Protection of Human Subjects: Informed Consent; Institutional Review Boards

ICR 201610-0910-003

OMB: 0910-0755

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0755 201610-0910-003
Historical Active 201307-0910-006
Protection of Human Subjects: Informed Consent; Institutional Review Boards
Extension without change of a currently approved collection   No
Approved without change 01/23/2017
Retrieve Notice of Action (NOA) 11/15/2016
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
01/31/2020 36 Months From Approved 01/31/2017
108,392 0 246,021
104,679 0 243,070
0 0 0

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.

US Code: 42 USC 262 Name of Law: PHS Act

Not associated with rulemaking

  81 FR 46935 07/19/2016
81 FR 76596 11/03/2016

  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
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.

Amber Sanford 301 796-8867 [email protected]


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:
    (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;
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.

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