Data and/ or subjects are considered anonymous when no identifying information is collected from the subject and when no one, not even the researcher(s), can link direct or indirect identifying data to the individual who provided it (e.g., a subject from a minority ethnic group might be identifiable based on the research sample or analyzing a combination of all data may link a subject to the data). "Anonymity" and "confidentiality" do not have the same meaning and are not interchangeable. Also see de-identified.
Data that has been stripped of all direct identifiers, but links each data piece by some randomly assigned code, which is linked to identifiable information (e.g., name, student id). The linking file must be separate from the coded data set and may be held by someone on the research team or someone not directly collecting and analyzing the data (e.g., Institutional Research). The code itself may not contain identifiers (e.g., subject initials). Coded data is not considered anonymous or de-identified.
A threat of harm intentionally presented by one or more persons to another in order to obtain compliance.
Data and/ or subjects are considered confidential when a link between the data and the individual who provided it is known and the research team knows of particular individuals who have participated in the research. There is an expectation that information provided to the researchers will not be disclosed in a manner inconsistent with disclosure procedures or to others outside the research team, except as clearly noted in the consent document. "Confidentiality" and "anonymity" do not have the same meaning and are not interchangeable.
An individual with expertise or knowledge concerning a specific topic who is asked to assist an IRB in the review of issues that require expertise beyond or in addition to that available on the IRB. For example, an IRB may seek the expertise of an outside consultant regarding a study’s methodology, population, locale, or risks.
The re-review of an approved research protocol. Re-review of approved research protocols are required to occur no less than once per year. Depending on the nature of the approved research, the IRB may require continuing review to occur at a frequency more often than once per year. Research protocols determined by the IRB to meet an exempt category are not required to apply for continuing review, unless the level of review should change.
Is an opportunity to provide subjects with a full explanation about any elements of the research that were either falsely or incompletely disclosed in accordance with the true hypothesis, purpose, or procedures of the research. Debriefing often occurs at the end of one’s participation or at the completion of the study.
A document that is used by researchers to orally explain the study to subjects to ensure required elements of debriefing are adequately addressed.
A document that is given to subjects to keep after an oral debriefing occurs between the researcher and subject or is otherwise made available to subjects after the research (e.g., debriefing is sent via email to those who have participated).
Deception (also see Incomplete Disclosure)
When subjects are deliberately given false information about some aspect of the research.
Data that has been stripped of all subject identifiers, including data which when combined with other information could readily identify an individual. Once all identifiers have been stripped and destroyed, such data may then be considered anonymous. NOTE: Data can be de-identified under the common rule, but not the HIPPA Privacy Rule (Identifiability and the Common Rule: Guidance)
Often used to denote a therapy (procedure, device, drug) that is unproven or not yet scientifically validated with respect to safety and efficacy.
The characteristics or conditions disqualifying one from the target subject population (i.e., the factors or reasons that make an individual ineligible to participate).
The faculty advisor is responsible for the oversight of a student's research project and is considered, by the IRB, a member of the investigative team. The faculty advisor is required to complete the required human subjects training.
Human Subject (45 CFR 46.102(f))
A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
Identifiable Data/ Information
Data or information that either identifies a specific individual or that when combined with other information can be used to readily identify an individual.
The defining characteristics or conditions of the target subject population (i.e., the factors or reasons that make an individual eligible to participate).
Incomplete Disclosure (also see Deception)
When subjects are not given information about the real purpose or nature of the research.
Interaction (45 CFR 46.102(f))
An interaction may include communication or interpersonal contact between investigator and subject.
Intervention (45 CFR 46.102(f))
An intervention may include both physical procedures by which data are gathered and manipulations of the subject's environment that are performed for research purposes.
IRB approval (45 CFR 46.102(h))
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
Key Research Personnel
Any investigator who will be interacting or intervening with human subjects or who will be working with (including analysis) identifiable human subject data. All key research personnel are required to complete the required human subjects training.
Minimal Risk (45 CFR 46.102(i))
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.
Principal Investigator (PI)
The investigator with primary responsibility for the design and conduct of the research protocol. The PI also serves as the primary point of accountability for the IRB and is required to complete the required human subjects training.
Private Information (45 CFR 46.102(f))
Includes 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 reasonable expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Research (45 CFR 45.102(d))
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
- Systematic Investigation
An activity that involves a prospective research plan, which incorporates data collection, either quantitative or qualitative, and data analysis (or detailed data evaluation) to answer a research question.
- Generalizable Knowledge
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 samples outside of the specific study sample) or generalize findings.
An attempt to obtain compliance through an offer of excessive, unwarranted, inappropriate, or improper reward; or other overture especially in cases where the subject is vulnerable.