Core elements of consent documentation for clinical research in Canada: guidance for policy

Abstract

Background:

Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research institutions. Under the auspices of the Canadian Institutes of Health Research and the Canadian Critical Care Trials Group, we identified a core set of elements for participant consent documents to be used in clinical research and present these as a template consent form.

Methods:

Our guideline core team comprised experts in the legal and ethical aspects of research, and a clinical trialist–scientist. We conducted a directed review to compile a list of applicable regulatory, policy, and guidance requirements for the documentation of informed consent for research conducted with human participants in Canada. We used a gap analysis to identify the elements required in a research consent form, based on these documents and in comparison with 10 existing research ethics board (REB) informed-consent form templates. The guideline, as well as a fillable template for the form, was created with input from a pan-Canadian advisory group, interested parties, and broad public input. We tested the template with a small group of studies across several research domains. Our process for managing competing interests adhered to Guidelines International Network principles.

Recommendations:

From our gap analysis, we identified 75 core elements for participant consent forms in clinical research, which we have grouped under 6 main categories (i.e., information for potential participants about participating in research in general and in the particular study; harms and benefits of participation; protection of participant data; points of contact; and giving consent) in a fillable consent template. Because studies vary, specific elements should be included in a study consent form only if relevant to the type of research being conducted and the corresponding compliance requirements, as identified in our gap analysis.

Interpretation:

The template with the core set of required elements is intended to be used by any researcher applying for REB approval to document participant consent and, when applied with consideration of our associated guidance, is sufficient to meet regulatory requirements for research in Canada. Identifying the required elements for consent forms is intended to streamline consent documents across the country, facilitate multi-site projects, and simplify the approval process for all those involved.

In 1947, the Nuremberg Memorandum, and later the Nuremberg Code, required that free, informed, and voluntary consent must be obtained from every person participating in research.^1,2 This requirement was later expanded and ratified in 1964 by the World Medical Association in its declaration of Ethical Principles for Medical Research Involving Human Participants (Declaration of Helsinki).³ The spirit of these documents is that individuals must be adequately informed with appropriate, necessary, and sufficient knowledge to be empowered to make decisions about participating in research.³

Application of the concept of free, informed, and voluntary consent has suffered successive alterations that have transformed the documentation of consent into a quasi contract between the research team and the participant because of increasing fears of institutional liability across all jurisdictions, including Canada.^4–6 Regulatory elements have become mandatory for all study types, and the inclusion of institutional risk-management elements is common practice. This has resulted in bloated consent forms that, in many cases, do little to help the participant understand the risk elements and, in some cases, have even been shown to detract from a person’s ability to make an informed decision.^5,7,8 The consent process has, to some extent, been reduced to a formal collection of a signature on an agreement, rather than a thoughtful evaluation by potential participants of the benefits of their participation against the potential for foreseeable harms. Risk — the relation between harms and benefits — is subject to a personal and relational interpretation and must be determined by the participant.

The emergence of cumbersome and lengthy templates for documenting informed consent is further complicated by jurisdictional (and often institutional) differences in format and interpretation of policy and legal requirements, which vary by province and territory.⁹ Clinical studies that involve multiple hospitals or research groups often require ethics approval in each applicable jurisdiction, each with specific institutional templates. These templates, and the tendency to add information with successive iterations, have led to consent forms that are difficult to understand, potentially compromising the process of informed consent.¹⁰

The purpose of this guidance for policy is to present a core set of elements for participant consent documents to be used in clinical research across Canada, and to facilitate harmonization of multi-site projects by simplifying the approval process for all those involved. These core elements can be also used as a research ethics tool when evaluating research projects with human participants.

Scope

This guideline is intended to be used by researchers applying for research approval from Canadian research ethics boards (REBs) that are compliant with the 2022 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2–2022),¹¹ to document informed consent. It defines the common required elements for informed-consent forms in Canada, a key requirement for submission of a complete research package for REB approval. We recognize that many multi-site studies must also address United States requirements, so we have also included these.

In this guideline, we focus on regulatory and policy requirements for the consent form and not the consent relationship or broader issues related to consent processes, which may include alterations to informed consent procedures permissible for certain types of research that have unique ethical and legal considerations (e.g., consent for research in medical emergencies).

The current ethics requirements for consent in research involving humans are not in question; we seek only to clarify their application in the consent form to improve communicability with participants. This approach to consent puts the participant in command by highlighting what is necessary for them to decide, in an essential step toward rebalancing the power relation between participants and researchers.

