Research Ethics Board: Apply for ethics review
Applicants must apply for ethics review before the start of the study. Note that the REB cannot retroactively review research involving humans. A letter of approval from the Decisional Authority of Health Canada or PHAC and a Certificate of Ethics Review must be obtained from the REB before the research begins.
Applicants are required to consult the Health Canada-PHAC Privacy Management Division (PMD) to assess whether the research project involves personal information and to assess the risk to privacy. Applicants are advised to contact PMD well before applying to the REB to allow sufficient time for the PMD to complete its assessment.
Important notice for PHAC researchers: PHAC researchers must obtain departmental approval of research involving humans before submitting their application to the REB. For further information and to obtain the necessary form, contact the Office of the Chief Science Officer: email@example.com.
On this page
- Pre-submission consultation with Privacy Management Division
- Application form
- Application form instructions
- Research protocol instructions
- Scientific peer review
- Evaluation and approval process
- Meeting and submission deadline dates
Pre-submission consultation with Privacy Management Division
Applicants must consult the Health Canada-PHAC Privacy Management Division (PMD) before submitting an application to the REB.
REB applicants and research staff are ultimately accountable for the management of personal information under their control and for ensuring that it is handled in a manner consistent with the requirements of the Privacy Act and Treasury Board policies. Examples of personal information include opinions, postal code information, age, ethnicity, educational background, employment history, health history, life experience, religion, social status, and human biological material. PMD supports applicants and research staff in meeting these obligations by providing privacy guidance and recommendations.
PMD will conduct an initial assessment of the research proposal to establish whether the project involves personal information that is under the control of Health Canada or PHAC and to determine the preliminary level of privacy risk. The level of privacy risk will dictate the depth of analysis PMD will undertake with respect to the study’s collection, use, disclosure, retention and disposal of personal information. PMD will work with the researcher to assess and propose mitigation of privacy risks.
PMD review process
The PMD review consists of two parts:
1. Preliminary privacy risk assessment
The purpose of this assessment is to enable PMD to assess the level of privacy risk associated with an REB application. The level of risk (low, medium or high) is calculated using three variables:
- The sensitivity of personal information;
- The type of information; and
- The third parties involved in the research project.
The assessment is conducted by PMD using information from the research protocol and/or in discussion with the applicant and in consultation with the PMD director to confirm the level of preliminary privacy risk. Depending on the level of risk, PMD may require that a Privacy Protocol Checklist be completed and/or make other recommendations that should be addressed in the research protocol.
2. Privacy Protocol Checklist
The purpose of the Privacy Protocol Checklist is to ensure that Health Canada/PHAC programs handling personal information for non-administrative purposes (e.g., research, audit, evaluation or statistical purposes) are meeting their Privacy Act and Treasury Board requirements.
PMD uses information from the research protocol to complete the Privacy Protocol Checklist, and consults with the applicant as needed to obtain any missing information. PMD will provide an overall privacy assessment and specific recommendations that the applicant must follow. A description of how these recommendations have been implemented must be included as part of the application package to the REB.
To reach the Privacy Management Division by email:
Individuals applying to the REB must complete the following form:
- Application for Initial Review of Research Involving Humans (PDF format, 588 KB, 16 pages)
Application form instructions
The instructions below provide detailed guidance on how to properly complete the application form for initial review of research involving humans. Incomplete applications will not be accepted for REB review; thus, applicants are strongly advised to follow these instructions carefully to ensure that their application packages are complete and accurate. For questions that are not addressed in these instructions, please contact the REB Secretariat at firstname.lastname@example.org or 613-941-5199.
Section 1: General Information
1.1 Project title
The title of the project should accurately reflect the nature of the study and should correspond to the title presented on all study materials (i.e., participant information, documents for recruitment, consent forms, etc.). The title should not exceed 200 characters, although it is recommended that the title be as brief as possible while still providing a meaningful description of the project.
1.2 Principal investigator / 1.3 Other investigators and team members
The principal investigator (PI) is the individual who provides overall leadership of the research team and assumes primary responsibility for the execution of the study, including the ethical conduct of the research. If two or more individuals are equally responsible for the project, one should be named as the PI who will be the primary point of contact for administrative issues, and the others should be listed as co-PIs.
The PI can be from HC/PHAC or external to HC/PHAC, depending on who is leading the project. When approval is being sought for HC/PHAC researchers to join an externally led project that has already begun under the authority of an external REB, the lead HC/PHAC researcher should be listed as the PI and the lead external investigator as co-PI. If it is unclear who should be named as the PI, contact the REB Secretariat for guidance.
Other investigators and team members who should be listed here are individuals who (in the PI’s judgment) make a significant contribution to the intellectual direction of the research and who play a key role in the conduct and execution of the study. Collaborators whose involvement is more limited need not be named here, but should be included in Section 5 (Third Party Involvement). A drop-down menu is provided to specify the role of each individual (i.e., co-PI, co-investigator, and community partner). If none of these options is appropriate, select “other.” If there is insufficient space to list all other investigators/team members, continue the list on an additional page and attach it to the application.
Information – place of work
- For researchers external to HC/PHAC: Provide the name of your institution (e.g., university, hospital, research centre, organization) and department, if appropriate.
