Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Allegation of Non-Compliance: An unproved assertion of Non-Compliance.
Community Based Participatory Research (CBPR): CBPR includes community members in all aspects of research including the conception, design, analysis and dissemination of the research. This approach to research engages community partners in collaboration with researchers to solve problems relevant to human health in communities.
Continuing Non-Compliance: A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance.
Expiration Date: The first date that the protocol is no longer approved. The date after the end date of the approval period.
Designated Reviewer: The IRB chair or someone designated by the IRB chair to conduct Non-Committee Review.
Finding of Non-Compliance: Non-Compliance in fact.
Human Research: Any activity that either*:
Is Research as Defined by DHHS and involves Human Subjects as Defined by DHHS; or
Is Research as Defined by FDA and involves Human Subjects as Defined by FDA.
Human Subject as Defined by DHHS: The federal regulations define a human subject as “a living individual about whom an investigator (whether professional or student) conducting research (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates indentifiable private information or identifiable biospeciments” (45 CFR 46.102(e)(1)(2))
- “Living individual” refers to data (information or biospecimens) collected from living subjects. For example, research using data from the 1880 Census would not be human subjects research.
- “About whom” refers to the fact that the information collected must be personal information about an individual. For example, a survey that collects data about the activities of an organization, rather than its members, is not human subjects research.
- “Intervention” includes physical procedures and manipulations of the subject or the subject's environment for research purposes. For example, taking a saliva or blood sample from a subject or having a subject view a video would be considered a research intervention.
- “Interaction” refers to communication between the researcher and the subject. For example, research that includes face‐to face, mail, internet and phone interactions (e.g. surveys), as well as other modes of communication would be considered an interaction.
- “Identifiable private information or biospecimen” means the identity of the subject is or may be readily ascertained by the researcher or others or associated with the information. For example, research with a de‐identified data set is not research with human subjects because the data are not individually identifiable.
- “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable in order to be considered information to constitute research involving human subjects. Examples of private information include medical or academic records or personal journals.
Human Subject as Defined by FDA: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.
Immediate Family: Spouse, domestic partner; and dependent children.
Information Sheet: An information sheet is typically used for studies that have been determined to be exempt and contain four basic elements: 1) that the activity is research, 2) that the individual’s participation is voluntary, 3) a brief description of the procedures, and 4) the contact information of the Principal Investigator. An information sheet may also be used when the requirement for consent has been waived.
Institutional Official: Vice Provost for Research (VPR) is designated as the Institutional Official (IO) for CUHS.
Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the participant's participation in the research procedure(s).
Long Form Consent Form: The long form consent form is the standard informed consent form template that includes all federal elements of consent as well as state and institutional requirements.
Non-Committee Review: Any of the following:
Determination of whether an activity is Human Research
Determination of whether Human Research is exempt from regulation.
Reviews of non-exempt research using the expedited procedure.
Determination of which subjects can continue in expired research.
Non-Compliance: Failure to follow the regulations, or the requirements or determinations of the IRB.
Related to the Research: A financial interest is Related to the Research when the interest is in (1) the sponsor of the research; (2) a competitor of the sponsor of the research; (3) the product or service being tested; or (4) a competitor of the product or service being tested.
Research as Defined by DHHS: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Research as Defined by FDA: Any experiment that involves a test article and one or more human subjects, and that meets any one of the following:
Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
Restricted: Applies to investigators or research staff members who are delinquent in meeting IRB requirements.
Serious Adverse Event: Any Adverse Event that (1) results in death; (2) is life-threatening (places the subject at immediate risk of death from the event as it occurred); (3) results in inpatient hospitalization or prolongation of existing hospitalization; (4) results in a persistent or significant disability/incapacity; (5) results in a congenital anomaly/birth defect; or (6) based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Serious Non-Compliance: Non-Compliance that affects the rights or welfare of participants.
Short Form Consent Form: Short form consent is an alternative to using a translated consent form and is used when you encounter a potential participant that does not speak English and there is not enough time to translate the English version of the approved consent document into a language the potential participant understands. It should not be considered a replacement for studies that expect to enroll individuals that do not speak English. The short form consent is a document, translated into the subject's native language, that contains a description of the required elements of informed consent and notes that these elements, as they pertain to the study, will be presented orally to the subject or legally authorized representative. Please contact the HUA IRB office for more information.
Suspension of IRB Approval: An action of the IRB, IRB designee, or Organizational Official to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. Suspended studies remain open and are subject to continuing review.
Termination of IRB Approval: An action of the IRB or Organizational Official to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review.
Unanticipated Problem Involving Risk to Participants or Others: Any information that is (1) unanticipated; (2) related or possibly related to participation in the research; and (3) indicates that participants or others are at increased risk of harm.
AAHRPP Evaluation Instrument for Accreditation: I.3.C, I.3.I, I.3.J, I.4.A, I.4.B, I.5.C, II.2.A, II.2.B, II.4.D
45 CFR §46
21 CFR §50.3, 21 CFR §56.102, 21 CFR §312.3, 21 CFR §812.2(a). 21 CFR 812.3(p)