Which documents do I need?

APPLICATION FORMS When can the form be used?

Document information

WA Health Single Ethical Review National Mutual Acceptance Conducting research at a site Accesssing participant tissue or data only
ETHICS

Human Research Ethics Application (HREA) &


WA Specific Module (WASM)

HREA (external site) is a streamlined ethics application using dynamic content and help to assist researchers consider and address the principles of the National Statement on Ethical Conduct in Human Research.

The HREA is not available electronically in RGS. If ethical review is by a WA Health HREC, the HREA must be completed via the NHMRC HREA website and uploaded to RGS as a pdf supporting document. There is no need to attach supporting documents to the HREA (on the NHMRC website) as they should be uploaded separately into RGS. If ethical review is by an NMA non-WA Health HREC, the HREA should be completed via the state/territory Governance application site. Please ensure all sites involved in the research project are listed in the HREA form.


WASM (PDF) addresses WA legislative requirements. It is completed in conjunction with the HREA for health and medical research projects conducted within WA or intending to access WA participants, tissue / data.

YES YES YES YES
WA Health Ethics Application Form (WAHEAF) WAHEAF (PDF) is used for intra-jurisdictional (within WA) single-centre or multi-centre-research or the HREA can be used accompanied by the WASM. YES NO YES YES
RESEARCH GOVERNANCE (RG)
Site Specific Assessment (SSA) Form SSA (PDF) covers legal compliance, financial management, accountability and risk management associated with research. YES YES YES YES
Budget Form Budget Form covers activities and resources required for the research project and is a tool for assessing the ability for the hospital to support the research project a the site YES YES YES YES
Access Request (AR) Form

AR Form is used instead of an SSA where the study is collecting data or information but the research is not being carried out on the site. This choice is determined when completing the RGS application.

  1. participant recruitment through staff distributing posters, leaflets, handouts, and letters of invitation (but does not involve participant recruitment.)
  2. distribution of surveys and questionnaires to personnel of the site by e-mail, in line with the site policies (but not collation and analysis of responses at that site.)
  3. access to medical records, data or tissue held in the site collections or databases under their management, in line with ethical conditions set out by the approving HREC (but not processing or analysis at that site).

In addition to the AR Form, for projects requesting access to the Department of Health data collections the investigator must submit anApplication for Data Form (external site)

RG determines whether to allow access to its participants, their tissue or data when a research project is not being conducted at the site.

When a study requires access across multiple sites within the jurisdiction of the same RG Office, then details regarding these sites may be documented on one AR Form, though a declaration of authorisation will be required from each site involved.In WACHS the Regional Director must also provide a declaration.

YES YES NO YES

 

 

TABLE A: ETHICS Documents – as applicable
DOCUMENT NAME Document information
Protocol

A research protocol is the guide for a research study. The protocol describes in detail what the researchers are intending to do and how they will do it. In writing a protocol all the major issues are considered in design and development of a particular research project.

Clinical Trial Protocol (suggested template) (external site)

A protocol will include the following as a minimum:

  • Background summarising the related literature and the justification for carrying out the study.
  • Inclusion and exclusion criteria for participant enrolment.
  • Study hypothesis or hypotheses
  • Aims and objectives
  • Intervention / Procedures - what will be done and how it will be done.
  • Study Conduct with a level of detail for others to know exactly how to run the study and the required resources.
  • Data to be collected and how it will be analysed.

Safety management describing any study-related safety and security measures.

Non Clinical Trial Protocol (suggested template) (external site)

Projects not classified as Clinical Trialsmayinclude,

  • Recruitment
  • Procedures
  • Intervention

They will usually not involve assessments of the efficacy/safety of drugs or other therapeutic or investigational products (including medical devices).

Peer Review Peer review is the evaluation of work by one or more people with similar competencies as the producers of the work. It functions as a form of self-regulation by qualified members of a profession within the relevant field.
PARTICIPANT INFORMATION & CONSENT FORMS (PICF)
  1. Participant Information Sheet and Consent Form (Master)
  1. A combined information and consent form in a multi-centre study where the lead site creates the study PICF and a Master version is provided to all other sites to add in local details.
  1. OR Participant Information Sheet (Master) / Participant Consent Form (Master)
  1. As above except there are two separate documents.
  1. AND/OR Participant Information Sheet and Consent Form (Site Master)
  1. Often used in multi-centre commercial studies - A combined information and consent form for a site where the sponsor has already created an Australian master version for submission to a lead HREC as part of the National Mutual Acceptance. They will then forward to each site for a local ‘Site Master’ version to be created and submitted to Governance.
OTHER DOCUMENTS
Participant documents i.e. identification card, diaries Any study document being used/completed by participants must be reviewed by ethics.
Questionnaires, surveys

Any study document being used/completed by participants must be reviewed by ethics.

