Submitting to the IRB

1. TMH IRB and Institutional Policies require investigators to fulfill training requirements prior to initiation of research activities. To learn more about these requirements, please visit the TMH IRB Guidance Document for Required Training

If you are not conducting human subjects research, but are conducting a Quality Improvement project, the training requirements do not apply. However, an IRB submission is still required.

After completing institutional training requirements, investigators will need to request access to the IRB submission platform, Cayuse. To request access to Cayuse, follow the instructions listed on the TMH IRB Guidance Document for Required Training.

2. All study team members must be eligible to conduct research activities at TMH. Utilize the table below to ensure that all listed study team members meet eligibility requirements.

3. All research activities being conducted at TMH must fulfill all applicable ancillary and feasibility reviews prior to IRB review:
      a.    Research Council: Research Council review ensures all facility needs for proposed research activities can be met. To submit to the Research Council, investigators will need to complete the Research Council Worksheet
      b.    Conflict of Interest (COI): All listed study team members must complete the COI training module (see Required Training section) and a COI disclosure form for each research study. The COI disclosure form can be accessed here.
      c.    Pharmacy: For studies using investigational drugs, a pharmacy utilization worksheet must be completed and submitted for appropriate approval. The Pharmacy utilization worksheet can be accessed here:
      d.    Radiation Safety

4. Researchers may submit to the TMH IRB through the online platform, Cayuse.
      a.    After receiving access to Cayuse (see step 1), researchers can log in using their username and password by accessing tmh.cayuse.com from a web browser (Google Chrome is recommended).
      b.    To navigate to the Cayuse Dashboard, select “Products” in the top right corner and select “Human Ethics” from the drop-down options.
      c.    The Cayuse Dashboard includes boxes and tabs that assist researchers with accessing their current studies and submissions. For step-by-step assistance with IRB submissions, please contact the TMH IRB office.

5. Tracking IRB submissions
      a.    The Cayuse Human Ethics dashboard includes clickable boxes to track the location of your TMH IRB submission. The Cayuse system will also provide notification emails throughout each step of the submission process. The TMH IRB has received your submission AFTER the PI has certified the submission (i.e., provided authorization) and the submission location appears in Pre-Review.
      b.    The graphic below demonstrates the general flowchart of IRB submissions.