- For HC/PHAC researchers: Provide the name of your branch, office or bureau (e.g., Health Products and Food Branch, National Microbiology Laboratory) and indicate whether you are with Health Canada or PHAC.
Current CVs must be submitted for the PI and all other investigators/team members listed in this section. The REB uses this information to assess whether the research team has the appropriate training and expertise to carry out the research. A relatively short CV (approx. 10 pages or fewer) describing only the most relevant contributions and experience is sufficient (e.g., following the format of the CIHR Biosketch or the NIH Biosketch). It is not necessary to provide an exhaustive record of each researcher’s professional and academic background. CVs are not required for collaborators listed in Section 5.
1.4 Health Canada/PHAC contact person
For projects where the PI is external to HC/PHAC, the contact person is typically the HC/PHAC project authority, project officer, funding officer, research coordinator, or another relevant HC/PHAC employee associated with the project. This section may also be used when the PI is from HC/PHAC, to designate another contact person in addition to the PI. If the contact person is a member of the core research team and listed in Section 1.3, please name her/him here as well. If there is no contact person to name, enter “N/A” in the ‘name’ field.
1.5 Role of Health Canada/PHAC in the project
Provide a brief description explaining HC/PHAC’s involvement in the project. If the project involves one or more HC/PHAC researchers as co-investigators/collaborators on an externally led project, it is particularly important to clearly describe the HC/PHAC component or contribution so that the REB can focus its review appropriately. Examples could include conducting sample analysis, providing access to specialized equipment or training in a specific technique, administering surveys to HC/PHAC employees, etc.
The role of funder should be selected when HC/PHAC is providing funding to an external researcher in the form of a grant or contribution, or if the research project is being conducted under contract to HC/PHAC. For HC/PHAC research supported by internal funding, the role of funder should not be selected, even if external parties will receive funding to conduct portions of the research project. Details on any contracts and funding agreements should be provided in Section 5 (Third Party Involvement).
1.6 Proposed study period
The start date refers to the intended or expected commencement of participant recruitment, or analysis in the case of secondary use. The end date is the point at which data collection and analyses have been completed in order to answer the original research question(s). If the exact start and/or end dates are not known, provide an estimate with a note that the dates are approximate.
If HC/PHAC researchers are joining an externally led project that has already begun under the authority of another REB, indicate the dates at which the HC/PHAC involvement will begin and end.
1.7 Other REB approval
Research involving multiple institutions or jurisdictions may require review by more than one REB. For projects that have already been approved by another REB, provide the date of the initial review and a copy of the most recent ethics certificate or decision letter. For projects pending review by another REB or that will be submitted in the near future, indicate the review date if known, and submit a copy of the decision letter to the REB Secretariat once available.
1.8 Additional approvals
Some research projects may require approval or authorization from other organizations and bodies. It is the applicant’s responsibility to obtain the necessary approvals and demonstrate these approvals to the REB. List the additional approvals required and their status (e.g., pending, received). Letters of support from community leaders and other partners or collaborators should also be included here.
Information – clinical trial research
Clinical trial sponsors are required to submit a clinical trial application to Health Canada for authorization to conduct a clinical trial in Canada. For more information, consult the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications.
Note that it is not necessary to list internal departmental approvals (e.g., senior management, ADM) or Privacy Management Division approval (covered in Section 4).
1.9 Funding information
The REB requires details on the funding for the research to assess the project’s feasibility and the relationship between the funder and the researcher. Be sure to provide details on each funding source (including name of funding organization, grant number, amount and duration of funding) in the text box in part (b). If funding has been applied for but not yet been secured, indicate the anticipated funding source and timeframe for obtaining funding. A study budget sheet must be included with the application detailing how the funding will be allocated for the research.
Section 2: Proposed Research
2.1 Plain language summary
Provide a brief summary of the research that uses clear, plain language and that can be easily understood by those without prior knowledge of the subject. The summary should be under 300 words and not exceed the size of the text box provided. The summary should describe the significance of the project (i.e., why the research is being conducted), the hypothesis/research question and major objectives of the project, the methods or procedures to be followed, and the expected outcomes/impact of the work.
Refer to the Public Service Commission Style Guide for tips on writing in plain language.
2.2 Key words
Provide up to five key words that relate to your research. Key words should describe the subject area and any distinctive elements of the project, including the methodology and study population (e.g., “biobank,” “artificial intelligence,” “HIV/AIDS,” “genome-wide association study,” “nutrition research,” “air pollution”).
2.3 Detailed research protocol
Researchers must attach a detailed description of the proposed research project to the application. For additional information and guidance, please refer to the research protocol instructions on the REB website. A formal protocol previously prepared for another purpose (e.g., project planning, program approval, grant proposal) may be submitted for the REB’s review so long as it is current and includes all the necessary information outlined in the research protocol instructions.
2.4 How does the research involve human participants
Research involving human participants includes research with living individuals, human remains, human biological materials, and/or information from or about humans. Research may involve studies on information or biological materials initially selected for a different purpose (secondary use). Select the category or categories that best apply to your research project.
Information – categories
Categories that may be unclear are explained in more detail below. For additional guidance concerning the other categories, please contact the REB Secretariat.
