Frequently Asked Questions
For many of us, the idea of joining a clinical research study may be exciting, yet unfamiliar. Questions that can arise in the process of deciding to join a study include:
- What is a clinical research study?
- What is Phase I research?
- Who conducts clinical studies?
- What do I need to know before I participate?
- Will I be compensated for my time?
- What are the benefits?
- What about the risks?
- What is informed consent?
- How do I qualify and participate?
- What can I expect when I enroll in a study?
- Where will I stay during the study?
- Can I change my mind?
- How often can I participate in studies?
- Is my study payment taxable?
- How do I learn about studies?
- Will you provide transportation if I need it?
- Will my information be sold to anyone?
What is a clinical research study?
A clinical research study is conducted to evaluate investigational medication for various medical conditions. If you agree to be a research participant, you’ll be asked to ingest the investigational medication under consideration and then allow medical personnel to take your vital signs as well as blood and urine samples on a regular basis. These samples are aggregated and analyzed as part of the sponsor’s application for approval from the United States Food and Drug Administration (FDA).
What is Phase I research?
Phase I studies include the initial administration of a new investigational medication to humans for the first time. However, by the time Phase I studies are conducted, investigation medications have already been thoroughly evaluated in laboratories and tested in animals.
Who conducts clinical studies?
Our professional staff consists of physicians, registered nurses, and clinical research professionals, many of whom are fluent in English and Spanish. Our medical professionals have extensive experience in evaluating investigational medications and treatment procedures.
What do I need to know before I participate?
Before you agree to participate in a research study, you’ll be given materials that clearly explain what happens during the trial, what kind of care you will receive, alternatives if applicable, and all the benefits and risks associated with the medication or procedure. You’ll also be given a pre-enrollment interview in which you’ll have an opportunity to have all your questions and concerns addressed.
Will I be compensated for my time?
Volunteers are usually compensated for their participation, although the exact amount varies according to the study, the amount of time involved, and the complexity of the required research procedures. Information regarding compensation will be disclosed to you during the screening process, and will be included in the informed consent document you will sign.
What are the benefits?
In Phase I research studies, you will rarely benefit directly from participation beyond your compensation, although you may find out health information that is useful, and your participation in the research may help others in the future. In late-stage studies drugs intended to treat specific conditions are tested in therapeutic doses. This may benefit some participants with that condition, although it must be understood that (in some cases) only a random sample of participants in a trial actually receive the investigational drug; the remainder receive a placebo, a substance containing no medication.
What about the risks?
Your safety is our primary concern. All procedures are first reviewed by an independent Investigational Review Board (IRB) before they are administered. This assures that the study is ethical and the risks are as low as possible and worth any potential benefits. All details and risks of the study will be explained to you during the informed consent part of your registration.
What is informed consent?
It is your right to have complete information about the study in which you will participate. The US Government requires complete and accurate disclosure, which allows you to make an informed decision about whether or not to volunteer. Before you are evaluated as a research participant, you will go through the consent process, where we will provide you with an informed consent form which you must understand and sign before enrolling. This form clearly lists the possible risks and side effects you might experience. If your native language is not English, we will provide translation assistance or the informed consent form will be available in your native language.
How do I qualify and participate?
Different studies have different enrollment requirements. Some require only healthy adults not on medications and over age 18; other studies may require people with existing medical conditions such as diabetes, rheumatoid arthritis, high cholesterol, or other conditions.
Click here to see details of the specific studies we are currently enrolling. When you call, you will be asked a series of questions regarding your current health and study interests. If you meet the initial study requirements, the representative will schedule an appointment for you to be evaluated by a doctor. If you do not qualify for a specific study at that time, with your permission, we may contact you regarding future clinical research studies.
What can I expect when I enroll in a study
These are the steps typically encountered during a clinical trial.
- Screening interview – Information will be taken concerning your age, medical history, medications, and other preliminary questions to make sure you fit the study requirements.
- Informed consent process – You will receive materials that clearly explain the nature of the study and how you will participate. Our research staff will tell you of any risks or potential side effects. It is very important that you ask questions and read the consent form carefully. You are encouraged to ask questions. They will all be answered accurately so that you fully understand the risks and benefits of your participation.
- Assessments and medication – Once you are enrolled in a study, you may receive a study-related physical exam, study medication, laboratory tests, and study procedures as necessary at no cost to you. During the course of the study, medical personnel will meet with you to monitor your progress. Our medical professionals have extensive experience in evaluating investigational medications and working with treatment-related procedures. These medical personnel will communicate with your primary doctor as appropriate. Your relationship with your regular doctor(s) does not change during or after your participation in a study.
- After the study – Any information you and your primary care doctor(s) would like to receive related to your participation can be shared after you give your written consent.
Where will I stay during the study?
For some studies, you will only need to visit the clinic, though you may be required to come in several times. Other studies require overnight stays which can vary from just one or two nights to one or more weeks. Comprehensive facilities have dorm-like settings with recreation areas, games, and large screen TVs.
Can I change my mind?
Of course. Your participation in a research study is entirely voluntary, and you may withdraw from participation at anytime and for any reason. During your screening visit and throughout the study, we will completely explain the risks and benefits of your study. If you change your mind, you may withdraw.
How often can I participate in studies?
Many of our participants have completed several studies. In general, you may be eligible to participate again in as little as 30 days. Some studies require a 60 or 90-day “wash-out” period, which allows the investigational medication(s) to be completely eliminated from your body before beginning a new study.
Is my study payment taxable?
Yes. By agreeing to participate in the study, you will be acting as an independent contractor. You must provide your Social Security number because the payments made to you for participating in the studies will be reported to the IRS as income, which is required by law. If you earn more than $600, we will send you a Form 1099 at the end of the year.
How do I learn about studies?
Register for our volunteer database. The telephone interview takes only a few minutes. Then we will call or email you when a study opens that meets your interests. Also, you can refer to the Enrolling Studies page of this website on a regular basis for postings of new study opportunities as they become available.
Will you provide transportation if I need it?
In some cases, transportation assistance is available.
Will my information be sold to anyone?
Never. All information you provide as a research participant is strictly confidential. It will not be sold and will be used only for the purposes required by the research study.