Recommendations

The core set of 75 required elements (out of a total of 118 we identified in our gap analysis) for participant consent forms in clinical research is grouped under 6 sections discussed below. Appendix 1 (available at www.cmaj.ca/lookup/doi/10.1503/cmaj.250500/tab-related-content) lists the included and excluded elements, by number, that are required under the 4 main regulatory documents guiding this review: Health Canada Regulations^12–14 (HCR) and Guidance^15,16 (HCG); TCPS2–2022;¹¹ US Food and Drug Administration (FDA) regulations;¹⁷ and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonized Guideline: Good Clinical Practice (GCP) E6(R3).¹⁸

In Table 1, we have summarized the components of consent (left side) and applicable guidance (right side). The guidance must be used to complete the template to ensure all required elements from the guideline are represented; it is meant to be read in tandem with the components of consent represented in the fillable template in Appendix 2 (available at www.cmaj.ca/lookup/doi/10.1503/cmaj.250500/tab-related-content).

Table 1:

Language for core consent elements,^* organized by template sections, with instructions for template completion

Template language	Instructions to complete template†‡
Preamble
[Title of study] [Name of principal investigator and their primary affiliation] is leading this study [Name of funder] has provided funding for this study. [Trial registration number, if applicable]	Number each page of the form.
Section 1: What do you need to know about taking part in research? *
• Taking part is voluntary.
Taking part in this research study is your decision. That means you can choose to take part or not. By agreeing to take part, you are giving your consent. Before making your decision, you are welcome to discuss this study with the study team, [your health care team] [and others, e.g., family, elders, spiritual and faith leaders, and friends].	Specify others whom potential participants may want to consult, depending on the study population.
At all times, researchers must conduct research with integrity. This means working honestly and ethically. The study team is responsible for the safety of people who take part. We also protect your information [and biological samples] and keep your information confidential.	Include information about biological samples only if applicable.
• You can stop taking part at any time.
You may choose to stop taking part at any time. If you stop, there will be no consequences or impact on your [e.g., health care, academic standing, employment, or any other situation that may be applicable]. If you choose to stop taking part, no more information will be collected about you from that point on.	In this field, describe any entitlements that may apply to the population, such as health care for patients, academic standing for students, employment if applicable, and so on. More than 1 entitlement may be listed, if applicable.
If you choose to stop taking part, we will tell you whether there is an option to remove information [or biological samples] that has already been collected. It may not be possible to remove your information if it has already been shared or published, or if we can no longer connect your information to you. We will tell you if we learn anything that is relevant to your decision to continue or stop taking part in this study.	Include information about biological samples only if applicable.
• Conflict of interest
[Declare conflicts of interest and any potential commercialization that may occur. Delete section if none.]	Include this section only if there is a financial conflict of interest to declare. If there is a conflict of interest, include information about possibility of commercialization as applicable.
Section 2: What does taking part in this study involve? *
• Purpose of this study
The purpose of this study is [purpose].	Be as succinct as possible when describing the purpose of the study. Include background information as necessary to clarify the purpose of the study. Technical and scientific words should be replaced by everyday words as much as possible. If you must use a technical or scientific word, explain it. If applicable: Provide summary description ONLY of investigational products, placebo, or comparator. Define scientific terms such as “placebo.” Full details may be provided in an appendix to this document if required. State whether an investigational product has been approved by Health Canada for use in this study.
• Research procedures
[Sufficient description of research procedures]	Describe the procedures in plain language. Technical or scientific words should be explained or replaced by everyday words as much as possible. If you must use technical or scientific words, explain them. Consider using bullet points, graphics, or tables to help describe complex procedures. If applicable: Provide summary description ONLY of investigational products, placebo, or comparator. Full details may be provided in an appendix to this document if required. Define study design with implications for participants (e.g., randomized, blinded, crossover, etc.), which must include probability for random assignment to each treatment and an explicit statement of which aspects of the trial are experimental. If biological materials are being collected, include the type and amount that will be taken, the manner in which they will be taken, and the safety and invasiveness of the procedures for acquisition.
There are approximately [number] people taking part in this study.	Include number of participants only if study is subject to ICH or US FDA regulations. Number means total number of participants in the study.
• Your responsibilities
Taking part in this study means that you will be asked to do the following: [Clear and succinct description of what the study asks the participant to do].	If applicable, include: detailed directions for use of the study products; statement about refraining from taking other medications without consulting the study team or alerting them to the use of other medications; statement about discussing lifestyle or dietary changes required by or unrelated to the trial with the study team. If pregnancy is a condition for exclusion from the trial, include the requirement for pregnancy tests and adequate birth control measures. Specific birth control measures do not need to be listed; the participant can be directed to speak to their care provider about birth control options; a visit or other relevant schedule as an appendix to this document and refer to the schedule here.
Taking part in this study is expected to take approximately [length of time] of your time.	Include total length of time as well as length of time per interaction or study visit, if applicable.
• Compensation or reimbursements
