HRPP Policy - Reportable Events

About This Policy

Effective date:
Last updated:
Policy Contact:

IU Human Subjects Office
(317) 274-8289

7.0 - Definitions

adverse event Any untoward or unfavorable occurrence, including medical, physical, and psychological harms, in a human subject associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.

audit (see also for-cause (directed) audit, internal audit, and not-for-cause (scheduled) audit) 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 applicable federal regulations, state laws, and institutional policies. Includes audits, monitoring visits, and compliance inspections.

authorization Per the Privacy Rule, an individual's permission to allow a covered entity to use or disclose the individual's protected health information (PHI) described in the authorization for the purpose(s) and to the recipient(s) stated in the authorization.

confidentiality The assurance that certain information about individuals, which may include a subject's identity, health, behavior, or lifestyle information, or a sponsor's proprietary information, will not be disclosed without permission from the subject or sponsor.

continuing noncompliance (see also noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) A pattern of the same or similar instances of noncompliance, occurring in reasonably close proximity, which continues to occur after discovery of noncompliance and implementation of a preventive action plan, or results from failure to implement a preventive action plan approved by the IRB.

device (medical device) As regulated by the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the National Formulary, or the United States Pharmacopeia, or any supplement to them; 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3) intended to affect the structure or any function of the body of man or other animals, and; which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.

enrollment Enrollment begins at the time of consent for the study. For research for which consent is not required, enrollment begins at time of data collection or when the subject agrees to participate.

HIPAA The Health Insurance Portability and Accountability Act of 1996. See also Privacy Rule.

humanitarian use device (HUD) As regulated by the FDA, a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

informed consent An ongoing process by which a subject (or, his or her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.

interaction Includes communication or interpersonal contact between research personnel and the subject.

life threatening Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of the clinical trial analysis is survival. Also includes severely debilitating, meaning diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of arm, leg, hand, or foot).

major protocol deviation (see also protocol deviation) May affect subject safety and/or the integrity of study data.

minor noncompliance (see also noncompliance, continuing noncompliance, observed or apparent noncompliance, serious noncompliance) Noncompliance that is neither serious nor continuing and which does not affect the scientific soundness of the research plan or the rights, safety, or welfare of human subjects.

noncompliance (see also continuing noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, requirements of VHA Handbook 1200.05, or institutional policies governing human subjects research or the requirements or determinations of the IRB.

observed or apparent noncompliance (VA; see also noncompliance, continuing noncompliance, minor noncompliance, serious noncompliance) Noncompliance that does not require further information to confirm its occurrence.

privacy Refers to persons and their interest in controlling the access of others to themselves.

protocol deviation (see also major protocol deviation) An alteration/modification to the IRB-approved protocol that is not approved by the IRB prior to its initiation or implementation.

regulatory agencies 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).

related or possibly related There is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research.

reportable event An event which may represent noncompliance or an unanticipated problem involving risks to subjects or others. Reportable events are reported to the IRB in accordance with the IU HRPP Policy on Reportable Events.

research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation 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), §507(d), 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 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.

research personnel (See also investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), Student, Fellow, Resident PI, 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.

serious adverse event (SAE) Any adverse event that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability/incapacity, congenital anomaly, or birth defect, or that requires medical or surgical intervention to prevent such an outcome.

serious noncompliance (see also noncompliance, continuing noncompliance, minor noncompliance, observed or apparent noncompliance) Noncompliance which: 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. For VA research, also includes noncompliance which (1) presents a genuine risk of substantive harm to the safety, rights, or welfare of human research subjects, research personnel, or others, including their rights to privacy and confidentiality of identifiable private information, or (2) substantially compromises a facilities' HRPP.

serious problem (VA) For research subject to VA regulations, problem that may reasonably be regarded as (1) involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research subjects, research staff, or others; or (2) substantively compromising the effectiveness of a facility's human research protection or human research oversight programs.

suspension Temporary cessation of some or all activities in a currently approved research study.

termination Determination made by the IRB to permanently withdraw approval for some or all activities of a currently approved research study.

unanticipated adverse device effect Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

unanticipated problem involving risks to subjects or others (UPIRTSO) In general, this includes any incident, experience, or outcome that meets all of the following criteria: 1) is 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) is 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, economic, or social harm) than was previously known or recognized.

unexpected adverse event (UAE) Any adverse event occurring in one or more subjects participating in a research protocol, the nature, severity, or frequency of which is not consistent with either 1) the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved research protocol, summary safeguard statement, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; or 2) the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject's predisposing risk factor profile for the adverse event.

written/in writing Writing on a tangible medium (e.g. paper) or in an electronic format.

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