A. Preparing and Submitting a Research Compliance Concern
Research Compliance concerns should be submitted by a complainant when they suspect there may be an issue in research they may or may not be involved in. The preferred method for submission of a research compliance concern is through U Report, in which the Office of Institutional Compliance will remand to the Vice-President for Research and the Research Intelligence and Compliance Team (RIACT) Director. Written research compliance concerns may also be submitted for review to their appropriate Regulatory Committee, or directly to the Office of the Vice President for Research (OVPR) via e-mail. Concerns may also be discussed with the RIACT Director, the Designee of a Regulatory Committee, and/or the Chief Compliance Officer.
B. Risk Intelligence and Compliance Team Intake
Upon receipt of a report of a research compliance concern, the Vice President for Research (VPR) or the Risk Intelligence and Compliance Team (RIACT) Director will either assume responsibility for the case or assign the case to another Designated Research Compliance Investigator (DRCI). The RIACT Director will maintain record of the investigative process, regardless of whether they are the DRCI. The VPR, RIACT Director, or other designated DRCI will assess the report to determine whether:
- it is sufficiently credible and specific so that potential evidence of a research compliance violation may be identified;
- federal regulations are applicable;
- the complaint meets the timelines listed in the associated policy;
- the activity should be investigated by the RIACT or be resolved by other deliberative or mediation procedures or specialized regulatory committees or research offices, such as the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Sponsored Projects Administration (SPA), etc. as designated in the associated policy;
- the DRCI has a conflict of interest in the case.
Conflict of Interest. The DRCI will notify the VPR if the DRCI has personal, professional, or financial conflicts of interest with the complainant or respondent in the process. If the DRCI has a conflict of interest with a case, the Vice President of Research (VPR) or RIACT Director assigns an alternate DRCI, based on the information provided. The case records will reflect the outcome of this conflict of interest determination, including confirmation that no conflict exists. Conflicts of interest include:
- coauthoring a book, paper, or grant proposal with any of the individuals directly involved with the alleged noncompliance (complainant or respondent) within the past seven years;
- professional or personal relationship with any of these individuals, e.g., current or former employee or mentor, direct supervisory or subordinate relationship, close friendship or romantic relationship, familial relationship, direct collaborator within the past seven years;
- financial ties to the involved individuals; or
- professional differences of opinion with any of the involved individuals that might reasonably be expected to affect objectivity in considering the case.
Intake Completion. If the process reveals that the research compliance concern will not be pursued or will be pursued by a regulatory committee or research office, the complainant will be notified. Otherwise, the complainant will be notified that the report has been received by the RIACT Director, and a case number and contact information for the DRCI will be provided.
C. Assessment Process
The DRCI will assess the complaint through an examination of the facts in the matter, gathered in writing or orally from the complainant (primarily using the original written complaint, but some follow-up inquiries are possible as well), the respondent(s), other parties (witnesses or others knowledgeable about the incident or issue) and relevant records.
The DRCI may include other individuals having specialized expertise (such as one or more representatives from a regulatory committee, such as the IRB or IACUC) in helping with the assessment process and determining whether any violation has occurred. Records, correspondence, emails, statements and data may be requested by the DRCI for use in the assessment process.
Anonymity/Confidentiality. Cases that depend specifically upon the observations or statements of a complainant cannot proceed without the involvement of that individual being known during the course of the investigation. Cases that can instead rely exclusively or primarily on documentary evidence may permit a complainant to remain anonymous. Anonymity is provided to the extent possible as outlined in the U Report FAQ.
The DRCI will inform the respondent of the obligation to provide all the evidence relevant to the allegation.
For those issues involving regulatory matters, the relevant regulatory committee (e.g., IRB, IACUC, IBC, SCRO, FTR etc.) will also review the matter. These committees have the authority to suspend or terminate research or take other actions as necessary to protect the welfare of research subjects or assure regulatory compliance. Additional actions may be taken by the Vice President for Research or other university officers.
At the end of the review and assessment phase, there will be one of four outcomes:
- A determination that no research compliance violation occurred or there was no material evidence of a research compliance violation;
- A determination that there is insufficient evidence available to make a conclusive determination;
- A determination that one or more research compliance violation(s) have occurred (which may be subject to regulatory agency reporting); or
- There is a need for a deeper or broader investigation.
