Ethics
If your study involves any of the listed elements below, seek HSREB Review. If your study does not contain any of the elements below, seek GREB Review.
- Conducting research in any of the Affiliated Teaching Hospitals (Kingston Health Sciences Centre (KGH and HDH Sites), Kingston General Health Research Institute (KGHRI), Hotel Dieu Hospital Research Institute (HDHRI), Providence Care Centre (PCC) and Ongwanada or in other health care, clinic, or medical settings;
- Participants from any of the Affiliated Teaching Hospitals or in other health care clinics, or medical settings at any point during the research;
- Pharmaceutical device, drug, or natural product(s) clinical trials;
- Medical or physical interventions, treatments, therapies or surgeries;
- New medical techniques or technologies, deviations from standard of care;
- Human biological materials from human participants (living or deceased);
- Physical exertion (beyond walking/ normal daily activities);
- Medical or dental patients, doctors, nurses, dentists, or any other health care professionals, rehabilitation therapy;
- Health or medical records;
- X-ray, CT Scan, PET Scan, MRIs, ultrasound, EKG or other medical tests or scans;
- Administration/ Ingestion of any substance;
- Biobanks
When in doubt, seek clarification from the Research Ethics.
All of the applications are found in the TRAQ system form to access the on-line forms to submit to the REB.
If you are not sure what form to submit in TRAQ, refer to Ethics Compliance Application Forms Descriptions.
Applications are judged on the level of risk involved. In general, full board reviews are required for high-risk and ethically complex studies or where diverse opinions across researchers are likely. This decision is admittedly subjective. The decision as to whether or not an application goes to full board or delegated review rests with the REB Chair. Possible Full Board review applications may also be flagged by the REB Ethics Coordinator.
If you feel your application may be subject to full board review, refer to the submission schedule and meeting dates: GREB/HSREB Meeting Submission Date Requirements.
You will need to ensure you have a TRAQ account via completion of the TRAQ Self-registration form .
The most useful resource would be the GREB page/HSREB page. In general, if there is a common ethical concern, we have drafted guidelines/policies about it.
Depending on your research you would want to be familiar with the following:
| GREB | HSREB |
|---|---|
There will also be a new version of the CORE tutorial . Completion of ethics training via the CORE tutorial or an equivalent ethics training module is mandatory for all human participant researchers at Queen’s. Contact the Ethics Office for any questions related to equivalent ethics modules and exemptions related to this requirement.
If you need help to learn to navigate the TRAQ system, reach out to the Ethics Office to schedule a session with one of our team. Key recommendations are to make sure you regularly save your work, as TRAQ does not have an auto save function. Do not use the back buttons in your web browser, only navigating within the system. You are able to export a version of the application form to Word, which can help facilitate your response memo back to the REB.
Any ‘research’ activity involving human participants that is occurring under the auspices of Queen’s (using Queen’s resources – people, facilities, online spaces, recruits Queen’s staff/students, etc.) requires local ethical clearance at Queen’s.
Article 2.5 of the TCPS 2 allows for an exemption to requiring ethical clearance where your activities are for a QI/QA/PE purpose. We have developed an application where you can obtain a formal exemption from our office for your activity.
Do you have plans to expand the use of the tool outside of the research setting (e.g. outside of Queen’s, KHSC – KGH/HDH or PCC) OR do you plan to generalize any of the findings outside of the research setting? If you do not have plans to generalize any of your findings, your project could classify as QA/QI/PE.
All research studies involving human participants, both living and deceased, require human ethics clearance, where research is defined as “An undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation.” However, there are some exceptions to the requirement to seek REB review as outlined in the TCPS 2 Chapter 2 :
- Research that relies exclusively on publicly available information when:
- The information is legally accessible to the public and appropriately protected by law;
- The information is publicly accessible, and there is no reasonable expectation of privacy;
- Information revealed on-line where there is a reasonable expectation of privacy is NOT EXEMPT from ethics review (e.g., Facebook).
- Research involving the observation of people in public places where:
- It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
- Individuals or groups targeted for observation have no reasonable expectation of privacy; and
- Any dissemination of research results does not allow for identification of specific individuals.
- Creative practice activities, in and of themselves, do not require ethics clearance; however, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question does require ethics clearance.
- REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.
- In some cases, research may involve interaction with individuals who are not themselves the focus of the research, in order to obtain information. For example, one may collect information from authorized personnel to release information or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is distinct from situations where individuals are considered participants because they are themselves the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or who are observed in their work setting for the purposes of research, are considered participants.
