1. Office of Research Integrity Responding to allegations of research misconduct and promoting better science through Responsible Conduct of Research (RCR) John Dahlberg, Ph.D. Director, Division of Investigative Oversightg Office of Research Integrity

3. ORI’s Mission Mission: To promote the integrity of PHS- supported extramural and intramural research programs Respond effectively to allegations Respond effectively to allegations of research misconduct Promote research integrity Promote research integrity

4. Definition of Research Misconduct Fabrication is making up data or results and recording or reporting them Fabrication is making up data or results and recording or reporting them 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 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

5. Definition of Research Misconduct Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit Research misconduct does not include honest error or differences of opinion Research misconduct does not include honest error or differences of opinion (42 CFR Part 93.103)

6. Proof of Research Misconduct Requires - That there be a significant departure from accepted practices of the relevant research community, and That there be a significant departure from accepted practices of the relevant research community, and The misconduct be committed intentionally, knowingly, or recklessly; and The misconduct be committed intentionally, knowingly, or recklessly; and The allegation be proven by a preponderance of the evidence, (42 CFR Part 93.104) The allegation be proven by a preponderance of the evidence, (42 CFR Part 93.104)

7. Additional ORI Activities Administer the Assurance program, a database of all institutions eligible to receive PHS funds Administer the Assurance program, a database of all institutions eligible to receive PHS funds Correct or retract research publications to protect the integrity of the scientific literature Correct or retract research publications to protect the integrity of the scientific literature Protect the confidentiality of respondents, complainants, and witnesses Protect the confidentiality of respondents, complainants, and witnesses Protect witnesses from retaliation Protect witnesses from retaliation (42 CFR 93.300 (d) ) (42 CFR 93.300 (d) )

8. ORI Activities (cont) Provide education in RCR Provide education in RCR Collaborate with the research community to improve biomedical research Collaborate with the research community to improve biomedical research Exclude dishonest investigators from PHS and Federal agency funded research Exclude dishonest investigators from PHS and Federal agency funded research Make public findings of misconduct so that institutions and individuals will be aware of wrongdoing Make public findings of misconduct so that institutions and individuals will be aware of wrongdoing

9. ORI lacks jurisdictions for many types of inappropriate behavior: some are referred to other agencies Misuse of human or animal subjects Misuse of human or animal subjects Misconduct and other complaints involving FDA-regulated research Misconduct and other complaints involving FDA-regulated research Financial mismanagement Financial mismanagement Radiation or biosafety hazards Radiation or biosafety hazards Conflict of interest Conflict of interest

10. For Whom Does ORI Serve? Research Performance Level Frequency FFPQRPRCRERP

11. Other issues not within ORI’s jurisdiction: Honest error or honest differences in interpretations or judgments of data Honest error or honest differences in interpretations or judgments of data Authorship or credit disputes Authorship or credit disputes Duplicate publication Duplicate publication Collaboration agreements or research- related disputes among collaborators Collaboration agreements or research- related disputes among collaborators Intellectual property Intellectual property

12. Issues not within ORI’s jurisdiction (Continued) Laboratory management Laboratory management Quality control/quality assurance (eg., surveillance data) Quality control/quality assurance (eg., surveillance data) Employment issues such as job changes, promotion, termination, salary, etc. Employment issues such as job changes, promotion, termination, salary, etc. Disputes over space, equipment access, collaborative work Disputes over space, equipment access, collaborative work

13. Research Misconduct in Clinical Research By policy, in clinical trails, certain types of falsifications are not handled by ORI as allegations of research misconduct. These include: By policy, in clinical trails, certain types of falsifications are not handled by ORI as allegations of research misconduct. These include: Failure to report an adverse event to the IRB or sponsor Failure to report an adverse event to the IRB or sponsor Protocol deviations such as entering ineligible subjects, administering an off-protocol drug, forging a physician’s signature on orders Protocol deviations such as entering ineligible subjects, administering an off-protocol drug, forging a physician’s signature on orders Failure to obtain informed consent Failure to obtain informed consent Breach of patient confidentiality Breach of patient confidentiality Failure to obtain IRB approval for changes to protocol Failure to obtain IRB approval for changes to protocol

