The Institutional Review Board (IRB) is a panel of Tufts’ faculty and staff, as well as at least one individual community member that reviews all human subject research proposals to determine if they are assuring adequate protection of human participants. The composition and authority of this committee is established by the federal government’s guidances on Research Ethics and Code of Federal Regulations. The IRB must conduct most of its business (with the exception of exemptions and expedited reviews) in convened meetings with a quorum present. Only the IRB has the authority to approve human subject research.
Failure to obtain IRB approval or an exemption prior to beginning human subject research is considered noncompliance. The University is required to report serious or continuing non-compliance or the suspension of human subject research to the Office for Human Research Protections at the Department of Health and Human Services and to any funding agencies that may be involved. For the researcher, noncompliance can result in suspension of research, inability to publish, destruction of data, and other sanctions. For the institution, it could mean the suspension of our FWA, which would cause all human subject research at Tufts to stop until we could get the FWA reinstated. Often, reinstatement requires that all studies be reviewed again before they resume. This is a serious matter for both individuals and for the community and it is critically important that everyone follow the appropriate procedures for human subject research.