For-Cause Investigations Related to Research Compliance Concerns
Responsible University Officer(s):
- Vice President for Research
- Director - Research Compliance Office
- Sarah Waldemar
The University is committed to the timely review and resolution of complaints or concerns about violations of research regulations, policies, procedures, or standards
As stated in Board of Regents Policy: Code of Conduct and Administrative Policy: Reporting Suspected Misconduct, members of the University community are expected to be proactive to prevent and detect any compliance violations and report suspected violations to supervisors or other University officials in a timely manner. This policy supplements the general University policy by providing specific guidance related to research compliance concerns. Research compliance concerns include alleged violations of regulations, policies, procedures, or standards related to the conduct of research. Concerns may be related such topics as to the appropriate use of human or animal subjects, issues related to compliance with sponsored projects requirements or misuse of research funding, or concerns related to biosafety related activities among others.
Included in For-Cause Investigations
The Research Compliance Office is responsible for conducting or overseeing for-cause investigations related to research compliance concerns. For-cause investigations include research compliance concerns escalated by a University regulatory committee, complaints related to the conduct of regulatory committees themselves, other matters identified through monitoring or trend data, or other issues assigned for review by the Vice President for Research.
Excluded from For-Cause Investigations
Research compliance concerns not falling into these categories - including concerns discovered through routine monitoring activities or concerns reported directly to a regulatory committee or research office (and not falling within the categories above) are addressed directly by those offices/committees and do not fall within this policy. Research compliance concerns also do not include scientific misconduct allegations, which are separately handled under Administrative Policy: Research Misconduct. See the definition of “Research Misconduct” in the definitions section below.
The Research Compliance Office will investigate a research compliance concern only one time except in instances involving receipt of material new information. The Research Compliance Office does not review concerns that occurred seven or more years prior to the submission of the complaint, except under the direction of the Vice President for Research who determines that the alleged conduct was not reasonably discoverable earlier.
Reporting a Concern
Complainants may submit any research compliance concern using UReport, the University’s centralized confidential reporting service (including via a confidential web link ). Their concern will then be forwarded to the applicable regulatory committee/office or the Research Compliance Office for review. Concerns may also be reported directly to regulatory committees/research offices as outlined in Administrative Procedure: Preparing and Submitting a Report of a Research Compliance Concern.
Protection from Retaliation
No member of the University community may retaliate against an individual because of the individual’s good faith participation in:
- reporting or otherwise expressing opposition to, suspected or alleged misconduct;
- participating in any process designed to review or investigate suspected or alleged misconduct or non-compliance with applicable policies, rules, and laws; or
- accessing the Office for Conflict Resolution (OCR) services.
A causal relationship between the good faith participation in one of these activities and an adverse action is needed to demonstrate that retaliation has occurred.
Reporting Retaliation Concerns
Individuals who believe that retaliation is occurring or has occurred, as a result of their good faith participation in one of the above referenced activities, should follow the reporting options available to them in Administrative Policy: Reporting Suspected Misconduct.
Reports of retaliation will be reviewed and investigated in the same manner in which other concerns of misconduct are handled. Any University member who engages in retaliation may be subject to disciplinary action up to and including termination of employment or expulsion.
Intentionally False Reports/Information
Individuals who, knowingly or intentionally, file a false report or provide false or misleading information in connection with an investigation may be subject to disciplinary action up to and including termination of employment, or expulsion.
Phases of Review
For-cause investigations conducted under this policy have several phases including receipt, review and assessment, conclusion/action and reporting. Some investigations may require the convening of an investigative panel or involve a referral to an outside organization for external investigation. These phases are outlined in related procedures.
Conditions Governing Investigations and Outcomes
For-cause investigations will be conducted by individuals without a conflict of interest and will include individuals with the necessary regulatory and subject matter expertise (including involving experts outside the University when internal expertise is not available). Reviews and corrective actions (if needed) will be undertaken in a manner fair to all parties. The Research Compliance Office will work with the appropriate regulatory offices, panels or academic units as appropriate to ensure that humans and animals are protected when research compliance violations occur.
Regulatory committees and/or academic or administrative officials, as appropriate, will take the actions needed to mitigate research compliance concerns found to be compliance violations. Outcome reporting will be accomplished in a manner that encourages transparency and institutional identification of trends and patterns, while protecting the privacy and well-being of witnesses, the complainant (if requested), and others involved in the investigation to the extent possible. At no time may any University employee take retaliatory action against a complainant because of a concern reported in good faith. Individuals reporting concerns are protected from retaliation and covered by other relevant University policies, including Administrative Policy: Reporting Suspected Misconduct.
REASON FOR POLICY
The University community, the public, accreditation entities, and funding sponsors expect that the University has and follows written procedures for addressing allegations and findings of non-compliance with regulatory requirements and standards, and that concerns are addressed in a timely manner. This policy provides direction for the good faith reporting of research compliance concerns, outlines the complaint review and resolution processes, and defines responsibilities as appropriate. The policy also allows the University to identify areas where additional oversight or training is needed.