14. Research Misconduct in Clinical Research, (Continued) Behaviors that are considered research misconduct: Falsifications: Falsifications: Substitutions of one subject’s record for another’s Substitutions of one subject’s record for another’s Changing research record to favor the study’s hypothesis Changing research record to favor the study’s hypothesis Altering eligibility dates and eligibility test results Altering eligibility dates and eligibility test results Falsifying dates on patient screening logs Falsifying dates on patient screening logs Falsified or forged consent forms Falsified or forged consent forms Fabrications: Fabrications: Not conducting interviews with subjects and creating records of the interview Not conducting interviews with subjects and creating records of the interview Making up patient visits and inserting that record into the medical chart Making up patient visits and inserting that record into the medical chart Recording the results of follow-up visits with deceased subjects Recording the results of follow-up visits with deceased subjects

15. Types of data that have been falsified or fabricated in clinical studies Interviews Interviews Entry criteria Entry criteria Screening logs Screening logs Approval forms Approval forms Follow-up exams/data Follow-up exams/data Consent forms Consent forms Test scores Test scores Laboratory results Patient data Number of subjects Dates of procedures Protocol Study results

16. Handling Cases of Research Misconduct Admin. action Allegation Assessment Inquiry Investigation DIO Review Recom- mendation Settlement or charge letter Hearing Appeal ORIJudge Institution

17. Some ORI Statistics 1992 to 2010 statistics: Total misconduct findings 224 Total misconduct findings 224 Findings involving clinical research ~30% Findings involving clinical research ~30% Total accessions from 1992 4377 Total accessions from 1992 4377 Total cases opened from 1992 580 Total cases opened from 1992 580 Total cases closed from 1992 630 Total cases closed from 1992 630

18. A Major Misconduct Case: ‘ Eric Poehlman University of Vermont

19. The initial allegations arose when Dr. Poehlman provided a colleague, about a week apart, two versions of a spreadsheet containing physical, dietary, energetic, and metabolic data on elderly men and women seen twice, on average, about six years apart. In the complainant’s own words: Initial Allegations

20. The incident that triggered my suspicions occurred in late September, 2000 - I was asked by Dr. Poehlman to write a paper from a longitudinal database (Protocol #678). The paper was to examine the effects of age on lipids in men and women… When I presented him with the data, he was not satisfied with the results and asked for the database in order to verify data entries and check for what he described as "reversed" datapoints, … It was my belief that I was mistakenly given a “true” version of the dataset originally and then given the manipulated version the second time… The incident that triggered my suspicions occurred in late September, 2000 - I was asked by Dr. Poehlman to write a paper from a longitudinal database (Protocol #678). The paper was to examine the effects of age on lipids in men and women… When I presented him with the data, he was not satisfied with the results and asked for the database in order to verify data entries and check for what he described as "reversed" datapoints, … It was my belief that I was mistakenly given a “true” version of the dataset originally and then given the manipulated version the second time… Initial allegations (cont)

21. The Scope of the Misconduct The following two slides provide a glimpse of the massive scope of Dr. Poehlman’s alterations in the data base for the longitudinal study of aging, protocol #678. The following two slides provide a glimpse of the massive scope of Dr. Poehlman’s alterations in the data base for the longitudinal study of aging, protocol #678.

22. Dr. Poehlman’s changes to total energy expenditure values included many fabrications (blue) and reversals of visit one and visit two values (red) The net effects were to greatly inflate the number of subjects and to reverse the apparent effect of aging. Correct TEE values Dr. Poehlman’s TEE values

23. Dr. Poehlman’s changes to glucose involved near complete reversal of T1 and T2 values, allowing him to claim that glucose levels rose with age when the real data showed the opposite.

24. Tip of the iceberg The total number of reversals, falsifications and fabrications made by Dr. Poehlman to the 467 database was greater than 4000, all in a small fraction of the hundreds of fields of data. Although he had reported data from this study in three unfunded grant applications, almost nothing was published, and the “harm done,” by itself, was not extensive. However, much more was subsequently revealed….

25. Additional Issues Dr. Poehlman claimed to have conducted a longitudinal study of the menopause transition involving 35 women seen twice six years apart. Dr. Poehlman claimed to have conducted a longitudinal study of the menopause transition involving 35 women seen twice six years apart. This study was reported in a 1995 paper in the Annals of Internal Medicine and five follow-up papers as well as in many grant applications. This study was reported in a 1995 paper in the Annals of Internal Medicine and five follow-up papers as well as in many grant applications. The study was not conducted: Dr. Poehlman falsified the number of subjects at T1 and never saw the women a second time. The study was not conducted: Dr. Poehlman falsified the number of subjects at T1 and never saw the women a second time.

