Research

Research

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.

Contact the IRB

651-232-5363
Fax: 651-326-8407
Send us an email

Address

Send completed application packets to:

HealthEast Institutional Review Board
1700 University Avenue
St. Paul MN 55104

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)

The investigator's attendance at the meeting is mandatory for review. Proposed activities will not be reviewed without the investigator present.

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:

  • Potential benefits to the subject and the general importance of the knowledge to be gained must outweigh the risks.
  • Selection of research subjects must be equitable and appropriate processes 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 HealthEast 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 HealthEast medical staff and employees at the discretion of the IRB.