HealthEast Research

Institutional Review Board

Community hospitals and clinics provide unique opportunities for research, utilizing a patient population different from more academic settings. However, just as in an academic setting, protection of the rights and safety of research subjects is critical.

The Institutional Review Board (IRB) reviews proposed research activities, ensuring that the rights and welfare of research participants are protected. Board members are volunteers from the community as well as health system employees. Meetings are held the third Monday of every month.

The IRB has the authority to approve, require modifications, or disapprove research activities involving human subjects. All proposed research using health system facilities, patients, or staff is subject to review prior to implementation.

Before submitting an IRB application, the investigator must:

  • Obtain Research and Education department approval
  • Obtain approval from the relevant site administrator(s)
  • Develop a budget, ensuring any needed funding
  • Complete human subjects research education

IRB meeting dates

The IRB meets on the third Monday of every month. All IRB meetings take place at St. Joseph's Hospital in the Board Room at 7:30 a.m.

The investigator's attendance at the meeting is mandatory for review. Proposed activities will not be reviewed without the investigator present.
Investigators will be contacted by the IRB for the exact meeting time and location.

       

MEETING DATE          SUBMISSION DEADLINE
 August 20, 2018   August 6, 2018
 September 17, 2018  September 3, 2018
 October 15, 2018  October 1, 2018
 November 19, 2018  November 5, 2018
 December 17, 2018  December 3, 2018

Research Guidelines

Applications must be received two weeks prior to the scheduled meeting. Pages should be single-sided and held together with removable clips — not staples. Arrangements may be made for electronic submission as well.

IRB application packet checklist:
  • Research department approval
  • Site approval from the relevant administrator(s)
  • Completed research/project review application form
  • Completed human subjects research education
  • Study protocol
  • Pharmacy information
  • Data collection tools
  • Budget
  • Appendices
  • Informed consent
  • HIPAA authorization
  • Financial disclosure form(s)
  • Any required signature(s)
  • IRB fees (if applicable)
Send completed application packets to:
Institutional Review Board
1700 University Avenue
St. Paul MN 55104

Some studies may not require IRB review, or may have the requirement waived. All research activities require approval by the Research and Education department, regardless of whether IRB review is needed.

Approval Criteria

For an application to be approved, several criteria must be met.
  • The potential benefits to the subject and the general importance of the knowledge to be gained must outweigh the risks.
  • The selection of research subjects must be equitable and appropriate processes must be used for obtaining and documenting informed consent.
    • Consent is necessary for all research and other activities that involve humans as subjects.
    • Informed consent is a process, not just a form. Researchers must fully disclose the nature of the research, completely describing all potential risks and benefits.
    • Procedures used to get consent should be appropriate for the target population; language, literacy and education level are important considerations. Consent must be documented, no matter how it is obtained.
  • Data must be secure and confidentiality of the subject protected. 
    • Medical information must be safeguarded at all times and reasonable efforts must be made to preserve the confidentiality of all patient and employee information.
    • Research data may not be used for any purposes other than the original intent described in the approved proposal without the approval of the IRB.

Other requirements

Conflict of interest – Investigators must disclose any financial ties and interest to the proposed research and research sponsors.
Reports and updates - Investigators are required to make periodic status reports, at least annually, to the IRB as dictated by Federal regulations. Investigators are required to immediately notify the IRB of all deaths or unanticipated adverse effects. Additionally, the IRB must approve any changes made in an emergency situation for the protection of human subjects.
Fees – The IRB will charge $1,200 fee for all sponsored research. The fee may be reduced or waived for medical staff and employees at the discretion of the IRB.

Forms and Policies

Application forms

  • IRB application form – This form contains the detailed information about the research you are proposing. This document should be well thought out, complete, and comprehensive. It will be used for both the Research and Education department and the IRB.
  • After completing this form, please call the Research and Education department at 651-232-5363 to schedule a meeting to discuss your proposal. We will help to answer any questions that you may have and work with you to complete the application.
  • IRB Application Short form – This form is to be used for studies derived from IRB-approved registries or databases. If IRB approval is required for this project, your completed application form must be submitted to the IRB at least two weeks prior to the IRB meeting. Your attendance at the IRB meeting is required for IRB approval. You will be contacted by the IRB for the exact meeting time and location, or you may call the Research and Education department at 651-232-5800 for a meeting schedule.

Financial disclosure forms

We provide forms to indicate any financial information relating to this project. If you or anyone involved with the proposed research will be receiving any monies for the project, the information must be disclosed on this form.

Other forms

Policies

  • Research Policy  (111b23.doc) – This is the policy document regarding research at our health system. It is simply provided for your reference. There is nothing to complete on this form.
  • Human Subjects Research Education Policy  – This is a policy document regarding training for principal investigators on human subjects research. It is simply provided for your reference. There is nothing to complete on this form.