26. The data from the Annals paper claimed to show that the menopause transition quickly leads to undesirable changes in weight, fat mass, resting metabolic rate, leisure time activity, and waist-to-hip ratio. None of these conclusions were legitimate (although cross-sectional studies have suggested that changes do occur eventually). Additional fabricated results from this study were reported in later papers and grant applications.

27. Additional Issues (cont) The UVM investigation, ORI, and the U.S. Attorney’s office determined that Dr. Poehlman falsified data in additional papers and grant applications in areas as wide ranging as Alzheimer’s disease, the effect of endurance training on RMR, and the effects of hormone replacement therapy on post-menopausal women. The UVM investigation, ORI, and the U.S. Attorney’s office determined that Dr. Poehlman falsified data in additional papers and grant applications in areas as wide ranging as Alzheimer’s disease, the effect of endurance training on RMR, and the effects of hormone replacement therapy on post-menopausal women. Many of these false claims were also made in talks given by Dr. Poehlman, some of which were documented, allowing additional findings of scientific misconduct to be made. Many of these false claims were also made in talks given by Dr. Poehlman, some of which were documented, allowing additional findings of scientific misconduct to be made.

28. Dr. Poehlman’s obstruction efforts Starting immediately after being accused of misconduct, Dr. Poehlman aggressively attempted to obstruct the University investigation, and subsequently the Government’s review. Starting immediately after being accused of misconduct, Dr. Poehlman aggressively attempted to obstruct the University investigation, and subsequently the Government’s review. He accused his young colleagues of having falsified the 678 database. He accused his young colleagues of having falsified the 678 database. He went to Federal court to attempt to block UVM from notifying ORI of the pending investigation. He went to Federal court to attempt to block UVM from notifying ORI of the pending investigation.

29. Obstruction (cont) During the investigation, he solicited letters of support from collaborators and former technicians who claimed that they had helped with the longitudinal menopause study; these claims resulted from Dr. Poehlman’s false assurances and edits of the letters, and they placed these witnesses in legal jeopardy. During the investigation, he solicited letters of support from collaborators and former technicians who claimed that they had helped with the longitudinal menopause study; these claims resulted from Dr. Poehlman’s false assurances and edits of the letters, and they placed these witnesses in legal jeopardy. Dr. Poehlman submitted falsified and fabricated documents to the UVM committee in an effort to show that the 35 women in the menopause study had visited the GCRC a second time. Dr. Poehlman submitted falsified and fabricated documents to the UVM committee in an effort to show that the 35 women in the menopause study had visited the GCRC a second time.

30. Why did it take so long to discover? “The reality is that an established and renowned principal investigator with this volume of complex data could easily generate and propagate false values for months, even years, without anyone catching on” (UVM Report, p. 19) “The reality is that an established and renowned principal investigator with this volume of complex data could easily generate and propagate false values for months, even years, without anyone catching on” (UVM Report, p. 19)

31. Summary Dr. Poehlman falsified and fabricated data in NIH grant applications and in published articles over a 10 year period with NIH funding of almost $3 million Dr. Poehlman falsified and fabricated data in NIH grant applications and in published articles over a 10 year period with NIH funding of almost $3 million Counting two USDA applications, he provided falsified and fabricated preliminary data to government agencies in 17 different competitive and non-competitive applications. Counting two USDA applications, he provided falsified and fabricated preliminary data to government agencies in 17 different competitive and non-competitive applications. Falsifications and fabrications were made in applications worth over $11,000,000 if funding would have been approved. Falsifications and fabrications were made in applications worth over $11,000,000 if funding would have been approved.

32. Summary The misconduct affected studies related to disease prevention, including research on the health of older men and women, the effect of diet, exercise, menopause status, hormone replacement, and disease status. The misconduct affected studies related to disease prevention, including research on the health of older men and women, the effect of diet, exercise, menopause status, hormone replacement, and disease status. The University of Vermont made 22 findings of scientific misconduct in areas represented by 3 GCRC protocols. The University of Vermont made 22 findings of scientific misconduct in areas represented by 3 GCRC protocols. ORI confirmed 21 of the findings made by UVM and made 35 additional findings in the same plus 2 additional areas ( 5 protocols). ORI confirmed 21 of the findings made by UVM and made 35 additional findings in the same plus 2 additional areas ( 5 protocols).

33. The role of the Justice Department: ORI Assurance Assurance on application form PHS 398, #15 Assurance on application form PHS 398, #15 Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application.

