Campbell IRB Regulatory Information
Federalwide Assurance Information
FWA#: FWA00008608
Organization: Campbell University, Inc.
Institutional Official & Designated Signatory Official: Michael L. Adams, PharmD, PhD, Vice President for Academic Affairs & Provost
Signatory Official: J. Bradley Creed, Ph.D., Chief Executive Officer
IRB Registration Information
IORG#: IORG0004771
Organization: Campbell U IRB#2
IRB Chair: Stephen Holly, PhD
IRB Contact: Lara Shields, M.Ed.
Rosters
Federal Regulations & International Guidelines
- The Belmont Report
- Pre-2018 Common Rule, 45 CFR 46
- 2018 Common Rule, 45 CFR 46
- Health Insurance Portability and Accountability Act (Privacy Rule), Combined
- Family Educational Rights and Privacy Act (FERPA)
- International Council for Harmonization Good Clinical Practice (ICH-GCP-E6) Guideline
HRPP Policies
- HSR-010 HRPP Policy: Human Research Protection Program Plan
- HSR-020 HRPP Policy Compliance and Reporting of Non-Compliance
- HSR-030 HRPP Policy Registration Projects and FLEX Review
IRB Manuals
HRPP/IRB Office Standard Operating Procedures
IRB Investigator Standard Operating Procedures
- HSR-310 IRB SOP: Requirements and Qualifications to Serve as a Principal Investigator
- HSR-311 IRB SOP: Investigator Conflict of Interest in Human Subjects Research
- HSR-320 IRB SOP: Responsibilities for Investigators Conducting Human Subject Research
- HSR-330 IRB SOP: Human Subject Research Protections Training Requirements
- HSR340-IRB SOP: Privacy and Confidentiality
- HSR350-IRB SOP: Data and Safety Monitoring Plans
- HSR-380 IRB-SOP: Compensation of Research Subjects
- HSR510-IRB SOP: Undergraduate Classroom Projects for Educational Purposes Only
- HSR550-IRB SOP: Lapsed/Expired IRB Approval of Human Subjects Research
- HSR660-IRBSOP: Use of CU Student Athletes in Human Subjects Research
- HSR740-IRB SOP: Research Involving Department of Defense and/or Military Participants
- HSR750-IRB SOP: Banking Projects
- HSR410-IRB SOP: Informed Consent Process for Human Subjects Research
- HSR420-IRB SOP: Informed Consent Documentation for Human Subjects Research
- HSR430-IRB SOP: Waiver or Alteration of the Informed Consent Process
- HSR440-IRB SOP: Waiver or Alteration of Documentation of Consent
- HSR650-IRB SOP: Use of Legally Authorized Representative (LAR)
- HSR610-IRB SOP: Research Involving Economically or Educationally Disadvantaged Persons
- HSR620-IRB SOP: Research with Subjects Likely to Manifest or Develop Decreased Decisional Ability
- HSR630-IRB SOP: Recruitment and Enrollment of Non-English Proficient or Limited-English Proficient Subjects
- HSR740-IRB SOP: Research Involving Department of Defense and/or Military Participants
- HSR750-IRB SOP: Banking Projects
- HSR610-IRB SOP: Research Involving Economically or Educationally Disadvantaged Persons
- HSR620-IRB SOP: Research with Subjects Likely to Manifest or Develop Decreased Decisional Ability
- HSR630-IRB SOP: Recruitment and Enrollment of Non-English Proficient or Limited-English Proficient Subjects
- HSR640-IRB SOP: Research Involving Minors/Children