#	Question Text	Instructions
1A	Project Title	The Project Title should match the title shown on all study-related documents.
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 the most recent one.
1C	Is Carleton the Primary REB for the Study?	For projects in which Carleton is not the primary REB and another REB, sometimes called the Board of Record, gave study approval first, then the primary REB should have approved the study before submitting to Carleton. Accordingly, if you answered No, include the outside REB's amendment approval letter along with all associated study documents (consent and recruitment materials, study data collection instruments, debriefing forms and others). If the main protocol form from the outside instutution gives substantially the same information as the corresponding CUREB form, then you may submit the outside form instead. In these circumstances, the Carleton REB approval process is somewhat expedited and may be faster than if Carleton is doing the primary review.
2A	Lead Researcher	The Lead Researcher is the Principal Investigator for the study at Carleton, and takes ultimate responsibility for all aspects of the study. The Lead Researcher may be a student, so long as they are playing a lead role. They must, except in unusual circumstances, be a member of the Carleton research community. Please contact us at ethics@carleton.ca if you will propose an outside person as Lead Researcher. The REB will correspond, and send all notices to the Lead Researcher and the Academic Supervisor, if any. If you wish any other research team members to receive study-related messages, note this with the researcher's name in 2C.
2B	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 the primary supervisor here, and include other(s) in 2C Project Team Members. The REB must have a signed REB Supervisor Approval Form, found here: carleton.ca/researchethics/wp-content/uploads/REB-Supervisor-Approval-Form-23-06-15.docx
2C	Project Team Members	List the project team members here including co-Investigators, collaborators, research assistants, etc., and the information requested. The REB will normally correspond, and send notices to the Lead Researcher and the Academic Supervisor, if any. If you wish to have any other research team members receive study correspondence from the REB, please indicate here.
2D	Project Funding	The REB requires information on study funding in order to communicate with the Carleton Office for Research Initiatives & Services (CORIS) or IPS, or in case there is an appearance of conflict of interest. It is not unethical to receive funding from, for example, a company that benefits from the research. However, conflict of interest considerations dictate generally that participants need to be aware of the funding source, and the potential for commercial benefit.
2E	Researcher Funding (for research contracts and personal consulting only)	List who will be receiving any funds directly as personal income, how much they will receive, and indicate the percentage of the total funding awarded. The REB uses this information to inform decisions on conflict of interest. While it is not unethical to receive personal income, the possibility of conflict must be considered and disclosed to participants.
2F	Request to Release Funds	A request to release funds is sometimes submitted when a research team needs to access funding prior to any involvement of human participants. If a researcher has been cleared for a release of funds by CUREB, please check the 'Yes' box and provide the 6 digit release of funds protocol number. This number can be found on CuResearch or within the clearance certificate for the release of funds file.
2G	Conflict of Interest	Conflicts of interest occur where any researcher has conflicted motivations between their obligation to conduct the study properly and any other personal or family interests. Some examples of conflicts of interest include where the researcher benefits financially from the success of the research, benefits personally by achieving participant recruitment targets, or where the researcher has an ownership stake in a company who may benefit from the success of the research. Such relationships are not by themselves unethical; however, they must be disclosed and managed to ensure that personal or financial factors do not affect the researcher's conduct of the study. In many cases, it may be sufficient to inform participants, in the consent materials, of any researcher's personal or financial conflicts in the research, but other conflict management strategies may be needed. Contact the REB at ethics@carleton.ca at any early stage to discuss any conflicts you have or may have, and the need for disclosure or other conflict management steps.
3A	Study Objectives	Briefly summarize the specific goals of the project. Two to three sentences is usually sufficient to describe the study objective. The REB uses this information to ensure that the study methods and procedures are reasonable in light of its goals. Do not cut and paste a lengthy passage from another document, such as a grant application or other, anywhere in this Form and do not include references or citations.
3B	Overview of Participant Interactions	Give a brief overview of the interactions with participants from the initial contact to the end of their study participation. The purpose of this item is to give reviewers an overall sense of study activities, for context when reading the more detailed information provided later in the Form.
