Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study.
The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions and activities to measure participant understanding.
In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.
Each federally supported or conducted clinical study and each study of a drug, biological product or medical device regulated by 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 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 (OHRP) and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
Ohio State's Office of Responsible Research Practices
All Ohio State University clinical trials are overseen by the university’s Office of Responsible Research Practices (ORRP), a unit of The Ohio State University Office of Research. ORRP supports the University’s goals of promoting the ethical conduct of research involving human and animal subjects. The ORRP provides administrative support for:
- University researcher education on the regulatory and ethical requirements for conducting clinical research
- Pre-review of protocol submissions for compliance with regulatory requirements
- The university’s research review boards
- Implementation of the university’s conflict of interest policy
- Conduct of the university’s classified research and contract activities
All clinical trials at Ohio State are evaluated, approved and monitored by an Institutional Review Board (IRB) under the ORRP. Ohio State has three IRBs – one each for biomedical sciences, cancer and behavioral and social sciences. These boards are staffed by physicians, scientists, patient advocates, clergy, community members and other healthcare providers who are collectively responsible for overseeing the protection of human subjects in research.
In addition, the Clinical Trials Office (CTO) of Ohio State’s Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute (OSUCCC-James) facilitates development and implementation of all OSUCCC-James clinical trials. By providing regulatory processing, subject recruitment, financial development, data collection and protocol-management services, the CTO fosters a supportive environment conducive to conducting clinical trials in a methodologically sound, expedient and cost-effective manner. Although enrollment in clinical trials at Ohio State is higher than the national average, the University is working to increase patient participation.
For more information, visit Ohio State's Office of Responsible Research Practices.