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The Responsible Conduct The Responsible Conduct of Research:of Research:

Research Misconduct Research Misconduct Prevention & Prevention & InvestigationInvestigation

Daniel R. Vasgird, PhD, CIPDaniel R. Vasgird, PhD, CIPOffice of Research ResponsibilityOffice of Research ResponsibilityUniversity of Nebraska, LincolnUniversity of Nebraska, Lincoln

dvasgird2@unl.edudvasgird2@unl.eduwww.unl.edu/research/orr/www.unl.edu/research/orr/

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The Fundamental The Fundamental PropositionProposition

Rules are just a small part of the Rules are just a small part of the picture. The alpha and the picture. The alpha and the

omega has to be omega has to be integrityintegrity from from which all else will follow, which all else will follow,

including compliance.including compliance.

““One is apt to think of One is apt to think of moral failure as due to moral failure as due to

weakness of weakness of character: more often character: more often

it is due to an it is due to an inadequate ideal.”inadequate ideal.”

Richard LivingstoneRichard Livingstone

““Ethics primarily Ethics primarily concerns the effects of concerns the effects of our actions on others.”our actions on others.”

Randy CohenRandy Cohen

Robert K. MertonRobert K. Merton

Stated that the disinterested pursuit Stated that the disinterested pursuit of truth is the norm of science, of truth is the norm of science, expressed as:expressed as:

– UniversalismUniversalism– CommunalismCommunalism– DisinterestednessDisinterestedness– Organized skepticismOrganized skepticism

““Fakery at a Top Fakery at a Top Research Lab”Research Lab”

NY Times, 10/1/02:NY Times, 10/1/02: J. Hendrik Schön of Bell LabsJ. Hendrik Schön of Bell Labs Published in Published in ScienceScience and and Nature (peer Nature (peer

review)review) Falsified Data Falsified Data Bell Labs: no Research Misconduct Bell Labs: no Research Misconduct

policy (“Can’t happen here”)policy (“Can’t happen here”) Afterword: PhD at U of Konstanz revokedAfterword: PhD at U of Konstanz revoked

UNL ORR MissionUNL ORR Mission

Foster a culture of integrity and Foster a culture of integrity and compliance within the University compliance within the University

directed at ensuring that directed at ensuring that participants in the University of participants in the University of

Nebraska, Lincoln research Nebraska, Lincoln research enterprise internalize and pursue enterprise internalize and pursue

the goal of self-directed responsible the goal of self-directed responsible conduct of research.conduct of research.

ORR Core AreasORR Core Areas

1)1) Human research protectionsHuman research protections2)2) Animal research protectionsAnimal research protections3)3) Research misconductResearch misconduct4)4) Conflict of interest and commitmentConflict of interest and commitment 5)5) Data acquisition, management, Data acquisition, management,

sharing, sharing, and ownershipand ownership

6)6) Mentor/trainee relationshipsMentor/trainee relationships7)7) Authorship and publicationAuthorship and publication8)8) Peer reviewPeer review9)9) Collaborative scienceCollaborative science10)10) Privacy (HIPAA)Privacy (HIPAA)

UNL RCR ProgramUNL RCR Program

UNL RCR Online Training UNL RCR Online Training SeriesSeries

RCR Research Misconduct RCR Research Misconduct ResourcesResources

FSGO Compliance ElementsFSGO Compliance Elements

Implementing written policies & procedures; Implementing written policies & procedures; Designating a compliance officer and Designating a compliance officer and

compliance committee; compliance committee; Conducting effective training and education; Conducting effective training and education; Developing effective lines of Developing effective lines of

communication;communication; Conducting internal monitoring and auditing; Conducting internal monitoring and auditing; Enforcing standards through well-publicized Enforcing standards through well-publicized

disciplinary guidelines; and disciplinary guidelines; and Responding promptly to detected problems. Responding promptly to detected problems.

HHS 8HHS 8thth Element Element

‘‘‘‘Defining roles and Defining roles and responsibilities and responsibilities and assigning oversight assigning oversight

responsibility’’responsibility’’

National Academy of National Academy of SciencesSciences

To maintain (public) confidence and To maintain (public) confidence and trust in this (the scientific) trust in this (the scientific) enterprise, researchers must protect enterprise, researchers must protect the the empirical objectivityempirical objectivity of research, of research, the the unbiased reportingunbiased reporting of results and of results and the the open sharingopen sharing of that information of that information for the good of society.for the good of society.

NAS Report Primary NAS Report Primary RecommendationsRecommendations

Research institutions should offer Research institutions should offer effective educational programs that effective educational programs that enhance RCR.enhance RCR.

Research institutions should promote Research institutions should promote integrity in research through integrity in research through top-downtop-down commitment to RCR through strong commitment to RCR through strong supervision, supervision, communicationcommunication, , socialization, etc. socialization, etc.

Research institutions should perform self-Research institutions should perform self-assessments to determine areas of need.assessments to determine areas of need.

HHS Research HHS Research Misconduct Misconduct

Final Rule (June, 2005)Final Rule (June, 2005)

Universities must:Universities must:– Foster an environment Foster an environment

that promotes RCRthat promotes RCR – Have research misconduct Have research misconduct

P&P’sP&P’s– Deal with allegations or Deal with allegations or

possible evidence of research possible evidence of research misconduct promptlymisconduct promptly