Please note some international questionnaires require approval to be used by the international group such as EQ-5D-5L.

Interview outlines Where participants are to be interviewed in an outpatient setting, on the ward or over the internet or the phone, a script should be provided for ethical review.
Recruitment documents i.e.letters Any study document being sent to participants or doctors must be reviewed by ethics.
Recruitment documents i.e. posters, advertisements Any study advertising must be reviewed and approved by ethics.
Radiological Council Approval When radiation exposure for study participants is above standard of care in usual management the Radiological Council will need to determine whether the exposure is acceptable through an application and approval process before the ethics and governance submissions. This is a separate submission process. The first line of contact is through SCGH Medical Physics to request a dosimetry report for the study to determine whether a Radiological Council submission is necessary. Factors considered are the study cohort and in the case of participants with life limiting illness, whether the additional radiation will impact their lifespan.

Data Application Form

(Data Linkage)

Data linkage is a technique for connecting pieces of information that are thought to relate to the same person, family, place or event. Linked data is used in Western Australia to support approved research, develop policies, plan services and evaluate services. This provides a more complete picture of the health of people in WA.

www.datalinkage-wa.org.au (external site)

Investigator’s Brochure (IB)

(DRUG studies only)

The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to ensure their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. The IB also provides insight to support the clinical management of the study participants during the clinical trial. The information should be presented in a concise, simple, objective, balanced, and non-promotional form. A medically qualified person should generally participate in the editing of an IB, but the contents of the IB should be approved by the disciplines that generated the described data.

Product Information This relates to study drugs and devices where the registration information is found via theTherapeutic Goods Administration (TGA) (external site)

 

 

TABLE B: GOVERNANCE Documents – as applicable
DOCUMENT NAME

Document information

Contracts

  1. AND/OR Service Agreement

WA Health uses Medicines Australia CTRA templates. (external site)

  1. A CTRA is a legally binding agreement that set out the relationship between the sponsor, the financial support and/or proprietary information and the institution that may be providing data and/or results, publication, input into further intellectual property.
  1. OR Funding Agreement
  1. Funding Agreement – a contract between the instiution and the research organisation where the organisation has agreed to contribute to the funding of the research.
  1. AND/OR Material Transfer Agreement (MTA)
  1. MTA – Where the institution has agreed that a third-party organisation (hospital/university) can receive certain study materials (tissue and/or fluids) obtained during the study for use in ethically approved clinical research.
  1. Clinical Trial Research Agreement (CTRA aka CTA)
  1. Service Agreement – Where WA Health is either providing or receiving a service with associated payments.
PARTICIPANT INFORMATION & CONSENT FORMS (PICF)
  1. Participant Information Sheet and Consent Form (Master)
  1. A combined information and consent form in a multi-centre study where the lead site creates the study PICF and a Master version is provided to all other sites to add in local details.
  1. OR Participant Information Sheet (Master) / Participant Consent Form (Master)
  1. As above except there are two separate documents.
  1. AND/OR Participant Information Sheet and Consent Form (Site Master)
  1. Often used in multi-centre commercial studies - A combined information and consent form for a site where the sponsor has already created an Australian master version for submission to a lead HREC as part of the National Mutual Acceptance. They will then forward to each site for a local ‘Site Master’ version to be created and submitted to Governance.
OTHER DOCUMENTS
Budget Supporting Document (optional) Further budgetary information that supports the application.
Confidentiality Agreement

RGS templates (external site)

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 Notification (CTN)

(Drug or device study)

OR


Clinical Trial Exemption (CTX) Documentation

(Drug or device study)

CTN – under the Therapeutic Goods Administration Act 1989 and Regulations, notification under the CTN Scheme (or application under the CTX Scheme) is required for:

  • any medicine or device not entered on the Australian Register of Therapeutic Goods, including any new formulation of an existing product or any new route of administration; or
  • the use of a registered medicine or device beyond the conditions of its marketing approval, including new indications extending the use of the product to a new population group and the extension of doses or duration of treatments outside the approved range.
  • Researcher: The person responsible for the conduct of the clinical trial at a trial site.
  • HREC: Responsible for assessing the scientific validity of the trial design, the safety and efficacy of the medicine or device and the ethical acceptability of the trial process, and for approval of the trial protocol.
  • Approving Authority: The institution or organisation at which the trial will be conducted gives the final approval for the conduct of the trial at the site.
  • Sponsor: The company, organisation, institution, body or individual (enterprise) that takes responsibility for the overall conduct of the trial. Notifies the TGA using the CTN form and paying the appropriate fee.

