ORI Operations Status during Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19)

The Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services acknowledges that the COVID-19 pandemic is causing disruption to the businesses and research institutions that receive funding from the Public Health Services (PHS).  During this period, ORI continues to perform mission critical functions and operations with ORI staff working with maximum telework flexibilities.  ORI is doing everything possible to accommodate the needs of the research community. 

We will provide updates on the ORI website as information becomes available.

Research Misconduct Inquiry and Investigation Deadlines
ORI can grant extensions to institutions conducting inquires or investigations of research misconduct due to delays caused by COVID-19.

The regulations at 45 CFR § 93.307 and § 93.311 state that inquiries must be completed within 60 days and investigations must be completed within 120 days. If an extension is needed, written requests must be submitted to ORI. With regular operations disrupted at institutions, ORI anticipates that inquiries and investigations likely will be delayed or interrupted.  To alleviate regulatory burden during this time period, ORI is able to grant extensions for research misconduct proceedings. Institutions may submit written requests via email to ORI if an extension is needed for their inquiry or investigation. Institutions may submit written requests for extensions of inquiries and investigations via email to the scientist-investigator assigned to the case, or Tracy Sumner at Tracy.Sumner@hhs.gov.

Whistleblower Complaints
ORI will continue to receive and process whistleblowers complaints during this time period. 

ORI will continue to conduct initial assessments of complaints and/or refer the allegations to the relevant institution for an assessment, inquiry, or other appropriate actions.  Whistleblowers should anticipate that institutions may not be able to respond to all allegations within a normal time period due to disruptions to their regular operations.

Assurance Requirements
ORI’s Assurance Program will continue to receive and process assurance submissions.

Institutions applying for and receiving PHS funding must have an active assurance with ORI. Institutions with current funding must submit the Annual Report on Possible Research Misconduct (ARPRM) form by April 30 each year to maintain their assurance.  ORI’s online reporting system is fully functional, and ORI staff are prepared to receive and process all reports to ensure institutions continue to receive funding. 

Packages and Deliveries
ORI requests institutions to delay sending physical mail, packages, and other deliveries for the time being.

While ORI staff are teleworking, our ability to receive deliveries to our office will be limited. If you already have sent something that may be in transit (physical packages), please contact Tracy Sumner at Tracy.Sumner@hhs.gov and Ray Fisher at Raymond.Fisher@hhs.gov to provide information about estimated delivery date, contents, and anything else relevant.  The Office of the Assistant Secretary for Health began receiving packages already in transit for ORI beginning on March 17, 2020, and will maintain security of them. If you have questions, please call ORI at (240) 453-8800 or email us at AskORI@hhs.gov

Source URL: https://ori.hhs.gov/blog/ori-operations-status-during-public-health-emergency-united-states-2019-novel-coronavirus