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LEGAL ISSUES IN RESEARCH MISCONDUCT CASES

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.

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LEGAL ISSUES IN RESEARCH MISCONDUCT CASES

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  1. LEGAL ISSUES IN RESEARCH MISCONDUCT CASES Kendra Dimond, Esq., Partner Epstein Becker & Green, P.C. 1227 25th 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

  2. HANDLING EVIDENCE • 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

  3. BURDEN OF PROOF • ORI bears burden under Preponderance of Evidence Standard that: • Respondent committed scientific misconduct • Cause for debarment exists • Proposed administrative actions are reasonable

  4. LEVEL OF INTENT • Intentional conduct • Knowing conduct • Reckless conduct • Not honest error or difference of opinion

  5. 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

  6. MOTIVE • Why was the misconduct committed? • Not required to be proved • Lack of motive may negate intent

  7. APPEAL OF ORI ADJUDICATIONS • Denovo 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

  8. USE OF THEFALSE 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

  9. 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 • Preventing and responding to retaliation against whistleblowers • Applies to entities who have a Research Misconduct Assurance filed • ORI Guidelines for Institutions and Whistleblowers: http://ori.hhs.gov

  10. DUE PROCESS FORTHE ACCUSED • Provision of written charges • Access to counsel • Opportunity to present evidence • Opportunity to appeal ORI decision

  11. BACKLASH AGAINST UNIVERSITIES • Accused researchers sue universities who accuse them • Immunity needed?

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