Generally speaking, REB submissions do require a local researcher to be listed on the ethics application. However, this does depend on the nature of the research, the access to Queen’s/hospital resources and the risk associated with the research. In the case of a low-risk research study, such as the collection of anonymous survey data, we likely do not require a local Queen’s person to be listed on the file.
Please refer to FAQ How do I Self-Register in TRAQ as an External User
No, we do not provide extensions. The Renewal Event Form must be submitted on time, or up to 30 days in advance of the expiry date, otherwise all research related activities must stop until the project can be renewed. The Renewal Event Form is very short and will only take a few moments to complete.
If you do not have time, we will have to follow our standard process to suspend/terminate the study until we receive the new Renewal Event Form in TRAQ.
If you are not using any Queen’s resources for your project, and the information will not be used under the auspices of Queen’s (e.g., Queen’s thesis/dissertation), ethics would not be required at Queen’s. If email addresses can be obtained from public resources, this would not constitute the use of Queen’s resources.
If you do plan to use Queen’s resources; have local Queen’s researchers with access to study data/participants; access/use Queen’s mailing lists, have Queen’s student/staff/faculty help with recruitment; you must submit an ethics application to Queen’s.
The only streamlined processes for multi-site ethics reviews are Clinical Trials Ontario (CTO)/Ontario Cancer Research Ethics Board (OCREB). Applications should be submitted to CTO for multi-site research studies (observational and clinical trials) with recruitment at 2 or more sites limited to ONTARIO. OCREB submissions are for oncology specific protocols for 2 or more sites limited to ONTARIO. All sites must be following the same protocol that is developed by the provincial applicant, and have a Qualified Investigator responsible for oversight of the study at each site. Each site must submit a centre application, in addition to a provincial application is using CTO/OCREB.
When it comes to consent in youth or assent in addition to parental/guardian consent, the TCPS does not specify a specific age. It comes down to the Decision-Making Capacity of the participant. The guidelines surrounding this can be found in Section C, Chapter 3 of the TCPS.
The risk of the activities combined with the context and design of the research can influence how
consent/assent is obtained. Some considerations are as follows:
- We have seen situations such as online anonymous surveys where an adolescent can consent on their own.
- A youth must be capable of understanding the research, risks/benefits involved and consent voluntarily.
- Voluntary consent in youth may be more difficult to judge with a power imbalance of adults doing the consent discussion. The researcher being involved previously may also cause undue influence from an existing relationship.
- If it is higher than minimal risk – parental consent is recommended (except in specific circumstances where parental involvement could pose a risk to the participant, i.e., pregnancy).
- When there is an intervention involved, parental consent may be required (depending on the intervention).
- The design of the research can influence requirements, i.e., the youth needs to get to and from a location and they do not drive.
- In addition, will their parents/guardian be aware of their involvement anyway and are they accessible?
All of the above factors can influence how consent is obtained when youth are involved. We ask researchers to propose their method of consent and include justification which addresses the above
concerns and reflects the TCPS guidelines.
NVivo is the most common transcription service we see used. NVivo is an online transcription service that has been reviewed by Queen’s privacy and ITS departments.
Generally speaking, when using an online transcription service it is important to consider the sensitivity of the data that you plan on submitting to the service and the related risk to a participant if a breach were to occur. If you decide to use this software, or a similar service, Queen’s privacy has provided the following recommendations:
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Ensure all audio files submitted to the service are truly anonymous / anonymized with no chance of identifying or re-identifying individuals. This will require the account holder to preview the audio before submitting.
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The account holder should permanently delete files from the service once the transcription has been downloaded and completed satisfactorily.
No, if they are collaborators and do not have access to data/participants, they do not need to complete CORE or be added to the ethics application.
No, lab volunteers do not need to be added to the ethics application. However, if these volunteers are performing significant study-related duties/have access to participants/data, they are still required to complete CORE training and these records should be maintained in the study files or lab/Department files in the event of a quality assurance review/audit.
How to Use and Understand Flesch-Kincaid Readability Statistics in Microsoft Word
Health Canada recommends the level of language used should be appropriate to the age and comprehension/reading level of the participant population, generally at approximately a grade 6 - 8 reading level.
Get your document's readability and level statistics
Minimal risk research is defined by the Tri-Council Policy Statement (TCPS 2) as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.
Impracticable refers to undue hardship or onerousness that jeopardizes the conduct of the research. It does not refer to mere inconvenience.
Secondary use refers to the use in research of data or originally collected for a purpose other than the current research purpose.
It is up to the study team to explain why SDM may not be used for their participant population.
In general, if capacity may be a concern, consent would be obtained by a SDM. Processes would need to also be in place in the event the participant does gain/regain capacity (i.e. they will consent on their own).
