Researchers seeking IRB approval should submit a completed application form and supporting documents via email to firstname.lastname@example.org. Include the completed application and all supporting files (e.g., consent form, research advisor form, recruitment materials, etc.) as attachments. Applicants should refer to the templates when creating supporting documents for their applications.
Macalester Institutional Review Board (IRB) Application Form
Does my research project require review?
The IRB cannot approve projects retroactively. Research involving human subjects that is conducted without IRB approval must not be used in any publication or public presentation. Plan ahead and consider possible future uses of the data to be collected and obtain necessary approval before initiating participant recruitment and data collection.
If you are unsure about whether to submit an application for IRB review, consider your responses to the following two questions:
1. Does my investigation constitute research?
According to the Code of Federal Regulations, research means “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR 46]. Generalizable knowledge refers to knowledge gained from a study that may be applied to populations beyond the specific study population, shared with an audience beyond class participants through publications or presentations, and/or used to inform policy decisions.
The federal Common Rule specifically excludes certain types of investigations from the definition of “research.” As such, these kinds of investigations are not subject to IRB review: “oral history, journalism, biography, literary criticism, legal research, and historical scholarship that focuses directly on the specific individuals about whom the information is collected.”
Quality improvement and quality assurance activities conducted solely for the intent of maintaining or improving the quality of services provided at Macalester are not considered “research” according to federal regulations. Thus, a study conducted in an education setting involving quality assessment or quality improvement of college services, instructional techniques, curriculum, or classroom management methods that do not contribute to generalizable knowledge beyond your academic or professional institutions is thus excluded from IRB review. Nevertheless, these projects often involve the collection of data using survey methods and for this reason, may require approval by the Office of Institutional Research.
To determine whether your investigation is “research,” according to federal regulations, answer YES or NO to the following questions:
1.a) Do you expect or intend to publish the results of your study?
1.b) Do you expect or intend to present the results of your study in a public setting, such as a workshop, conference, or poster session?
If your answer was NO to both of these questions, your study is not considered research in the Federal definition. Formal application is waived and you are free to begin your study. Keep in mind that IRB approval cannot be given retroactively. If there is some future possibility that your findings might be presented in a scholarly or professional context as research, you are encouraged to submit an application for IRB approval before collecting any data.
If your answer was YES for either question, your study is considered research. Continue to Question 2.
2. Is my inquiry considered research on Human Subjects?
To determine whether your study is considered research on Human Subjects, answer YES or NO to the following questions:
2.a) Will people themselves be the subjects of study? (e.g., If you interview a physics professor to learn about black holes, she is not a human subject of your investigation. If you interview her about her experiences as a physicist, however, she is a human subject.)
2.b) Will the study involve interacting with living people?
2.c) Will you gather information that would ordinarily be private (e.g. personal beliefs)?
2.d) Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g. their homes)?
If you answered NO to all four of these questions, your study is not considered to involve human subjects. You do not need to apply for IRB approval of your research and are free to begin your study.
If you answered YES to question 2a AND to one or more of the other three questions, your study is considered to involve human subjects, and you do need to apply for IRB approval of your research.