Research glossary

Associate investigators

Associate investigators are members of the research team. Unlike the chief or principal investigators and mentors, they don’t need to be a health practitioner who works for us.

Chief investigators

Chief investigators lead research including clinical trial teams. They supervise associate investigators. They’re health practitioners employed by either us or Mater Health. They may also be called principal investigators.

Clinical trial

A clinical trial is a research study involving human participants to investigate a new treatment and its effects on health outcomes.

Clinical research

This is research that helps find out if medications, devices, diagnostic products and treatments are safe and effective.

Coordinating principal investigator

Coordinating principal investigators are members of the research team. They submit applications to the Human Research Ethics Committee (HREC) and update them with any changes to the application.

Confidential information

This is identifying information about a person who is using or has used a public sector health service. It's information you gain in your role as a designated person.

For a full description, read section 139 of the Hospital and Health Boards Act 2011 (Qld) on the Legislation Queensland website.

Data custodian

Data custodians review and approve Public Health Act (PHA) applications. If you need data from multiple data sets that have different data custodians, you'll need to get the PHA signed by all data custodians.

Find a data custodian (PDF 227 kB) using our contact list.

Data linkage

This is a process that uses identifying information to find records in one or more databases that relate to one person. Identifying information may include a name and date of birth.

We use probabilistic methods to perform project specific data linkage. We apply anonymised person ID that researchers can use to combine information from different sources.

Ethics approval

This is the approval you must get before you can start a research project. A Human Research Ethics Committee (HREC) will assess your project against the National Health and Medical Research Council guidelines (NHMRC).

Low risk projects, such as clinical audits or quality assurance activities, may not need a full ethics review.

Ethics Review Manager (ERM)

The ERM is an online system that helps you complete your research ethics applications electronically.

Experienced researcher

Experienced researchers are members of a research team who have either:

• completed a relevant post-graduate qualification by research 6 or more years ago
• have obtained competitive funding, over $150,000, as the principal or chief investigator of a research project.

They’ve also demonstrated a commitment to research capacity building in the health practitioner workforce. They generally have significant experience in doing research, presenting research results and publishing with a substantial publishing history, including as first author.

Governance authorisation

This is the authorisation you must get before you can start a research project. To get this, you must submit a site-specific assessment (SSA) application through the Ethics Review Manager (ERM).

Hospital and Health Service (HHS)

These are Queensland public hospitals and health care facilities, including health centres. You’ll partner with our HHS when you do research.

Read more about our HHSs.

Human Research Ethics Committee (HREC)

HRECs do ethical reviews of proposed research. Before you can start a research project, you must get HREC approval.

Infonetica IT Helpdesk

The helpdesk provides technical support for the ERM system.

Information

This refers to information we hold about a person’s health or health services they’ve received that can identify them. This includes information about a deceased person.

In a Public Health Act 2005 application, it refers to information that meets the definitions set out in the Act.

For full descriptions, see Schedule 2 of the Public Health Act 2005 on the Legislation Queensland website.

Intellectual property (IP)

IP is the knowledge and output that results from intellectual activity. In terms of research, IP can be input, such as ideas, findings, or teaching materials, or output, such as authorship, inventions, and patents.

Master Participant Information Sheet and Consent Form (PICF)

This form lets participants know why they're being invited to take part in a teletrial research project. It also requests their consent for:

• information about their participation to be collected for reporting purposes.
• their name and contact details to be given to a research teams.

Mentors

Mentors work with new and mid-career researchers who are applying for funding and are associate investigators in a research team. They're health practitioners employed by us who have experience in designing and implementing research.

Mid-career researchers

Mid-career researchers are members of a research team who may be in the process of completing a higher degree by research. They may also be less than 6 years out after completing a relevant higher degree by research.

They generally have some experience in doing research, publishing research outcomes and presenting research results. They may have obtained some competitive research funding, less than $150,000 in total.

Multi-centre research

A multi-centre research trial is a clinical trial done at more than one facility or site. Most large clinical trials, particularly Phase III trials, are done at several sites.

