Establishing an Assurance
All institutions that apply for or receive Public Health Service support for biomedical or behavioral research, research training, or related activities establish an assurance with ORI by completing the “Research Integrity Assurance Establishment” form (PHS-7091) in pdf format or online. When completing the form, small institutions may submit a Small Institution Statement instead of written policies and procedures, as allowed under 42 CFR § 93.303. ORI provides guidance to help institutions assess if they are eligible to use this option.
All institutions completing the “Research Integrity Assurance Establishment” form that are not small institutions—including foreign institutions—must submit written policies and procedures that comply with the Public Health Service Policies on Research Misconduct (42 CFR Part 93). Institutions should submit their policies and procedures in English. The Foreign Institution Statement is no longer used.
Maintaining an Assurance
To maintain an assurance, all institutions must submit an annual report to ORI between January 1 and April 30 of each year as required under 42 CFR § 93.302(b). The “Institutional Assurance and Annual Report on Possible Research Misconduct” form (PHS-6349) can be submitted to ORI online or as a PDF form.
Institutions are responsible for keeping their policies and procedures up to date and may revise or upload updated policies and procedures at any time online through the Annual Report on Possible Research Misconduct (ARPRM) system. ORI provides sample policies and procedures and guidance to help institutions meet the requirements of 42 CFR Part 93.
The contents of this webpage do not have the force and effect of law and are not meant to bind the public in any way. This webpage is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.
