Research Misconduct Procedures

Question

What procedures need to be followed if research misconduct is suspected?

Answer

A. RECEIPT AND ASSESSMENT OF ALLEGATIONS

1. Where to Report
   • Any employee, student, or individual associated with USD who becomes aware of possible misconduct shall promptly report it to the Vice President for Research/ VPR
2. Form of Allegation
   • Should be in writing and signed
   • Should include all available documentation supporting the allegation
3. Confidentiality
   • The identity of complainants, respondents, and witnesses is limited to those with a legitimate need to know, which may include IRBs, journals, publishers, co-authors, collaborators, and federal agencies
   • This limitation no longer applies after a final institutional determination (ORI Final Rule)
4.  Preliminary Assessment
   • The VPR determines whether the allegation:
     • Falls within the regulatory definition of research misconduct
     • It is sufficiently credible and specific to justify moving to an inquiry
   • If not, the matter is closed at this stage and documented

B. SEQUESTRATION OF RESEARCH RECORDS

1. Timing
   • Sequestration occurs on or before the date the respondent is notified that an inquiry will begin
2. Items to Sequester
   • Laboratory notebooks
   • Electronic data
   • Hard-copy data
   • Proposals, manuscripts, publications
   • Emails and correspondence
   • Any materials relevant to the allegation
3. How to sequester
   • Obtain original materials when possible
   • If originals cannot be obtained, substantially equivalent copies may be used
     • Document:
       • What was taken
       • Who collected it
       • From where
       • When
       • Chain of custody
4. Ongoing Sequestration
   • Records may continue to be sequestered when newly identified or relevant (Final Rule)

C. INQUIRY

1. Purpose
   • To determine whether the allegation warrants a full investigation
   • Not to make a final finding
2. Who Conducts the Inquiry
   • Per Final Rule:
     • The VPR or a designated official may conduct the inquiry
     • A committee is not required at this stage
3. Notice to Respondent
   • Respondent receives written notice including:
     • Allegation description
     • Scope of inquiry
     • Sequestration steps already taken
     • Their rights
4. Inquiry Activities
   1. Review sequestered records
   2. Interview complainant, respondent, or witnesses (interviews may be transcribed)
   3. Perform preliminary analyses
5. Timeline
   • The inquiry must be completed within 60 days, or delays must be documented

D. INQUIRY REPORT REQUIREMENTS

1. The Final Rule requires the inquiry report to include:
   1. Identity of the respondent
   2. Description of allegations(s)
   3. Description of PHS or federal support
   4. Analyses conducted
   5. Transcripts of any interviews that were transcribed
   6. Timeline and procedural history
   7. Inventory of all sequestered records
   8. Institutional actions taken during the inquiry
   9. Basis for recommending whether an investigation is warranted​​​​​​​
2. Respondent Access
   • Respondents must be provided with access to all interview transcripts
3. Outcome
   • If investigation is warranted → proceed to Investigation
   • If not → matter closed and reported to complainant and respondent

E. INVESTIGATION

1. When to Begin
   • Must be initiated within 30 days after completion of the inquiry
2. Notice to Respondent (Expanded)
   • Includes:
     • Allegations being investigated
     • All ORI-required notifications
     • Policies and procedures
     • Committee membership
     • Rights/responsibilities
3. Committee Appointment
   • Five impartial USD faculty members, appointed by the VPR with concurrence of Faculty Senate Chair
   • At least two must have scientific expertise in the area
   • Committee chair must hold academic rank at least equal to respondents
4. Multiple Respondents
   • If additional respondents are identified:
     • A new inquiry is NOT required
5. Multiple Institutions
   • If multiple institutions are involved:
     • A lead institution is designated to coordinate and obtain all research records
6. Committee Meetings
   • Chair schedules meetings
   • Respondent and complainant may participate as outlined
   • Proceedings are confidential
   • Detailed minutes maintained
7. Mode of Investigation
   • Review all research records and evidence
   • Conduct recorded and transcribed interviews
   • Perform scientific, statistical, or forensic analyses
   • Maintain chain of custody and documentation
8. Respondent Rights
   1. Present at meetings where evidence is received
   2. Submit questions for witnesses
   3. Access to documentation
   4. Provided all interview transcripts
   5. Right to counsel (counsel may attend but not participate)
9. Timeline
   • ​​​​​​​​​​​​​​Per Final Rule, investigation must be completed within:​​​​​​​
     • 180 days, including:
       • Conducting investigation
       • Preparing the Investigation Report
       • Allowing for respondent comments
       • Submitting to ORI (with extension request if needed)

F. INVESTIGATION REPORT REQUIREMENTS

1. The Final Rule requires the Investigation Report to include:
   1. Allegations
   2. Description of federal/PHS support
   3. Institutional charge
   4. Policies and procedures used
   5. Inventory of all sequestered materials and how sequestration was conducted
   6. Transcripts of all interviews
   7. Scientific or forensic analyses conducted
   8. Findings:
      • Whether misconduct occurred
      • Specific facts supporting findings
      • Whether intent (intentional, knowing, reckless) was established
      • Type of misconduct (FFP)
      • Impact and extent
      • Recommended actions
2. Respondents are provided with the report and may respond in writing

G. INSTITUTIONAL DETERMINATION

1. Deciding Official reviews the Investigation Report for:
   • Objectivity
   • Thoroughness
   • Procedural compliance
   • Proper application of the misconduct definition
2. The DO may:
   • Accept findings
   • Reject findings
   • Request for additional investigation
   • Appointing a new committee
3. Finality of Decision
   1. ​​​​​​​ Institutional findings are final and do not require ORI agreement to take effect
   2. Respondents, complainants, and committee are notified in writing

H. REPORTING TO ORI AND SPONSORS

1. The University must notify ORI:
   1. Within 24 hours if criminal violations are possible
   2. When an investigation is initiated
   3. During the investigation if:
      • Health hazard exists
      • Funds/equipment require protection
      • Persons require protection
      • Public disclosure is likely
      • Criminal violations suspected
2. At the completion of investigation, the University must provide ORI:
   • The entire institutional record, including:
     • Assessment
     • Inquiry Report + all records reviewed
     • Investigation Report + all records reviewed
     • All interview transcripts
     • DO decision
     • Appeal records
     • Index of evidence collected
     • Description of sequestered but unused records

I. RETENTION OF RECORDS

1. All research misconduct records—including:
   • Data
   • Interviews
   • Minutes
   • Reports
   • Evidence
   • Sequestration documentation
2. Must be retained for at least 3 years after completion of the proceeding or longer if required by ORI​​​​​
3. Respondent Record Retention
   • ​​​​​​​​​​​​​​ Destruction of research records
   • Refusal to provide records
   • Intentional withholding of records
4. May constitute evidence of misconduct
5. Simple failure to maintain adequate records alone is not evidence of misconduct

J. SUBSEQUENT USE EXCEPTION

1. An allegation older than six years may proceed if the respondent:
   • Cites
   • Republishes
   • Or otherwise uses
2. The research record is alleged to be fabricated, falsified, or plagiarized for their own benefit
3. The citation must be to the specific portion of the record alleged to be misconduct