National Statement on Ethical Conduct in Human Research (the National Statement)

This sets out the standards for the ethical design, review and conduct of research involving humans. It describes the roles and responsibilities of institutions, researchers, sponsors and ethical review bodies when doing research. It applies to both single centre and multi-centre research.

Read the National Statement on the National Health and Medical Research Council (NHMRC) website.

New researchers

New researchers are members of a research team who may be in the process of completing a relevant higher degree by research. They usually have no or minimal research experience and haven't received competitive funding over $50,000 for a research project.

Non-identifying information

This is information that doesn’t identify a person. It doesn’t include information such as their name, address or Medicare number.

Pathology information

This refers to information we hold about a person’s health gathered from pathology tests. For example, blood or saliva testing results.

Public Health Act (PHA) application

A PHA application is used by researchers to apply for information they’re unable to get consent for under the Public Health Act 2005.

Primary sites

Primary sites are responsible for and coordinate trials across a cluster of satellites sites to enhance participant reach, recruitment and management.

Primary Site Workflow checklists

This checklist is completed by the primary site for each satellite site in the teletrial cluster. The primary site should complete it with the Regional Clinical Trial Coordinating Unit that's assisting the satellite site.

Principal investigator

Principal investigators lead research including clinical trial teams. They supervise associate investigators. They’re clinicians employed by either us or Mater Health.

Regional Clinical Trials Coordinating Centre (RCCC)

The RCCC is a specialist clinical trials support unit staffed with senior clinical research coordinators. They work with primary and satellite sites to set up a teletrial.

Re-identification

This is the process where non-identifying information, when used in various combinations, can identify a person.

A combination of factors, such as date of birth, sex or postcode may make information potentially identifiable. For example, where a person has an uncommon disease or condition and lives in a small community.

Research governance officer

A research governance officer is responsible for reviewing the site-specific assessment (SSA) form for a clinical or teletrial.

For teletrials they also organise the signing of the teletrials subcontract between their site and the satellite sites.

Research registry

A research registry is a collection and analysis of health and medical information that's used to evaluate specified outcomes.

Satellite sites

Satellite sites are health facilities that are connected geographically to a primary site. They can be in metropolitan, regional or rural areas and do research that's delegated to them by the primary site.

Site-specific assessment (SSA)

Before you start a research project, you must get an SSA. This is part of the governance authorisation process and helps us approve your research project.

The SSA considers the suitability and risk of the site and what resources may be needed for the research.

Sponsors

Sponsors can be individual researchers such as medical practitioners. They can also be organisations such as hospitals, area health services, non-government organisations and cooperative research groups. The type of sponsor will vary from trial to trial, depending on who takes overall responsibility for the trial. They also finance the research.

Start-up specialists

Start-up specialists work in the Queensland Regional Clinical Trials Coordinating Centre (QRCCC). They act as cluster start up specialists and may travel to satellite sites to help train staff and set up clinical trials.

They work with primary sites to establish clusters and develop teletrial specific changes to study documentation. They help develop supervision plans and budgets for each satellite site and notify the Human Research Ethics Committee of any changes.

Supervision plan

A supervision plan outlines the process a principal investigator follows when supervising other members of the research team. It includes, but isn’t limited to, details about meetings and other activities done by the research team and independent third parties.

Teletrials

A teletrial uses telehealth technology to communicate between a primary site and satellite sites. This gives patients access to clinical trials closer to home and people living in rural and remote areas.

Waiver of consent

A waiver of consent can only be granted by a Human Research Ethics Committee (HREC). They may do this if getting consent isn't possible or appropriate and an opt-out approach can't be used to get information.

It may be granted for research done prospectively or retrospectively where participants won’t know that they, their tissue or data, are involved in research.

When a HREC grants a waiver of consent, it doesn't overrule state or national privacy and confidentiality laws. An application under the Public Health Act may also still be required.

Read Chapter 2.3 of the National Statement on the NHMRC website for more information.