Handling Misconduct Cases-Problem Areas

1. Handling Misconduct Cases-Problem Areas Chris B. Pascal, J.D., Director Office of Research Integrity

2. ORI 9/07 2 Problem Areas (cont) Initial allegations are handled by the laboratory instead of informing the Research Integrity Officer (RIO) immediately Securing the research data and other evidence is not done in a timely manner The inquiry and investigation committees lack expertise in the scientific subject areas

3. ORI 9/07 3 Problem Areas (cont) Interviews are conducted poorly or improperly annotated or not annotated at all when handling exhibits and other evidence Interviews are not transcribed or are transcribed poorly and cannot be reconstructed

4. ORI 9/07 4 Problem areas (cont) Institutional counsel does not adequately protect against aggressive outside counsel, allowing the respondent�s counsel to set the agenda Institutions fail to follow up on new allegations even when the evidence indicates that other misconduct may have occurred

5. ORI 9/07 5 Problem Areas (cont) Institutions often provide little or no support for complainants, i.e., whistleblowers Whistleblowers are not always right, but the institution should at least provide them with information on how to protect themselves and provide them with access to the ORI regulations The accused individual should also receive information on his or her rights under the ORI regulation and institutional policies

6. ORI 9/07 6 Problem areas (cont) Some institutions provide poorly documented inquiry and investigation reports which impede the process of case resolution This slows down the process for both the institution and ORI and may needlessly delay resolution for the complainant, respondent, and the institution

7. ORI 9/07 7 Problem Areas (cont) Done well admissions of misconduct expedite the process, save time, and allow the respondent to get on with his or her life Written agreements approved by legal counsel at the institution and by the respondent�s counsel ,if appropriate, can lead to fair and quick resolutions Unclear and ambiguous statements can delay or derail case resolutions

8. ORI 9/07 8 Problem areas (cont) NIH requires by regulation that grantees retain the research records ORI has seen many cases where this requirement was not followed Institutions should require their investigators to retain the research records If the records are missing or incomplete the research study may well be unsalvageable

9. ORI 9/07 9 Problem Areas (cont) In ORI�s experience many Principal Investigators or lab chiefs do not spend enough time providing advice and guidance to post-docs, students, lab techs and others Good science does not happen by accident Dedicated and consistent effort by the entire research team is needed

10. ORI 9/07 10 Problem areas ( cont) Many institutions do not have current policies and procedures that are consistent with the new ORI regulation adopted in 2005 (42 CFR Part 93). Please check your policies to see if they are up to date Students often conduct research; if they are accused of misconduct, the ORI regulation should be applied

11. ORI 9/07 11 Problem Areas (cont) Sometime IRB�s try to investigate research misconduct when they see something inappropriate in reviewing proposed clinical research or problems with a research proposal or protocol In ORI�s experience, most IRB�s don�t have sufficient expertise to investigate the alleged problem ORI recommends that the problem be reported immediately to the RIO who is more likely to have the expertise to determine whether the problem requires a misconduct investigation

12. ORI 9/07 12 Problem Areas (cont) Institutions and RIOs are always welcome to contact ORI for advice and technical assistant