3C	Minimal Risk Review	Definition of Minimal Risk: The TCPS2 defines minimal risk as "the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research." The answer should address how much additional risk the protocol brings into the participant's daily life. CUREB will decide whether an application is reviewed at full board (for greater than minimal risk studies) or by a delegated process (for minimal risk studies).
3D	Dates of Recruitment/Participant Interaction	The exact dates may not be known, but the start date should be after the submission date and give a reasonable time for the study to be reviewed and cleared by the REB, and the recruitment to start. The end date should be a realistic estimate of when all aspects of participant interactions will be completed.
3E	Additional Reviews	The REB uses this information to consider the scientific or scholarly background of a protocol and to give reassurance that the study is worthwhile and its methods are reasonable. For example, it may help determine whether the potential benefits of the proposed study outweigh the associated risks.
4A	Description of Participants	Indicate pertinent details about the population from which you plan to recruit, such as age group, gender, language, race, ethnicity, medical conditions or other relevant characteristics. If applicable, describe any exclusion criteria, that is, characteristics that would make prospective participants ineligible for the study. If recruiting different samples with different characteristics, or a separate sample of control participants, describe these groups as well.
4B	Number of Participants (Sample size)	If a precise number is not available, an estimate must be provided. Your sample must be sufficient to yield meaningful results, but not significantly greater than needed, including a provision for predicted withdrawals. For studies in which the participant numbers were calculated using statistical methods (e.g. power analysis), briefly explain the rationale. If your planned sample changes significantly during your research, you must submit a Change to Protocol Form to describe and justify the change proposed.
4C	Benefits to Participants	Such potential personal benefits may be to the participants' health or well-being, or to better inform participants about an issue of interest to them, but do not include any compensation to be paid or given for study participation.
4D	Vulnerable Population	Vulnerable groups are those who have a reduced ability to give free and informed consent because of their condition or circumstances. Examples of vulnerable groups are children, persons with dementia or other disordered thinking, prisoners or other persons in an inherently coercive environment, and possibly marginalized groups in society. A group may not normally be vulnerable, but are so in the context of the study and its requirements. For example, students are not normally a vulnerable group, but would become so if they perceive that participation in the research would or might affect their grades. Participants may also be vulnerable because of some condition or circumstance that may make them more likely to suffer more serious physical, emotional, social, privacy or legal harm from study procedures or questions. Tri-Council policy: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter4-chapitre4/#ch4_en_a4.7
4E	Participant Relationship to Researcher	Note the circumstances if any researcher has a pre-existing relationship with any prospective participants being recruited. Researchers should guard against recruiting individuals who may feel obliged to take part, or who might feel unduly influenced to agree.
4F	Researcher Training with Participant Group	Researchers may require specific training because of the circumstances of the study or particular needs of participants. For student projects, the supervisor must be satisfied that the student(s) have been adequately prepared to carry out the particular study with these participants, in light of any special needs or vulnerabilities among participants. Any special training or experience needed must be described here.
5A	Research involving Indigenous People and Communities	Based on guidance from the TCPS-2, Chapter 9 "Research Involving the First Nations, Inuit, and Métis Peoples of Canada," these are criteria that would indicate research involving Indigenous peoples and communities and that the provisions of Chapter 9 apply to the study. If any of these boxes are checked, then you must answer the rest of the items in this section 5. With respect to the third item, Indigenous identity must be a key factor in data analysis, not just one of a number of racial or ethnic identities. Accordingly, this item does not need to be checked only because one of the categories in a demographic list of ethnic or racial backgrounds is indigenous, or the plan is to compare responses across different ethnic/racial groups, including indigenous identity.
5B	Consultation	Engagement and consultation with affected Indigenous Peoples must form the core of study planning and must be substantially concluded prior to your ethics submission. Such consultation must determine whether the study is a priority area of research for the affected persons, and how it can be carried out in harmony with the needs, wishes and traditional practices of the affected Indigenous group(s).
5C	Approvals and Agreements	Describe here any letters, memoranda or other agreement entered into with the affected group, and submit a copy of any documents confirming the group's support and consent to the project as jointly conceived and planned. Tri-Council policy: www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter4-chapitre4/#ch4_en_a4.7
5D	Benefits to Participant Community	Because of a history of exploitive research conducted using Indigenous Peoples, study plans must provide fair benefits to the affected group, as agreed by that group. Benefits may include answering research questions important to the Indigenous group, providing technical or other expertise to group members, or other such benefits.