- Human cell lines: Research involving human cells that are maintained in culture, including both primary and immortalized cell lines, falls within the TCPS 2 definition of “research involving humans.” As such, it is subject to review by an REB (TCPS 2, Article 2.1).
- Physical measures: Examples include the measurement of height, weight, heart rate, blood pressure, respiration, body temperature, energy expenditure, eye movement, etc.
- Personal information: As defined in the Privacy Act, personal information is “information about an identifiable individual that is recorded in any form.” Details on the types of personal information can be found in TCPS 2, Chapter 5, Part A.
- Other: Examples include studies in which human participants are recruited but the information or data comes from other non-human sources (e.g., the participants’ pets, participants’ homes or workplaces for environmental monitoring including air, water and food sources).
2.5 Study population
Select the category or categories that best describe the research study population. The emphasis should be placed on the population specifically recruited or targeted for the study, and not on subgroups that may happen to be part of that population but were not specifically targeted. For example, if a study population includes a cross-section of the adult population in a particular region, only select “females” and “males” even though the population may happen to include other subgroups such as pregnant women, Indigenous people, specific population groups, sexual and gender minorities, etc.
Information – categories
Categories that may be unclear are explained in more detail below. For additional guidance concerning the other categories, please contact the REB Secretariat.
- Specific population (ethnic) groups: Where participants are specifically recruited based on ethnicity (e.g., White, South Asian, Chinese, Black, Filipino).
- Adults with diminished decision-making capacity: As stated in TCPS 2, “Decision-making capacity refers to the ability of prospective or actual participants to understand relevant information presented about a research project and to appreciate the potential consequences of their decision to participate or not participate.” Refer to TCPS 2, Chapter 3, Part C, for more information.
- Other: Examples may include prisoners, homeless persons, persons with specific medical conditions or disabilities, other vulnerable/marginalized groups, and official language minority communities. If working with human cell lines (see Section 2.4(a)), select this category and provide any available details on the individuals from whom the cells were derived.
2.6 Collection of samples/data/personal information
Research involving humans cannot begin without a certificate of REB review and approval from the HC/PHAC Decisional Authority. For most applications, it is expected that sample/data collection related to the proposal in question will begin only after HC-PHAC REB approval has been granted, unless the research involves secondary use of previously collected material.
For certain externally led projects, another REB may have already approved the project, and primary sample collection for the project has begun or been completed. In such cases, HC-PHAC REB approval must be obtained before the HC/PHAC researchers begin working on the project. Wherever possible, applicants in this situation are strongly encouraged to submit their application to the HC-PHAC REB as early as possible in the project lifecycle, and preferably at the same time it is submitted to the external REB, so that any recommendations from the HC-PHAC REB can be incorporated into the project’s design.
Applicants are reminded that REB approval must be obtained prior to the start of the study (or the start of HC/PHAC involvement in an externally led project). The REB cannot provide retroactive approval for research involving humans. For more information about when to apply to the HC-PHAC REB, please contact the REB Secretariat.
2.7 Study attributes
Select the category or categories that best describe the research project’s attributes. Note that these attributes will not necessarily apply to all studies. Thus, if none is relevant to the current proposal, select “none of the above”.
Information – categories
Categories that may be unclear are explained in more detail below. For additional guidance concerning the other categories, please contact the REB Secretariat.
- Creation of a biobank: A collection of human biospecimens and associated data compiled for research purposes. For more information on the storage and banking of human biological materials, refer to TCPS 2, Chapter 12.
- Clinical trial: An investigation in respect of a drug or device for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug/device, identify any adverse events in respect of the drug/device, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug/device. See TCPS 2, Chapter 11, for more information.
- Human genetic research: As stated in TCPS 2, Chapter 13, “Human genetic research involves the study of genetic factors responsible for human traits and the interaction of those factors with each other, and the environment. Research in this area includes the identification of genes that comprise: the human genome; functions of genes; the characterization of normal and disease conditions in individuals, biological relatives, families, communities and groups; and studies involving gene therapy.”
- Biomonitoring: The measurement of substances such as parent compounds, their metabolites or their reaction products in human tissues and fluids.
2.8 Independent scientific peer review
To be ethically acceptable, research involving humans must be methodologically sound and meet the scholarly standards of the relevant research discipline. The REB relies on independent scientific peer review in assessing the methodological rigour and validity of the proposed research. Reviewers should not be directly associated with the research project team and should have no real, potential or perceived conflicts of interest concerning the research. Reviewers should also be highly knowledgeable and experienced in the relevant field, and sufficiently qualified to provide an expert assessment of the scientific merit and quality of the proposed research.
Two independent scientific peer reviews must be attached to the application. Applicants must also indicate how they have addressed the reviewers’ comments in the research proposal and associated documents (e.g., consent forms). This can be done by preparing a separate document listing the reviewers’ comments along with a brief description of whether and how the research proposal was changed. Alternatively (or additionally), the changes can be indicated in the relevant documents using track changes and/or comment boxes. If the reviewers had no specific comments to address and therefore no changes were made to the proposal, check the corresponding box in Section 2.8(b).
