Allina Institutional Review Board Forms

Submission Freeze: No IRB or SPA Submissions will be accepted from 10/31/2009 through 11/8/2009.

IRB Forms

To submit an application for IRB review, please see the IRB/SPA Submission (eProtocol) page.

IRB Fee Schedule
IRB Required Training

Supplemental Forms for Initial Review of a Research Study

Submit the following supplemental forms as necessary.

For detailed instructions, see Institutional Review Board Review Process and Instructions.

Form	Instructions
Internal Transfer of Funds Form	Upload a completed copy of this form in eProtocol if the site is paying the IRB review fee by an internal transfer of funds.
Unaffiliated Investigator's Agreement	Upload a scanned version of 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.

Consent Form Requirements

The following samples are provided as guides for the information that the consent form should include.

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

IRB Form Used for Ongoing Studies

For detailed instructions, see Institutional Review Board Review Process and Instructions.

Form	Instructions
Non-Local Serious Adverse Event Reporting Log	Submit this form to report more than three non-local serious adverse event reports received during the period of one month.

HIPAA Research Authorization

Allina Institutional Review Boards (IRBs) serve as HIPAA Privacy Boards. These boards assure that adequate provisions are in place to protect the privacy of subjects and inform subjects of the use and disclosure of their Protected Health Information (PHI).

The sample HIPAA authorization documents a subject's permission to use and disclose his or her Protected Health Information (PHI). Complete requests for alterations or waivers of the HIPAA Authorization in Section 21 of the eProtocol Biomedical Expedited/Full Board application.

For detailed instructions, see Institutional Review Board Review Process and Instructions.

Form	Instructions
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.

HIPAA Research Disclosure Forms

These forms are internal forms used to access Protected Health Information (PHI) (e.g., medical records) within Allina facilities.

These forms are submitted directly to the facility for their review and approval.

Do not submit these forms to the IRB Administrative Office.

Form

Instructions

Facility Disclosure Form

Research participants must sign this form, and the researcher must present a copy to the facility's Health Information Department when requesting PHI for research purposes.

Research Disclosure Request Form

This form must be completed and given to the facility's Health Information Department staff when requesting medical records for research purposes.

Research Request for PHI - Decedents

This form must be completed and presented to the facility's Health Information Department when requesting medical records of decedents for research purposes.

Research Request for PHI Preparatory Research

This form must be completed and presented to the facility's Health Information Department when requesting medical records to prepare for research (e.g., identifying study populations).

This form allows the study personnel only to review the records in order to find out if it is feasible to conduct the study. Study personnel cannot remove any PHI or use any PHI reviewed in the subsequent research study.

IRB Administrative Office

Mailing Address:
Mail Route 10105
PO Box 43
Minneapolis, MN 55440-0043

Phone: 612-262-4920
Fax: 612-262-4953

Office Location:
Allina Commons at Midtown Exchange
Mail Route 10105
2925 Chicago Avenue
Minneapolis, MN 55407-1321

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