IRB Written Notification to Approve or Disapprove Research, 56.109(e); Continuing Review, 56.109(f); Elements of Informed Consent (IC), 50.25; Documentation of IC, 50.27

Protection of Human Subjects: Informed Consent; Institutional Review Boards

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	IRB Written Notification to Approve or Disapprove Research, 56.109(e); Continuing Review, 56.109(f); Elements of Informed Consent (IC), 50.25; Documentation of IC, 50.27	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 56 21 CFR 50

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,520	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 60 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	100,800	-139,200	240,000
Annual IC Time Burden (Hours)	100,800	-139,200	240,000
Annual IC Cost Burden (Dollars)	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.