Informed consent begins with a discussion between the researchers and the prospective participants. Based on this discussion with the researcher, participants are asked to sign a consent form that includes this same important information in writing. Prospective study participants can take the consent form home to discuss it with family and friends before signing it. Once the form is signed, participants are given a copy of the signed consent form so that they can review it at any time. Participants should feel free to ask the researchers questions before, during, and after the study.
Informed consent is an ongoing process.
An IRB is the group or committee that is given the responsibility by an institution to review that institution's research projects involving human subjects. The primary purpose of the IRB review is to assure the protection of the safety, rights and welfare of the human subjects . An investigational or experimental drug is a drug that is not yet approved for marketing - it is not commercially available. In some studies, the participants in a control group may be given a placebo. The principal investigator is the chief researcher - the person in charge of carrying out a study.