1. Conducting Research at Essentia

2. Conducting Research: Overview
This is intended to be an overview of the research process at Essentia
More details on content and process when you are ready to initiate a project can be found at: 2

3. Essentia Institute of Rural Health
Essentia Institute of Rural Health (EIRH) is the center for Research and Education for Essentia
All research conducted at Essentia goes through EIRH
The vision of EIRH is:
EIRH, through collaborative research, education, discovery, and learning, will support and enhance Essentia Health to improve the patient experience of care, improve population health, and reduce per capita cost of healthcare
The Institute also is an active partner in regional and national networks collaborating in research and educational activities. 3

4. Our Research Partners 4

5. Overview of Research at Essentia
Essentia has been engaged in research since 1978 when the first National Cancer Institute (NCI) clinical trials were initiated.
Over $3.3 million and 290 active studies including investigator initiated projects, NCI oncology clinical trials, and industry sponsored clinical trials.
Research to improve care for our patients and the health of our communities across all disciplines 5

6. Research Infrastructure
Physician/Provider and PhD Research Scientists
Clinical Trials (Oncology, Cardiology, All Other Specialties)
Pre- and Post-Award Grant Management
Institutional Review Board
Scientific Review Board
Research Informatics and Biostatistics
Research Support Staff
Investigational Pharmacy
Research Laboratory
Library 6

7. Key Policies Research at Essentia is guided by institutional policies:
Principal Investigator – Eligibility, Roles & Responsibilities
Financial Conflict of Interest – Research
Clinical Learner Projects (Student Research Projects) 7

8. Is my project research?
Office for Human Research Protections (OHRP) provides graphic aids (decision charts) as a guide for to determine whether an activity is research
If research:
It must be submitted for IRB review to determine:
whether full or expedited review is required
whether informed consent is required 8

9. Pathway of a Research Project
Preliminary Steps:
Preliminary Study Proposal Form
Determine Feasibility
Required Training: Human Subjects and Financial Conflict of Interest
Grant Application (if applicable)
Review Boards
Active Study 9

10. Preliminary Steps: Preliminary Study Proposal Form
Preliminary Study Proposal Form is the first step for all projects requesting EIRH resources/support.
To determine relevance to Essentia Mission/Vision
Approval to move forward with project development
Allows tracking of all projects in development
This form is required to gain access to EIRH services
Approval comes from EIRH Executive Director
Preliminary Proposal Forms

11. Preliminary Steps: Training Required to Conduct Research
Training must be completed prior to IRB review
Collaborative Institutional Training Initiative (CITI)
satisfies human subjects protection
recertification required every three years
Financial Conflict of Interest Training (FCOI)
assigned by Essentia Office of Integrity and Compliance 11

12. Preliminary Steps: Project Funding
Obtaining full funding for a project is the responsibility of the Principal Investigator/Project Director. Nominal start-up support (1-10 hours) may be provided subject to the approval of the EIRH Executive Director. 12

13. Preliminary Steps: Grant Applications
All research grant and contract applications are processed by the EIRH Grants and Contracts office.
Notify the Grants Manager as soon as project is being developed to allow sufficient time for all necessary steps.
The EIRH Grants and Contracts team is available to:
Help identify funding opportunities
Assist with preparing grant or contract applications
Budget and justification preparation
Conduct administrative review and obtain official signatures
Submit applications on behalf of EIRH 13

14. Essentia Health Duluth Clinic Foundation (DCF) Proposals
DCF Board of Trustees makes decisions about proposals at its Board meetings normally held at least three times per year.
Proposals can be submitted to the Foundation either electronically or in hard copy.
Proposals are due ten business days prior to a Foundation Board meeting.
Applicants or their designee will be required to present their proposals at the Foundation Board meeting.
Applicants are notified of Board decisions within seven business days of the Board meeting.
All research proposals must be reviewed and approved by the Scientific Review Board. For research involving human subjects, all proposals must be reviewed and approved by the Institutional Review Board prior to submission. For applicants from other institutions, this may be the Institutional Review Board associated with the proposal writer’s own institution.
Contact Deb Ellingsen at ext with additional questions.

15. Review Boards: Scientific Review Board (SRB)
SRBs evaluate the scientific merit of investigator-initiated research proposals that involve human subjects
EH SRBs:
Oncology
All Other Specialties
EH SRB review authority primarily for proposals to Essentia Health or Miller-Dwan Foundation and department funded projects
SRB approval must be obtained prior to IRB review
Industry-sponsored clinical trials, federally sponsored research, or external foundations are reviewed externally for scientific merit 15

16. Review Boards: Institutional Review Board (IRB)
The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Essentia Health.
The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
Additional details are available on the EIRH Website: 16

17. Review Boards: iRIS
iRIS is a web-based system that facilitates SRB/IRB application submission, tracking, review, post-approval compliance activities, and project regulatory management
training is available
additional information can be found on the EIRH website: 17

18. Research Agreements
ALL research agreements are processed through EIRH Grants and Contracts with assistance from Essentia legal
Examples include but are not limited to:
Memorandum of Understanding
Data Use Agreement
Grant Agreement or Contract
Subaward or Subcontract
Vendor Agreement
Consultant Agreement
Letter of Support 18

19. Contact EIRH anytime with questions or requests for assistance.
Active Study
Once a project has received all the required reviews and approvals, including secured funding and finalization of any research agreements, research activities can begin.
Contact EIRH anytime with questions or requests for assistance. 19

20. Physician Scientist Research Mentors
Essentia Physician Scientists are available to serve as research mentors and may be contacted for consultation or mentorship:
EIRH scientists and staff are also available anytime for questions or requests for assistance.
Specialty
Bret Friday, MD, PhD
Oncology
Michael Mollerus, MD
Cardiology/All Other Specialties
Timothy Rich, MD
Pulmonary/All Other Specialties 20

21. For Questions About:
Contact
Developing a Research Project
Preliminary Study Proposal Form
Research Grant Applications
Research Grant/Contract Agreements
Nancy Dold, ,
Cardiology/All Other Specialties Clinical Trials
Christine Leone, ,
Oncology Clinical Trials
Tammie Mlodozyniec,
Clinical Learner Projects
Kate Dean, ,
Scientific Review
Human Research Protections/ Institutional Review Board
Research Training
Deneice Kramer,
Biostatistics/Informatics
Paul Hitz, ,
General Questions
Kevin Galazen, ,

22. We are here to help you with your research questions
Call on us and we will connect you to the resources you need. 22