Policy on Protection of Human Subjects
III. Definitions
anonymous data: 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 respondent). 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).
confidential data: 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, normally in writing.
data: facts, figures, and information. For the purpose of this policy, the term "data" is considered to be material from primary sources analyzed as part of scholarly efforts.
deception: intentionally misleading or providing untruthful information, any concealment or withholding of information from a participant; use of trickery, or deceit.
HSRC: Human Subjects Review Committee, now known as the IRB (see section VI for composition). This is commonly called the Institutional (Internal) Review Board (IRB).
human subject: (1) any specific living person about whom a researcher obtains personal 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.
minimal risk: Federal guidelines state, "minimal risk 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."
naturalistic studies: observations performed without any intervention except the observations themselves.
non-anonymous data: 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 he or she so desired.
original research:any activity conducted 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. This includes pilot projects and feasibility studies. Works dealing entirely with properly attributed secondary sources are not considered original research for the purposes of this policy. Public data sets are considered such secondary sources.
Individual student projects (including 500, 555, 600, 700), 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.
Activities where human subjects perform exclusively for instructional purposes* are not original research (i.e., are not subject to these reviews).
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 are excluded from the category of original research under the purview of this committee.
principal investigator: the primary person conducting the research. The principal investigator can be a professional or a student.
review: a process of oversight resulting in an acknowledgment of the status ("approved," "pending required amendments," or "not approved") of a project under the guidelines of this policy.
risk: potential for physical, psychological, social, or financial harm. A research protocol eemed to put its subjects at no risk may be eligible for Level I approval (see below). (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 See Section VI for more information on the levels of IRB approval
unreasonable harm: 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.