Frequently Asked Questions (FAQ)
New REB Name
1. What does the name change mean for me?
A. No more submitting to both institutional REBs for studies involving the UOHI and TOH, only one REB review is required.
2. Do I need to revise my consent forms?
A. Yes, you will need to revise the consent forms to include the new REB name at the time of renewal or amendment, whichever comes first.
3. My study is regulated by Health Canada, what do I have to do?
A. For OHRI or Heart Institute sponsored, regulated, investigator-initiated trials, we have received confirmation from Health Canada that you are required to submit a revised Clinical Trial Site Information (CTSI) form to Health Canada for each trial to indicate the revised REB name. A “notification” submission is NOT required.
B. For industry sponsored regulated trials, please inform your sponsor of the REB name change and obtain a revised CTSI form for completion and submission to the sponsor.
Electronic Application
1. How do I share the initiated application with another person on my team?
A. In order for someone else to see an application you have created they need to have a myTOH account as well as be named on the application (investigator or staff).
i. Send a link to the application to the person you want to be able to see the application. Once you send the link the person will have full access to the application, including being able to add/remove information. To do this you will need to know if that person is internal or external to TOH.
- If they are internal then simply copy the web address at the top of your application. It will look something like this: https://iris/CRRF/Link.aspx?ID= (with the CRRF ID).
- If they are external to TOH you will need to go in through myHospital for the link. It will look something like this: https://ohriiris-theottawahospital.msappproxy.net/CRRF/Link.aspx?ID= (with the CRRF ID). They must be logged into their myHospital account before pasting in the link or they will get an error message.
2. Who can be listed as Principle Investigator (PI) on the application?
A. For all research projects (Regulated and Non-Regulated)
i. The PI should be a local investigator and not an external investigator. The PI field is used by various departments within our institution, such as Finance, HR and Contracts, and as a result we need to ensure a local investigator is identified as PI. If an external PI is listed, you will be asked to revise the application to list the local investigator.
ii. A non-TOH/UOHI can be a PI if the applicant is using our Board as their board of record only, i.e. not using TOH/UOHI patients/facilities.
iii. Students will need to identify a local TOH/UOHI investigator in the PI section.
B. For Health Canada regulated protocols, the PI must be either a physician or dentist and a member in good standing of a professional medical or dental association as defined in Part C Division 5 of the Food and Drug Regulations.
3. How do I forward my application to the different departments for signature?
A. The application can be sent to the different departments for signature electronically. Save the application and email it to them. Here are some options on how to save the application and its attachments.
i. Option 1) Save as a Webpage to email as an attachment (modifiable, with live uploads)
- Open the application
- Click print icon (top right of page)
- At this point you are able to print the document out or save it
- Click the ‘file’ tab of the web browser
- Select ‘ save as ’
- Rename the file if you want and save wherever you want to save the file (i.e. drive on hospital server, study specific folder, etc.)
- Saving the file as a ‘ web page complete ’ file will allow all attachments to be opened in the file. Then Health Records or other departments can see the application and any uploaded documents such as the protocol or consent form. The file may then be attached to emails and sent to departments for review.
ii. Option 2 ) PDF to email as an attachment but you will need to also upload documents such as protocol and consents (Must have Adobe Professional to use this option)
- Save just the application as a PDF file if you have Adobe professional installed on your computer. Then you would simply email the PDF file, along with the protocol file, etc. to the person you wish to review the application.
iii. Option 3) Send the department a link to the application (modifiable, with live uploads). Follow the instructions in question #1 above.
4. Do I have to have all of the applicable impact signatures in order to submit?
A. We recognize that sometimes you do not have all of the signatures in place prior to submitting your application. You may submit your application without all of the impact signatures but the REB will not approve your protocol until all signatures have been uploaded.
5. Do I have to have all of the investigator signatures in order to submit?
A. No, you do not need all of the signatures prior to submitting your application but the REB will not approve your protocol until all signatures have been uploaded.
6. I don’t have funding, but have applied for funding and the budget section won’t let me upload a budget. Is there somewhere else I can add the upload?
A. You may upload the budget in section 25 Additional Documents.
7. When I upload revised documents, should I delete the previous versions?
A. No, you must not delete previous versions of the documents once the review period has begun. Be sure to include the version date in your file naming convention to allow for quick identification of the most recent version. (e.g. English Informed Consent Form, version 1, dated Jan 14, 2013)
8. I tried to make changes to the application but it won’t let me. Why?
A. Once you hit the ‘submit’ button the application is locked and changes can no longer be made. If you need to revise a section, email the Research Ethics Coordinator and ask them to unlock the application for you. If the application is currently under review by the Chair or Board members, the application cannot be unlocked and you will have to wait until the Board’s comments have been sent to you.
9. Do I respond to the REBs letter of concerns/recommendations in hard copy, via email, or in the comment sections like I did during the initial pre-review period?
A. The comment sections (bubbles) used during the initial pre-review period is no longer active. Your response should be emailed to the REB as well as making any requested changes directly into the application. Your email should also list all changes made to the application. (e.g. Section 17a has been revised to indicate the REB and OHRI/UOHI have access to study files for audit purposes)
10. My study is investigator-initiated and supported by industry through a grant or drug/device supply. How do I complete section 4.6?
A. In section 4.6 you would check off the appropriate level of industry support and nothing else. Unless you have checked off “a) Industry-initiated and sponsored (conducted) protocol?” the application is automatically considered ‘Investigator/Initiated’. The REB is able to assess who the coordinating site is and whether the study is regulated or not by your responses to earlier questions.
11. I have an amendment/renewal form that needs to be submitted. Do I submit it in hard copy or electronically?
A. At this time only the initial application is electronic. Once the study receives its initial REB approval, all other documents should be submitted in paper format.
12. I see my name in investigator (staff) drop down list but my title or other contact information is incorrect. Should I create a new entry?
A. No, the investigator (staff) names are tied to the studies in our database. Please contact the REB clerk with the correct information and our database will be updated.
General Questions
1. This research study is part of my thesis project, do I need to submit anything with my application?
A. Yes, you are required to provide a copy of your Thesis Committee’s approval (this document should be added section 25 “Additional Documents”).
2. I revised my consent form; do I need to ask the participants to sign the revised consent form?
A. This depends on the revisions. If the revisions are administrative, formatting, spelling errors then no you do not need to have the participants sign the new consent. If the changes are content related (e.g. study visits have changed, risks revised, etc.) then yes the participants must be asked whether or not they wish to remain in the study and to sign the new consent form.
3. Who needs to take the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans online tutorial?
A. All Principal Investigators, Co-investigators and clinical research personnel are required to successfully complete the TCPS 2 tutorial. Applications, amendments, and renewals will not be approved unless the Principal Investigators, Co-investigators and personnel listed on the study have completed the tutorial by the specified date.
4. Who needs to take the Good Clinical Practice CITI online course?
B. The Principal/Qualified Investigator and all staff and co-investigators with delegated responsibilities in an interventional trial from the Principal/Qualified Investigator must have evidence of training on the ICH-GCP guidelines and the applicable Health Canada regulation(s).