A research study is a research study designed to investigate a product, therapy, or treatment. Studies are developed with different requirements, needs and objectives, and are conducted under the professional supervision of scientific research experts. They have different lengths, amount of visits and number of participants. Each study has different qualifications for who can join.
What is a research study?
What do I need to bring to the clinic for my first visit?
You need to bring a photo ID.
What is an Informed Consent Document (ICD)?
The Informed Consent Document states details about the study visit and procedures, study product and compensation. If the subject would like to participate in the study and agrees to the study requirements, the subject will be asked to sign the informed consent document.
How do I know if I am eligible for a study?
Prospective participants are reviewed objectively for a variety of study specific guidelines. Prospective participants will be phone screened by a recruiter and go through an informational section and physical with our clinic staff. If you are not eligible for a particular study, we encourage you to register for another study of interest to you. There are many opportunities at StayWell; we receive new studies every month.
Are there any side effects or risks for participation in the study?
Any possible risks or side effects will be discussed in your informed consent document, which you will read if you decide to participate in the study. For any additional questions, you may consult the clinic staff during your first visit.
What is a Placebo Controlled Study?
A study using a "placebo" uses a method of research in which an inactive substance (the placebo) is given to one group of participants, while the products or substance being tested is given to another group. The participants, as well as the research staff, do not know which group each individual participant is in. The results obtained in the two groups are then compared to see if the treatment is more effective than the placebo. When both patient and doctor do not know which group is the placebo group, it would then be called a "double-blind" study.
When will I receive compensation for my participation in the study?
Compensation is in the form of a check, which is available to you for pick up or mail delivery within 75 days after your last completed visit. A detailed explanation of the compensation is discussed in the informed consent document, which you will be asked to read and sign during your first visit if you are selected and choose to participate in the study.
What is fasting?
Fasting is when you do not eat or drink for 10 or 12 hours prior to your scheduled visit (drinking water is allowed). Not all studies require fasting.
Do I fast?
The screening visit may involve a laboratory procedure that will require fasting. You have the option to fast before the screening visit or come back to the clinic another day, having fasted the night before. If you decide to come back to the clinic another day, you will not be compensated for the additional visit. Please check with a research recruiter for screening visit procedures.
What is considered approved birth control for females?
Abstinence, birth control patch, cervical caps, condoms, diaphragms, hysterectomy, implantable contraceptives, injectable contraceptives, IUDs (intrauterine device), oral contraceptives, sponges, tubal ligation, vasectomy.
What is considered approved birth control for males?
Vasectomy, abstinence, condoms. This is to prevent a pregnancy from occurring during a study. Abstinence does not apply for the men's sexual health studies*
Why do I have to use approved birth control during the study?
To ensure that a pregnancy does not occur during the study. Pregnancy can impact your ability to participate and/or the results.
Can I participate in a study if I am starting a new diet or exercise program?
It is usually permissible to bring a participant into a study if they are doing a new diet/exercise program, so long as they start it prior to their clinic screening and continue it throughout the study.
Are the study products FDA approved?
StayWell Research focuses on dietary supplements, functional foods, and medical foods. These products are currently not required to have FDA approval. However, we conduct all our research studies to pharmaceutical industry and FDA standards. All research studies conducted by StayWell Research are monitored by an independent review board
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