Levels of IRB Review

To submit an application to the IRB, an appropriate level of review must be requested. The IRB will verify or correct the level of review requested for an IRB submission.

 


What doesn’t need IRB review

Not Human Subjects Research (NHSR)

Not Human Subjects Research (NHSR) applications are used to determine if a project meets the regulatory definition of human subjects and/or research. When the IRB determines a project does NOT meet the regulatory definitions, a determination letter will be generated which states IRB approval is not required. If the IRB determines the project DOES meet the regulatory definitions, it will be reviewed normally as an IRB study application. NHSR determinations are made by the IRB staff when considering an IRB study application in iStar. Please submit your application by filling out the IRB study form.

 


What needs IRB Review

Human Subjects Research

An activity requires IRB review if it fits the federal definition below for research and human subjects
or the FDA definitions of clinical investigation and human subjects

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

 


Levels of IRB Review

Human subjects research is reviewed by an IRB according to the following categories:

Exempt Review

Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a member of IRB staff. They do not require a convened committee meeting.

Expedited Review

Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories. Expedited reviews are conducted by a member of the IRB committee. They do not require a convened committee meeting.

Full-Board Review

Research that does not qualify for expedited or exempt review (presents more than minimal risks to subjects) will receive review at a fully convened IRB committee meeting.


Duration of IRB Approval (Continuing Review)

To continue a study beyond the period for which it was initially approved, a Continuing Review application must be submitted. Studies that require Continuing Review will receive email notifications from iStar with instructions for how to submit a Continuing Review application.

What if study approval lapses?

If the expiration date has lapsed, the investigator must email the IRB a request to continue study subjects currently on the trial and/or continue data analysis. The investigator will receive confirmation from the IRB. The investigator may not recruit or enroll new subjects until the study’s continuing review has been reviewed and approved by the IRB.