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What's it Like to be in a Study?

Participating in a clinical research study is a voluntary choice and there are many factors that need to be weighed before making a decision that is right for you and your family. Ultimately it is a personal choice that you and your healthcare team have to make together.

Typically, prior to enrolling you'll discuss the following with the study coordinator: inclusion and exclusion criteria, the length of the study, the number and interval of visits required, the labwork and other tests required during the study and the scope of the questionnaires that are completed at each visit. Any study related physical exam or muscle testing measures will be described. The study consent (for parent, if participant will be under age 18) and assent (for participants age 7 -17) will be described, mailed and later discussed prior to enrollment.

Once a decision is made to enter the study, a baseline visit will be scheduled to discuss and answer any questions prior to signing of study consent and/or assent and to complete all questionnaires, exams and lab work associated with entering. It is important to note that you and/or your child's participation is totally voluntary and that you may, at any time, resign from the study without penalty. For many families, participation in a clinical trial involves sacrifices of personal and family time, as well as finances which we attempt to minimize. The cost of all the tests and examinations associated with clinical studies are covered and no study-related fees are submitted to your insurance.

Here are some Q and A's that may give you more understanding of some of the logistics of participating in a clinical study.

Q: How do I find the nearest CINRG clinical testing site?
A: You can check out this website under "CINRG Network" to find the participating centers that are near you. You can also access clinical trials via www.clinicaltrials.gov, then enter your specific diagnosis to find the status of all trials in and outside the U.S. that may be relevant to you.

Q: Can I come to a CINRG research site to get a second opinion for my child?
A: Yes, however, it will not be a research visit. You will need insurance or self pay coverage for the expenses during the visit.

Q: If the nearest CINRG site is far from my home town, is there financial assistance available for travel?
A: No, but depending on family income there may be access to air travel via the National Patient Travel Center (www.patienttravel.org) and overnight accommodations via Ronald McDonald House at some of the CINRG sites.

Q: If my child enrolls in a CINRG research study do they have to stay overnight?
A: There are some study visits that are required to be within two days of each other. If you are traveling from out of town it is most likely you will have to stay overnight in that city.

Q: How many visits are included in a CINRG study?
A: This varies with the study. You should contact a CINRG project manager for more study information.

Q: What type of testing would be involved if we enroll our child in a CINRG research study?
A: Each study varies in the testing that is performed. In the CQMS section there is a list of the testing that CINRG typically uses.

Q: Is it possible to talk to other families about their experiences with CINRG?
A: CINRG can not provide contact information for other patients, however, we could possibly ask a family to contact a new patient.

Q: We are planning to move in the next year. Can we change testing sites in the middle of a study?
A: Yes, this is possible if the center is a member of the CINRG network.

Q: Who can refer my child to a CINRG testing center?
A: You do not need a referral to a CINRG testing center. You may self refer.

Q: If I come in for a visit (screening visit) to see if my child is eligible for the study, will I need to stay overnight? Where will we stay?
A: The screening visit may require a one or two day visit and you may need to stay overnight. The study coordinator will discuss the visit dates and give you hospital based contacts or resources to locate discounted lodging.

The National Heart, Lung, and Blood Institute (NHLBI) has developed a video that is useful in understanding what a research study is and what a child's role is in this process. NHLBI, part of the NIH and the U.S. Department of Health and Human Services, points out that in the past, children have had to receive medicines that are known to work in adults but have not been tested in children. As a result, the community is working to make research available to children to test these drugs to ensure they are safe, effective, and the best option for a child. Their video is useful in understanding and answering some questions you may have. You can link to the website at: http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php

The U.S. National Institutes of Health have an online registry of both federal and private funded clinical trials worldwide (www.clinicaltrials.gov). There is also a useful question and answer section for understanding what is involved when you participate in a research study (http://clinicaltrials.gov/ct2/info/understand).

The FDA, the National Institute of Neurological Disorders and Stroke and the National Institute of Arthritis and Musculoskeletal and Skin Diseases also have information about participating in clinical trials. Remember, your physician and healthcare team are great sources of information too.


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