There are several factors to determine a healthy volunteer:
- Typically Age, 18-65
- Currently taking no medication
- Within a healthy weight range
- A healthy weight is determined by your BMI (Body Mass Index). This is the measure of the percentage of your body weight that is fat vs. muscle. A healthy BMI is somewhere between 18 and 30.
- Medical history
- Lifestyle habits
- Typically our studies allow for light to non-smokers and people who consume fewer than 14 alcoholic drinks in a week.
- Illicit drug use is not allowed and a drug test will be given during screening and before check-in.
These are all general requirements; requirements will vary study to study.
We have several dormitories for the study volunteers. During your stay you will have access to bedside TVs, recreation rooms with flat screen TVs, computers, wireless internet access, videogame systems and some of the latest DVD rentals. Plus we have staff that organizes activities such as dominoes and cards almost everyday.
All clinical study participants receive quality medical care. You also help with the development of safer and better medications for future generations.
The Food and Drug Administration (FDA) is charged with ensuring the safety and effectiveness of all prescription medications marketed in the United States. Before the FDA gives the medication manufacturer approval for marketing a given medication, it considers two primary points: whether the clinical studies provide substantial evidence that the medication is effective and whether the medication is safe under the conditions outlined in labeling. Ultimately, what the FDA considers is whether the benefits of the medication outweigh its risks. For life-threatening diseases, the FDA has mechanisms to accelerate the approval process so the treatment can be available to patients sooner.
You have the right to ask any number of questions of the clinical study doctors and sponsors prior to volunteering. Some questions may include:
- Has this medication been tested on humans before? If so, to what extent?
- What is the purpose of the medication?
- What are the perceived risks?
- Which company developed the medication?
- How often will I be given the medication?
- Will there be any invasive procedures carried out?
- What is the samples type and how often will samples be taken?
- How long does the trial last?
Informed consent refers to the process by which volunteer patients discover the details of their clinical study. Participants must be provided all facts about a trial prior to giving consent to participate, including treatment details and possible risks and benefits. The informed consent form must be signed by volunteers prior to participation. The informed consent process continues throughout the clinical study.
Clinical study protocols are developed to ensure that participants are not put at undue risk. These protocols are carefully reviewed by a committee of experts and lay persons, called an Independent Review Board (IRB), before testing can start. As a volunteer, you have the right to refuse treatment at any point in the clinical study and to leave at any time and for any reason.
Our studies are conducted in Overland Park, Kansas location of IQVIA at 6700 W. 115th Street. Clinical studies are typically held within a Phase I unit – the facility in which the study is conducted. For Phase I, volunteers stay within the unit throughout the trial and generally are not allowed to leave the premises due to safety reasons.
At its most basic level, a clinical study tests the effects of a potential new treatment on participants. Some participants do not actually receive the test treatment, but instead receive a placebo or standard treatment as part of the “control” group. Your progress is followed closely by doctors.
There are many individual and personal reasons for participation. Medications on trial today could go on to become the licensed medications of the future, and benefit you or family members. Some participants also enjoy the social interaction with fellow volunteers and staff that they experience while participating in clinical studies.
Yes, you will be compensated for the time you spend with us. Compensation varies by study and depends on time and type of study. We offer in-house and out-patient studies, each varying in length.
All trials contain some form of risk. We have been successfully conducting trials for more than 30 years and have an excellent safety record. Our most experienced experts review the trials and compounds to help enhance participants’ safety.
Typically we require blood and urine samples for analysis, but this may differ from trial to trial. You should be provided with this information during the informed consent process.
Volunteer populations vary by study. We offer male only, female only, and mixed population studies. Contact our recruitment line to check if any such studies are currently available. You may also register to be informed of any studies you are likely to be suitable for.
Phase I studies can last anywhere from a few days to a few months. We also conduct out-patient studies where periodic visits are required; these studies usually take place over the course of a month or more.
Yes, these tests will be conducted at screening, check-in and randomly throughout the course of a study. All results will be treated as confidential.
Yes. Results will be treated as confidential. However, the state must be informed of positive results.
Contact our recruiting department, steps to become a volunteer can be found in our How Do I Qualify Section. There is an application process you will go through in order to be considered a qualified participant.
You are provided with information about the study and a doctor will give you a complete physical. Blood and urine samples will be taken and tested for recreational drug and tobacco use. If your health status matches the criteria for the study, you will be given the option to participate.
- Deodorant (Speedstick for men, Dove for women is recommended)
- Toothpaste (non-whitening formula, Crest is recommended)
- Personal grooming products (comb, toothbrush, etc)
- Shower Products (Make sure to inspect soap and shampoo ingredients to insure they don’t contain any of the items listed on the do not bring list.)
- Shower Shoes
- Personal electronics, laptops, books, cards, etc.
- Food, gum, candy, alcohol, street drugs.
- Weapons; including pocketknives.
- Medications, over-the-counter or prescription.
- Electronic recording devices; including video cameras.
- See our complete list in our FAQ section.
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