Allina Institutional Review Board Submission Forms

IRB Application

Submit this application to request expedited or full IRB review for a new research study.

IRB Exemption Application

Submit this application to request exemption from IRB review for research studies that meet the criteria for IRB exemption.

IRB Expedited Review Form

Submit this form to request an expedited review for studies that meet the criteria for expedited review by the IRB.

Additional Study Personnel Form

Submit this form if the study has more personnel than fits in the space provided on the application.

Researcher Qualifications and Education Form

Submit this form to document the training of all study personnel.

Internal Transfer of Funds Form

Submit this form directly to the IRB office with the submission materials if the site is paying the IRB review fee by internal transfer of funds.

Unaffiliated Investigator's Agreement

Submit this form if the research study is federally funded (e.g., NIH, NCI, etc.) and the principal investigator is not affiliated with Allina Hospitals & Clinics.

Tissue Banking Form

Submit this form if the study involves the collection of extra tissue that will be stored for future research.

Drug and Biological Product Form

Submit this form if the study involves the use of a drug or biological product.

Medical Device Form

Submit this form if the study involves the use of a medical device.

Conflict of Interest Disclosure Form

Submit this form to identify any relationship the principal investigator and other research personnel may have with the study's sponsor.

Waiver or Alteration of Consent Form

Submit this form to request IRB approval to:

• waive the requirement for the research consent process, or
• alter some or all of the elements of the research consent process
.

Research Subject's Bill of Rights

The Research Subject's Bill of Rights must be included in all consent forms.

• If the Abbott Northwestern Hospital IRB is reviewing the study, place the text on the first page of the consent form.
• If the United Hospital IRB, Mercy & Unity Hospitals IRBs or the Phillips Eye Institute IRB is reviewing the study, the Bill of Rights may be included in the consent form or on a separate page attached to the consent form

Consent Form - Sample

Use this sample consent form template when creating or revising a study consent form. This template contains all federal and Allina required elements and suggested language. For further guidance on the consent process, see The Research Consent Process - A guide for researchers.

Change to Approved Study Form

Submit this form to request a change to an ongoing study.

Study Personnel Change Form

Submit this form to:

• change the study title
• update the contact information for current study personnel (principal investigator, co-investigator or study coordinator)
• add or remove a principal investigator, co-investigator, or study coordinator
• change the sponsor or the sponsor's contact information

Local Serious Adverse Event Reporting Form

Submit this form to report a local serious adverse event.

This form provides criteria to help you determine if the event if considered a serious adverse event.

Non-local Serious Adverse Event Reporting Log

Submit this form to report all non-local serious adverse event reports received during the period of one month.

Continuing Review and Request to Close Study Form

Submit this form to request IRB continuing approval for an on-going study or to close a study.

Protocol Deviation/Violation/Exception Reporting Form

Submit this form to report a protocol deviation or violation or to request approval to make an exception to the approved protocol.

HIPAA Authorization for the Use & Disclosure of PHI - Template

Use this template to create an authorization form that describes the use and disclosure of Protected Health Information (PHI) in the study.

The form must be reviewed and signed by the research subject. It grants a Covered Entity (CE) (hospital or clinic) permission to disclose the subject’s PHI for a research study.

Waiver of HIPAA Authorization Requirement Form

Submit this form to request the IRB approve a waiver of the HIPAA Authorization requirement to access the PHI of a research subject for a research study.

Alteration of HIPAA Authorization Requirement Form

Submit this form to request the IRB approve an alteration of the HIPAA Authorization requirements to access the PHI of a research subject for a research study.