Research Misconduct Confidentiality and Notification SOP

• All individuals involved in research misconduct proceedings, including the Research Integrity Officer (RIO), Investigation Committees, and other relevant personnel, must maintain confidentiality regarding the identity of the respondent and the details of the case while the case is ongoing, except when disclosure is required by law.
• Evidence and documents related to the investigation will be securely stored and access restricted to authorized personnel only.
  • Protected health information in evidence and the institutional record will be deidentified and/or redacted if possible.
• Information about the research misconduct case will be shared with individuals who have a legitimate need to know in order to carry out their responsibilities in the research misconduct proceedings.
  • In addition to members of inquiry and investigation committees, members of the Research Integrity Standing Committee may be given case-specific information in order to advise those committees and Research Integrity Office staff.
• Those who need to know may include individuals and/or institutions who are impacted by the research misconduct proceedings, such as institutional officials or staff, compliance committees, journals, editors, publishers, co-authors, professional organizations, and collaborating institutions.
• The RIO, in consultation with the DO and other department and/or institutional officials, will determine who needs to know specific details of the case and will ensure that these individuals understand their obligation to maintain confidentiality.

When information about research misconduct proceedings is shared with individuals outside the Research Integrity Office, the RIO will use the following mechanisms to ensure all parties to research misconduct proceedings are aware of their confidentiality obligations:

Handling accidental disclosures or a breach in confidentiality is crucial to maintaining the integrity of the research misconduct proceedings. For example, such breaches may include the following:

If a breach occurs, the following steps should be taken:

1. Immediate containment: As soon as a breach is identified, the discloser must take immediate steps to contain the breach. This may involve recalling emails, securing physical documents, or restricting access to digital files.
2. Notification: The discloser must immediately inform the Research Integrity Officer (RIO) about the accidental disclosure. Transparency is key to managing the situation effectively.
3. Assessment: The RIO will conduct a thorough assessment to determine the extent of the breach and identify the information that was disclosed and evaluate the potential impact on the proceedings and the individuals involved.
4. Mitigation: The RIO will implement measures to mitigate the impact of the disclosure. This could include reinforcing confidentiality obligations, providing additional training to staff, and enhancing security protocols.
5. Communication: The RIO will inform appropriate parties of the breach, including the respondent, and the steps being taken to address it. The RIO will ensure that these communications are done sensitively and maintain as much confidentiality as possible.
6. Documentation: The RIO will document the incident, including the nature of the disclosure, the steps taken to address it, and any measures implemented to prevent future occurrences. This documentation will be included in the case file.
7. Review and improvement: The RIO will review the incident to identify any weaknesses in the current confidentiality protocols and will use this information to improve policies and procedures to prevent similar breaches in the future.

Example Scenario: An email containing sensitive information about a research misconduct proceeding is accidentally sent to an unauthorized recipient. The RIO is immediately notified, and the email is recalled. The RIO assesses the breach, informs appropriate parties, and documents the incident. Additional training on email security is provided to staff, and email protocols are reviewed and updated to prevent future occurrences.

• If the RIO determines that the allegation does not meet the definition of research misconduct but may involve other types of noncompliance and/or misconduct, the RIO will refer the case to the appropriate university office or official for further action.
• In cases where the research misconduct involves collaborators or institutions outside of Indiana University, the RIO will coordinate with the external institutions to ensure a thorough investigation. Such coordination may involve the following, at a minimum:
  • Reporting allegations for the external institution’s action pursuant to their own policies and procedures
  • Conducting joint inquiry or investigation proceedings
  • Providing inquiry or investigation reports, or excerpts thereof

The following institutional officials will be notified of inquiry and investigation initiation and results and findings and may share the information with additional individuals who need to know. When possible, institutional officials will consult with the RIO before sharing such information.

• DO
• Dean of Respondent’s school
• Division chief/Department head of the Respondent’s unit
• Respondent’s direct supervisor, especially for respondents who are post-doctoral fellows or staff
• If investigation is initiated: senior campus official such as Chancellor (IUI) or Provost (IUB)
• General Counsel

Complainants will be provided limited information after allegation assessment and at inquiry and investigation completion; however, the DO may require that more specific information, including inquiry/investigation reports, be provided.

