FY 2020 Annual

Report

The U.S. Office of

Research Integrity
Meet the Directors

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06

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ORI Investigative Oversight

Communications

08

Research

09

ORI Grants Program

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Compliance

11 Contact Us

TABLE OF CONTENTS
ORI INVESTIGATIVE OVERSIGHT

Fiscal Year 2020

Cases

Opened

Total

Closures

204

Allegations

Received

34 72

3

Cases

Continued

35

ORI's Rapid Response for Technical Assistance (RRTA) program provides technical

assistance to institutions responding to allegations of research misconduct that involve

PHS funded research. The goals of the RRTA program are to facilitate high-quality and

well-documented investigations and to help resolve research misconduct cases

promptly. Examples of technical assistance available from ORI are:

Sequestration of records

Forensic analyses

Image enhancement and statistical analyses of data

Handling allegations and preliminary assessment

Handling complainants, respondents, and witnesses

Voluntary admissions

Referral/notification to other federal agencies or institutions

Review of institutional research misconduct proceedings

Whistleblower and retaliation issues

361 Technical Assistance sessions provided by ORI

Note: Fiscal Year 2020 is October 1, 2019 - September 30, 2020. Some of the cases and allegations that were

closed in FY 2020 were opened in previous years. Closures represents the total number of closed cases (45)

and closed allegations (27).
See the research

misconduct case

summaries!

Click Here

8

No Research

Misconduct

Findings of

Research

Misconduct

11

Decline

to Pursue

26

ORI INVESTIGATIVE OVERSIGHT

Certification

Required

5

Supervision

Plan

Required

5

Prohibition

from PHS

Advisory

Service

11

Debarment/

Voluntary

Exclusion

5

Publication

Retractions/

Corrections

Requested

21

Voluntary

Exclusion

and

Supervision

1

Fabrication

1

Falsification/

Fabrication

7 1

Falsification/

Fabrication/

Plagiarism

Outcomes in FY 2020 Closed Cases

4

Number of PHS Findings of Research Misconduct

by Allegation Type

2

Falsification

Administrative Actions in PHS Findings

Note: Some cases had multiple administrative actions. Some of the cases closed in FY 2020 had been

opened in previous years. Debarments are federal-wide. Supervision plans are for PHS-funded research.

Multiple research misconduct findings were made in each of the 11 cases closed with findings.

Over $75

Million

The amount of federal

funds* impacted by

research misconduct in

ORI’s FY 2020 findings of

research misconduct

*This is a preliminary estimate of direct or collaborative funding. ORI has begun to

conduct additional assessments based on these preliminary estimates.
564

TWEETS

5,224

FOL LOWERS

E-Blasts

18,644 4 15

Subscribers Distribution Lists Email Updates Sent

223

Locales*

947,250

Visits

2,104,980

Page Views

Website

Did You Know?

ORI offers a variety of RCR resources, such as

videos, infographics, and modules, that can be

downloaded or streamed directly from our

website.

22,258

ENGAGEMENTS

158 REPLIES

939,822

IMPRESSIONS

1 ,060

RETWEETS

5,701 URL

CLICKS

261 HASHTAG

CLICKS

1 ,326 PROFILE

CLICKS

1 , 165 LIKES

Twitter

COMMUNICATIONS

ORI posts regular updates for stakeholders

via its Twitter account, website, and listserv.

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*This includes countries, territories, and geographic

regions identified by Google Analytics.
As the use of technology and laboratory record keeping evolve, ORI is interested in

continuing to update the guidance, training, and technical assistance that we provide to

institutions for handling allegations of research misconduct.

 Sequestration is a key aspect of handling allegations of 

 research misconduct and is heavily impacted by evolving 

 technologies and laboratory record keeping practices. 

 For this reason, ORI sought to learn from the research

 integrity community about challenges and solutions in 

 sequestering digital evidence. Examples include data 

 stored in cloud environments and on personal electronic 

 equipment or storage devices.

ORI published a Request for Information to ask members of the research integrity field

about major challenges that exist in the sequestration process and approaches to

overcome them, especially regarding digital evidence. ORI received thoughtful comments

from the research integrity community and is considering this information as it develops

resources on this topic.