If consent were to be obtained by a SDM/parent/guardian, assent should still be sought from the participants that lack capacity if they were able to do so. If not able to provide assent, the study team would need to explain why not.
The assent process does not have ‘mandatory’ elements that need to be communicated, as these are outlined in the ICF. If using an assent process it would need to be tailored to the participant population. This can be as simple as ‘will you play this game with me’ when asking children, to providing an assent form that participants can sign. I usually suggest including a summary of key information only in these documents (refer to the US regulatory section on the Assent Template for Pediatric Clinical Research. The assent and consent processed do need to be documented in study records.
So to answer your question, if you do not think it is reasonable to have SDM in your study (e.g., participants need the capacity to participate for some study criteria) then you would just need to explain why you do not have this process in place for your study.
Do I need to obtain ethics clearance from Queen’s if...
If you can obtain contact information publicly, and do not need to use Queen’s resources for the survey, you do not need ethics clearance from Queen’s.
If you will be using Queen’s resources to conduct the data analysis, you do require REB review at Queen’s. You will need to complete a REB application in order to get clearance for use of this data.
Hospital-Based Research
If you are a researcher with a KHSC account, you will be able to access it at khscnow.kingstonhsc.ca/im/microsoft-365
This is the webpage on KHSC’s internal website that provides all the background for Microsoft 365, including OneDrive. All KHSC staff will have a personal OneDrive account, which is safe for storing personal health information and can be used to share this information internally with those that need to know it for the purposes of their job.
It’s important to note that at this time external sharing has been disabled, so KHSC staff are not able to share information on their personal OneDrive with someone outside of the organization. They will need to continue to follow the KHSC Email Usage policy to securely send PHI via email by password protecting it or use other methods (i.e. fax, mail, etc.).
The ethics office does not have any oversight with respect to the TRAQ DSS process, as that process is distinct from ethics review and is specific to obtaining hospital approval. For information regarding your TRAQ DSS submission, please contact Lisa McAvoy at Lisa.McAvoy@kingstonhsc.ca
Please note that Queen’s doesn’t permit students/residents to submit TRAQ DSS applications. Students and residents can complete the fields and then add their Faculty Supervisor as the PI, and add themselves as a team member (Co-Investigator). Then, let your supervisor know to submit the application.
You will need approval from Queen’s Undergraduate Medical Education (Queen's UME).
Please attach your approval from the Queen’s UME to your ethics application. Similarly, you will need to obtain approval to gain access to a listserv of medical students. Only a local researcher (affiliated with Queen’s) can gain access to this information. This information applies to all student categories (e.g. nursing students, OT students), as student emails are not public, thus you will need someone local to circulate the emails (i.e. use Queen’s resources) and require ethics at Queen’s.
Per the Personal Health Information Protection Act (PHIPA), someone in the circle of care or the Health Information Custodian (HIC) (i.e. KHSC administration) should reach out to patients to see if they would be interesting in participating in research. In general, the study team should not be contacting patients that have not explicitly provided consent to be contacted for research purposes or about participation in an upcoming study.
Ideally, the HIC can ask/mail out the letter/call all potentially eligible participants to see if they have interest in being contacted about the study. You could then follow up via a phone call or at the clinic visit via the study team once explicit consent has been provided to be contacted for research purposes.
Another option is to start a data base on any current studies to contact participants about future research to create your own ‘permission to contact for research’ database. Many research groups include this on their consents to help with future study recruitment.
Clinical Trials Ontario
Clinical Trials Ontario (CTO) Stream, our Ontario-built online system, enables all research sites participating in a clinical trial to undergo a single ethics review rather than separately applying to their local research ethics boards, reducing the time and labour required to obtain research ethics approval.
The Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER) is a cross-province streamlined ethics review process for multi-site studies to achieve a single ethics review for child health studies in Canada.
For more information visit cheerchildhealth.ca
The study will include two or more CTO participating sites.
The Provincial Applicant (PA) refers to the individual who takes overall responsibility for submitting all study-wide (provincial) materials to the REB of Record on behalf of all participating Ontario sites.
The provincial materials include the clinical trial initial application, all ongoing submissions such as proposed changes to the study amendments, reportable events and continuing review applications.
Additionally, each participating site must complete a centre application, in order to be eligible to participate in the research.
Tools for Research at Queen's (TRAQ)
For more manuals, videos and how-tos visit queensu.ca/traq
Steps 1 & 2 are the same for all TRAQ FAQs
- Visit queensu.ca/traq/signon if you use SSO (Single Sign On) or queensu.researchservicesoffice.com/Romeo.Researcher.Admin if you use your full email address as Username.
