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Allina Health Institutional Review Board (IRB) Forms and Submission Instructions

Allina Health's Human Research Protection Program has engaged Quorum Review IRB and Schulman Associates IRB to assist in review research studies conducted by Allina Health employees or in Allina Health facilities.

What studies should be submitted to Quorum Review IRB?

What studies should be submitted to Schulman Associates IRB?

  • Submit new non-industry studies to Schulman Associates IRB.
  • Submit emergency use reports to Schulman Associates IRB.
  • Submit Compassionate or Treatment Uses of Investigational Drugs or Devices.
  • Schulman Associates IRB.

What studies should be submitted to Allina Health’s IRB?

  • At this time the only new submissions Allina Health IRB is accepting are Exempt Determinations.

Helpful Information

What are the educational requirements for researchers who submit studies for IRB review?


Allina Health’s Institutional Review Boards require training for research personnel in the protection of human research subjects. Documentation of this training is required before any new study will be approved by the IRB and for all ongoing studies at the time of continuing review. Training certifications must be renewed every three years and must be current before the IRB manager can endorse the Institutional Cover Page for Quorum Review IRB submissions. Please see the Training Information Sheet for the IRB's requirements regarding researcher training.

IRB Forms for Quorum Submissions


Submit the forms below to the Allina Health IRB to initiate the Quorum IRB review process for commercially funded studies. Note that Quorum Review IRB requires the IRB staff's signature on the Institutional Cover Page before they will review a new study submission from an Allina Health-affiliated researcher.

Form

Instructions

Allina Health-Quorum Institutional Cover Page

Submit a completed copy of this form to the Allina Health IRB for signature. A scanned copy of the signed form must accompany all new study submissions to Quorum Review IRB.

Study Personnel Roster

Submit a completed copy of this form to the Allina Health IRB for review. This form must accompany the Institutional Cover Page.

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.

Required Consent Form Elements for Quorum Submission

Please include the exact language from this document in the Quorum consent form.


IRB Forms for Schulman Associates IRB Submissions


Submit the forms below to the Allina Health IRB to initiate the Schulman Associates IRB review process. Note that Schulman Associates IRB requires the IRB staff's signature on the Cover Page before they will review the study submission from an Allina Health-affiliated researcher.

Form

Instructions

Allina Health-SAIRB Institutional Cover Page

Submit a completed copy of this form to the Allina Health IRB for signature. A scanned copy of the signed form must accompany all new study submissions to Schulman Associates IRB.

Study Personnel Roster

Submit a completed copy of this form to the Allina Health IRB for review. This form must accompany the Institutional Cover Page.

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.

Required Consent Form Elements for Schulman Submission

Please include the exact language from this document in the Schulman Associates IRB consent form.


IRB Forms for Allina Health Studies


Submit the forms below, when necessary, for studies reviewed by an Allina Health IRB.

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.

Non-Local Serious Adverse Event Reporting Log

Submit this form at the time of continuing review to report non-local serious adverse event reports received during the preceding year.

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 Health.


Consent Form Requirements


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

Form

Instructions

Clinical Trial Consent Form Template

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

Survey Consent Template

Use this survey consent template when creating or revising a consent information sheet for a study involving survey research only. Note that most survey research qualifies for a waiver of documentation of consent; therefore, the form does not include signature lines.

Research Subject's Bill of Rights

The Research Subject's Bill of Rights must be included in consent forms for clinical trials.




HIPAA Research Authorization

Allina Health 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.

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 Health 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.

Back to Allina Health Research Administration
 

 

IRB Administrative Office

Mailing Address:
Mail Route 10807
PO Box 43
Minneapolis, MN 55440-0043

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

Office Location:
Allina Commons at Midtown Exchange
Mail Route 10807
2925 Chicago Avenue
Minneapolis, MN 55407-1321