IRB Policies, Guidelines and Guidances

IRB Policies

Investigator Guidelines

A

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

B

Banks

C

Case Reports

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)

ClinicalTrials.gov

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

D

Decedent Research

Deception in Research

Department of Defense Obligations (HRP-810)

Department of Education Obligations (HRP-813)

Department of Justice Obligations (HRP-812)

Deviation Reporting

E

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

F

FDA and DHHS Regulations – Significant Differences

FDA Obligations (HRP-815)

FDA Test Articles and Research

Finders Fees

Foster Children and Research

G

Good Clinical Practice (GCP) Training

Group Consent vs Group Recruitment

GWAS

H

HIPAA and Research

Humanitarian Device

I

IAPS

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

L

Legally Authorized Representative (LAR)

M

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

MRI Standard Language for Consent Forms

N

Non-Human Research

O

Over Enrolling Study Subjects

P

Paying Subjects to Participate in Research

PI Qualifications

Pregnancy Test in Minors (for Research Purposes Only)

Q

Qualifications for Principal Investigator

Quality vs. Research

R

Recruiting Subjects

Research Involving Deception

Research Involving Foreign Nationals

Research Involving Foster Children

Research Involving Student Athletes

Research Team Responsibilities

Research Using FDA Test Articles

Revisions

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

State Laws and Research

Status Report

Student Athletes and Research

Student Research

Suicide Assessment for Research or Subject Screening

T

Telephone Script for Recruiting Subjects

Telephonic Consent

Training Requirements for Conducting Research

U

UAA Research

Unanticipated Problems

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

Wards of the State

 

Regulatory Guidances

Sorry for the inconvenience, this section is currently under construction.  Check back later for updated Guidances.

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