You [will or will not] be paid to take part in this study. [Describe any compensation or honoraria the participant will receive.] You [will or will not] be reimbursed for costs that you incur to take part in this study. [Describe any anticipated costs to be incurred by participants. Describe whether those costs will be reimbursed.]	If applicable, describe compensation. If applicable, describe any reimbursements for additional costs that may result from participation, such as travel and parking costs, Internet usage, etc.
• Stopping the study early
We may take you out of this study early if [list stopping rules]. If you are removed from the study, the study team will tell you and explain why you have been removed.
• Sharing study results
Section 2: What does taking part in this study involve? *
When this study is complete, we will share the results [description of publication or knowledge mobilization plan].	Refer to required registries as applicable. If US FDA regulated, include the following language: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by US Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”19
• Alternatives to taking part in this study
Instead of taking part in this study, you could: [List alternatives to participation.] [Describe important risks of harm and benefits of each.]	A description of the possible harms and benefits of alternatives to participation is applicable only to trials subject to the ICH Guideline for Good Clinical Practice, including Health Canada–regulated clinical trials. If applicable, direct participants to speak with their care providers about alternatives to participation, including information about standard of care.20
Section 3: What are the possible harms and benefits of taking part in this study? *
There are possible harms and benefits that you might experience by taking part in this study. Possible harms include: [Clear and succinct description of all reasonably foreseeable harms arising from participation in the research study].	Explain technical and scientific language or replace with everyday words as much as possible. Consider indicating whether harms are severe, short- or long-term, lasting or reversible, rare or common. This section should not be a product monograph list of harms but should be a succinct summary of possible harms to participants. Consider potential harms to individuals as well as communities. Do not include potential harms associated with standard of care; these distract from the actual risks of participation. However, if applicable, describe any loss of opportunity as it relates to standard of care. If applicable, include a summary description of adverse effects from investigational products, placebo, or comparator. Level of detail in the description of risks should be proportional to potential risk of harm. If applicable, list any contraindicated medications to investigational drug, placebo risks, or comparator. Do not need to state if there are no known contraindicated medications. If applicable, list any rescue medications. If proportionally important, state that there may be unknown risks of harm. Otherwise, do not need to state this information. If applicable, include discussion of plan to address any material incidental findings, using the following guidance: https://ethics.gc.ca/eng/incidental_findings.html21 For phase 1 clinical trials: State the untested nature of therapy at the top of the harms section to ensure participants pay special attention to it. Consent procedures should ensure participants are aware of the untested nature of the therapy and that participants do not accept, because of the incentives being offered, risks they would otherwise refuse. For phase 2 clinical trials onward: If applicable, provide details on access to the new drug upon trial completion. Use of placebo: If applicable, inform participants about any intervention or therapy that will be withdrawn or withheld for purposes of the research, and the anticipated consequences of doing so. Participants should be also told about rescue therapies offered during the study, if applicable. If applicable, include risks, or lack of knowledge of risks, to reproduction, including risks to nursing infants or a fetus. Critical inquiry: In the case of critical inquiry, if permission is not sought from the person’s institution or group to conduct this research, tell the individual about any risks this may pose to them. See article 3.6 of TCPS2-202211 for more information.
Possible benefits include: [Clear and succinct description of all reasonably foreseeable benefits arising from participation in the research study].	Benefits include that the study aims to provide direct benefit to the participant or benefit others like them in the future, for example. There may also be no benefits to list. Studies subject to the ICH Guideline for Good Clinical Practice should state if there is no intended clinical benefit of the research.
Section 4: How will we keep your information safe? *
While you take part in this study, we will collect a variety of information about you. This may include [personal information about you/biological samples/genetic information].	Include only types of data that are being collected in your study. If you are collecting genetic information, refer to the genetic core consent template for guidance and incorporate those requirements into this form as needed.12
This study is being conducted at several sites with the lead site at [organization name, jurisdiction]. They will receive a copy of your information so they can review all of the information collected at all of the sites together.	Include if you are conducting a multi-site study. This paragraph should name your partners and what kind of data they are going to receive (e.g., health records, genetic information).
Your information will be stored, shared, and used according to the privacy and security standards of [university/hospital/health authority/other research institution]. These standards can be found at [include URL]	Include link to institutional privacy and security standards.
Your information will be [digitally or physically] stored by [custodian (individual or organization)] for [time], as required by [PI’s lead site institution or regulatory requirements].	Complete these fields according to your institutional policies and other applicable regulatory requirements. State whether there are different institutional or regulatory requirements for biological materials. Include details of biospecimen storage if applicable.
Information that does not directly identify you might be published and might be shared with other researchers from around the world for research studies that will be planned in the future. This information will always be shared securely and confidentially.	For clarity, this section refers to the concept of open science and data that are not identifiable. This section is not referring to data registries or biobanking, which are discussed below. Sharing of identifiable information is covered in the table included in Appendix 2, Section 4.