5E	Participant involvement in research findings	Research Involving Indigenous People and Communities must be a cooperative endeavour, with meaningful participation by representatives of the group in the data collection, analysis, and study findings and dissemination.
5F	Data Ownership, Control, Access and Possession	CUREB endorses the OCAP Principles of ownership, control, access and possession of the data collection processes, collected data and how study information is to be used. The use and handling of the study product must be negotiated in advance to ensure there are no misunderstandings about data and findings resulting from the research in accordance with OCAP Principles. For information about OCAP and OCAP training, see fnigc.ca/ocap-training/
6A	Recruitment Methods	In general, we discourage "cold" or uninvited calls or emails to prospective participants, except where contact information is publicly available online, such as on a institutional or organizational website, when recruiting people because of their particular expertise or relating to their position in that institution or organization. With snowball recruiting, researchers should generally ask existing participants to give study contact information to others, but not give others' information to the researcher without explicit consent. Researchers planning to recruit participants online must specify what platform they will use; where the link to the study will be placed online (e.g., forums, Facebook); and provide a copy of the recruitment notice.
6B	Recruitment Location	Identify where you will recruit participants for the study. Be aware that some recruitment sites have their own ethics review process. Examples are schools, hospitals, correctional facilities. It is the researcher's responsibility to find out about, and satisfy, any such requirements.
6C	Third Parties in Recruitment	"Third parties" refers to people or organizations other than the research team who will be assisting with recruitment, and may be the recruitment locations referred to in 6B . Examples are community or advocacy groups, clinics or other institutions with relevant mailing lists or where staff may identify potential participants for the researcher. In general, third parties should not be asked to give contact or other information about their members to researchers. Rather, the researchers should prepare a study invitation message for members, and have the organization, if willing, send it out to members without disclosing identities or contact information to the research team.
6D	Recruitment Risks to Participants	Describe any risks to participants during the recruitment phase. Could any prospective participant suffer harm by communicating with the researcher or being identified as a member of the sample target group?
6E	Recruitment Risks to Researchers	Describe any risks to any member of the research team during the recruitment phase. (e.g., unstable politics/violence in the recruitment region, participants with history of violent behaviour.) CUREB recommends researchers discuss such situations with Carleton's risk manager with respect to and risk mitigation strategies, insurance, and other safeguards, particularly when travelling to other countries. Email to: risk@carleton.ca
6F	Compensation	The REB has no formal policy on the sufficiency or limits on compensation. Compensation should be reasonable, but not excessive. Overcompensation may endanger the voluntariness of participant consent, and cause prospective participants to disregard otherwise significant risks. In general, participants should be compensated equally for the same tasks, but a draw or lottery scheme is acceptable so long as each participant has the same or very similar likelihood of winning. The TCPS provides advice on the use of incentives in research in Article 3.1. ethics.gc.ca/eng/tcps2-eptc2_2022_chapter3-chapitre3.html#a
6G	Personal Data (subject to FIPPA)	Researchers may seek to use personal information from University records to analyze the information itself or, more commonly, to aid with recruiting a suitable sample of individuals for the study. In general, these FIPPA requirements apply only to records held by the University, but not records of University affiliated clubs or other groups. If unclear whether a FIPPA Agreement is legally required, or for more information, contact the Carleton University Privacy Office at: University_Privacy_Office@carleton.ca.
