HRPP Policy - IRB review process

About This Policy

Effective date:
03/29/2018
Last updated:
07/01/2019
Policy Contact:

IU Human Subjects Office
(317) 274-8289
irb@iu.edu

IU HRPP Documents

Related IRB Questionnaires

  • Conflicts of Interest
  • A – Level of Review Assessment
  • B – Lay Summary & Research Design
  • C – Sites & Collaborations
  • D – Recruitment Materials
  • E – Risks, Benefits, Protections
  • F – Data Safety Monitoring
  • G1 – Children
  • G2 – Individuals Lacking Consent Capacity
  • G3 – Prisoners
  • G4 – Transnational Research
  • H – Informed Consent Process
  • J – Child Assent & Parental Consent Process
  • K – HIPAA
  • L – VA Research
  • Amendment
  • Renewal
  • Reportable Event (FYI)
  • Study Closure/Closeout Report

View KC Crosswalk

Related Forms and Templates

  • Drug or Biological Product Form
  • Medical Device Form

Browse IU HRPP Forms

7.0 - Definitions

2018 requirements, adverse event, assent, audit, authorization, biological product or biologic, biospecimen, confidentiality, corrective action, department or agency head, device, drug, enrollment, exempt from IDE requirements, federally-funded, federalwide assurance, HIPAA, identifiable private information, informed consent, interaction, intervention, investigational device exemption, investigational new drug application, investigator, IRB-approved protocol, key personnel, legally authorized representative, minimal risk, noncompliance, noninvasive, nonsignificant risk, principal investigator, prisoner, privacy, privacy rule, private information, protected health information, recruitment, research, research personnel, significant risk device, sponsor, student/fellow/resident PI, suspension, termination, test article, transnational research, written/in writing
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