Information – peer review
- Guidance on what constitutes a conflict of interest in peer review can be found in the Conflict of Interest and Confidentiality Policy of the Federal Research Funding Organizations and the CIHR Peer Review Manual.
- If the research has already undergone independent scientific review by a granting agency, internal board, steering committee, advisory board, thesis committee, etc., these reviews may be sufficient for the REB’s purposes. Please submit the reviews along with sufficient details of the review process for the REB to assess the quality and independence of the reviews (e.g., organization that oversaw/solicited the reviews and for what purpose, names and/or qualifications of the reviewers).
- In certain cases where the proposed research poses no more than minimal risk to the participants, the REB Secretariat may waive the requirement for peer reviews. Applicants should contact the REB Secretariat before submitting their application if they wish to seek an exemption. If an exemption is granted, or if for some reason it is not possible to provide peer reviews, explain this in the text box provided.
- For situations in which acceptable peer reviews of the proposed research have not already been obtained, the REB Secretariat has created a template for scientific peer reviews that applicants are encouraged to use when soliciting reviews to accompany their REB application.
Section 3: Recruitment and Informed Consent
If participants will be recruited for the research project and compensation or incentives will be offered, the REB needs to assess the potential impact of the compensation or incentives on voluntariness of participation (see TCPS 2, Chapter 3, for more information). Specify the nature and amount of any compensation or incentives, including whether and how the compensation/incentives will be affected if the participant withdraws before completing the study.
If the research project does not involve recruitment of human participants, select “N/A”.
3.2 Obtaining consent/assent
A copy of the documents used to obtain consent or assent from participants must be included within the application for ethics review. If consent/assent is being obtained verbally, include a copy of the verbal consent script and explain how consent/assent will be documented.
As outlined in TCPS 2, Chapter 3 Part B, it is permissible in certain specific situations to conduct research without obtaining consent of the participants. Applicants who are seeking an exception to the requirement to seek prior consent are advised to consult with the REB Secretariat before submitting their application. Provide the rationale for not obtaining consent from participants in the space provided on the application form.
Information – consent requirements
TCPS 2 provides additional information on the consent requirements for the following types of studies:
- Research that involves an alteration to the consent requirements (TCPS 2, Article 3.7A)
- Use of identifiable information for secondary use without consent (TCPS 2, Article 5.5A)
- Research that relies exclusively of secondary use of non-identifiable information without consent (TCPS 2, Article 5.5B).
In all cases, the applicant must demonstrate that the requirements set out in the relevant article have been satisfied.
If the research project does not involve recruitment of human participants, select “No” and enter “N/A” in the text box.
Section 4: Privacy and Confidentiality
4.1 Privacy Management Division (PMD) review
All applicants to the HC-PHAC REB must consult the HC-PHAC Privacy Management Division (PMD) to obtain an assessment of privacy risks. The review consists of two parts:
- Preliminary privacy risk assessment: streamlined review to assess the overall level of privacy risk (low, medium or high) and to determine the need for completing a privacy protocol checklist
- Privacy protocol checklist: only required for high risk and certain medium risk proposals
The results of the preliminary privacy risk assessment and the privacy protocol checklist (if applicable) should be included with the application. In some cases, the consultation with PMD and the review by the HC-PHAC REB may be conducted concurrently; however, the ethics certificate will generally be issued only after the PMD review has been completed and the REB Secretariat has received the results. For more information, contact the REB Secretariat.
It is not necessary for applicants external to HC/PHAC to consult with PMD, as long as no HC/PHAC employees are part of the research team and HC/PHAC will not have control of any personal information associated with the research. If this is the case, or if PMD has confirmed that a preliminary privacy risk assessment is not required for any other reason, provide details in the text box provided and attach any relevant correspondence from PMD to the application.
Information – control of personal information
In determining whether a record is under the control of a government institution, some of the factors to be considered include whether:
- it is held by the institution, whether at headquarters or at a regional, satellite or other office, either within or outside Canada, or at an off-site location such as a private storage facility or a federal records centre (records storage facility administered by Library and Archives Canada containing records that remain under the control of institutions);
- it is held elsewhere on behalf of the institution (e.g., records maintained by agents, consultants or other contracted service providers); and
- the institution is authorized to grant or deny access to the record, to govern its use and, subject to the approval of the National Archivist, to dispose of it.
If there is any uncertainty around control, contact PMD for assistance.
Section 5: Third Party Involvement
5.1 Third party implications
If there are any individuals and/or organizations not listed in Section 1 who are involved in carrying out the research project, list them here with a brief explanation of their role. The REB requires this information to assess the nature and scope of their involvement for any ethical concerns. Examples of third parties that should be listed include:
- Individuals who are collaborating with the core research team to provide a specific service (e.g., access to equipment, provision of specific reagents, training in a specialized technique, statistical analysis, access to a patient population). The terms of the collaboration are typically informal but may be defined through a collaboration agreement.
- Organizations and/or individuals who are formally engaged through a service contract or research agreement to conduct specific activities related to the research project (e.g., provide access to datasets and/or perform data analysis, develop and/or deliver participant surveys, conduct specialized laboratory services such as sample analysis or DNA sequencing, provide translation or transcription services).
