Proposal Status Forms and Levels of Review
Status Forms
What Qualifies for Expedited Review?
To qualify for Expedited Review, the research must meet all of the following criteria:
- Be of minimal risk to the subjects;
- Must not involve pregnant women, prisoners or mentally impaired persons;
- Involve only procedures listed in one or more of the following categories:
Categories for Expedited Review
- Research involving materials (data, documents, records) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language communication, cultural beliefs or practices, social behavior), or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
What Types of Research Require Convened IRB Review?
Research that requires full committee review may include one or more of the following:
- Prisoners
- Pregnant Women
- Fetuses
- Mentally Disabled Persons
- Poses greater than minimal risks to subjects (unless qualifying for Exempt review)
- Vulnerable Populations (see definitions, below)
This list is not exhaustive. The final decision as to whether an application is reviewed by the Board at a convened meeting is that of the IRB Chair and/or Board.
Vulnerable Populations:
Individuals whose willingness to volunteer in a study or clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces (i.e., ROTC or Corps of Cadets), and persons kept in prison or detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
Revised September 2018