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103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent
Protection of Human Subjects: Common Rule (56 FR 28003)
OMB: 0990-0260
IC ID: 10389
OMB.report
HHS/HHSDM
OMB 0990-0260
ICR 201203-0990-003
IC 10389
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0990-0260 can be found here:
2021-06-25 - Revision of a currently approved collection
2018-05-18 - Extension without change of a currently approved collection
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
45 CFR 46
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
6,000
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Not-for-profit institutions
Percentage of Respondents Reporting Electronically:
5 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
235,980
0
0
0
0
235,980
Annual IC Time Burden (Hours)
235,980
0
0
0
0
235,980
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.