Descriptions Archive

Research security requirements for Horizon Europe include:

• A focus on the protection of classified information and/or the potential need to classify research results.
• Security assessments that review the potential for activities, methods, technologies or knowledge to be misused for malevolent purposes and any other security concerns, including national security restrictions, not captured in other categories.

During the proposal preparation stage, researcher applicants are required to complete a security self-assessment, which is included as part of the grant application. Depending on the nature of the specific funding opportunity or any concerns identified during the review of the self-assessments, an additional security review may be required. Security checks can also be conducted during or after the life of a project.

While the TCPS presumes that Masters or Doctoral thesis projects qualify as research, there is no such presumption for undergraduate projects, such as Arts and Social Science or other Honours theses or Capstone projects and it is often uncertain whether such a project requires REB Review. 

In such cases, seeks to determine whether there appears to be a primary research intent, that is an intention to create new knowledge.  Does the project appear to have a primary intention to train or teach research methods and skills, or is there a genuine intent to generate new information, of potential significance to the relevant scientific or scholarly community?   In addition, does the project meet relevant scholarly or scientific methodological standards, such that the project “…is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.” Relevant questions would be: Is the data collection systematic?  Are the sample size and other elements of the methodology rigourous enough to potentially yield broadly useful findings?  Would the elements of the study satisfy a reasonable body of scientists or scholars in the field as to the project’s credibility and validity? 

Renewal: According to the TCPS, the REB may only get approval for a maximum of one year, and therefore all studies require annual renewal. Renewal emails are sent out starting one month prior to the anniversary date of the clearance, or most recent previous renewal. You can simply reply to this email, filling in the requested information about the previous year’s study activity.

Closure: When the research concludes, the research team should submit a CUREB Renewal/Closure Form in cuResearch to close the protocol.

The following events and happenings must be reported to the REB if they occur during your study, in accordance with the Adverse Events and Unanticipated Problems Form. Here is a brief summary of these reportable events:

• Adverse Event: Any untoward occurrence affecting a study participant with a reasonable likelihood of being causally related to a study activity or intervention. For example, a data privacy breach or a situation where a participant faints or suffers distress.
• Material Incidental Finding: Any unanticipated discovery made in the course of research that is outside the scope of the research but that nevertheless will or may significantly affect a participant’s welfare. For example, a finding of suspected child abuse or that a participant has suicidal ideation, or some possibly significant cardiac abnormality on an ECG.
• Protocol Deviation: Any change or alteration from the study procedures provided in the REB-cleared study protocol, consent documents, or other study materials. A Protocol Deviation may be deliberate (e.g. to avoid potential harm) or unplanned (e.g. by error or oversight, or in response to unexpected circumstances). For example, by oversight, a participant signs an out-of-date version of the consent form or there is a change of location of a research activity.
• Other Unanticipated Problem: Any unanticipated event that may increase the level of risk to participants or that may affect participants’ welfare or willingness to continue to participate in the study or that may adversely affect data integrity. An Unanticipated Problem includes also the discovery of any new information that may have any of these effects. For example, that a relevant finding discovered in the published literature affects the safety or efficacy of some aspect of study interactions.

If your study involves interactions with people who, it is reasonable to suppose, might express suicidal feelings, you must follow CUREB’s Suicidal Ideation Protocol and submit a completed Suicidal Ideation Reporting Form if required to do so under the protocol.

No substantive changes to a cleared study may be initiated until cleared by the REB, unless the change is made urgently to avert serious harm to a participant or any other person, and the change is submitted as soon thereafter as possible. 

For a fuller description of the REB’s policy on Changes to Protocol, including a description of substantive research, see the CUREB Policy on Review of Changes to Protocol.

To request approval for a study change, prepare and submit a Change to Protocol Form and upload to cuResearch. Outline the changes and include any attachments (e.g., new versions of any research documents, including the submission form, recruitment materials, consent forms, or data collection instruments required to be revised as a result of the proposed Changes.

CUREB-A or -B will review the protocol and determine whether the study is minimal risk (eligible for delegated review) or is greater than minimal risk (study must be reviewed by the full board at a monthly meeting).  Decisions are sent to the researcher via email.

The review team prepares a list of questions, comments, and requirements which is sent to the research team by email for response. 

The research team must respond with appropriate answers, explanations, and revisions, in the form of a point-by-point response letter, and copies of all documents requiring revision with changes highlighted in yellow, through cuResearch.

Once the study revisions are satisfactory, the study will be cleared by the REB and the research team will be notified. Research can begin, subject to any other requirements, only once the clearance letter has been received.

• All CUREB A and B submissions are made through cuResearch.
• For step-by-step instructions, refer to the CUREB cuResearch User Guide.
• We also have a webpage with more information about cuResearch.

The CU Commitment Form provides documentation, in a single location, of all Carleton contributions to a research project, including detailing any relevant conditions or restrictions on the contributions. This provides clarity to you, as the researcher, on the full details on how to access and maximize the benefits from these contributions when you are awarded the funds.

A duly completed CU Commitment Form also ensures that OVPRII can more efficiently pay out contributions from OVPRI to you (the principal investigator [PI]), without follow-up by yourself to each contributor, upon fund opening.

Your cash or in-kind contributions to research projects need to be documented for several reasons: 

1. Facilitate award management and reporting of Carleton’s cash and/or in-kind contributions to research projects by Research Financial Services.
2. Create a written record that you have approved the contribution. 
3. Provide documentation to mitigate the risks of over-committing your time, existing research funding, and/or other resources that may jeopardize the ability to fulfill obligations under the proposed project. 

PIs need to sign a Commitment Form when they are committing cash from existing research funding or research time (if eligible) in an application, institutional letter, or agreement. 

Any fund holder is required to sign the Commitment Form to ensure sufficient documentation of their cash contributions to the project. Similarly, Commitment Forms are used to ensure that in-kind contributions are approved by those with the authority to make those contributions. This applies to the PI, where you are committing their own research funds and research time (if eligible) to a project. 

When required, the form should be prepared by an OVPRII staff member, the Dean’s office, or the PI with the support of a research facilitator (as applicable) and circulated to all relevant signatories, in advance of the submission of an application to the funder, or the institutional signature on a letter of support or a research agreement.

As a PI, you may be asked to sign a Commitment Form in cases where you are making contributions from your own research funding or research time (if eligible) to a project.

A Commitment Form is required when:

• there are committed cash and/or in-kind contributions committed as part of a funding application, institutional letter of support, or research agreement; or
• there is an agreement at the time of application that part of the research funding will flow to Carleton or its administrative units for specific costs (for example, PI fees, salary recovery, course buyout, etc.).