Study Plan Attachments

• Attachment A:  Nonsignificant Risk Devices

• Attachment B:  Placebo

• Attachment C:  Genetic Research

• Attachment D:  Employees and Students

• Attachment E:  Illiterate Participants 

• Attachment F:  Research Involving Children

• Attachment G:  Research Involving Individuals With Impaired Decision-Making Capacity 

• Attachment H:  Request for Waiver of Participant Consent

• Attachment I:  Request for Waiver of Participant Signed Consent Form

• Attachment J:  Drugs or Biologics

• Attachment L:  International Research 

• Attachment M:  Pregnant Women, Fetuses and Neonates