The new ethics system Researcher Manual for Psychology.
All University of Waterloo research conducted with human participants MUST receive prior ethics clearance from the University of Waterloo Research Ethics Committee.
This page provides:
- General UW guidelines: Research conducted with humans
- General UW guidelines: Research conducted with animals
- Department of Psychology ethics application instructions
- Research conducted through Psychology Research Experiences Group (REG)
University of Waterloo’s Research Ethics Boards and its Office of Research Ethics
The University of Waterloo has two Research Ethics Boards (REBs): the Human Research Ethics Board (HREB) and the Clinical Research Ethics Board (CREB). The HREB has jurisdiction over most research involving humans conducted under the auspices of the University of Waterloo including the Department of Psychology. The CREB has jurisdiction over clinical trials research involving a drug or natural health product or involving medical device testing. The University of Waterloo’s Office of Research Ethics (ORE) works in close association with the two REBs.
The mandate of the REBs and the ORE, on behalf of the University, is to protect the rights and welfare of human participants who take part in research conducted under the auspices of the University. The ethics review process is intended to ensure that the research meets ethical principles and that it complies with all applicable regulations, guidelines and standards pertaining to human participant protection. These include but are not limited to the University of Waterloo’s Statement on Human Research; its Guidelines for Research with Human Participants (Guidelines) and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2).
For clinical trials, the REBs follow Health Canada’s Food and Drugs Act, the International Conference on Harmonization (ICH) Good Clinical Practice: Consolidated Guideline, and where applicable, U.S. federal regulations. The University of Waterloo’s REBs review research that poses greater than minimal risk to participants. Consistent with the TCPS 2 (i.e., Article 6.12), the Director and Managers, ORE, who have ex officio membership on at least one of the two REBs, are delegated with authority to review research applications that pose no greater than minimal risk to participants.
The ORE also provides centralized administration for the REBs and for the research ethics operation at the University of Waterloo. In addition, the ORE is responsible for developing guidelines and procedures for the ethics review process, ensuring consistency with evolving provincial, federal and international research ethics requirements, and responsiveness to changing societal values and evolution in the area of research ethics. Within the ORE, and consistent with its education mandate, educational programs and materials are developed and delivered to UW students, staff and faculty involved in research with humans.
For more information you may visit the Office of Research Ethics (ORE).
Research requiring ethics review
At the University of Waterloo, and consistent with TCPS 2 (i.e., Article 2.1), the following research requires ethics review: a) research involving living human participants; and b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells from living and deceased individuals. The TCPS 2, defines research as “an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation” (TCPS 2, p. 15). At Waterloo, activities requiring ethics review include, but are not limited to, interviews, questionnaires (web-based or paper format), focus groups, oral histories, unobtrusive observations on individuals or groups where there is no expectation of privacy, physiological assessments and measurements, clinical trials, analysis of secondary data not in the public domain and not anonymous, program evaluation, quality assurance and quality improvement activities for research purposes. It includes research conducted by University faculty, undergraduate and graduate students and staff with human participants. These activities may be conducted on- or off-campus and may be funded or unfunded.
For more information you may visit the Office of Research Ethics (ORE).
Psychology’s research ethics education session
Research conducted in the Department of Psychology follows the ethical guidelines set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2 ), the University of Waterloo’s Statement on Human Research and its Guidelines for Research with Human Participants.
Associated with the TCPS 2 is an online tutorial called Course on Research Ethics (CORE). The CORE Tutorial is comprised of 8 modules, is self-paced and includes interactive exercises and multi-disciplinary examples. A certificate of completion is provided. In order to ensure that researchers have a sound understanding of the TCPS 2, all faculty, staff, graduate students in Psychology and undergraduate students that are working as Research Assistants and/or completing their Honours thesis are required to complete the CORE Tutorial as described below. This certificate, in accordance to the University of Waterloo guidelines, needs to be renewed every 5 years. Currently, the TCPS 2: CORE is not able to provide updated completion certificates for users but hope to have this feature added to the next version of the tutorial soon.
During the first week of each Fall Term, new graduate students are expected to attend a Research Ethics Orientation session at which a Manager from ORE, will provide an overview of the TCPS 2, the University of Waterloo guidelines and the research ethics application process. The Psychology’s Delegated Ethics Review Committee (DERC) Officer will also discuss department-specific research ethics application procedures and general information about the departmental participant pools available to researchers. Graduate students are encouraged to complete the CORE Tutorial prior to the ORE Research Ethics Orientation session.
