Preparing and Submitting a Report of a Research Compliance Concern
Questions about Research Compliance or a Potential Research Compliance Concern
To discuss a potential research compliance concern, anyone (including members of the public) may contact either the Research Compliance Office or one of the applicable University regulatory offices, panels, or research administration related offices, including any listed below. Contact information for these offices/regulatory committees and information about Hotlines or on-line forms some offices use for submission of research compliance concerns is available [See Contact List associated with this policy]
- Human Research Protections Program (HRPP)
- Institutional Animal Care and Use Committee (IACUC)
- Institutional Biosafety Committee (IBC)
- Institutional Review Board (IRB)
- Fetal Tissue Research Committee
- Stem Cell Research Oversight Panel (SCRO)
- Dual Use Research of Concern Committee (DURC)
- Research Administration Office at Fairview
- Research Animal Resources (RAR)
- Sponsored Projects Administration (SPA)
- Sponsored Financial Reporting (SFR)
- Internal Audit
- Office of Institutional Compliance (OIC)
- Research Compliance Office (RCO)
Potential complainants may meet with university officials for information and advice about proceeding with a complaint. In some cases the university official may be obligated to independently proceed with a report, particularly if the potential complainant does not proceed with the filing of a report within a reasonable period of time. Examples of such circumstances include perceived risk to the public or the University community, humans or animals participating in research, fraud, theft, or a serious violation of federal regulations. In such instances, the University official becomes the “complainant”.
Because records, memories, and access to involved individuals degrade over time, and because research compliance procedures, standards, and expectations evolve, and consistent with other University policies, research compliance concerns that occurred seven or more years prior to the submission of a report under this policy will not be investigated. Exceptions may be made by the Vice President of Research if circumstances indicate that the concern was not reasonably discoverable earlier.
How to Prepare a Complaint or Report of a Research Compliance Concern
The complainant should provide the information requested in the University’s confidential on-line reporting system, UReport, and/or prepare a written statement fully describing the issue, including as much detail as available (backup documents may be included if desired). [This statement or information may in turn be uploaded into UReport.]
It is important to be as specific as possible about the concern, including naming the individuals (when known), dates, as well as what was perceived to be wrong and why. If information is available that ties the alleged wrongdoing to a specific research study or sponsored project, provide as much identifying information as possible. If not all of the information is available, simply include as much as possible.
|Instead of …||Try to do this instead …|
|“I was involved in a clinical trial but I wasn’t consented properly.”||Include information known about the clinical trial (such as its title, protocol number, or subject area, the personnel involved in the consent process, the date the trial was discussed with you) and what precisely you felt was wrong about the consent process (e.g., there was no one available to answer my questions about the clinical trial; I was told to just sign at the bottom of the page but not given time to read the document, I wasn’t provided a copy of what I signed, etc.)|
|“An investigator in my department makes me buy personal items for her on her grants and then she takes them home. I know that isn’t allowed by the regulations. “||Include information known about the project(s) and circumstance, such as the name of the PI, the grant number(s) and agency or title(s), the date(s), the items you were required to buy, whether or not you explained to the requestor that the item wasn’t allowable, who else you told and what they advised you to do or what action they took or didn’t take, what the investigator said after you said it wasn’t allowable, what knowledge you have about the terms and conditions of that particular award that tells you the cost is unallowable, and what the PI directed you to do.|
Where to Submit a Complaint or Report of a Research Compliance Concern
A report of a Research Compliance Concern may be submitted directly to the applicable regulatory committee/research office, or may be submitted through the University’s confidential UReport system, as follows:
- Regulatory committee/Research offices
The complete list of offices and contacts may be found at: [Add URL here]. Some offices have their own on-line form or a Hotline in addition to permitting complaints to be submitted to a named contact individual.
- UReport (https://secure.ethicspoint.com/domain/media/en/gui/9167/index.html.)
The Office of Institutional Compliance forwards complaints submitted to this service to the appropriate entity for action. For more details about which research compliance concerns are assigned to which entity for review and action, see the associated policy.
If the concern reported is investigated under this policy, the Research Compliance Office will notify the complainant that the investigation has been completed and will provide a summary of the disposition of the investigation to the extent permitted under the Minnesota Government Data Practices Act.
If the reported concern is submitted to or remanded to a regulatory committee or research office, it will follow the review and reporting procedures specific to that office.