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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Supporting Statement_0990-0260_Common Rule_30-Day PRA_15Aug2024.docx Supporting 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
.117(a) [Pre-2018 and 2018 Requirements] – Documentation of informed consent
.46.116(h) – [2018 Requirements] – Posting clinical trial consent form
.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent
.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research
.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities
.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All Historical Document Collections

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

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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