A
- AAHRPP: Association for the Accreditation of Human Research Protection Programs — Accredits the UAMS human research protection program.
- ACH: Arkansas Children’s Hospital
- ACRI: Arkansas Children’s Research Institute
- ACNC: Arkansas Children’s Nutrition Center
- AE: adverse event
C
- CTO: Clinical Trials Office at the Winthrop P. Rockefeller Cancer Institute
- CFR: Code of Federal Regulations.
- Children in Research
- CIRB: Central Institutional Review Board (National Cancer Institute)
- CITI: Collaborative Institutional Training Initiative — site for the required human subject protection training
- CLARA: Clinical Research Administration system
- ClinicalTrials.gov
- COG: Children’s Oncology Group
- COI: conflict of interest
- Common Rule — Regulations governing federally funded research
- Compliance Statement
- CR: continuing review
- Criteria for Approval
D
- DCFS: Division of Children and Family Services (Arkansas Division of Human Services) Mentioned in IRB Policy 17.1.
- Disease Oriented Committee
- DOJ: Department of Justice
- DSM: Data and Safety Monitor; data and safety monitoring
- DSMB: Data and Safety Monitoring Board
- DSMC: Data and Safety Monitoring Committee
- DSMP: Data and Safety Monitoring Plan
- DUA: data use agreement
E
- ePHI: Electronic Protected Health Information
- Exception from Informed Consent (EFIC) research Also known as “planned emergency research”
F
- FDA regulations — Govern research involving FDA-regulated products. 21 CFR 50 addresses human subject protections. 21 CFR 56 addresses IRB functions.
- FERPA: Family Educational Rights and Privacy Act
- FWA: Federalwide Assurance
G
- GOG: Gynecologic Oncology Group
H
- HDE: Humanitarian Device Exemption. See questions 7-10 in this guidance for information about the IRB’s role in HUD use.
- HIPAA: Health Insurance Portability and Accountability Act
- HITECH: Health Information Technology for Economic and Clinical Health Act
- HRPP: Human Research Protection Program
- HUD: Humanitarian Use Device. See HDE above for references.
I
- Informed Consent
- ICMJE: International Committee of Medical Journal Editors
- IDE: Investigational Device Exemption
- IND: Investigational New Drug
- IRB: Institutional Review Board
L
- LAR: legally authorized representative (in a consent form)
- LDS: limited data set
M
N
- NCT: National Clinical Trials (number) — a unique identifier given to a clinical study on ClinicalTrials.gov (National Institutes of Health)
- NDA: non-disclosure agreement
- NICE: New Investigation Consult and Education (Office of Research Compliance review of investigator-initiated studies following Institutional Review Board approval)
- Noncompliance (minor, serious, continuing)
- NSR: Non-significant Risk (pertains to an investigational device only)
O
- OHRP: Office for Human Research Protections (U.S. Department of Health and Human Services)
- ORC: Office of Research Compliance
- ORSP: Office of Research and Sponsored Programs
P
- PCRU: Pediatric Clinical Research Unit (Arkansas Children’s)
- PHI: Protected Health Information
- PI: principal investigator
- POG: Pediatric Oncology Group
- Planned Emergency Research Also known as EFIC research
- PPRU: Pediatric Pharmacology Research Unit (Arkansas Children’s)
- PRI: UAMS Psychiatric Research Institute
- PRIM&R: Public Responsibility in Medicine and Research
- Prisoners in Research
- PRMC: Protocol Review and Monitoring Committee
R
S
- Significant Risk (pertains to investigational devices only)
- SOP: Standard Operating Procedure
- SWOG: Southwest Oncology Group
T
- TRI: UAMS Translational Research Institute
U
- UPIRTSO: unanticipated problems involving risks to subjects and others