[HOWTO] Get ethics approval for your human trial at Western

Hello friends,

After spending a lot of time trying to navigate the ethics application process, I thought I would document our group’s journey for others. I’ve written this document as a Wiki, so if you want to contribute, simply hit ‘edit’ and make whatever edits you think improve things. As of right now, this document is not yet complete.

Ethics application materials

ROMEO access

Lawson pre-approval documents

  1. TCPS2
  • Select institutional access and the option for needing to complete CORE
  • You must use LAWSON Health Research Institute affiliation (not Western) and use your LHSC email address. If you don’t and there are problems, our contact cannot find you in the system
  • It might take several hours for them to send you the email to complete the registration so that you can begin the module
  • This module takes 1-2 hours to complete so get a coffee and settle in
  • ACTION: Save a copy of the certificate of completion and email it to the Division research office (Mel or Kristine)
  1. ACTION: Print a copy of your Privacy certificate from iLearn

  2. Lawson Core SOPs

  • If accessing off-site, use your hospital desktop log-in as your user name and password
  • Any of the modules listed as CORE
  • Also SOP 006, 008, and 009 (required if obtaining consent) and modules specific to your area of research (there are 2 modules specific to medical devices)
  • ACTION: Save the final quizzes in a folder on your computer so that if you are ever asked for proof of training you can provide it

Once you have finished the training print the attached document. ACTION: Fill in the completion date for all training that is marked as required (ignore all other training) then PRINT the form, physically initial (must be done by hand or they will not accept the document) beside each completed training module and drop the form off with Kristine or Mel.

LHRI

You have to become a member of LHRI. First, contact Sharon MacDonald sharon.macdonald@lawsonresearch.com. She will send you an invitation letter along with some other forms that you have to fill out and sign. Once done, send these back to her.

Research Ethics Board (REB) schedule

Clinical trials number

You must get a clinical trials number at ClinicalTrials.gov. As a Lawson researcher, the contact person is Janet Knechtel Janet.Knechtel@lhsc.on.ca. Write her an email providing her with: The PI’s name for your study; Your hospital email address