Human Ethics

• Carleton Researchers: All research involving human participants, as described in the TCPS, conducted by members of the Carleton community must be cleared by the appropriate REB. This includes research conducted at Carleton, research conducted off campus (e.g., businesses, hospitals, prisons, schools), and research approved by another academic institution. For more detailed information, including exemptions from review, see what research needs REB review and the CUREB Scope of Authority Policy.
• External Researchers Conducting Studies at Carleton: All externally approved research that is taking place on the Carleton campus or specifically targeting Carleton University staff and/or students as participants must have approval by CUREB. However, external studies from an outside institution, with no other Carleton involvement, that have REB approval at their own institution, which do not involve using students as research participants, and that do not request, from any Carleton office, access to non-public contact information, do not need review.

If you are unsure whether your project needs REB review, contact us at ethics@carleton.ca.

Different types of studies require different forms to be submitted to the REB. For information about which form is the right one for your study, see the instructions.

• Always include a completed Application Checklist prior to submitting a protocol to either REB.  This will help guide you as to what ancillary documents need to be submitted along with your Form. In general, the REB meets to review the final form of any document that is to be seen by any participant or prospective participant.
• Complete the appropriate form and required attachments, and begin a new application in cuResearch. New users should complete the online form: Create a cuResearch Account.   Go to the section Submit an Application below for information about the process of submitting a proposed study to cuResearch.
• All students, including undergrads, graduate students and Post-Docs require a Faculty supervisor, and must submit a signed Supervisor Signature Form. Email approval from a supervisor for a student’s project is not accepted. Research projects may be submitted either by the student (so long as the student is registered in the system) or the faculty supervisor. 
• For more instructions and samples of forms and document templates, visit Forms and Templates.
• If you are unsure what form and ancillary documents you need to submit for your study, contact us at ethics@carleton.ca.
  

• Lead Researchers, and all research personnel listed on the relevant submission form must complete the TCPS2 web-based tutorial of by the Tri-Council Panel on Research Ethics, and submit their certificate of completion. Certificates must be less than five years old.

• All CUREB A and B submissions are made through cuResearch.
• For step-by-step instructions, refer to the CUREB cuResearch User Guide.

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.

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.

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.

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.