If it is unclear whether an individual or organization should be listed in this section, contact the REB Secretariat for direction.
5.2 Contract/agreement Information
For research that involves third parties external to HC/PHAC, contracts and agreements are typically established to define those third party relationships. It is important for the REB to review these agreements as part of the ethics review process in order to have a full understanding of the scope of the research and to help assess issues like privacy of the human participants and protection of personal information. Examples of documents to include in this section include:
- Contracts or contribution agreements from HC/PHAC to external PIs to fund the research
- Any agreements between members of the study team and/or with third parties listed in Section 5.1, such as research or collaboration agreements; service contracts; data-sharing or material transfer agreements; and memoranda of understanding (MOUs) or memoranda of agreement (MOAs)
The REB recognizes that it can take time to finalize agreements and that in some cases parties cannot enter into agreement until HC-PHAC REB approval has been obtained for the research. Thus, if there are any agreements still in development at the time of submission, provide details in the space provided and attach draft copies of the agreements wherever possible. Depending on the nature and importance of the agreement, the REB may withhold approval until the agreement has been finalized.
If it is unclear whether a particular document should be included in this section, contact the REB Secretariat for assistance.
Section 6: Conflicts of Interest
6.1 Declaration of conflicts
Conflicts of interest (real, potential or perceived) arise when an individual in a position of trust has competing professional or personal interests. Such competing interests may influence their professional judgment, objectivity and independence and can potentially influence the outcome of a decision, for personal benefit. As noted in TCPS 2, Chapter 7, it is always preferable to avoid or prevent being in a position of conflict of interest. When it is not possible to avoid a conflict of interest, the conflict must be disclosed and procedures put in place to manage and/or mitigate the conflict. In such cases the REB will assess the information and determine the appropriate steps to manage the conflict of interest.
Information – Other applicable policies
HC/PHAC employees are subject to the Values and Ethics Code for the Public Sector and the HC-PHAC Scientific Integrity Policy, which include directives regarding the avoidance and management of conflicts. REB approval of a conflict of interest management plan does not absolve HC/PHAC researchers of their obligations under either of these policies.
Section 7: Signatures
Information – obtaining and submitting signatures
Digital signatures are accepted and encouraged. If any signatures are not obtained electronically, print Section 7 and obtain all necessary signatures in hard copy. Once Section 7 is complete, scan the signed pages and include them in the application package, along with an electronic copy of the completed application in PDF format and all other supporting documents as required.
7.1 Health Canada / PHAC departmental approval
- PHAC departmental approval must be obtained prior to submission of an REB application. Applications that do not include a completed and signed PHAC Departmental Approval of Research Involving Humans form will be rejected. The form can be obtained by contacting PHAC’s Office of the Chief Science Officer. Note that the PHAC Departmental Approval form is not required for projects led by external applicants funded through PHAC contributions. In such cases, the signed copy of the contribution agreement (as requested in Section 5.2) serves as evidence of approval.
- For HC projects, sign-off is required from the PI’s supervisor (generally director-level or above). If the PI is external to Health Canada, the manager of the HC contact person should sign. The signature should normally be obtained prior to submitting the application to the REB. If obtaining this level of approval is not feasible, or if the signatory is not available to sign the application before the application deadline, contact the REB Secretariat to determine if an exception can be made.
7.2 Attestation of principal investigator and other investigators/team members
Signatures from the principal investigator and all other investigators/team members (as listed in Sections 1.2 and 1.3) should be obtained prior to submitting the application to the REB. If this is not possible, contact the REB Secretariat to discuss. If an exception is granted, all necessary signatures must be obtained prior to approval from the REB and the HC/PHAC Decisional Authority.
Section 8: Attachments
Attachments can be submitted in any standard format including Word documents, PDF files, images (JPEG, TIFF, etc.), Excel spreadsheets, and PowerPoint documents. Filenames should include the section of the application to which the document relates and a brief description of the content (e.g., “1‑CV_Einstein,” “2-Research protocol”). If the application includes attachments not indicated in the list, or if additional pages were required due to insufficient space on the application form, select “Other” and list the attachments in the text box provided.
Separate files for each attachment are preferred, rather than a single document containing multiple or all attachments. If certain attachments are contained within another document (e.g., if the study budget sheet is included within the research protocol rather than as a separate attachment), please explain in the text box provided.
Research protocol instructions
The research protocol is a critical component of the REB application. The REB relies on the protocol to obtain a complete and accurate picture of the work that will be undertaken, and in particular how human participants will be involved in the research. Because of its central importance to the ethics review process, the research protocol must be readily understandable by each REB member. Applicants are reminded that the REB members come from a wide variety of backgrounds, and not all will necessarily be familiar with the field of study or methodology for the proposed research. Thus, care should be taken to ensure that the protocol is understandable to an intelligent non-expert. Applicants are welcome to include figures and tables where appropriate, as these can be helpful tools to organize and present information.
The instructions provided below describe the elements that must be addressed in the research protocol. Applicants are encouraged to structure their protocols according to this outline and to number the pages for ease of reference. It is also acceptable to use a research protocol that has been prepared for another purpose (e.g., to apply for funding, to obtain internal approval), as long as it addresses all the elements described below and it accurately reflects the research for which REB approval is being sought.