34. This is what led to Dr. Poehlman pleading guilty to a felony

35. What Was the involvement of the Vermont U.S. Attorney Defended civil litigation brought by Dr. Poehlman to prevent mandatory reporting of misconduct investigation to ORI Defended civil litigation brought by Dr. Poehlman to prevent mandatory reporting of misconduct investigation to ORI Opened civil and criminal fraud investigations into Dr. Poehlman’s research activities, assisted by ORI and HHS OIG Opened civil and criminal fraud investigations into Dr. Poehlman’s research activities, assisted by ORI and HHS OIG Decided that false claims of Dr. Poehlman warranted a criminal charge and personal monetary settlement of $180,000 Decided that false claims of Dr. Poehlman warranted a criminal charge and personal monetary settlement of $180,000 Dr. Poehlman sentenced to jail term of one year and a day based on admission to one felony count and ordered to a federal prison work camp in Maryland Dr. Poehlman sentenced to jail term of one year and a day based on admission to one felony count and ordered to a federal prison work camp in Maryland

36. ORI actions and the Whistleblower’s role ORI/ASH actions against Dr. Poehlman include lifetime debarment from Federal research funding and retraction/correction of ten published papers ORI/ASH actions against Dr. Poehlman include lifetime debarment from Federal research funding and retraction/correction of ten published papers The whistleblower in this case later filed a qui tam suit under Federal fraud laws and received a relator’s share of 12% ($22,000) of the Federal recovery of $180,000 The whistleblower in this case later filed a qui tam suit under Federal fraud laws and received a relator’s share of 12% ($22,000) of the Federal recovery of $180,000

37. Impact of Dr. Poehlman’s Actions in the Scientific Community Millions of dollars in Federal grant money have been mis-spent. Millions of dollars in Federal grant money have been mis-spent. The careers of Dr. Poehlman’s students and collaborators have been damaged or impaired. The careers of Dr. Poehlman’s students and collaborators have been damaged or impaired. Other researchers have wasted their time and laboratory resources trying to reproduce and extend the false claims made by Dr. Poehlman. Other researchers have wasted their time and laboratory resources trying to reproduce and extend the false claims made by Dr. Poehlman.

38. Impact of Dr. Poehlman’s Actions on the General Public Dr. Poehlman’s research attempted to identify ways to modify life style to lengthen life and improve its quality. Dr. Poehlman’s research attempted to identify ways to modify life style to lengthen life and improve its quality. The loyal and dedicated volunteers in the Vermont community felt betrayed and may be reluctant to continue volunteering for studies at UVM. The loyal and dedicated volunteers in the Vermont community felt betrayed and may be reluctant to continue volunteering for studies at UVM. Dr. Poehlman’s actions had a negative impact on the level of trust in science for health care consumers who rely on honest research results for improved health care. Dr. Poehlman’s actions had a negative impact on the level of trust in science for health care consumers who rely on honest research results for improved health care.

39. Lessons Learned Research misconduct can go undetected for years, even when the misconduct is massive Research misconduct can go undetected for years, even when the misconduct is massive A determined cheater can mislead collaborators indefinitely A determined cheater can mislead collaborators indefinitely Institutional commitment and careful adherence to policies and procedures are needed for successful investigations Institutional commitment and careful adherence to policies and procedures are needed for successful investigations ORI and the research community rely heavily on honest scientists in the lab to come forward with evidence of misconduct ORI and the research community rely heavily on honest scientists in the lab to come forward with evidence of misconduct

40. DIO Oversight: Forensics During the 20 years that OSI/ORI have existed, investigators have developed a number of computer-assisted tools and approaches to help strengthen institutional findings. The following slides will provide a few examples of this.

41. Detection of Fabricated Numbers If sets of transcribed are provided as “raw data” rather than instrument printouts, consider whether the numbers might have been fabricated. If sets of transcribed numbers are provided as “raw data” rather than instrument printouts, consider whether the numbers might have been fabricated. Research by ORI and others shows that insignificant (right-most) digits in numbers, if real, e.g. from instruments, are uniformly distributed while numbers made up by people often are non- uniform.

42. Here is a DIO scan of a spreadsheet submitted by a respondent that was unaccompanied by an instrument printout. Under pressure, he subsequently provided similar data that was accompanied by printouts from a scintillation counter.

43. ORI 4/0543 Bar graphs effectively illustrate the distribution of digits for the two right most positions for the data sets without counter tapes (left) and those with counter tapes (right).

