Review Categories
There are three levels of review for research projects involving human subjects, each with its own application form: Exempt, Expedited, and Full. It is the researcher's responsibility to determine the category under which their research falls and to fill out the appropriate form. Researchers are welcome to contact the IRB chair (at irb@gettysburg.edu) for help in determining which category their research falls under, but we ask that you please carefully review the information on our webpages first.
In order to help you select the appropriate category for your research project the federal Office of Human Research Protection provides a series of decision charts. We encourage you to use these charts to help to properly categorize your project for the IRB. The charts are available at https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html
Note that all IRB forms and webpages have were changed on January 21, 2019 to accord with the revised Common Rule (new federal regulations on research with human subjects). The Exempt category was significantly altered and expanded, although the Expedited and Full categories remain the same.
The Three Types of IRB Review
Exempt from Review: Although Exempt research is supposedly so low-risk that it does not warrant review, those conducting "Exempt" research must still fill out an abbreviated form, which allows an IRB member to confirm that the research is Exempt. The form also enables the IRB to conduct a “limited review,” which is now mandated for some Exempt categories by the revised Common rule. Exempt research poses “No more than minimal risk,” which means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” There are eight sub-categories research that are Exempt. Exempt research will be reviewed by the IRB chair and the Provost’s representative on the IRB within two weeks of proposal submission. If the IRB reviews the proposal and determines that the research is not Exempt, the board will ask the researcher to resubmit with the appropriate form.
Expedited Review: such research poses “no more than minimal risk,” or it poses some risk to the research subject, in the sense that identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing. However, in the latter case the researcher has implemented reasonable and appropriate protections so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. There are seven sub-categories of research that can undergo Expedited review. Research that undergoes expedited review will be read by two members of the IRB within two weeks of proposal submission, unless they refer the proposal to the full committee for review.
Full Review: such research poses a risk to the research subject. This would be either a direct risk of bodily harm or emotional stress /discomfort as a result of a research intervention (questionnaire, experiment, lab procedure, etc.), or a risk linked to confidentiality, since the identification of the subjects and/or their responses could reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing. Although the form for Full review is the same as Expedited, Full review proposals will be reviewed by the entire IRB committee at their monthly meeting, in order to facilitate discussion and the resolution of ethically complicated issues. The researcher should submit a proposal for full review whenever they feel that risk is “more than minimal.” Certain types of research will always require full review (see below). Furthermore, any proposal submitted as Expedited may be referred to the full board if a reviewer believes it warrants more careful consideration, or if the two reviewers doing the Expedited review disagree. Research that undergoes Full review will be read by all members of the IRB and discussed at the next monthly meeting (on the third Tuesday of the month).
Be assured that the goal of IRB review is not to prevent research that involves risk, but to ensure that proper efforts are made to mitigate risk (including risk management, informed consent, and assurance of privacy).