More specific information about inquiry and/or investigation, including inquiry/investigation reports, may be provided to appropriate institutional officials, including division chiefs, department heads, or direct supervisors, at the DO’s request, especially to ensure appropriate institutional actions are completed and that appropriate departmental leadership understands the context of any results.

Information about inquiry and/or investigation results and findings, including inquiry/investigation reports, may be provided to additional external entities, especially to ensure appropriate institutional actions are completed, including:

• Journals, editors, and publishers
• Co-authors
• Professional organizations
• Collaborating institutions
• Funding agencies  

When the disputed research is supported by or involves federal funds, information about research misconduct proceedings will be shared with relevant federal oversight agencies in accordance with federal, state, and location regulations as defined below. The RIO may make additional notifications as needed.  

• When the disputed research is supported by PHS funds, the RIO will make the following notifications to the Office of Research Integrity (ORI), per 42 CFR 93:
  • When the DO makes a decision that investigation is warranted, the RIO will provide ORI with a copy of the inquiry report within 30 days.
  • At the completion of an investigation, after the DO has made a determination, the RIO will provide ORI with the institutional record.
  • The RIO will notify ORI if the RIO plans to close a research misconduct proceeding on the basis that the respondent has admitted to research misconduct.
  • If there is reason to believe any of the following special circumstances exist, the RIO will notify ORI:
    • Health or safety of the public is at risk, including an immediate need to protect human or animal subjects
    • HHS resources or interests are threatened
    • Research activities should be suspended
    • There is reasonable indication of possible violations of civil or criminal law
    • Federal action is required to protect the interests of those involved in the research misconduct proceeding
    • HHS may need to take steps to safeguard evidence and protect the rights of those involved
• When the disputed research is supported by NIH funds, the RIO will make the same notifications to the NIH Extramural Research Integrity Officer as are made to ORI.
• When the disputed research is supported by NSF funds, the RIO will make the following notifications to the Office of Inspector General, per 45 CFR 689:
  • The RIO will notify the Office of Inspector General (OIG) immediately if an inquiry supports a formal investigation and keep OIG informed throughout the investigation.
  • At the completion of an investigation, after the DO has made a determination, the RIO will provide ORI with the institutional record.
  • If there is reason to believe any of the following special circumstances exist, the RIO will promptly notify OIG:
    • Health or safety of the public is at risk, including an immediate need to protect human or animal subjects
    • NSF’s resources, reputation, or other interests need protecting
    • Research activities should be suspended
    • There is reasonable indication of possible violations of civil or criminal law
    • Federal action may be required to protect the of a subject of the investigation or of others potentially affected
    • The scientific community or the public should be informed
• When the disputed research involves VA research, the RIO will contact the Research Integrity Office at the relevant VA location to ensure proceedings align with VHA Directive 1058.02. Notification will be made, at a minimum, at inquiry and investigation initiation and investigation completion.
• When the disputed research is supported by DOD funds:
  • The RIO will notify the appropriate DOD agency when the DO makes a decision that investigation is warranted.
  • At the completion of an investigation, after the DO has made a determination, the RIO will provide the institutional record to the appropriate DOD agency.
• When the disputed research is supported by USDA funds:
  • The RIO will notify the OIG and the USDA RIO when the DO makes a decision that investigation is warranted.
  • At the completion of an investigation, after the DO has made a determination, the RIO will provide the institutional record to the USDA Research Integrity Officer. 
  • If there is reason to believe any of the following special circumstances exist, the RIO will promptly notify the Agency Research Integrity Officer:
    • Public health or safety is at risk
    • The resources, reputation, or other interests of USDA are in need of protection
    • Research activities should be suspended
    • Federal action may be needed to protect the interest of a subject of the investigation or of others potentially affected
    • A premature public disclosure of the inquiry into or investigation of the allegation may compromise the process
    • The scientific community or the public should be informed
    • There is reasonable indication of possible violations of civil or criminal law

When the disputed research is supported by funds other than federal funds, information about research misconduct proceedings will be shared with the sponsor or funding agency in accordance with any relevant contracts. The RIO may make additional notifications as needed or as directed by the DO.