Human Subject Protection

Purpose and Regulatory Authority

The main purpose of the Institutional Review Board (IRB) is to protect the rights and safety of human subjects involved in research. The IRB is appointed by, and responsible to, the Western Connecticut Health Network Board of Directors to assure compliance with:

The Federal Food, Drug and Cosmetic Act
The regulations of the Food and Drug Administration (FDA)
The regulations of the Department of Health and Human Services

The IRB is compliant to these regulations through the Office of Human Research Protections (OHRP) as it pertains to human subject research. In its attention to Federal regulatory compliance, the IRB reviews and approves, and conducts periodic review of biomedical and social-behavioral research involving human subjects.

All research studies must be reviewed and approved by the IRB before initiation. This includes all research conducted by Danbury Hospital, New Milford Hospital, and Western Connecticut Medical Group physicians, staff and students, and any research which takes place or recruits subjects on these premises.

The Western Connecticut Health Network IRB has the authority to disapprove, amend, or approve studies, and oversees the conduct of such studies. The primary purpose of such review and oversight is to assure:

That the rights and safety of human subjects are adequately protected
That subjects are not exposed to unnecessary risks
That they are provided with enough information about a study so that they may give effective informed consent

Humanitarian Device Exceptions

In addition to clinical research trials and projects, the IRB also has regulatory responsibility for use of experimental Humanitarian Device Exceptions (HDEs) and acquiring release of highly experimental, single patient use drug products in exceptional medical cases.

IRB Review

The Federal regulations allow for levels of review in our process, and largely determine the allowable category:

Full board review
Expedited review
Exempt

The IRB Chair and/or the IRB Administrator will decide the process or category used for review. For instance, if a research project does not meet the federal criteria to be handled through our expedited process, we will not be able to do so. If it does meet the criteria, occasionally the IRB may determine a need or interest in sending it for full board review.

The Exempt category should not be misconstrued to mean “Exempt from IRB Review.” In review of the submission, the IRB may determine the project to be “Exempt from further IRB Review.” The best example of this category is a single case report.