- Adverse Action
- Any action that might deter a reasonable person from engaging in reporting suspected or alleged misconduct, expressing opposition to alleged misconduct, participating in an investigation related to a misconduct allegation, or accessing the Office for Conflict Resolution services. Examples of adverse action include, but are not limited to: impeding the individual’s academic advancement; departing from any customary academic or employment practice regarding the individual; firing, refusing to hire, or refusing to promote the individual; transferring or assigning the individual to a lesser position in terms of wages, hours, job classification, job security, employment or academic status; and threatening or marginalizing an individual. In some situations, retaliatory conduct may also include inappropriate disclosure of the identity of the individual who has made a complaint protected by this policy.
- See UReport FAQ.
- The phase in which the complaint is assessed to determine whether it is (a) subject to this policy, and (b) sufficiently credible and specific to warrant further review or investigation.
- Charge Letter
- Document provided by the Designated Research Compliance Investigator (DRCI) to an investigative panel that provides direction about what matters in a for-cause investigation require their review and response.
- See: UReport FAQ.
- A written disclosure (or oral disclosure after having been reduced to writing) indicating an alleged failure to comply with University policy/procedure or governmental or sponsor requirements or regulations related to the conduct of research at the University. The Research Compliance Office does not review concerns that occurred seven or more years prior to the submission of the complaint, except under the direction of the Office of the Vice President for Research who determines that the alleged conduct was not reasonably discoverable earlier.
- The individual or individuals who in good faith report or provide information about a research compliance concern.
- Compliance Concern
- See Research Compliance Concern.
- Compliance Violation
- See Research Compliance Violation.
- Designated Research Compliance Investigator (DRCI)
- The University official, either the Associate Vice President for Research or designee, with primary responsibility for directing the case from allegation review through disposition of the case.
- Investigation of a research compliance concern because of a specific allegation. For-Cause differs from post-approval monitoring, post-approval review, or general review of compliance with policy and procedure, as those activities are intended to verify or identify the degree of compliance with one or more specific requirements, or to serve as quality control. Issues identified and subsequently corrected during monitoring activities do not typically rise to the level of for-cause, but might do so if there were an alleged failure to take appropriate and timely corrective action. [See also Roles and Responsibilities].
- Good Faith Participation
- Reporting, or otherwise expressing opposition to, misconduct based on a reasonable belief that misconduct has occurred. Or, honestly participating in an investigation of misconduct or accessing conflict resolution services.
- Investigative Panel
- A group of non-conflicted individuals charged by the Research Compliance Office to review part or all of an individual report of an alleged research compliance concern. Selected individuals may or may not be affiliated with the University. Panels receive a specific charge to determine whether or not misconduct or a violation of research regulation, policy, procedures or standards has occurred. The panel may also be asked to recommend to the Research Compliance Office whether further review of part or all of the matter is needed by a regulatory committee.
- Material Information/Material New Information
- Information about an occurrence, event, or situation that is sufficiently significant to influence an individual into acting in a certain way. In formal court procedures, a material fact is anything needed to prove one party's case, or tending to establish a point that is crucial to a person's position.
- Regulatory Committee
- A standing committee at the University of Minnesota responsible for a certain area of regulatory compliance, such as the Institutional Review Board (IRB) for human subjects; the Institutional Animal Care and Use Committee (IACUC), or Institutional Biosafety Committee (IBC). These types of committees are responsible for making decisions on compliance violations and corresponding actions in their respective areas.
- For the purposes of this policy, research is a systematic study leading to generalizable new knowledge, whether funded via internal University funds or via an externally funded sponsored project. In addition, for this policy only, the term also includes other sponsored projects (public service, other sponsored activities, training, and instruction).
- Research Compliance Concern
- An alleged violation of regulations, policies, procedures, or standards related to the conduct of research. Concerns may be related to (but are not limited to) the appropriate use of human or animal subjects, issues related to compliance with sponsored projects requirements or unallowable use of research funding, or concerns related to biosafety related activities. If found to be valid, a research compliance concern becomes a research compliance violation.
- Research Compliance Violation
- A determination that there was a violation of University policy, procedure or standard, or a violation of governmental or funding agency requirements, or research regulations.
- Research Misconduct
- The fabrication or falsification of data, research procedures, or data analysis; destruction of data for fraudulent purposes; plagiarism; abuse of confidentiality; or other fraudulent actions in proposing, performing, reviewing, or reporting the results of research or other scholarly activity. Research misconduct does not include honest error and the ambiguities of interpretation that are inherent in the scientific and scholarly process, but are normally corrected by further research. Research Misconduct is subject to Administrative Policy: Research Misconduct.
- Report in Good Faith
- A report made by an individual who reasonably believes that misconduct has occurred and reports the incident.
