Protection of Human Subjects and Institutional Review Boards

OMB 0910-0130

The information collection supports FDA regulations governing Institutional Review Boards and the rights and welfare of human subjects involved in FDA-regulated research. Respondents to the collection are sponsors, members, or other individuals subject to the requirements of 21 CFR parts 50 and 56..

The latest form for Protection of Human Subjects and Institutional Review Boards expires 2023-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
IRB Waiver FRIA -- 11-27-23.docx Supplementary Document
Minimal Risk Final Rule SSA Fall 2023 RIN AH52 CLEAN.docx Supporting Statement A
Recordkeeping associated with 21 CFR parts 50 and 56
FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation
Requests for Discretionary Certificates of Confidntiality Other-Statutory Authority
Reporting associated with 21 CFR parts 50 and 56
Disclosures associated with 21 CFR parts 50 and 56

All Historical Document Collections

202311-0910-012 Approved without change	Revision of a currently approved collection	2023-11-27
202301-0910-012 Approved with change	Revision of a currently approved collection	2023-01-24
201912-0910-008 Approved without change	Revision of a currently approved collection	2020-01-15
201704-0910-001 Approved without change	Extension without change of a currently approved collection	2017-04-25
201403-0910-007 Approved without change	Extension without change of a currently approved collection	2014-03-20
201012-0910-005 Approved without change	Extension without change of a currently approved collection	2010-12-27
200711-0910-003 Approved without change	Extension without change of a currently approved collection	2007-11-19
200408-0910-002 Approved without change	Extension without change of a currently approved collection	2004-08-12
200108-0910-001 Approved without change	Extension without change of a currently approved collection	2001-08-10
199808-0910-004 Approved without change	Extension without change of a currently approved collection	1998-08-21
199501-0910-003 Approved without change	Reinstatement without change of a previously approved collection	1995-01-27
199104-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1991-04-12
198711-0910-004 Approved without change	Revision of a currently approved collection	1987-11-18
198608-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1986-08-01
198307-0910-008 Approved without change	Revision of a currently approved collection	1983-07-28
198107-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1981-07-17

OMB Details

Recordkeeping under 21 CFR parts 50 and 56

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