The review process differs based on the type of review and submission type. There are three main types of review: Exempt, Expedited, and Full Board.

EXEMPT

Exempt research is a type of human subjects research that does not require ongoing continuing review if submitted after January 19, 2019. Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. These categories include such things as research involving educational tests, surveys, interviews, or observation of public behavior; research involving benign behavioral tests with adults, taste and food quality studies, or secondary research involving biospecimens. Studies that qualify for exemption must be submitted to the IRB for review before starting the research. There is not a separate IRB application form for studies that could qualify for exemption – an eProtocol IRB protocol form must be filled out and submitted to the IRB for these studies.

EXPEDITED

Expedited research is a type of human subjects research that involves minimal risk and can be evaluated by a single experienced reviewer, rather than a full IRB committee. Research can qualify for expedited review if it meets one of nine (9) categories such as research involving drugs or devices that do not require an IND or IDE; collection of voice or video data for research purposes; collection of blood, nail clippings, saliva, or other biological specimens by routine clinical or non-invasive means; non-invasive clinical procedures including moderate exercise, ECG, EEG; or research involving medical records that have been or will be collected for non-research purposes. Most expedited studies submitted after January 19, 2019, do not require continuing review, but determination solely rests with the IRB. There is not a separate IRB application form for these studies – an eProtocol IRB protocol form must be filled out and submitted to the IRB.

FULL BOARD

Full board research requires review by the convened IRB at a meeting. Full board studies involve either greater than minimal risk or do not otherwise qualify for exempt or expedited status and include research involving vulnerable populations (e.g., children (beyond minimal risk or outside permitted categories), prisoners, or individuals with diminished decision-making capacity) and research involving deception.  All full board studies require ongoing continuing review, typically annually.  An eProtocol IRB protocol form must be filled out for these protocols and submitted to the IRB.

DECISION TREES

Is this human subjects research?

Is this human subjects research an exempt IRB?