Informed Consent in clinical research is required from every participant before he/she can participate in any part of a clinical research study. The “Informed Consent Form” is a document that describes the clinical research study purpose, basic methods, along with the possible risks and benefits, among other important aspects of the study. Every clinical research study has its own specific Informed Consent Form to insure that a participant is only agreeing to participate in what is specifically detailed within that form. Potential research participants begin every study by reading the form, after which either an Investigator or Clinical Research Coordinator will review the contents with the potential participant, checking that he/she understands the form contents, and answers all questions. After this point, the potential participant can agree to participate and sign the form. Importantly, the potential participant may decide he/she does not want to participate after reviewing the contents of the Informed Consent Form, or he/she may wish to take the form home to review and discuss with others, and these decisions are perfectly acceptable to all of the staff at SEC Clinical Research.
Informed Consent in clinical research starts with the Informed Consent Form, but that is not where it ends. Signing an Informed Consent Form is not the equivalent of signing a mortgage, and at any time during the research study, the participant is free to withdraw consent for participation without any negative consequences. Sometimes a change in life circumstances for the participant (eg, moving to a location far from our research site), or side effects that the participant feels are caused by the investigational medicine, are some typical situations that may lead to the withdrawal of consent. In summary, Informed Consent is an ongoing process throughout the duration of the research study, and volunteers are free to end their participation at any time without any type of penalty.
For those interested in more information about Informed Consent, we recommend the following FDA website: http://www.fda.gov/ForPatients/ClinicalTrials/InformedConsent/default.htm