University of Georgia
Institutional Review Board (IRB)
Human Subjects Office (HSO)
Guidelines for Researchers

(Click here for a Print friendly version)

Introduction and Policy

• I. Categories of Research Requiring Approval
• II. Materials Required for Submission to the IRB
• III. Time Considerations for Review
• IV. Criteria for IRB Approval of Research
• V. Responsibilities of Researchers
  • Reporting Adverse Events
• VI. IRB Disapproval and Appeals Process
• VII. Research Involving Minors
• VIII. Informed Consent - General Requirements
  • Required Format for Consent Forms
    • (Click HERE for a separate printout of these consent form guidelines)
  • Consent Checklist
    • (Click HERE for a separate printout of the checklist)
  • Sample Consent Forms
    • Sample Consent Form
    • Sample Parental Permission Form
    • Minor Assent Form
    • Child Assent Script
    • Sample Class Project Consent Form
    • Informational Letter
• IX. Continuing Review
• X. IRB Records
• XI. Violations of IRB Policy
• XII. Class Projects Exemption
• XIII. Internet Research

INTRODUCTION

The University policy on activities involving human subjects is to fully comply with regulations of the Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA), and to implement the principles outlined in the Belmont Report.

The University of Georgia has a signed compliance agreement with the Office for Human Research Protections (OHRP), a subdivision of the Department of Health and Human Services. The assurance document provides written assurance that all federally-funded research conducted at this institution which involves human subjects will be in compliance with the Code of Federal Regulations (CFR) Title 45, Part 46. These regulations have been adopted by UGA to cover all research activities involving human subjects. The institution also abides by the regulations of the U.S. Food and Drug Administration Code of Federal Regulations, Title 21, Part 50 and Part 56.

At the University of Georgia (UGA), all human subjects research activities come under the purview and oversight of the Human Subjects Office and the Institutional Review Board, irrespective of whether the research is funded or non-funded, minimal risk or more. The human subjects policies apply to all UGA affiliated faculty, staff, and students conducting human subjects research on or off-campus (domestic or international sites) as well as visitors conducting research at UGA.

The IRB is charged with the responsibility of protecting the rights and welfare of human subjects involved in research. The composition of the IRB and the number of members on the committee are in accordance with federal regulations. IRB members are appointed by the Vice-President for Research on the recommendation of the Chairperson of the IRB. Members are appointed for renewable, three-year terms and include faculty with expertise in the various disciplines engaged in human subjects research on campus as well as community members. All members, whether regular or alternate, have full voting rights. There is no remuneration for individuals serving as IRB members. No IRB members participate in the review of any study on which they are a Principal researcher or Co-researcher.

The Chairperson of the IRB conducts an orientation for new members which includes review of relevant materials provided (Belmont Report, Federal Regulations, University Policy, IRB Guidelines), and details concerning committee function and procedures. Each new member attends at least one IRB meeting for the purpose of observation, before participating in the actual review of studies.

The IRB may, at its discretion, invite individuals with competence in special areas (consultants) to assist in the review of complex issues that require expertise beyond, or in addition to that available on the committee. The consultant does not take part in voting. Similarly, researchers may request, or be invited, to attend IRB meetings to clarify issues concerning their proposed research activity. These researchers do not take part in committee deliberations or voting.

The IRB reports to the Vice-President for Research. The Administrator of the Human Subjects Office serves as the liaison between the researchers and IRB.

The Human Subjects Office provides administrative and secretarial support for the IRB, and assists researchers through the application and approval process. The Administrator acts on behalf of the IRB and the University when providing assurance of human subjects approval to sponsoring agencies, or when dealing with regulatory agencies. The Human Subjects Office staff is responsible for regularly monitoring IRB compliance, and updating IRB procedures with current and/or new relevant federal or state regulations.

Correspondence (including application materials) to the IRB should be directed to:

Human Subjects Office
Office of the Vice-President for Research
612 Boyd Graduate Studies Research Center
The University of Georgia
Athens, Georgia 30602-7411
Telephone: (706) 542-3199
Fax: (706) 542-3360
e-mail: IRB@uga.edu

Go Back to Human Subjects Main Page