Research Compliance Services (RCS) staff, in conjunction with the RCS Director and the IRB Chairs, determine the category of review for submitted projects. The Human Subject Regulations Decision Charts published by the federal Office for Human Research Protections may help you understand which category of review your project may be qualified for. In addition, you may contact RCS for assistance.
Regardless of the level of assessment, the researcher may be requested to revise his or her protocol to meet IRB review criteria.
Exempt (Administrative) Review
Human subjects research identified by RCS, in conjunction with the IRB, as meeting one of the six categories of research established by the US Department of Health & Human Services receives a determination of "Exempt". An "Exempt" determination must be made by RCS.
Research identified as Exempt is approved for five years from the determination date. If research extends beyond the five year period, RCS requires the submission of a new application. Exempt research is not subject to annual continuing reviews; however, any changes to a protocol must be pre-approved by RCS to ensure the changes do not affect the determination.
The researcher may be required to submit revisions if the project does not meet the minimum requirements for approval. Researchers should submit all protocol applications at least six to eight weeks prior to the anticipated start date for human subject activities. If other deadlines necessitate submission outside of this timeframe, the researcher should contact RCS as soon as possible.
The federal regulations governing human subjects research establish nine categories of research that qualify for review under an Expedited review process; in addition, the research must present no more than minimal risk of harm to subjects. Under the Expedited review process, the protocol is reviewed by one or two IRB members instead of by the full board.
If a project qualifies for Expedited review, RCS will perform an administrative review of the project in addition to the review performed by the IRB member. Based on the results of these reviews, the researcher may be required to submit revisions. Researchers should submit the protocol application six to eight weeks in advance of the anticipated start date for human subjects activities in order to ensure timely review. If other deadlines necessitate submission outside of this timeframe, the researcher should RCS as soon as possible.
Full Board Review
Projects that potentially pose more than minimal risk to subjects or involve certain populations may require Full Board review. Protocols requiring Full Board review are considered at convened meetings of the Committee for the Protection of Human Subjects (CPHS).
Projects involving any of the following will always require Full Board review:
- Research on prisoners.
- Research involving ionizing radiation.
- Research involving invasive procedures.
Projects involving other populations or activities may also require Full Board review. In particular, the CPHS may require sensitive interventions using special subject populations to be considered by the full committee.
If you anticipate that your protocol may need Full Board review, be aware of the CPHS meetings dates and submission deadlines.
If you are unsure if your project will need Full Board review, contact RCS for assistance.