FAQ

• There are many potential benefits to participating in clinical trials.
• You have access to new medications or treatments before it becomes available to the public.
• You are given exclusive access to providers and are monitored closely for side-effects to the medication or treatment
• You are allowed to become more active in your healthcare
• You contribute to the advancement of medicine and medical research

• There may be potential risks associated with any research study. Some risks include the following:
• The medication or treatment may not work or may not be better than the standard treatment.
• The medical product might cause serious side effects or uncomfortable
• The clinical trial could inconvenience you. Ex. medical appointments may take up a lot of time, you may need to travel to the study site several times, etc.

No, you are never required to pay to participate in a clinical trial.

• Informed consent is the process in which a healthcare provider or qualified staff member educates a participant about the risks, benefits, and alternatives of a given medical product or treatment. The research staff will explain the purpose of the trial, how long it will take, and information on the privacy of your medical records.
• If you want to participate in the study, you will sign a consent form that will detail all the information that was discussed with the research team. You will also receive a copy of the consent form upon your signing.
• Informed consent continues throughout the clinical trial. If new information becomes available about the study, medication, or side effects you will be made aware, and a new informed consent form will need to be signed.

Yes, you are free to stop participating in a study at any time for any reason.

• Thoroughly read and understand the informed consent form before signing.
• Ask questions if you do not understand something about the study, your rights as a participant, or you need more information
• Follow directions for proper use, dose, and storage of the study medication or treatment
• Follow directions for abstaining from non-study medications, or contraindicated medications during the study duration
• Show up to scheduled appointments on time, and inform research staff within a reasonable time if you need to reschedule
• Provide honest answers to questions asked during the screening and enrollment period of the study
• Inform the staff if you need additional medical accommodations during the study
• Report any side-effect, adverse reaction, or hospitalization to the study staff as soon as possible.
• Keep the study staff informed of any changes to contact information (phone number, address, email).
• Keep information about the study confidential, if asked to do so.
• If you decide to withdraw from the study, inform the staff and follow all study withdrawal procedures.

All personal information that is provided in the study will be seen by the study doctor and his/her staff. This information may also be reviewed by the sponsor, the U.S. Food and Drug Administration (FDA), Department of Health and Human Services (DHHS), governmental agencies in other countries, and the IRB. Every attempt is made to keep your medical records confidential. However, there may be times when your medical information cannot be kept confidential due to federal laws.

A placebo is a harmless pill, medication, or treatment that has no therapeutic effect. If a placebo is part of a clinical study you chose to participate in, you will be informed at the start of the study. Typically, when a placebo is included in the study neither you nor the study team will know whether you are receiving the investigational medication or placebo. There are measures that have been put in place in the event that this information must be known.

Yes, Children are allowed to participate in some clinical research studies. If a child is enrolled in a research study, a participant or legally authorized representative is required to provide informed consent allowing the child to participate.

For any concerns about your rights as a participant, contact the Institutional Review Board (IRB) that is provided in the informed consent form. The consent form should include the address, phone number, and email of the IRB in charge of the study.