Research IntegrityResearch Integrity

Is it just following the regulations Is it just following the regulations and avoiding misconduct?and avoiding misconduct?

Research Misconduct

P.D. Magnus, Michael Kalichman, September 2002

Background

There are some indications that research misconduct occurs only rarely. In 20 years, the federal government found an average of about 10 cases of research misconduct per year; that is, about 1 case per year for every 10,000 researchers. However, there are many barriers to accurately quantifying the extent of research misconduct; cases may go unreported and institutions may be biased against finding misconduct. The actual rate of research misconduct could be as low as 1 in 100,000 or as high as 1 in 100. (Steneck, 2000)

In the past 20 years, numerous serious cases of alleged misconduct have been widely publicized. In many cases, the allegations were borne out by subsequent investigation. It is noteworthy that in these cases both whistleblowers and those accused of wrongdoing paid a price whether the allegations were ultimately sustained or not.

What does this mean?What does this mean?

"Scientists are not a special breed of human being," says Thomas Murray, president of the Hastings Center, a bioethics institute in Garrison, N.Y. "But they function in a special environment.... They are bright people working in a community where the best ideas rise to the top. If you're not in first place, you're no place.“

Federal MandateFederal Mandate

42 C.F.R. Part 50--Policies of General Applicability

Subpart A--Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science

What does it Say?What does it Say?

Institution must have misconduct policy if it accepts PHS funds

Institution’s policy must meet the minimum standard outlined in federal regulations

Institution must have a Research Integrity Officer who acts as the gatekeeper for this policy and serves as the interface with the federal gov’t for reporting purposes

PrinciplesPrinciples

1.1. The integrity of science depends on the integrity of research.The integrity of science depends on the integrity of research.Science is predicated on trust -- without confidence in the integrity of Science is predicated on trust -- without confidence in the integrity of their peers, scientists would be unable to trust one another's work. their peers, scientists would be unable to trust one another's work. The demands of ethical and responsible conduct may not always The demands of ethical and responsible conduct may not always seem expedient. seem expedient.

2.2. The integrity of research depends in part on self-policingThe integrity of research depends in part on self-policing..Just as peer review operates to assure the legitimacy of published Just as peer review operates to assure the legitimacy of published reports, self-policing operates to assure the legitimacy of research reports, self-policing operates to assure the legitimacy of research at a deeper level. This means that scientists should be familiar with at a deeper level. This means that scientists should be familiar with definitions of research misconduct and procedures for dealing with definitions of research misconduct and procedures for dealing with it, regardless of whether they are actually party to allegations. Self-it, regardless of whether they are actually party to allegations. Self-policing also demands that scientists attempt to communicate with policing also demands that scientists attempt to communicate with one another to foster an environment in which responsible research one another to foster an environment in which responsible research is explicitly discussed and encouraged. is explicitly discussed and encouraged.

GuidelinesGuidelines

DocumentationDocumentationA failure to keep good records can have serious consequences for A failure to keep good records can have serious consequences for the progress of a research project, but can be particularly the progress of a research project, but can be particularly

devastating for someone involved in an allegation of misconduct.devastating for someone involved in an allegation of misconduct.

Rules and ProceduresRules and ProceduresAlthough institutions receiving federal funds need to meet a Although institutions receiving federal funds need to meet a common set of minimal requirements, individual institutions are common set of minimal requirements, individual institutions are granted substantial leeway in the rules and procedures for handling granted substantial leeway in the rules and procedures for handling

of allegations of misconductof allegations of misconduct..

Institutional channels are preferable to public Institutional channels are preferable to public channels. channels.

2.13 09 University Handbook for 2.13 09 University Handbook for Appointed PersonnelAppointed Personnel

Policy and Procedures for Investigations of Policy and Procedures for Investigations of

Misconduct in Scholarly, Creative, and Misconduct in Scholarly, Creative, and

Research ActivitiesResearch Activities

http://www.vpr.arizona.edu/integrity/ResearchIntegrityPolicy-Final1.pdfhttp://www.vpr.arizona.edu/integrity/ResearchIntegrityPolicy-Final1.pdf Approved by Faculty Senate February 3, 2003 and Adopted by Approved by Faculty Senate February 3, 2003 and Adopted by

President Likins April 4, 2003President Likins April 4, 2003

Key Points in UA Misconduct PolicyKey Points in UA Misconduct Policy

Applies to everyone - faculty, staff, students, fellows, visitors, guests, consultants, collaborators

Applies to all scholarship, research and creative endeavors conducted at UA, funded or unfunded (not just PHS funded)

Key Points in UA Misconduct Policy Key Points in UA Misconduct Policy (continued)(continued)

Misconduct is fabrication, falsification, or plagiarism in proposing, performing or reviewing research or creative endeavors, or in reporting research results or the results of creative endeavors. It does not include honest error or differences in interpretation or judgments in evaluating research methods or results or differences in opinion.

