1. Misconduct Investigations: the Elements Christine Boesz, Dr. PH Inspector General National Science Foundation OECD Global Science Forum Workshop on Best Practices 22-23 February 2007

2. 2 Brief History Series of high profile RM cases 1989: Establish Federal research misconduct definition and process 1989-2000: Debate with stakeholders on definition, process, key features, responsibility 2000: Federal-wide definition, process responding to concerns, creating uniformity across agencies and awardees Throughout: Concern for research integrity and approach to allegations

3. 3 Concept of Referral Government address wrongdoing related to federal programs, operations, funds University responsible for wrongdoing related to Federal funds Consistent University / Government RM process and terminology Government “refers” allegations to universities University committee of peers assess allegations University takes appropriate personnel action University provides investigation report to Government Government facilitates : Access to records Access to witnesses

4. 4 Issues considered in developing Federal Process Stakeholder concerns Features Consistent application Distinct phases in handling an allegation

5. 5 Stakeholders in the process Public Government University Subject, complaint, witnesses Research community

6. 6 Stakeholders: Considerations Public  Funds are spent on research that is reliable Government  Trust in research being conducted  Uniform approach to addressing problems University  Maintain integrity in campus research environment  Concern regard reputation  Address issues raised by / about employees Subject, complaint, witnesses  Confidentiality  Reputation  Role in process Research community

7. 7 Essential features of the process Authority Confidentiality Accuracy / Objective Completeness Fairness Timely Access

8. 8 Features: Considerations Authority  High level individual responsible for integrity program, research misconduct program Confidentiality  Create environment to carefully consider issues  Protect reputations of accused  Prevent retaliation Accuracy / Objective  Ensure facts are presented and evaluated without bias Completeness  Ensure all relevant facts and circumstances are considered

9. 9 Features: Considerations Fair  Ensure no favoritism / bias / retaliation factors into evaluation  Address any conflicts of interest  Complainant is only a witness  Subject reviews and responds to reports Timely  Ensure fairness  Protects vulnerable data / research subjects / public Access  Ownership of records  Preservation of records  Complete access to written and electronic records  Ability to interview all relevant individuals  OIG has subpoena authority

10. 10 Hallmarks of consistency Common Objectives  Ensure integrity of research environment  Ensure inherent fairness in system  Ensure Federal funds are spent on high quality research Common Definition  FF, P are RM  Honest error is NOT RM Common Process  Clear definition for each phase of an investigation  Similar process at awardee and Federal Government  Rely on peer community for evaluation Common Outcomes  Similar actions for similar offenses  Protect reputation of innocent and witnesses

11. 11 Key phases in the process Receipt Inquiry Investigation Adjudication Appeal

12. 12 Phases Defined Receipt  Anonymous, confidential  Neutral, unbiased intake  Written or oral Inquiry  Assess whether allegation is:  About research misconduct  Substantive  University relies on committee of peers, with legal advice, for assessment  Conflict of interest review on committee  Subject and representative have input

13. 13 Phases Defined, cont’d Investigation  Fact based analysis to determine if research misconduct occurred  University relies on committee of peers, with legal advice for assessment  Conflict of interest review for committee  Subject or representative review report  Recommend appropriate actions  Assess elements of a finding  Act (F, F or P)  Intent (gross negligence, knowing, or reckless)  Act and intent supported by preponderance of evidence  Significant departure from accepted practices

14. 14 Phases Defined, cont’d Adjudication  Independent, objective review of investigation report  Adjudication organizationally separated from Investigation  Assess:  How serious was the RM  How intentional was it  Impact on research record  Part of a pattern of such behavior Appeal  Address only NEW facts presented by subject  Independent, objective review of report and decision