Definition of Terms
Below are definitions for common IRB terms.
Data that by virtue of the method of collection can never reasonably be connected with the person providing them. This can be accomplished by questionnaires that are returned by mail (in envelopes with no return address or other identifying markers), questionnaires that are collected by one of a group of subjects and returned to the researcher, or internet surveys (with software that renders it virtually impossible to connect answers with respondents). Questionnaires that collect data anonymously do not require a separate written consent; consent to use the data is implied in the respondent’s completion of the questionnaire (a statement to this effect should be affixed to the beginning of any such survey).
Non-anonymous data which a human subject provides an investigator with the understanding or assumption that the human subject’s privacy will be honored. Divulging the source of non-anonymous data to an outside party, or failing to ensure that no outside parties will be able to connect data with their source, normally constitutes a violation of confidentiality. This IRB presumes that all data collected from human subjects is properly considered confidential, unless subjects have explicitly waived their presumption of confidentiality in writing.
Intentionally misleading or providing untruthful information; any concealment or withholding of information from a participant; use of trickery or deceit.
Generalizable knowledge can be applied to other people, times, situations, and places.
Any specific living person about whom a researcher obtains (1) data through interaction with the individual, or (2) private information. Interaction includes contact (including observational studies) or communication with the individual, manipulation of the subject, or manipulation of the subject’s environment. Private information includes information that can be identified with an individual and that is obtained in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been recorded for specific purposes and which the individual can reasonably expect will not be made public (e.g., medical records). Experts sharing facts or professional opinions in the area of their expertise are not considered human subjects for the purposes of this policy.
Interaction includes contact (including observational studies) or communication with the individual, manipulation of the subject, or manipulation of the subject’s environment.
The Institutional Review Board. Middlebury College’s IRB is responsible for the ethical oversight of all research involving human subjects conducted by College faculty, students, or staff, as well as such research conducted on the Middlebury College campus by outside investigators.
Data that, by virtue of the method of collection or nature of the information, can be connected at some point, no matter how brief, to the person providing them. This includes questionnaires that the researcher collects personally from a group of subjects (unless a ballot box or envelopes are used). It also may include cases where the researcher is familiar with the handwriting of one or more of his or her subjects. In these cases it is possible for the researcher to match the data with a specific respondent if they so desired.
Oral history is defined as a method of gathering and preserving historical information through recorded interviews with participants about past events and ways of life, is not subject to IRB review if the researcher does not seek to generalize to a larger population beyond the oral history case study.
See examples that illustrate the distinction.
Researchers using oral history methods should follow the ethical guidelines of the Oral History Association.
Systematic investigation, including pilot projects and feasibility studies, designed for the purpose of expanding knowledge or understanding, including the collection and analysis of data from questionnaires, observation, manipulation, sampling, experimentation, etc. Research using human subjects, even if it is simply verifying existing hypotheses, theses, theories, or ideas, is considered original research.
For the purposes of this policy, the following are not considered “original research” and thus do not fall under the purview of the IRB:
- Works dealing entirely with secondary sources (public data sets are considered such secondary sources).
- Activities where human subjects perform exclusively for instructional purposes (though the intent or effort to publish data from such activities—at any time—converts these activities to original research involving human subjects).
- Data gathering for the purposes of fundraising by the external affairs offices; market research for the purposes of admissions recruiting; recruiting efforts for faculty or staff; statistical data collected for the management of institutional affairs; and attitudinal research of alumni, students, or parents.
- Information collected for entertainment purposes.
Individual student research projects (including 500, 555, 600, 700 projects), even if conducted as part of the institutional curriculum, are subject to the same guidelines as other scholarship (i.e., are original research) and require review.
Principal Investigator (PI)
The primary person conducting the research. The principal investigator can be a professional or a student.
Private information includes information that can be identified with an individual and that is obtained in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been recorded for specific purposes and which the individual can reasonably expect will not be made public (e.g., medical records).
Potential for physical, psychological, social, or financial harm. A research protocol deemed to put its subjects at no risk may be eligible for Level I approval. (Anonymous surveys often constitute no-risk research.) By contrast, minimal risk means that some potential for harm exists, but that the probability and magnitude of harm 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. Research that involves minimal risk often is eligible for Level II approval.
A systematic investigation is designed to collect information in a consistent manner that will produce useful data. Quantitative data is often collect specifically to test a particular hypothesis. Qualitative data may be collected in order to formulate a hypothesis.
Any physical, psychological, social, or financial damage or injury that can be avoided without sacrificing the goals of the research. Unreasonable harm also includes any damage or injury so extensive that it cannot be justified by any contribution the research might make to human understanding.