• Identifiable information
We might have to share information that could identify you for [legal reasons related to public health and child protection] auditing, quality control, or other reasons to assess your safety and make sure the study is being done correctly.	Include only if relevant for your study. This refers to mandatory infectious disease reporting, child protection laws, or other local regulations that may apply.
Auditors or inspectors would use this information to check that we are keeping you safe and doing the study correctly. In those cases, your information will be shared only with people in organizations that have data protection policies and security measures in place.	Data repositories and broad consent: If the study is seeking broad consent for future use of data, include a general description of the repository and its governance; whether data or biological samples could be shared with researchers not subject to TCPS2-2022;11 whether the research will or might include whole genome sequencing or similar technologies that may pose a substantial risk of reidentification of participant or material incidental findings; and whether linkage of data is anticipated. If a data repository is part of an optional study, a separate biobanking consent form should be created using this template.
Your family doctor or health care provider might be informed that you are taking part in a study. This is to make sure that you receive appropriate medical care. If you do not want your family doctor or health care provider to be informed, please inform the study team.	Include this statement if applicable.
This table shows which other organizations might access information that could directly identify you and why they might need access.	See data table in the formatted template (Appendix 2, Section 4). Succinctly describe who will receive identifiable data, what specific data they will receive, where data are being sent, and for what purpose. The purpose of the table is to clearly present information about the collection, use, and disclosure of identifiable information that is being shared with third parties such as apps, vendors, or industry sponsors that are outside the control of the study team. Not required to list local study team, multi-site research partners, REBs, auditors or monitors, Health Canada, FDA, public health or other oversight bodies in the table. These entities are covered in the preceding paragraph. Do not include this table if data are not being shared. Create a new line for each distinct organization that will be receiving data. If sharing biological materials, include anticipated linkage of biological materials with information about the participant. Delete the last column of the table if not applicable. We recognize that legal requirements and terminology on the collection, use, and disclosure of information in research vary by local jurisdiction and acknowledge that Section 4 and this table may require additional local language or the use of slightly different terms. However, any additions should be brief and required by local regulations so as not to increase the length and complexity of Section 4 overall.
Section 5: Who can you contact if you have questions? *
Before you agree to take part, you are welcome to ask us any questions.
If you notice any adverse effects or signs of medical distress, meaning you are not feeling well either physically or emotionally, contact: [Name and title/role] [Email and phone]. In an emergency, call 9-1-1 or go to an emergency department.	Include only for interventional studies.
If you are having thoughts about suicide or hurting yourself or others, contact [local suicide hotline].	Include where appropriate, otherwise remove.
If you have questions about this study, please contact: [Name] [Contact information; e.g., phone, email, social media contact, etc.].	Include research team contact information.
If you have questions about your privacy or your rights, please contact: [Name and title/role] [Email or phone].	Include contact information as required in local site. This will likely be REB contact information. In Quebec, include research team and ombudsman contact information instead of REB contact information.
If you are injured as a result of taking part in this study and need medical treatment, seek out medical care and contact us right away. You will receive medical care at no cost to you. [Describe compensation for injuries].	Include only if appropriate. If applicable, describe any compensation offered for injuries incurred during participation in the study.
Section 6: Giving your consent to take part in this study *
Taking part in this study is voluntary. You can choose to take part or not. If you have reviewed the details of this study and would like to take part, you can give your consent by [consent action].	This should reflect the way consent is being collected, which could include signature, clicking a button on an online form, verbal consent, or another format approved by your local institution and REB.
Agreeing to take part does not mean you have given up any legal rights. You are not giving up the right to bring legal action if you are injured or harmed because of this study.
I have read and understood this document. I CONSENT	Documentation of consent: Document consent according to requirements of the researcher’s institution and local regulatory environment. Consent for research can be an indication (checkbox, e-signature, completion of a form) or acknowledgement, and does not necessarily require a signature. This form should also include signature lines for witnesses, authorized third parties, etc., when relevant. Health Canada requires a written, signed, and dated consent form and statement that the participant has read and understood the entire form. This statement about reading and understanding the form can be used instead of an initial on each page. Research studies subject to the ICH Guideline for Good Clinical Practice must include the signature of the person obtaining consent.
Are you willing to be contacted to learn about future research studies? YES/NO	Include questions about future participation after the consent action. Your institution may have processes in place that differ from this or make this unnecessary. Contact individuals for future research only according to your institutional guidelines and requirements.
[Optional studies]	Include optional studies within the main consent form, or separate from the main consent form, according to REB and local requirements. In all instances, they should be after the consent action for the main study.