- Sign on with your Queen's Net ID (or full email address) and password.
Once signed on please follow these steps.
- Click the 'Applications: Drafts' link under the applicable Project ‘Role’ (i.e. Principal Investigator or Project Team Member)
- Select ‘Applications: Drafts’.
- Select ‘Delete’ beside the DRAFT you would like to delete.
Download "How do I delete a DRAFT application form in TRAQ?" as a PDF (567 KB)
Once signed on please follow these steps.
- Click 'My Reminders' (if due within 30 day) or 'Applications (Submitted-Post Review)'.
- Click the 'EVENTS' link next to the file no TRAQ FILE NUMBER.
- Select the form titled Annual Renewal/Closure Form by clicking on its hyperlink under "New Event Forms" section.
- Complete all fields.
- Save.
- Submit.
Download "How do I submit an Annual Renewal Form in TRAQ?" as a PDF (243 KB)
Once signed on please follow these steps.
Complete this form for amendments including change in study team requests.
- Click 'My Reminders' (if due within 30 day) or 'Applications (Submitted-Post Review)'.
- Click the 'EVENTS' link next to the file no TRAQ FILE NUMBER.
- Select the form titled Amendment of Approved Studies Form by clicking on its hyperlink under "New Event Forms" section.
- Complete all fields.
- Save.
- Submit.
Download "How do I submit an Amendment Form in TRAQ?" as a PDF (237 KB)
Once signed on please follow these steps.
Complete this form for amendments including change in study team requests.
- Click 'My Reminders' (if due within 30 day) or 'Applications (Submitted-Post Review)'.
- Click the 'EVENTS' link next to the file no TRAQ FILE NUMBER.
- Select the form titled Change in Study Team Request Form by clicking on its hyperlink under "New Event Forms" section.
- Complete all fields.
- Save.
- Submit.
Download "How do I submit a Change in Study Team Form in TRAQ?" as a PDF (239 KB)
Once signed on please follow these steps.
- Click the 'EVENTS' link next to the file no TRAQ FILE NUMBER.
- Select the form titled Serious Adverse Event Report (Local OR Non-Local) by clicking on its hyperlink under "New Event Forms" section.
- Complete all fields.
- If applicable, download, fill out and attach the multi-event reporting form.
- Save.
- Submit.
Download "How do I submit a Local SAE Form in TRAQ?" as a PDF (242 KB)
Once signed on please follow these steps.
- Click the 'EVENTS' link next to the file no TRAQ FILE NUMBER.
- Select the form titled Health Sciences Research Ethics Board Protocol Deviation Form by clicking on its hyperlink under "New Event Forms" section.
- Complete all fields.
- If applicable, download, fill out and attach the multi-event reporting form.
- Save.
- Submit.
Download "How to submit a HSREB Protocol Deviation Form" as a PDF (239 KB)
- If you are a Queen's Student (undergraduate and graduate), or Postdoctoral Fellow complete Self-registration form .
- Complete mandatory fields and optional information.
- Ensure you enter an email address that you use regularly, as all ethics communication will be sent to the listed email address in TRAQ.
- Please enter a telephone number you can be reached at in the event of ethics-related questions.
- Ensure you complete the RANK section correctly (***If this step is not completed correctly registration in TRAQ may be delayed***).
- Under Affiliation: select ‘Add New’.
- Under Level: If you are a STUDENT enrolled in one of the following Departments you must select ‘UnitREB’
- Cultural Studies Program
- Dan School of Drama and Music
- Faculty of Education
- Film and Media
- Gender Studies
- Geography and Planning
- Global Development Studies
- Political Studies
- Psychology
- Smith School of Business
- School of Kinesiology and Health Studies
- Sociology
Under Level: If you are a STUDENT and you are not affiliated with a Unit REB select ‘Department’ (***If this step is not completed correctly registration in TRAQ may be delayed***).
- Under Unit: Select the Department you are affiliated with (***If this step is not completed correctly registration in TRAQ may be delayed***).
- Check: ‘Primary Affiliation’.
- Select ‘Save’.
- Review all information for accuracy and completion.
- Select ‘Register’.
- An email confirmation with instructions on how to create your password and how to log in will be generated shortly after you register.
- If you have any questions or comments about the Research Portal, contact the TRAQ Help Desk
Download "How do I Self-Register in TRAQ as a NEW Student?" as a PDF (330 KB)
- If you are an External User (other non-Queen's Institution) complete the Self-registration form .
- Complete mandatory fields and optional information.
