#

Question Text

Instructions

0

Introductory Text Substantive amendments to cleared protocols need REB review, using this Change to Protocol Form, which must be submitted along with any documents revised to reflect such substantive amendment(s), with changes indicated. Most amendments made to studies are substantive, and include those that make any non-trivial changes to the study population, recruitment methods, terms of the consent, changes to study methodology, risks to participants, and changes to identifiability, confidentiality, or protection of privacy of study data. Non-Substantive amendments do not need REB review prior to initiating the change but should be summarized, with documents revised as a result attached, in the next annual renewal on the ASR filing. Examples of non-substantive changes would include changes to the sample size, minor wording changes, or changes to the timing of study activities or milestones, so long as these do not adversely affect the risk or voluntary, informed consent of participants. Any changes to study personnel need to be submitted on this Form. If you have any questions about whether a particular amendment is substantive, and therefore requires REB review prior to initiation, please contact the REB at ethics@carleton.ca.

1A

Project Title The Project Title should match the title shown on all study-related documents. If the study title is to change, include the original title in this section and the new title in s. 2A.

1B

Submission Date Please renew this submission date every time you submit a revised Form. CUREB uses this version date to identify the order of revised submissions, and to identify the most recent one.

1C

Ethics Protocol # This is the six-digit number issued by the REB for the original protocol that is to be amended with this Form.

1D

Lead Researcher Insert the name of the current PI/Lead Researcher, even if a change to the PI is requested. No change is effective until reviewed and approved by the REB, so the current PI must make this application. The new PI is identified in s. 2C.

1E

Academic Supervisor Insert the name of the current Academic Supervisor. All students and Post-docs must have an academic supervisor who is a Carleton Faculty Member. If there is more than one supervisor, identify only the primary supervisor who is currently overseeing the student's research. If a new supervisor is to be substituted, use s. 2B.

1F

Is Carleton University the primary REB? If this is a multi-site study, for which Carleton is not the primary REB, identify the institution that gave the first REB approval for the project. For projects in which Carleton is not the primary REB, and another REB gave study approval first, then the primary REB should also approve any substantive changes to the study before submitting to Carleton. Accordingly, if you answered No, attach the outside REB's amendment approval letter along with any study documents revised as a result of the amendment, with changes highlighted.

2A

Change of Project Title If the title is to be changed, then all associated documents must be submitted, showing the changed title, highlighted.

2B

Change of Supervisor Insert name, department, faculty and Carleton email of new Supervisor, along with signed Supervisor. If this is not a student-led study, check N/A.

2C

New Study Team Members Provide all requested information for all new research team members. All team members must have completed the TCPS 2 Tutorial training, and submit a certificate of completion. Exemptions from this requirement are given in very limited circumstances only for researchers with a very tenuous connection to study conduct or participant interactions. Contact the REB by email with any questions about TCPS 2 training exemption and justify in s. 5 below.

For new students, we need their student numbers, Department, and level (Undergraduate, Masters, Doctorate or Post-Doc) for each to allow us to register them in the system.

2D

Study Team Members to be Removed The name of the team member is sufficient for us to remove them from the study file. Once removed, these individuals can play no further role in the study, or interact in any way with participants.

2E

Researchers to be Included in Correspondence Our practice is to include only the Lead Researcher and Supervisor, if any, in REB correspondence relating to the study. If you wish any other team members to be included as well, indicate in this section.

3A

Changes to Study Design or Methodology Please answer Yes or No to the questions in Section 3. If you answer Yes to one or more questions, describe all these changes in Section 4A, and submit copies of all revised or new relevant documents, highlighted in yellow to indicate revised content. In this section, check Yes if you are changing the study design or methods and describe the proposed changes in 4A. Check No if not.

3B

Changes to Participant Group Check Yes if you are changing the target participant population you wish to sample and describe the proposed changes in 4A.

3C

Changes to Recruitment Check Yes if you are changing your plan for recruiting suitable participants and describe the proposed changes in 4A.

3D

Changes to Data Collection Instruments Check Yes if you are adding or changing any questionnaire, survey form, interview or focus group questions, or any other data collection instrument(s) and describe the proposed changes in 4A.

3E

Changes to Consent Form or Text, or Procedures Check Yes if you are changing any consent materials or procedures, including adding or deleting any consent documents, forms, text, or scripts and describe the proposed changes in 4A.

3F

Changes Required by External Research Ethics Committee If the ethics committee of an outside institution is the primary reviewer, and changes have been approved there first, check Yes and attach the Amendment approval letter and all revised documents, highlighted to indicate any changes.

3G

Other Changes Check Yes if you are making any other changes not described above and describe the proposed changes in 4A.

4A

Description of Changes Summarize all changes referred to in Section 3. Changes should be reflected in revisions to the CUREB Form and other study documents to ensure that they accurately describe the amended study aims, methods, and procedures.

4B

Changes Implemented Prior to Submission No substantive changes to any aspect of the study or its procedures may be implemented without REB clearance, except if such changes are needed to avert serious harm to participants or others, and a Change to Protocol form reflecting such changes is submitted as soon as reasonably possible thereafter. If any changes have been implemented without REB clearance, please explain and justify.

5

Attachments Please indicate the documents included with this Form. Make sure you submit any study documents that have to be revised to reflect the changes proposed, and highlight the changes. Check all that apply and describe any others in the field below.

6

Declarations By submitting this Form, you confirm that all of the statements under s. 6 are true. The researcher(s) must carry out the research project in accordance with the cleared protocol, which includes the use of only the approved consent, recruitment, data collection and other ancillary materials. If a further amendment to the study is needed, you must submit another Change to Protocol, and not initiate any such change until it has been cleared by the REB, except if a change is initiated to avert an urgent and serious harm and you submit the Change Form as soon as reasonably possible thereafter.

If problems arise in the study that may affect participants, the risks they face or the consent they have given, the REB must be informed and may require study changes as a result. Required changes that may be imposed by the REB will depend on the circumstances, but may include revisions to the study methods or consent form, study procedures, re-consenting some or all existing participants or, in extreme cases, suspending or terminating the study.

7

Improving the Form (Optional) We are grateful for any feedback on this Form or any of its questions, or in the explanations or instructions given. In particular, we would like to know if you found any part of this form to be unclear or ambiguous, or if you have any suggestions for improvement.