Frequently Asked Questions
About Our Seattle Clinical Research Center and Clinical Trials
GENERAL CLINICAL TRIAL QUESTIONS
-
Everyone has a different reason for participating in a clinical trial. People often participate in clinical trials because they’re not satisfied with their current treatment, and participation may mean identifying better treatment options. It is also a great opportunity to see some of the best doctors in their medical fields. Another benefit can be advancing medicine for other people living with the same condition. Participation helps contribute to a great cause. By signing up, volunteers can help bring new preventative tactics, treatments, and diagnostic tests for health conditions of all kinds.
-
It depends on the study, but generally any US citizen is eligible to participate. For non-US citizens, if you have a work visa and are allowed to work and earn money in the US, you shouldn’t have any issues with participating in a research study. Potential participants that have an ITIN (Individual Taxpayer Identification Number) would also be eligible. The ITIN is a 9-digit tax processing number issued to those not eligible for a social security number (SSN) but they file and pay taxes in the U.S. If you have an ITIN, you may be able and eligible to join a research study.
OUR CLINIC
-
We are located on Yesler Way between 6th Ave and I-5 at the intersection of the International District, the Central Business District, Pioneer Square and First Hill. From I-5 north or south take the James exit.
-
Yes, we have ample free participant parking at our site. We have several parking spaces in front of the building labeled “SCRC Participant” and “SCRC Guest” for you to park in upon arrival. There are lots of public transit options nearby: we are a few blocks from two different Link light rail stations, multiple bus stops, and the Capitol Hill streetcar.
-
This depends on the requirements of the study, however, most of our studies do require you to be on-site for some or all the visits. If a study has any virtual or telephone requirements, those will be reviewed and specified during the screening process.
COMPENSATION
-
In most cases, you may be eligible to receive reimbursement for your time and participation in the research study. The amount and method may vary by study, but it is typically based on completed visits or procedures. At the completion of each study visit, the stipend for that visit will be loaded onto a card within 2-3 business days. Our site commonly uses a RealPay card to issue payments. This card functions like a debit card and can also be linked to your bank account, allowing you to transfer funds directly. Each stipend will be loaded onto your RealPay card, which can be used for the current study and any future studies you participate in at our clinic. If your card expires, a new one will be issued, and any remaining balance will be transferred to your new card.
-
Any compensation that is received for participating in the research study is subject to Federal reporting requirements on your annual tax return if you receive $2000.00 USD or more in a calendar year. A 1099-MISC form will be sent to you by the end of January for any compensation received of $2000.00 USD or more for the prior calendar year.
-
The typical time between your study visit and when compensation is provided is 2 –3 business days. A text message alerting of the payment to the RealPay card will be sent, unless you have opted out of text alerts from our clinic.
-
All participants are volunteers and do not pay to take part in the research study. Qualified participants will receive all investigational medication and study related medical exams at no cost to themselves. If you have health insurance, your health insurance will not be billed for any study procedures.
-
The compensation that is paid for the study is intended to cover the cost of travel. Certain studies may offer additional travel stipends. This will be reviewed within the informed consent of the study.
PERSONAL MEDICAL CARE, DOCTORS, AND INSURANCE
-
It varies from study to study, but any lab work done we can provide you with printed copies or emailed copies of the results. Routine bloodwork, PAP smears, STI testing, urine testing, ECG, mammograms, DXA scans, and ultrasounds are some of the common lab procedures we perform, and we can absolutely provide you with the results after our study team has reviewed them. Of note, the results will be de-identified and will show your subject number (ex: 1234) instead of your full name. For certain studies like vaccine studies that are “blinded,” meaning you don’t know if you received the placebo or the active drug, lab work like “immunogenicity” (which shows your body’s immune response to the product) or “Pharmacokinetic (PK) bloodwork” won’t be accessible to the study team or to you as the participant, as that would “unblind you” to the treatment you got.
-
It varies from study to study, but we cannot guarantee that the sponsor of the study will inform the participants of which treatment they were assigned. In the study’s consent form, it will usually contain information about this specific to the study. If our site is sent this information, we will contact you to inform you of which treatment you received. If you did receive placebo, you will not be able to get the actual drug at the end of the study, unless specified in the study protocol and consent form. There is no waiting list at our site to be put on to receive the drug once/if it is approved, but we encourage you to monitor the study on ClinicalTrials.GOV and you can see when the study data is published. Additionally, the pharmaceutical company (sponsor) of the study will issue press releases if the drug is approved. However, the drug approval process can often take many years to complete.
-
No, you do not need health insurance to participate in a clinical trial. However, while your study- related care and treatment costs are covered by the company running the study, you do remain responsible for paying any other standard medical care costs you incur while participating in a trial – the same as you would if you were not participating in a trial.
-
Yes, you can continue to see any primary care physicians or anyone else you’d like on your health care team. And yes, you can discuss the study with your doctor. In fact, it is recommended that your primary care physician be informed that you are enrolled in a study. With your informed consent and permission, the study team can share this information with your provider(s).
SAFETY & SIDE EFFECTS
-
When performing clinical trials, researchers put the safety of the participants above all else. All the clinical trials available through our site are FDA-authorized and thoroughly evaluated against ethical and safety standards.
-
During the study, it’s important that we are informed of any changes to your health. On your first visit, the study team will explain any expected side effects of the study product, if applicable. They will also introduce your main point of contact for the study and provide their phone number and email, along with a 24/7 on-call doctor line for any study-related emergencies that do not require calling 911. If you experience a medical emergency that requires immediate care, please call 911 or go to the nearest emergency room. Once safe to do so, notify the study team so we can follow up appropriately. In some cases, if you experience an illness or injury that is determined to be directly related to the study treatment or procedures, the study sponsor will cover the associated medical costs. Our team will stay in close contact with you throughout the study and will support you if this situation arises.
-
If it is determined that the hospitalization was directly related to the investigational product/device then compensation for any medical expenses related to the hospitalization will most likely be covered by the sponsor. In most cases, this does not include lost wages or childcare expenses and can vary from study to study, but our study team will be in close contact with you throughout the course of the study and can assist if this situation arises.
-
Phase 1 trials could potentially be “first in human” trials. Trials that are phase 2 or 3 mean the product has already gone through several rounds of testing in humans. Typically, later phases test on a larger patient population. While we are always looking at safety and looking out for any side effects, later phases tend to be more focused on evaluating the efficacy of the product both on its own and in comparison, to other similar products. The informed consent form reviewed at your first visit will detail how many trials and participants this drug has been studied thus far.
-
Yes, your participation in a clinical trial is voluntary, and you can choose to stop participating in a trial at any time and for any reason. You are not obligated to continue in any clinical trial if you do not want to continue. In fact, in some situations, if you are experiencing undesirable side effects, our doctors may recommend you stop participating in the study, because your comfort and safety is our number one priority.
BIRTH CONTROL STUDIES
-
To participate in our birth control study, you must be willing to accept the potential risk of pregnancy. While the study product is designed to prevent pregnancy, no birth control method—even those that are FDA-approved—is 100% effective. For this reason, the study includes frequent pregnancy testing through both urine and blood tests.
If you do become pregnant during the study, please contact us as soon as possible so we can schedule a visit. The study does not cover any pregnancy-related medical costs, and we are unable to provide termination (abortion) services. However, our study team is here to support you. We will help you understand your options, provide referrals if needed, and continue to follow you through the outcome of your pregnancy.
Join A Study
Sign up to be notified about the latest research studies that could give you access to new treatments and expert care.
