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Joining a research study is a major step. No doubt you have many questions. That’s why Banner Alzheimer’s Institute has created the following faqs. If you have additional questions, please contact us at (602) 839-6500.
What are research studies and why should I (or my loved one) consider participating in one?
Ending Alzheimer’s requires many kinds of studies, including some that are designed to evaluate the effectiveness of new treatments and therapies.
People who volunteer for these research studies play a very valuable role in this process. Without volunteers, there would be no new drugs, treatments and therapies available to fight Alzheimer’s disease or other medical conditions.
Joining a study helps advance research, but it also gives participants access to treatments and therapies not currently available to the general public. This is important to people for whom established therapies have not been effective.
The research team at Banner Alzheimer’s Institute gets involved in many valuable research studies and we hope you’ll consider joining one that is of significance to you.
Are research studies safe for participants?
By the time a new treatment is available to be tested by people, it’s been carefully studied for years in laboratories and evaluated thoroughly for safety. In order for a trial to be approved for a specific site – like Banner Alzheimer’s Institute – it must also be approved and then monitored by an Institutional Review Board (IRB). The IRB serves as an “ethics committee” as its members review research studies and related activities. The IRB’s role is to protect the rights and welfare of clinical trial participants.
I understand I’ll need to sign an informed consent form before participating in a research study. What does that mean?
The informed consent form contains important information about your research study, including what will be asked of you during the research study and why the research is being done. Read it thoroughly. It’s designed to ensure that you understand the nature of the research study. The informed consent form also emphasizes that participation in the research study is voluntary and gives you the right to withdraw from the research study at any time.
I’m a caregiver for a person with Alzheimer’s/dementia. Do I have the right to enroll her in a research study I believe may beneficial to her?
In addition to the informed consent, research studies that involve participants with Alzheimer’s disease/dementias also include what’s called an “assent process.” This enables a caregiver or another legally authorized representative to enter a participant into a research study. The Banner Alzheimer’s Institute staff will, to the greatest extent possible, confirm with the person with Alzheimer’s/dementia his or her desire to participate. However, given the vulnerability of this population, it’s critical that you, as the caregiver, understand the requirements and be willing to assist in fulfilling the study responsibilities with the person for whom you care.
Who sponsors the research studies?
In most cases, research studies are sponsored by the federal government – through the National Institutes of Health (the nation’s medical research agency) – a pharmaceutical company or both. The researchers, physicians and other health care professionals who run the research study are known as “trial investigators.” They are chosen for their medical expertise in a specific therapeutic area.
What role does Banner Research play in this process?
Banner Research, a corporate division of Banner Health, is dedicated to ensuring that research is conducted ethically, safely and efficiently. Research activities conducted at any Banner facility, including Banner Alzheimer’s Institute, are overseen by an Institutional Review Board (IRB). Our IRB ensures that the rights and welfare of clinical study participants are protected in accordance with U.S. Food and Drug Administration (FDA) regulations.
How do I know if I am eligible to participate in a research study?
All research studies have specific eligibility requirements. These are outlined by the pharmaceutical company, the U.S. Food and Drug Administration (FDA) and the agency or institution leading the trial. Your Banner Alzheimer’s Institute team will discuss whether you (or your loved one) meet these eligibility requirements. If you do, our team will advise you on which participation application to complete.
What happens after the research study concludes?
After a study ends, all of the information is collected, analyzed and used to determine the effectiveness, safety and side effects of the drug. U.S. Food & Drug Administration (FDA) medical advisors and specialists closely review this information before approving any new drug for use by the general public.
Even after a new drug is approved, pharmaceutical companies continue to conduct studies to compare the safety, effectiveness and cost of the new drug with others already on the market. They may also want to determine if a specific therapy can be administered to other populations. Some studies may continue to assess the long-term effects of a drug and its impact on individual quality of life.
Do study participants continue to receive the study medication after the research ends?
When a research study ends, a pharmaceutical company may continue providing study medication to study participants who responded well. In other cases, people will stop receiving the investigational treatment. Once the drug becomes available to the public, they can resume the treatment.