Human Research Protection Program

Policies and Procedures

This page provides the policies and procedures of the 香港管家婆资料免费大全鈥檚 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 础濒辫丑补产别迟颈肠补濒听翱谤诲别谤.

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 香港管家婆资料免费大全.

General

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

Management of Incoming Information

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

Non-Committee (Exempt聽and Expedited) Review

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

Committee (Full Board) Review

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

Review Process

050 鈥 Conflicting Interests of IRB Members and Consultants
051 鈥 Consultation to the IRB
052 鈥 Post-Review and Communication of Review Results
053 鈥 Scientific or Scholarly Review
054 –聽Institutional Conflicts of Interests
055 鈥 Financial Conflicts of Interests
057 –聽Continuing Review
057 – Continuing Review Temporary Addendum to Provide Business Continuity
058 –聽Review of Modifications to聽Previously Approved Research
059 – Review of Research Subject to the Revised Common Rule

Periodic Tasks

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

Records

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

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080 –聽滨搁叠听贵辞谤尘补迟颈辞苍
081 –聽滨搁叠听搁别尘辞惫补濒
082 –聽IRB Membership聽Addition
083 –聽IRB Membership Removal
084 –聽IRB Meeting Scheduling and Notification

Investigator

090 鈥 Informed Consent Process for Research
091 鈥 Documentation of Informed Consent
092 鈥 Participant Selection and Recruitment
093 鈥 Participant Incentive and Compensation
094 鈥 Research with Vulnerable Populations
095 鈥 Students as Research Participants
096 鈥 Family Educational Rights and Privacy Act (FERPA) and Use of Education Records
097 鈥 Deception or Incomplete Disclosure
098 鈥 Internet Research
099 鈥 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
FDA-Regulated Research
IRB Fees and Appendix
Guidance on Human Subjects Research Requirements for Small Business Innovation Research (SBIR)/ Small Business Technology Transfer (STTR) Grant Recipients