The University of Virginia is committed to protecting the rights and ensuring the safety of human subjects participating in research. When conducting clinical research, our most important job is to protect the participants enrolled in the research.
We protect our participants by, first, ensuring that each study is reviewed and approved by the Institutional Review Board (IRB). Every clinical research study in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others designated to review and approve a research study, including its set plan (protocol), informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is the IRB’s responsibility to ensure that the study adheres to all government regulations.
Secondly, we protect research participants by following well-planned protocols. The protocol is the study plan on which the study is based. It:
- Explains the treatment plan
- Details what will be done during the clinical trial
- Gives the number of participants that will take part in the clinical trial
- Lists eligibility criteria, which are guidelines to decide who may join the clinical trial
- Explains safety information.
In addition, we protect the study participants by conducting a careful informed consent process with everyone considering participation in a clinical trial.