Human Research Protections Office (HRPO)
What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) has the job of making sure healthcare providers in the United States live up to these expectations for quality care whenever patients or other individuals are involved in research studies.
An IRB is a committee of scientists, nonscientists, and community members who decide whether research proposals meet specific standards, regulations, and policies. IRB members have different kinds of knowledge, experience, and backgrounds to ensure that their decisions are well informed and objective. IRB committees review, approve, and monitor human research activities in hospitals, medical institutions, and other healthcare environments.
What does an IRB do?
Federal law says that any human research, even research that is not funded by the federal government, has to be approved by an IRB before it can take place. The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are responsible for setting the guidelines and regulations that govern human research. They define what human research is, what kinds of research studies can take place, and what roles the IRB and healthcare institutions have in the research. IRB committees look for six basic things when they decide whether or not a research study can take place:
- the risks to the research subjects are minimized and justified
- the risks to the research subjects are reasonable in relation to the possible benefits of the study results
- the selection of the research subjects is equitable
- enrollment of the research subjects includes a process of informed consent and documentation
- that adequate preparation is taken to protect the privacy and confidentiality of the research subjects
- that adequate resources are available to evaluate and monitor the welfare of the research subjects throughout the research study
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