This section should explain the purpose and rationale for conducting the research. It should include the hypothesis or research questions the project is intended to answer, and briefly describe the expected knowledge that will be generated and the anticipated outcomes of the research.
2. Background/literature review
This section should provide the context for the proposed work and identify the knowledge gaps that the research intends to fill. Applicants should explain how the research will build on what is already known and how it will add to the body of existing knowledge. It is important to demonstrate that there is a sound theoretical basis for the proposed work, and that the research will fill a significant knowledge gap.
If the protocol builds on a pilot study or a related research study, describe the results of the previous work and indicate how they have informed the design of the current protocol.
This section should describe how the proposed research will be conducted. Recognizing that not all REB members will necessarily be familiar with the field of study, the description of the methods should avoid excessive technical or scientific jargon while still providing a sufficient level of detail for the REB to critically assess the scientific validity of the proposed approach. The following elements should be included in this section, to the extent that these are applicable to the proposed research:
- The major procedural steps that will be followed and the activities that will be undertaken in conducting the research
- Timeline and key milestones for the research
- Where the research activities will take place
- Activities for which each member of the research team will be responsible, and whether any activities will be conducted by third parties outside of the research team (provide details on the nature of the arrangements and copies of contracts or research agreements where applicable)
- Nature and source of the samples/data/information that will be studied
- Techniques and instruments that will be used to collect the samples/data/information (i.e., questionnaires, interview scripts, focus group guides, physical monitoring, blood collection, etc.)
- How the samples/data/information will be used and analyzed
Important – supplemental materials
All data collection materials must be included with the research protocol in an appendix or separate attachment (i.e., surveys, questionnaires, telephone scripts, focus group discussion guides, interview scripts, etc.).
4. Recruitment of human participants
If human participants will be recruited to take part in the research study, the following information should be provided:
- Recruitment strategy, including the target population(s), recruitment methods and materials (e.g., radio or print ads, social media posts)
- Study population, including sample size, inclusion/exclusion criteria, and sex and gender considerations (with appropriate justification and rationale)
- How research participants will be involved in the study, what they will be asked to do, and the expected time commitment
- Whether participants will be offered incentives and/or compensated for their participation in the research, and in what form (e.g., cash, gift cards, meals)
- Justification for any incentives offered as part of the recruitment strategy and their potential impact on voluntariness of participation
Important – supplemental materials
All recruitment materials must be included with the research protocol in an appendix or separate attachment (i.e., invitation letters and emails, telephone recruitment scripts, flyers, brochures, social media posts, etc., in the language(s) understood by the participants).
5. Informed consent/assent process
The importance of free, informed and ongoing consent of human participants in research is central to research ethics review. As described in TCPS 2, Chapter 3, the core ethics principle of respect for persons implies that individuals who participate in research should do so voluntarily, understanding the purpose of the research, and its risks and potential benefits, as fully as reasonably possible. Thus, this section of the research protocol should clearly explain:
- How consent/assent will be obtained and documented
- How consent/assent will be maintained throughout the research project
- How participants will be informed of their right to withdraw from the study, to what extent participants will be able to review and withdraw their information, and how their samples/data/information will be managed following withdrawal (i.e., whether they will be destroyed, kept for a specific period of time, etc.)
- How participants will be informed of the potential harms and benefits of participating in the study
- If vulnerable populations (including participants with diminished decision-making capacity) will be recruited, what additional steps (if any) will be taken to protect the participants’ interests (including the use of authorized third parties to make a consent decision)?
- If minors will be recruited, how will their assent or consent be obtained, and what role will their parents or guardians play in the consent process?
- If participants will be recruited from different linguistic groups, what is the plan for translating information and consent documents and/or providing access to interpreters?
- If there is the potential for future use of participants’ samples/data/information, what steps will be followed to inform participants and obtain their consent?
- If the research involves partial disclosure or deception, why is it warranted, and what is the plan for debriefing participants and for offering them the possibility of refusing consent and/or withdrawing their samples/data/information from the study?
- If participant consent will not be sought, a clear rationale must be provided
Important – supplemental materials
All participant information and consent materials must be included with the research protocol in an appendix or separate attachment. Consent materials must be in the language(s) understood by the participants, written in plain language at an appropriate reading level (i.e., grades 6 to 8).
6. Potential harms and benefits to participants
As part of the ethics review process, the REB must decide whether the harms anticipated to research participants, their families and communities can be justified ethically in terms of the potential benefits to the participants, to others and to society as a whole. Thus, this section should describe:
- All known and reasonably anticipated harms which might be expected to occur, with estimates as to their potential seriousness and frequency (note that harms may be social, behavioural, psychological, physical or economic in nature)
- The approaches taken to minimize or mitigate the potential harms
- Known or potential benefits to research participants, their families, communities or society as a whole (note that compensation or incentives for participating are not considered a benefit and should not be listed as such)
For some research projects, it may be true to say that no potential harms and/or benefits can be identified. If applicable, this should be stated and justified.
