Participant Information & Consent Form

Research Access and Information Network (RAIN)

Implementation and Evaluation  Invitation

 

Thank you for interest in volunteering to participate in St Vincent’s Hospital’s Research Access and Information Network (RAIN).

RAIN is a research resource developed by Professor Kay Wilhelm for Faces in the Street, Urban Mental Health and Wellbeing Research Institute at St Vincent’s Hospital. This is an initiative of the Inner City Health Program at St Vincent’s.

 

Before you decide whether or not you wish to participate in RAIN, it is important for you to understand what RAIN is, why it is being developed and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish.

 

1. ‘What is the purpose of RAIN?’

Research is an essential part of improving health care and treatments. Researchers investigating illness, treatment and health service provision need people to participate in their research studies, and increasingly, to seek feedback of research from community members. The purpose of RAIN is to increase access for people to participate in research, by linking people to research opportunities. This database will contain contact details of potential research participants who are willing to have information forwarded to them regarding suitable research opportunities.

 

2.  ‘Why have I been invited to participate in this study?’

RAIN is a research resource not an individual study. You were selected as a potential participant because you responded to a recruitment advertisement seeking participants who are willing to have information forwarded to them with the purpose of participating in research.

 

3.  ‘What if I don’t want to take part in this study, or if I want to withdraw later?’

Participation in RAIN is voluntary. It is completely up to you whether or not you participate. If you decide not to participate, it will not affect the treatment you receive now or in the future from St Vincent’s Hospital. 

 

If you wish to withdraw from RAIN once it has started, you can do so at any time without having to give a reason. If you email us that you wish to withdraw, we will confirm the receipt of your email, and request that you complete a short set of questionnaires. Completion of these questionnaires is voluntary.

 

4.  ‘What does participation in RAIN involve?’

RAIN is a research resource not an individual study. If you agree to participate in RAIN, an online consent will be sought from you prior to:

  1. Your name and contact details being retained by RAIN for the purpose of sending information to you regarding research opportunities you may wish to participate in.
  2. You being asked to complete a short online questionnaire detailing the research area of interest to you and allowing you to indicate the level of participation you are interested in.
  3. You being asked to complete a lifestyle behaviour questionnaire. An automated feedback report will be sent to you to view and discuss with you doctor or other health professionals, if you wish.

 

Information in research studies in the topics you have expressed interest will be sent via newsletters, emails and displayed on the RAIN webpage. Consent to participate in research studies will be obtained directly between the researchers of individual studies and the participant, not between RAIN on behalf of the researchers.  

 

What is involved if I wish to consent to take part in a specific research opportunity?

A person cannot be entered into any research opportunity without giving their consent.  The informed consent process ensures that you volunteer of your own free will to take part in any research opportunities (including studies, community consultation and feedback and opportunities to volunteer).

RAIN will give you the contact details of the particular research opportunity but it will be up to you to contact the people involved.

To give consent for a research study, you must understand what the research is about, what the risks involved may be, what are the benefits if any and the safeguards in place to protect you.  You should always be made aware of the extent of your involvement.  You can talk about this with the researcher before you decide to take part and you can ask as many questions as you like.  It is sometimes possible to provide translators or advocates who can help you to make your decisions.  You do not have to stay in a study if you do not want to, even when you have given your consent to take part.

How many people will be recruited for RAIN?

Open to anyone over 18 years of age.

 

How long will you be involved in RAIN?

As long as you wish to participate as you can withdraw at anytime. RAIN will be an established research resource for St Vincent’s research institutes with ongoing involvement from participants

 

5.   ‘How is this study being paid for?’

It is paid for from the budget of the Inner City Health Program at St Vincent’s Hospital.

 

6.  ‘Are there risks to me in taking part in RAIN?’

No risks are anticipated by your participation in RAIN. Risks for the individual research studies that you wish to participate in will be identified by the researchers of those studies prior to you providing your consent to those studies.  The main risk to participants who answer the lifestyle questionnaire may be the possibility of feeling uncomfortable by answering questions about their own lifestyle (eg, rating that you don’t exercise enough).

