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  3. Human Subjects Protection Program (HSPP)
  4. HSPP Policies and Procedures
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HSPP Policies and Procedures

Investigators and study personnel are responsible for being knowledgeable of the following policies and procedures of the Human Subjects Protection Program (HSPP).

  • 2009-001.0 – Reporting Unanticipated Problems to the Institutional Review Board (6/29/2018)
  • 2009-002.0 – Reporting Non-Compliance to the Institutional Review Board (6/9/2023)
  • 2009-003.0 – Imposing and Lifting Suspensions of IRB Approval or Imposing Terminations of IRB approval – (6/5/2023)
  • 2009-004.0 – Required Reporting to Institutional Officials and External Agencies (12/30/2021)
  • 2009-005.0 – Monitoring of IRB Approved Studies (6/5/2023)
  • 2011-006.0 – Additional Protections – General (2/5/2018)
  • 2011-006.1 – Additional Protections – Pregnant Women, Fetuses or Neonates (6/9/2023)
  • 2011-006.2 – Additional Protections – Prisoners (3/16/2023)
  • 2011-006.3 – Additional Protections – Children (6/15/2017)
  • 2011-006.4 – Additional Protections – Other Vulnerable Groups (6/5/2023)
  • 2011-006.5 – Additional Protections – Fetal Tissue Transplants (6/5/2023)
  • 2011-007.0 – Definitions Applied to Policies (11/20/2023)
  • 2011-008.0– Informed Consent – Forms (3/16/2023)
  • 2011-008.1 – Informed Consent – Process (6/9/2023)
  • 2011-008.2 – Informed Consent – Waivers and Alterations (1/22/2024)
  • 2011-008.3 – Informed Consent – Assent (5/1/2017)
  • 2011-008.4 – Informed Consent – Short Form (11/20/2023)
  • 2011-008.5 – Informed Consent – Providing and Obtaining Informed Consent (6/5/2023)
  • 2011-009.0– Institutional Review Board – Membership (6/5/2023)
  • 2011-009.1 – Institutional Review Board – Submission of Materials (5/1/2017)
  • 2011-009.2 – Institutional Review Board – Exemptions (6/9/2023)
  • 2011-009.3 – Institutional Review Board – Expedited Reviews (11/20/2023)
  • 2011-009.4 – Institutional Review Board – Convened Meeting Operations (11/20/2023)
  • 2011-009.5 – Institutional Review Board – Review by Convened Board (11/20/2023)
  • 2011-009.6 – Institutional Review Board – Consultants (5/1/2017)
  • 2011-009.7 – Institutional Review Board – Assignment of Status Codes (6/9/2023)
  • 2011-009.8 – Institutional Review Board – Appeals Process (6/9/2023)
  • 2011-009.9 – Institutional Review Board – Verification of No Material Changes  (5/1/2017)
  • 2011-009.10 – Institutional Review Board – More Frequent Review (7/20/2023)
  • 2011-009.11 – Institutional Review Board – Studies Conducted in Foreign Locations (11/20/2023)
  • 2011-009.12 – Institutional Review Board – Criteria for Approval (6/9/2023)
  • 2011-009.13 – Institutional Review Board – Lapse in IRB Approval (6/9/2023)
  • 2011-009.14 – Institutional Review Board – Human Subject Research Determinations (6/5/2023)
  • 2011-009.15.a – Institutional Review Board – Reliance on UConn Health as IRB of Record (11/20/2023)
  • 2011-009.15.b – Institutional Review Board – Reliance on External IRB (11/20/2023)
  • 2011-009.16 – Institutional Review Board – Undue Influence  (8/17/2017)
  • 2011-010.0 – VACANT
  • 2011-011.0 – Research Personnel (6/9/2023)
  • 2011-012.0 – Conflict of Interest – Research Personnel (6/5/2023)
  • 2011-012.1 – Conflict of Interest – IRB Members (6/5/2023)
  • 2011-013.0 – Translation Policy (8/17/2017)
  • 2011-014.0– Health Insurance Portability and Accountability Act (HIPAA) in Research (10/29/2019)
  • 2011-015.0 – Recruitment and Payment (6/9/2023)
  • 2011-016.0 – Scientific Review (6/9/2023)
  • 2011-017.0 – UConn Health as Statistical, Operational or Coordinating Center (8/17/2017)
  • 2011-018.0 – Complaints, Concerns, Suggestions (8/17/2017)
  • 2011-019.0 – Research Registries and Repositories (3/25/2022)
  • 2011-020.0 – Humanitarian Use Device (6/5/2023)
  • 2011-021.0 – Investigational Device Studies (9/26/2017)
  • 2011-021.1 – Investigational Device – Single Emergency Use (9/26/2017)
  • 2011-022.0 – Study Drug – General (6/5/2023)
  • 2011-022.1 – Investigational Drug Studies (9/26/2017)
  • 2011-022.2 – Investigational Drug/Biologic – Expanded Access for Treatment Use, Including Single Emergency Use (6/5/2023)
  • 2011-023.0 – Educational Requirements (6/5/2023)
  • 2011-024.0 – File Requirements & Record Retention Requirements (9/26/2017)
  • 2015-024.1 – Record Retention Format (12/29/2015)
  • 2011-025.0 – HSPP Evaluation / Institutional Support (11/20/2023)
  • 2011-026.0– Planned Emergency Research (6/15/2017)
  • 2013-027.0 – Additional Requirements – Department of Defense (11/20/2023)
  • 2014-028.0 – Additional Requirements – National Institute of Justice (11/20/2023)
  • 2014-031.0– Additional Requirements – Department of Energy (11/20/2023)
  • 2014-032.0 – Additional Requirements – Environmental Protection Agency (11/20/2023)
  • 2014-033.0– Additional Requirements – Federal Bureau of Prisons (11/20/2023)
  • 2014-034.0 – Additional Requirements – Department of Education (Federal) (6/9/2023)
  • 2023-035.0 –  HSPP Emergency Preparedness Plan (6/12/2023)
  • Combined Policy Manual (pdf) (1/22/2024)