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Agenda
Reg Review
ICR
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
Modified
5200
5200
0
Other-cfr
.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research
Modified
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
New
150000
75000
0
.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived
New
60000
60000
0
.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent
New
150000
75000
0
.46.116(h) – [2018 Requirements] – Posting clinical trial consent form
New
300
150
0
Total burden requested under this ICR:
611500
1442350
0
To view an IC, click on IC Title