Research activities requiring IRB review can involve data related to humans regardless of whether a direct interaction or intervention occurs.
The HRPP has created a worksheet to help university students, faculty, and staff determine whether or not their project requires IRB review. The Human Subjects Research Determination Worksheet can be found here.
Human Subjects Research Determination Worksheet
If you are unsure whether your project requires IRB review, first try completing the worksheet, and then contact the HRPP staff via your college liaison or utkirb@utk.edu if you have additional questions.
If you have used the HSR Determination Worksheet and would like an official determination letter from the HRPP office, email your worksheet results and a brief summary of the project to utkirb@utk.edu and list in the subject line that you are requesting an HSR determination letter. A determination letter may be requested from a publisher or sponsoring agency.
Examples of Activities that may not be Human Subjects Research:
- Biography or oral histories, if the information being collected focuses directly on the specific individuals about whom the information is collected and not on generalizing the information or findings to other individuals.
- Publicly Available Datasets if there are no conditions placed on the use of the data and if datasets will not be combined in a way that would make individuals identifiable.
- Quality Assurance Projects if the activities are designed to determine whether aspects of practice are being performed in line with established standards.
- Quality Improvement Projects if the knowledge generated is for immediate local application.
- Research involving only coded private information if the following conditions are met:
- the information was not collected specifically for the currently proposed research research project through an interaction or intervention with living individuals; and
- the investigator(s) cannot readily ascertain the identity of the individuals to whom the coded private information pertain because, for example:
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- the investigators and the holder of the code key enter into an agreement prohibiting the release of the key to the investigators under any circumstances;
- there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances;
- there are other legal requirements prohibiting the release of the key to the investigators.
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Definitions
Research– a systematic investigation designed to develop or contribute to generalizable knowledge.
- An activity that involves a prospective study plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a study question.
- Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.
- A living individual about whom an investigator either:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; and/or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
- Both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Communication or interpersonal contact between an investigator and subject. Note that this contact does not have to occur in person to be considered an interaction for research purposes.
- Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.