HRPP Policy - Policy Definitions

2018 requirements, administrative hold, adult, adult individuals lacking consent capacity, adverse events, applicable clinical trial (ACT), assent, audit, for-cause (directed) audit, internal audit, not-for-cause (scheduled) audit, audit trail, authorization, biological product or biologic, biospecimen, children, clinical trial, co-PI, collaborative research, confidentiality, continuing noncompliance, corrective action, covered entity, data use agreement, de-identified, department or agency head, device, directory information, drug, emancipated minor, enrollment, exempt from IDE requirements, experimental subject, federally-funded, federalwide assurance, fetus, generalizable knowledge, greater than minimal risk, HIPAA, human subject, humanitarian device exemption (HDE), humanitarian use device, identifiable biospecimen, identifiable private information, identifiable sensitive information, identifier, in loco parentis, informed consent, institutional review board (IRB), interaction, intervention, investigational biologic/drug/device/test article, investigational device exemption, investigational new drug application, investigator, IRB-approved protocol, IU-affiliated research personnel, key personnel, legally authorized representative (LAR), life-threatening, limited data set, major protocol deviation, minimum necessary, minimal risk, minor noncompliance, neonate, non-affiliated research personnel, other research staff, noncompliance, noninvasive, nonscientist, nonsignificant risk, parent, personally identifiable information (PII), pregnancy, preventive action, principal investigator, prisoner, privacy, privacy board, privacy rule, private information, protected health information, protocol deviation, psychotherapy notes, recruitment, regulatory agencies, related or possibly related, reliance, relying institution, reportable event, representative, research, research involving a human being as an experimental subject, research personnel, reviewing IRB, Secretary, serious adverse event (SAE), serious noncompliance, serious problem, significant financial interest, significant risk (SR) device, site-specific PI, source documents, sponsor, sponsor-investigator, student education records, suspension, systematic investigation, termination, test article, transnational research, unanticipated adverse device effect, unanticipated problem involving risks to subjects or others (UPIRTSO), unexpected adverse event (UAE), viable, ward, written/in writing