Note: ICH = International Council for Harmonization, PI = principal investigator, REB = research ethics board, TCPS2 = Tri-Council Policy Statement (2022), US FDA = United States Food and Drug Administration.

^*The required core elements (by number) for consent are listed in Appendix 1, available at www.cmaj.ca/lookup/doi/10.1503/cmaj.250500/tab-related-content. Section 1 addresses required elements 2, 5–8, 20, and 21; Section 2: 11, 14–18, 22, 31, 34, 38, 40, 48–51, 53–55, 62, 69, 70, 76, and 116–117; Section 3: 19, 41–43, 77–79, 81–86, 110, 111, and 113; Section 4: 23, 26–30, 44, 45, 80, 106, and 109; Section 5: 24, 25, 46, 56, and 71; and Section 6: 32, 35, 47, 58 and 63.

^†The fillable template is available in Appendix 2, available at www.cmaj.ca/lookup/doi/10.1503/cmaj.250500/tab-related-content.

^‡These instructions must be used to complete the fillable template (Appendix 2) and include specific guidance for customizing the information in italics in square brackets found in the first column.

The fillable template, when applied with consideration of all the associated guidance, is sufficient to meet regulatory requirements for research in Canada.

Section 1: What do you need to know about taking part in research?

In this section, we recommend that elements common to all research studies be addressed together at the beginning of the consent form (Table 1). It is common for existing consent templates to include a “summary” section at the beginning that provides an overall description of the particular study; this is intended to help readers understand and digest very long and complex consent forms. However, we recommend excluding such a summary section when using the fillable template, because it does not serve a purpose with a shorter form.

We recommend including a statement about conflicts of interest only if a conflict is present. This should generally be specific to financial conflicts and the possibility of commercialization, as the REB and institutional review processes should deal with other types of conflicts of interest (e.g., professional interests). During the consent process, the participant should not be expected to negotiate and resolve all issues relating to competing interests connected with the conduct of the study. Nor should they be told about risks that do not pertain to that particular study, such as declaring that there are no conflicts to disclose. Public funding for the conduct of a study should not be considered a conflict.

This section addresses required elements 2, 5–8, 20, and 21 (Appendix 1).

Section 2: What does taking part in this study involve?

This section addresses details specific to the study (Table 1). Consent templates commonly include extraneous sections such as background, description of study intervention, phase of study, and rationale. We recommend a very brief purpose and succinct description of research procedures only.

Participants should be referred to their responsible physician for discussions about standard of care, if applicable. Standard of care should not be described in the consent, even if it is the primary alternative to the study intervention.

This section addresses required elements 11, 14–18, 22, 31, 34, 38, 40, 48–51, 53–55, 62, 69, 70, 76, and 116–117 (Appendix 1).

Section 3: What are the possible harms and benefits of taking part in this study?

No activity can be considered fully harmless. Also, no one can forecast all possible ways harm can be consequent to an activity. In this section, we recommend a clear and succinct description of possible harms and benefits of participating (Table 1). Because the principles of informed consent largely relate to balancing harms and benefits,³ attention should be paid to ensuring this section appropriately explains these concepts to participants.

This section addresses required elements 19, 41–43, 77–79, 81–86, 110, 111, and 113 (Appendix 1).

Section 4: How will we keep your information safe?

This section outlines what information is collected and why, and the standards by which it is stored and secured (Table 1). Participants’ autonomy is not surrendered by being part of a research study. This fact, and the respect with which individuals must be treated, should be unequivocally demonstrated by the research team.

This section also provides sufficient detail about how information is shared with other organizations as part of the research study and describes the standard uses of identifiable information in research that are required for regulatory and other purposes to ensure participant safety.

We recognize that legal requirements and terminology regarding the collection, use, and disclosure of information in research vary by local jurisdiction and acknowledge that this section may require additional local language or the use of slightly different terms. However, any additions should be brief and include only those required by local regulations so as not to increase the length and complexity of this section overall.

The template (including a fillable table) provides enough detail for participants to understand the collection, use, and disclosure of identifiable information to any party not covered by the standard users (if applicable) for the study (Appendix 2).