7A	Obtaining Informed Consent	Include all consent and assent materials: e.g., written consent form, oral consent script or survey consent text. If you are recruiting participants who will do different tasks, consider using separate consent forms to avoid confusion. Written consent is the norm; however, alternative forms of consent, including oral consent is acceptable if reasonable in the circumstances. If recruitment, consent, or study interactions are to take place in a language other than English, then copies of any participant-facing documents or materials (including recruitment, consent, surveys and other data collection instruments, debriefing, etc.) must be submitted. If materials are to be professionally translated, then submit the translation certificate(s). If materials are to be translated by a member of the research team, confirm that the translator is fluent in that language and that the translation reflect accurately the content of the English-language materials. There is no fixed age for a participant to consent for themself. A person may give consent if they are capable, that is, they are able to understand the relevant information about study participation including its risks, and appreciate the reasonably foreseeable consequences of giving or withholding consent. Persons 16 years or older are generally assumed to be capable, but this is still an individual judgement. If a person is not capable then, in some cases, the REB may approve the use of a substitute decision-maker, usually a parent, guardian or other close family member. If consent will be accepted from a parent, guardian or other legal representative, describe this process, and whether assent will also be obtained from the participant. Assent is a process of explaining the study to an incapable person and giving an opportunity for them to refuse to participate, even if a parent or guardian has consented. Contact the REB at ethics@carleton.ca if you are at unsure about any questions surrounding consent.
7B	Deception	Deception occurs when researchers intentionally provide false information or intentionally omits key information for a legitimate study purpose. It may be used when full knowledge about the study purpose would skew participants' responses rendering findings unreliable. Deception in research is acceptable only when 1) no other non-deceptive method is available to study the phenomenon of interest; 2) the study makes significant contributions to scientific knowledge; 3) the deception is not expected to cause significant harm or severe emotional distress to research participants; and 4) the deception is explained to participants as soon as the study protocol permits. If proposing to use deception, prepare and submit a debriefing form to be given to participants after the interaction. This form should explain the deception and the reason why it was necessary to the validity of the study. Researchers should also provide a secondary consent form, where the participant may agree, or not agree, that their data may be used, in light of the deception.
7C	Debriefing	Although debriefing will differ across projects, the goal should be to educate participants who may be curious about the purpose and background of the study, to address any potential harm caused as a result of the study (e.g., by deception or embarrassment), and to provide resources for future reference. Debriefing is not always required. However, written debriefing is the norm when used in research, and shows respect for participants' contribution to the study. Debriefing after deception is described in the instructions to 7B above. Debriefing also gives an opportunity to provide contact information for resources in case of any emotional harm caused by participating. Sample debriefing materials are available on research ethics website:  carleton.ca/researchethics/wp-content/uploads/Debriefing-Template-2024-02-20.docx
7D	Withdrawal Procedures	Generally, participants can withdraw at any time with no consequences, unless it is immediately unsafe to do so. Under the principles of on-going consent, researchers should give participants at least a reasonable amount of time after their study participation to reconsider their decision to take part, and have their data withdrawn from analysis or publication. An exception may be made if the data collection is completely anonymous and so there is no possible way for the researcher to know what data was supplied by whom. Accordingly, please determine some length of time after the interview within which the participant may withdraw their data, usually a month is sufficient, and include withdrawal deadline here and in the Consent Form.
8A	Data Collection Methods	Describe data collection methodologies you propose to use. QUESTIONNAIRES: If using a standardized questionnaire: Provide details on validity, etc. Has permission been obtained to use the questionnaire or survey instrument? INTERVIEWS: Provide a copy of the interview question guide. Questions must be provided even for semi-structured interviews. Use this section to describe the interviews. FOCUS GROUPS: Provide a copy of the focus group questions and briefly describe the conduct of the focus group. Other testing or data collection: Provide a description and a copy, if any, of all methodologies to be used and any associated device or equipment.
8B	Location of Participant Interactions	Specify where the research will take place. (Include building room or lab number if known/applicable.) If the location has special requirements or permissions for entry or use, indicate here. Provide a copy of all necessary documentation and approvals.
8C	Frequency and Duration of Participant Interactions	If you interact only once with participants, estimate how long it will take, including the consent process. If multiple interactions occur over time, explain how many and how long each interaction is planned to take, and how long participation will last overall.
8D	Photography or Recordings	Describe any plans for audio or video recording, or for taking photographs of participants here, in any study invitation materials, and in the Consent Form. In the case of video or photographs, justify why participant images are needed for the study. Participants must give specific and separate consent to audio, video, or photography, usually in the signature area of the Consent Form, or use our Photo-Video Form template found on our website. carleton.ca/researchethics/wp-content/uploads/2024-01-17-Photo-Video-Release-Form-Template-GD-revision-Jan-2024-1.docx If participants will be ineligible for the study unless they agree to any such recording or photography, this must be disclosed here, in study invitation materials, and the consent form. Also, clarify ownership of the images or recordings, once taken. If any images will appear in reports, articles or presentations of the study, please describe and justify, and say if the participants will be identifiable from such images.
