Why should I participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. It is no exaggeration to say that a large share of the credit for current treatment successes belongs to the people who participated in the clinical trials conducted over the last decade.
Are clinical trials safe?
Clinical trials are conducted according to a strict oversight by the Food and Drug Administration (FDA). The FDA sets the rules to make sure that people who agree to be in studies are treated safely.
All clinical research plans—known as “research protocols”—must go through a rigorous process to ensure that the research is not only scientifically sound, but also safe for study volunteers’ health and human rights. All research studies conducted in the U.S. must abide by the ethical principles found in the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and other strict federal guidelines. Clinical trials also enlist the support of Institutional Review Boards (IRB) to protect participants’ safety. An IRB is an independent group made up of scientists, doctors and other people. IRBs play a critical role in protecting the interests of study volunteers by ensuring that any risks to their safety are minimized and study volunteers’ rights are fully protected.
While study volunteers’ safety is paramount, there may be risks, both known and unknown, associated with taking an experimental treatment. When considering participation, it’s critical to understand the known potential side effects and weigh these with any potential benefits. Moreover, as a study volunteer, its crucial to know what to do if a complication should arise.
What can volunteers expect if they choose to participate?
Participants receive a physical examination and their medical histories are reviewed by a research staff member once they are enrolled in the study. The volunteers’ health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms along with specific clinical trial information.
What is informed consent?
Informed consent means that the volunteer agrees to participate in the trial under conditions explained by the investigators. However, the volunteer is not legally bound to remain in the trial, and may leave at any time without penalty. It is hoped that volunteers will remain in the trial so that study results are not skewed by dropouts.
Informed consent will review infomation such as:
• The study's plan
• Treatment to be given during the trial
• Tests that will be carried out
• Follow-up procedures after the trial
Once signed, all Mountain View Clinical Research volunteers will be given a copy of their Informed Consent.
Will it cost me anything?
No. The trials conducted by Mountain View Clinical Research are provided at no cost to the volunteer. Volunteers may be reimbursed for time and travel. The details of covered costs will be explained to you at your first visit and each volunteer will be given a copy of the “Informed Consent” which outlines reimbursement in detail.
How long does a study last?
Clinical trials vary in length. Some are as short as a few weeks or as long as a few years. You will be fully informed about how long you need to participate, and you may quit at any time though it is hoped that volunteers will remain in the trial so that high quality data can be provided.