Medical Student and Medical Resident Investigators

Requirements for Submission of Research

  1. You need to be a Medical Student or Medical Resident enrolled in the CMU College of Medicine Program and performing clinical practice at Covenant Health Care.
  2. Your project needs to be reviewed and approved by the CMU IRB.
  3. You must have a Faculty Advisor or Primary Investigator associated with your study.
  4. You must contact the Neli Ragina, Director of Research at CMU at ragin1n@cmich.edu. She will guide you through the process and make sure that all elements of the research are completed prior to submission to the Covenant IRB.
  5. You must notify and gain permission from the unit manager of any area that may be involved and have them complete the Research Impact Statement Form (if applicable).
  6. Any research that involves direct subject contact (those other than chart review or some simple survey) will require IRB full board review.
    • Generally, these types of studies will require an Informed Consent Form and a HIPAA Authorization Requirement for Informed Consent.
    • If you are utilizing Covenant resources ( nurses, rooms, equipment), the project will also need to be reviewed by Dianne Androsuk, Clinical Research Administrator at Dianne.Androsuk@chs-mi.com or at (989) 583-5173 for financial and billing considerations.
    • The project may require the review of the Business and Ethics Committee, contingent upon contractual consideration.

Submission Process

Covenant Medical Center IRB utilizes IRBNet as a gateway for submission of protocols and for communication between the IRB office and the research team. There are a couple of additional tasks that will need to be completed in order for your submission to be reviewed by this IRB.

  1. If you have used the IRBNet system for other projects at other sites (university, another hospital) you DO NOT need to register. You just need to add Covenant Medical Center as an affiliation since you already have an established account.
  2. Register on IRBNet (our web based submission tool).
  3. Complete the Full Board and Expedited Application or, if indicated by the Exempt Determination Tool, the Exempt Application. They can also be found on the main web page or under the forms and templates tab in IRBNet. Your University application is not acceptable.
  4. Submit a new protocol.
  5. Upload the new application, University IRB approval letter, data collection tool, informed consent form (if applicable), any other pertinent research related materials and the curriculum vitae or resume and CITI training of all investigators. Once all your documents are added, make sure your package is signed and submitted.
  6. Once received, the IRB office will pre-review your submission. If it's complete, it will be forwarded to the IRB Chair or placed on the IRB agenda or given Expedited Review (based on appropriate level of review).

Reference Documents

The following items are available under the “Forms and Templates” tab in IRBNet (READ ME DOCUMENTS) to assist you with your IRB submission process and on the main page of the web site.