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At PB-Solutions, people come first. Part of this commitment involves conducting medical research with the goal of helping patients live happier, healthier lives. We conduct research programs independently and also in association with pharmaceutical companies.
Through clinical studies, and the volunteers who participate in them, researchers can better understand how to diagnosis, treat and prevent diseases. They are the primary method by which we learn if new treatments are actually helpful. These studies are often part of the FDA approval process for new treatments.
Deciding to Volunteer
Without willing volunteers, research is not possible. The potential for personal benefit varies between studies, and between individuals. People participate in these trials for many reasons. For example, some hope to find a better medication for their illness while others want to improve care for future generations. Whether or not you participate is a personal choice you should make after carefully considering the risks and benefits.
You have no obligation to participate in any study, and participation is not right for everyone. After enrolling in a study, you may leave at any time for any reason. We make every attempt to continue treatment for patients after leaving clinical trials.
Making an Informed Decision
Ask Questions: If you have questions when deciding to join a research study or at any time during it, ask a member of the study team. If your questions or concerns are not satisfactorily addressed, contact the study’s principal investigator, or the IRB identified in the consent form. You will be given a copy of the consent form to take home, and it may also answer your question.
Informed Consent: Before deciding to participate in a study, you will be asked to review an informational document called an “informed consent” form. The doctor or research nurse staff will review the informed consent form with you. This form explains the clinical trial’s purpose, plan, risks and benefits. You must sign the informed consent form in order to participate in the study, though it is not a contract — you may still choose to leave the study at any time. (Teenagers and children will sign an “Assent” form and their parents or legal guardians will sign the “informed consent” form.)
Considerations:
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The reason for the clinical trial (what the doctors hope to learn)
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What is known about the type of treatment being studied?
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Possible risks and benefits (based on what is known so far)
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Other treatments that may be options
Risks and Benefits
Each clinical trial has its own benefits and risks. You may benefit from our medical research in one of the following ways:
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If the new treatment works, you may be one of the first people to benefit.
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You may be able to help future patients.
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The trial sponsor may pay for some of your medical care or tests. (Staff will clarify what costs are covered.)
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Experts design the treatments used in clinical trials.
Some possible risks include:
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Side effects may be worse than those of the standard treatment.
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Side effects may occur that the doctor does not expect.
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New treatments sometimes fail to work.
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As with standard treatment, the new treatment may not work for you even if it works for other patients.
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You may be assigned to placebo during part or all of the study
Can I Decide to Leave the Clinical Trial?
All patients in our medical research are volunteers. You can choose to quit a clinical trial at any time, but please talk to the doctor first. He can tell you how quitting the trial might affect your health and if there are other treatment options. More importantly, he will help you in the transition back to non-experimental therapy. Your relationship with your healthcare providers will not be changed by your decision.
Please take a moment to review information about volunteering for research studies and if you’d like to be a part of a study, use the form below to apply. We appreciate your time and willingness to volunteer!
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