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Frequently Asked Questions
Participating in a clinical study is an important personal decision, and as with any medical procedure, there are always questions to consider. The following are among the most common.
- What is a clinical study?
- Why should I consider enrolling my child in a study?
- Are there benefits to participating?
- Are there risks to participating?
- What are the requirements of participating?
- What is informed consent?
- Do I need a doctor’s referral?
- Are there costs associated with participating?
- Will I be paid for participating?
- How can I find a relevant study?
- Where can I get more information about clinical trials?
- What about confidentiality?
- Are clinical studies safe?
What is a clinical study?
Clinical studies engage volunteers with medical professionals to address specific health questions, such as how and whether a particular therapy or treatment contributes to improvement of a group of patients. Without volunteers and public support for clinical research, advancement in healthcare would not be possible.
Why should I consider enrolling my child in a study?
There are a number of good reasons to consider participating in a clinical trial. In addition to personal attention and individualized care, participants often have access to therapies or FDA-approved medications that may not yet be available to the general public. Trials are also an opportunity to learn more about a medical condition and meet others with similar conditions.
Are there benefits to participating?
The potential benefits from participating in clinical trials help prove whether a treatment is effective and/or can help determine the safe dosages required and the potential side effects that can occur with a new drug. You also gain the satisfaction of knowing that your participation in the study may lead to advancements that will benefit others in the future.
Are there risks to participating?
All medical procedures – even proven therapies – have risks. Every clinical trial is different, but anticipated risks will be reviewed with each potential participant as part of the informed consent process.
What are the requirements of participating?
Requirements vary depending on the study. Participants will need to meet certain eligibility and screening requirements in advance. If those criteria are met, there will be an initial screening examination at which time an informed consent document will be reviewed with the parent/guardian. Once admitted to the program, usually visits to Children’s Hospital of Pittsburgh to meet with medical professionals for examination or treatment will be part of the regimen, however the frequency of appointments will vary.
What is informed consent?
Informed consent is a process that assures you have all the necessary facts about a clinical trial before deciding whether or not to participate. The medical professionals running the study will explain all details and answer all questions. The researchers will provide an informed consent document that provides the study details, purpose, duration, required procedures, risks and potential benefits. The participant then decides whether to sign the document, indicating they reviewed and understood its content. It is not a contract. Participants may withdraw from a trial at any time.
Do I need a doctor’s referral?
Participants often join clinical trials as a result of a referral from their own pediatricians, but that’s not always the case. You will, however, find it helpful to confer with your child’s physician and other members of your family or friends about deciding to join a clinical trial.
Are there costs associated with participating?
Patients who participate in clinical studies will not be charged for visits with medical professionals or for equipment or medicines or materials required by the study.
Cost of research studies are paid in one of two ways. Hospital and laboratory expenses are paid by the grant when such expenses are only for research purposes. Non-research expenses that are part of the treatment of a child’s condition will be the patient’s financial responsibility and will be charged to the insurance provider.
Will I be paid for participating?
Some studies will compensate subjects for time and inconvenience for participation in a trial, but for others, study participants are not paid. Generally expenses associated with visits, such as travel costs or parking while in clinic for study procedures are reimbursed. The study coordinator will explain reimbursements during the informed consent process.
How can I find a relevant study?
At any given time, Children’s has hundreds of studies underway. To see if there is a trial appropriate to you or a member of your family, please Search for Clinical Trials to view brief descriptions of all current studies.
Where can I find more information about clinical trials?
For further help in guiding your decision, the National Institutes of Health provides a discussion about Clinical Trials, which addresses additional questions you may have.
What about confidentiality?
The identity of participants in a research study is kept confidential. In addition, scientific publications that result from the research do not identify participants without specific prior approval.
Are clinical studies safe?
All research protocols implemented at Children’s Hospital of Pittsburgh of UPMC are carefully examined and reviewed by the Institutional Review Board (IRB) of the University of Pittsburgh. The IRB protects the rights and welfare of individuals recruited to participate in research activities and ensures that only safe, ethical and scientifically valuable research is being conducted.
December 22, 2011
December 22, 2011