Application for Initial Review of Research Involving Humans: Instructions

Individuals applying to the Health Canada and Public Health Agency of Canada Research Ethics Board (HC-PHAC REB) must complete the form entitled Application for Initial Review of Research Involving Humans. The instructions below provide detailed guidance on how to properly complete the application form. 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 hc.reb-cer.sc@canada.ca 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

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.

Information – consent requirements

TCPS 2 provides additional information on the consent requirements for the following types of studies:

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.

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