7. Privacy and confidentiality
Researchers have an ethical and legal obligation to respect and protect the privacy and confidentiality of human participants in research. Thus, a key element of the REB’s evaluation is to examine how participants’ privacy and confidentiality will be addressed by the researchers. Research protocols are also examined by the Health Canada-PHAC Privacy Management Division (PMD) to ensure that any personal information is handled appropriately and all requirements of the Privacy Act are met. PMD will assess whether the research project involves personal information and if the project does determine the preliminary level of privacy risk.
To assist both the REB and PMD in their reviews, the following elements should be addressed in the research protocol, as appropriate to the nature of the research being proposed:
Nature of the samples/data/information
- What information about the participants is being collected, and in what format (e.g., paper, computer files, online, audio/video recordings, physiological measures, photographs)?
- What is the sensitivity and subject of the information being collected?
- Highly sensitive (e.g., information with a serious risk of harm or discrimination such as banking information or illicit drug use)
- Sensitive (e.g., medical information such as physical disabilities or medical conditions)
- Contextually sensitive (e.g., information related to a sensitive Health Canada or PHAC program such as the Office of Medical Cannabis)
- Limited contextual sensitivities (e.g., home phone number or exercise and eating habits)
- Non-sensitive (e.g., business contact information)
- Who is responsible for the initial collection of the samples/data/information, and in the case of secondary use of samples/data/information, how will the researchers obtain access?
- Type of information about participants Footnote 1:
- Is the information directly identifying (e.g., name, personal health number, other identifying numbers)?
- Is the information indirectly identifying; that is, information that could be used alone or in combination with other information to identify an individual (e.g., date of birth, place of residence or unique personal characteristic)?
- Is the information coded, and if so, how was the code established and who has access to the key?
- Will the information be anonymized (i.e., the information is irrevocably stripped of direct identifiers and a code is not kept to allow future re-linkage), and if so, how?
- Is the information anonymous (i.e., never had identifiers associated with it and cannot be linked to any other information to re-identify individuals)?
Access to and storage of the samples/data/information
- Who will be the primary collector or custodian of the samples/data/information, and who will have access?
- How will the samples/data/information be securely stored and maintained (e.g., in a locked room or file cabinet with restricted access, as encrypted and password-protected computer files)?
- Will any samples/data/information be stored outside of Canada, and if so, what controls and safeguards will be put in place to protect participants’ confidentiality and minimize privacy risks?
- If data or datasets will be combined or linked for the purposes of analysis and/or publication, who will be responsible for linking the data, how will the linkage be done and is there a risk of re-identification of participants?
Sharing and disclosure of samples/data/information
- Will any samples/data/information be shared with individuals or organizations outside of Health Canada or PHAC, and if so, with whom and by what transmission method (e.g., courier service, encrypted server)?
- If the research will be done in collaboration with individuals or organizations from outside Canada, what are the organizations that are involved, and does that jurisdiction have a strong privacy regime?
- Has consent been obtained from the participants to disclose their information?
- If the research generates important incidental findings about the health and safety of participants or third parties, how will this information be communicated to the participants and/or the authorities as appropriate, and how will confidentiality be maintained?
- Will the results of the research be published or disseminated, and if so, how will the privacy of the participants be respected (e.g., by excluding names, nicknames, physical descriptions, clues to their location or place of study)?
Retention and disposition of the samples/data/information
- For how long will the samples/data/information be stored?
- How will the samples/data/information be destroyed?
For research protocols that involve personal information Footnote 2 under the control of Health Canada/PHAC researchers, applicants should also describe:
- The authorized Health Canada/PHAC program or project under which the personal information is collected (e.g., paragraph 4 of the Department of Health Act, or paragraph 3 of the Public Health Agency of Canada Act), and the reason that the proposed research requires the information
- Whether and how participants will be notified of the purpose for which their personal information is being collected
- How the personal information will be used, and whether the information will be used for a purpose other than that for which it was collected
Please Note: PMD may request for their analysis additional details on how personal information is collected, used, shared and disposed of. However, every effort will be made to leverage all information provided in the research protocol to minimize duplication and additional work for the researcher.
8. Potential biases and limitations
Conflicts of interest have ethical implications in that they could, or could be perceived to, introduce biases into the research as it is performed, including the recruitment of participants. The REB therefore needs to be made aware of any real, apparent or potential conflicts of interest that may affect how the research is done, and the steps that will be taken to minimize their impact. For additional information, consult TCPS 2, Chapter 7.
Applicants should also describe any important limitations to their study, such as those that may result from the study design, sample size or population, analysis plan, or scope of the proposed research, and the strategies that will be taken to mitigate those limitations. For significant limitations, indicate whether and how the research project will still be able to generate meaningful results and accomplish the desired objectives.
9. Knowledge translation and dissemination plan
Researchers have an obligation to share the results of their research. When the research involves human participants, it is especially important that the participants themselves, and their communities, receive and can benefit from the results of the research. Thus, applicants must explain their knowledge translation plan and how they intend to disseminate the results of their research, including whether the results of the study will be made available to the study participants. For certain types of research, the activities may consist solely of publishing a manuscript in a peer-reviewed (and ideally open access) journal or publishing a report online. However, for other types of research, particularly those involving strong community engagement, a more extensive knowledge translation plan will be expected that describes:
- Who the target audience will be
- How the information will be disseminated (i.e., the products, tools and processes that will be used)
- How and when the results are expected to be used by the target audience
Applicants are reminded that a study budget sheet must be included with the application, either as a separate attachment or as a section within the research protocol. The study budget should provide a clear picture of how the funds will be expended, broken down by project year and activity (e.g., personnel and salary costs, equipment, consumables, service contracts, travel, knowledge translation activities).
