IRB APPLICATION – Appendix A

HCMCRESOURCEUTILIZATIONCOVERAGEANALYSISCHECKLIST
AllHCMC resources that willbe utilized in the proposed research must be identified in detailon this form, including not only patient care services, butallHCMC resources (e.g. informatics, data acquisition from electronic health records, IT, etc.).This checklist is also required to determine if patientcare services should be billed to: (1)Medicare (2)Research Study and/ or(3)an alternate Third Party Payer.
Questions: Please email:
Prepared By: / Date Prepared:
Email: / Phone:
StudyTitle:
Est.#ofParticipants: / Department:
Projected StartDate: / Projected End Date:
NCT#:(clinicaltrials mustbe registered) / HSR#
PIName:
PISignature:
PIEmail: / PIPhone:
Sponsor:
Isthisan HCMCResidentresearch project?
If non-sponsored/non-residentidentifysource offunds:
PartI.ResourceIdentification
Please List all HCMC resources that may be used during the research study. Be sure to consider all departments, which may include patient care(e.g. Radiology, Laboratory, Pharmacy, Cardiology), as well as other non-patient care services (e.g. Electronic Health Records, Informatics, IT, etc.)
If none, please enter “None” in the space below.
Please be aware: all research subjects receiving patient care services in the HHS System must be registered in Epic.
Department / Description ofService / CPT/HCPCS
Code / Standard of Care
Cost per unit / Yes / No
Patient Care
Non-Patient Care
Data
PartII. QualifyingResearchProtocol
STEP I. PreliminaryAnalysis
1. Does yourNEW Study include patient careservices billed in HCMC'sHennepinHealthSystem?
(Patientcareservices=patientproceduresonsite,orscheduledwithintheHennepinHealthSystem.)

2. If submitting study MODIFICATIONS to IRB, does yourmodification include changes to patient careservices?

3. Does the sponsorpay for ALL patient careservices?
(ALL patient care services = standard of care required byprotocolresearch procedures, studydrug ordevice, expanded care.)Nothing billed to insurance

4. Will the research be completed at HCMC orat a satellite clinic?
Name of satellite clinic:
Ifyouchecked"No"toanyoftheabovequestionsproceedtothenextquestion.
Ifyouchecked"Yes"STOP!DonotfillouttherestofPartII.
STEP II. MedicareQualification
Does this study qualify to bill patient careservices under Medicarerules?Todetermine, followthe questionnairebelow.
SECTION 1: Medicare Requirements Coverage of Routine Costs
1. Is the study'spurpose to evaluate an item or service that is covered by Medicare?
(Help is available at )

2. Does this study have therapeutic intent?

3. Will this study enroll patients with a diagnosed disease/ condition rather than only healthy volunteers?

If you checked "No"to anyquestion in Section 1, Studydoesnot qualifyforMedicare coverage.Proceed to Section 4 and check, "No."
If you checked "Yes"to allquestions in Section 1, proceed to Section 2.
SECTION 2: Automatically Qualifying “Deemed” Studies
1. Is the study funded by NIH,CDC,AHRQ,CMS,DOD, orthe VA?
(Help is available at )

2. Is the study funded by centers or cooperativegroupssupported by the above agencies?

3. Is the study conducted underan Investigational New Drug(IND) application reviewed by the FDA?

If "No"proceed to the next question.If you checked "Yes"provide yourINDNumber. / IND#
4. Is the study exempt from having an IND under21 CFR 312.2.(b)(1)?

If you check"No"to allquestions in Section 2 proceed to Section 3.If you checked "Yes"to anyquestion in Section 2, studyqualifiesforcoverage underMedicare rules.Proceed to Section 4, check"Yes."
SECTION 3: “Desirable” Characteristics
1. Is the principal purpose of the study to test whether the intervention potentially improves participants’ health outcome?

2. Is the study well supported by available scientific and medical information or intended to clarify or establish the health outcomes of interventions already in common clinical use?

3. Do you agree that the study does not unjustifiably duplicate existing studies?

4. Is the study's design appropriate to answer the research question being asked?

5. Is the study sponsored by a credible organization?

6. Is the study in compliance with the Federal regulations relating to the protection of human subjects?

7. Are all aspects of the study conducted according to the appropriate standards to scientific integrity?

If you checked "No" to any question in Section 3, study does not qualify for coverage under Medicare rules. Proceed to Section 4 and check "No."
If youchecked "Yes" to all 7 questions in Section 3 the study meets requirements for Medicare coverage. meets requirements for Medicare coverage. Proceed to Section 4 and check, "Yes."
SECTION 4: Conclusion
Part III. Submission and Study Set Up in EPIC
Thank you for completing this form. It should be signed by the Principal Investigator on page 1 and submitted with each IRB Application when a new study is being proposed, and/ or when a protocol revision is being submitted to the IRB that involves the use of hospital resources.
All research projects that obtain patient care services in the HHS System must be set up in EPIC under a Study Administrative Record, and all research subjects that receive patient care services in the HHS System must be registered and assigned a Medical Record Number. The MMRF Research Information Technologies (RIT) Manager may contact you or the Principal Investigator with any questions regarding the information provided, and ensure that study personnel who are responsible for accessing HCMC resources have received the necessary EPIC training.
Questions about this form or the HCMC clinical research process can be sent to or the RIT Specialist at .