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 obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.
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: A process by which a subject voluntarily confirms their willingness to participate. 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, on-line 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).
Privacy: Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
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.
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.
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 2) each subject will be asked whether they want documentation linking themselves with the research, and their wishes govern the final decision.