SOP 701 - Informed Consent Form Requirements and Documentation

1.0 PURPOSE

This standard operating procedure (SOP) describes the requirements for the informed consent form and the process for waiving or obtaining and documenting initial and ongoing informed consent.

2.0 SCOPE

This SOP pertains to REBs that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

The Researcher is responsible for providing the REB with a detailed description of the rationale for a consent waiver or the consent documents, and a description of the consent process. The Researcher is also responsible for describing the recruitment methods and materials (if applicable).

When a written informed consent form is used, the Researcher, the research Sponsor, and the REB are jointly responsible for ensuring that the consent form contains all the basic elements of consent and the applicable additional elements of consent. The REB is responsible for verifying that the consent form (if applicable) contains the required elements.

The REB is responsible for determining whether informed consent exemptions or waivers are applicable and appropriate.

The REB Chair or designee is responsible for reviewing consent forms or changes to consent forms if the changes meet the criteria for delegated review.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

5.1    REB Review of Required Elements of Informed Consent

5.1.1    REB Office Personnel and REB members will review the proposed consent process for appropriateness and the proposed consent form(s) for general readability, for appropriateness of the language and content, and the inclusion of the applicable elements per the organization’s guidelines and all applicable regulations;

5.1.2    The REB will review the proposed consent form to ensure that it contains adequate information to safeguard the privacy and confidentiality of research participants.

5.1.3    The REB may require a separate consent form for optional procedures or sub-studies (e.g., tissue, blood, genetic testing or specimen banking).

5.1.4    Following review, the REB may approve the submitted consent form(s) or require changes.

5.1.5    When changes are required by the REB and are made by the Researcher, the REB or designee will review the consent form(s) to confirm that the required changes have been made and that the version date has been updated.

5.1.6    When the changes meet the criteria for delegated review, the revised consent will be provided to the REB Chair or designee for review and approval.

5.1.7    When changes do not meet the criteria for delegated review, the revised consent form will be reviewed at the next Full Board meeting.

5.2    Translation of Informed Consent Documents

5.2.1    The informed consent document should be in language understandable to the research participant (or acceptable representative).

5.2.2    When a research participant is non-English or French speaking, documentation of informed consent can be by one of two methods:

• Written consent: The REB approved English/French version of the informed consent document is translated into the research participant’s native language. The REB requires that translated informed consents be accompanied by an attestation from a translator certifying that the translated informed consent accurately reflects the REB approved English informed consent. The attestation should have the version date of the REB approved English consent form that was used for the translation. The product of the translation should also have the same version date as the English approved consent from. This method is preferred if it is anticipated that a significant percentage of a prospective research population is non-English speaking. A translated informed consent document does not replace the need for an interpreter to be present during the consent process and throughout the research. The research participant will sign the translated version of the informed consent form document. A study team may wish to use a study team member as a translator. HSREB and GREB will accept this translation if it is accompanied by a letter from the study team member indicating this is a true reflection of the REB approved English version. NOTE: the English version of the document must be approved first. Any translated documents can be submitted as an amendment after the English document approved. In the event that a translated document has been submitted at the time that the English document is being reviewed, any requests for edits or modifications to the English document must be applied to the translated document. In this case, the translated document would have to be resubmitted with a new translation certificate to indicate that edits or modifications have been incorporated.
• Oral consent: If applicable/acceptable, a qualified interpreter fluent in both English/French and the research participant’s native language orally interprets the REB approved English /French consent form to the research participant. The interpreter should be an impartial person. When the person obtaining consent is assisted by an interpreter, the interpreter must sign and date the consent form.

5.2.3    If a research participant is unable to read, an impartial witness must be present during the entire informed consent discussion. Verbal consent is obtained from the research participant after the informed consent document and any other written information is read and explained to the research participant. Signatures will be obtained from the research participant (if capable) and the impartial witness on the informed consent document, where applicable. The signature of the impartial witness attests that the information was accurately explained to, and apparently understood by, the research participant, and that informed consent was freely given by the research participant.

