With the recent appointment of an HHS leader as its permanent director and a former Johns Hopkins misconduct official to another key post, the HHS Office of Research Integrity (ORI) has a full complement of permanent leaders for the first time since 2016.
ORI, which provides education and enforces research misconduct regulations, is responsible for ensuring that the billions of dollars in research funded by the Public Health Service (PHS), including that supported by NIH, is free of fabrication, falsification and plagiarism. ORI has two divisions: the Division of Investigative Oversight (DIO) and the Division of Education and Integrity (DEI). The leadership level is rounded out by a deputy director.
In addition to the recent appointments, ORI has seen a slight uptick in activity of late, releasing its second misconduct finding of the year on May 11, but this pace still puts it far behind its historical output. Additionally, ORI published a request for information (RFI) in April in preparation for guidance it intends to issue within a few months.[1]
The new appointments may bring stability to a pivotal agency that has been wracked by internal discord and personnel departures beginning nearly a decade ago, with the director and education division posts particularly difficult to keep filled. In January 2019, all four of the leadership positions were either vacant or being held by officials in acting or interim capacities.[2]
Discord Preceded Departures
When former director Kathryn Partin assumed the job in December 2015, she inherited a spot that had been open nearly two years, following the high-profile resignation of David Wright, who cited dysfunction at HHS for the end to his two-year tenure. But Partin’s management style proved controversial almost immediately, leading first to the departure of former DEI Director Zoë Hammatt in December 2016, and DIO Director Susan Garfinkel 11 months later—both reportedly pushed out by Partin.[3]
Research misconduct investigators began to resign under Partin and closure rates also suffered. In 2016 and 2017, ORI issued seven misconduct findings each year, a low not seen in the previous 16 years and less than half the typical number in preceding years. It issued no findings from August 2016 to June 2017.
HHS took action after Garfinkel left, moving Partin in December 2017 to a “temporary” detail at the Uniformed Services University of the Health Sciences, but she never returned to ORI. Partin was ultimately appointed to an NIH intramural research integrity leadership post.[4]
Instead, longtime HHS leader Wanda Jones stepped in as the interim ORI director. In the meantime, the deputy director that Partin hired also left, leaving Jones doing double duty for extended periods of time.
The first vacant leadership position HHS filled on a permanent basis was the deputy director job, which HHS gave to Jones in June 2019. Next was the DIO job, which went to Alexander Runko a month later.[5] A scientist-investigator at ORI from 2010-2016, Runko returned following a post as director of the extramural genomic program at the National Heart, Lung, and Blood Institute.
Also in July of last year, HHS named Elisabeth Handley, previously with the Centers for Medicare & Medicaid Services (CMS), interim ORI director, and in March of this year she was given the position on a permanent basis. Also in March, Karen Wehner joined ORI as DEI director from her former post as associate director of the Division of Research Integrity at the Johns Hopkins University School of Medicine, although her appointment wasn’t announced until April.[6]