1. What is a research study?
2. Who can participate in a research trial?
3. What should I know before I volunteer?
4. What are the benefits and risks of participating in a research study?
5. How long will it take for someone to contact me after I register in the Volunteer Research Register?
6. What happens after I am invited by email to participate in a study?
7. What happens during a research trial?

8. What is informed consent?
9. What if I read something on the consent form that I don't like?
10. Can a participant leave a study after it has begun?
11. What is a protocol?
12. What is a placebo?
13. What is a control or control group?
14. How can I be sure that I am assigned to the study group that I want?
15. Will it cost me anything to participate? Will I be paid?
16. If the study is evaluating a medication or medical device, will I know the name of the medication or medical device I may be taking or using?
17. How much time is involved?
18. How often do I need to update my information in the Volunteer Research Register?
19. Does every enrolling research study at the Black Dog Institute and the University of New South Wales use the Volunteer Research Register to recruit participants?
20. How will my privacy be protected?
21. What if I no longer want to be in the Volunteer Research Register?
22. Who should I contact if I have any questions?
23. What if I am under 18? Can I still register for the Volunteer Research Register?
24. I haven't been diagnosed with a mental health problem but I think I may have one, can I still join the Volunteer Research Register?
25. I live outside of Australia, can I still join the Volunteer Research Register?
26. Can I change my email address on the Volunteer Research Register?



1. What is a research study?
A research study, also called a research trial, is an organised investigation involving human participants to answer a specific scientific question. Research studies are carried out to determine the best way to treat, diagnose or prevent a disorder or a disease. Often they require people without the disorder as well as those with the disorder to take part in the research. Research studies can test the safety or effectiveness of a treatment such as a psychological intervention or a drug, study feelings or behaviors, or simply gather other types of information. They help scientists determine whether we are using the best treatments. The information learnt from research studies helps improve medical care for future patients.

2. Who can participate in a research trial?
All research studies have guidelines about who can participate and these guidelines help to provide valid and reliable results. The factors that determine who is eligible for a study are called "inclusion criteria". Those that rule out someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a research study, a person must qualify for the study. Some research studies seek people with illnesses or conditions to be studied in the trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the scientific questions they are asking.

3. What should I know before I volunteer?
You should find out as much as possible before agreeing to participate in a research study. The researcher will provide you with a Participant Information Statement which will contain all of the relevant details about the study. If you have any questions about the study, you can ask the researcher.

Here are some things to consider:
• What is the purpose of the study?
• What are the risks?
• How might I benefit?
• What is involved?
• What do I have to do to sign up for the study?
• How might this trial affect my daily life?
• How long will the trial last?
• Is there any long-term follow up?
• Will I be reimbursed for any associated costs?
• Will results of the trial be provided to me?
• Who will be in charge of my care?

4. What are the benefits and risks of participating in a research study?
Benefits:
Possible benefits from a research study will be outlined to you clearly in the Participant Information Statement for each research study. Other possible benefits might include:
• gaining access to research advances before they are widely available.
• helping others by contributing to medical research.
Risks:
There may be risks to participating in a research study, and these will be outlined to you clearly in the study’s Participant Information Statement. Before participating, you should consider the risks and benefits carefully and talk with the researcher, your doctor, family and friends before making a decision to participate.

5. How long will it take for someone to contact me after I register in the Volunteer Research Register?
After you submit your registration in the Volunteer Research Register, we will call you within a few days to verify some of the details you provided on your registration form. Once your details have been verified, we will search the register to see if there are any studies that are looking for people who match your details. If there are studies, we will send you an email invitation. There is also the possibility that you will not qualify for any studies at this time. Therefore, months may pass before you are matched to a study and sent an email invitation. If there is a particular study that you have heard about or want to get involved in, you can contact the researcher directly.

6. What happens after I am invited by email to participate in a study?
When you receive your email invitation, you will need to follow the instructions about giving your consent for us to pass your contact details onto the researcher. The researcher will want to contact you to ask you some questions and may ask you to come in for an interview. Without your consent, we will not release your name and contact details to a researcher.

