RESEARCH INTEGRITY AND THE NIH

Transcription

1 RESEARCH INTEGRITY AND THE NIH NOVEMBER 9, 2017 PATRICIA VALDEZ, Ph.D. NIH EXTRAMURAL RESEARCH INTEGRITY OFFICER Important Goal of the NIH To exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. 2 1

2 Overview What is research misconduct? How does NIH handle allegations of RM? Institutional and ORI findings of research misconduct Assurances and reporting 2 2 HHS ORI oversees allegations of RM involving PHS-funded activities Public Health Service includes these OpDivs: NIH, CDC, FDA, HRSA, IHS, SAMHSA 4 2

3 What Constitutes Research Misconduct? 42 CFR a. Fabrication b. Falsification c. Plagiarism - In proposing, performing or reviewing research or in reporting research results d. does not include honest error or differences of opinion. 5 ORI Policy on Plagiarism Excludes: The limited use of general phrases that describe methodology or procedures - Not substantially misleading or of great significance Disputes among collaborators (present or former) - Authorship disputes; IP rights 6 3

4 Research Misconduct in Clinical Studies Examples of Fabrication: Making up patient visits Creating record of interview that never occurred Filling in missing vitals Examples of Falsification: Altering prescreening results to meet eligibility Substituting one subject s record or samples for another s Selectively eliminating data 7 Research Misconduct in Clinical Studies Reminders: Most clinical research misconduct picked up during routine audits. Research misconduct can be committed by anyone in the research team, not just the principal investigators or the scientific staff. When human participants are involved, priority is to ensure their safety. 8 4

5 HOW THE NIH HANDLES ALLEGATIONS OF RESEARCH MISCONDUCT 9 National Institutes of Health Agency Research Integrity Liaison Officer Agency Intramural RIO Agency Extramural RIO Extramural RIOs 26 Extramural IC RIOs 10 5

6 Research Misconduct Allegations (OER RI) 1 1 Process for Handling Allegations Allegation IC RIO ERIO/ERILO & AERIO ORI Office of Research Integrity Allegation from a reviewer, whistleblower, PI, colleague, etc. Designated senior NIH Officials in ICs Dr. Lauer and designated staff 12 6

7 Process for Handling Allegations OHRP Office of Human Research Protections Allegation IC RIO ERIO/ERILO & AERIO ORI Office of Research Integrity Allegation from a reviewer, whistleblower, PI, colleague, etc. Designated senior NIH Officials in ICs Dr. Lauer and designated staff OMA Office of Management Assessment OLAW Office of Laboratory Animal Welfare 13 ORI AND INSTITUTIONAL FINDINGS 14 7

8 From Allegation to ORI Oversight Allegation Assessment Inquiry Investigation ORI oversight ORI or Institution Does allegation meet definition? Credible and specific? Involves PHS funds? Institution Inquiry involves sequestration; prelim fact-finding Inquiry determines whether investigation is warranted Investigation based on institution s rules 60 days 120 days 15 Institution s Responsibilities During an Investigation Protect human subjects, animals, environment Protect scientific integrity of the project Determine whether project can continue Ensure proper expenditure of funds, if appropriate NIH GPS

9 ORI Requirements for Making a Finding of Research Misconduct a) Significant departure from accepted practices; and b) Committed intentionally, knowingly, or recklessly; and c) Proven by a preponderance of evidence. Plus, additional considerations 17 HHS ORI Findings ( ) Number of findings 18 9

10 Publication of Research Misconduct Findings 19 Announce In PubMed 20 10

11 NIH era Links to PHS Administrative Action Bulletin Board 21 Finding of Research Misconduct Involving SBIR Application ORI found that the Respondent: (1) used research images and descriptions posted on the Internet to create seven figures in the application and used that material, its associated text, and text from other publications obtained from the Internet without attribution; (2) misrepresented research results in two of the plagiarized figures as exemplar applications of the company s proprietary technology; and (3) misrepresented his research bibliography in that application and to ORI staff during the investigation

12 Finding of Research Misconduct Involving SBIR Application Respondent entered a Voluntary Exclusion Agreement with ORI: Accepted PHS findings and agreed to terms Debarred for 3 years Not allowed to serve in PHS advisory capacity for 3 years 23 ASSURANCES AND REPORTING 24 12

13 Grantee Responsibilities Hold active assurance of compliance with ORI Have written policies & procedures for addressing allegations of research misconduct Foster environment promoting research integrity Ensure confidentiality and protect whistle-blower Cooperate with and make reports to ORI Submit Annual Report on Possible Research Misconduct to ORI January each year 25 Provision for Small Institutions Small institutions (1-10 persons) usually cannot conduct inquiry or investigation themselves May file Small Organization Statement Agreement to report all allegations of research misconduct to ORI Still need to follow other provisions, including submission of Annual Report 26 13

14 ORI Website: 27 Annual Report System 28 14

15 Scenario A retraction by an NIH-supported PI appears on Retraction Watch. Retraction notice indicates an institutional investigation found falsified data in NIHsupported paper. What should the NIH do now? 29 Scenario NIH contacts the institution for more information. Finds that a current award is based on falsified data. NIH compliance oversight required

16 Communication is Key!

17 Interactive Training Videos on Research Misconduct Available at ori.hhs.gov 33 THANK YOU! 34 17