DefinitionsDefinitions

Fabrication –Making up data or results and recording or reporting

them

Falsification –Manipulating research or scholarship materials,

equipment, or processes, or changing or omitting data or results such that the scholarship or research is not accurately represented in the record

Plagiarism –The appropriation of another person’s ideas, processes,

results, or words without giving appropriate credit

FabricationFabrication

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; and preparing records for calls and follow-up contacts to subjects who had already died.

FalsificationFalsification

substituting one subject's record for that of another subject; falsely reporting to a data coordinating center that certain clinical trial staff, who were certified to perform the procedures on the subjects, had done so, when they had not; 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;

Falsification (cont)Falsification (cont)

failing to update the patients' status and representing data from prior contacts as being current; 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.

PlagiarismPlagiarism

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.

The theft or misappropriation of intellectual property includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review.

What Does Research Integrity Officer What Does Research Integrity Officer Do?Do?

Receives allegation(s)

Conducts Pre-inquiry

Notifies sponsors as appropriate

Notifies respondent

Notifies Chair of UCEC (faculty ethics panel) of need for Inquiry into allegation(s)

Obtains and preserves evidence (paper, electronic, equipment etc.)

What Does Research Integrity Officer What Does Research Integrity Officer Do? (cont)Do? (cont)

Receives report from Inquiry Panel

Initiates ad hoc Investigative Committee if appropriate

Receives & transmits final investigation report to VPR & Provost

Notifies parties involved of outcome

Research IntegrityResearch Integrity

The UA promotes Responsible Conduct of Research by expecting all those involved in research to adhere to all university, state, federal, and other policies relating to the research or creative activity carried out under his/her direction.

Sign up for the PRIE Newsletter by emailing Ruth Daniels at rhk@u.arizona.edu

Visit the PRIE website to view past issueshttp://www.vpr.arizona.edu/integrity/index.html

More thoughts………….More thoughts………….

In the end, no system is infallible, ethicists note. "If you have someone determined to fabricate evidence, no screening system will catch that," says Alto Charo, a law professor at the University of Wisconsin who specializes in biomedical and research ethics. "You have to rely on the integrity of the individual."

Responsible Conduct of Responsible Conduct of ResearchResearch

Data sharing/ownership

Mentor/trainee responsibilities

Publication Practices & Responsible Authorship

Peer Review

Collaborative Science

Human Subjects

Research Involving Animals

Research Misconduct

Conflict of Interest & Commitment

Where do I go for information/help?Where do I go for information/help?

Dr. Cindy RankinDr. Cindy Rankin

Research Integrity OfficerResearch Integrity Officer

Biosciences West 274Biosciences West 274

621-3104621-3104

crankin@email.arizona.educrankin@email.arizona.edu

Ruth DanielsRuth Daniels

Program CoordinatorProgram Coordinator

Program in Research Integrity EducationProgram in Research Integrity Education

626-7643 626-7643

Research Compliance OfficeResearch Compliance Office

1203 North Mountain1203 North Mountain

rhk@email.arizona.edurhk@email.arizona.edu

Alice LangenAlice Langen

Director, Research ComplianceDirector, Research Compliance

Associate Director, Program in Research Associate Director, Program in Research Integrity EducationIntegrity Education

Office of the VP for ResearchOffice of the VP for Research

Administration Bldg 601Administration Bldg 601

621-5196621-5196

langena@email.arizona.edulangena@email.arizona.edu

Office of Research Office of Research Integrity Integrity http://ori.dhhs.gov/http://ori.dhhs.gov/

ExamplesExamplesResearch Assistant Engaged in Scientific Misconduct (8/17/06)Research Assistant Engaged in Scientific Misconduct (8/17/06)

