Department of Otorhinolaryngology

Otorhinolaryngology

Frequently Asked Questions

What is a Clinical Trial?
A clinical trial is an organized study in which one or more human subjects receive a new therapy (drug, device or intervention) in order to test the safety and effectiveness of that therapy. For more information, please refer to either the University of Pennsylvania's Office of Human Research web site or the National Cancer Institute web site. Each has another list of frequently asked questions for patients who are considering participating in research.

What is an Investigational New Drug?
A drug or device permitted by FDA to be tested in humans, but not yet determined to be safe and effective for a particular use in the general population, and not yet licensed for marketing.

What is a Protocol?
A Protocol is a clearly defined written plan that describes the what, how, when, and why's of how the clinical trial will be organized and implemented.

What is the difference between the care I would receive if I participated in a clinical trial versus the care I would receive if I did not enroll in a clinical trial for my condition?
Your doctors at the University of Pennsylvania are committed to providing you with the highest level of care, regardless if you do or do not participate in a clinical trial. If you choose not to participate, your doctor will continue your treatment along the acceptable clinical guidelines. Your participation in this study is strictly voluntary. Your decision not to participate will not affect your care.

Should you want to participate in a trial, your doctors will meet with you to discuss the benefits and risks associated with the specific trial. In general, participation in a clinical trial provides you with closer monitoring and more frequent follow up visits with your doctor and study team. In addition, participating in a clinical trial may offer you access to experimental technologies, therapies, and/or medications new to the field.

Will I be paid if I participate in a Clinical Trial?
You may or may not be paid to participate in a Clinical Trial. While some trials do offer compensation, others do not. Each trial has its own specific financial compensation. Compensation is explicitly stated in each study's consent form.

Will I have to pay for anything?
Each trial will have its own specific guidelines for costs/reimbursements stated in the consent form. You and/or your health insurance may be billed for the costs of medical care during this study if these expenses would have happened even if you were not in the study, or if your insurance agrees in advance to pay. The investigational therapy you receive will be at no charge to you.

What if I want to withdraw from the study after I have signed consent to participate?
You can withdraw from the study at any time. Participation is completely voluntary. Your doctor may also withdraw you from the study should he/she believe it is necessary for your health or safety. The Food and Drug Administration (FDA) may also decide to stop the study. Withdrawal will not interfere with your future care.

How is research conducted at Penn?
Federal regulations govern the conduct of clinical trials. Institutional Review Boards (IRBs) are independent university committees empowered by the government to review, approve, or deny clinical trials. At Penn, IRBs are part of the Office of Regulatory Affairs whose web site is listed below for more information.

Additionally, Penn has its own institutional departments and committees that also oversee clinical trials that involve human subjects. These include the Office of Human Research (OHR), which has a section on its website dedicated to Research Patients/Volunteer Information.

Please refer to the OHR website for more information:

Will my health information be kept private?
Every attempt will be made by the investigators to maintain all information collected in this study strictly confidential, except as may be required by court order or by law. Authorized representatives of the University of Pennsylvania Institutional Review Board (IRB), a committee charged with protecting the rights and welfare of research subjects, may be provided access to medical or research records that identify you by name. If any publication or presentations results from this research, you will not be identified by name. Additionally, every patient receives the University of Pennsylvania Health System’s HIPAA: Notice of Privacy Practices document that explains how medical information about you may be used and disclosed.