The Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services acknowledges that an important issue in the course of institutional investigations into allegations of research misconduct is the determination of the scope. The scope of research misconduct refers to an institution diligently pursuing all significant leads discovered to be relevant to an investigation

(42 C.F.R. § 93.310(h)). An institution that does not adequately address the scope of the potential research misconduct in accordance with § 93.310(h) and perform timely sequestration of research records (§ 93.307(b) and § 93.310(d)) may compromise the effective handling of the investigational process and may allow undetected research misconduct to remain in the literature or to be used in applications for U.S. Public Health Service (PHS) funds.

To assist institutions with determining whether a significant issue or lead may be relevant while conducting a research misconduct proceeding, ORI has constructed several hypothetical case examples and included them in an informational document (available at: https://ori.hhs.gov/handling-misconduct). ORI has provided these case examples as representative scenarios that institutions may encounter to illustrate how the scope of research misconduct may be determined.

ORI recognizes that these hypothetical case examples do not address all of the particular challenges or concerns that institutions may face when determining which leads or significant issues to pursue in their research misconduct proceedings. The Division of Investigative Oversight (DIO) can provide assistance concerning the scope of the research misconduct or the handling of cases. The DIO Director or DIO Scientist-Investigators can be contacted at (240) 453-8800 or by writing to AskORI@hhs.gov.  

The contents of this notice do not have the force and effect of law and are not meant to bind the public in any way. This notice is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.