Reference no: EM133050816

Please summarize each bold section paragraph by sections using the information provided using your own words. Please keep information with headings.

Introduction:

You have been enrolled in a research study for the treatment for Diabetes.  Please allow yourself the adequate amount of time to discuss the study with family, friends and/or anyone that you may feel comfortable to do so.  The decision is up to you whether or not you want to continue with participating in the study.  During this research/study there will be a series of research, log keeping, vaccines and data collection that will be done. There has been a study where test done with vaccines on mice to determine the dosages and strengths.  There have been several studies that have been conducted for years trying to find a cure for type 1 diabetes.  After the study please feel free to share with anyone that you feel this may help.

What Will Be Expected: 

There will be a tutorial by a diabetes specialist on explaining the condition and how the illness affects the immune system and the attack of the body's insulin-producing beta cells. You will have to be prepared to stay for an extended period of time. The study will take place at a facility where a MA and/or RN will be present to administer the vaccines, record the dosages and maintain the log. Any reactions from the vaccines and side effects will be noted also.   

Time Required:

One Week

Risk and Benefits:

While participating in this study there are risks that you could experience such as sweating, chills, lightheadedness, nervousness, irritability, slight blurred vision and difficult sleeping. If any experience of these signs is normal.  The possible benefit from this study is create a vaccine that stops the immune system from attacking the body's insulin -producing beta cells.  If any previous history of high blood pressure, low blood pressure or previous heart problems you will be excluded from the study.

Confidentiality:

The study is strictly confidential, and no names will be used.  The identity of all individuals that participate will be replaced with alphabets and numbers combined.  The numbers and alphabets will be associated with names.  All name information will remain anonymous and replaced with alphabets and numbers.

Voluntary participation:

The participation in this research study is strictly on a voluntary basis. 

Right to withdraw from the study:

If at any point during the stay one does decide to discontinue participation, they are welcome to leave. No penalty will be given if one chooses to not participate any longer.  All information will be discarded.

Whom to contact if you have questions about the study:

If any questions or concerns, please feel free to contact the Director of Clinical Diabetes Study at 1855-745-8555 and leave a detailed message if your call is not answered.

Agreement:

If you consent to participate in this study, please sign the form below.