IRB — Glossary

Anonymous data: Data that, by virtue of the method of collection, can never reasonably be connected with the person providing the data.

Coercion: An overt or implicit threat of harm that is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.

Confidential data: Anonymous or non-anonymous data that a human subject gives 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 are properly considered confidential, unless subjects have explicitly waived their presumption of confidentiality in writing.

Deception: The intentional use of misleading or untruthful information; unnecessary concealment or withholding of information from a participant.

Human subject: Any specific living person about whom a researcher obtains personal or private information or data through interaction with the individual. Experts sharing facts or professional opinions in the area of their expertise are not considered human subjects for the purposes of this policy.

Human subject research: Systematic collection of personal or private data from living human beings.

Informed consent: Informed consent is based on the principle of respect for the rights of others to make informed decisions concerning participation. It is not merely a document or a moment, but an ongoing practice. Procedures for informed consent provide research participants with sufficient knowledge about the purpose of the research, their involvement in the study, and the potential risks and benefits. Based on this knowledge, participants can then make an informed decision as to whether they would like to participate in the research project. All investigators are required to secure written informed consent of the participant or the participant's legally authorized representative.

Interaction: Contact (including observational studies) or communication with a human subject, manipulation of the human subject, or manipulation of the human subject's environment.

Intervention: Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

IRB: Institutional Review Board. Centre 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 research conducted on Centre's campus by outside investigators.

Minimal risk: Some potential for harm exists, but the probability and magnitude of harm are not greater in and of themselves than are those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Non-anonymous data: Data that, by virtue of how it is collected or the nature of the information, can be connected (no matter how tenuously), to the person providing the data. Examples include surveys the researcher collects directly from subjects, and surveys in which the researcher may recognize the handwriting of one or more of the subjects and could therefore potentially match the data with the specific respondent.

Original research: Systematic investigation, including pilot projects and feasibility studies, designed to expand generalizable knowledge or understanding, including collecting and analyzing data from questionnaires, observing subjects, manipulating experimental conditions, sampling, experimenting, etc. Research using human subjects, even if conducted to verify existing hypotheses, theses, theories, or ideas, is considered original research. Student research projects, even if conducted as part of the institutional curriculum, are subject to the same guidelines as original research and require some level of review.

For the purposes of this policy, the following are not considered original research and thus do not fall under the purview of the IRB:

• Research that deal entirely with secondary sources (e.g., public data sets)
• Activities in which human subjects perform exclusively for instructional purposes, such as in class demonstrations and lab exercises. (The intent or effort to publish data from such activities—at any time—converts these activities into original research involving human subjects. The research would then require IRB review.)
• Data gathering for the purposes of fundraising by the development office, market research for admissions recruiting purposes, recruiting efforts for faculty or staff, statistical data collected for the management of institutional affairs, and attitudinal research of alumni, students, or parents
• Journalism
• Information collected for entertainment purposes
• Oral history

OHRP: Office for Human Research Protections. OHRP is part of the Office of the Assistant Secretary for Health (OASH) in the Office of the Secretary (OS), U.S. Department of Health and Human Services. OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP also supports the Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues of human subject protections.

Principal investigator (PI): The primary person conducting the research. The principal investigator can be a professional or a student.

Private information: Information that can be identified with a human subject and 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 which the individual can reasonably expect will not be made public (e.g., medical records).

Protocol: a detailed plan of the study to be conducted.

Risk: Potential for physical, psychological, social, legal, or financial harm.

Unreasonable harm: Any physical, psychological, social, legal, 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.