*Please note: These descriptions and FAQs are based on generalizations from past studies. Each study has its own qualifications, rules, consent, and other factors that can vary any part of the process. If you would like more specifics on our studies, please feel free to ask our Recruiting Team, nurses, or doctors any questions you may have. Just give us a call at 913-825-4400.
Can I participate?
Each study varies its qualifications, but typically a healthy volunteer falls within these guidelines:
A medical history without significant health issues
Healthy lifestyle habits including no/light use of alcohol and drugs
A healthy weight – this is determined by your BMI (Body Mass Index), a measurement of your weight of fat vs. muscle. A healthy BMI ranges from 18-45
*Please Note: Each study varies its qualifications. Please call our Recruiting Team at 913-825-4400 to see if you qualify for any of our current studies.
What is a vaccine?
Imagine your body is a boxing ring with the champion being your immune system. Any time a challenger (or in this case a bacteria or virus) tries to invade the ring, your immune system has to fight it off.
A vaccine is a training partner. It mimics the germ, pathogen, etc. that causes the disease, and trains your body to beat it without ever having to come into contact with the actual germ. Now in the future if you ever come into contact with that disease-causing pathogen, your body will be able to attack it, thanks to the training from the vaccine.
For more information on vaccines, please visit the World Health Organization’s website.
What’s BMI? And how do I calculate it?
BMI stands for Body Mass Index and is a way to relatively measure a person’s size by his/her height and weight. For adults 20 years of age and older, BMI is determined by standard weight status categories that are the same for all ages and both sexes. Children from the ages 2-20 have BMI standards that are categorized by age and gender.
You can calculate your BMI here using the National Heart, Lung, and Blood Institute’s BMI calculator.
Why is there a pre-screening phone call?
Before participating in our studies, our Recruiting Team will speak with you over the phone to discuss our current studies and their various requirements. They will then ask you a series of questions to determine if you meet the qualifications for our current studies. If not, they can record your information and contact you the next time we have a study that you qualify for.
If you do qualify, our recruiters will then schedule your appointment for your screening visit. This is also a great time to ask them questions about the study, our facility, or any concerns you may have.
What is a screening visit?
A screening visit is your first visit here at our facility and takes roughly 2-4 hours depending on the study. After that, you will be given a consent form to read over, and one of our nurses will go over the details of the form with you. This is the perfect time to ask any questions you have about the study and how participating in the study will affect you. Our nurses will also go over your medical history and take your vitals.
The next step is you will have a physical with one of our doctors. If our doctor deems you healthy enough for the study, you will then see our phlebotomist for a blood draw.
We recommend you take these steps to prepare for your screening visit:
The night before:
- Hydrate, hydrate, hydrate
- Avoid a large consumption of alcohol
- Avoid sugary foods and drinks
The morning of:
- Continue to hydrate well
- Eat a light, healthy breakfast (Examples: bagels, scrambled eggs, yogurt, fruit, whole grain cereal)
- Make sure you have your photo i.d.
- Make sure you have a form of entertainment (Examples: Books, magazines, mobile video game systems, laptops, etc.)
What are the benefits of volunteering?
There are several personal benefits you’ll receive for participating in our studies. We do compensate you for your time and travel, and the amount varies depending on the study. We also offer snacks and drinks while you are at our facility. You also receive the benefit of a free physical during your screening visit.
On a larger scale, you can also leave with a sense of pride for helping us advance medicine through our clinical studies. Because of you and your participation, the medical community is one step closer to providing the world a new medication or vaccination that can benefit many people.
What is informed consent?
Informed consent is the process of our volunteers being given all the information about the study. For your protection, all clinical trial facilities MUST give you all the details (including risks and benefits) pertaining to the studies before you give consent to volunteer. All volunteers must sign the informed consent before they can participate in a trial. And as the study progresses, there may be more informed consent forms for you to sign.
JCCT takes this process very seriously. You will be given 1 on 1 time with one of our nurses to go over the consent form and ask as many questions as you like before you sign.
What questions should I ask the nurses?
First, you can ask our nurses any questions that come to your mind at any point of the process. But some good examples are:
- Has this new medication/vaccine been tested on humans before?
- What is the purpose of this new medication/vaccination?
- What are the risks involved?
- What company developed the medication/vaccine?
- What is the procedure?
- How/What samples are collected?
- How long is the trial?
How am I protected?
Before testing can start, clinical study protocols are put into place for each study to ensure that volunteers aren’t put at undue risk. These protocols are reviewed by a group of experts called an Independent Review Board (IRB).
Furthermore, as a volunteer, you have the right to withdraw consent and refuse to participate at any point during the study.
How safe are these clinical studies?
All clinical studies come with some form of risk. However, our team of nurses and doctors are dedicated to every person’s safety. Plus, every study is reviewed by experts to help enhance your safety.
