Attachment 11: OMB Form-0990-0263

OMB No. 0990-0263

Approved for use through September 30, 2027

Protection of Human Subjects Assurance Identification,
IRB Certification, and Declaration of Exemption
(Common Rule) Form
Policy: Research activities involving human subjects may not be conducted or supported by the Departments and Agencies adopting the Federal Policy for the Protection of Human Subjects (the Common Rule), unless the activities are exempt from or approved in accordance with the Common Rule. The pre-2018 Common Rule (or “pre-2018 Requirements”) was originally promulgated in 1991 and amended on June 23, 2005 (70 FR 36325). The 2018 Common Rule (or “2018 Requirements”) was originally published on January 19, 2017 (82 FR 7149) and amended on January 22, 2018 (83 FR 2885) and June 19, 2018 (83 FR 28497). The categories of exempt research are provided in section 101(b) of the pre-2018 Common Rule and section 104(d) of the 2018 Common Rule.
The pre-2018 Common Rule requires institutions to certify that each application or proposal for research covered by the regulations, and that does not qualify for exemption, has been reviewed and approved by an institutional review board (IRB) (section 103(f)). The 2018 Common Rule requires institutions to certify that each proposed research study covered by the regulations, and that does not qualify for exemption, has been reviewed and approved by an IRB (section 103(d)). Institutions must have an assurance of compliance that applies to the research to be conducted and must submit certification of IRB review and approval according to the pre-2018 or 2018 Requirements, as applicable, to the satisfaction of the Department or Agency head. Purpose: The purpose of this form is to provide institutions engaged in research conducted or supported by departments and agencies that have adopted the Common Rule a simplified method of collecting information for IRB certification to satisfy the requirements of the Common Rule at section 103. This form also collects information for identification of assurance status, and if applicable, declaration of exempt status. These collections provide institutions a method of administrative tracking and record keeping for proposed research studies.

1. Request Type

☐Original
☐Continuation
☐Exemption

2. Type of Mechanism

☐Grant
☐Contract
☐Fellowship
☐Cooperative Agreement
☐Other:

3. Name of Federal Department or Agency and, if known, Application or Proposal 6. Assurance Status of this Project (Respond to one of the following)