46706 Federal Register / Vol. 86, No. 158 / Thursday, August 19, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Viravuth Yin, Ph.D. (Respondent), 

former Associate Professor, Mount 

Desert Island Biological Laboratory 

(MDIBL). Respondent engaged in 

research misconduct in research 

supported by U.S. Public Health Service 

(PHS) funds, specifically National 

Institute of General Medical Sciences 

(NIGMS), National Institutes of Health 

(NIH), grants P20 GM104318 and P20 

GM103423. The administrative actions, 

including supervision for a period of 

two (2) years, were implemented 

beginning on August 2, 2021, and are 

detailed below. 

FOR FURTHER INFORMATION CONTACT: 

Wanda K. Jones, Dr.P.H., Acting 

Director, Office of Research Integrity, 

1101 Wootton Parkway, Suite 240, 

Rockville, MD 20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the Office of Research 

Integrity (ORI) has taken final action in 

the following case: 

Viravuth Yin, Ph.D., Mount Desert 

Island Biological Laboratory: Based on 

the report of an investigation conducted 

by MDIBL and analysis conducted by 

ORI in its oversight review, ORI found 

that Dr. Viravuth Yin, former Associate 

Professor, MDIBL, engaged in research 

misconduct in research supported by 

PHS funds, specifically NIGMS, NIH, 

grants P20 GM104318 and P20 

GM103423. 

Respondent neither admits nor denies 

ORI’s findings of research misconduct. 

The settlement is not an admission of 

liability on the part of the Respondent. 

The parties entered into a Voluntary 

Settlement Agreement to conclude this 

matter without further expenditure of 

time, finances, or other resources. 

ORI found that Respondent engaged 

in research misconduct by knowingly, 

intentionally, and/or recklessly 

falsifying and/or fabricating data 

included in the following three (3) 

published papers and two (2) submitted 

manuscripts: 

• Smith AM, Dykeman CA, King BL, 

Yin VP. Modulation of TNFa Activity 

by the microRNA Let-7 Coordinates 

Heart Regeneration. iScience 2019;15:1– 

15; doi: 10.1016/j.isci.2019.04.009 

(hereafter referred to as ‘‘iScience 

2019’’). 

• Smith AM, Dykeman CA, King BL, 

Yin VP. Modulation of TNFa Activity 

by the microRNA Let-7 Coordinates 

Heart Regeneration. iScience 

2019;17:225–29; doi: 10.1016/ 

j.isci.2019.06.017 (hereafter referred to 

as ‘‘iScience Correction’’). 

• Beauchemin M, Smith A, Yin VP. 

Dynamic microRNA–101a and Fosab 

expression controls zebrafish heart 

regeneration. Development 

2015;142:4026–37; doi: 10.1242/ 

dev.126649 (hereafter referred to as 

‘‘Development 2015’’). 

• Smith AM, Dykeman CA, Yin VP. 

Modulation of epicardial TNFa Activity 

by the microRNA Let-7 Coordinates the 

Zebrafish Heart Regeneration. 

Manuscript submitted to iScience in 

2018 (hereafter referred to as ‘‘iScience 

2018 draft’’). 

• Smith AM, Dykeman CA, Yin VP. 

Modulation of epicardial TNFa Activity 

by the microRNA let-7 coordinates the 

zebrafish heart regeneration. Manuscript 

submitted to PNAS in 2018 (hereafter 

referred to as ‘‘PNAS 2018 draft’’). 

Specifically, Respondent 

intentionally, knowingly, and/or 

recklessly falsified and/or fabricated 

data by: 

• Reusing, relabeling, and reporting 

Phosphate Buffered Saline (PBS) 

controls as scrambled antisense Locked 

Nucleic Acids (LNAs) in the following 

experimental results: 

—RT-qPCR data representing the 

knockdown of let7 expression in 

Figure 2B of PNAS 2018 draft, 

iScience 2018 draft, and iScience 

2019 

—images of tcf21:Dsred expression in 

LNA-let-7 treated hearts at 3, 14, and 

21 days post- amputation (dpa) 