44. Probabilities obtained with DigiProbe for the 11 assays and for the assays with and without counter tapes grouped together.

45. Observations The most compelling evidence for misconduct in this case was obtained from the fabricated data sets not examined by the university. This conclusion is made significantly stronger by the presence of “control data” from companion assays for which counter tapes were available. In no instance was the distribution of non-leading digits non-uniform when tapes were available, and in each of the three assays without tapes, digits were non-uniform at both positions.

47. Examples of analyzing images Several examples follow which illustrate how ORI can examine images provided by institutions during their investigation. Many of ORI’s cases involve images that are duplicated from paper to paper or paper to grant application. This may be duplicate publication, but when such images are said to be the result of different experiments, one of the images, at minimum, has been potentially falsified. The first example, however, is a little different.

48. ORI 4/0548

49. ORI 4/0549 Screen shot from Photoshop showing analysis under way – the small circle in the Color Picker is the brush size moved to a color approximately matching the image’s background.

50. ORI 4/0550 The result of removing most of the “scribbling.”

51. Corner of Film In this case, 1 film was used to represent 2 experiments the same film used for mouse a and mouse Myo D and Myo G This is why the RIO sent the previous sample to ORI for Review

52. Scanned film separated by hue Result: writing in red erased from film then re-labeled

53. In this example, the respondent published a figure (shown to the right) and claimed that the blot had been stripped and re-probed to provide a loading control (not shown). ORI’s review of the notebook showed that she had cut a film into two fragments and claimed that one-half was the loading control. However, forensic examination clearly established that the two films were cut from a single exposure of a blot.

54. When the films were aligned and scanned in reflection mode: Image processing tools bring out hidden features: common edge scratches and prints crossing edge

55. Moving to the digital age The next examples illustrate the importance of the eye to detect evidence of inappropriate image manipulation. In addition, many ORI cases rely on prompt sequestration of evidence, including hard drives and portable storage media, to ensure that manipulated images can be shown to have originated with a particular individual. Time-date stamps are often probative with respect to how and when the manipulations occurred.

56. A Slippery Slope The next few slides show how difficult it can be to determine if a manipulation is appropriate, possibly inappropriate, or obviously fraudulent. Generally, ORI is reluctant to make findings of misconduct when an image has been “beautified” by altering background, or by reuse of loading controls, when the actual data verifies the factual findings claimed in the grant or paper. However, adding or removing important elements of a figure can often be considered evidence for intentional falsification.

60. An example of unique images that alerted the institution to apparent falsification. The original images were of all positive or all negative cells positive for a gene different from HIV DNA or RNA.

63. How to detect non-obvious changes Some of the following slides will illustrate how Photoshop can be used to help our eyes visualize alterations to images, and verify suspected duplications, through the use of specific tools such as the gradient map, contours, and various enhancements such as contrast and intensity.

64. DETECTION Increase Visibility of “Hidden” Details Principles/Methods

65. Forensic Examination of Scientific Images 1.Contrast Enhancement (“Curves”) - human eye is not very good at detecting small differences in gray scale 2.Texture, Variance – examination for erasures 3.Histogram Equalization – quick look for background inconsistencies 4.Gradient Map – powerful tool to reveal many similarities in background and band morphologies 5.Embossing – shadowing makes the image slightly dimensional to reveal borders in background or edges 6.Overlay of Images – shows similarities of images

66. Contrast Enhancement – detecting small differences in gray scale Contrast EnhancedOriginal Data

67. Effect of Histogram Equalization: “SPLICED” DATA? manipulation DOES NOT mean research misconduct (shown with permission) Effect of Histogram Equalization: background inconsistencies

68. Embossed Embossing – reveals borders in background or edges Original Data Published Data

69. Forensic Value of Background: ► ► Harder to see since it has the least contrast ► ► Overlooked since not of primary interest, i.e., below the perceptual “radar screen”

70. When a is Problem Found: Extend Visualization Visualization shows the BANDS ARE TOO SIMILAR TO BE DIFFERENT

71. Gradient Map – reveals similarities in background and bands Original Data Colorized Data

72. MORPHOLOGICAL FEATURES OF BANDS

73. False Colorization “Gradient Map” Reveals Mini-features 67 MW band 32 MW band LOWER BANDS SHOW NO SIMILARITY

74. Immunity, Figure 1 panel1panel 2 panel 3panel 4 panel 5panel 6 questioned panels Page 1 Use of the Image Overlay procedure