Former University of Maryland at Baltimore research assistant Sylvia Okoro Former University of Maryland at Baltimore research assistant Sylvia Okoro was found by the Office of Research Integrity to have engaged in scientific was found by the Office of Research Integrity to have engaged in scientific misconduct by fabricating and falsifying patient data in research supported misconduct by fabricating and falsifying patient data in research supported by the National Institute on Aging. Okoro "intentionally and knowingly" by the National Institute on Aging. Okoro "intentionally and knowingly" fabricated and falsified information on one patient data form, and on two fabricated and falsified information on one patient data form, and on two other study subjects she failed to note that each patient had taken a fall as other study subjects she failed to note that each patient had taken a fall as was documented in their medical charts. For a three-year period, which was documented in their medical charts. For a three-year period, which began July 17, 2006, Okoro is prohibited from serving in any advisory began July 17, 2006, Okoro is prohibited from serving in any advisory capacity to the Public Health Service (PHS); in addition, if any institution capacity to the Public Health Service (PHS); in addition, if any institution applies for PHS research support that includes Okoro's involvement, a plan applies for PHS research support that includes Okoro's involvement, a plan to insure scientific integrity must be designed and submitted to ORI. to insure scientific integrity must be designed and submitted to ORI. Link:Link:

http://http://ori.dhhs.gov/misconduct/cases/Okoro.shtmlori.dhhs.gov/misconduct/cases/Okoro.shtml..

Examples (continued)Examples (continued)Former Vermont Professor Sentenced to Prison (6/29/06)Former Vermont Professor Sentenced to Prison (6/29/06)

Eric Poehlman, a former University of Vermont College of Medicine Eric Poehlman, a former University of Vermont College of Medicine (UVM) professor, drew a one-year and one day prison term (UVM) professor, drew a one-year and one day prison term yesterday for fabricating data and making false statements related yesterday for fabricating data and making false statements related to his research studies. Poehlman will be the first researcher to to his research studies. Poehlman will be the first researcher to serve prison time as a result of falsifying data in a grant application serve prison time as a result of falsifying data in a grant application to the National Institutes of Health. In 2000, a research assistant to the National Institutes of Health. In 2000, a research assistant began to question what appeared to be the addition of falsified data began to question what appeared to be the addition of falsified data to the datasets Poehlman used. UVM launched an investigation to the datasets Poehlman used. UVM launched an investigation after the research assistant filed a formal complaint. The university after the research assistant filed a formal complaint. The university concluded that data had been falsified and turned the results over to concluded that data had been falsified and turned the results over to the Office of Research Integrity and the Department of Justice. the Office of Research Integrity and the Department of Justice. From approximately 1992 to 2000, Poehlman was awarded NIH and From approximately 1992 to 2000, Poehlman was awarded NIH and Department of Agriculture grants worth $2.9 million; those grant Department of Agriculture grants worth $2.9 million; those grant applications, the government found, included false and fabricated applications, the government found, included false and fabricated research. research. Link:Link: http://http://ori.dhhs.govori.dhhs.gov//. .

Examples (continuedExamples (continued))ORI Finds Student Fabricated Data (12/21/06)ORI Finds Student Fabricated Data (12/21/06)

Nicholas McMaster, an undergraduate biology student at the University of Nicholas McMaster, an undergraduate biology student at the University of Chicago, was found to have engaged in research misconduct in connection Chicago, was found to have engaged in research misconduct in connection with grants supported by the National Institute of Environmental Health with grants supported by the National Institute of Environmental Health Sciences and National Institute on Aging. McMaster was found to have Sciences and National Institute on Aging. McMaster was found to have fabricated data in research connected to the reproductive behavior of fabricated data in research connected to the reproductive behavior of female rats. McMaster voluntarily agreed, for a period of three years female rats. McMaster voluntarily agreed, for a period of three years beginning on Nov. 14, 2006, to exclude himself from serving in any advisory beginning on Nov. 14, 2006, to exclude himself from serving in any advisory capacity to the Public Health Service, and he agreed to the requirement that capacity to the Public Health Service, and he agreed to the requirement that any institution that submits an application for PHS support for a research any institution that submits an application for PHS support for a research project on which his participation is proposed or which uses him in any project on which his participation is proposed or which uses him in any capacity on PHS-supported research, or that submits a report of PHS-capacity on PHS-supported research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for funded research in which he is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval. Link:supervision of his duties to the funding agency for approval. Link:

www.ori.dhhs.gov/misconduct/cases/McMaster.shtmlwww.ori.dhhs.gov/misconduct/cases/McMaster.shtml..