showing defects in wound closure in 

Figure 2C of PNAS 2018 draft, 

iScience 2018 draft, and iScience 

2019 

—quantification of tcf21:Dsred 

expression within the resection 

wound in LNA-let-7 treated hearts in 

Figure 2D of iScience 2019 

—images exhibiting proliferating 

cardiac muscle (CM) in Figure 3A of 

PNAS 2018 draft, iScience 2018 draft, 

and iScience 2019 

—suppression of CM proliferation 

indices in LNA-let-7 hearts at 3 and 

7 dpa in Figure 3B of PNAS 2018 

draft, iScience 2018 draft, and 

iScience 2019 

—severity of the injured heart 

phenotype in Figure 3C of PNAS 2018 

draft, iScience 2018 draft, and 

iScience 2019 

—quantification of the severity of the 

injury heart phenotype in Figure 3D 

of iScience 2019 

—electron microscopy images of remote 

and injury zones of resected 7-dpa 

hearts in Figure 4A of PNAS 2018 

draft, iScience 2018 draft, iScience 

2019, and iScience Correction 

—images of Tg(gata4:GFP) expression in 

the primordial heart muscle layer in 

Figure 4B of PNAS 2018 draft, 

iScience 2018 draft, iScience 2019, 

and iScience Correction 

—quantification of gata4:GFP 

expression in control and LNA-let-7 

treated hearts in Figure 4C of iScience 

2019 and iScience Correction 

—RNA transcripts identifying 

differentially upregulated TNFa 

transcripts in Figure 5A of PNAS 2018 

draft, iScience 2018 draft, iScience 

2019, and their resultant qPCR results, 

which identified increased TNFa 

expression in Figure 5C of PNAS 2018 

draft, Figure 5B of iScience 2018 draft, 

iScience 2019, and Table S1 of 

iScience 2019 

—CM proliferation analyses results in 

Figures S4B and S4C of PNAS 2018 

draft and iScience 2018 draft, and 

Figures S5B and S5C of iScience 2019 

—images representing the function of 

let-7 in Figure 2C of iScience 

Correction and reusing and relabeling 

images from an unrelated experiment, 

such that let-7 function is not 

represented in the image 

—images reporting the function of let-7 

in Figure 3A of iScience Correction 

—images representing differences in the 

effects of miR–101a depletion on 

Met2 and PNA expression and the 

quantification of cardiomyocyte 

proliferation in uninjured control and 

Tg(hs:miR-101a-sp) heat exposed 

hearts (CM proliferation analysis) in 

Figures 2A, 2B, 2C, and 2D, and 

results in Figure 2E of Development 

2015 

—muscle, fibrin, and collagen staining 

images representing increased scar 

tissue presence in Tg(hs:miR-101a-sp) 

heat-treated hearts, as compared to 

wild type hearts in Figures 3A, 3B, 

3C, 3D, 3E, and 3F of Development 

2015 

—scarring indices and the size of the 

injured area in wild type versus 

Tg(hs:miR-101a-sp) heat-treated 

hearts in Figures 3G and 3H of 

Development 2015 

—differences in (1) the amount of 

scarring, as represented by AFOG 

staining in control and Tg (hs:miR101-a-sp) ventricles from resected and 

heat-treated hearts in Figures 4B and 

4C; (2) the amount of scar tissue in the 

presence of suppressed miR-101a 

expression in Tg(hs:miR-101a-sp) 

hearts, compared to control hearts in 

Figures 4H and 4I; and (3) the 

quantification of the scarring indices 


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Federal Register / Vol. 86, No. 158 / Thursday, August 19, 2021 / Notices 46707 

in control versus Tg(hs:miR-101a-sp) 

hearts in Figure 4J of Development 

2015 

—differences in (1) the amount of 

scarring, as represented by comparing 

AFOG staining in control and 

Tg(hs:miR-101a-sp) and Tg(hs:miR133a1-pre) hearts exposed to long 

term heat therapy in Figures 5A, 5B 

and 5C, or Tropomyosin staining in 

Figures 5D, 5E, and 5F; and (2) the 

quantification of the scarring indices, 

tropomyosin expression, and injury 

area in Figures 5G, 5H, and 5I of 

Development 2015 

—increased Fosab expression in 

Tg(hs:miR-101a-sp) ventricles relative 

to controls in Figures 6A and 6B, RNA 

in situ hybridization studies in 

control and regenerating hearts 

detecting miR-101a expression in 

Figures 6C, 6D, 6E, and 6E’, and Fosab 

expression in Figures 6F, 6G, 6H, and 

6H’ of Development 2015 

—images reporting significant 

differences in Dsred expression, 

cardiomyocyte proliferation, collagen 

and fibrin staining, and scar tissue 

removal in ventricles from zebrafish 

treated with lna-Let-7, as compared to 

scrambled control, to support the 

importance of miR-101a in scar tissue 

removal/ventricular regeneration in 

Figures 6H, 6I, 6J, 7C, 7D, and 7E of 

Development 2015 

• reporting research methods and 

statistics that were not performed in the 

following experimental results: 

