Human Subjects

Alphabetical Listing of Policies and Procedures

This page provides the policies and procedures of the University of Georgia’s Human Research Protection Program (HRPP) in alphabetical order. These policies are routinely evaluated against federal, state and institutional regulations, ethical and accreditation standards, and best practices on human subjects protection and revised, or new policies created, as needed. The current policies will be posted on this site as they are approved and implemented. These policies and procedures are also available in Topical Order.

Annual Evaluations of the HRPP

Class Projects

ClinicalTrials.gov Registration

Community-Based Participatory Research

Conflicting Interests of IRB Members and Consultants

Consultation to the IRB

Continuing Review

Deception or Incomplete Disclosure

Definitions

Designated and Regulatory Review

Determination of Human Subjects Research

Documentation of Informed Consent

Emergency and Off-Label Use of Drugs, Biologics and Medical Devices

Emergency Use of a Test Article Post-Review

Emergency Use of a Test Article Review

Engagement Determination

Exempt Review

Expiration of IRB Approval

Family Educational Rights and Privacy Act (FERPA) and Use of Education Records

Financial Conflicts of Interests

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

Incoming Information Directed to the IRB

Informed Consent Process for Research

International Research

Internet Research

Investigator Manual

Investigator Training

IRB Formation

IRB Meeting Attendance Monitoring

IRB Meeting Conduct

IRB Meeting Minutes

IRB Meeting Preparation

IRB Meeting Scheduling and Notification

IRB Membership Addition

IRB Membership Removal

IRB Records and Records Retention

IRB Removal

Legally Authorized Representatives for Adults with Diminished Consent Capacity and for Children

Non-Committee Review Preparation and Conduct

Non-Compliance

Observation of the Consent Process

Participant Incentive and Compensation

Participant Selection and Recruitment

Pilot Activities

Policies and Procedures

Post-Review and Communication of Review Results

Pre-Review of IRB Submissions

Principal Investigator Eligibility

Quarterly Evaluations of the HRPP

Reliance on an External IRB

Research with Vulnerable Populations

Review of Modifications to Previously Approved Research

Review of Not Otherwise Approvable Research

Scientific or Scholarly Review

Students as Research Participants

Suspensions or Terminations of IRB Approval

Use of External Sites in Research