OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Protection of Human Subjects: Common Rule (56 FR 28001)

OMB 0990-0260 · HHS/HHSDM.

OMB 0990-0260

The Federal Policy for the Protection of Human Subjects, codified for HHS at 45 CFR part 46, subpart A (also known as the Common Rule) adopted in June 1991 (56 FR 28001), establishes Federal policy for the protection of human subjects involved in Federally conducted or supported research. The Common Rule requires applicant and awardee institutions to establish procedures to report, disclose, and maintain required information, including information related to informed consent and an assurance of compliance with the regulatory requirements.

The latest form for Protection of Human Subjects: Common Rule (56 FR 28001) expires 2028-01-31 and is listed under ICR 202407-0990-001.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Supporting Statement_0990-0260_Common Rule_30-Day PRA_15Aug2024.docxSupporting Statement A
2018 Requirements - 2018 Common Rule_June 2021.pdf Supplementary Document
Pre-2018 Requirements - Pre-2018 Common Rule_ June 2021.pdf Supplementary Document
42 U S C Section 289_0990-0260_ June 2021.pdf Supplementary Document
.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived Information collection
.117(a) [Pre-2018 and 2018 Requirements] – Documentation of informed consent Information collection
.46.116(h) – [2018 Requirements] – Posting clinical trial consent form Information collection
.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent Information collection
.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research Information collection
.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities Information collection
.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting Other-cfr

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202407-0990-001 Extension without change of a currently approved collection 2024-08-21
202104-0990-003 Revision of a currently approved collection 2021-06-25 Approved without change
201803-0990-003 Extension without change of a currently approved collection 2018-05-18 Approved without change
201502-0990-003 Extension without change of a currently approved collection 2015-04-23 Approved without change
201203-0990-003 Extension without change of a currently approved collection 2012-03-28 Approved without change
200812-0990-001 Extension without change of a currently approved collection 2008-12-30 Approved without change
200510-0990-002 Revision of a currently approved collection 2005-10-18 Approved without change
200508-0990-001 Extension without change of a currently approved collection 2005-08-12 Approved without change
200203-0990-002 New collection (Request for a new OMB Control Number) 2002-03-14 Approved without change

OMB Details

.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting

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