Final Report of the College of Education and Human Ecology Investigation Committee Concerning Allegations of Misconduct in Research March 3, 2017 Introduction On August 24, 2015, the Ohio State University Biomedical Institutional Review Board (IRB) met to discuss allegations of possible non-compliance with human subjects protection requirements, and to assess if the research conducted under Dr. Devor’s IRB protocol #2011H0124, “Ventriculovascular Coupling in Resistance and Aerobic Athletes: The Effects of Neural Sympathetic Nerve Activity & Endothelial Function” supported the publication: “Crossfit-Based High-Intensity Power Training Improves Maximal Aerobic Fitness and Body Composition” published in the Journal of Strength and Conditioning, in November 2013 (see attachment folder 3/files A2 and A3). The IRB reviewed the matter and made a finding against Dr. Devor of “Serious and Continuing Noncompliance” under the Ohio State Human Research Protection Program policy, “Noncompliance.” On March 14, 2016, Dr. Janet Weisenberger, Senior Associate Vice President for Research notified Dr. Devor that as a result of the IRB’s findings his PI privileges were suspended effective December 8, 2015 for a period of three (3) years. As part of its investigation, the IRB noted significant discrepancies between Dr. Devor’s research documents and the published article detailing this work and therefore on September 21, 2015, the IRB referred the matter to Dr. Jennifer Yucel, Research Integrity Officer, for review under the University Policy and Procedures Concerning Research Misconduct (the “Policy”, attachment 1). As required by the Policy, a Preliminary Assessment was conducted and on October 23, 2015 the conclusion reached that an inquiry was warranted (see attachment folder 3/A0). A Committee of Initial Inquiry (“CII”) was formed on October 27, 2015 to review allegations of possible research misconduct. On December 8, 2015, Dr. Yucel received additional allegations from the IRB stemming from the IRB’s audit of Dr. Devor’s open studies (see attachment folder 3/A7). The CII was asked to review for possible research misconduct the following 4 publications which reference IRB protocol #2011H0124: 1  Smith, M.M., Sommer, A.J., Starkoff, B.E., and Devor, S.T. (2013). “CrossfitBased High-Intensity Power Training Improves Maximal Aerobic Fitness and Body Composition.” The Journal of Strength and Conditioning Research (2013) Vol. 27 (11):3159-3172. (see attachment folder 3/A3) • Smith, M.M., Trexler, E.T., Sommer, A.J., Starkoff, B.E., and Devor, S.T. (2014). “Unrestricted Paleolithic Diet is Associated with Unfavorable Blood Lipids in Healthy Subjects.” The International Journal of Exercise Science, Volume 7 (2), pg. 128-139. (see attachment folder 3/A8) • Smith, M.M., Hanson, N.J., De N Lucas, A.R., and Devor, S.T. (2013). “Endothelial Response of Running a Marathon - A Tale of Three Runners”. The International Journal of Exercise Science, Volume 6 (3) pg. 236-241. (see attachment folder 3/A9) • Smith, M.M. (2012) Dissertation entitled “Effects of Neural Sympathetic Nerve Activity and Endothelial Function on Ventriculovascular Coupling Efficiency in Resistance and Endurance Trained Athletes.” (see attachment folder 3/A10) the associated publication Smith, M.M., Buffington, C.A.T., Hamlin, R.L., and Devor, S.T. (2015). “Relationship between muscle sympathetic nerve activity and aortic wave reflection characteristics in aerobic- and resistance-trained subjects.” European Journal of Applied Physiology, Vol 115:2609-2619 (see attachment folder 3/A13) The CII reviewed all available evidence, conducted interviews with Dr. Devor, former graduate student and Dr. Zadnik, Chair of the IRB and on July 28, 2016, the CII issued their Final Report (attachment 3). The CII determined that the allegation that Dr. Devor had knowingly and intentionally made false statements to multiple journals regarding the IRB approval of the studies being published, had sufficient substance to warrant investigation. Specifically the statement “All the subjects provided written informed consent, and all study methods and protocols were approved in advance by the Institutional Review Board at The Ohio State University”, included in all three journal articles, represents falsification in the reporting of research. Regarding the concerns involving the integrity of the data being reported, the CII did find evidence of sloppiness and poor record-keeping, however, the CII did not find sufficient evidence of possible research misconduct to move that allegation forward to an investigation. On October 5, 2016, the allegation of possible research misconduct against Dr. Devor was referred to the College for investigation under the Policy (attachment 4). 