Royal Perth Hospital (RPH) Research Foundation Biostatistical Consulting Service

The RPH Research Foundation Biostatistical Consulting Service is a key resource used by researchers at EMHS and the Foundation. It offers expert support to help researchers ensure high-quality research methodology, analysis, and output.

For more information visit:
Biostatistical Consulting Service 

Essential Reading

Researchers should be familiar with the following key documents when developing research projects, assessing their feasibility, and preparing research ethics and governance submissions.

These documents are also essential references for any medical researcher, Principal Investigator responsible for a clinical trial or member of the wider research and trials workforce (such as Clinical Trials Coordinators) working within EMHS and the WA Health system. 

Knowing your broad responsibilities as a researcher in Australia:

• National Health and Medical Research Council, Australian Research Council and Universities Australia:
Australian Code for the Responsible Conduct of Research (2018)

How to design and conduct ethically acceptable research:

• NHMRC National Statement on Ethical Conduct in Human Research (2023)
• World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (2018)

How to design research about and to the benefit of Aboriginal people:

• NHMRC Ethical guidelines for research with Aboriginal and Torres Strait Islander peoples
• AIATSIS Code of Ethics 2020
• Seek advice and review from the WA Aboriginal Health and Ethics Committee (WAAHEC). 

Processes and responsibilities when conducting clinical trials:

• Therapeutics Goods Administration (TGA) Australian Clinical Trial Handbook which includes information about the role of site Principal Investigators.
• ICH Guidelines for Good Clinical Practice with TGA Annotations 
• WA Health Translation Network (WAHTN) GCP in Australia online training

NHMRC requirements for safety reporting and monitoring of clinical trials:

• NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods 

How research and clinical trials are governed within WA Health:

• The WA Health Research Governance Framework (Policy and Procedures)
• How to conduct multi-centre research within WA Health

Writing a Research Protocol

All research conducted in WA Health must have a protocol. This document describes how the research project will be conducted and outlines:

• The background, aims and hypotheses
• Design and methodology
• Statistical analysis plan
• Recruitment process and treatment of participants
• Data management plan
• Ethical considerations

A well-developed protocol ensures the safety of the participants, maintains the integrity of the data collected and increases the likelihood of the project reaching a successful conclusion, generating publishable and/or translatable findings.

The World Health Organisation (WHO) provides a summary of what is typically included in a good research protocol:
World Health Organisation - Recommended Protocol Format (external site)

There are many protocol templates available. Regardless of the format or template used, the quality of the content is of primary importance. WA Health has several templates to assist those who do not already have a preferred template: 
RGS Document Templates

If you use a template, it is essential that you fully adapt it for your project, including only the sections relevant to your project and deleting any instructions prior to submission.

The EMHS Research Hub team can also assist by providing a range of protocol templates and examples of real project protocols used with permission of the researchers. 

Intellectual Property (IP)

If you think a proposed research project might generate IP, the WA Health Office of Medical Research and Innovation (OMRI) facilitates the responsible management of IP and serves as the central contact for IP advice and assistance. The EMHS RG office can also provide advice and, if required, assist you in liaising with OMRI.

For more information, visit: 
• Intellectual Property website (external site) 

Library and Information Service

The EMHS/SMHS Library offers extensive resources and services to assist researchers.  

Services available:
http://selibrary.health.wa.gov.au/services/searches

When off-site, you can login using your usual network credentials to access resources:
http://selibrary.health.wa.gov.au/ 

Research guide:
http://selibrary.health.wa.gov.au/research 

To build your profile as a researcher, obtain an Open Researcher and Contributor ID (ORCID) via the following link:
https://orcid.org/