- Ensure you enter an email address that you use regularly, as all ethics communication will be sent to the listed email address in TRAQ.
- Please enter a telephone number you can be reached at in the event of ethics-related questions.
- Ensure you complete the RANK section correctly (***If this step is not completed correctly registration in TRAQ may be delayed***).
- Under Affiliation: select ‘Add New’.
- Under Level: select ‘Department’ (***If this step is not completed correctly registration in TRAQ may be delayed***).
- Under Unit: select ‘External Department (please specify in comments)’.
- Check: ‘Primary Affiliation’.
- Select ‘Save’.
- Enter the name of your External Affiliation in the Comments Section (e.g., University of Ottawa).
- Review all information for accuracy and completion.
- Select ‘Register’.
- An email confirmation with instructions on how to create your password and how to log in will be generated shortly after you register.
- If you have any questions or comments about the Research Portal, contact the TRAQ Help Desk
Download "How do I Self-Register in TRAQ as an External User?" as a PDF (228 KB)
Once signed on please follow these steps.
Complete this form for any updates/changes to your research except for changes to your study team.
- Click 'My Reminders' (if due within 30 day) or 'Applications (Submitted-Post Review)'.
- Click the 'EVENTS' link next to the file no TRAQ FILE NUMBER.
- Select the correct event form for HSREB or GREB titled, ‘HSREB Amendment Form’ OR ‘NEW - GREB Amendment Form - August 2021’ by clicking on its hyperlink under "New Event Forms" section.
- Complete all fields.
- Save.
- Submit.
If you have problems/questions as you complete your renewal event form, please email chair.greb@queensu.ca or hsreb@queensu.ca
If you are having problems accessing the application in TRAQ, please submit a Helpdesk webform request.
Qualtrics
- Apply Smith Support for an account.)
- Log in Smith Support if your account is with the Smith School of Business.)
- Contact Qualtrics Support directly for all specific survey-related questions. (Choose sign-in via SSO; the company org ID is "queensu", lower case.)
- For general Qualtrics survey platform questions and how-tos, see Qualtrics Topics From A to Z .
- For on-demand video training, see Qualtrics CoreXM Basecamp .
- For Qualtrics account questions, contact us at oirp@queensu.ca.
Common Research related Qualtrics questions:
Guidance for Qualtrics - Conducting Anonymous Surveys
Anonymous information is defined by the latest edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2 (2018)) as ‘information that has never had identifiers associated with it through which the risk of identification of individuals is low or very low.’
- If you have promised anonymity to participants, this must be respected.
- When using Qualtrics, ensure that IP addresses are not collected, by enabling “Anonymize Responses” in “Survey Options”. If this function is not selected, IP addresses will be collected.
- If you distribute the survey using the Anonymous Link function, IP addresses will also be collected if you have not selected “Anonymize Responses”.
Instructions to create an anonymous survey using Qualtrics:
- Create project title and select project folder storage options.
- Select “Survey Options” (pictured below).
- Scroll down to “Survey Termination”.
- Select “Anonymize Response. Do NOT record any personal information and remove contact association” (pictured below).
- Select “Save”.
- Design Survey.
If you have inadvertently collected IP address information in error,
please contact the Ethics Office for further guidance.
For more information, Research Ethics
Download "Guidance for Qualtrics - Conducting Anonymous Surveys" as a PDF (277 KB)
How You Distribute Your Survey ‐ Impacts on Responses and Reminders
1. Open Access Survey using Anonymous Link
Distribute With:
- Anonymous Link (right) sent via your email, pasted on website, social media.
- Use Qualtrics mailer, but choose Anonymous Link in Advanced Options.
- This type of link can be re‐used and forwarded as access is open to anyone.
Responses:
- Response file data is anonymous; it contains no identifying information.
- It does collect IP Address.
- To turn IP Address collection off, Choose Survey Options >> Anonymize Responses.
Reminders:
- Qualtrics cannot send reminders using this option.
2. Closed Access Survey using Individual Link
Distribute With:
- Use Qualtrics mailer, and default Individual Link (Advanced Option, right).
- This type of link can only be used once, and only by the recipient of the email invitation.
Responses:
- By default the respondent identifying information (email, name, etc.) is stored in the response file, and needs to be kept
- confidential and protected.
- To fully anonymize these responses, Choose Survey Options >> Anonymize Responses.
Reminders:
You can use the Qualtrics mailer to send Reminders to those who haven’t completed your survey, even if the responses are anonymized. (Thank you emails are disabled when anonymized responses option is selected.)
Download "How You Distribute Your Survey ‐ Impacts on Responses and Reminders" as a PDF (140 KB)