5.2.4    The REB requires that the translated informed consent materials be submitted for review and approval prior to use in enrolling non- English/French-speaking participants. The REB may require that the Researcher include a certificate or statement signed by the translator indicating that the translated materials are a true and accurate translation of the REB approved English materials.

5.2.5    The REB may follow delegated review procedures to review and approve translated informed consent materials if the English language materials have already been approved (particularly if a signed translation certificate or statement is on file).

5.2.6    An interpreter should be available to the research participant throughout the research.

5.2.7    The interpreter must sign and date the consent form attesting that the research was accurately explained to, and appeared to be understood by, the research participant.

5.3    Consent Update for Ongoing and Completed Research Participants

5.3.1    The Researcher must inform research participants of any new information that might affect their willingness to continue their participation in the research or that may affect their long-term health even if they have completed their participation in the research, including those who have withdrawn or been removed from the study.

5.3.2    The Researcher must obtain the currently enrolled participant’s consent to continue to participate if there is a significant change to the research or risk.

5.3.3    If required, written documentation of ongoing consent for currently enrolled participants may be obtained by having the research participant sign an REB-approved consent document containing the updated information.

5.3.4    If applicable, ongoing consent may be obtained orally by contacting the research participant by phone, providing the updated information and documenting their agreement to continue.

5.3.5    The nature of the provision of the new information to currently enrolled participants and the documentation required will be determined by the REB.

5.3.6    The Researcher must inform former research participants of any new information that may be relevant to their long-term health by contacting them via phone or mail or in person, as applicable.

5.4    Recruitment Methods

5.4.1    Researcher’s patients: If the patient is under the care of the Researcher, the Researcher may approach the patient directly but in such a manner that the patient does not feel pressured or obligated. In this instance, an individual other than the Researcher should obtain the patient's consent. Any exceptions to this procedure must be appropriately justified and submitted to the REB for review.

5.4.2    In circumstances where the Researchers will obtain consent: The Researcher must ensure that the consent has been obtained without undue coercion or influence and that there is no likelihood of therapeutic misconception, if applicable.

5.4.3    Referrals: The Researcher may send a letter to colleagues asking for referrals of potential patients. The Researcher may provide colleagues with an REB- approved consent form or research information sheet to give to their patients. The patient will then be asked to contact the Researcher directly, or, with documented permission from the patient, the Researcher may initiate the call.

5.4.4    Health Records Department: The Researcher may ask the Health Records Department to identify patients who appear to meet the research’s eligibility criteria. The Researcher should supply Health Records with a standard letter describing the research to give to the patient’s physician and asking whether the physician would be willing to approach their patients about participation. It is NOT acceptable for the Researcher or their staff to contact patients identified through hospital records, clinic charts or other databases independently by phone unless the patient has previously agreed or is already under the medical care of the Researcher.

5.4.5    Registries: If the REB has previously approved a patient research registry and the patient has provided permission to be contacted for potential research, the Researcher or their research team may contact these patients directly. The person contacting the patient should identify themselves as associated with the patient’s clinical caregiver and remind them that they have agreed to be contacted. The patient must be offered the option of having their name removed from the database.

5.4.6    Advertising: The REB must first review and approve the text and the use of any advertisements, notices or media messages.

5.5    Recruitment Materials

5.5.1    The REB reviews the recruitment materials (e.g., advertisements (including email recruitment templates), letters, and notices) for evidence of coercion or undue influence and consistency with the REB-approved research and informed consent document.

5.5.2    Advertisements should be reviewed by the REB, as applicable, and according to REB requirements; HSREB and GREB require the following information on recruitment materials:

• Institutional Logo
• Ethics Approval Statement
• Study Title (simplified)
• Purpose of the study
• Target population
• Tasks/time commitment of participant
• Compensation. NOTE: it is recommended that compensation is not included in the recruitment materials.
• Study contact information or QR code

5.5.3    All recruitment materials must be approved by the REB and by each organization where the recruitment material will be displayed, as per local practice, before their use.

