For patients and consumers

What is research?

Research is an original investigation undertaken to gain knowledge, understanding and insights. It can involve the systematic investigation of a research question to establish facts and draw new conclusions. Research can also involve the use or application of existing knowledge in a new and creative way to generate new concepts, methodologies or understanding.

Why is research important in health care?

Research is an important part of our health in Metro North and can provide us with:

• new information on health care systems, processes or services, to ultimately improve the quality of care by allowing us to improve our health care service delivery
• new information to improve the diagnosis or treatment of diseases or ill health
• opportunities to test new medications, devices, treatments or technologies, to see if they are effective.
• new contributions to medical knowledge which change the way people are cared for in Metro North and around the world.

Will I be approached to participate in research at Metro North?

As a patient or a health care consumer in Metro North you may be asked to participate in research. For example, you might be approached to participate in a research study if you are admitted to a Metro North hospital, visit an outpatient clinic or attend a Metro North community health care service.

As a potential research participant and Metro North patient or health care consumer, you can be assured that:

• your choice to participate is always voluntary.
• your choice to participate, or not to participate, will not affect your care.
• your rights, safety, dignity, well-being and confidentiality will always be respected.
• you will receive full information about the research project, and be given the opportunity to ask questions.
• you can change your mind or withdraw from a research project at any stage.

One of your treating clinicians or another Metro North staff member may approach you to participate in research.

If you are approached to participate in research, Metro North encourages you to feel comfortable to ask questions and seek further information about participation if you do not understand. The person approaching you will be able to demonstrate the research study is approved, and they are appropriately authorised to approach you to participate.

What does research participation involve?

Participation in research is voluntary. Because every research study is different, your level of involvement and the type of participation will depend on the individual research project. In general, the Participant Information and Consent Form (PICF) will explain what is involved and what you can expect. This will always be explained when you are approached to consider participating, and you can always ask questions to find out more information.

There are many different ways that you can participate in research, including:

• observation of your routine medical care.
• permission to collect samples such as blood or urine and undertake diagnostic tests such as an x-ray.
• permission to access information from your medical record, for example a blood test or treatment history.
• answering a survey online or completing a paper based questionnaire or form.
• being involved in an interview either in person or over the phone.
• attendance at follow-up sessions or clinical appointments.
• attendance at a facility or service not operated by Metro North, for example a clinical research facility.

It is important to consider what participation means to you, and how it fits in with your personal circumstances. This involves understanding all of the requirements for participation, such as study visit locations or the time involved.

Why participate in research?

Participating in research can be an opportunity to take a more active role in your own health care. You might gain new or increased insights into your own health conditions or concerns, and you may have an opportunity to better understand your health care treatment and management.

In some cases, participation in research involves access to trial new treatments under development, new services and models of care, or participate in research better designed to understand your health care experiences.

It is also possible that you might not gain any direct or immediate benefit for yourself by participating in research. Your participation in research may help others, either now or into the future, by enabling the discovery of more effective models of health care, better treatments, and ultimately better management of health outcomes.

The discovery of new interventions that can help people to live longer, have less pain or be free of ill-health or disability is possible through research and the willingness of people to voluntarily participate in research. Both healthy participants and those diagnosed with a health condition or disease are needed to help in finding new ways to prevent, diagnose, treat and potentially cure diseases or health conditions. By taking part in research, you can contribute to the advancement of scientific understanding and, in some cases, to improved health for yourself and others with the same disease or health condition.

If you are healthy or otherwise free of the health condition or disease related to the clinical trial, you may choose to participate to help others, to contribute to improved health care or to contribute to improving scientific knowledge. You may even have a personal interest in the research, or you may even have a family member or friend with the disease or health condition.

Whilst your voluntary participation may help improve the lives of family, friends or others and is an extraordinary gesture of kindness and goodwill, potential participants should think carefully about participation. There are considerations around the demands on your time and the risks and benefits (if any), which should be carefully thought through before providing your informed consent to participate in research.

What if I no longer want to participate?

Participation in research is voluntary. It is not compulsory. You are free to withdraw from a research project at any time. If you no longer wish to participate in a research project, you can decide to not continue without it affecting your access to ongoing treatment or ongoing care. You can be sure that you will always continue to receive the best care we are able to offer you.

Are there any risks associated with participation in research?

There may be some risks associated with participation in clinical research, and it is important to read all of the information you are provided carefully and ask questions so that you feel comfortable with your understanding of the risks involved. All known risks will be described to you in writing, provided in a document we commonly call a Participant Information and Consent Form (PICF). The researchers will provide this to you before you decide to take part in any research and answer any questions that you may have about the risks.

Are there any costs involved with participation in research?

Sometimes research will be conducted as a part of your routine care and may not involve extra visits or services.

It is important to discuss these considerations with the researcher when you are first invited to participate and should be outlined clearly when discussing participation in a research project.

What about time off work to attend research project appointments?

If being involved in a research study requires you to take off work, you are able to request a medical certificate from the research team.

How do I know the research is ethical and approved by the Hospital?

In all cases, research must first be approved by a nationally certified Human Research Ethics Committee (HREC) which is responsible for assessing the ethical principles of research, and for protecting the rights of research participants.  The research must then be signed off by the hospital executive (known as governance approval) prior to commencing discussions with potential participants and actually starting a study.

Before being enrolled onto any research project, you will receive a written information sheet which contains important details about the study and you will be required to sign a consent form, which has been approved by the ethics committee.

If you have any concerns about the conduct of a study at any time, you can speak with: the Chair of the Human Research Ethics Committee that approved the study or, the local Research Governance Officer at the hospital where you are involved in the research. The names of all the various people you can contact to discuss your participation in the clinical trial, including the study doctors will be listed on the study information sheet.