Upon completion of the CORE Tutorial a copy of the certificate of completion should be downloaded and kept in a file (pdf format) to be used in the new ethics system.
Research ethics application process
All UW researchers whose studies involve human participants (i.e., adults and/or children) must apply to receive ethics clearance through a University of Waterloo Research Ethics Committee by completing the online form.
Department of Psychology’s Delegated Ethics Review Committee (DERC)
The Office of Research Ethics (ORE) receives research ethics applications from University of Waterloo researchers in all faculties and departments, and in cases where the research is identified as minimal risk the applications are reviewed by the Managers/Director in the ORE. However, in the Department of Psychology at the University of Waterloo, the HREB delegates authority for ethics review of certain categories of Psychology research to the Psychology Delegated Ethics Review Committee (DERC). DERC consists of i) Psychology faculty members, generally from different Psychology divisions, who are current members of the HREB and ii) a staff member i.e., the DERC Ethics Review Officer/Research Experiences Group (REG) Coordinator.
Psychology DERC: Application and Review Process
Step One: Complete the ORE research ethics application
- The human research ethics application form is submitted online through the new ethics system.
- Applications for ethics review from faculty, graduate students, honours theses and administration researchers and applications for undergraduate class projects require completion of the online ethics application process.
- You can complete the online application form at one time or over multiple sessions. The online application uses your WatIAm login credentials to provide security and to allow you to return to the application form to continue, edit or revise what you have written.
- The Principal Investigator must submit the application to be review. This is done as an acknowledgement of the protocol and is in place of the signature.
- For Undergrate/Honours thesis students to be recognized by the system they must log in first (and then log out). They can then be added to the protocol, initiate a protocol, or initiate an amendment. Do not add them as external researchers.
- The ORE website also provides a training guide and provides a number of sample materials such as telephone scripts, information/consent materials and feedback forms for both deception and non-deception studies. All supporting documents must be uploaded to the application before submitting for review.
- It is also useful to talk with your faculty supervisor or other students in your lab and to view examples of telephone scripts, information consent forms and/or feedback letters that have received ethics clearance. Your faculty supervisor (or PI) will need to review the application thoroughly before submitting it for review through the new ethics system.
Step Two: Submit an application for ethics review
- Student Investigator completes the application online and uploads the supporting materials in PDF format (recruitment materials, flyers, Information Letter and Consent form, Feedback Letter, SOPs) including a sample of stimuli and/or questions, measures. The ORE number is generated at this time.
- All TCPS2 information MUST be completed. A pdf copy of the TCPS2 completion certificate is highly recommended.
- if this information is not completed, or if there is an error in the completion date, the DERC Officer will 'withdraw' the application and: 1) make the necessary change; OR 2) send an email to the Researchers requesting the update/revision be made.
- Application is submitted by the Principal Investigator/Faculty Supervisor via the new ethics system.
- NO MORE PAPER COPIES
- The Psychology Research Ethics Officer (DERC Officer) reviews submitted applications for completeness and forwards on to a Reviewer.
NOTE: Researchers will not have further notification of the progress of their applications until they are provided with an email indicating revisions are required or approval.
All revisions are to be submitted through the new ethics system. Please make uploaded revised materials identifiable with clear headings.
Example: 2018-09-04 - Revised Information letter
Upon receipt of the application
Upon receipt of the application, the DERC Officer:
- reviews for completeness
- assigns a Reviewer to protocol
Researchers must not begin data collection until they have received full ethics clearance from the ORE. Full clearance typically can take 3-4 weeks but may be longer depending on the complexity of the research project and volume of applications under review at the time.
- Ethics Clearance is valid for 12 months from ethics clearance date. Applications may remain active for as long as the study is in progress as long as you submit your annual continuing review reports (formerly Form 105) in a timely fashion through the new ethics system, and in the absence of factors which may alter the risk level (e.g., significant adverse events and major cumulative modifications and protocol deviations).
- An amendment (formerly Form 104 Modification) is to be submitted through the new ethics system for changes to the research design, methodology, participants or investigators.