Challenges and Approaches to Sequestration of Evidence

RESEARCH

6

Needs Assessment: Promoting Research Integrity

ORI conducted an assessment of the resources currently available for use in research

integrity (RI) and responsible conduct research (RCR) educational and training activities.

The goal of the assessment was to identify gaps and unmet needs, in both format and

content, that should be addressed in the future development of new RI/RCR related

resources.

This work identified a gap in available resources related to detrimental research practices

and a need for new resources (e.g., scenarios, case studies, role playing, video clips, and

interactive videos) to cover these areas. This work also highlighted the need to optimize

existing resources (scenarios, case studies, and video clips) for more effective use, by RCR

educators and research integrity professionals, through the development of accompanying

facilitator and discussion guides. ORI is exploring how to best address the needs and

opportunities identified by this assessment and plans to develop resources that address

them by 2022.
Retractions/corrections are a means of maintaining the integrity of the scientific literature

and are necessary to alert the scientific community to serious problems identified within a

published article. Thus, they help ensure that future research is not built upon problematic

research. ORI has begun to monitor each of its requested corrections and/or retractions.

Early results from this work highlight the value of ORI’s investigative work and the

importance of capturing the results through this process.

 An initial review of misconduct cases closed 

 by ORI from 2015 to 2019 revealed that 40 of

 the 50 respondents had a total of 164

 publications involving research misconduct. 

 For 154 publications (94%), the journals had 

 corrected the record in some manner.

 Retractions accounted for most corrections

 (122, 74%), while the remainder included

other less serious journal actions such as editorial expressions of concern, corrections,

and errata. Of the original 164 publications, 6% remained in the literature, unchanged, as

of July 1, 2020.

RESEARCH

Correcting the Scientific Record

Status of Publications Found to Contain Research Misconduct

(n=164) in ORI Findings of Research Misconduct (2015-2019)

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To protect the scientific literature and public health from flawed

research, ORI will continue to monitor and report on retractions as it

studies new ways to decrease the time to retraction and mitigate the

number of citations after retraction.

Did You Know?

An analysis* of the 164

papers described above

revealed that they were cited

in subsequent publications a

total of 7,318 times!

Those publications were in

turn cited in 301,716

papers!

*Note: analysis done on articles that appeared in PubMed through 9/24/2020
RRI

$420,235

Awarded

in FY 2020

Research Integrity Program Development and Evaluation

(PD&E)

ORI GRANTS PROGRAM

Conferences on Research Integrity (CRI)

Research on Research Integrity (RRI) Grant Awards

Seeks to develop an evidence base for creation or enhancement of

educational and interventional programs that promote research

integrity and prevent research misconduct

Funds innovative original research related to the: (a) prevention of

research misconduct; (b) facilitation of whistleblowing and the

protection of whistleblowers; and (c) promotion of the responsible

conduct of research and the furtherance of research integrity

Seeks to provide a forum for discussion, production of tangible outcomes,

and broad dissemination of generalizable knowledge on the topics related

to: (a) Responsible Conduct of Research (RCR) training; (b) fostering an

environment that promotes research integrity; (c) prevention of research

misconduct; (d) effective handling of research misconduct allegations; and

(e) whistleblowing and protection of whistleblowers

Funds projects that plan and implement conferences or workshops on

research integrity and compliance with the Public Health Service Policies

on Research Misconduct (42 C.F.R. Part 93)

Seeks to support innovative projects that aim to develop and

evaluate programs and resources related to: (a) fostering research

integrity; (b) preventing or detecting research misconduct;

(c) protecting whistleblowers, respondents, and other vulnerable

individuals; and (d) enabling the proper handling of allegations of

research misconduct

Funds the creation of materials, resources, tools, and expertise to

support a variety of new or existing programs

3

Grants

PD&E

$188,173

Awarded

in FY 2020

2

Grants

CRI

$43,769

Awarded

in FY 2020

1

Grant

8

10

The number of research publications

citing support from the ORI Extramural

Research Program during FY 2020.

Click here for more information on ORI's FY 2020 grantees.
This was an

increase of

263 from

the previous

year

5,126

The number of active

institutional assurances on file at

the end of calendar year 2019*

An institution is eligible when it has an active assurance on file with ORI stating

that it has developed research misconduct policies and will comply with the PHS

Policies on Research Misconduct (42 C.F.R. Part 93).