2 College of Education and Human Ecology Investigation Committee Under the Policy and University Rule 3335-5-04 regarding complaints against faculty, the College of Education and Human Ecology Investigation Committee (the “Committee”) conducted a formal investigation of the allegations of possible falsification in the reporting of research. The College of Education and Human Ecology Investigation Committee reviewing the matter included the membership of the following Ohio State University Faculty:  Dr. Anatasia Snyder (Chair), Associate Professor, Department of Human Sciences, Associate Dean for Faculty Affairs, College of Education and Human Ecology;  Dr. Carla Miller, Professor, Department of Human Sciences, College of Education and Human Ecology;  Dr. Christopher Wolters, Professor, Department of Educational Studies, College of Education and Human Ecology;  Dr. David Bloome, EHE Distinguished Professor, Department of Teaching and Learning, College of Education and Human Ecology; and  Dr. John Casterline, Professor, Department of Sociology, College of Arts and Sciences. The Committee did not consult with any outside persons or consultants. Research Records and Evidence No additional research records or evidence beyond what was sequestered and/or identified during the course of the CII’s review were obtained or reviewed by the Committee. Meetings and Discussions of the Committee The Committee first met on December 15, 2016. The following documents related to the allegations were provided to the Committee:  The University Policy and Procedures Concerning Research Misconduct (attachment 1)  University Senate Rule 3335-5-04 (E) (attachment 2)  The Final Report of the Committee of Initial Inquiry Concerning Allegations of Research Misconduct (attachment 3) 3  A computer disk (CD) containing the following files:  The Preliminary Report and Final Reports of the Committee of Initial Inquiry Concerning Allegations of Research Misconduct and all referenced attachments (A1-A24) (see attachment folder 3); During their initial meeting, the Committee discussed the research misconduct policy and process, the allegations and specific charge to the Committee, and briefly reviewed the documents provided. Dr. Snyder was appointed Chair of the Committee and the Committee scheduled to meet again to discuss the case on January 5, 2017 after the members had a chance to review all of the case materials. The Committee asked that Dr. Yucel contact Dr. Devor to arrange an interview with the Committee. Dr. Yucel contacted Dr. Devor by email on December 19, 2016, to schedule an interview of Dr. Devor by the Committee (attachment 5). Later that same day, Dr. Devor responded to Dr. Yucel, declining to be interviewed by the Committee but indicating: “If any of the committees have anything additionally for me, please have it sent via campus mail or e-mail.” In addition, Dr. Devor notified the Committee that he had resigned from the University effective May 31, 2017 (attachment 6). The Committee met via conference call on January 5, 2017 to discuss the case, to determine if there were any questions that the Committee had for Dr. Devor, to determine if there was anyone else that Committee wanted to interview, and if ready to come to a determination based on their review of the case. The Committee discussed the materials and evidence provided by the CII. It was determined by the Committee that the CII had provided a very full record, containing the necessary and sufficient evidence on which to render a decision, and that the Committee did not have any specific additional questions for Dr. Devor or for anyone else involved in the case. Findings of Committee The Committee discussed the evidence warranting the charge of research misconduct by Dr. Devor. This included a discussion of the definitions of key words in the official university language related to research misconduct. Specifically, the committee discussed the meaning of intentionally, knowingly, or recklessly committing research misconduct. Based on a preponderance of the evidence, the Committee ultimately concluded that Dr. Devor had engaged in research misconduct. The most convincing evidence for the Committee that Dr. Devor committed research misconduct was that in 4 three separate journal articles he co-authored, it was falsely stated that for the research presented within the article, all subjects had provided written informed consent and all study methods and protocols had received approval by the IRB. The transcript of CII’s interview of Dr. Devor clearly indicated that he had full knowledge that the central aspects of the research presented in these articles was not reviewed nor approved by the IRB. Authoring these statements and endorsing their publication was determined by the Committee to have been done intentionally and with full knowledge that the relevant research in fact had not received IRB approval. In addition, the Committee considered this repeated, intentional, action of authorizing the publication of false statements within multiple journals by Dr. Devor, to be a significant departure from the accepted practices of academic researchers in his field. Conclusions Reached Regarding the allegation of Research Misconduct by falsification, as defined under the University’s Policy and Procedures Concerning Research Misconduct, “Falsification” is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.” Further, a finding of Research Misconduct requires that there is a significant departure from accepted practices of the relevant research community, that the misconduct be committed intentionally, knowingly, or recklessly and that the allegation be proved by a “Preponderance of the Evidence.” Regarding the allegations of Research Misconduct by the falsification in the reporting of research data in three publications made against Dr. Devor, the Committee finds, by a unanimous vote of (5:0), using the preponderance of the evidence standard, that Dr. Devor, did knowingly, intentionally, and recklessly, commit research misconduct related to the falsification in reporting of research. Therefore, the allegations of Research Misconduct by the falsification of research data made against Dr. Devor are substantiated. When complaints are filed against faculty at the University, any investigation and / or proposed sanctions shall follow the process under University Rule 3335-5-04 (attachment 2). Under this process, the findings of the College Investigation Committee shall be based on a “Clear and Convincing” evidence standard. Pursuant to this standard, the Committee finds by a 5:0 vote that Dr. Devor committed research misconduct related to the falsification in reporting of research. 