- An Adverse Event (formerly Form 106) Reporting Form must be submitted as needed
Submitting an amendment (formerly Form 104) or Annual Progress Report (formerly Form 105) for ethics review
An amendment (formerly Form 104s) are submitted via the new ethics system. These amendments are done to the original application submitted in the system. It will create a new 'version'. If the change requires the supporting documents to be updated (eg. change in duration and remuneration) please upload the new documents, ensuring that the document title indicates that it is a new document (see labelling example in 'Returning Revisions' section).
Annual Progress Reports (formerly Form 105s) are submitted via the new ethics system. The ethics system will begin sending notifications via email at 60 days before the renewal due date. The next notification will be at 30 days. Then a notification will be sent days prior to the renewal due date. If a renewal request or closure request have not been submitted by this point the ethics system will 'suspend' the protocol. The should stop recruiting and administering the task until this has been clarified.
University of Waterloo’s Animal Care Committee and its Office of Research Ethics
The University of Waterloo requires that all research and teaching activities involving the use of live, non-human vertebrate animals conducted on or off-campus by its faculty, post-doctoral fellows, graduate and undergraduate students and staff must undergo prior review and approval by members of the multidisciplinary Animal Care Committee (ACC). The ethics review process is intended to ensure that the experimental procedures are ethically acceptable under the Canadian Council on Animal Care Guide for the Care and Use of Experimental Animals, the Animals for Research Act of Ontario, and the University of Waterloo Guidelines for the Care and Use of Animals in Research and Teaching. The University of Waterloo endorses the importance of the ethics review and approval processes as a mechanism to facilitate and ensure the conduct of ethical and responsible research with animals.
The ORE also provides centralized administration for the ACC. In addition, the ORE is responsible for developing guidelines and procedures for the ethics review process, ensuring compliance with evolving provincial and federal animal research ethics requirements, and responsiveness to changing societal values and evolution in the area of animal research ethics.
Ethics review and approval requirements for research with animals
Application for ethics review of animal research is made through the Office of Research Ethics (ORE) using the new ethics system.
Requirements for researchers’ education and training
Consistent with the ACC’s education mandate, educational programs and materials for animal research are developed jointly by the ACC and the ORE. Each person listed on the animal utilization project proposal (AUPP) must complete at a minimum, the seven introductory modules of the online training program before initiation of the project. Depending on the nature of the study, researchers may also be expected to complete the three advanced level modules. In addition, research-specific workshops are also available.
Additional information on animal research guidelines, online application process and training courses and workshops can be found at ORE research with animals.
The Research Experiences Group (REG)
REG coordinates the recruitment and participation of students from selected introductory and upper year Psychology courses using the SONA online software system which ensures that all participants receive appropriate participation credits for their study participation. REG is overseen by the REG Management Committee which consists of a full-time staff member (the REG Coordinator), UW Departmental faculty representatives from the various divisions, and a grad student. The REG Coordinator may be contacted in person at the REG office (PAS 3006), by e-mail or by phone at (519-888-4567 x42690).
Please refer to REG researchers for important user information.
Using the SONA participant pool
To access and use the REG/SONA pool, researchers must either complete the online training module (grad students only) or attend a 1 hour REG/SONA Researcher training session (see the available dates) provided by the REG Coordinator. Training sessions are held at the beginning of the term, or by appointment if necessary. Training provides instruction on SONA usage procedures and policies for creating and managing lab and online studies as well as information about research etiquette and REG policies. Please note that access to SONA is also contingent upon completion of the CORE tutorial as described above.
Prescreen questionnaire and Mass Testing survey on SONA
Researchers often need to select participants based on demographic criteria or based on their scores on psychological measures. To accommodate this, we administer a demographics “Prescreen” questionnaire as well as a multiple measures “Mass Testing” survey. Both are created anew at the beginning of each term to accommodate only those studies that will be conducted during that term. REG participants complete the Prescreen Questionnaire as a pre-requisite to completing the Mass Testing Survey. The Prescreen Questionnaire gathers personal, relationship, language, birth country, culture/ethnicity, religion/spirituality, academic, medical and miscellaneous information. The Mass Testing Survey includes measures, standardized and others, submitted by researchers. All measures must be public domain or have obtained copyright permission for use. In addition, deletion or revision of Prescreen questions and submission of measures into Mass Testing is done at the end of each term in preparation for the next term, through online submission forms and response to email requests from the REG Coordinator.