They should be completed externally and then uploaded into the RGS and submitted with your application as a supporting document.
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Investigator Response Letter Templates
WA Health Standard PICF template.
These templates are provided for use by investigators who are required to provide additional information, to either an ethics committee (subcommittee or Human Research Ethics Committee) or a Research Governance Office, regarding a research project application. They can be uploaded in the RGS as a supporting document when re-submitting forms or documents.
WA Health Research Protocol Templates
These templates are provided as a guide for investigators who do not already have a protocol for their research project. It is a requirement of WA Health that a protocol is submitted with the ethics application.
These templates are based on the Therapeutic Goods Administration (TGA) “Integrated
Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)” 2016 and the World
Health Organization (WHO) Recommended format for a 'research protocol'. To meet Good Clinical Practice Guidelines the
Protocol should contain, but not be restricted to, the information contained
within this template.
Participant Information Consent Forms (PICFs)
WA Health investigators are encouraged to utilise the National Health and Medical Research Council's standard PICFs. These documents provide guidance in the formulation of consent forms for both single-centre and multi-centre research projects.
The templates should be used as a minimum starting point prior to the addition of jurisdictional and project specific information. Sections that are not applicable to the research project may be removed.
The 12 forms include three participant categories as identified by the National Statement:
External research personnel who will be either conducting a research project within WA Health or accessing WA Health participants, their tissue or data for a research project will have to complete one or both of the following confidentiality declarations:
The WA Health Declaration of Confidentiality must be completed in the RGS by all research personnel who are non-WA Health employees accessing a project. This includes research personnel with joint appointments, when the WA Health employee is conducting a project in their non-WA Health employee capacity.
Confidentiality Disclosure Agreement
WA Health has established a standard Confidentiality Disclosure Agreement (CDA) which is recommended for use in clinical trial research and data registries, which can be negotiated with the external party in line with WA Government legal and legislative policy and guidelines.
Clinical Trial and Clinical Investigation Research Agreements
A standard, system-wide approach to the agreements and indemnities applying to research projects conducted in WA Health is in place. For further information regarding the governance of research projects within WA Health refer to the WA Health Research Governance Framework.
Consistent with other jurisdictions, WA Health uses the Medicines Australia (MA) and Medical Technology Association of Australia (MTAA) template agreements. Each of these agreements provides for amendments to be made to the terms presented in the body of the agreement. WA Health has specified a number of amendments to be included in the relevant schedule to the agreement, in line with WA Government legal and legislative policy and guidelines.
These agreements were updated in March - May 2017.
A standard, system-wide approach to the agreements and indemnities applying to research projects conducted in WA Health is in place. For further information regarding the governance of research projects within WA Health refer to the WA Health Research Governance Framework. WA Health has research agreements available for research projects not involving clinical trials, clinical investigations or registries.
For commercial clinical trials, sponsors (or the contract research organisation) are required to provide the relevant Medicines Australia Form of Indemnity for Clinical Trials. These forms reference the 'Guidelines for Compensation for Injury Resulting From Participation in a Company-sponsored Clinical Trial' which the sponsor agrees to adhere to if injury is suffered by a participant while participating in the Study (project). Investigators must make it clear to the participants that the project is being conducted subject to those Guidelines.
For commercial clinical investigations, sponsors (or the contract research organisation) are required to provide the relevant Medical Technology Association of Australia Standard Indemnity Form for a Clinical Investigation.
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