Research Misconduct Delia Y. Wolf, MD, JD, MSCI Associate Dean, Regulatory Affairs & Research Compliance Harvard School of Public Health Email: dywolf@hsph.harvard.edu February 21, 2014

Case #4 Dr. Marion W. long ago learned that good data management practices are essential to responsible conduct of research. She therefore carefully supervises the work of her assistants and students, checking notebooks, backing up computer files, and from time to time verifying results for herself. As she is wrapping up work on one project before starting another, the technology transfer officer at her university calls. A graduate student who previously worked in her laboratory has moved to another university and filed a patent for work that may have been done in Dr. W’s laboratory on her research funds. If this is the case, the graduate student may not be able to lay claim to the patent. What evidence will Dr. W. need to show that the work was done in her laboratory? If the Dr. W’s research was funded by an NIH grant, who owns and controls the data collected in her laboratory? If Dr. W’s work was funded by NIH, but under a contract, would data ownership change? Do computer records pose any unique problems for Dr. W to prove the date of data collection?

Case #5 Dr. Young is a pediatrician, who works in several Harvard-affiliated community based clinics. He is also a faculty member at HSPH. Dr. Young is conducting a 12-month study to find the best dose of Vitamin D to treat teenagers to prevent deficiency. Healthy children between ages 12 and 17 are eligible to participate. Other than taking vitamin D pills, study procedures include quarterly blood test for vitamin D level and measuring height and weight. Each participant will receive a $20 Barnes and Nobles gift cards at the end of each visit. In addition, parent of each participant will receive $100 at the end of the study. In order to be paid however, Dr. Young will have to collect their social security number. Which data/information security category (level 1 – 5) the data/information Dr. Young collects fall under? Since Dr. Young works in clinics in several locations, he would like to store all his data in a thumb, so he can access his study data from his personal laptop whenever and wherever he wants. Can he do that? Why/why not? If in reality, Dr. Young can only meet Harvard’s network security requirements for data that are categorized at level 3 and below, is it still possible for him to conduct the study? If so, how?

Research Misconduct Public Health Service Policies on Research Misconduct, 42 CFR 50 & 93 Office of Research Integrity: http://ori.dhhs.gov Be familiar with your institutional policy The institution may make findings of research misconduct or other breaches of research integrity under internal policies and standards adopted by the institution even if no misconduct or other breaches of integrity are found under the HHS regulation 4 4

Definitions Research Misconduct means fabrication, falsification, or plagiarism, in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion Fabrication is making up data or results and recording or reporting them 5 5

Definitions (cont.) 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 Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit 6 6

Definitions (cont.) Plagiarism: ORI considers plagiarism to include both the theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work. It does not include authorship or credit disputes. unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review 7 7

Definitions (cont.) Allegation means any disclosure, whether by written or oral statement, or any other communication, to an institutional, Department of Justice (DOJ), or a DHHS official who receives the allegation while acting in their official capacity, that a covered institution or member thereof has engaged in research misconduct 8 8

Definitions (cont.) Whistleblower is an individual, who makes an allegation or demonstrates an intent to make an allegation (or what is perceived to be an allegation) while a member of the institution at which the alleged research misconduct occurred 9 9

Definitions (cont.) Good faith allegation means an allegation of scientific misconduct made with a belief in the truth of the allegation which a reasonable person in the whistleblower's position could hold based upon the facts. An allegation is not in good faith if made with reckless disregard for or willful ignorance of facts that would disprove the allegation 10 10

Definitions (cont.) Retaliation means any adverse action or credible threat of an adverse action taken by a covered institution, or member thereof, in response to a whistleblower's good faith allegation of scientific misconduct Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issues is more probably true than not 11 11

Finding of Research Misconduct There must be significant departure from accepted practices of the relevant research community The misconduct must have been committed intentionally, knowingly, or recklessly The allegation must be proven by preponderance of the evidence 12 12

Who has the burden of proving The institution or HHS has the burden of proving research misconduct The respondent must prove by a preponderance of the evidence that honest error or difference of opinion occurred The finder of fact must give due consideration to admissible, credible evidence of honest error or difference of opinion presented by respondent 13 13

PHS Responding to Allegations receipt of an allegation preliminary assessment of the allegation conduct of the inquiry and investigation institutional decision ORI oversight review PHS decision option to request a hearing imposition of PHS administrative actions when research misconduct is found 14 14

Complainant The complainant (whistleblower) is an essential element in the effort to protect the integrity of research determine what information should be included in the allegation, to whom the allegation should be reported, what protections are provided for the complainant, and what role the complainant will play in the ensuing proceedings 15 15

Complainant (cont.) Research misconduct allegations should be made to the institutional official named to receive such allegations in the institutional policy for responding to research misconduct allegations. Allegations may also be made to ORI HSPH – all allegations of research misconduct shall be brought to the attention of the Dean of the School of Public Health 16 16