8E	Translation or Transcription	Describe what steps will be taken to ensure the privacy and confidentiality of the participants in the translation and transcription processes. Provide a copy of the confidentiality agreement to be used, a template can be found on our website: carleton.ca/researchethics/wp-content/uploads/Confidentiality-Form-Study-Personnel-2021-05-20-1.docx Note: Include information on the destruction of any audio recordings or transcripts related to the transcription or translation process. If you are not destroying these materials, explain why. If you will be using AI for translation or transcription, ensure participants are aware of the use of AI, whether there are any associated risks (e.g., privacy), and whether the AI provider will use data for any other purposes (e.g., training its models).
8F	Online Data Collection	When researchers select an online survey tool or service, it is important for them to know and describe in their proposal the geographical location of the servers that host the survey and store participants’ data. The location of their server is often listed on the survey program main page. If not, researchers should contact the platform administrator directly for this information. What survey company platform will be used? Is the host survey company Canadian-owned with servers based in Canada? If not, in what country will the host data be stored? Data anonymity and confidentiality may be threatened by governments' and companies' ability to access study data. When data are stored outside of Canada, the researcher has less control over data protection. For example, data stored on servers based in the US may be subject to security legislation, that permits law enforcement officials to access the personal records of any person without that person’s knowledge. Given this, if the risk to the participants of such a data breach are significant, researchers should explain the data storage in the informed consent. For example, this requirement would differ depending on whether the survey is anonymous and/or the survey topic sensitive or not. If survey software is hosted at Carleton, provide details on the software and hosting setup/configuration. If the survey company collects IP addresses, will that feature be disabled? Please note: Some companies do not delete data from their servers even after it is transferred to the researchers. It is obviously preferable that data be deleted from company servers once transferred to researchers. If the survey is not anonymous or is above minimal risk: Describe the process for transferring the data from the host server to you and verification that the host server is no longer in possession of the data. CUREB recommends the following disclaimer language: "Your data will be stored and protected by [ORGANIZATION] in [SERVER LOCATION], but may be disclosed via a court order or data breach."
8G	Biological Samples or Fluids	The TCPS2 outlines researcher obligations when acquiring biological specimens for use in research in Section B of Chapter 12. ethics.gc.ca/eng/tcps2-eptc2_2022_chapter12-chapitre12.html#b Researchers using specimens or fluids should ensure that biohazards clearance is in place in needed.
8H	Physical, Biological, or Physiological Interventions	Bio-instruments include wristbands and other worn sensors. The category would also include in-home sensors. Other examples include novel medical instruments, intense exercise, and stress-provoking scenarios. Testing experimental drugs or medical devices may require Health Canada filing or clearance. The regulations governing research involving medical devices are complex, and if you are unsure, you would be advised to seek knowledgeable advice before proceeding.
