What is Informed Consent?
An informed consent is a process in which researchers communicate with potential and enrolled participants about a clinical study. This is when researchers:
- Provide all the important information about the study, so that potential participants can decide whether to enroll (or, if enrolled, to continue participating)
- Ensure that potential participants understand the risks and potential benefits of participating in the study and the alternatives to the research being conducted
- Stress that enrolling in (and staying in) a clinical study is completely voluntary. Because giving consent to participate in research is not a contract, participants can leave a study at any time.
The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends. The researcher and potential participant have discussions that include answering the participant’s questions about the research. All the important information about the study must also be given to the potential participant in a written document that is clear and easy to understand. This informed consent document is reviewed and approved by the human subjects review board for a study before it is given to potential participants. Generally, a person must sign an informed consent document to enroll in a study.
The risks and benefits of participating in a study:
- Patient safety is our first priority in all research protocols conducted at OIC
- Studies provide study related laboratory testing and study medications at no cost to you
- Studies may provide travel stipend/compensation
- Minimal risks are generally associated with research protocols
- Any known risks are discussed prior to enrolling into the study
- Any risks that are identified during the study are relayed to you as soon as possible
- All research protocol’s must go before an institutional review board
“IRB” for approval in addition to the FDA (Food and Drug Administration)
Institutional review boards
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by the FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).
Various Federal agencies, including the Office of Human Subjects Research Protection and the FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.