5 Recommended Actions Under the University Policy and Procedures Concerning Research Misconduct, section IV.F.5, the Committee shall include recommended sanctions in cases where allegations of Research Misconduct are substantiated. The Committee understands from Dr. Devor that he has submitted his resignation, effective May 31, 2017. As Dr. Devor will be leaving the institution, there are limited sanctions or corrective actions that can be taken. However, given the serious nature of the research misconduct findings against Dr. Devor, the Committee recommends that the following corrective actions and/or sanctions be implemented before Dr. Devor leaves the institution:  Dr. Devor is required to contact the current editors of the Journal of Strength and Conditioning Research and the International Journal of Exercise Science via certified mail (with copies to the Office of Research Compliance and the Associate Dean for Research, College of Human Ecology and Education) to inform them in writing that statements within the three relevant articles were known by him to be false at the time of publication. Specifically, the published studies were not conducted under an approved IRB protocol as was stated in the original published articles. In addition, Dr. Devor must take whatever steps the journals’ editors require to correct or retract the publications;  Dr. Devor’s base pay be reduced by 33% for the 2017 calendar year;  The IRB’s sanction involving the Dr. Devor’s loss of PI Privileges remain in effect until he leaves the institution or until the term of the suspension has ended;  Dr. Devor’s Graduate status be revoked, and that he be prevented from serving on any doctoral or dissertation committees.  A written reprimand reflecting the conclusions of the Committee, signed by the Dean of the College, be added to Dr. Devor’s personnel file. The Committee also recommends that the following sanction be implemented after Dr. Devor leaves the institution:  Dr. Devor be denied Emeritus faculty status if he ever makes this request after he leaves the university. 6 Appendix Complainant: The Ohio State University, Biomedical Institutional Review Board (IRB) Respondent: Dr. Steven Devor, Associate Professor, Department of Human Sciences Administration, College of Education and Human Ecology Committee Members:      Dr. Anastasia Snyder (Chair), Associate Professor, Department of Human Sciences, Associate Dean for Faculty Affairs, College of Education and Human Ecology; Dr. Carla Miller, Professor, Department of Human Sciences, College of Education and Human Ecology; Dr. Christopher Wolters, Professor, Department of Educational Studies, College of Education and Human Ecology; Dr. David Bloome, EHE Distinguished Professor, Department of Teaching and Learning, College of Education and Human Ecology; and Dr. John Casterline, Professor, Department of Sociology, College of Arts and Sciences. Ex Officio Members:   Jennifer K. Yucel, Ph.D., Director and Research Integrity Officer Courtney Mankowski, Research Integrity and Compliance Manager Known Federal Support: There was no known federal research support. Correspondence and Documentary Evidence: The University Policy and Procedures Concerning Research Misconduct (attachment 1) University Senate Rule 3335-5-04 (E) (attachment 2) The Final Report of the Committee of Initial Inquiry (CII) Concerning Allegations of Research Misconduct, dated July 28, 2016 (attachment 3) and all referenced files (see attachment folder 3) Letter from Dr. Richard Lomax, Chair, CII to Dr. Cheryl Achterberg, Dean, College of Education and Human Ecology, dated October 5, 2016, referring case to College for Investigation (attachment 4) 7 Email from Dr. Jennifer Yucel, Research Integrity Officer, to Dr. Steven Devor requesting to schedule an interview with the investigation committee, dated December 19, 2016 (attachment 5) Email from Dr. Devor to Dr. Yucel, declining to be interviewed by committee, dated December 19, 2016 (attachment 6) Email from Dr. Devor to Courtney Mankowski, containing comments on the preliminary report, dated February 27, 2017 (attachment 7) Letter from Dr. Yucel to Dr. Caroline Whitacre with the Final Report, dated March 3, 2017 (attachment 8) Length of Proceedings Commencement of the Investigation was delayed due to the unusual circumstances of the case and other factors being reviewed by the College external to the Research Misconduct process. However, once initiated, the Investigation was completed well within the required timeline of one hundred and twenty days (120). 8