Volunteers - Frequently Asked Questions
How should I prepare for my first visit?[+]
To prepare for a first visit participants should bring a list of questions. Be sure to ask what the first visit entails and if participants need to arrive fasting or ready to urinate. Participants will need to bring a list of all of the medications they are currently taking, including over the counter medications and supplements. Plan to arrive a few minutes early to allow time to fill out appropriate paperwork at the front desk.
What if I join a research study, then decide to not participate any longer?[+]
Participants may withdraw from a study at any given time for any reason. Heartland Research Associates, LCC simply asks that you let the research staff know that you wish to withdraw from the study and why you are choosing to discontinue the study. Most protocols ask that participants that choose to discontinue the study early complete a final safety visit upon exiting the study.
Will I be paid to participate in a clinical trial?[+]
In addition to investigational-related care at no cost, most studies provide compensation for time and travel. It is important to understand that research is not a job or a career choice. The stipends offered are merely compensation for our volunteers’ efforts.
Do I tell my primary care provider that I’m participating in a clinical study?[+]
Heartland Research Associates, LLC always encourages volunteers to share with their primary provider their involvement with a study. A clinical study usually provides treatments for a certain condition, but is not intended for complete health care. The intent is not to replace a primary provider, only to enhance a participant’s treatment. With the participant’s permission the clinic staff will be happy to consult with the primary care provider in order to ensure that medications and treatments will not interact. Records will be shared with a participant’s primary provider or kept confidential upon the request of the participant.
What questions should I ask when considering joining a clinical study?[+]
A few questions to ask would be:
- Why is this research being done?
- What is the purpose of the study?
- How will my treatment within the study differ with treatment I would receive otherwise?
- What kind of procedures and tests will be done during the trial?
- How long is the study?
- How often are the visits for the study?
- Will I be able to take my regular medications while I am in the study?
- What are my responsibilities while I am in the study?
- How do the risks and benefits of the study compare to the approved treatments?
What is a side-effect?[+]
Side effects are any effects of a drug that is in addition to its intended effect. Side effects may range from a harmful effect to an unexpected benefit. Negative side-effects may include headache, skin irritation, nausea or other physical problems. A well known example of a positive side-effect is that many oral contraceptives not only prevent pregnancy but also help acne.
What does it mean if a study is blinded or double blinded?[+]
A blinded study is when the participants do not know which of the possible treatments they are receiving. Double blinded means the patient and the study staff do not know which of the possible treatments the participant is receiving. This is done to prevent the patient or the doctor from influencing the study results with their expectations. However, if a situation ever arose where it became medically necessary, the doctor has the ability to “break the blind” and find out what medication the participant was taking.
What is placebo and why is it used?[+]
Many patients site fear of placebo as their number one reason for not participating in a clinical research study. Placebo is an inactive treatment that appears identical to the investigational treatment but does not contain an active ingredient. Placebo is used to help researchers conclude if participants are safely improving due to the investigational drug or because they believe they are safely improving. Placebo is not used when withholding treatment may harm patients or if patients have a life threatening condition and a current treatment already exists. In these cases the current standard of treatment is often compared to the investigational treatment.
What happens while I am in a clinical study?[+]
At Heartland Research Associates, LLC participants work with a research team including Doctors, Clinical Research Coordinators, Patient Referral Specialists, and other health care professionals. Upon contacting our facility a Patient Referral Specialist will briefly explain the study of interest and help volunteers determine if they are a potential candidate. Once eligibility is established an appointment will be made; participants will have their overall health checked, and be given more detailed information about the study along with specific directions regarding their participation. The Clinical Research Coordinator and the Doctor will work together to monitor the participant during the trial, and follow-up after the trial is completed as necessary.
Who can participate in clinical trials?[+]
Participants may be varying ages, ethnicities, and medical backgrounds. Each clinical trial has its own eligibility requirements called inclusion/ exclusion. These criteria are important for enabling researchers to produce reliable results when testing an investigational treatment. Some studies are looking for people with a certain condition or a certain age while others studies seek healthy volunteers. Most studies identifying healthy volunteers are Phase 1 trials, vaccine trials, and trials on preventative care for adults or children. In order to properly identify and protect participants it is important that anyone considering volunteering always answers questions regarding health history and other factors honestly and completely.
Who sponsors clinical trials?[+]
Clinical trials are sponsored by pharmaceutical companies, government agencies, health care institutions, physicians, and companies that develop medical equipment and devices. Trials are conducted in hospitals, clinics, and universities to research medicines, devices and equipment.