 

7.  What happens if I suffer injury or complications as a result of participating in RAIN?’

If you have any questions or concerns, you are welcome to contact the researcher, Professor Kay Wilhelm 02-8382-1540 or Andrea Millar 02-8382-1540.

 

8.  ‘Will I benefit from the study?’

RAIN aims to further medical knowledge. However it may or may not directly benefit you. However, if you decide to sign up for the newsletter, you will be sent general information about health and wellbeing, and at times, some information about research findings that are specific to the areas you have said you are interested in.

 

9.  ‘Will taking part in this RAIN cost me anything, and will I be paid?

Participation in RAIN will not cost you anything other than the costs associated with using your computer or accessing the internet.  You will not be paid.  You will receive any newsletters, feedback on lifestyle questionnaire or information as a free service.

 

10.  ‘How will my confidentiality be protected?’

RAIN is committed to protecting the confidentiality of participants. Systems have been rigorously tested to ensure your personal information is secure. There is an unlikely risk of breach of confidentiality as any identifiable information that is collected about you in connection with RAIN will remain confidential and will be disclosed only with your permission.  Only the Faces in the Street researchers will have access to your personal details which will be held securely at St. Vincent’s Hospital.  RAIN will link you with research studies you are interested in by providing study contact details to you. RAIN will not give your details to external researchers.

 

Information collected from the online baseline questionnaire and the lifestyle questionnaire will be in a form that you cannot be identified that you cannot be identified.

 

11.  ‘What happens with the results?’

We will analyse the results of your questionnaires as de-identified reports. We plan to publish the results of your group in peer-reviewed journals, presentations at conferences or in other professional forums. In any publication, information will be provided in such a way that you cannot be identified. Results may be discussed with the St Vincent’s Hospital Research Ethics Committee for monitoring purposes.

 

12.  ‘What should I do if I want to discuss RAIN further before I decide?’

When you have read this information, you are welcome to contact the researcher, Professor Kay Wilhelm. If you would like to know more at any stage, please do not hesitate to contact her on (02) 8382 1540.

 

13.  ‘Who should I contact if I have concerns about the conduct of this study?’

RAIN has been approved by St Vincent’s Hospital HREC. Any person with concerns or complaints about the conduct of this study should contact the Research Office who is nominated to receive complaints from research participants. You should contact them on 02 8382 2075 and quote HREC Reference Number (14/205).

 

THANK YOU FOR TAKING THE TIME TO CONSIDER THIS STUDY

 


 

RESEARCH ACCESS AND INFORMATION NETWORK (RAIN)

ST. VINCENT’S HOSPITAL

CONSENT FORM

1.         I agree to participate as a participant in the Research Access and Information Network (RAIN) described in the Participant Information Sheet attached to this form.

2.         I acknowledge that I have read the Participant Information Sheet, which explains why I have been selected, the aims of the RAIN and the nature and the possible risks of the investigation, and the statement has been explained to me to my satisfaction.

3.         Before signing this consent form, I have been given the opportunity of asking any questions relating to any possible physical and mental harm I might suffer as a result of my participation and I have received satisfactory answers.

4.         I understand that I can withdraw from RAIN at any time without prejudice to my relationship to St Vincent’s Hospital.

5.         I agree that research data gathered from the results of the study may be published, provided that I cannot be identified.

6.         I understand that if I have any questions relating to my participation in this research, I may contact Professor Kay Wilhelm on telephone 8382 1540 or kay.wilhelm@svha.org.au who will be happy to answer them.

  • I acknowledge I have viewed this Consent Form and the Participant Information Sheet
  • I consent for my contact details to be retained by RAIN for the purpose of receiving information regarding participation opportunities in research areas I have expressed interest in
  • I consent to complete a short Online Baseline Questionnaire
  • I consent to complete the Fantastic Lifestyle Measure
  • I understand RAIN  will not forward my details to any third party

Complaints may be directed to the, Research Office, St Vincent’s Hospital Research Ethics Committee DARLINGHURST 2010 AUSTRALIA (phone 8382 2075, fax 8382 3667, email research@stvincents.com.au).