This section addresses required elements 23, 26–30, 44, 45, 80, 106, and 109 (Appendix 1).

Section 5: Who can you contact if you have questions?

Participants need to know whom they can contact when they have questions or concerns about the research project, ethical and privacy issues, and their well-being during their time participating in a study. This section includes these details in 1 succinct section to ensure patients can locate the information easily (Table 1). It also includes a description of any compensation participants might receive if they are injured as a result of participating in a study.

This section addresses required elements 24, 25, 46, 56, and 71 (Appendix 1).

Section 6: Giving your consent to take part in this study

Participants’ informed, voluntary, and uncoerced active involvement in the research project must be established, as explicitly acknowledged in this section (Table 1).

This section addresses required elements 32, 35, 47, 58, and 63 (Appendix 1).

Methods

The Ethics Office at the Science Policy Branch of the Canadian Institutes of Health Research (CIHR) and the Canadian Critical Care Trials Group (CCCTG) conceived of and managed this guideline document. The guideline development followed the methods of a previous guideline, developed by the CIHR Ethics Office with the Institute of Genetics, to create a core set of elements for documents used to obtain participant consent for human genomics research in Canada.¹²

Details of the timeline (January 2022 to March 2025) for this initiative are outlined in Table 2 and discussed in detail below. Our process for managing competing interests adhered to Guidelines International Network (GIN) principles.¹⁹

Table 2:

Timeline of engagement (all meetings virtual unless otherwise stated)

Phase of process (type of meeting; participants)	Dates
First meeting of the core team	December 2022
Literature search	January 2023–May 2023
Establishment of the advisory group	March 2023
Gap analysis completed	May 2023
First meeting of advisory group	May 2023
Presentation to CAREB 2023 annual meeting for input	June 2023
Template drafted	August 2023–May 2024
Second meeting of advisory group	May 2024
Meetings with individual experts	May–June 2024
Creation of a dedicated website for the project, with option to sign up to receive information (hosted by CCCTG)	May 2024
Presentation to CAREB 2024 annual meeting for input	May 2024
Presentation to CCCTG 2024 spring scientific meeting (in person) for input	June 2024
CIHR meeting of clinical trials enabling organizations	June 2024
ACT 2024 fall meeting of participating networks	June 2024
Meetings with regulatory experts	June 2024
Draft template released for public consultation	September 2024
Close of public consultation	October 2024
Final meeting of advisory group	November 2024
CTO Workshop — provincial informed-consent form	February 2025
Meetings with other experts and groups, including those with expertise in Indigenous research, clinical trials, and plain language and accessibility	February 2025–March 2025
Finalizing template and writing guideline	March 2025

Note: ACT = Accelerating Clinical Trials Consortium, CAREB = Canadian Association of Research Ethics Boards, CCCTG = Canadian Critical Care Trials Group, CIHR = Canadian Institutes of Health Research, CTO = Clinical Trials Ontario.

Composition of participating groups

A core team was established to lead the project and comprised research ethics experts (H.L. and J.F.); people with legal training (B.S.) and experience in qualitative methods (H.L., J.F., and B.S.) and public policy (B.L.); and a clinician–scientist (S.M.), who collectively have extensive experience in research ethics and REB oversight. Two members (J.F. and H.L.) also previously collaborated on a guideline for consent for genomics.²⁰ The core team also worked together on a previous publication about research ethics oversight in Canada.⁹

The core team established an advisory group with 45 members to represent broader perspectives from key organizations. The advisory group included clinicians, biomedical researchers, ethicists, chairs and administrators of REBs, legal experts, and research coordinators from across Canada. It also included a patient advisor, and representatives from the federal government and CIHR and its institutes. Eight provinces were represented in total.

The core team led the development of this guidance, including developing the methodology, conducting the analysis and engagement with the advisory group, and drafting successive versions of the guideline and corresponding fillable template.

Selection of priority topics

The central topic addressed in this guideline is defining the minimal elements for a consent form to meet applicable regulatory and policy requirements in Canada. The core team met to define the methodology and agreed, by consensus, to create a corresponding fillable template for consent that would accomplish 3 objectives: to address applicable legal and policy requirements for research in Canada; to exclude detail extraneous to those requirements; and to ensure decisions about the content and language are considered from the perspective of the needs of a potential participant.

Literature review and analysis

Directed review

From January 2023 to May 2023, the core team conducted a directed review, compiling a list of all applicable regulatory, policy, and guidance requirements for the documentation of informed consent for research conducted with human participants in Canada. Namely, this included requirements from Health Canada regulations^12–14 and guidance documents;^15,16 TCPS2–2022,¹¹ US FDA regulations,¹⁷ and the ICH GCP E6(R3).¹⁸ We recognize the importance of other federal regulations, such as the Privacy Act,²² but worked under the assumption that TCPS2–2022 incorporates the most important requirements reflected in those documents. This review resulted in our finding 118 total elements related to consent (Appendix 1).