Prior to a final response to the complainant or the respondent, the proposed outcome and corresponding evidence for the conclusion will be reviewed by the Office of General Counsel.
D. Outcome Report & Notifications
Upon completion of the assessment, the DRCI communicates with the complainant and the respondent, summarizing the issue and steps taken to pursue the matter and indicating the outcomes. As indicated in Section E, notifications may also occur with sponsors or applicable regulatory agencies if needed. Outcome reports will also be used by the University in its assessments of the health of the research enterprise and ongoing refinements in training and business practices.
Most reports of research compliance concerns are expected to be resolved by completion of the steps above.
In some cases, the DRCI may determine that the review and assessment process described above is not sufficient to respond to part or all of a research compliance concern (e.g., additional specialized scientific expertise is needed to draw an informed conclusion, or a broader review is warranted). In these instances, the VPR, in consultation with the DRCI, decides that further investigation via an investigative panel is warranted. Neither complainants nor respondents are involved in such decisions.
If a decision is made to pursue a deeper or broader investigation via an investigative panel, the complainant and respondent are provided a copy of this procedure.
Generally, discovery and assessment (including outcome reporting and notifications) will be completed within 90 days of receipt of the original complaint, but this timetable may be extended by the DRCI if needed to allow for full access to relevant information or expertise. The complainant and respondent will be notified if and why additional time is needed.
E. Investigative Panel (Used by DRCI only when needed)
If an investigative panel is needed, the following process occurs:
DRCI Convenes an Investigative Panel.
The investigation will be carried out by a panel of non-conflicted individuals with appropriate knowledge, appointed by the DRCI. The DRCI will first seek these knowledgeable individuals from within the University, deploying the assistance of applicable regulatory committees (e.g., IRB, IACUC, IBC, SCRO, FTR) or senior university officials to recommend appropriate individuals as needed. For investigations involving a respondent who is a faculty member, the investigative panel will include at least one faculty member. In cases where additional scientific expertise is needed nominations or recommendations will be requested for an external expert. If the investigation is likely to involve the action or potential action of a regulatory committee, at least one member of the panel will be from the applicable regulatory committee. Cases involving financial impacts should include a cost assessment by the appropriate office (e.g., Sponsored Projects Administration, Sponsored Financial Reporting, Fairview, Gillette, Internal Sales, or the Controller’s Office.) The panel will have an odd number of members, with the DRCI as chair. The DRCI informs the respondent and complainant of the proposed members for the panel and allows them five working days to object to any of the panel members on grounds of conflict of interest.
The panel conducts the investigation as expeditiously as practicable and generally completes it within 90 days after the panel membership has been determined, following the steps outlined below.
- DRCI Provides a Charge Letter to the Panel.
The DRCI will provide the panel with an explicit Charge Letter. The University's Office of General Counsel advises the chair of the panel on the appropriate protocol and practices that should be followed. The DRCI notifies the complainant and respondent when the investigation phase of this procedure commences. The respondent may seek the assistance of an advisor (legal counsel or another individual, for example a mentor) at this point if assistance has not already been sought. All parties involved will cooperate with the proceedings in providing information relating to the case.
- The Investigative Panel Conducts Its Investigation
The panel examines the appropriate material to determine whether one or more research compliance violations have occurred. The panel may rely on the information gathered during the assessment phase as well as gather any additional information it believes pertinent to the matter.
The panel notifies the respondent of the allegations and supporting evidence in a timely manner to facilitate the preparation of a response. The respondent has the opportunity to address the charges and evidence in detail in writing and/or via meeting with the panel, and may provide the names of other witnesses or experts with whom the panel should consult. The respondent may have an advisor present during any meeting with the panel.
- The Panel Prepares and Issues a Report
Step 1: Preliminary Report. When the panel reaches a conclusion regarding the case, the DRCI transmits a preliminary investigative panel report to the respondent. This report reviews all the information considered and explains the panel's conclusion. The report is furnished to the respondent for review and comment. The respondent has 15 calendar days to provide any comments that the panel should consider before finalizing its report.
Step 2: Investigation Panel Report. The panel's charge is to generate a report that compiles all the information it considers and make findings regarding whether a research compliance violation has occurred. The report must consider any feedback provided by the respondent in Step 1.
