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Submission Instructions

A woman conducts research under a microscope in a lab

Ann Arbor Institutional Review Board Submission Requirements

Everyone involved in reviewing or conducting research including all research team members and IRB members, etc. must complete the required educational courses offered through the CITI subscription website.

To access:

  • Go to www.citiprogram.org and register.
  • Once there, click on "Register".
  • In the "Select your organization affiliation" section, select "Trinity Health- Michigan Region" in the "Participating Institutions" drop-down box. 
    NOTE: Selecting the incorrect institution may lead to the completion of different or unnecessary modules.
  • Follow the prompts to complete registration and course selections.

The following courses are required:

  • Human Subjects Research (HSR) – complete every four years
  • Conflict of Interest (COI) − complete every four years
  • Responsible Conduct of Research (RCR) − complete every four years
  • Good Clinical Practice (GCP) – complete every three years if your study is a clinical trial*
    • All Investigators, study coordinators, and research staff who are involved in the conduct, oversight, or management of a clinical trial or clinical investigation no matter the source of the funding, are required to complete Good Clinical Practice (GCP) education and training. Training is offered for individuals involved in clinical trials of drugs, biologics, and devices, as well as for those individuals involved in behavioral intervention and social science research studies.

You may use multiple logon sessions to complete the course. The minimum score for passing each of the required courses is 80%.

Upon completion of the required course, save and retain the completion record to your computer/research files. You will need to submit all completion records for each study team member with any New Study Application and as necessary throughout the conduct of a study.

For further information refer to Education and Training on Human Research Subject Protections.

 

What do I submit for a new research project?

An initial application submission includes the following required items:

  • A New Project Application Form - For either research that meets an expedited category or requires full board review 
    OR
  • Exempt Research and Not Human Subjects Research Determination form - For projects that are not human subjects research or for research that meets an exempt category (see form for definitions)
  • Your department chairperson's signature is required on the Application Form as well as the Principal Investigator and co-investigator signature(s)
  • A protocol, Investigational Brochure, survey(s) or any data collection tool/case report form.
  • An informed consent form and HIPAA form (utilizing the Michigan template found on the Forms page) in Word.
  • CITI completion reports for all study team members, 
  • CV of the Principal Investigator
  • Significant Financial Interest Disclosure Form for all study team members, if not already submitted for the current year.
  • For studies that are utilizing a device, submit the Significant Risk determination from the Sponsor and/or the FDA and the FDA approval letter.
  • For clinical trials, please submit the FDA approval letter for the IND, IDE, PMA or 510K as appliable. 
  • Any documents such as advertisements, recruiting information, informational brochures, or anything to be seen or used by a potential research participant.

For further information refer to policy Initial Review of Research – Expedited and Full Board policy.

What if there is a change to the study protocol?

Complete and submit all the information requested on the required Request for Revision Form, along with a summary of changes, including risks to participants along with tracked and final versions of all documents being updated.

If changes only involve study team member updates submit the Change in Research Team.

For further information refer to Amendments and Revisions to Approved Research Policy.

What do I do if I have to report an Internal Adverse Event (unexpected serious adverse effect)?

Complete and submit all the information requested on the required Internal Adverse Event Form. For information on what to report to the IRB see Flow Chart- AE and UP reporting and Chart for Reporting AE and Ups.

For further information refer to policy Unanticipated Problems or Adverse Events Reporting.

What do I do if I have to submit a Continuing Review Report?

Complete and submit the required Continuing Review Form with all the information and attachments requested on the form, include a summary of all study activities that have occurred since the last IRB annual or initial review.   

For further information refer to policy Continuing Reviews Policy.

How do I submit to the IRB?

Submit ALL materials for review electronically to the e-mail below. Hard copy material is no longer accepted. You can access all the required forms on the Forms Page. For further information regarding IRB submission or reviews go to the Policy page or contact us by email aasjirbsubmissions@trinity-health.org or phone 734-712-5470. 

Please note: if any portion of the required materials/forms is not complete, it will be returned to the submitter, this includes signatures on the applicable forms, as well as attaching all for the study team. 

If the Principal Investigator feels the study will be considered "exempt", the Ann Arbor Exempt Research and Not Human Subjects Research Determination Form, study proposal, and applicable documentation is still required to be submitted and reviewed for an IRB determination.

Send all IRB submissions to: aasjirbsubmissions@trinity-health.org