Human Subjects

Policies and Procedures

This page provides the policies and procedures of the University of Georgia’s Human Research Protection Program (HRPP). 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.These policies and procedures are also available in Alphabetical Order.

Investigator Manual

103 – Investigator Manual

This manual is designed to guide the Principal Investigator and research team members through current policies and procedures related to the conduct of human subjects research that are specific to the University of Georgia.

General

001 – Definitions
002 – Determination of Human Subjects Research
005 – Pilot Activities
006 – Principal Investigator Eligibility
007 – Investigator Training
008 – Engagement Determination
009 – Use of External Sites in Research
010 – Reliance on an External IRB
012 – Observation of the Consent Process
013 – Legally Authorized Representatives for Adults with Diminished Consent Capacity and for Children
014 – International Research

Management of Incoming Information

020 – Incoming Information Directed to the IRB
021 – Pre-Review of IRB Submissions
022 – Non-Compliance
023 – Emergency Use of a Test Article Review
026 – Suspensions or Terminations of IRB Approval
027 – Emergency Use of a Test Article Post-Review

Non-Committee (Exempt and Expedited) Review

030 – Designated and Regulatory Review
031 – Non-Committee Review Preparation and Conduct
033 – Exempt Review

Committee (Full Board) Review

040 – IRB Meeting Preparation
041 – IRB Meeting Conduct
042 – IRB Meeting Attendance Monitoring
043 – IRB Meeting Minutes
044 – Review of Not Otherwise Approvable Research

Review Process

050 – Conflicting Interests of IRB Members and Consultants
051 – Consultation to the IRB
052 – Post-Review and Communication of Review Results
053 – Scientific or Scholarly Review
055 – Financial Conflicts of Interests
057 – Continuing Review
058 –Review of Modifications to Previously Approved Research

Periodic Tasks

060 – Annual Evaluations of the HRPP
061 – Quarterly Evaluations of the HRPP
063 – Expiration of IRB Approval

Records

070 – IRB Records and Records Retention
071 – Policies and Procedures

Committee Management

080 – IRB Formation
081 – IRB Removal
082 – IRB Membership Addition
083 – IRB Membership Removal
084 – IRB Meeting Scheduling and Notification

Investigator

090 – Informed Consent Process for Research
091 – Documentation of Informed Consent
092 – Participant Selection and Recruitment
093 – Participant Incentive and Compensation
094 – Research with Vulnerable Populations
095 – Students as Research Participants
096 – Family Educational Rights and Privacy Act (FERPA) and Use of Education Records
097 – Deception or Incomplete Disclosure
098 – Internet Research
099 – Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

Guidance Documents for Investigators

Class Projects
ClinicalTrials.gov Registration
Community-Based Participatory Research
Emergency and Off-Label Use of Drugs, Biologics and Medical Devices