Researchers may request a study review type, but according to Federal regulations, the IRB must evaluate the protocol and make the final determination regarding the appropriate level of review. The following checklists will help determine the researcher’s initial request.
Full committee review requires more preparation time for both investigators and the committee; therefore, researchers requesting full board reviews must submit their protocols to the IRB on or before the deadline listed on the IRB website: www.seattleu.edu/irb. (Note: Monthly review deadlines apply only to full board submissions. Exempt and expedited submissions are accepted and reviewed on a first-come, first-served basis.)
Protocols received after the deadline will typically be reviewed at the next meeting after the upcoming meeting. The IRB Coordinator will contact researchers within five business days after the IRB meeting to indicate the status of the review. If the IRB requests any changes or modifications, it is the researcher’s responsibility to demonstrate the implementation of these requests before approval is granted.
Protocols must be submitted for full board review if the project meets the Federal definition of research as described in Section 1, and involves any of conditions enumerated below.
- In many, but not all cases, subjects under the age of 18.
- Pregnant or nursing women subjects (If a subject becomes pregnant during the course of the study, the researcher must submit a protocol modification form to be reviewed by the full board.)
- Frail or infirm elderly subjects
- Incarcerated subjects or persons under a correctional sentence (parolees)
- Cognitively-impaired subjects
- False or misleading information to subjects
- Research involving abuse, drug use, sexuality, AIDS
- Withholding information such that subjects’ consent is in question
- Biomedical procedures
- Procedures that are experimental or not accepted practice
- Risky procedures or harmful effects, including discomfort, risk of injury, invasive procedures, vulnerability to harassment, invasion of privacy, or information creating legal vulnerability
- Research involving the use of drugs, dietary assessment/manipulation, or any medical/clinical assessment of non-anonymous patients or volunteers