HRPP Policy - Policy Definitions

About This Policy Page

Effective date:
07/01/2020
Last updated:
01/19/2021
Policy Contact:

IU Human Research Protection Program (HRPP)
(317) 274-8289
irb@iu.edu

1.0 - Abbreviations

CFR: Code of Federal Regulations

DOD: U.S. Department of Defense

DOJ: U.S. Department of Justice

ED: U.S. Department of Education

FDA: U.S. Food and Drug Administration

IU HRPP: IU Human Research Protection Program

HHS: U.S. Department of Health & Human Services

IU: Indiana University

OHRP: DHHS Office of Human Research Protections

ORC: IU Office of Research Compliance

QIO: IU Quality Improvement Office

Roudebush VAMC: Richard L. Roudebush VA Medical Center, Indianapolis, IN

VA: U.S. Department of Veterans Affairs

VHA: U.S. Veterans Health Administration

VHA ORD: VHA Office of Research and Development

VA ORO: Office of Research Oversight

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2.0 - Glossary of Terms

2018 requirements, administrative hold, adult, adult individuals lacking consent capacity, adverse events, 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

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