IRB Policies, Guidelines and Guidances
IRB Policies
HRP-020 IRB Member Review Expectations
HRP-021 Legally Authorized Representatives
HRP-022 Expiration Date of IRB Approvals
HRP-080 IRB Member Review Expectations – HUD
HRP-103 Non-Full Board Review Preparation
HRP-104 Non-Full Board Review Conduct
HRP-105 Full Board Review Preparation
HRP-106 Full Board Review Conduct
HRP-107 Full Board Review Monitoring
HRP-109 Not Otherwise Approvable Research
HRP-111 Post Review Procedures
HRP-113 Unexpected Incarceration
HRP-115 Subject Complaints and Allegation of Non-compliance
HRP-132 IRB Member Addition and Removal
HRP-134 Designated Exempt Reviewers
HRP-135 Designated Exempt Review Conduct
HRP-142 Quality Improvement Evaluations
HRP-170 External IRB Screening
HRP-180 Emergency and Compassionate Uses
HRP-193 IRB-01 as the NF/SG VA Medical Center Affiliate IRB
Investigator Guidelines
A
Adults Lacking Capacity to Consent
Advertising for Research Subjects
Alachua County School System Research
Animal Research – Use of Animals as Part of a Human Subjects Research Study
B
C
Certificates of Confidentiality
Changes to IRB Approved Research Protocols
Clinical Trials – GCP Obligations (HRP-816)
Closed or Closed to Accrual Studies
Concerns or Complaints about Research
Consent2Share Study Subject Recruitment
Consenting Subjects Who Cannot Speak or Read English
D
Department of Defense Obligations (HRP-810)
Department of Education Obligations (HRP-813)
Department of Justice Obligations (HRP-812)
E
Environmental Protection Agency Obligations (HRP-814)
Expanded Access of a Test Article
F
FDA and DHHS Regulations – Significant Differences
G
Good Clinical Practice Training
H
I
Informed Consent for Minors in Research Studies
International Organization for Standardization (ISO) (HRP-817)
Investigator Obligations (HRP-800)
L
Legally Authorized Representative (LAR)
M
Mechanical Turk (use of Amazon MTurk for Social/Behavioral Research)
MRI Standard Language for Consent Forms
P
Paying Subjects to Participate in Research
Pregnancy Test in Minors (for Research Purposes Only)
Q
Qualifications for Principal Investigator
R
Research Involving Foster Children
Research Involving Student Athletes
Research Using FDA Test Articles
S
Social Security Numbers and Research
T
Telephone Script for Recruiting Subjects
Training Requirements for Conducting Research
U
Unanticipated Events Reporting
Unwed Pregnant Minors and Unwed Minor Mothers
V
Venipuncture – Use of Non-Clinical Space for Research Involving Blood Drawing
Regulatory Guidances
HRP-300 Waiver of Consent – DHHS
HRP-301 Waiver of Consent – Emergency Research
HRP-302 Waiver of Consent – Leftover Specimens
HRP-303 Waiver of Documentation of Consent
HRP-306 Neonates of Uncertain Viability
HRP-309 Unexpected Incarceration
HRP-311 Wards (Foster Children)
HRP-313 Non-significant Risk Device
HRP-401 Scientific and Scholarly Review
HRP-405 Department of Defense – Additional Criteria for Approval
HRP-406 Department of Justice – Additional Criteria for Approval
HRP-407 Education Research – Additional Criteria for Approval
HRP-408 Environmental Protection Agency – Additional Criteria for Approval
HRP-409 Department of Education – Additional Criteria for Approval
HRP-410 International Research – Additional Criteria
HRP-412 Financial Interest Management
HRP-414 Decisionally Impaired Adults
HRP-428 HIPAA Waiver of Authorization
HRP-450 Criteria for Approval HUD
HRP-451 Emergency Use Drugs and Biologics
HRP-453 Compassionate Use Devices
For additional policies related to the University of Florida Human Research Protection Program, please see http://research.ufl.edu/hrpp.html