Submission Process

A woman conducts research under a microscope in a lab

Submission Instructions/Requirements

All research submissions are submitted to the IRB via OneAegis, our electronic submission portal. Prior to beginning a new submission, ensure all research study staff have OneAegis access. All research personnel are required to provide their electronic signature regarding conflict of interest related to the study as well as a confidentiality agreement if they are not employed by or affiliated with Trinity Health. To obtain OneAegis access, complete the OneAegis Access Request Form and submit to IRBAdministrator@trinity-health.org.

What do I submit for a new research project?

For studies requiring full board review or that meet an expedited category, complete the New Project Application. For studies that meet an exempt category (e.g., retrospective record reviews) or studies that are research but not human subjects research, complete the Exempt/NHSR Application. Please contact the IRB Administrator at IRBAdministrator@trinity-health.org if you require assistance in determining if your study qualifies for an expedited or exempt review.

New submissions will require:

Written documentation of review by a research review committee
Sign off by the department head where the research will occur (exempt submissions only)
Annual Significant Financial Disclosure Form for all study team members (for the current calendar year). This form is for disclosure of all conflicts of interest, whereas the conflict of interest disclosure on an IRB application is specific to the study.)
Principal Investigator’s current CV (signed and dated within past 3 years)
Copies of the required CITI training for all research study staff
- Required CITI training for all research includes:
- HSR (Human Subjects Research) – complete every 4 years
- RCR (Responsible Conduct of Research – complete every 4 years
- COI (Conflicts of Interest) – complete every 3 years
- GCP (Good Clinical Practice) if the study is a clinical trial – complete every 3 years
- Ensure you affiliate with Trinity Health – Michigan Region so the required modules populate for each course
- Link to CITI: https://about.citiprogram.org/
- For additional information, refer to the IRB policy Education and Training on Human Subject Protections
Study documents must contain version dates (and page numbers on multiple page documents)

Study documents you may need to include in your submission:
- Protocol (template available) ^*Required
- Data Collection Tool(s) including data collection sheets, surveys, questionnaires, etc. ^*Required
- Informed Consent Document(s), including HIPAA Authorization (templates available)
- Documents such as advertisements, recruitment materials (ads, flyers, posters, phone scripts, press releases, etc.), informational brochures or other documents to be seen or used by potential research participants
- Investigator's Brochure, if applicable
- Drug or Device studies - a copy of the FDA approval letter for the IND, IDE, PMA or 510k
- Device studies also require the Significant Risk determination from the sponsor and/or FDA in addition to the FDA approval letter

Once the Principal Investigator signs the application, all research study staff will be required to sign off on conflict of interest. Anyone external to Trinity Health will also be required to sign the Confidentiality Agreement included in the application.

What if there are changes to the study?

If you have updates/changes to your study protocol or any other study document, you must submit an Amendment Application for the study to be updated. To do this, log into OneAegis and open the study requiring revisions. On the left sidebar, select “Start xForm”. From the list of available options, select Amendment Application and complete the form.

You will be prompted to attach copies of any new study documents as well as both a tracked and clean copy of each revised document. Revised documents should reflect an updated version date.

For changes in research study staff, complete the Research Personnel Request Application. When adding new study staff, you will be prompted to attach a copy of all required CITI certificates and confirm that each new study staff member has completed the Annual Significant Financial Interest Disclosure form. New study staff will not be added to a study until all the above criteria are met.

How do I submit a Continuing Review Report?

To submit a continuing review report, log into OneAegis and open the study to be renewed. On the left sidebar, select “Start xForm”. From the list of available options, select Continuing Review Application and complete the form. Once the Principal Investigator signs the form, all research study staff will be required to sign off on conflict of interest. Anyone external to Trinity Health will also be required to sign the Confidentiality Agreement.

How do I report a Protocol Deviation or Internal Adverse Event (unexpected Serious Adverse Event)?

Minor Protocol Deviations should be reported with the submission of a Continuing Review Application. The form will prompt you for the information. For major protocol deviations (those that negatively impact the rights, safety or welfare of human subjects, affect the scientific soundness of the research plan or quality of the data), complete the separate Reportable New Information form in OneAegis.

Major protocol deviation examples: Incorrect consent form was used, consent was not obtained, the wrong person obtained consent, enrollment of a participant did not meet inclusion criteria, drug dosing error, study visit outside of window that affected participant safety.

Questions?

Email: IRBAdministrator@trinity-health.org

Call: 616-685-6198