Gap analysis

Gap analysis is an established method used in a variety of fields.¹² It can be especially useful when applied across heterogeneous documents to determine the presence and absence of thematic content.

We selected 10 publicly available informed-consent templates that represented a cross-section of Canadian provinces and types of research institutions. Using a qualitative gap analysis, we compared the findings from the directed review against each of the 10 selected templates to determine whether existing templates contained the core elements.

The core team worked, by consensus, to group common elements into emerging themes to assist with data organization and analysis. We evaluated each identified individual line item and removed elements that spoke only to processes associated with informed consent (e.g., research should not commence before participants provide their consent; there should be no coercion or undue influence in the consent process).

The gap analysis showed that most selected templates far exceeded the requirements for consent forms dictated by relevant regulations, policy, and guidance. Many duplicated topics and included extraneous information, often intended to mitigate legal risks, further demonstrating that informed-consent forms are also being used for purposes related to addressing institutional risk rather than solely for the benefit of participants.^4–6

Development of recommendations

From the results of the gap analysis, we extracted the remaining elements (i.e., excluding those that were related to process only) to develop a core set of 75 required elements. We presented these to the advisory group in May 2023 (Table 2). The group’s input informed the first draft of the fillable template and accompanying guidance (the core elements were incorporated into the template or guidance, as appropriate).

We conducted a series of external consultations (see External Review section), after which we presented the revised draft template to the advisory group in May 2024 for further input.

The fillable template and accompanying guidance were tested with a small number of studies across a few research domains. These examples are available at https://www.ccctg.ca/core-consent.

External review

To obtain feedback on the core set of required elements and the template, we conducted several rounds of consultations with researchers, ethicists, members of REBs, and other knowledge users and groups (Table 2), including presentations to those attending the annual meeting of the Canadian Association of Research Ethics Boards (CAREB) in 2023 and 2024. We also had informal discussions with other experts, including those with specific expertise in Indigenous research.

We released the draft template and accompanying guidance for Canada-wide public consultation in September 2024. Feedback was accepted in both English and French, and public consultation closed after 1 month, in October 2024. We received 57 written submissions and incorporated them into our review.

Many of the public comments expressed concern about elements that were missing. In almost all cases, this was language related to institutional risk or privacy law. A few respondents to the public consultation requested that the template include a universal signature block (the list of all signatories to a consent form and their corresponding information).

We held a final virtual workshop with the advisory group in November 2024, during which key aspects of the public consultation input were discussed. The group agreed that many of the missing elements mentioned in the consultation do not belong in a consent form for participants, and instead should be included in the study protocol and application. Additionally, although a signature block is certainly a requirement for some studies, such as regulated clinical trials, addressing how it should be presented is beyond the scope of the current guideline.

The core team incorporated feedback regarding required elements into the guideline and finalized the template wording, using consensus.

Management of competing interests

We adhered to the GIN principles for managing competing interests.¹⁹ We agreed that any member of the core team declaring a competing interest at any point in the process would be asked to excuse themselves from the core team; our competing interests were declared and documented at each meeting. For advisory group members, participants were asked to declare verbally any potential competing interests at the start of formal group meetings, with the core team assessing and monitoring the presence of competing interests throughout the guideline development process. If any issues related to competing interest had arisen, we planned to consult legal counsel, but none arose. None of the core team or advisory group members have direct financial or indirect benefits from the publication of this guideline.

Implementation

The guideline, template, and guidance elements are available in different formats at https://www.ccctg.ca/core-consent, and can be implemented immediately.

We expect that researchers will deploy this template to make consent forms shorter, with the aim of aiding comprehension and encouraging more equitable, diverse, and inclusive participation in research. The shorter amount of text also makes translation less expensive and better enables use of participant-centred communication tools such as images, videos, infographics, and figures.

The template can be used for adolescent assent, parental consent, substitute decision-maker consent, or participant consent, negating the need for separate documents in many cases. It can be easily shortened and adapted for use as a separate assent form for younger children and others who do not have the capacity to understand a longer form.