- Action on the Investigative Panel Report
Regulatory Committee Review (when applicable)
The final Investigation Report is sent to the Chair of the related regulatory committee. The regulatory committee will take such actions as it deems appropriate on matters determined to be regulatory non-compliance.
The Chair will notify the DRCI of actions which will be taken by the regulatory committee and provide any desired additional feedback about non-regulatory issues or recommendations to the DRCI. These actions should take place within 30 days of receiving the report unless an alternative timetable is arranged with the DRCI. If an alternative timetable is arranged, the DRCI will notify the complainant and respondent.
The DRCI will confer with the VPR and determine any other actions needed or concur that there appears to be no research compliance violation. Examples of the types of other actions that might be taken in the event of research noncompliance include (but are not limited to):
- Additional specialized training
- Restriction from engaging in some portion of the research
- Specialized monitoring of future work
- Removal from a particular project
- Restriction from serving as a principal investigator or protocol director
- Referral to an academic disciplinary process
Final Outcomes Report
The DRCI finalizes the outcome report to reflect the actions taken by regulatory committees and/or the VPR or other University officials. The final report will be reviewed by the Office of General Counsel before it is released.
F. External Investigation
At any point after a compliant is reported and before a final outcome is reached, the DRCI will make a written recommendation to the RIACT Director and VPR that an external investigation of the complainant’s allegations be considered, if any of the following factors emerge:
- It is likely or certain that the health or safety of humans has been materially compromised;
- Multiple University offices or personnel are credibly implicated;
- There are credible indications that a high-ranking University official (e.g., department chair, dean) has engaged in or approved of unlawful conduct;
- The scope or complexity of the issues involved cannot reasonably be handled by University personnel, due to constraints of time or expertise;
- The allegations involve a systemic, widespread shortcoming that cannot reasonably be assessed by the University without creating at least the appearance of a conflict of interest; or
- Credible evidence of willful, criminal misconduct is found.
The VPR, after consultation with the Office of General Counsel and any other experts the VPR identifies, will decide in writing whether to refer an investigation to an outside organization.
If a determination is made to commence an external investigation, the DRCI will
- Take the lead in identifying an outside organization that has the necessary expertise and no conflict of interest;
- Work with the outside organization to scope and structure the investigation in a manner consistent with the University’s commitment to principles of integrity, efficiency, fairness, and, to the extent feasible, confidentiality; and
- Act as the principal point of contact between University personnel and the outside organization.
G. Final Notification and Closeout
Complainant: The DRCI notifies the complainant about the disposition of the investigation to the extent permitted under the Minnesota Government Data Practices Act.
Respondent: The respondent will be notified by the Vice President for Research or the DRCI of the final actions taken on the matter. Normally such notifications will also include the respondent’s department head and research associate dean.
The respondent will receive a copy of the final report and notification that the matter will be considered closed upon satisfaction of the required action steps. The respondent will be notified that the University intends to track and use the report for internal trending and educational purposes.
Sponsoring and Regulatory Agencies (if needed): The appropriate regulatory office promptly notifies or initiates notification to the sponsoring and regulatory agencies of the outcome of the investigation and any corrective actions. The respondent is copied on such communications.
- Archive records.
Records related to this case are maintained securely under the supervision of the DRCI for seven years. The records include documentation reviewed by the assessment/investigation panel, summaries of witness interviews, and the findings of the panel.
- Corrective Action Monitoring
If the final Outcome Report defines corrective actions that must be taken, the RIACT Director monitors to ensure that the corrective actions are taken in a timely manner. Failures to complete actions in a timely manner are reported to the Vice President for Research and other applicable University officials for potential disciplinary action.
H. Other Information
Interim Administrative Actions.
At any stage of an investigation, the University reserves the right to take interim administrative actions to protect the health and safety of research subjects, university staff, students or resources.
Such interim actions may range from slight restrictions to reassignment of the activities of the respondent including removal from any leadership roles in research studies. Any actions will be in accordance with regulatory requirements and the procedures specified in Board of Regents Policies directly related to the area of research, the policy on Faculty Tenure, the contract between the Board of Regents and labor represented groups, any other labor agreements, or other applicable employee policies. Interim administrative actions will be taken with full awareness of how they might affect the respondent and the ongoing research projects of the University and after consultation with the Office of General Counsel.