Categories of Review
IRB protocols can be broken into three main categories of review: research exempt from IRB oversight, research following expedited procedures for review, and research that requires full Institutional Review Board review.
Some research involving human subjects may be exempt from the regulations. All research that an investigator believes falls into the exempt category, must go to the IRB Chair for confirmation of the relevant review category via a Request for an Exemption Form. It is not the duty of the researcher to determine if the research is exempt – a third party must make this determination. This form may be submitted to the IRB Administrator at any time, it does not have to meet the deadlines established for proposals requiring Full Board Review. The categories of exemptions are listed below. Please note that an exemption can be invoked only if all components of the research fit the category as described. You might find the following decision charts helpful.
Proposed research that qualifies under the Expedited Review category must involve no more than minimal risk, and the research must meet specific exemption criterion described in the link above.
Proposals which fall into the Expedited category may be submitted to the IRB Administrator at any time, they do not have to meet the deadlines established for proposals requiring Full Board Review. If research involves vulnerable populations, as defined by federal law and further defined by UC policy and procedures, the research does not qualify for expedited review and will be submitted to the Full Board for review.
Examples of research that may be expedited include: observation, interviews, questionnaires, or surveys of adults, secondary analysis of restricted, identifiable or private use data, and analyses linking survey data to geographical or community level indicators.
Any research project that uses vulnerable populations as research subjects must have Full Board review. Any research project that cannot be reviewed using the Expedited Review procedure will be subject to Full Board review.
Vulnerable populations include sick persons, pregnant women, fetuses, prisoners, children, elderly persons, mentally disabled persons, and persons who are educationally or economically disadvantaged.
All members of the Board will discuss the proposal. A majority vote of the Board is required for approval of a proposal. The Chair votes only in case of a tie by the other members. Minutes of Full Review discussions will be kept, and a summary of those minutes will be available, on request, to the principal investigator, the human subjects of the research project, and relevant federal, state, or local authorities and funding agencies.