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Contact Information for Questions or Concerns
If you or your child is a participant in a study
The Consent Form you received when you were invited to be a research subject includes contact information for the study. The telephone number and mailing address of the principal investigator and the study coordinator, if there is one for the study, will usually be provided.
When you call or write about a concern, please provide as much information as possible. This will help University officials to look into your concern. When reporting a concern, you do not have to give your name unless you want to.
See below for contact information to report concerns to the university.
What Parents Should Know About Clinical Trials
Content adapted from the Philadelphia Children's Hospital site
How and why would parents be approached to have their child participate in a clinical trial?
Your child's pediatrician may ask you based upon his or her knowledge of your child's medical history. If your child is hospitalized or is being seen in a clinic, you may be approached directly by an investigator or a clinical coordinator. Some hospitals maintain a database of patients and diagnoses. The database may be searched if researchers are looking for a particular disease or condition. In a hospital setting, physicians meet at least once a week to review challenging cases and your child's case may be one of them. It's very important that you do not feel pressured into making a decision, even if it is your child's pediatrician asking you to participate.
Does my child have the disease or problem that the study targets?
A drug study should always be a match for the child. Obviously, a child should not participate in the study of an epilepsy drug unless the child has epilepsy. However, some conditions are so common that all children will benefit by having your child participate. For example, researchers may be investigating a new drug to treat fever or ear infections in children.
Will my child be able to cope with a trial?
You know your child better than anyone else. Does your child have the temperament and personality to cope with the disciplined regimen required by a clinical trial? Children have a great sense of altruism and they will benefit by understanding that they're helping others.
What is a protocol?
A protocol is the document by which all research studies flow. It's essentially the research "bible" that outlines the exact procedures for the investigator to follow. There must be no deviation. A protocol begins by explaining what is being studied and why. It will also include the name of the sponsor and the names of the principal investigators. The sponsor may be a pharmaceutical company, the National Institutes of Health or a foundation. The protocol will describe the study design, how many people will be in the study, how many times each patient will be seen, what laboratory tests will be done and how often. It will also explain the risks and potential benefits of the study. The protocol also contains all the information required by the Food and Drug Administration (FDA).
What is involved in the study?
You should receive a verbal explanation of the study and the details of the protocol should be included in a written consent form. Although the consent form should give you most of the details, there are a few extra items you may want to ask about. For example, will you be actively involved with collecting and reporting data? If your child is older, will he or she be required to keep a diary or to phone in reports? How many visits will there be? Will blood be drawn? What are the risks? The expected benefits?
What are the doctor's hours?
Does the investigator have evening and weekend hours? You'll want to minimize disruptions to your work schedule and to your child's school day. When you arrive at the doctor's office, will you be seen promptly? When you are participating in a trial, you should be seen right away without waiting as you might for a routine office visit.
Will my child be safe?
The FDA has established strict guidelines for how clinical trials are to be conducted. It requires the sponsor of the trial to scrutinize the credentials of the clinical investigators who conduct the trial. Your child will be monitored closely during the trial and may need to be seen more often.
Will we be compensated for participating?
If there are no extra visits or procedures, you should not expect to receive any compensation. However, if there are, parents should expect to be compensated for the trouble they take to participate in a study. This includes reimbursement for transportation, meals and overnight accommodations. Your child may also be offered a small gift, such as a savings bond or a gift certificate for toys or books. However, be wary of expensive gifts as a lure to participate in a study.
What if my child is a girl of childbearing age?
Because there is so little information about the effects of drugs on pregnant women and developing fetuses, drug companies and clinical investigators will want to be sure that your daughter is not pregnant and will not become pregnant during the course of the trial. This may be a difficult issue for parents of young girls who are capable of child bearing but are not yet sexually active. A pharmaceutical company may require your daughter to take a pregnancy test and may also require her to use some form of birth control. Some companies may accept abstinence as a means of birth control.
Is the doctor experienced?
Has he or she conducted studies previously? You have a right to ask for the credentials of the principal investigator and of anyone else involved in the trial.
Is there an experienced study coordinator, nurse or other resource person who is going to be available to me?
Ask to meet the principal investigator, the study coordinator and anyone else who will work with you during the study. It's important for you to feel at ease with all of them and to be confident they will be available whenever you have questions or problem.
Has the protocol been reviewed by an Institutional Review Board (IRB)?
The Institutional Review Board is a committee within the organization or hospital that ensures the protection and ethical treatment of all participants in a clinical study. The IRB is an impartial, independent group that has no relationship with the individual clinical trial.
If my child is injured during the course of the trial, who is responsible for paying for the cost of his or her treatment?
Usually this issue is addressed in the consent form. You should discuss this topic with the investigator before you sign the form.
Can we drop out of the trial at any time?
You should understand that you can drop out of the trial at any time, for any reason, and without a penalty.
Do you understand the consent form?
You will be given a detailed consent form to sign. It should be written in a language you speak with words that you can understand. Informed consent is not a single event. It is an ongoing process during which you must have time to understand, to make an informed decision and to continually reevaluate your willingness to participate. You should be given a copy of the consent form so that you can reread it to refresh your memory about the study details.
What if I have trouble making a decision?
In some instances, parents are overwhelmed, especially if they have just learned that their child has a serious illness. Sit back and listen to what your doctor and the clinical investigator have to say. Try to take in as much information as you can. Read through the materials they present to you. Feel free to consult with your child's pediatrician and with other health care professionals. Remember, it's OK to say "no" if the study is not a good match for you or your child.
U-M Compliance Help Lines
To report concerns regarding human subject studies, including privacy concerns:
- University of Michigan Compliance Hotline at 1-866-990-0111 (for campus studies)
- University of Michigan Health Ethics & Compliance Help Line at 1-888-296-2481 (for Health System studies)
If you have questions, concerns, or suggestions about human research protections at U-M but you're not sure who to contact, email us at email@example.com.