Potential Risks in Clinical Studies
Cincinnati Children's Hospital Medical Center Clinical Trials Office understands that you have questions about the research study process. If you have any further questions about clinical studies, please contact the Clinical Trials Office, (513) 636-0098.
What Are the Risks Associated with Clinical Trials?
All of the research studies conducted at Cincinnati Children's must comply with the rules and regulation established by the Food and Drug Administration (FDA) and Cincinnati Children's Institutional Review Board (IRB). The IRB, a group of people separate from the investigator, has to evaluate the benefits and the risks of the trial. However, there are uncertainties in research. Participants have side effects or adverse reactions to treatments.
Subjects who experience any serious reactions are immediately removed from the study and given appropriate, expert care. (It is important to note that the risks are low, and that the majority of the drugs used in the pediatric trials have already been tested in adults.) It is also possible that the treatment being tested may not be effective for the participant or that he/ she could receive no treatment (placebo).
What is Informed Consent?
In the United States, every participant in a clinical trial and, if appropriate, his or her guardian have the right to give informed consent. The U.S. Government strictly enforces the guidelines that regulate all medical research involving people.
Before you decide whether or not to participate in a clinical trial, you must be properly "informed." If your child is participating in a study, he or she must also be informed and you both must clearly understand:
- Participation is voluntary
- Why the research is being done
- What the researchers want to accomplish
- What will be done during the trial and for how long
- What risks are involved in the trial
- What possible benefits can be expected from the trial
- What other treatments are available
- That you have the right to leave the trial at any time without interfering with your regular care
You will receive a consent form. You must read or be read to and understand completely before making your decision to participate. Some pediatric trials also require assent (an agreement to the trial) from your child. It is a good idea to take all documents home and discuss them with family members or friends.
Cincinnati Children's wants you to feel comfortable with your decision. You can change your mind at any time. The informed consent process continues throughout the clinical trial. You should ask questions and express concerns.
What is an Institutional Review Board?
The Institutional Review Board (IRB) is an independent committee that consists of healthcare professionals, non-healthcare citizens and experts. The IRB is designated by Cincinnati Children's to review, approve the initiation of, and to conduct periodic review of all biomedical research involving all human subjects including children.
All IRB members must be independent of the study or the study sponsor in order to vote on any study. The primary purpose of the IRB is to protect your rights and welfare. Every institution that conducts biomedical research involving human subjects must, by federal regulation, have an IRB.
An IRB approves and monitors every clinical trial performed to minimize the risks to the study participants and to make sure that the potential benefits of the trial outweigh those risks. This includes the review of all study-related documents, informed consent forms, physician credentials and eligibility, and patient recruitment materials, such as media advertisements.
