Research Ethics Board: Apply for ethics review

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.

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.

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.

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 Canada.ca Content 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.

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.

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".

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).

3.1 Compensation/incentives

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.

If the research project does not involve recruitment of human participants, select "No" and enter "N/A" in the text box.

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.

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.

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.

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 (manager-level or above) with Section 34 authority. If the PI is external to Health Canada, the HC contact person should sign. The signature should normally be obtained prior to submitting the application to the REB. 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.

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.

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.

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

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

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

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.

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.

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.

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).

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.

List all references cited in the research protocol.