Are needles involved?
Typically, our studies do require a blood draw during the screening process as well as dosage through a syringe. However, we do have an excellent phlebotomist on staff who has been working in the medical field for 20 years. Our nurses are also very skilled and will work with you to the best of their abilities to ensure that the parts of the process that involve needles go as smoothly and quickly as possible.
What happens in a clinical study?
If we’re getting down to brass tacks, a clinical research study is a way to test the effects of new potential medications/vaccinations on volunteers. It’s also very possible that you will not receive the investigated treatment/vaccination, and instead, you will receive the placebo or standard treatment as part of the “control group.”
A placebo is an inactive substance that will have no effect on you. Placebos are used on participants to form the “control group” – this is a group that is the benchmark for how we measure the effectiveness of the medication/vaccine on the other group.
Will I get paid?
Yes, you will be compensated for your time and travel. The amount varies per study. You will be informed of the amount during your pre-screening phone call with our Recruiting Team as well as during your screening visit.
What procedures are involved with participating in your clinical studies?
Generally, a urine sample and blood draw is required. Of course, this varies depending on the study. But you will be given that information during the informed consent process.
Are there drug and alcohol screenings?
Again, each study varies, but for most studies, we are required to administer these tests.
What can I bring with me?
As you will be here for roughly 2-4 hours each visit, we highly recommend you bring some form of entertainment with you. Please feel free to bring books, magazines, laptops, mobile video game systems, etc.
All we ask is that if you are using an electronic device to watch videos, listen to music, or play games that you bring headphones as not to disturb other volunteers.
What if I’m injured while taking part in a trial?
You should inform the trial doctor and call the 24-hour telephone contact number listed on the first page of your informed consent form as soon as you feel that you have had an illness or injury which may be related to the trial, so that you can get proper health care. If you become sick or injured as a direct result of a properly performed trial procedure or because you received the trial vaccine as directed, the sponsor may pay for the reasonable and necessary costs associated with this care. No other compensation or payment will be provided to you, including lost wages.
Provision of medical care does not imply any fault or wrongdoing on the part of the sponsor, your trial doctor, or the trial site. By signing the consent form, you are not giving up your legal rights and are not releasing the trial doctor or study sponsor from their legal and professional responsibilities.
To pay medical expenses, the study sponsor may need to know some information about you like your name, date of birth, and Medicare Beneficiary Identifier. This is because the study sponsor needs to check to see if you receive Medicare and, if you do, report the payment it makes to Medicare.
What if I decide I no longer want to participate in a clinical trial?
Your participation in a clinical trial is voluntary. You may decide not to participate, or you can leave the clinical trial at any time. If you choose not to take part in the clinical trial or to leave the clinical trial, this will not result in any penalty, and you will not lose any benefits to which you are entitled. Your regular care and your relationship with the hospital or clinic and your doctors will not be affected.
If you decide to stop participating in the clinical trial, contact the trial team to determine the best way to leave the trial.
- You may be asked to complete the procedures that are part of the end of trial visit.
- You may be asked the reason you no longer wish to participate in the clinical trial.
- You do not have to complete any additional procedures or answer any additional questions if you do not want to. However, the information you provide could help the researchers better understand the disease or condition being studied.
It is recommended that you tell the trial team if you are thinking about stopping your participation in the trial so any potential risks can be evaluated by the trial doctor and discussed with you. The trial doctor may also discuss recommendations for your follow-up care and testing after you leave the trial.
After you leave the trial,
- We will keep and continue to use data that was already collected before you left the trial.
- No new information will be collected from you unless you clearly agree.
- You can request that your remaining biological samples be destroyed, so they cannot continue to be used after you leave the trial, by writing to the trial doctor at the address listed on the first page of this document. If you withdraw from the trial but do not request destruction of your samples in writing, your samples will continue to be used as described in the consent form.
Are there other reasons my participation in this trial could be stopped?
Your participation in the clinical trial can be stopped by your trial doctor, study sponsor, or a regulatory authority without your permission. Some examples may include the following:
- It is in your best medical interest.
- You have a side effect that requires you to stop participating in the trial.
- You need a treatment that is not allowed in the trial.
- You do not follow instructions about what to do in the trial.
- It is discovered that you do not meet the requirements to participate in the trial.
- The trial is cancelled.
- Enrollment is complete, or for other administrative reasons.
The study sponsor may stop the clinical trial at this trial site for any reason at any time.
If the clinical trial is stopped for any reason, you will be notified about being removed from the trial. You may be asked to complete the procedures that are part of the end of trial visit. You do not have to complete any additional procedures or answer any additional questions if you do not want to; however, the information you provide could help the researchers better understand the disease or condition being studied.