Clinical Research FAQ
SIH created the Office of Clinical Research to support investigators and, therefore, to better protect research volunteers. The decision to participate in research is very important and personal. You should ask many questions and take as much time as needed to decide before volunteering. Here are the answers to some questions you may already have.
What is a clinical research study?
A clinical research study involves research using human volunteers that is intended to answer a question and add to medical knowledge. Clinical research studies are conducted by medical personnel, such as doctors, who are also called investigators. The team of research assistants that help investigators with studies is called study staff.
Studies may be either observational or interventional. In an observational study, the investigator assesses health outcomes during regular treatment. The investigator treats the illness or medical condition using medical judgment but volunteers are not assigned to specific treatment. Data is collected during and after treatment to compare with other treatments.
Interventional studies are also called clinical trials. A clinical trial is a controlled study involving human subjects, designed to evaluate the safety and effectiveness of new procedures, drugs, or devices. Volunteers are assigned to a specific intervention, and then the outcomes of all volunteers are measured and compared.
What can I expect to happen during a clinical research study?
Before you enroll in a clinical research study, the investigator and study staff will determine if you are eligible, discuss the study with you, and answer all of your questions. You will then sign an informed consent document that states you want to volunteer.
During the clinical research study, the investigator and/or study staff will:
- Check and record information about your general health and your health history
- Give you specific instructions for volunteering in the study
- Closely monitor your safety and check on your progress during the study. This may happen face-to-face, by phone, or a combination of these
- Be available to answer your questions or address your concerns
- Stay in touch with you after the study is finished if needed
Some studies require more tests and doctors visits than you would normally have for your particular illness or medical condition. These additional tests and visits are necessary to help your investigator monitor your health and safety during the trial.
Studies require study staff to gather specific data at specific times. To make the study results as reliable as possible, it is very important for volunteers to follow instructions carefully. This means you will need to be at all of your doctor visits and tests, take any medications on time, and complete logs or questionnaires just as the study staff has instructed you. It is also very important for you to contact your investigator right away if you have any new or worsening health symptoms.
Who pays for clinical research studies?
Clinical research studies are sponsored (funded) by various organizations like foundations, pharmaceutical companies, medical device manufacturers, or government agencies. There are two different types of costs involved in a clinical research study: patient care costs and research related costs.
Patient care costs are for items or services you would have received to treat your illness or medical condition whether you volunteered for a clinical research study or not. These costs are usually billed to your insurance company. Some insurance companies will not pay for any care or costs while a patient is enrolled in a clinical research study because the treatment is considered experimental. You will need to check with your insurance company to fully understand what will or will not be covered.
Research related costs are items or services provided solely for the conduct of the clinical research study. These items would not be provided during the care of patients unless enrolled in the clinical research study. These costs are usually paid for or provided by the clinical research study sponsor.
Will volunteering for a clinical research study cure me?
The answer to this question is unknown and is one big factor to consider before enrolling in a clinical research study. You may get better. You may see no change in your illness or medical condition. You may actually get worse. You must weigh the potential benefits and risks of volunteering.
What are the potential benefits and risks of volunteering in a clinical research study?
Each clinical research study has its own specific benefits and risks. These will be explained to you before you volunteer. There are some more universal benefits and risks to volunteering in a clinical research study.
- Play an active role in your own health care
- Gain access to new medical treatments before they become widely available
- Obtain expert medical care at healthcare facilities during the research
- Help others by contributing to medical knowledge
- There may be unpleasant, serious or life-threatening side effects during the clinical research study treatment
- The clinical research study treatment may not be effective for you
- The protocol may require more of your time and attention then would another treatment, including more trips to the doctor, more medical treatments or tests, complex dosage requirements or patient diaries and logs.
How is my safety protected?
Investigators follow the same ethical and legal codes that apply to doctors. Additionally, most clinical research studies are even more regulated with safeguards built in to protect volunteers.
At SIH, every clinical research study must be reviewed, approved, and monitored by the SIH Institutional Review Board (SIH IRB). This group of people makes sure the risks are as low as possible and are worth any potential benefits.
Can I leave a clinical research study after I have started?
Yes, you have the right to stop being a research volunteer at any time. Before you do stop, you need to discuss this with the investigator and/or study staff. This allows them to help minimize any risks to your health.
Can I continue to see my primary health care provider while in a clinical research study?
Yes. Clinical research studies generally provide short-term care and monitoring for a specific illness or medical condition. They are not designed to provide long-term primary care. You are encouraged to continue seeing your primary health care provider and let him/her know that you are volunteering in a clinical research study.
What is an investigational treatment?
Procedures, drugs, medications and medical devices not yet approved for use by the Food and Drug Administration (FDA) or other governing body are called investigational treatments. Some investigators also call them “experimental”.
What is a protocol?
A protocol is a study plan, written by the study sponsor, which directs the clinical research study to answer specific medical research questions. Investigators and study staff receive training on following the protocol to safeguard your health. The protocol will include:
- Who is eligible to volunteer in the clinical research study
- Detailed schedule of tests, procedures, medications, and dosages
- How long each volunteer will be in the clinical research study
- How many volunteers are expected
- How often and when volunteers are to be seen or contacted by the investigator or study staff to monitor health