Conducting Research at Essentia

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: www.essentiainstitute.org 2

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

Our Research Partners 4

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

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

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

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 http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1 8

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

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

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 http://www.essentiainstitute.org/EssentiaInstitute/CITIFAQs.aspx Financial Conflict of Interest Training (FCOI) assigned by Essentia Office of Integrity and Compliance 11

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

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

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. 61619 with additional questions.

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

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: www.essentiainstitute.org/EssentiaInstitute/HumanSubjectsProtection.aspx 16

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: www.essentiainstitute.org/EssentiaInstitute/iRIS1.aspx 17

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

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

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 E-mail Bret Friday, MD, PhD Oncology Bret.Friday@EssentiaHealth.org Michael Mollerus, MD Cardiology/All Other Specialties Michael.Mollerus@EssentiaHealth.org Timothy Rich, MD Pulmonary/All Other Specialties Timothy.Rich@EssentiaHealth.org 20

For Questions About: Contact Developing a Research Project Preliminary Study Proposal Form Research Grant Applications Research Grant/Contract Agreements Nancy Dold, 218-786-2698, nancy.dold@eirh.org Cardiology/All Other Specialties Clinical Trials Christine Leone, 218-786-4869, cleone@eirh.org Oncology Clinical Trials Tammie Mlodozyniec, 218-786-4367 tammie.mlodozyniec@essentiahealth.org Clinical Learner Projects Kate Dean, 218-786-3008, kdean@eirh.org Scientific Review Human Research Protections/ Institutional Review Board Research Training Deneice Kramer, 218-576-0489 deneice.kramer@essentiahealth.org Biostatistics/Informatics Paul Hitz, 218-786-1008, phitz@eirh.org General Questions Kevin Galazen, 218-786-2127, kgalazen@eirh.org

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