LEGAL ISSUES IN RESEARCH MISCONDUCT CASES Kendra Dimond

HANDLING EVIDENCE n n n Prompt and complete sequestration of evidence through institutional evidence

BURDEN OF PROOF § ORI bears burden under Preponderance of Evidence Standard that: Respondent

LEVEL OF INTENT § § Intentional conduct Knowing conduct Reckless conduct Not honest error

MATERIALITY Significance of the alleged misconduct to the research project, PHS grant application and/or

MOTIVE § Why was the misconduct committed? § Not required to be proved §

APPEAL OF ORI ADJUDICATIONS De novo hearing before a Research Integrity Adjudication Panel of

USE OF THE FALSE CLAIMS ACT § Submitting false records or statements to the

WHISTLEBLOWER PROTECTION Current regulatory language 45 CFR 50. 103(d)(13) § November 2000, HHS Notice

DUE PROCESS FOR THE ACCUSED § § Provision of written charges Access to counsel

BACKLASH AGAINST UNIVERSITIES § Accused researchers sue universities who accuse them § Immunity needed?

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LEGAL ISSUES IN RESEARCH MISCONDUCT CASES Kendra Dimond, Esq. , Partner Epstein Becker & Green, P. C. 1227 25 th Street, N. W. Washington, D. C. 20037 (202) 861 -4186 (phone) (202) 296 -2882 (fax) kdimond@ebglaw. com Presented to Second Annual Medical Research Summit Washington, D. C. March 25, 2002 Epstein Becker & Green, P. C. 1

HANDLING EVIDENCE n n n Prompt and complete sequestration of evidence through institutional evidence management process Data and products generated under PHS grants or cooperative agreements belong to the institution, not the principal investigator Identifiable chain of custody Epstein Becker & Green, P. C. 2

BURDEN OF PROOF § ORI bears burden under Preponderance of Evidence Standard that: Respondent committed scientific misconduct ü Cause for debarment exists ü Proposed administrative actions are reasonable ü Epstein Becker & Green, P. C. 3

LEVEL OF INTENT § § Intentional conduct Knowing conduct Reckless conduct Not honest error or difference of opinion Epstein Becker & Green, P. C. 4

MATERIALITY Significance of the alleged misconduct to the research project, PHS grant application and/or funding process, or scientific paper § Not a required element to establish a finding of research misconduct § Useful concept in establishing requisite intent or knowledge n Epstein Becker & Green, P. C. 5

MOTIVE § Why was the misconduct committed? § Not required to be proved § Lack of motive may negate intent Epstein Becker & Green, P. C. 6

APPEAL OF ORI ADJUDICATIONS De novo hearing before a Research Integrity Adjudication Panel of the Departmental Appeals Board of the Department of Health and Human Services § Panel may include scientists and attorneys § Hearings are open to the public n Epstein Becker & Green, P. C. 7

USE OF THE FALSE CLAIMS ACT § Submitting false records or statements to the government to get false claims paid § In research misconduct cases, submitting grant applications and progress reports to NIH that contain false information § Generally filed against both institution and individual, see Thomas Jefferson Univ. 2000 § PHS administrative procedures need not be exhausted prior to filing Epstein Becker & Green, P. C. 8

WHISTLEBLOWER PROTECTION Current regulatory language 45 CFR 50. 103(d)(13) § November 2000, HHS Notice of Proposed Rulemaking on Whistleblower Protection, 65 Fed Reg 70830 n Preventing and responding to retaliation against whistleblowers ü Applies to entities who have a Research Misconduct Assurance filed ü § ORI Guidelines for Institutions and Whistleblowers: http: //ori. hhs. gov Epstein Becker & Green, P. C. 9

DUE PROCESS FOR THE ACCUSED § § Provision of written charges Access to counsel Opportunity to present evidence Opportunity to appeal ORI decision Epstein Becker & Green, P. C. 10

BACKLASH AGAINST UNIVERSITIES § Accused researchers sue universities who accuse them § Immunity needed? Epstein Becker & Green, P. C. 11

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