Terms and definitions related to Human Subjects Research are included in the Guidelines as Appendix A -
Operational Definitions, pp. 21-24.
View Appendix A - Operational
Definitions (PDF).
These terms are also included below for your reference:
Adverse Event An outcome experienced by a subject that was either not
anticipated by the researcher or is of a magnitude greater than was originally anticipated by the
researcher.
Anonymity An assurance that no identifiable private information is being
gathered, (i.e., the investigator will not be able to identify subject).
Assent Agreement by an individual not competent to give legally valid informed
consent (e.g., a child or cognitively impaired person) to participate in research.
Benefits The potential for positive outcomes arising from the research. Benefits may
be to the scientific community, in the form of enhanced knowledge about a phenomenon; to the
researcher, in the form of increased knowledge of research procedures; or to the subject participants,
in the form of a good – tangible or intangible- that arises from their participation. See also,
Incentive to Participate.
Coercion Activities that under normal circumstances may create feelings of
being compelled by force or threat to participate in research.
Compensation for Injury Monies of services provided to treat negative
physical outcomes caused by participation in research.
Compensatory Follow-up Activities undertaken in the interest of ensuring equal treatment of all subjects. In “blind” experimental studies, this might involve making a successful treatment available to members of a control group.
Computer Mediated Research Research conducted with the aid of information and communication technology, most commonly the personal, or desktop computer. When information is stored on the recordable media specific to the device, or transferred solely from the original drive to a drive or disk for permanent storage, such research is not considered “online research”.
Confidentiality An assurance that all-identifiable private information will be kept secret and not be made available to anyone other than the investigator to whom it was entrusted.
Consultative Comments and Suggestions Statements made by Human Subject Research (HSR) to investigators following HSR review are intended to strengthen and improve the methodology or outcomes of a project. There is no requirement that investigators adhere to these statements as they have no bearing on the safety of human subjects.
Covered Entities Under the HIPPA Privacy Rule organizations that create, maintain, or transmit identifiable health information as a normal course of business or their business associates.
Counseling Advice, particularly information that would help a person think or feel differently about themselves or their activities.
Debriefing Immediately following data collection, subjects should be given clarification for any misconceptions that may have arisen. Subjects should be told the general nature of responses and told who (when and where) to contact if any follow-up is needed, e.g., counseling.
Deception The engagement of subjects in fraudulent activities, the provision of false information, or the intentional omission of information as necessitated by the research design.
Documented Informed Consent (see also Informed Consent) A permanent, physical record of information about the research as provided to subjects. Such consent includes the subject's signature (or the signature of the subject's parent or legally authorized representative), or acceptable substitute, indicating that such information has been provided.
Exculpatory Language Wording that implies a clearing from blame or fault; phrases that could make it appear as if the subject had waived all or part of his or her rights.
Exempt Activities Research activities included in the descriptions provided in Appendix B are considered to be exempt from the ongoing oversight of the All-College Board for Human Subjects Research. This means that the regulations included in Section 3.9 of these guidelines do not apply. Requests for Certification of Exemption can be submitted, with proper documentation, to the Associate Provost at any time. Upon receipt of such certification, research may commence.
Human Subject A person about or from whom an investigator/researcher obtains data or identifiable private information through intervention or interaction.
Identifiers Information that can be used, alone or in combination, to single out an individual from a group.
Incentive (or Inducement) Rewards (goods or monies) provided for participation in research.
Informed Consent Potential subjects are informed in language appropriate for their level of understanding about all features of the research that may affect their willingness to participate; their questions should be answered; and they should be free to choose to participate or not, and to discontinue participation at any time.
Interaction Communication or interpersonal contact between investigator and subject.
Internal Validity In experimental research designs, truthfulness that is ensured by careful control over the conditions of the study.
Intervention Procedures by which data are gathered through manipulations of the subject or environment that are performed for research purposes.
Legal Consent Consent to participate in research given by a person 18 or over and who is legally able to act on his or her own behalf.
Limited Data Set Data that has been de-identified, by removing all information that may be unique to an individual within the subject population (e.g. address, JD numbers, some combination of age+sex+race). Limited Data Sets are not considered PHI.
Minimal Risk Risks of harm anticipated in the project are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Online Research Research conducted with the aid of the Internet wherein data are collected or aggregated by, pass through, or are stored on a server (or servers) not owned by Ithaca College, the Principal Investigator, or a member of the research team. For research purposes, the campus' Novell Network is considered remote storage for computers with a permanent network connection, and thus, information transferred from one point on the network to another point on the network is not considered "online research." See also 'Computer Mediated Research'.
Personally Identifiable Information Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and the information provided for a specific purpose considered to be private. Individuals must be individually identifiable by the investigator to constitute their consideration as subjects falling under these Guidelines.
Principal Investigator For purposes of the research project, the person who will serve as the main investigator contact for subjects and for the Review Board, and who will be responsible for the storage of records related to the research.
Privacy Control over the extent, timing, and circumstances of one's participation in research. In general, this means knowing who might have access to identifiable research results in addition to the researcber(s).
Protected Health Information (PHI) Individually identifiable health information held and maintained by a Health Covered Entity (according to HIPAA, a covered entity is a health care provider or insurer or business associates acting on their behalf). Health information collected (from physical or electronic files or directly from subjects) by researchers in the course of their research does not qualify as PHI unless the researcher is formally affiliated with a covered entity.
Protected Populations Persons who qualify as research subjects under 45CFR Part 46, Subpart B (Women, Human Fetuses, and Neonates), Subpart C (Prisoners), and Subpart D (Children). While research may still proceed using these persons as subjects, special rules for their protection apply.
Protocol A defined set of procedures through which data are gathered. A complete protocol includes information about everything from sampling and recruitment to debriefing and follow-up in addition to specifying the data collection process.
Research Gathering of data by systematic means with the intent of making scientific claims (broadly conceived) about phenomena or in the interest of developing generalizable knowledge. Research is herein defined operationally beginning on p.7 of these guidelines.
Risk The probability or magnitude of harm. Potential harms can be physical, psychological, social, legal, or economic in nature.
Stipulations Essential conditions or requirements that must be met in order to receive approval from Human Subjects Research committee to implement the project.
Validity Generally, the “truthfulness” of the research.
