Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting Removed 0 0 0 Other-cfr
.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research Unchanged 150000 75000 0
.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities Modified 96000 1152000 0
.117(a) [Pre-2018 and 2018 Requirements] – Documentation of informed consent Modified 120000 60000 0
.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived Modified 30000 15000 0
.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent Unchanged 150000 75000 0
.46.116(h) – [2018 Requirements] – Posting clinical trial consent form Modified 2125 1063 0
Total burden requested under this ICR: 548125 1378063 0  
To view an IC, click on IC Title