IRB Policies, Guidelines and Guidances

IRB Policies

Investigator Guidelines


Adults Lacking Capacity to Consent

Adverse Event (AE/SAE) Reporting

Advertising for Research Subjects

Alachua County School System Research

Ancillary Committees

Animal Research – Use of Animals as Part of a Human Subjects Research Study

Assent of Children

Auditing Research Studies




Case Reports

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

Compounding Pharmacy

Concerns or Complaints about Research

Consent2Share Study Subject Recruitment

Consenting Subjects Who Cannot Speak or Read English

Continuing Review


Decedent Research

Department of Defense Obligations (HRP-810)

Department of Education Obligations (HRP-813)

Department of Justice Obligations (HRP-812)

Deviation Reporting


Electronic Informed Consent (eConsent)

Emergent Use

Enrolling Study Subjects

Environmental Protection Agency Obligations (HRP-814)

Event Reporting

Exempt Submissions

Expanded Access of a Test Article

Expedited Submissions

Expired Study


FDA and DHHS Regulations – Significant Differences

FDA Obligations (HRP-815)

FDA Test Articles and Research

Finders Fees

Foster Children and Research


Good Clinical Practice (GCP) Training

Group Consent vs Group Recruitment



HIPAA and Research

Humanitarian Device



Incidental Findings

Informed Consent for Minors in Research Studies

Informed Consents

Informed Consent Form – Which Template Should I Use?

International Organization for Standardization (ISO) (HRP-817)

Investigational Medication

Investigator Obligations (HRP-800)

Investigators Brochure


Legally Authorized Representative (LAR)


Mechanical Turk (use of Amazon MTurk for Social/Behavioral Research)

MRI Standard Language for Consent Forms


Non-Human Research


Over Enrolling Study Subjects


Paying Subjects to Participate in Research

PI Qualifications

Pregnancy Test in Minors (for Research Purposes Only)


Qualifications for Principal Investigator

Quality vs. Research


Recruiting Subjects

Research Involving Foreign Nationals

Research Involving Foster Children

Research Involving Student Athletes

Research Team Responsibilities

Research Using FDA Test Articles



Scientific Review and Monitoring Committee (SRMC)

Social Security Numbers and Research

State Laws and Research

Student Athletes and Research

Student Research


Telephone Script for Recruiting Subjects

Telephonic Consent

Training Requirements for Conducting Research


Unanticipated Problems

Unwed Pregnant Minors and Unwed Minor Mothers


Venipuncture – Use of Non-Clinical Space for Research Involving Blood Drawing


Wards of the State


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-305 Pregnant Women

HRP-306 Neonates of Uncertain Viability

HRP-307 Nonviable Neonates

HRP-308 Prisoners

HRP-309 Unexpected Incarceration

HRP-310 Children

HRP-311 Wards (Foster Children)

HRP-313 Non-significant Risk Device

HRP-400 Criteria for Approval

HRP-401 Scientific and Scholarly Review

HRP-402 Advertisements

HRP-403 Payments

HRP-404 Short Form

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-409 Department of Energy – Additional Criteria for Approval

HRP-410 International Research – Additional Criteria

HRP-411 Reportable Events

HRP-412 Financial Interest Management

HRP-413 Closure Criteria

HRP-414 Decisionally Impaired Adults

HRP-421 Human Research

HRP-422 Engagement

HRP-423 Exemptions

HRP-424 Expedited Review

HRP-425 Drugs

HRP-426 Devices

HRP-427 HIPAA Authorization

HRP-428 HIPAA Waiver of Authorization

HRP-430 IRB Composition

HRP-431 Quorum

HRP-432 Contracts

HRP-450 Criteria for Approval HUD

HRP-451 Emergency Use Drugs and Biologics

HRP-452 Emergency Use Devices

HRP-453 Compassionate Use Devices

HRP-470 External IRB Screening


HRP-481 Protection of Pupil Rights Amendment (PPRA)

For additional policies related to the University of Florida Human Research Protection Program, please see