If you will be doing research or evidence-based practice/quality improvement (EBP/QI) projects at UnityPoint Health – Allen Hospital, you need to be aware of the following information to ensure cooperation and approval from the project setting.

Clinically-focused research projects may be referred to the UnityPoint Health – Des Moines Institutional Review Board for review and oversight. Even if referred to another IRB, researchers completing projects at UnityPoint Health – Allen Hospital must complete the Obtaining Documentation of Cooperation process as outlined. For questions about which IRB is best suited for a proposed project, please contact the ACIRB via email at ACIRB@AllenCollege.edu.

Obtaining Documentation of Cooperation

Send an email to the Regional Hospital Compliance Officer: Namira.Romero@unitypoint.org. Before sending this email, students must have project approval from their faculty advisor.

• The subject line of the email should be "EBPQI/Research Project Approval." Select EBPQI or Research as appropriate.
• The body of the email will be comprised of text documenting cooperation with the project and will need to be approved by a hospital Senior Leader. This text will include the PI's name, name of the project, a brief description of the project, including any data access and data use requirements, and an affirmation of approval of the project by the signee.
• Attach the completed ACIRB EBPQI or research review application along with other relevant forms to the email. For student projects, all attached forms must have been approved by the student's advisor.
• The Privacy Officer will review the project information for any HIPAA and /or privacy concerns. If needed, a small group of hospital leaders will be convened to discuss the project and come to consensus on the hospital’s willingness to be used as a project site.
• After the Privacy Officer's review, if there are no concerns, the documentation of cooperation content will be sent to the appropriate Senior Leader for review. If approved, the Senior Leader will sign the letter. The Privacy Officer will send the signed letter of cooperation to the PI and ACIRB@miyao2009.com.

Obtaining Approval for Project-Related Forms and Educational Materials

Any forms and/or educational materials that will be used by patients, even if only for the project pilot period, will need to be approved for use and appropriate branding by the Allen Hospital Marketing Manager. Materials needing such approval should be submitted separately to Carson.Tigges@UnityPoint.org for review and approval. Note that appropriate branding and the expected budget for the items will be considered in this approval process, so this information should be included in the request.

Note that approval of branding and use of forms/materials is a separate process and may take some time to complete, so investigators should plan for this approval process in their project proposal timeline.

For student projects, any forms and/or educational materials that will be used during the project will be considered temporary and will not require approval through the usual UnityPoint Health Forms Committee process. The forms will be scanned and kept in the electronic medical record in a location identified by the Privacy Officer. If a decision is made to permanently adopt a practice change started with a student project, department personnel will be responsible for getting materials approved for permanent use.