Institutional Review Board

Thank you for your interest in conducting research at Covenant Medical Center. Covenant Medical Center only accepts research projects from privileged physicians, student employees, or medical students/medical residents who are enrolled in the CMU College of Medicine program. Below is a series of steps listed to help you through the many aspects of conducting research at this organization. Contact IRB@chs-mi.com (IRB Administrator) for further inquiries.

The information below is intended for Non-Student Investigators. If you are a Student Investigator and are interested in conducting a research project at Covenant Medical Center, please click the students link for specific requirements.

The Covenant HealthCare Institutional Review Board (IRB) uses IRBNet as a gateway for submission of protocols and communication.

IRBNet Information

• You must register on the IRBNet website in order to start the process.
• IRBNet will generate an email upon your initial registration in the site. You must click the link located within the registration email you get from IRBNet. This will activate your account. If you do not complete this step, the IRB office will not be able to access your documents, and therefore will not receive your submission.
• If you have used IRBNet for prior research, you will not need to re-register. Simply sign on, and add Covenant as an affiliation.
• If you are a member of an investigation team, you may want to share access of the protocol with other members of the research group. See instructions on how to share a submission.
• General instructions regarding IRBNet usage can be found here: IRBNet Training Energizer for Researcher Part 1 and IRBNet Training Energizer for Researcher Part 2
• Document Submission Requirements
• How to submit a new protocol
• How to sign and submit a document
• How to submit new information to an open protocol

Forms
Many of the forms you are required to complete (application, continuing review, revision of a protocol) are contained within the IRBNet site under the Forms and Templates Library, and can also be found here.

There are two types of applications (levels of IRB review): Exempt and Full Board/Expedited.

1. If you are interacting with patients through intervention you will need to use the Full Board/Expedited Application. Survey projects may require full board or may be expedited. It depends on the study. Chart review/retrospective review generally will be an exempt or expedited review.
   • Full Board Application
2. If you are collecting data and performing chart review you should complete the "Exempt Category Determination Tool" to see if you qualify for exempt status. If yes, use the Exempt Application. If you do not meet these criteria, please complete the Full Board/Expedited Application provided above.
   • Exempt Category Determination Tool
     
   • Exempt Application

Additional IRBNet Submission Forms

• Annual Update Form
• Closure Form
• Continuing Review Renewal Form
• Clinical Unanticipated Problem with Risk Reporting Form
• Non-Clinical Unanticipated Problem Reporting Form
• Revision to Protocol Form
• Humanitarian Use Device (HUD) Continuing Review Renewal Form
• Research Impact Statement Form
• Conflict of Interest Signature Form
• Guest Confidentiality Signature Form
• Intent to Engage in Performance Improvement

Submission Process

Please review the Covenant IRB Research Application Process, Investigator Responsibilities (all Investigators) and determine your Investigator type (if you are a student) prior to completing and uploading your project. Student investigators have additional requirements to complete prior to research submission.

Please upload the following documents:

• Your completed and signed application (electronic signature preferred)
• CV/resume of the investigator and that of any sub-investigators
• Data collection tool
• Protocol or Abstract (if applicable)
• Investigator Brochure (if applicable)
• FDA IND or IDE approval letter (if applicable)
• Any other applicable materials related to the study
• This IRB does require that you provide evidence of completion of a Human Research Subject Protection education. If you have completed Human Subject Protections Training modules in CITI training within the last 2 years, please upload the completion certificate(s). If you have not, click this link https://gcp.nidatraining.org/, register for an account and complete this training module.  You will be able to download a certificate of course completion at the end of this training.

Communication with the Covenant IRB Office

• You need to use the “project email” tab within your project in IRBNet for all communication with this office. This will allow the IRB Office to track and audit our correspondence.

Timeline for Review

• Expedited or Exempt Review: These submissions are reviewed as they are submitted and generally have a one to two week turn-around time for determination.
• Full Board Review: The IRB full board committee meets monthly.

Investigator Types

• Nursing Student Investigators
• Undergraduate Investigators or Graduate Investigators
• Medical Student Investigators and Medical Resident Investigators

Resources and References

• HIPAA Authorization Requirement for Informed Consent
• Elements of Informed Consent
• Research vs Quality Chart
• Covenant Medical Center Clinical Research Policy
• IRB Review Fee Schedule
• Identifiable Data Elements for HIPAA Consideration
• Nuremberg Code
• Declaration of Helsinki
• Belmont Report
• Expedited Review List
• 45 CFR 46-HHS Protection of Human Subjects
• 45 CFR 160-164 HHS Administrative Data Standards (HIPAA)
• 21 CFR 50-FDA Protection of Human Subjects
• 21 CFR 56-FDA Institutional Review Boards
• 21 CFR 312-FDA Investigational New Drug Application
• 21 CFR 812-FDA Investigational Device Exemptions

Covenant Research Related Contacts

• IRB Administrator: Pam Bonds - IRB@chs-mi.com
• Director of Research, Central Michigan University: Neli Ragina - ragin1n@cmich.edu
• Director of Clinical Research, CMU College of Medicine: Nawar Hussin, MD - hussi1n@cmich.edu; P: 989-746-7744