—PCR data in the graph represented in 

Figure 2B of PNAS 2018 draft, 

iScience 2018 draft, and iScience 

2019, by representing the data from 

two (2) remote PCR experiments as 

being from the same experiment 

—PCR data in the graph represented in 

Figure 2B of iScience Correction by 

reusing and relabeling a graph 

containing data that were the result of 

different experimental conditions 

(exposure to heat shock), to include 

scrambled control data 

—control data and statistical differences 

between control and experimental 

data represented in PNAS 2018 draft, 

iScience 2018 draft, iScience 2019, 

and iScience Correction, by falsely 

reporting the use of both antisense 

scrambled and LNA oligonucleotides 

that were designed and administered 

to adult animals via intraperitoneal 

injection at 10ug/g body weight 

—representing the ‘‘n’’ of one biological 

replicate or one experiment as being 

multiple independent samples or 

experiments in iScience 2019 and 

iScience Correction 

—control data and statistical differences 

between control and experimental 

data and the reported methods in 

Development 2015, concluding that 

miR-101a controls both CM 

proliferation and scar tissue removal, 

by falsely reporting the use of LNA 

oligonucleotides to modulate miR-101 

activity in vivo to elucidate its 

contributions during adult heart 

regeneration 

Dr. Yin entered into a Voluntary 

Settlement Agreement (Agreement) and 

voluntarily agreed to the following: 

(1) Respondent agreed to have his 

research supervised for a period of two 

(2) years beginning on August 2, 2021. 

Respondent agreed that prior to 

submission of an application for PHS 

support for a research project on which 

Respondent’s participation is proposed 

and prior to Respondent’s participation 

in any capacity on PHS-supported 

research, Respondent shall ensure that a 

plan for supervision of Respondent’s 

duties is submitted to ORI for approval. 

The supervision plan must be designed 

to ensure the scientific integrity of 

Respondent’s research contribution. 

Respondent agreed that he shall not 

participate in any PHS-supported 

research until such a supervision plan is 

submitted to and approved by ORI. 

Respondent agreed to maintain 

responsibility for compliance with the 

agreed upon supervision plan. 

(2) The requirements for Respondent’s 

supervision plan are as follows: 

i. A committee of 2–3 senior faculty 

members at the institution who are 

familiar with Respondent’s field of 

research, but not including 

Respondent’s supervisor or 

collaborators, will provide oversight and 

guidance for a period of two (2) years 

from the effective date of the 

Agreement. The committee will review 

primary data from Respondent’s 

laboratory on a quarterly basis and 

submit a report to ORI at six (6) month 

intervals setting forth the committee 

meeting dates and Respondent’s 

compliance with appropriate research 

standards and confirming the integrity 

of Respondent’s research. 

ii. The committee will conduct an 

advance review of any PHS grant 

applications (including supplements, 

resubmissions, etc.), manuscripts 

reporting PHS-funded research 

submitted for publication, and abstracts. 

The review will include a discussion 

with Respondent of the primary data 

represented in those documents and 

will include a certification to ORI that 

the data presented in the proposed 

application/publication is supported by 

the research record. 

(3) Respondent agreed that for a 

period of two (2) years beginning on 

August 2, 2021, any institution 

employing him shall submit, in 

conjunction with each application of 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved, a certification to ORI that the 

data provided by Respondent are based 

on actual experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript or abstract. 

(4) If no supervisory plan is provided 

to ORI, Respondent agreed to provide 

certification to ORI at the conclusion of 

the supervision period that he has not 

engaged in, applied for, or had his name 

included on any application, proposal, 

or other request for PHS funds without 

prior notification to ORI. 

(5) Respondent agreed to exclude 

himself voluntarily from serving in any 

advisory capacity to PHS including, but 

not limited to, service on any PHS 

advisory committee, board, and/or peer 

review committee, or as a consultant for 

a period of two (2) years, beginning on 

August 2, 2021. 

(6) As a condition of the Agreement, 

Respondent will request that the 

following papers be retracted in 

accordance with 42 CFR 93.407(a)(1) 

and § 93.411(b): 

• Development 2015 Dec 

1;142(23):4026–37 

• iScience 2019 May 31;15:1–15 

• iScience 2019 Jul 26;17:225–29 

Respondent will copy ORI and the 

Research Integrity Officer at MDIBL on 

the correspondence. 

Dated: August 16, 2021. 

Wanda K. Jones, 

Acting Director, Office of Research Integrity, 

Office of the Assistant Secretary for Health. 

[FR Doc. 2021–17777 Filed 8–18–21; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Cancer Institute 

Clinical Trials and Translational 

Research Advisory Committee. 

The meeting will be held as a virtual 

meeting and is open to the public. 

Individuals who plan to view the virtual 

meeting and need special assistance or 

other reasonable accommodations to 

view the meeting, should notify the 


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