8I	Risk of Psychological Harm	Research studies can put participants in situations that may make them feel uncomfortable in order to learn about their reaction to a situation. The result can be psychological harm that can manifest in worry (warranted or unwarranted), feeling upset or depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence, or may trigger distressing memories or responses. If the magnitude of psychological harm is judged to be mild, moderate, or extreme in magnitude: 1. Describe the type and source of psychological risks in the context of the study. 2. Indicate how likely the psychological risks are to occur. 3. Describe how the psychological risks will be mitigated, and provide suitable resources available to any participant who suffers psychological harm. Magnitude: This item addresses two dimensions:  First, the extent to which participants may feel uncomfortable, demeaned, embarrassed, anxious or upset and second, the degree of personal intrusiveness associated with the research. Researchers must consider the potential for psychological harm during any stage of the research (e.g., recruitment, informed consent, screening, data collection, debriefing, follow-ups, publication). Researchers should also consider psychological harm to the research team. - none or not applicable: (research is not sensitive nor personally intrusive in any way. For example, participants are presented with a row of numbers and are asked to indicate which numbers are even or odd, or participants are required to rate the effectiveness of a new ergonomically designed keyboard). - Mild: Research is mildly sensitive or personal. For example, the participants are asked to report their attitudes (e.g., how much they support or agree with a series of statements) about a sensitive topic (e.g., religion, politics, the sex trade, pro life/choice, crime. - Moderate: Research is moderately sensitive or personal in nature. For example, the participants are asked to self-report personal information about themselves (e.g., existence of physical or mental  health diagnoses, abuse history) or self-report sensitive behaviours that they themselves have engaged in such as abusing alcohol/drugs, cheating, criminal conduct, criminal activity). - High: Research is extremely sensitive or personal in nature or is quite likely to induce upsetting emotions. Some examples include using visual/audio recording of sexually explicit images or messages of assault, visual images intentionally designed to invoke disgust, the intentional manipulation of attitudes/emotions in short term (e.g., Trier Stress Test), or the long term (clinical intervention to change attitudes or behaviours, interviewing terminally ill individuals about their views about doctor-assisted suicide).
8J	Risk of Physical Harm	1. Describe the magnitude or severity of physical risks; 2. Indicate how likely the physical risks are to occur; and 3. Describe how the physical risks will be mitigated. Identify the degree of physical invasiveness and the degree of physical harm associated with medical procedures, the administration of a physically painful stimulus, or the ingestion of a substance. Researchers must consider the potential for physical harm during any stage of the research (e.g., recruitment, informed consent, screening, actual data collection, debriefing, follow-ups).  Researchers should also consider physical harm to participants from taking part or giving responses about disfavoured topics in an unstable or authoritarian region.
8K	Risk of Social and/or Economic Harm	This item considers the magnitude of social harm e.g., loss of status, reputation, stigma, or privacy) as well as economic harm (e.g., financial loss, legal risk following disclosure of duty-to-report events. Researchers must consider the potential for social or economic harm during any stage of the research, (e.g., recruitment, informed consent, screening, actual data collection, debriefing, follow-ups, publication.  1. Describe the nature, severity and likelihood of social and economic risks. 2. Indicate how likely the social and economic risks are to occur. 3. Describe how the social and economic risks will be mitigated.
8L	Incidental Findings	Incidental findings are unanticipated discoveries that affect the welfare of participants or others, but are unrelated to the study objectives. If there is a possibility of discovering information about abuse of a child, or imminent harm to a participant or third party, Canadian law (and sometimes professional practice) imposes a "duty to report". CUREB recommends the following language in the consent form: "All data will be kept confidential, unless release is required by law (e.g. child abuse, harm to self or others)". Your approach to managing any findings should also be described in the informed consent. Other examples include becoming aware of possible health risks (via DNA or device testing) to the participants. If there is a likelihood that information on a participant may be requested by subpoena or other court order, consider how will you handle this. Participants must be made aware of your approach in the informed consent. The TCPS2 provides guidance on cases in which when the researcher's ethical duty of confidentiality must give way to their ethical duty to disclose information:  ethics.gc.ca/eng/tcps2-eptc2_2022_chapter5-chapitre5.html#b
9A	Identifiability of Collected Data	The TCPS 2 defines identifiability of information as follows: ⦁ Directly identifying information – the information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number). ⦁ Indirectly identifying information – the information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic). ⦁ Coded information – direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a list that links the participants' code names with their actual names so data can be re-linked if necessary). ⦁ Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low. ⦁ Anonymous information – the information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low. Directly or indirectly identifying information should be marked “identifiable.” Note that we use the terms “anonymized” and “de-identified” interchangeably. Finally, note that the category “anonymous” has a specialized meaning as information that never had identifiers associated with it. The identification of anonymized or de-identified information was once known by someone, but the identifiers have been irrevocably stripped. Truly anonymous information, as defined by the TCPS-2, is rare in most studies.
