If your research meets ANY of the following criteria, check “YES” to Question 1.6 within the TRAQ DSS FORM:
- Research occurs in a hospital setting;
- Research utilizes or requires hospital staff, space, services and/or other resources;
- Research offices for yourself and/or your research staff/students/trainees are located in a hospital setting OR your research lab, unit, centre, space, and/or equipment is located in a hospital setting, even if your research project is occurring off-site;
- Research involves recruitment from an outpatient clinic or program that occurs in or is managed the hospital;
- Research involves obtaining or retrieving patient biological samples/specimens from patients seen (or samples stored) at one of the hospitals for lab projects and transported to your research lab located within OR outside of the hospital (i.e. Botterell Hall, CRI);
- Research involves extracting patient data from hospital medical records;
- Research involves purchasing supplies or equipment at/through the hospitals;
- Research involves the use of hospital services and payment to hospital departments;
- Research funds will be held within one of the hospitals/hospital research institutes.
Appropriate Hospital Operational Directors and Research Directors
If your answer is “YES” to Question 1.6 in the TRAQ DSS FORM, you MUST select the appropriate Research Director(s) to approve based on which hospital(s) are impacted and selected under Questions 3.1-3.3.
Research Directors are as follows:
- Kingston Health Sciences Centre (KHSC) - Hôtel Dieu Hospital (HDH) or Kingston General Hospital (KGH) site - RESEARCH – Steven Smith
- Providence Care (PC) – RESEARCH - Allison Philpot
You MUST also identify ALL hospital departments that will be impacted by your research on the "Other Approvals" under the APPROVALS tab. You must check off the hospital department even if you or your research staff/students/trainees are the ones accessing the space (versus Hospital staff) and carrying out the research activities OR if the study involves usual care/standard of care. The hospital departments need to be made aware of any impact to the flow of patient operations even if hospital staff and resources are not used.
Only the Principal Investigator (a Faculty Member) can submit a TRAQ DSS FORM
A TRAQ DSS FORM* MUST be completed:
- (1) if you are applying for any internal or external research funding
- (2) there are no funds for the research project (for ethics only) BUT your research is considered Hospital-based Research as HODs & Research Directors’ signoff is required,
- OR (3) if you require legal review of your agreements/contracts.
It is important for researchers to consult early with the various hospital departments (Hospital Operational Directors (HODs)) to get an estimate (e.g. lab, pharmacy, and imaging costs, salary and benefit recovery for hospital staff used, supplies, equipment, and medication costs) to help develop their budgets. The TRAQ DSS FORM MUST be submitted at least 15 business days in advance of the funding agency deadline to ensure all hospital approvals are in place. It is also recommended that PIs consult with HODs well in advance of the deadline (> 1 month) to discuss any issues involving impact on patient flow, budgeting for hospital services and cost recovery, preparing a human ethics review submission, etc.
For Hospital-based Research projects, researchers MUST attach the following documents with their TRAQ DSS FORM prior to submission:
- Research proposal or study protocol (draft version accepted)
- Budget or budget justification (if applicable, draft version accepted)
- Hospital Departmental Impact & Information Form
- KGH/HDH Laboratory Services Study Request Form if using KGH/HDH lab services for ANY biological samples/specimens used in your research project (standard of care AND/OR above standard of care).
- KGH/HDH Pharmacy Services Study Request Form if using KGH/HDH pharmacy services for ANY drug monitoring, storage, mixing or blinding in your research project (standard of care AND/OR above standard of care). Other important documents to upload, if applicable:
- For research projects involving an Informed Consent Form, please upload if available
- For research projects working with industry or other academic partners outside of Queen’s and/or local hospital(s)/hospital research institute(s) that require legal review of an agreement/contract, please upload the Study Agreement so that the contract review process can commence at Queen’s
- Future Study Agreement Amendments: Please log into TRAQ and under your Applications (post review), add an event to your TRAQ DSS FORM file. Click on EVENTS tab and select the AMENDMENT FORM link. Complete the Amendment Form and upload an electronic version of the Amendment contract and submit. This will initiate the review of the amendment by Queen’s.
- Investigator Brochure or Product Monograph, if available (industry-sponsored clinical drug trials)
- HSREB, CTO and/or OCREB certification approval letter, if already obtained.
PLEASE ENSURE ALL DOCUMENTS ARE UPLOADED TO THE TRAQ DSS FORM PRIOR TO SUBMISSION.
HODs & Research Directors DO NOT have access to the Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB) information and therefore do not have a complete picture of the proposed study and the proposed flow of patients/participants within and outside the hospitals for their visits. You MUST include the documents listed above and attach the files to your TRAQ DSS FORM under the “Attachments” Tab. These documents are required before ANY HOD and/or Research Director can sign-off. The combination of supporting documents and the revised Hospital Department Impact and Information Form attached to a TRAQ DSS FORM will help to expedite the hospital review process. Once signed off, the file will be forwarded to your Queen’s Department Head for approval. The approvals process is as follows:
PI submits TRAQ DSS - Hospital Signing Authority - Departmental Signing Authority (Queen's Dept. Head) - Faculty Signing Authority - Research Services Receives TRAQ DSS
If there are funds to be received for your project, you need to indicate the amount of funding you will be requesting from the agency by completing a “funding disbursement” screen. Start by clicking on “Add New” at the bottom of the Sponsor Info screen. Enter the anticipated start date of your project, the fiscal year data field above will automatically populate. Enter the total amount of requested cash (this amount should include the overhead if applicable), or expected in-kind contribution. You can indicate ‘draft’ in the notes section on this page; if your project receives funding, the final budget will be verified prior to submission to Research Accounting. If your study is a clinical trial, please provide an estimate budget by multiplying the estimated number of subjects by the case cost per subject. If you are applying for an overhead waiver please also note this in the comments section and upload your signed waiver form to your TRAQ DSS FORM.
Pending certification(s) still need to be linked even if you are not applying to an ethics review system (HSREB, CTO, OCREB) at the time of your submission to a granting agency. You will need to have your certifications in place before you can commence your research or open a research account. Thus, linking your pending certifications in your TRAQ DSS FORM can help to avoid delays in starting your research or opening a research account once your grant or contract is funded. Please remember to check off in the TRAQ DSS FORM the type of ethics review (i.e. HSREB, OCREB or CTO) being used for your project. The TRAQ DSS FORM also captures all of your HODs & Research Directors and Department Head approvals, which are required when submitting to a granting agency or having an agreement reviewed by the Queen’s Industry Partnership Office. Please remember to Click “Add New” under Related Certifications to make note of HSREB/CTO/OCREB certifications submitted OR your intention to submit to these review committees.
Yes. All researchers conducting Hospital-based Research MUST complete a TRAQ DSS FORM, even if there are no funds administered (for ethics only) for your research project. The TRAQ DSS FORM captures all of your HODs, Research Director(s), Department Head, and Faculty approvals.