During our testing (i.e., adapting existing REB-approved research consent forms to this template), we were repeatedly able to reduce Flesch–Kincaid Grade Level readability from grade 10 or higher to below grade 8 (using readable.com readability checker). A reading level of grade 6–8 for participant consent forms is encouraged by CIHR²³ but rarely accomplished, particularly for clinical trials.⁴

The template should in no way be used to interfere with the choices of Indigenous organizations, study teams, and communities who may have their own preferred templates. These groups may choose to use this template; however, their right to self-governance and data sovereignty must be respected. There may be portions of the template that refer to topics like open data access, for example, that are not applicable to Indigenous research.²⁴ All researchers should carefully consider how the design of their studies may affect Indigenous Peoples and other groups that have historically been excluded from or harmed by research.

Formal implementation and adoption by REBs will be facilitated by engagement of the guideline advisory group, CAREB, and members of CCCTG to enhance awareness. The core team has met with many provincial ethics organizations that are expected to adopt the guideline and template after publication. The core team will also encourage federal funders to include it in the funding application template.

The core team will reassess the core elements as appropriate, in consultation with members of the advisory group and other interested parties, to ensure that it is in keeping with national and international best practices. Users can make suggestions for updates at https://www.ccctg.ca/core-consent.

Other guidelines

No similar national guideline exists for Canada.²⁵ Most REBs, including centralized REBs, have created templates for the informed-consent form within their jurisdiction. Typically, these are created from existing templates and are not always accepted across jurisdictions or disease domains.

The CT:IQ in Australia created a participant-centred, simplified participant information and consent form for Australian health and medical research in 2024.²¹ Designed with an emphasis on plain language and participant accessibility, the form also includes the key information that a potential participant would need to decide. The form was drafted with extensive consultation and patient advisor input; reviewed by that project team for compliance with the National Statement on Ethical Conduct in Human Research (2023) and Australian privacy laws; then underwent a legal review.²⁶ The result is very similar to our template but understandably does not address the minimal required elements to address policy and regulatory requirements in Canada or other jurisdictions.

Our guidance was developed to complement other important Canadian initiatives to streamline and support consent forms for research, including the core elements of participant-consent documents for Canadian human genomics research,¹² Health Data Research Network Canada’s informed consent wording for administrative data linking,²⁷ TCPS2 How to Address Material Incidental Findings,²⁸ and the requirements from CIHR’s Stem Cell Oversight Committee (https://cihr-irsc.gc.ca/e/19306.html) for studies subject to their review. Studies that fall into the domains covered by these other initiatives can integrate their required wording into the consent template where appropriate.

Limitations

The guideline is applicable to research in Canada, including clinical research and clinical trials. It may not be applicable in other countries. We recognize that it may not meet the needs of industry sponsors and that it may not replace other negotiated streamlined consent templates that are working well in certain disease domains like cancer.

Because the ways in which consent is documented depend on regulatory requirements pertaining to certain research types and on local regulatory requirements regarding capacity to consent and other issues, we recognize that REBs may have to make adjustments or additions to satisfy local conditions and regulations for their jurisdiction. However, in keeping with the spirit of this guideline, we suggest that additions should be minimal, with the primary aim to maintain clear, concise language in the consent form. Users are encouraged to review and practise guidance for plain language,^25,29,30 particularly in the description of possible risks of participating.

Additionally, we encourage REBs to develop guidance for clear and simple documentation — such as signatures by a substitute decision-maker, use of an interpreter, assent, virtual consent, and regained capacity for consent — that were not within the scope of this guideline.

Gaps in knowledge

None of the relevant regulatory bodies have created template language to address specific regulatory requirements. This has been left to individual institutions. Additionally, we are not aware of any research demonstrating whether the ethical basis for existing policy and regulations is appropriate or adequate to protect individuals.

We have based this template on the existing regulations to clarify all elements that are required from a regulatory perspective in a consent form. We encourage researchers working in this area to experiment with different ways of presenting required information that are participant centred and concise, as intended in this initiative.

Effective metrics to consistently evaluate participant understanding and retention of information related to research have not been endorsed or required in Canada. We are not aware of any systematic approach to evaluate this topic across jurisdictions in Canada.

We encourage further research about specific ways to improve the informed consent process and the oversight of research.

Conclusion

This guideline and the associated template have the potential to streamline consent documents across the country, facilitate multi-site projects, and simplify the approval process for all those involved.

However, vigilance regarding a participant-centred approach will be required. This template facilitates the presentation of information in a clear and concise manner, which could improve participant comprehension and enable more diversity and inclusiveness in research participation. To be effective, the template must be applied with this same goal in mind. It should be completed for specific studies, using plain language.

We have presented these core requirements for consent in the hope that it will facilitate a return to the purpose of research consent, speaking to the core required elements of consent that were originally designed to deliver essential information about research to potential participants. The aim of the consent form is to empower the participant, not to protect the institution.