For many patients, the phrase "informed consent" brings to mind a long legal document and a signature. In reality, informed consent is a process, not a piece of paper — a conversation designed to make sure you fully understand a clinical trial before you decide whether it is right for you. Confusion or hesitation about what consent really involves is one of the most common reasons patients delay looking into research, so this guide walks through exactly what informed consent means, what you can expect from the process, and what rights it protects.

Every clinical trial conducted at our Plantation, FL facility, led by Dr. Frank Hull, who brings more than 20 years of pulmonary clinical research experience, follows the same informed consent standards required by the U.S. Food and Drug Administration (FDA) and overseen by an independent ethics review board. Understanding this process can help you feel more confident asking questions and making the decision that is right for you.

What Informed Consent Actually Means

Informed consent is the process by which a research team explains a clinical trial to you in clear, understandable language so that you can decide, without pressure, whether you want to take part. It is meant to give you the information a reasonable person would want before agreeing to any medical procedure or investigational treatment. This includes the purpose of the study, what will happen at each visit, how long participation may last, and what is already known and not yet known about the investigational treatment being studied.

Importantly, informed consent is not a one-time event. While you will sign a written consent document before any study-related procedures begin, the research team's obligation to keep you informed continues for as long as you remain enrolled. If new information becomes available that could affect your willingness to continue — for example, a newly identified side effect — you must be told, and you may be asked to sign an updated consent form.

The Consent Process: What to Expect

Before You Enroll

Before any study procedures take place, a member of the research team will review the consent document with you in detail, in person, at our Plantation office. You will be given as much time as you need to read the document, ask questions, and, if you wish, discuss the decision with family members or your primary care physician. You are never expected to decide on the spot.

During the Consent Discussion

The consent conversation should cover the study's purpose, what will be asked of you, how long it will take, and how it differs from your usual medical care. It is also your opportunity to ask about anything that is unclear — there is no such thing as a question that is too basic when it comes to deciding whether to enroll in research.

Ongoing Consent Throughout the Study

Once enrolled, your research coordinator and Dr. Hull remain available to answer questions at every visit. Consent is treated as an ongoing dialogue: you can ask about your results, the study's progress, or anything else that comes up for the entire time you participate.

Your Right to Withdraw at Any Time

This right to withdraw is one of the most fundamental protections in clinical research, and it is explained clearly during the consent process so there is never any ambiguity about it.

What Must Be Disclosed to You

Federal regulations require that certain information be disclosed as part of informed consent before you agree to participate in any clinical trial:

Risks

The consent process must describe reasonably foreseeable risks or discomforts, including known side effects of the investigational treatment and any risks associated with study procedures such as blood draws, breathing tests, or imaging.

Potential Benefits

You will be told about any potential benefits of participating, described honestly and without overstatement. It is important to understand that an investigational treatment may help with your condition, but no clinical trial can guarantee a specific outcome or that a treatment will work for you individually.

Alternatives

You must be told about alternative treatments or courses of action available to you outside of the study, including continuing your current care, so that you can weigh the clinical trial against your other options.

Compensation

If compensation for time and travel is offered, the amount and payment schedule will be explained clearly during consent, along with any costs that may or may not be covered.

IRB Oversight: Independent Review for Your Protection

Every clinical trial conducted at Lung Research Florida is reviewed and approved by an independent Institutional Review Board (IRB) before enrollment begins. An IRB is a committee, separate from the research team, made up of physicians, scientists, and community members whose job is to evaluate whether a study's risks are reasonable relative to its potential benefits and to ensure the informed consent document itself is clear, complete, and free of coercive language.

The IRB does not stop overseeing a study once it approves the initial protocol. It continues to review the trial as it proceeds, including any changes to the protocol or new safety information, for as long as the study remains open.

HIPAA and Confidentiality

Your protected health information is handled in accordance with the Health Insurance Portability and Accountability Act (HIPAA) throughout every stage of research. As part of informed consent, you will also review a separate authorization explaining specifically how your health information may be used and shared for purposes of the study — for example, with the study sponsor or regulatory authorities — and for how long. You are entitled to ask questions about these protections before you sign anything, and your information is never used for purposes outside what the consent document describes.

Informed Consent for Patients in Plantation and Broward County

Patients across Broward County — including Plantation, Fort Lauderdale, Sunrise, Davie, and Weston — who are considering research for severe asthma, COPD, chronic cough, or bronchiectasis go through the same consistent, carefully explained consent process at our Plantation office. Dr. Frank Hull and our research coordinators take the time to walk through the consent document in person, answer every question, and make sure you feel comfortable with your decision before any study procedure takes place. If you are new to the overall research process, our step-by-step participant guide covers what happens from first contact through study completion, and our page on clinical trial phases explains how a study's phase relates to what you're told during consent.

You are always free to take the consent document home, discuss it with family or your own physician, and take as much time as you need before deciding.

Frequently Asked Questions

What is informed consent in a clinical trial?

Informed consent is the process of learning the key facts about a clinical trial — its purpose, procedures, potential risks and benefits, and alternatives — before deciding whether to participate. It is documented in a written consent form, but the process itself is ongoing.

Can I withdraw from a clinical trial after I sign the consent form?

Yes. Signing consent is not a binding contract to remain in a study. You may withdraw at any time, for any reason, without penalty and without affecting your regular medical care.

Who reviews a clinical trial before I am asked to consent?

An independent Institutional Review Board (IRB) reviews every study protocol and consent form before enrollment begins and continues to monitor the study as it proceeds.

Is my health information kept confidential during a clinical trial?

Yes. Your protected health information is handled in accordance with HIPAA, and the consent process includes a specific authorization explaining how your information may be used and shared for the study.

For broader questions about trial safety, compensation, and confidentiality, visit our full Clinical Trials FAQ.

This information is for educational purposes only. Please consult your physician or the study team with specific questions about your health or trial participation.