IRB Policies, Guidelines and Guidances
Special Guideline for Investigators from the UF Office of Research:
Conducting Approved Human Subject Research during the COVID-19 Pandemic
IRB Policies
HRP-004 Implementation of the 2018 Common Rule
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
Adverse Event (AE/SAE) Reporting
Advertising for Research Subjects
Alachua County School System Research
Animal Research – Use of Animals as Part of a Human Subjects Research Study
B
C
Ceding Review to an External IRB
Certificates of Confidentiality
Changes to IRB Approved Research Protocols
Classroom Activities as Research
Clinical Trials – GCP Obligations (HRP-816)
Closed or Closed to Accrual Studies
Community Based Participatory Research
Concerns or Complaints about Research
Consent2Share Study Subject Recruitment
Consenting Subjects Who Cannot Speak or Read English
Consenting Subjects Who Are Deaf
Consenting Subjects Who Are Illiterate
COVID-19: Investigator Guideline: Re-opening Research due to the COVID-19 Pandemic
COVID-19: Investigator Guideline: IRB COVID-19-Related Protocol Revisions
D
Department of Defense Obligations (HRP-810)
Department of Education Obligations (HRP-813)
Department of Justice Obligations (HRP-812)
E
Electronic Informed Consent (eConsent)
Environmental Protection Agency Obligations (HRP-814)
Exception from Informed Consent (EFIC) for Emergency Research
Expanded Access of a Test Article
F
FDA and DHHS Regulations – Significant Differences
FDA Test Articles and Research
G
Good Clinical Practice (GCP) Training
Group Consent vs Group Recruitment
H
HIV Testing for Research Puposes
I
Informed Consent for Minors in Research Studies
Informed Consent Form – Which Template Should I Use?
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)
Media Organizations and Researcher Involvement
MRI Standard Language for Consent Forms
N
O
P
Paying Subjects to Participate in Research
Pregnancy Test in Minors (for Research Purposes Only)
Probiotics and Clinical Research
Q
Qualifications for Principal Investigator
R
Research Involving Foreign Nationals
Research Involving Foster Children
Research involving Supplements or Probiotics
Research Involving Student Athletes
Research Team Responsibilities
Research Using FDA Test Articles
S
Scientific Review and Monitoring Committee (SRMC)
sIRB – Using UF as a Single IRB
Social Security Numbers and Research
Social Security Numbers and the VAMC
Suicide Assessment for Research or Subject Screening
T
Telephone Script for Recruiting Subjects
Training Requirements for Conducting Research
U
Unwed Pregnant Minors and Unwed Minor Mothers
Using UF as a Single IRB for Multi-Institutional Research
V
VAMC Real SSN Access Request Process
Venipuncture – Use of Non-Clinical Space for Research Involving Blood Drawing
W
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 Department of Education – Additional Criteria for Approval
HRP-408 Environmental Protection Agency – 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