Researchers at Waterloo are a busy and productive bunch!
Over the last two years the Office of Research of Ethics (ORE) has seen an increase in the volume and complexity of applications we have received.
In addition to conducting reviews of ethics applications and helping you manage problems you encounter in executing your research, ORE staff have also been working on your behalf to develop other resources and processes which will make all of our lives easier in the future including:
- implementing a new ethics system,
- securing external accreditations for our ethics committees,
- negotiating collaborative ethics review agreements,
- developing webinars,
- making required changes to our guidelines and policies,
- developing new guidelines in areas which are typically problematic for researchers,
- offering customized training sessions,
- supporting researchers in meeting their research integrity obligations.
These new initiatives are not only necessary but they will also improve our shared process efficiency and effectiveness in the future.
Please consider the current application response timelines to ensure you can meet your own research objectives:
- Initial application review: Expect the review feedback to be sent to you within 4 to 6 weeks after your application has been assigned a number.
- Revisions: Expect the review of your revisions to take 10 to 15 business days after being received by the office.
- Modifications: Expect the review of amendments to take 10 to 15 business days after being received by the office.
- Course projects and teaching and learning projects:
- Deadlines for submitting an application for review
- April 5 for a project to begin in the Spring term
- August 5 for a project to begin in the Fall term
- December 5 for a project to begin in the Winter term
- Deadlines for submitting an application for review
These times may increase during peak periods such as in March, June, and November.
This duration may also vary if the application requires review:
- if the application requires review by one of the Research Ethics Committee, RECs, or
- if the application is incomplete when received.
The University of Waterloo Research Ethics Committees (RECs) have authorized delegated review of research that poses no greater than minimal risk to participants. Research that poses minimal risk to the participant typically undergoes delegated ethics review through the Office of Research Ethics or through an approved departmental delegated review committee, such as the Delegated Ethics Review Committee (Psychology). Research that poses greater than minimal risk will be reviewed by the Human Research Ethics Committee (HREC) or the Clinical Research Ethics Committee (CREC) depending on the procedures.
If your project is a quality assurance or improvement activity please refer to the Waterloo guidelines on quality assurance or improvement projects.
Refer to the Research Ethics Committees (RECs) meeting and submission dates.
Do I need to submit an ethics application if the data has been collected by someone else and de-identified?
Yes, an application needs to be completed (Form 101) for secondary use of information. Secondary use refers to the use in research of information originally collected for a purpose other than the current research purpose.
Not all questions in the Form 101 are applicable for this type of research, however, the application should detail the purpose of the study, how the data will be obtained, what permissions are needed, and the research team's procedures for confidentiality, security, and retention of the data.
As outlined in the Tri-Council Policy Statement, Chapter 5, Section D, Consent and Secondary Use of Identifiable Information for Research Purposes researchers who have not obtained consent from participants for secondary use of identifiable information shall only use such information for these purposes if:
- identifiable information is essential to the research;
- the use of identifiable information without the participants’ consent is unlikely to adversely affect the welfare of individuals to whom the information relates;
- the researchers will take appropriate measures to protect the privacy of individuals, and to safeguard the identifiable information;
- the researchers will comply with any known preferences previously expressed by individuals about any use of their information;
- it is impossible or impracticable to seek consent from individuals to whom the information relates; and
- the researchers have obtained any other necessary permission for secondary use of information for research purposes.
Researchers do not need to seek consent from individuals for the secondary use of non-identifiable information.
Yes, a Form 101T should be completed if a research project involves the use of human tissue or bodily fluids and there is no involvement of human participants. If the project involves human participants and the collection of human tissue or bodily fluids from the participants then only Form 101 is to be completed.
There are a number of considerations involving the categorization of a device as a medical device including: the class of the medical device, the need for an investigational testing authorization, the need for a Health Canada license, the need to report adverse events to Health Canada, the need for establishments producing the device to be ISO compliant, and the need to maintain records of your study trials. Refer toL
- the Canadian Agency for Drugs and Technologies in Health which has information on medical device regulations in Canada, and
- the UWaterloo guidelines on medical device research.
I am interested in conducting research in schools but not with schools in Waterloo Region. What do I need to do?
Researchers who wish to conduct projects in other school board jurisdictions are responsible for ascertaining whether the specific board has board-level or other approval requirements and, if so, to make their own arrangements for access to these Boards. The requirement for prior ethics clearance applies.
I need access to my grant funds and I will not be able to submit a complete ethics application for at least 6 months. What do I do?
Contact Leslie Copp, Associate Director, Funding Agencies and Not for Profit Sponsors, for more information on approval for an for early release of funds.
I am looking for information on the evolution of research ethics and historical examples of the protections. Where can I find this information?
Please refer to our summary of the evolution of protections for humans in research.
I am looking for a guest to speak with my class on research ethics. Is there someone who can give a presentation?
The staff members in the Office of Research Ethics are available to speak with students and give presentations. Please contact the appropriate person to discuss a guest lecture.
I am wanting to collect some data from Waterloo students and faculty for program improvement purposes. Does this require research ethics review?
Please refer to the Waterloo guidelines on quality assurance or improvement projects.