Elements of Informed Consent

• Research Purposes, expected duration, procedures to be followed, which procedures are experimental.
• Risk of test procedures, to embryos and fetuses.
• Benefits to research subjects and others (principal investigator, sponsor, future patients).
• Alternative Procedures and Treatment Options Available to help you decide if volunteering is right for you.
• What If New Evidence Becomes Available About a New Treatment During a Trial? We will strive to keep you informed of the latest discoveries in medicine. For example, if you are volunteering for an experimental treatment for cancer and during your study, a cure for cancer becomes available, of course we will terminate the study so that you may receive the new approved treatment.
• Confidentiality of Medical Records FDA and sponsor will have access to medical records for research purposes only and will protect your privacy.
• Injury Should the research involve more than a minimal risk, we will outline how we will pay for medical treatment. By and large all drug companies want to pay for all research related injuries to help promote future studies.
• Whom to Contact for Research Related Questions?
• The Drug Study Institute
• The sponsor (Drug Company)
• The Institutional Review Board (IRB) listed on the ICF
• The Office of Protection from Research Risk (OPRR)
• The FDA
• The Office of Research Integrity
• The Research Subjects Review Board
• Statement Describing the Voluntary Nature You may choose to volunteer or you may not. Whichever, we want to ensure you are happy with your decision.
• The Investigator May Terminate the Drug Study and Stop the Subject's Participation Without Cause If we feel a drug trial is not in your best interest, we will get you out of it. We care about you and your welfare.
• Additional Costs to Subjects Due to Participation We will strive to look for any hidden costs and to bring these to your attention. It is our intention to cover all additional costs and to make sure there are no hidden surprises.
• How a Research Subject/Patient Withdraws from a Study We ask you to call us and let us know that you are withdrawing consent. We will help to make the withdrawal process safe.
• The Approximate Number of Subjects Involved in This Drug Study Many drug companies recruit study volunteers from all over the world. We will be glad to discuss this with you.