Before you commit to participate in any clinical research, you should find out as much as possible about the research site, its staff, and the specific research study before you agree to participate in a clinical trial. Do not ever consider volunteering for a clinical research trial without asking the questions below, and make sure that all your questions are answered to your satisfaction. In addition to the questions below, you can find out even more information about the federal regulations and other items pertaining to the conduct of clinical trials on human subjects by checking out the websites listed on the Resources page.
- About the Principal Investigator (PI)
The person responsible for the study conduct is called the Principal Investigator(PI). You need to ask the following questions before you consider participating in any study at a site:
- Who is the PI for this study?
- Is the PI a licensed MD?
- Is the PI a board certified sub-specialist in my disease?
- Is the PI an Association of Clinical Research Professionals (ACRP) Certified Principal Investigator (CPI)?
- How often will the PI examine and talk to me while I am in a study?
- Before I participate in a study, will I be able to talk directly with the PI to discuss any questions or concerns that I have about a study?
- Other than funding for this study, does the PI have any other financial relationships (such as office lunches, office supplies, speaking honorarium, or any other monetary equivalents) with the research company sponsor or any other companies?
The person with whom you will have most contact with during your participation in a clinical trial is the Study Coordinator. You need to ask the following questions before you consider participating in any study at a site:
- Will there be one Coordinator who is responsible for conducting tests and monitoring me during a study?
- Is the Coordinator an Association of Clinical Research Professionals (ACRP) Certified Clinical Research Coordinator (CRCC)?
- How many clinical trials has the Coordinator conducted in my disease?
- Does the Coordinator receive any type of bonus or incentive for the number of people in a study?
- Other than funding for this study, does the Coordinator have any other financial relationships (such as office lunches, office supplies, speaking honorarium, or any other monetary equivalents) with the research company sponsor or any other companies?
You need to ask the following questions about the Research Site before you consider participating in any study at a site:
- How long has the Site been conducting clinical research trials?
- Does the Site ever conduct studies using anyone other than board-certified medical sub-specialists as PIs ?
- Has the Site ever received a FDA 483 Warning Notice (a notice of non-compliance with federal regulations regarding the conduct of human research studies)?
- If yes, was it for: Investigator misconduct? major Protocol violation?, or violation of the Informed Consent Process?
- Other than funding for clinical research studies, does the Site have any other financial relationships (such as accepting free meals, office supplies, honorarium, or other monetary equivalents) with the research company sponsor or any other companies?
You need to have the following questions answered about any study in which you are considering participating, All the answers to these questions from Office of Human Research Protection (OHRP) website) should also be clearly written in plain language in each Informed Consent Document that research study staff and PIs should review with you prior to your participation in any study.
- Why is the research being done?
- What will be done to me as part of the research?
- How will I benefit from the research?
- Will I be compensated for my participation?
- Could I be hurt from the research?
- What will be done with my information obtained from my participation?
- Will the research cost me anything?
- How long will I be in the study?
- What happens if I decide to leave the study early?
- Who pays if I am unexpectedly injured due to a study-related procedure or medication?
- Who should I contact if I have questions about the research?
CONTACT US if you want to be contacted to screen for one of our current clinical trials
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