COMPLIANCE

Compliance Review Program

Assurance Program

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Ensures that institutions comply with their policy and the PHS Policies on Research

Misconduct (42 C.F.R. Part 93) when responding to allegations of research misconduct

Monitors the implementation of PHS administrative actions

Responds to retaliation complaints from whistleblowers

Responds to instances of noncompliance by requiring specified corrective actions be

taken

Closed in

FY 2020

Continued

into FY 2021

17

New in

FY 2020

20

From Previous

Years

15 12

32 Compliance review cases handled in FY 2020

In calendar year 2019, assurances on file increased from institutions of higher

education, other health/ human resources/ environmental services organizations, and

small businesses. In contrast, filings decreased from research organizations/ institutes/

foundations/ laboratories, independent hospitals, and educational organizations other

than higher education.

*Calendar year 2019 assurances were filed from January 1, 2020 through April 30, 2020.

The Assurance Program is responsible for

ensuring that PHS research funds are awarded

only to eligible institutions.
Elisabeth Handley, M.P.A., Director of the Office of Research Integrity (ORI) Before

joining ORI, Ms. Handley held multiple jobs in the Centers for Medicare and Medicaid Services

(CMS), including Deputy Center Director and Acting Director of the Center for Program Integrity,

and earlier conducted evaluation and inspections in the HHS Office of Inspector General. At the

National Cancer Institute (NCI), the Office of the National Coordinator for Health Information

Technology, and the Health Resources and Services Administration, Ms. Handley was responsible

for grants and program integrity. Ms. Handley began her federal career as a Presidential

Management Fellow at the Social Security Administration, after receiving a master’s degree in

public administration from Florida State University.

Karen Wehner, Ph.D., Director of the Division of Education and Integrity (DEI) Prior to

joining ORI, Dr. Wehner served as the Associate Director of the Division of Research Integrity at

the Johns Hopkins University School of Medicine (JHU SOM). In this role, she was responsible for

overseeing, developing, and delivering Responsible Conduct of Research training for faculty,

postdocs, and staff at JHU SOM as well as consulting on and supporting RCR training for graduate

students. Dr. Wehner also functioned as Assistant Research Integrity Officer, providing

comprehensive support for the institution’s response to allegations of research misconduct.

Dr. Wehner earned her Ph.D. in Genetics at Yale University, completed postdoctoral work at

Stanford University School of Medicine, and conducted basic biomedical research at JHU SOM.

Alexander Runko, Ph.D., Director of the Division of Investigative Oversight (DIO)

Dr. Runko worked at ORI as a Scientist-Investigator from 2010-2016, where he was involved in

handling and assessing allegations and reports of inquiries and investigations of research

misconduct that involve Public Health Service funding. In that role, he also trained and provided

guidance to research institutions, federal agencies, and journal editors on forensic and analytical

tools to examine and uncover the falsification and fabrication of scientific data. Dr. Runko has a

Ph.D. in biochemistry and molecular pharmacology from the University of Massachusetts

Memorial Medical Center, where his research focused on neurogenesis, embryology,

developmental biology and genetics, and completed his postdoctoral training at NIH’s National

Institute of Neurological Disorders and Stroke, where he analyzed the genetic and molecular

mechanisms underlying neurodegenerative diseases.

Wanda Jones, Dr.P.H., Deputy Director, and Associate Director, Research and Scientific

Integrity Prior to joining ORI, Dr. Jones was in the Office of the Assistant Secretary for

Preparedness and Response where she led development of the HHS 2017 update to the

Pandemic Influenza Plan. From 2009 to 2016, Dr. Jones was the HHS Principal Deputy Assistant

Secretary for Health (PDASH) where she oversaw ORI operations and was the signing official on

voluntary settlement agreements on research misconduct findings. Dr. Jones joined the Centers

for Disease Control and Prevention (CDC) in 1987, where she led laboratory training efforts in

HIV/AIDS testing, then moved to a science advisory role in HIV/AIDS policy at CDC, focusing on

policies related to neonatal screening, women and HIV/AIDS, vaccine development, and HIV

reporting. In 1994, she established CDC’s Office of Women’s Health, and was selected to lead the

HHS Office on Women’s Health in 1998.

MEET THE DIRECTORS

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U.S. Department of Health and Human Services

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