ORI Guidance to Institutions Concerning Sequestration during Closure of Institutions due to 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 interrupting and delaying regular operations at institutions, including research misconduct (RM) proceedings.
Since the regulation at 42 C.F.R. Part 93.305 requires institutions to “promptly take all reasonable and practical steps” to sequester evidence in a RM proceeding, institutions should take those steps that are reasonable and practical under the current circumstances. If is not possible to access records on-site due to office or building closures, the institution: (1) should promptly begin sequestering electronic evidence remotely to the extent that it has the technological capability to do so (i.e., data and emails on network computers, servers, and cloud environments); and (2) may postpone sequestering physical and other electronic evidence (i.e., laboratory notebooks, blots/films, other research records, and evidence on non-networked computers and devices) until it becomes reasonable and practical to sequester such evidence.
The regulation at § 93.305(a) requires that an institution must sequester evidence either before or when the institution notifies the respondent of the allegation, inquiry or investigation. Section 93.307(b) requires an institution to make a good faith effort to notify the respondent in writing at the time of or before beginning an inquiry and to sequester evidence on or before the date on which the respondent is notified or the inquiry begins, whichever is earlier.
Thus, an institution may sequester evidence before notifying the respondent of an allegation. The institution can postpone notifying the respondent to preserve the integrity of the evidence until sequestration is complete, as long as the institution notifies the respondent in writing by the time of the inquiry.
ORI emphasizes that this timing of the sequestration process prior to notification of the respondent is critical for ensuring the integrity of the research record and other relevant evidence. Any modifications to an institutional process to address unforeseen circumstances must adhere to the basic requirements of the regulation and must be documented in the institution’s RM report to ORI.
ORI recognizes that these are challenging times for institutions and remains at operational status. Institutions can direct specific questions and concerns to ORI by contacting the scientist-investigator assigned to the case 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.