- Taking an adverse action against an individual because of the individual’s good faith participation in reporting suspected or alleged misconduct, expressing opposition to alleged misconduct, participating in an investigation related to a misconduct allegation, or accessing the Office for Conflict Resolution services (see also Adverse Action). A causal relationship between good faith participation in reporting and an adverse action is needed to demonstrate that retaliation has occurred.
- Any external entity, including, but not limited to, companies, agencies of the U.S. federal and state governments, foundations, industry associations, and others, that supports or is directly involved in the scholarly work that is the subject of the research compliance concern. Note that this definition is broader than that used by the FDA in determining the sponsor of a clinical trial, or that used by Sponsored Projects Administration for determining the sponsors of externally funded agreements.
- For-cause investigations vary significantly in the degree of review, assessment and investigation that is required, and may involve action by other parties (including regulatory committees). In general, however, the Research Compliance Office targets completion of reviews within 90 days from its receipt of a complaint, or when an investigative panel is required, within 90 days following determination of panel membership. If a review cannot be completed within that time, the complainant will be notified that additional time beyond that time frame will be needed.
- Attorney, Office of the General Counsel
- Provides advice in the appropriate practices
- Director, Research Compliance Office
- Serves as the Designated Research Compliance Investigator (DRCI) for each for-cause investigation, or delegates that responsibility to another named individual. Determines whether an investigative panel is needed. Reviews outcome report and makes recommendation to Vice President for Research for final (non-regulatory) action needed.
- Files good faith complaint or report of a potential compliance violation.
- Designated Research Compliance Investigator (DRCI)
- Serves as the lead official on a for-cause investigation (typically this role is handled by the Director, Research Compliance Office or designee). The DRCI accepts a case on behalf of the Research Compliance Office, determines the allegation assessment steps needed, obtains needed information and analyzes the data and/or makes arrangements for the proper subject matter experts to analyze the data. For research compliance concerns not requiring an investigative panel, the DRCI creates an outcome report after obtaining relevant feedback. The DRCI (if not also the AVPR) recommends to the AVPR whether an investigative panel is required. If the AVPR determines a panel is needed, the DRCI seeks input and assigns appropriate members to the investigative panel, charges the panel and serves as its chair, seeks regulatory committee review if warranted, drafts the investigative report after obtaining panel input, and recommends outcome actions to the AVPR. The DRCI also monitors reviews to ensure timeliness, provides required notifications to complainants and respondents, stores investigation data, and provides outcome data for accountability metrics. For requests related to re-review of previously submitted research compliance concerns, the DRCI, in conjunction with the Office of General Council, determines whether new information meets the definition of Material (New) Information.
- Investigative Panel
- Follows the Charge Letter provided by the DRCI to examine the appropriate evidence to determine whether one or more research compliance violations has occurred. The panel may rely on the information gathered during the assessment phase, determinations of regulatory compliance or non-compliance issued by applicable regulatory committees, as well as gather any additional information it believes pertinent to the matter. Generates a report that compiles all the information it considers and make findings regarding whether research compliance violation(s) have or have not occurred.
- Research Compliance Office (RCO)
- Provides oversight and compliance review of research activities at the University of Minnesota. Works to reinforce and enhance research compliance activities of university faculty, staff, and students. Conducts for-cause investigations (see Designated Research Compliance Investigator (DRCI)).
- Research Offices (also known as “Central Research Offices”)
- Central offices charged with conducting and/or monitoring specific aspects of research administration or who work to support designated research activities. Examples include Sponsored Projects Administration (SPA), Sponsored Financial Reporting (SFR), Institutional Review Board (IRB), and Research Animal Resources (RAR). Reviews research compliance concerns arising from monitoring activities or reported based on their processes and procedures. Escalates research compliance reviews to RCO when required under this policy. Reports monitoring and research compliance review data to RCO.
- Regulatory Committees/Panels
- Regulatory committees or review panels (Institutional Review Board [IRB]), Institutional Animal Care and Use Committee [IACUC], Institutional Biosafety Committee [IBC], Stem Cell Research Oversight Panel [SCRO], Dual Use Research of Concern Committee [DURC]) charged with regulatory oversight and action specific to their areas. Review research compliance concerns arising from monitoring activities or reported based on their own processes and procedures. Escalate research compliance reviews to RCO when required under this policy. Report monitoring and research compliance review data to RCO. Provide data and expertise to assist RCO in conducting for-cause investigations related to their specific topical area. Provide recommendations for appropriate members for an investigative panel, and timely review of research compliance violations requiring potential regulatory action.
- Vice President for Research
- Makes final determinations on allegations of research compliance wrongdoing (non-regulatory), whether to commence an external investigation, and administrative actions. For compliance concerns older than the policy limit, determines whether a review should be conducted. At any time, may charge RCO to conduct a for-cause investigation arising from research compliance concerns brought to their attention.
- July 2017 - Minor Revision. The section on Retaliation has been updated to be consistent with core language in Administrative Policy: Retaliation.
- July 2016 - New Policy. Provides direction for the good faith reporting of research compliance concerns. Outlines the compliance review and resolution process. Defines responsibilities and timelines.