Printed on: 12/05/2024. Please go to policy.umn.edu for the most current version of the document.
University of Minnesota  Administrative Policy

For-Cause Investigations Related to Research Compliance Concerns

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Policy Statement

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 these policies 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 to such topics as the appropriate use of human or animal subjects, compliance with sponsored projects requirements or misuse of research funding, concerns or issues arising from the actions or activities of regulatory boards or committees or biosafety related activities, among others.

Included in For-Cause Investigations

Research Integrity and Compliance (RIC) 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 and Innovation.

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, 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.

RIC will investigate a research compliance concern only one time except in instances involving receipt of material new information. RIC 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 and Innovation 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 RIC for review. Concerns may also be reported directly to regulatory committees/research offices as outlined in Administrative Procedure: Preparing, Submitting, Receiving and Investigating 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; or
  • 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.

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 listed below.

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. RIC 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.

Contacts

SubjectContactPhoneEmail
Primary Contact(s)Danielle Rintala, Research Integrity and Compliance (RIC) Director612-624-8349[email protected]
Responsible Individuals
Responsible Officer Policy Owner Primary Contact
  • Associate Vice President for Research Integrity and Compliance
  • Research Integrity and Compliance Director
  • Danielle Rintala
    Research Integrity and Compliance Director

Definitions

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.

Anonymity/Confidentiality

See UReport FAQ.

Assessment

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.

Complaint

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. Research Integrity and Compliance (RIC) does not review concerns that occurred seven or more years prior to the submission of the complaint, except under the direction of the Research and Innovation Office who determines that the alleged conduct was not reasonably discoverable earlier.

Complainant

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 and Innovation, the Research Integrity and Compliance (RIC) Director, or a designee, with primary responsibility for directing the case from allegation review through disposition of the case.

For-Cause

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 which 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 RIC 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 RIC 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.

Research

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, research regulations or findings related to the conduct of institutional regulatory boards and committees.

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.

Retaliation

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.

Sponsor

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.

Timely

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, RIC 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.

Responsibilities

Attorney, Office of the General Counsel

Provides review and advice related to the findings of the DRCI which may include recommendations related to disciplinary actions.

Research Integrity and Compliance (RIC)

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 and Innovation for final (non-regulatory) action needed.

Complainant

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. The DRCI accepts a case on behalf of the Research and Innovation Office (RIO), 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 the Vice President for Research and Innovation) will convene a panel if recommended after discussion with the Vice President for Research and Innovation, and will 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 Vice President for Research and Innovation. 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 Counsel, 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 Integrity and Compliance (RIC)

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),Human Research Protection Program (HRPP), Institutional Animal Care and Use Committee (IACUC), Office of Biotechnology Activities Oversight (OBAO), 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 the RIC Director when required under this policy. Reports monitoring and research compliance review data to the RIC Director.

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 RIC when required under this policy. Report monitoring and research compliance review data to RIC. Provide data and expertise to assist RIC 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 and Innovation

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 RIC Director to conduct a for-cause investigation arising from research compliance concerns brought to their attention.

Related Information

History

Amended:

May 2022 - Policy updated to reflect current reporting structure. The Research Compliance Office was dissolved, and a new office, Risk Intelligence and Compliance Team (RIACT), was formed. The language was updated to reflect this, as well as the change in reporting, as the investigation will go through the RIACT Director and directly to the Vice President for Research (VPR) vs. being handled by the Associate Vice President for Research (AVPR) as previously noted in the older version of the policy. This is a minor shift given that the RIACT Director reports directly to the VPR. This is primarily reflected in the procedure. The other key addition to the procedure is that instruction has been added to describe how a concerned party may submit a research compliance concern, as the current version lacks this information.

Amended:

May 2021 Comprehensive Review. 1. Updated use of trademarks for specific groups. 2. Revised language to align with and support other administrative policies. 3. Added clarification to prohibitions section.

Amended:

July 2017 - Minor Revision. The section on Retaliation has been updated to be consistent with core language in Administrative Policy: Retaliation.

Effective

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.