Research compliance
Research Compliance Program
The Allina Health Research Compliance Program ensures that all research conducted by Allina Health and/or within Allina Health's facilities is in compliance with applicable laws, regulations, guidelines and Allina Health policies and procedures.
If you wish to contact the Research Compliance Program team, please send an email to researchcompliance@allina.com, call the Integrity Line at 1-800-472-93011-800-472-9301, or submit a secure web report.
Conflicts of interest
Conflicts of Interest (COI) in research can be broadly described as any interest that competes with an organization’s or individual’s obligation to protect the rights and welfare of research subjects, the integrity of a research study, or the credibility of the research program. Conflicts of interest can be financial or non-financial.
Allina Health is committed to evaluating and appropriately addressing the relationships of personnel involved in research or Federal Projects and the relationships to Allina Health related research to help ensure the work is free from potential or actual bias in order to focus on well-designed or scientifically sound discoveries and programs that will serve our patients and their communities.
Allina Health is further committed to identifying and managing individual and Institutional Conflicts of Interest (ICOI) to safeguard the integrity of Allina Health Research, and protect patients who participate in Allina Health Research. Institutional Conflicts of Interest may arise from either the Financial Interests of Allina Health as an organization, or personally-held interests of Allina Health's Key Officials for Research given their leadership and supervisory responsibilities. ICOIs are of concern when Institutional Interests create the potential to compromise, or reasonably appear to compromise, Allina Health Research or Sponsored Programs.
Allina Health's Outside Interests and Conflicts Management Policy addresses and ensures disclosures are made and handled in a consistent and timely manner.
Complying with Allina Health conflict of interest requirements
The Outside Interests and Conflicts Management (OICM) Policy applies to the following individuals involved in research or sponsored programs:
- All employed and non-employed personnel who are responsible for the design, conduct, or reporting of research at Allina Health and/or research that is subject to the review of the Allina Health IRB or an external IRB requiring Allina Health to enter into an Inter-Institutional Authorization Agreement with the external IRB. This includes all research regardless if is publicly or privately funded.
- Employees responsible for the design, conduct or reporting of a federal project.
- Non-employed personnel who are involved in the design, conduct or reporting of research or a PHS-funded federal project when neither the individual nor the individual's employer has a COI policy that meets the requirements set forth in the Public Health Service's Rule (42 CFR Part50, Subpart F)
- Members of Allina Health's Institutional Review Board (IRB)
- Members of Allina Health's Research Conflicts of Interest Committee (Research COI Committee)
- Other Allina Health personnel designated by the Research COI Committee
Education
Allina Health has contracted with the Collaborative Institutional Training Initiative (CITI) to use the training tools it has developed, as well as adding an Allina Health module.
For answers to questions about conflict of interest training requirements, contact researchcoi@allina.com.
Allina Health's disclosure requirements
All Investigators who apply for federal funding or submit a funded/sponsored application to the IRB must disclose the information, interests, and roles required on the COI Smart disclosure form, including all Financial Interests and Non-financial Interests held personally, or by their spouse and dependent children. Interest disclosures must be made at the following times:
- Prior to the submission of a proposal for federal funding;
- Prior to the approval of a research protocol by the IRB;
- Annually after an initial submission has been made, so long as the Investigator has an active funded/sponsored research or Federal Project at Allina Health;
- Within 30 days of the discovery or acquisition of Significant Financial Interests or Significant Non-financial Interests;
- As otherwise requested by Research Integrity and/or the office of OICM
In summary, the COI Smart Disclosure form is required on an annual basis and must be updated as new interests are acquired or discovered. If you do not have access to COI Smart, contact researchcoi@allina.com.
PHS research
Allina Health policy requires any consultant, subrecipient or subcontractor (External Partner) on a PHS award to certify that it has a policy that is consistent with the PHS regulations or complies with Allina Health's policy. If the External Partner has a policy that is consistent with the PHS regulations, the External Partner must either submit a Subrecipient Financial Conflict of Interest Disclosure Form or be registered with the Federal Demonstration Partnership. If the External Partner does not have a consistent policy, each investigator must follow Allina Health's Outside Interests and Conflicts Management Policy and complete the required disclosure forms.
If you have questions about the COI requirements for PHS-supported research, please contact researchcoi@allina.com.
Contact: researchcoi@allina.com
Policy: Outside Interests and Conflicts Management Policy
COI Smart Website
CITI Training Website
Research privacy
Allina Health follows both state and federal regulations regarding the use and disclosure of patient medical record data for research purposes under HIPAA legislation.
Read Use and Disclosure of Protected Health Information for Research Policy for more information.
Minnesota state statute requirements
In addition to HIPAA compliance, Allina Health abides by Minnesota state law concerning the release of health records for research purposes. Minnesota law (Minnesota Health Records Act, sections 144.291 to 144.298) contains restrictions on access to PHI that are more protective of patient rights than HIPAA and therefore must be followed. Researchers must ensure compliance with both HIPAA and Minnesota law.
The Minnesota Health Records Act requires that patients authorize the release of their health records to external researchers. Allina Health obtains such authorization by having patients sign a Minnesota Research Authorization (MRA). The MRA is part of a document called the Consent for Release of Information and is obtained through the patient registration process.
Contact: Research Compliance at researchcompliance@allina.com
Policy: Use and Disclosure of Protected Health Information for Research Policy
Disclosures for 50+ Patient PHI for Research Form
Research on PHI of Decedents Attestation
Prep to Research Attestation
MRA Decision Tree
Research billing
The Office of Sponsored Programs (OSP) is responsible for the financial management of government grants and other sponsored project funds awarded to Allina Health along with the
Allina Health Research Billing Compliance Program.
Research misconduct
Allina Health creates a research environment that encourages appropriate behavior; ensures compliance with regulatory requirements; and maintains the confidence of our patients, research subjects, employees and peers.
Contact: Research Integrity Officer at rio@allina.com
Policy: Research Misconduct
Biosafety
Allina Health is committed to minimizing the risks to patients, research subjects, investigators, researchers, staff, the community and the environment. Any use of recombinant or synthetic nucleic acid molecules and biohazardous materials agents and/or toxins is done with care and complete compliance with policies, regulations and law.
Contact: Research Compliance at researchcompliance@allina.com
Policy: Use of Biohazardous Materials
Clinicaltrials.gov
When Allina Health is the Responsible Party, as defined in FDAAA 801, Allina Health will comply with all requirements of a Responsible Party, including registering applicable clinical trials and submitting required result information on clinicaltrials.gov (See procedure).
Allina Health is also committed to registering and submitting required result information for applicable clinical trials consistent with requirements imposed by funding sources (e.g., National Institutes of Health) and/or publications (e.g., ICMJE).
Contact: researchcompliance@allina.com
Policy: Registration of Clinical Trials on clinicaltrials.gov
Documents: ACT Checklist, ACT Decision Tree
Export controls
Allina Health is committed to complying with U.S. Export Control Laws and Economic Sanctions. All persons performing research at Allina Health will conduct their activities in accordance with U.S. Export Control Laws and Economic Sanctions. These Laws and Economic Sanctions protect U.S. national security, promote U.S. foreign policy objectives, and further U.S. economic interests. It is a violation of this policy to engage in any activity that is prohibited by U.S. Export Control Laws and Economic Sanctions. Violations of these Laws could result in criminal and/or civil penalties, loss of research contracts, government funding and/or the ability to export items.
Contact: Research Compliance at researchcompliance@allina.com
Policy: Export Controls and Economic Sanctions Policy