7. What happens during a research study or a research trial?
The process depends on the kind of study or trial being conducted. Typically, the researcher will ask you questions at the beginning of the trial, give specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch after the trial is completed. Some research trials involve more questionnaires and tests than others and some may require visits. These details will be clearly stated at the outset for you, so that you can make a decision as to whether you wish to take part or not.

8. What is informed consent?
Informed consent is the process of learning the key facts about a research study before deciding whether or not you want to participate. To help someone decide whether or not to participate, the researchers involved in the trial explain the details of the study. Then the researcher provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained too. You then decide whether or not to sign the document. Informed consent is not a contract, and you may withdraw from the study at any time by notifying either the Volunteer Research Register or the researcher in charge of the study.

9. What if I read something on the consent form that I don't like?
Although previously you might have talked to the researcher, you might read the consent form and find out something about the trial that you didn't expect. Perhaps it never occurred to you to ask about the risks of a certain procedure, or a placebo period. Maybe you didn't know that there might be side-effects, and maybe any one of these details is enough for you to decide that you don't want to join after all. You can decline to sign the consent form. There will be no hard feelings!

10. Can a participant leave a study after it has begun?
Yes. A participant can leave a study, at any time. When withdrawing from the study, the participant should let the VRR or the researcher in charge of the study know.

11. What is a protocol?
A protocol is a study plan on which all research studies are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.

12. What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In research trials, investigational treatments are often compared with placebos to assess the investigational treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or investigational treatment. Not all studies use placebos.

13. What is a control or control group?
A control is the standard by which the study observations are evaluated. In many research studies, one group of patients will be given a drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

14. How can I be sure that I am assigned to the study group that I want?
Well, you actually can't. The study group you are assigned to is decided randomly, like flipping a coin or drawing a card. Often, a computer program randomises research participants. The researcher has no influence as to which study group you are assigned within a given research study.

15. Will it cost me anything to participate? Will I be paid?
Some studies may offer to cover travel and parking expenses that the study might cause you.

16. If the study is evaluating a medication or medical device, will I know the name of the medication or medical device I may be taking or using?
Yes. You will be informed of the name of the medication or medical device involved in the study. This information can be found in the informed consent form.

17. How much time is involved?
Each study is designed differently. The informed consent will tell you the length of time involved.

18. How often do I need to update my information in the Volunteer Research Register?
Ideally, we would like participants to update their information each time their health or personal information has changed. This will also allow for other matching opportunities as criteria from studies often change. You can do this on your own by accessing the Edit Profile page on the VRR.

19. Does every enrolling research study at the Black Dog Institute and the University of New South Wales use the Volunteer Research Register to recruit participants?
No. Some research teams do not use the Volunteer Research Register and recruit their participants from elsewhere.

20. How will my privacy be protected?
This is outlined in our Privacy Policy.

21. What if I no longer want to be in the Volunteer Research Register?
You can request that you be taken out of the Volunteer Research Register at any time by going to the Edit Profile page and clicking on the link at the bottom that says ‘Withdraw consent to participate in Volunteer Research Register’.

22. Who should I contact if I have any questions?
If you have any questions about the Volunteer Research Register, please contact: vrradmin@blackdog.org.au or call 02 9382 9517. Questions about research studies should be directed to the researcher in charge of the study.


23. What if I am under 18? Can I still register for the Volunteer Research Register?
Sorry, only people aged 18 and over can join the VRR.

24. I haven't been diagnosed with a mental health problem but I think I may have one, can I still join the Volunteer Research Register?
Yes, you can still join the VRR if you have never received a diagnosis of a mental health problem.

25. I live outside of Australia, can I still join the Volunteer Research Register?
The VRR is for residents of Australia only.

26. Can I change my email address on the Volunteer Research Register?
Yes, you can update any of your information by going to the Edit Profile page which you can access from a link on the top right corner of the VRR Home Page.
Last modified: Wednesday, 23 November 2016, 7:48 PM