The IRB certifies human subject research at the three following review levels:
Although the category is called "exempt," this type of research does require IRB review and registration. The exempt registration process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into one of six federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. The following are examples of Exempt Research:
* subjects cannot be identified in the research data directly or statistically, and no one can track subjects' identities
* the sources are publicly available.
* the subjects cannot be identified, directly or statistically; or
* the responses/observations could not harm the subjects if made public; or
* federal statute completely protects all subjects' confidentiality;
* all respondents are candidates or elected or appointed public officials.
* If potentially exempt because subjects cannot be identified, the research must protect anonymity; and
* If subjects give information about others, inadvertent disclosure presents no more
than minimal risk to those others.
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.
To qualify for an expedited review, research must fall into one of nine federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:
All projects that do not fall into either the Exempt or Expedited Review categories, or deal with special concerns or vulnerable populations go to the full IRB for review. This is the most rigorous level of review. Full Board Review Research involves the following:
* Children: Both assent of child and permission of parents is required. Research with more than minimal risk but no direct benefit to the child is restricted. Researchers conducting research within the school and/or during the school day will need prior permission from the school system’s superintendent or school board showing cooperation for research that may otherwise be devoted to the curriculum. Some K-12 school systems have their own IRB and / or IRB process requiring internal processing.
* Pregnant women or fetuses: Research is severely restricted; the IRB must assure appropriate process to select, inform, and obtain consent of subjects.
* Subject selection is from individuals considered to be representative of an ethnic minority group or are unable to speak English.
* Prisoners: Severely restricted research. Researchers will need prior permission from the prison’s warden or prison system’s own IRB which ever they require.
* People with mental impairment: No regulations apply, but because informed consent is problematic, and the subjects are vulnerable, this type of research should be limited.
- For genetic research, and research using blood and other body tissues: the protocol must:
a. discard the blood/tissue without doing tests beyond the protocol, or have no personal identifiers; and
b. either promise not to grow perpetual cell lines, or mention that possibility in the consent process.