IRB Policies, Guidelines and Guidances

IRB Policies

Investigator Guidelines

A

Adults Lacking Capacity to Consent

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

B

Banks

C

Case Reports

Certificates of Confidentiality

Changes to IRB Approved Research Protocols

Clinical Trials – GCP Obligations (HRP-816)

ClinicalTrials.gov

Closed or Closed to Accrual Studies

Compounding Pharmacy

Concerns or Complaints about Research

Consent2Share Study Subject Recruitment

Consenting Subjects Who Cannot Speak or Read English

Continuing Review

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)

Event Reporting

Exempt Submissions

Expanded Access of a Test Article

Expedited Submissions

Expired Study

F

FDA and DHHS Regulations – Significant Differences

FDA Obligations (HRP-815)

Finders Fees

G

Good Clinical Practice Training

GWAS

H

HIPAA and Research

Humanitarian Device

I

IAPS

Incidental Findings

Informed Consent for Minors in Research Studies

Informed Consents

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

Investigational Medication

Investigator Obligations (HRP-800)

Investigators Brochure

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

Quality vs. Research

R

Research Involving Foster Children

Research Involving Student Athletes

Research Using FDA Test Articles

S

Social Security Numbers and Research

Student Research

T

Telephone Script for Recruiting Subjects

Telephonic Consent

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-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 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-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-480 FERPA

HRP-481 Protection of Pupil Rights Amendment (PPRA)

For additional policies related to the University of Florida Human Research Protection Program, please see http://research.ufl.edu/hrpp.html