SECTION V
RESPONSIBILITY OF RESEARCHERS

A. Once a project is approved by the IRB, the researcher must:

1. Conduct the project as approved by the IRB.

2. Promptly report any revisions or amendments to the research activity for review and approval by the IRB prior to commencement of the revised protocol. The only exception to this policy is in situations where changes in protocol are required to eliminate apparent, immediate hazards to the subject.

3. Promptly report any unanticipated problems involving risks to subjects or others to the IRB. Reportable events include any harm or injury (physical, psychological, social or economic) or other unexpected events occurring as a result of participation in a research study. Such events, unless considered serious, must be reported in writing to the IRB within 72 hours of any member of the investigative team becoming aware of the event. All events may be reported by phone (706)-542-3199 and followed in campus mail by a written explanation.

• Serious Adverse Events are defined as death due to any cause, a permanent or substantial disability, hospitalization (inpatient admission or overnight stay) or prolongation of hospitalization, an immediately life-threatening event, report of overdose, or report of congenital anomaly. Such events must be reported in writing to the IRB within 24 hours of any member of the investigative team becoming aware of the event. All events may be reported to the IRB at (706) 542-3199 or faxed (706) 542-5638 and followed in campus mail by an original written explanation. These events must also be reported to the sponsor as described in the study protocol or agreement. Serious adverse events occurring at sites other than UGA that are reported to the researcher by a sponsor [usually referred to as IND Safety Reports] must be submitted to the IRB within 72 hours of receipt by any member of the investigative team. IND safety reports should be carefully reviewed to determine if any changes are needed to the IRB approved protocol. An addendum may be appropriate for this information.
• All reports (Reportable Events, Serious Adverse Events or IND Safety Reports) must include the IRB project number, the protocol title, the Principal researcher's name and the name of the person submitting the report.
• The IRB will review all reports of unexpected and adverse events and make decisions regarding the need to halt the research and or modify procedures and consent forms.
• If there are any questions about whether an event is reportable, contact the Human Subjects Office at 706-542-3199.

4. Request an extension of the approval period prior to the expiration date if data collection is not complete.

5. Notify the Human Subjects Office when data collection is complete.

B. The IRB has the authority to suspend, terminate, or place restrictions on any study in which the researcher has not met the above requirements, or in the event where information is disclosed to the IRB that indicates that the rights and/or welfare of human subjects are at risk.

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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

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