CTX - under theTherapeutic Goods Administration Act 1989 and Regulations, application under the CTX Scheme (or notification under the CTN Scheme) is required for:

  • any medicine or device not entered on the Australian Register of Therapeutic Goods, including any new formulation of an existing product or any new route of administration; or
  • the use of a registered medicine or device beyond the conditions of its marketing approval, including new indications extending the use of the product to a new population group and the extension of doses or duration of treatments outside the approved range.
  • Sponsor: Submits an application to conduct clinical trials to the TGA for evaluation and comment. Signs CTX Part 1 Section 1.3 and Part 2 Section 1.6 TGA: Completes the evaluation of the trial and provides advice to the researcher.
  • Researcher: A copy of the TGA advice must be provided to the reviewing HREC. Signs CTX Part 2 Section 2.
  • HREC: Responsible for approving the proposed trial protocol after reviewing information received from the sponsor and investigator, and any additional comments from the TGA. Signs CTX Part 2 Section 2. HREC must ensure that TGA advice has been provided by researcher.
  • Approving Authority: Signs CTX Part 2 Section 4.
Indemnity Form

RGS templates (external site)

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.

Institutional Biosafety Committee Notification The Institutional Biosafety Committee is responsible for reviewing all research that involve the use of biological agents.Contact the Research Governance Office regarding the forms to complete and whether additional SSA signatures are required.
Insurance Certificate of Currency (Clinical Trials) Certificate of Currency is a document confirming that the insurance policy is current and includes details of the sums insured, the policy type as well as the policy expiry date.
Insurance Policy (Clinical Trials) The insurance policy demonstrates that there is adequate insurance and indemnity arrangements in place for the clinical trial to be conducted at WA Health Organisations.
Medical Physicist Report The dosimetry report states the total dosage of radiation exposure the participant will have during the study and whether this is thought to be reasonable.
NHMRC Embryo Research Licensing Committee Licence The Licensing Committee (external site) oversees the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act). It regulates research activities that involve the use of human embryos created by assisted reproductive technology (ART) or by other means. There are strong penalties for non-compliance with the legislation. The legislation also prohibits human cloning for reproductive purposes and a range of other practices relating to reproductive technology.
Office of the Gene Technology Regulator Approval The Office of the Gene Technology Regulator (external site) provides administrative support to the Gene Technology Regulator in the performance of the functions under theGene Technology Act 2000. All studies using Genetically Modified Organisms (GMOs) must seek approval and/or apply for a licence to have their facilities certified.
Reproductive Technology Council Approval Reproductive Technology Council (external site) - Makes sure that any research carried out by or on behalf of a licensee on eggs, sperm, or participants, has general or specific approval of Council; Encourage and facilitate research into the causes and prevention of all types of human infertility and on the social and public health implications of reproductive technology.
HREC Approval letter The letter provides ethics approval for the study and named study sites.
HREC Approval letter (Specialist) The letter provides ethics approval for the study and named study sites undertaken by a specialist in the area of the study.
Amendment Approval letters for latest approved documents, site related investigators or CPI change Where study documents are altered or the CPI or PI change, the revised documents must be submitted for approval before the changes are enacted.

Which supporting documents should be submitted?

  • Before submitting the application, the Coordinating Principal Investigator (CPI) or the Principal Investigator (PI) should ensure all required supporting documentation is attached.
  • A research protocol MUST be submitted with the ethics application.
  • Templates are available from the RGS Document Templates (external site) tab as a guide for investigators who do not already have a protocol for their research project.

Reminders

  • The Research Governance Office (RGO) must be able to review the latest approved ethics documents (as per Table A) except for the Recruitment and Research Tools (unless separate site branding is required).
  • If the ethics application has been submitted through the RGS all WA Health RG Offices will have access to the submitted ethics forms, documents and approval letters so these do not need to be submitted again.
  • However, if this has not occurred, the latest approved ethics documents listed above will have to be submitted via the RGS to the RG Office along with the governance documents.
Last Updated: 06/09/2021