11. Other considerations
The following considerations may not apply to all research protocols and only need to be addressed where relevant. Applicants are welcome to include a separate section if necessary to address these issues; however, in most cases it is expected that these considerations can (and should) be addressed throughout the protocol, and especially in the Methods section.
- Multicentre or multijurisdictional research
For research projects involving multiple centres and/or jurisdictions, describe the activities that will be conducted at the various sites. Applicants must also explain the plan for obtaining approval from other REBs and authorities where needed if not already secured or in progress.
- Sex and gender
The Government of Canada is committed to using Gender-Based Analysis Plus (GBA+) to develop effective policies and programs. GBA+ is an analytical tool used to assess the potential impacts of policies, programs, services and other initiatives on diverse groups of people, taking into account sex, gender and other intersecting identity factors (such as age, culture, language, education, sexual orientation, ability and faith). From an ethical perspective, GBA+ aligns with the core principle of justice – the obligation to treat people fairly and equitably. Applicants are therefore expected to consider sex and gender in their research design, methodology and analysis.
- Official languages
Health Canada and PHAC have obligations and responsibilities under the Official Languages Act and to Official Language Minority Communities (OLMCs). These include ensuring respect for English and French; ensuring equality of status and equal rights and privileges as to the use of both languages in federal institutions; supporting the development of English and French linguistic minority communities; and advancing the equal status and use of English and French. Applicants should ensure that appropriate consideration is given to the use of French and English, and to the engagement of individuals from both linguistic communities (including linguistic minority communities).
- Indigenous research
Research involving Indigenous peoples must take into account their unique status and must respect community customs and codes of research practice. Applicants should adhere to the principles outlined in TCPS 2, Chapter 9 and ensure that their research protocol aligns with these principles.
- Community engagement
Research involving humans often extends beyond individuals to include the broader community, for example through community-based participatory research. Community engagement is also a key requirement in Indigenous research. Where appropriate, applicants should describe how the community will be engaged in the research and include letters of support from community leaders.
- Legislation and regulations
Legislation and regulations at federal, provincial or local levels can influence the performance of the proposed research. Applicants should note any legislation or regulation that could affect the proposed research and describe the steps that will be taken to ensure the research is in compliance.
Scientific peer review
Applicants must include two independent scientific peer reviews with their application. Applicants are encouraged to use the following template when soliciting reviews of their research protocol:
- Scientific Peer Review of Research Involving Humans (PDF format, 419 KB, 10 pages)
Evaluation and approval process
Upon receipt of an application, the REB Secretariat will review the application for completeness, identify outstanding items that are required for REB review and follow up with the applicant to request the required information. Once the application is deemed complete, it will be referred for REB review.
At the REB review meeting, applicants are invited to make a brief presentation on their research (either in person or remotely) and respond to questions from the REB members. The REB’s recommendations are sent to the applicant within 7 to 10 business days following the meeting. The research under review will receive one of the following decisions from the REB:
- The application meets ethics requirements for research involving humans.
- The REB requires modification of the application or clarification before the members can finalize their assessment.
- The application does not meet ethics requirements for research involving humans and it is unlikely that revision will lead to a positive determination.
If clarifications or revisions to the protocol are required, the letter of approval and Certificate of Ethics Review will not be issued until the REB has reviewed and approved the applicant’s response. It is the responsibility of the researcher to respond promptly to the REB’s concerns.
Meeting and submission deadline dates
Applications for initial review of research involving humans are normally reviewed at the monthly meetings of the full REB as per the schedule below. Applications for each meeting are accepted on a first come, first served basis and must be received by the application deadline for that meeting. The Secretariat reserves the right to limit the number of applications reviewed by the REB at each meeting. Applicants are encouraged to inform the REB Secretariat in advance of the deadline of their intention to submit an application.
All documents should be sent by email to the REB Secretariat: email@example.com.
|Meeting dates||Submission deadlines|
|January 21, 2021||December 31, 2020|
|February 18, 2021||January 28, 2021|
|March 18, 2021||February 25, 2021|
|April 15, 2021||March 25, 2021|
|May 13, 2021||April 22, 2021|
|June 10-11, 2021||May 20, 2021|
|July 15, 2021||June 24, 2021|
|August 2021||No meeting|
|September 9, 2021||August 19, 2021|
|October 7, 2021||September 16, 2021|
|November 4, 2021||October 14, 2021|
|December 9, 2021||November 18, 2021|
- Footnote 1
For more information, including definitions of the types of information, see TCPS 2, Chapter 5, Part A https://ethics.gc.ca/eng/tcps2-eptc2_2018_chapter5-chapitre5.html#a
- Footnote 2
Personal information is information about an identifiable individual that is recorded in any form. It can include name; contact information; health, financial and biometric information; personal opinions; and identifying numbers.
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