Complainant (cont.) Institution is required to: Provide confidentiality to all respondents, complainants, and research subjects identifiable from research records or evidence Take all reasonable and practical steps to protect the positions and reputations of good faith complainants, witnesses and committee members and protect them from retaliation by respondents and other institutional members 17 17

Respondent When accused of research misconduct, a respondent should review the PHS Policies on Research Misconduct - 42 C.F.R. 93, review the institution’s policies on responding to research misconduct gather documentation and identify witnesses consider whether an advisor, expert, or counsel is needed avoid actions which are or could be perceived as, retaliatory against the whistleblower, and maintain the confidentiality of the proceedings 18 18

Respondent (cont.) In responding to an allegation, an institution must provide notification of receipt of an allegation confidential treatment to the maximum extent possible an opportunity to comment on allegations and findings a copy of the inquiry report for comment notification whether an investigation will be initiated a prompt, fair, objective, thorough and competent investigation a copy of the investigation report for comment access to the evidence on which the report is based a diligent effort, as appropriate, to restore the reputation of the respondent if the allegation is not confirmed 19 19

Allegations Allegations are made to the institution where the research misconduct has occurred A whistleblower may also make an allegation of research misconduct to ORI or a PHS funding agency 20 20

Allegations (cont.) An allegation should contain the following information: Name of respondent(s) Name of whistleblower(s) Names of witnesses Description of misconduct When misconduct occurred Where misconduct occurred Supporting documentation Grant number or title Funding source 21 21

Preliminary Assessment Falsification: substituting one subject's record for that of another subject; altering the dates and results from subjects' eligibility visits; altering the dates on patient screening logs and/or submitting the same log with altered dates on multiple occasions; failing to update the patients' status and representing data from prior contacts as being current; 22 22

Preliminary Assessment (cont.) Falsification (cont.) altering the results of particular tests on blood samples to show that the test accurately predicted a disease or relapse; backdating follow-up interviews to fit the time window determined by the study protocol; and falsifying the times that blood samples were drawn from human subjects 23 23

Preliminary Assessment (cont.) Fabrication: creating records of interviews of subjects that were never performed making up progress notes for patient visits that never took place and inserting them into the medical record to support published and unpublished research reports preparing records for calls and follow-up contacts to subjects who had already died 24 24

Inquiries Following the preliminary assessment, if the institutional official determines that the allegation provides sufficient information to allow specific follow-up, he/she should immediately initiate the inquiry process The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation 25 25

Investigation The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent The findings of the investigation need to be set forth in an investigation report that is submitted to ORI for oversight review 26 26

Institutional Decisions The institution’s deciding official usually makes the final determination whether to accept the investigation report, its findings, and the recommended institutional actions The deciding official's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of ORI review When a final decision on the case has been reached, the institution needs to notify both the respondent and the whistleblower in writing 27 27

ORI Oversight Review During its review, ORI staff examine the institution’s report and conclusions to determine whether the institutional findings are defensible, well supported by the evidence, and acceptable as a final resolution of the allegations When ORI completes an oversight review of an institutional inquiry or investigation, it usually prepares an ORI oversight report that describes the institutional process and the rationale it developed for determining whether the allegation was substantiated 28 28

PHS Decision and Hearing The Assistant Secretary for Health (ASH) makes the final PHS/HHS decision on the imposition of administrative actions after reviewing the recommendations made by ORI ORI sends the respondent a copy of the final ORI report and a notification letter that describes the proposed administrative actions to be taken against the respondent If a hearing is not requested by the respondent within 30 days from receipt of the notification, the research misconduct finding and administrative actions become final 29 29

Administrative Actions The administrative actions PHS may take against respondents include, but are not limited to: debarment from eligibility to receive Federal funds for grants and contracts prohibition from service on PHS advisory committees, peer review committees, or as consultants certification of information sources by respondent that is forwarded by institution certification of data by institution imposition of supervision on the respondent by the institution submission of a correction of a published article by respondent submission of a retraction of a published articles by respondent 30 30

The Poehlman Case Eric Poehlman, PhD, was an internationally recognized, tenured professor at the UVM In October 2000, Walter Denino, a junior member of Poehlman’s laboratory became convinced that he had altered data from a study on aging volunteers from the Burlington area The case developed into one of the most significant cases of scientific misconduct in the history of the DHHS ORI, launching a DOJ civil and criminal fraud investigation and eventually, to a guilty plea and felony conviction 31 31

The Poehlman Case (cont.) Poehlman admitted to 54 findings of scientific misconduct made by the UVM and ORI Was sentenced on June 28, 2006 to a year in prison Permanently barred from obtaining federal research grants Agreed to retract or correct ten of his publications 32 32