any untoward or unfavorable 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 research. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
A systematic and independent examination of study-related activities and documents to determine whether the evaluated study-related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to approved IRB protocol and applicable federal regulations, state laws, and institutional policies. Includes audits, monitoring visits, and compliance inspections. See also:
- for-cause (directed) audit
- internal audit
- not-for-cause (scheduled) audit
A pattern in which either the same instance (or a similar instance) of noncompliance occurs over time and/or noncompliance which continues after it is discovered or after an IRB approved corrective action plan is implemented. Continuing noncompliance can also occur when an investigator fails to implement a corrective action plan that has been approved by the IRB. See also:
- noncompliance
- serious noncompliance
Action taken to correct an occurrence or occurrences of noncompliance.
(see also audit, internal audit, not-for-cause (scheduled) audit) Internal audit requested by an IRB, IRB chair, the Director of the HRPP, or Institutional Official related to reported or suspected noncompliance.
A human subject as defined by the Common Rule is a living individual about whom an investigator conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzed the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)]
Appropriately constituted group formally designated to provide review and oversight of research involving human subjects to assure the protection of the rights and welfare of the subjects.
(see also audit, for-cause (directed) audit, not-for-cause (scheduled) audit) Audit conducted by the QA/QI program.
Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with IRB approved protocol, federal or state regulations, institutional policies governing human subjects research or the requirements or determinations of the IRB. See also:
- continuing noncompliance
- serious noncompliance
(see audit, for-cause (directed) audit, internal audit) Internal audit which is a part of the UTK HRPP audit plan.
A process implemented to prevent occurrence of an event in the future.
(see also co-PI, investigator, UTK affiliated research personnel, key personnel, non-affiliated research personnel, other research staff, research personnel, site-specific PI) Responsible leader of a team of research personnel who has the ultimate responsibility for the conduct of the research.
Government organizations, anywhere in the world, that set standards, establish policies, advocate laws, and provide oversight of specified activities within a country, such as the United States Food and Drug Administration (FDA).
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)). The terms research, clinical research, clinical study, and clinical investigation are synonymous for purposes of FDA regulations.). The following activities are deemed not to be research under this definition:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected;
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters);
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes;
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions;
(see also co-PI, investigator, UTK-affiliated research personnel, key personnel, non-affiliated research personnel, other research staff, principal investigator, site-specific PI) Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.
Noncompliance (as determined by convened IRB) which meets any one of the following criteria:
- Significantly increases the probability and/or magnitude of risk to subjects beyond what was previously recognized for the study
- Significantly compromises the rights and welfare of subjects
- For greater than minimal risk research, compromises the research such that important conclusions can no longer be reached, or
- Results from significant disregard for policies and/or regulations intended to protect human subjects and results in actual harm to subjects.
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.