Frequently Asked Questions
What is informed consent?
Informed consent is a process through which you learn details about the study before deciding if you wish to participate. This may also include providing you new information throughout the study as it becomes available.
The Informed Consent Form (ICF) provides in-depth information about a study. It includes an explanation of of what the study drug is in development for, explains what will be involved in participating in the trial, the screening process, how long the study will last, the study design, the schedule of overnight stays, outpatient visits and phone calls. The ICF will provide information about the known risks and benefits associated with the study treatment.
Your participation in a clinical trial is voluntary. You have the right to refuse to participate, or to withdraw your consent, at any time. At the screening visit, you will have the opportunity to have all of your questions answered. We advise that you do not sign the ICF until all of your questions have been answered.
Our primary concern is the health and safety of our volunteers and you will be monitored closely throughout the study. The study physician may withdraw a participant at any time if he/she determines that continued participation is not in the subject’s best interest.
What is a placebo?
A placebo is a control, an inactive substance, which may be given to some of the study participants. This provides a comparison for study results. Results can be attributed to the study drug being tested when compared to the control substance.
Why should I participate in a clinical trial?
Subjects choose to participate in clinical trials for different reasons, such as helping others by helping to develop medicines and contribute to medical science. Some subjects are more interested in compensation.
The compensation schedule for your chosen study will be explained to you in detail in the study information documents.
How do I prepare for the screening visit?
Please confirm the fasting time for your screening visit by visiting our website and looking at the study listing. You need to bring a valid, non-expired photo ID with you. We accept the following forms of identification: driver's license, state issued ID card, passport or military ID. You will need to arrive at least 30 minutes in advance of your appointment to fill out paperwork. You may be required to bring medical records as part of the screening process and we will inform you if this is necessary.
How will I receive payment?
Study payments will be made by check and mailed to the address you have provided or you can pick up your check. Checks are generally mailed within 10-15 business days after you have completed the study and its requirements.
What are my responsibilities as a participant in a clinical trial?
A participant must be honest with the study doctor when reporting medical and surgical history, current health condition, all medications and social habits such as smoking or drinking. This is for your safety. We also have rules about staying at the clinic and the rules will be reviewed at the screening visit.
What can I bring for overnight stays?
You will need to bring clothing, personal items, toiletries, etc. for overnight stays. However, there are restrictions for the items you are allowed to bring to the unit.
Do I have to pay to be in a clinical trial?
There is no cost associated with participating in a clinical trial. Study participants may be compensated for their participation and for related time and travel.
What are clinical trials and why are they important?
Before medications and devices can be approved, they must first be tested. Testing must be done for new medications/devices, new uses for approved medications and devices, or for approval to use products already in use in other countries. Clinical research trials are designed to determine a safe dosage range and identify any potential side effects of a new treatment.
Testing and approval by the Food and Drug Administration (FDA) is mandatory before any pharmaceutical product can go into production to help patients. Clinical research trials are conducted under strict regulations and protocols.
Who runs clinical trials?
The majority of clinical research studies are sponsored by pharmaceutical companies. Other sources for funding include federal agencies, clinical research organizations, medical foundations, physicians, private and public medical centers, universities.
How do I refer friends to participate at ICON?
We hope that you will refer your friends. Please see our Refer A Friend Program for more information.
Where do clinical trials happen?
Clinical trials take place in many settings. Studies can be done in various settings, including clinical research centers, hospitals, a doctor’s office and teaching institutions.
We are located at:
ICON Early Phase Services
8307 Gault Lane
San Antonio, TX 78209
Tel: +1 210 225-5437
Toll Free: +1 877-848-7425