Healthy Male works with leading researchers from all around Australia. You can find out about ongoing research studies conducted by our partners and perhaps volunteer to participate at the bottom of this page.

 

Human research studies – What they are and how can you get involved?

Healthy Male provides easy access to scientific and medical research on male reproductive and sexual health for everybody, regardless of gender, age, education, sexual orientation, religion or ethnicity.

We want to make it easy for you to know about local research studies that are underway in case you want to participate, or just have a more up-to-date knowledge of research that might be relevant to your health.

There are different types of human research studies used to collect the evidence that guides healthcare. Knowing which type of study is used for what can help you to assess the quality of evidence that comes from human research studies, whether a study is relevant to you and, in some circumstances, to decide if you might want to volunteer to be a subject.

We often think of medical research as involving new medicines, but new ideas about diet, exercise, and exposure to things in our environment all require people to participate in studies so that reliable evidence can be collected about the benefits and potential harms.

 

Types of human research studies
Observational studies

Observational studies involve the collection of data from participants, without giving them any treatment or changing anything else. Observational studies might involve collection of data from medical records, surveys, or measurements made specifically for the study (e.g. blood tests, X-rays, blood pressure).

Interventional studies

For interventional studies, researchers change something. Examples include changes to the healthcare participants receive, a different medicine, a change in diet, a new exercise program or the provision of new information. Interventional studies are sometimes called clinical trials.

In the development of new treatments, there are specific stages of gathering evidence about whether the new treatments are safe and effective. These stages use different phases of clinical trials.

Phase 0 is when researchers use a small number of healthy people to make sure that a low dose of a new treatment is not harmful.

Phase I clinical trials use more healthy people as test subjects, to find the best dose and way of giving a treatment. Phase I clinical trials identify the maximum amount of a treatment that can be given without serious side effects.

Phase II clinical trials enroll participants who have the condition that the new treatment is intended to treat. This phase works out whether the treatment works. It is not designed to find out if there are rare side effects of the treatment or if it is safe overall.

Phase III clinical trials are large studies of patients with the disease the treatment is intended for, to see if it is at least as safe and effective as the existing treatment (this is usually required for government approval of new treatments). Phase III clinical trials often give the treatment to some patients and compare their health to another group of patients who receive a placebo.

Further studies of treatments occur after phase III, to look at long term effectiveness and side effects.

 

Volunteering to participate in human research studies

There are a few reasons why you might want to volunteer for a human research study.

Participating in research is one way that you can contribute to your community. It’s an opportunity for you to help potentially thousands of people worldwide.

Trial participants are the first people to receive new treatments, although not all treatments studied in clinical trials are eventually proven to be effective.

Some people have suggested that there’s a health benefit simply from participating in a trial, as a consequence of the health monitoring and other things that are part of being in a trial. Early studies that suggested this ‘trial effect’ have since been followed by other studies showing no effect. This lack of certainty is a characteristic of research that relates to the reproducibility and quality of different studies.

 

Safety of participants in research studies

There are checks and balances to make sure that people involved in research studies are as safe as possible.

If research might result in anything more severe than discomfort for participants, studies require the approval of Human Research Ethics Committees. These committees are tightly regulated. They weigh up the balance between risk to participants and overall benefit. They ensure the research is necessary, that the appropriate methods are used, and that participants are aware of the risks of being involved. Formal documentation to inform participants of the study and its risks, and written consent to participate, is required.

There are official channels for participants to report any concerns.

Participants in human research studies are free to leave the study at any stage, without having to provide a reason. If a participant withdraws from a study, all the data and any other materials from that person cannot be used.

 

Researchers can enquire about listing their study on the Healthy Male Research Studies webpage by completing the Research Study Notification form.

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