Institutional Review Board (IRB)

Institutional Review Board – IRB

The institutional review board (also known as an independent ethics committee or ethical review board) is designated to approve, monitor, and review biomedical and behavioral research involving humans in order to protect the rights and welfare of the research subjects. The IRB must follow regulations established by the Food and Drug Administration and the Department of Health and Human Services (DHHS).

IRB documents

Sharon House (houses@readinghospital.org) will help walk the investigator through the process.
Click here for the IRB schedule.

Key information regarding submission to the IRB is as follows:

1.  Any study that meets both of the  following criteria should be addressed with the IRB:

a. Research – Federal regulations define research as: “a systematic investigation designed to develop or contribute to generalizable knowledge”
b. Human subjects: The Department of Health and Human Services regulations define a human subjects as a “living individual about whom an investigator (whether professional or student) conducting research obtains: (i) data through intervention or interaction with the individual or (ii) identifiable private information*

*Private information includes (i) information about behavior that occurs in a setting in which the individual can reasonably expect that no observation or recording is taking place or(ii) information that has been provided for specific purposes, other than research, where the individual can reasonably expect that it will not be made public (e.g. a medical record)

2. If a research study is planned, IRB review should be obtained BEFORE initiating a the study protocol.