Research Process & Tools

If you want to conduct a research study or a project at Essentia Health, review the processes and references you need to know about and follow before, during, and after your study begins. You’ll find information on this page to guide you through the study steps.

All research at Essentia goes through the Essentia Institute of Rural Health (EIRH). The links below will take you to the different phases of a study.

Preliminary Study Steps

Explore regulations, policies, and processes before you begin your study proposal:

Review Federal Regulations & Guidance

Determination of Research

The OHRP Human Subject Regulations Decision Charts provide a guide to decide if an activity is research involving human subjects requiring review by an IRB.

Use the Determination of Human Subjects Research form if you believe your project doesn’t meet the definition of “human subjects research” or you are still unsure if your project meets the definition of “research” or “human subjects research.” Email the Human Research Protection Program office for an official determination.

All Essentia projects with a definition of “research” or “research” and “human subject research” must submit a Preliminary Study Proposal Form. In addition, projects with a definition of “research” and “human subject” also receive IRB review.

Preliminary Study Proposal

Research and human subject research projects requesting EIRH resources or support must complete a preliminary study proposal form to get approval to move forward with project development.

Follow the directions on the Preliminary Study Proposal form [Word] to submit. The EIRH executive director approves study and project forms. When you receive study approval, you can move forward with completion of training requirements, study development and IRB approval.

Research Training Requirements

Complete the required Human Subjects Protection (HSP) training, if you conduct, support, review, or oversee human subjects research.

Initiate Financial Conflict of Interest (FCOI) training before or after HSP training by emailing the IRB. You will receive instructions for FCOI training via your Essentia email address.

Apply for iRIS Access

Request an iRIS (integrated research information system) account for access to the Essentia IRB study submission software. You will use iRIS to submit your study to the Essentia IRB.

Study Development

Work with Essentia research support departments and resource templates to develop your study. Follow these preparation activities:

Resources & Department Review

Review your proposed study resources to ensure you have the necessary safeguards for human subjects involved in research. The review includes areas such as staff, study costs, and other resources such as equipment, storage, and more. Sponsored Programs Administration can provide more information and assistance with your study review.

Research Funding

Essentia requires funding for all projects. There are several types of research funding sources, including federal, state, and Essentia Health Foundation. The PI is responsible for obtaining full research funding.

Nominal start-up support may be available with the approval of the EIRH executive director.

A Medicare coverage analysis is required for all clinical research studies for third-party billing of costs associated with items and services related to patient care.

Find more funding guidance and information.

Research Protocol Document

All Essentia research requires a protocol document. The study protocol explains the purpose and function of the study, and a detailed plan for conducting the study.

Use the protocol templates as guides for writing your research protocol.

Follow your funding source’s instructions for protocol content and form or your proposal may be returned without review.

Informed Consent

Human subjects research projects require informed consent documents or a request for a waiver of all or part of the consent process.

iRIS Study Shell

Create the “study shell” for human subjects research projects in iRIS to prepare for IRB submission and HRPP-facilitated scientific review. Find instructions to create the study shell in the iRIS Quick Guide 2.1 within iRIS Help.

Scientific Merit

Essentia requires Scientific Review Committee review and approval before project submission for IRB review. The Essentia Scientific Review Committee reviews Essentia Health and Miller-Dwan Foundation proposals and Essentia department-funded projects.

Industry-sponsored clinical trials, federally sponsored research, and external foundations are reviewed externally for scientific merit

Student Projects

Students can participate in research only if an Essentia-approved PI is functioning as the Lead PI for the research project. Learn more about student research projects at Essentia.

IRB Review

The IRB review has three processes:

  • Research project application submission
  • Review of your research by the IRB
  • Evaluation and approval of your research by EIRH research administration

IRB Submission

To submit your research to the IRB, complete the following steps in iRIS:

  • Complete the IRB application – View sample iRIS IRB Applications
  • Complete the Initial Review Submission Form or the Initial Review External IRB Review Request
  • Obtain department sign-off
  • Complete the Financial Conflict of Interest (FCOI) Survey (if applicable) – Department sign-off automatically triggers iRIS notification to the Essentia Health Organizational Integrity and Compliance office (OIC). Compliance and/or IRB staff will determine if your project requires additional information, depending on the funding source. If there is a conflict, compliance staff will work with you to address it.

Your submission will move to IRB review after the IRB office determines that your submission is complete.

IRB Review

The IRB conducts initial reviews at convened meetings—except for studies that fall into one of the expedited review categories. You’ll receive a notification in iRIS when your submission is assigned for IRB review. The investigator or study staff will receive notification if they are required to attend the IRB meeting.

During its review, the IRB determines if the research meets the regulatory criteria for IRB research approval.

Investigators can’t solicit subjects or begin data collection until IRB approval—or a decision that your research is exempt.

Research Administration Review

After your submission receives IRB approval, the EIRH research administration must review it. EIRH review may include:

  • Check of the final contract and finances by the EIRH grants and finance departments
  • Collection of contract signatures, if needed
  • Verification of applicable department reviews and consistency between the consent form and contract

The project is active in the iRIS system and can begin after EIRH administration review and approval.

After IRB Approval

After your project receives all the required reviews and approvals, including secured funding and finalization of research agreements, your research activities can begin.

During your study, you’ll need to:

Continuing Review

Nonexempt research projects are reevaluated at least once a year. The PI and study contacts get reminders from iRIS before the review is due. Complete the Continuing Review Form in iRIS before the date in the reminder. Review a sample Continuing Review Form.

Amendments

You must conduct your research project as approved by the IRB. Your study will need additional IRB approval before you can initiate any changes in:

  • Subject population
  • Recruitment plan
  • Research procedures
  • Study sites
  • Research personnel

Submit changes to your research personnel with the Add/Remove/Change Study Personnel Form or modify your study details with the Amendment-Change-Update Form in iRIS.

If you implement a change before IRB approval, it may constitute a protocol violation.

Event Reporting

Use the Event Report Form in iRIS to notify the IRB of unanticipated problems or events posing a new or increased risk to subjects, and could be related to the research procedure.

Record Keeping

Keep research records according to your study responsibilities:

  • Researcher – Maintain all the “use of human subjects in research” documents for at least three years from the completion of IRB-related work; and six years for research subject to comply with HIPAA requirements, including original consent forms and HIPAA authorizations, and copies of other regulatory documents
  • Principal investigator – Maintain the exact same records as the IRB has for your study—if the IRB holds an original document, the principal investigator should hold a copy

IRB records are subject to inspection by federal authorities. Sanctions for incomplete or nonexistent records include fines, suspension of funding and/or research privileges, and exclusion from future funding.

Manage your study using a regulatory binder and tracking logs.

Study Closure

When a study is complete, researchers must complete a Permanent Study Closure Form in iRIS as a final report on the project.

If a Permanent Study Closure Form or a Continuing Review Form isn’t submitted and the researcher does not respond to IRB requests, the investigator cannot participate in new projects until the lapse is properly addressed.

Quality Assurance

The Essentia Health Research Compliance and Assistance Program (RCAP) conducts quality assurance reviews to ensure study compliance with regulations and policies and to evaluate study conduct, organization, record keeping, and documentation.

Learn More

Email Nancy Dold, research grants manager, or call 218-786-2698 for information about:

  • Developing a research project
  • Preliminary study proposal forms
  • Research grant applications and contracts

Email Deneice Kramer, human subjects protection program manager, or call at 218-576-0489 for more information about:

  • Human research protections
  • Scientific review
  • Institutional review