We are recruiting volunteers to take part, as healthy participants to be controls, in a research study aimed at gaining a better understanding of Multiple Sclerosis.
Multiple Sclerosis is thought to be due to an error in the immune system and is the most common non-traumatic neurological disorder in young adults. The cause of Multiple Sclerosis is due to a genetic susceptibility triggered by environmental factors. The aim of this study is to examine the interaction of genetic and non-genetic components involved in MS. The outcome of this research will provide insight into the mechanisms of the disease process and provide new targets for therapy. To identify genetic factors associated with multiple sclerosis we require a population of healthy volunteers to compare and contrast differences between the two groups (healthy subjects versus multiple sclerosis patients).
The information below explains the research study and the tests involved. Knowing what is involved will help you decide if you want to take part in the research. Read this information carefully. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or your local doctor.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. You will receive the best possible care whether or not you take part.
If you decide you want to take part in the research study, you will be asked to sign a consent form. By signing it you are telling us that you:
- Understand what you have read
- Consent to take part in the research study
- Consent to have the tests that are described
- Consent to the use of your personal and health information as described.
You will be given a copy of the Participant Information Statement to keep.
What is involved?
We are looking for volunteers, over the age of 18, not breastfeeding or pregnant, and have no history of autoimmune disease. If you fit this criteria and would like to participate, we will conduct a brief interview seeking information about your background and medical history. From each participant up to 50 ml of blood will be drawn. DNA and RNA will be isolated to detect genetic variations involved in MS and to measure the activity of these genes. There will be no other genetic tests done on your blood samples.
When will I see a result?
Each participant can, if they so wish, receive any published material that has been presented in a medical journal. This will, however, have no bearing with respect to your medical care as these will be research results that if significant would require additional independent studies from other researchers around the world.
Blood samples and Information will be de-identified for analysis and end results will be published in a medical journal. Medical records identifying you will be kept strictly confidential. Your data will be identified by a code and only authorized researchers will be able to decipher the code. The information will only be used for the purpose of the study. Information will be stored under secure conditions for 15 years, after which they will be destroyed.
Your health records and any information obtained during the study are subject to inspection by Hunter New England Human Research Ethics Committee. Your personal information will be accessed, used and stored in accordance with commonwealth privacy laws, and the NSW Health records and information privacy act 2002. By signing the attached Consent Form, you authorise release of, or access to, this confidential information to the relevant study personnel and regulatory authorities as noted above.
What are possible risks or benefits of taking part?
The risks with blood samples being taken include slight discomfort, minor bruising and possibly inflammation of the vein. You may not benefit directly from this study.
Further Information or Any Problem
If you are interested in this study, require further information or if you have any problems concerning this study, please contact one of the investigators below:
Kira Groen – email firstname.lastname@example.org or phone (02) 4042 0304
Dr Vicki Maltby - Email email@example.com or Phone (02) 4042 0286