science
About
HSIRB

Health Sciences IRB

The Health Sciences Institutional Review Board (HS IRB) reviews, monitors and approve biomedical and social, behavioral, and educational research.

All submissions to the Health Sciences IRB must be done through eIRB.

New Studies

There are four types of review that can be applied to new research study applications: Not Human Subjects Research, Exempt, Expedited and Full. It is important to understand that none of the types of review is superior or inferior to the other. The type of review is strictly dependent on the research study design and the nature of the research.

Modifications

According to federal regulations, investigators are responsible for obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects [45 CFR 46.103(b)(4)]. Depending on the type of research and the scope of the modification, these may be reviewed by expedited review or by full IRB review.

Continuing Review

According to federal regulations, an IRB must conduct continuing review of previously approved research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR 56.108(a)(1) and 56.109(f)]. Depending on the type of research, continuing review may be performed by expedited review or by full IRB review.

Continuing Review

Reportable New Information

During the course of a research study, unanticipated problems involving risk to subjects or others, non-compliances, and other events may occur that need to be reported to the IRB in accordance with 45 CFR.46.103(b)(5) and 21 CFR 56.108(b)

Reportable New Information