9B	Identifiability of Stored Data	In general, study data should be de-identified (anonymized) to the extent possible, and as soon as possible, consistent with the needs of the study. De-identification may be delayed, for example, during the period of time that participants are permitted to withdraw their data, or for some other valid study related reason. A list of participants may be retained, for example, to permit them to be compensated or, with their explicit consent, to be re-contacted for future research, although these purposes generally do not need that any data or responses be associated with individual participants, so the code key may be deleted. Please clearly explain the reason for delaying the destruction of identifiers or maintenance of a code. Sometimes, often with qualitative data, participants wish to have their responses or views quoted in dissemination materials, such as publications or presentations. This is acceptable, but the researcher must have the clear and explicit consent of such participants to use identifiable quotations or other content, usually as a specific checkbox in the signature section of the consent form.
9C	Identifiability of Published Data	Usually, data is published without attributing individual data points to specific identifiable persons, or data is aggregated and not identiable. Sometimes however, often with qualitative data, participants wish to have their responses or views quoted in dissemination materials, such as publications or presentations. This is acceptable, but the researcher must have the clear and explicit consent of such participants to use identifiable quotations or other content, usually as a specific checkbox in the signature section of the consent form.
9D	Data Storage	All electronic data should be stored in password protected files. Greater security, such as higher levels of encryption may be needed for more sensitive data, that is, data that may cause greater harm to participants or others if released. Physical documents should be stored in locked cabinets, in rooms that are kept locked when not in use. If some other safeguarding measures are proposed, they should be described and justified.
9E	Data Disposition	Will data be retained or destroyed once the project is finished? Please describe if and when data will be destroyed, if that is the plan. However, it is acceptable, and even encouraged, to retain reliably de-identified data for future use by the research team and, under appropriate conditions, to be shared with other researchers seeking to replicate, check, or build upon your work. Indeed, journals increasingly require that published data be retained and made available for these purposes. If this is your plan, please describe how data will be de-identified, stored, protected from unauthorized disclosure, and made available to others. If identifiers need to be maintained, please describe safeguards and disclose this plan in the consent form.
9F	Sharing Study Results and Findings	At this time we do not require that researchers offer to communicate findings to participants. However, doing so shows respect and gratitude for the contribution that participants have made to the study. Participants may understandably feel a connection to the study and be interested in the study questions you have addressed and curious about your findings.
9G	Risk of Data Breach	The privacy of participants may be compromised by a breach or other unauthorized disclosure of personal information or other data. The level of risk to the participant will vary based on the level of psychological, physical, social, or economic harm that may result from such disclosure. Concerns include, what if the server on which the data was stored became compromised? What if the data becomes searchable on the Internet or elsewhere? The likelihood of data breach is the researcher's best guess as to the probability of unauthorized disclosure and the harms that may result.
10A	Supervisor Approval	Every student research project must have a faculty supervisor signs and submits the Supervisor Approval Form. Such approval indicates that the supervisor has read the entire submission and associated documentation, and is satisfied that the project is appropriately prepared and meets applicable disciplinary and ethical standards.
10B	Additional Approvals Required	While REB clearance is required for research projects that involve human participants, other approvals are very often also needed before your study can start. The checklist on the left gives some common approvals that may be needed, but the particular circumstances of your study may give rise to other requirements.
10C	TCPS-2 Tutorial	CUREB requires researchers to complete the TCPS tutorial (tcps2core.ca/welcome) unless appropriate justification and agreement of the REB. As examples, the TCPS Certificate requirement may be waived when a collaborator in another country has completed a similar tutorial accepted there, or where the researcher's involvement in the study is peripheral and does not involve interactions with participants or prospective participants. If you believe that a waiver is justified, explain and justify in the text box.
11A	Declaration #1	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 an Amendment to the study is needed, you must submit a Change to Protocol, and not initiate any such change until the Change has been cleared by the REB, except if a change is intiated to avert an urgent and serious harm and you submit the Change Form as soon as reasonably possible thereafter.
11B	Declaration #2	Check the box to confirm your agreement.
11C	Declaration #3	Check the box to confirm your agreement.
11D	Declaration #4	As a part of its obligations of on-going review, if problems arise in the study that may affect participants, the REB must be informed and may require study changes as a result. Required changes will depend on the circumstances, but may include revisions to the study methods or consent form procedures or risks, re-consenting some or all existing participants or, in extreme cases, suspending or terminating the study.
12A	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.