75. panel 5 vs 2panel 5 vs 4 Figure 1 (panel 5 vs 6) panel 6 (black) is a subset of panel 5 (red) red and black = unique blue = overlap no overlap

76. Responsible Conduct of Research (RCR) What can ORI and institutions do to help prevent research misconduct?

77. Human Subjects Mentor/ Trainee Responsibilities Research misconduct Animal Welfare Data Acquisition, Management, Sharing, & Ownership Collaborative Science Publication Practices & Responsible Authorship Conflict of Interest and Commitment Peer Review 3124 85769 RCR Instructional Areas

78. What can you do at your institution? You can help set the tone for the institution and make integrity a high priority You can help set the tone for the institution and make integrity a high priority As an administrator, you can develop and implement policies that support integrity As an administrator, you can develop and implement policies that support integrity As a principal investigator, you can establish specific standards for your staff on recording, retaining, reporting, and publishing data As a principal investigator, you can establish specific standards for your staff on recording, retaining, reporting, and publishing data As a junior scientist in the lab, you can make a personal commitment to integrity and practice it on a daily basis As a junior scientist in the lab, you can make a personal commitment to integrity and practice it on a daily basis

79. RCR at the Individual Level encompasses: Intellectual honesty in proposing, performing, and reporting research Intellectual honesty in proposing, performing, and reporting research Accuracy in representing contributions Accuracy in representing contributions Fairness in peer review Fairness in peer review Transparency in conflicts of interest Transparency in conflicts of interest

80. RCR at the Individual Level also entails: Assuming personal responsibility for avoiding or managing conflicts Assuming personal responsibility for avoiding or managing conflicts Taking responsibility for protecting human subjects and for the humane care of animals Taking responsibility for protecting human subjects and for the humane care of animals Appropriately recording research results and retaining research records Appropriately recording research results and retaining research records Careful and thoughtful mentoring of students and junior scientists Careful and thoughtful mentoring of students and junior scientists

81. How can RCR be implemented at the institutional level? Provide leadership in RCR Provide leadership in RCR Facilitate productive interactions between trainees and mentors Facilitate productive interactions between trainees and mentors Advocate adherence to rules regarding the conduct of research Advocate adherence to rules regarding the conduct of research Provide training to both mentors, junior scientists, and students tailored to their respective needs Provide training to both mentors, junior scientists, and students tailored to their respective needs

82. RCR at the Institutional level (cont.) Conduct inquiries and investigations into alleged misconduct Conduct inquiries and investigations into alleged misconduct RCR training should include discussions of misconduct cases and their adverse consequences to respondents RCR training should include discussions of misconduct cases and their adverse consequences to respondents Consider publicizing your cases (suitably redacted) to ensure that staff realize that you take misconduct seriously and act on allegations Consider publicizing your cases (suitably redacted) to ensure that staff realize that you take misconduct seriously and act on allegations

83. A few key issues that DIO has found contribute most significantly to allowing misconduct 1. Inadequate record keeping and lack of guidance from mentors on how to record and retain research data; 2. Failure of mentors to regularly review raw data; overreliance on derivative data (PowerPoint presentations) at lab meetings 3. Unquestioning acceptance of data that others consider “too good to be true”

84. More issues that facilitate misconduct 4. Lack of transparency within the laboratory and among the staff 4. Lack of transparency within the laboratory and among the staff 5. Labs so large that authority becomes diffuse 5. Labs so large that authority becomes diffuse 6. P.I.s are spread too thin, and do not provide adequate training and guidance to students 6. P.I.s are spread too thin, and do not provide adequate training and guidance to students The bottom line – good mentorship and the constant review of raw data can profoundly reduce the likelihood of a mentee committing research misconduct.

85. ORI can provide assistance 240 453 8800; AskORI@hhs.gov AskORI@hhs.gov Telephone or on site assistance available Telephone or on site assistance available Allegation assessment Allegation assessment Advice on policies and procedures, for example : Advice on policies and procedures, for example : Sequestration of evidence Sequestration of evidence Acquisition of digital information (forensic imaging of hard drives) Acquisition of digital information (forensic imaging of hard drives) Properly getting an inquiry or investigation under way Properly getting an inquiry or investigation under way Analysis of the evidence, such as assisting with analysis of questioned images Analysis of the evidence, such as assisting with analysis of questioned images Investigative strategy and legal problems Investigative strategy and legal problems

86. Conclusion DEVELOP AN RCR PROGRAM THAT WORKS FOR YOU! http://ori.hhs.gov