Protection of Human Subjects: Informed Consent; Institutional Review Boards

Forms and Documents

Document Name	Status
0755_Supporting Statement.doc Supporting Statement A	2016-11-10

IC Document Collections

IC ID	Document Title	Status
224395	Written statement about minimal risk research when documentation of informed consent is waived 56.109(d)	New
207945	Reinstatement of an IRB or Institution, 56.123	Modified
207944	IRB Response to Lesser Administrative Actions for Noncompliance, 56.120(a)	Modified
207943	Suspension of Termination of IRB Approval of Research, 56.113	Modified
207942	Exception from Informed Consent for Emergency Research, 50.24	Modified
207941	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	Modified

ICR Details

OMB Control No: 0910-0755	ICR Reference No: 201610-0910-003
Status: Historical Active	Previous ICR Reference No: 201307-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Protection of Human Subjects: Informed Consent; Institutional Review Boards
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/23/2017
	Date Received in OIRA: 11/15/2016
Terms of Clearance: Previous terms continue: The burden associated with 21 CFR § 50.25 (Elements of Informed Consent) and 21 CFR § 50.27 (Documentation of Informed Consent) is limited to the burden of development and approval by an institutional review board (IRB) of a site-specific informed consent document, and the documentation of informed consent. OMB does not grant approval for the content of individual consent forms that are reviewed and approved by IRBs and subsequently presented to research participants.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	01/31/2017
Responses	108,392	0	246,021
Time Burden (Hours)	104,679	0	243,070
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request addresses limited collections of information not currently approved under an OMB control number for institutional review boards (IRBs) and clinical investigators involved with human subject research regulated by the Food and Drug Administration (FDA). IRBs are required to review for approval FDA-regulated research activities. Clinical investigators are required to obtain informed consent from research subjects participating in FDA-regulated clinical trials. These limited collections of information help protect the rights, safety, and welfare of human subjects who participate in research actitivies within FDA's jurisdiction.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 46935	07/19/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 76596	11/03/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
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
Exception from Informed Consent for Emergency Research, 50.24
Suspension of Termination of IRB Approval of Research, 56.113
IRB Response to Lesser Administrative Actions for Noncompliance, 56.120(a)
Reinstatement of an IRB or Institution, 56.123
Written statement about minimal risk research when documentation of informed consent is waived 56.109(d)

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	108,392	246,021	0	0	-137,629	0
Annual Time Burden (Hours)	104,679	243,070	0	0	-138,391	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: FDA estimates that the total annual burden hours have decreased from 243,070 to 104,695, due primarily to a reduction in the estimated number of respondents because of more accurate information about the number of IRBs that review research involving FDA-regulated products. Based on the number of active IRBs in OHRP’s registration system that indicate they review FDA-regulated research, the number of respondents has been reduced from 6,000 to 2,520.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 11/15/2016

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