Reviews Requiring Special Consideration Policies & Forms

SC 501 Vulnerable Populations

Prisoners
Children
Pregnant Women and Fetuses

• SC 501-A Checklist - Requirements for Research Involving Children
• SC 501-B Checklist - Requires for Research Involving Pregnant Women & Fetuses
• SC 501-C Checklist - Requirements for Research Involving Cognitively Impaired Adults

SC 502 Categories for Research

Clinical Research Involving Devices
Genetic Research
Emergency Use of Unapproved Medical Devices
Emergency Use of an Investigational Drug or
  Biologic in an Unplanned and Life-Threatening
  Situation
Medical Records and Chart Review
Residual Body Fluids, Tissues and Recognizable
  Body Parts
Protocols Lacking Definite Plans of Human
  Involvement

• SC 502-A Reporting Emergency Use of a Test Article
• SC 502-B Notice of IRB Approval/Acceptance of Emergency Use
• SC 502-C Reporting of Emergency Use - Investigator Template
• SC 502-D Checklist - Emergency Research Conducted Under 21 CFR 50.24

Policies & Forms: General Administration IRB Organization Functions and Operations Review of Research Review Requiring Special Consideration IRB Communication and Notification Informed Consent Responsibilities of Investigators Quality Assurance

Appendix: A Belmont Report with Acknowledgement Form B Statement Authorizing the IRB (FWA) C Studies Requiring IRB Review D List of Committees E Expedited Review Procedures F Significant Risk and Nonsignificant Risk Medical Device Studies

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