Terms and Definitions

Adverse event (AE): Any undesirable and unintended (although not necessarily unexpected) event experienced by a subject occurring as a result of interventions, interactions, or collection of identifiable private information in research. An adverse event can be internal or external as it relates to the location of the site.

Alteration of Informed Consent: An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent. For example, a study involving deception may not be able to fully state the true purpose (a required element) of the study in the consent. Therefore, the IRB must approve an alteration of the consent requirement.

Anonymous: Data is considered “anonymous” if it cannot be connected to the individual who provided it. This includes the researcher as well. Even in situations where direct identifiers such as name, address or student identification numbers are not collected, the cumulative collection of other individual characteristics (indirect identifiers) might make it possible to identify an individual from a pool of subjects. Examples: participant who is a member of a minority ethnic group might be identifiable from even a large data pool; open ended questions from a small group of participants.

Archival Data: Data collected prior to the time of application to the IRB. These data may have been collected for either research or non-research purposes.

Assent: A child’s affirmative agreement to participate in research. In order for children to participate in research, assent for children ages 7-17 is required. Parental permission must also be sought. Assent and parental consent may be waived or altered depending upon the criteria presented to the IRB.

Coded Data: Coded data means that: 1) identifying information (direct identifiers such as the name, student ID# or medical record #) has been replaced with a number, letter, symbol, or combination of coding mechanisms; and 2) a key to decipher the code exists, enabling linkage of the identifying information to the data.

Confidentiality: Confidentiality relates to how the research data is protected. Collecting the minimum necessary identifiable information is advised. Proper practices should be applied to collecting, maintaining, storing, and destroying identifiable information is collected: substituting codes for identifiers, removing identifiable information.

Deception: Deception involves an incomplete disclosure of the research purpose or the various elements of the research. When appropriate, once the research subject has completed their participation, they should be debriefed about the information that was not fully disclosed to them previously. In some instances the debriefing may cause more harm and might not be appropriate.

Existing Data: See Archival Data

Human Subject: a living individual about whom an investigator (whether professional or student) conducting research:

1. (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
   (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Interaction: Communication or interpersonal contact between investigator and subject.

Intervention: Procedure during the experiment in which a treatment or manipulation of the environment occurs to elicit a change in behavior or physiological functioning.

Identifiable Private Information: Private information or specimens are individually identifiable when they can be linked to the individual research participant by investigator(s) or others either directly or indirectly through coding mechanisms. Obtaining identifiable private information or specimens for research purposes falls under the definition of human subjects research.

Informed Consent: is typically a written document, whereby after a verbal discussion of the document with an opportunity for the subject to ask questions, the subject then signs it. At times it may be appropriate for an altered consent process to occur, such as a verbal process, online process, or obtaining a waiver of the requirement to obtain a written signature.

Minimal Risk: The probability (likelihood) and magnitude (degree or level) 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.

Non-compliance: Non-compliance is any departure from the IRB approved protocol procedures, forms, and other attachments and/or any failure to follow any applicable human research protection regulations and policies (including but not limited to HHS, FDA, and Marquette IRB).

Parent/Guardian Permission: The agreement of the parent(s) or guardian for their child or ward to participate in research. This is required for children under the age of 18 to be eligible to participate in research (unless a waiver is granted).n research protection regulations and policies (including but not limited to HHS, FDA, and Marquette IRB).

Privacy: Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Protocol deviation: Any deviations, whether intentional or unintentional, from the IRB-approved protocol that are implemented without prior to IRB approval. Examples include, but are not limited to accidental over-recruitment for a minimal risk study; a change implemented without prior Marquette IRB approval to eliminate apparent immediate hazards to research subjects; and posting of a recruitment flyer without prior Marquette IRB approval.

Publicly Available: Refers to public sources of data, such as new papers, data bases, libraries, and the internet. Data obtained from data banks, archives, or organizations that make data sets broadly accessible at a reasonable cost to the research community are also considered publicly available.

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Risk: The probability that harm (including physical, psychological, social, legal, or economic) will occur as a result of participating in a research study.

Serious adverse event (SAE): Adverse events classified as serious include those resulting in death, life-threatening injury, hospitalization or prolongation of hospitalization, persistent or significant disability, or a congenital anomaly or birth defect.  Events not meeting the above criteria but requiring intervention to prevent one of these outcomes are also considered serious adverse events.

Unanticipated adverse event (UAE): An adverse event that is not consistent in nature, frequency, or severity with the current IRB protocol, investigator's brochure, device manual/instructions for use, consent form, or other available information.

Unanticipated problems involving risks to subjects or others: Unanticipated problems involving risks to subjects or others are defined as any incident, experience, or outcome that meets all of the following criteria:
(1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

(2) related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and

(3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, health, economic, or social harm) than was previously known or recognized.

Waiver of Informed Consent/Alteration of Informed Consent: An IRB may waive or alter some or all elements of consent, if the research meets the following requirements: 1) the research involves minimal risk to the participants; 2) the waiver will not adversely affect the rights or welfare of the participants; 3) the research could not practicably be carried out without the waiver; 4) When appropriate, the participants will be provided with additional pertinent information after participation; 5)if using identifiable private information or identifiable biospecimens, the research could not practicably be carried out using deidentified information or biospecimens.

Waiver of Documentation of Informed Consent: An IRB may waive the requirement for obtaining a signed consent document if: 1) The only record linking the participant and the research is the consent document and the principle risk of the research would be potential harm resulting from a breach of confidentiality, and each subject will be asked whether they want documentation linking themselves with the research, and their wishes govern the final decision; or 2) The research involves no more than minimal risk and involves no procedures for which consent is required outdie of the research context; or 3)The subjects are members of a distinct community or cultural group in which signing forms is not the norm, the research is minimal risk and there is an alternative mechanism of documenting that informed consent was obtained.