5.6    Documentation of Informed Consent

5.6.1    The REB typically requires documentation of informed consent by the use of a written informed consent form approved by the REB and signed and dated by the research participant or the research participant’s legally acceptable representative and by the person obtaining consent.

5.6.2    As required by the Research Sponsor or if required by organizational policies, the Researcher must also sign and date the informed consent form for clinical trials.

5.6.3    A copy of the signed and dated consent form shall be provided to the research participant.

5.6.4    The Researcher or designee should document details of the consent process in the research participant’s medical record, according to the organization’s guidelines.

5.6.5    The Researcher should inform the research participant’s primary physician about the research participant’s involvement in the research if the research participant agrees to the primary physician being informed.

5.6.6    The REB may approve a short form written consent document in cases where the research participant may lack the capacity to consent. The short form consent form contains all required elements of informed consent. A written summary of the information in presented orally to the research participant or their substitute decision maker. The short form consent document is signed by the research participant or the substitute decision maker. An impartial witness must be present during the oral presentation. The witness must sign the short form consent document and a copy of the written summary. The person obtaining consent must sign a copy of the written summary of the information that is presented orally.

5.6.7    The REB may approve a process that allows the informed consent document to be delivered by regular mail, email or facsimile to the potential participant and to conduct a consent interview by telephone or videoconference when the participant can read the consent document as it is discussed. All other applicable conditions for documentation of informed consent must also be met when using this procedure.

5.6.8    In some types of research, and for some groups or individuals where written signed consent may be felt by the participants as mistrust on the part of the Researcher, the REB may approve the process of oral consent, a verbal agreement or a handshake.

5.6.9    Where consent is not documented in a signed consent form, Researchers may use a range of consent procedures (e.g., oral consent, field notes, implied consent through the return of a completed questionnaire). The procedures used to seek consent must be documented by the Researcher and approved by the REB.

5.6.10    Whenever possible, the research participant should have written documentation of participation in a research project unless it may compromise their safety or confidentiality.

5.7    Consent Monitoring

5.7.1    In considering the adequacy of informed consent procedures, the REB may require monitoring of the consent process by an impartial observer.

5.7.2    Such monitoring may be particularly warranted when the research presents significant risks to participants, or if participants are likely to have difficulty understanding the information to be provided.

5.7.3    Monitoring may also be appropriate as a corrective action when the REB has identified problems associated with a particular Researcher or a research project.

5.8    Waiver or Alteration of Informed Consent

5.8.1    The REB may approve a consent procedure that does not include, or which alters, some or all the elements of informed consent, or waive the requirements to obtain informed consent, provided that the REB finds and documents that:

• The regulatory and ethics guidance framework supports the waiver,
• The research involves no more than minimal risk to the participants,
• The waiver or alteration is unlikely to adversely affect the rights and welfare of the participants,
• The research could not practicably be carried out without the waiver or alteration,
• The precise nature and extent of any proposed alteration is defined,
• The information is used in a matter that will ensure its confidentiality,
• Whenever appropriate, the participants will be provided with additional pertinent information after participation.

5.8.2    Debriefing should be a part of all research involving an alteration to consent requirements whenever possible, practicable and appropriate.

5.8.3    Participants should be allowed to refuse consent and request the withdrawal of their data and/or specimens whenever possible, practicable and appropriate.

5.8.4    These findings and their justifications shall be documented in the REB minutes when the REB exercises this waiver provision;

5.8.5    Researchers are not required to seek participant consent for secondary use of non-identifiable information or non-identifiable biological specimens.

5.9    Consent for Research Involving Individuals Who Lack Capacity

5.9.1    For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the REB must ensure that, at a minimum, the following conditions are met:

• The Researcher involves participants who lack the capacity to consent on their own behalf to the greatest extent possible in the decision- making process,
• The Researcher seeks and maintains consent from authorized third parties,
• The authorized third party is not the Researcher or any other member of the research team,
• The Researcher demonstrates that the research is being carried out for the participant’s direct benefit or for the benefit of other persons in the same category. If the research does not have the potential for direct benefit to the participant, the Researcher shall demonstrate how the research will expose the participant to only a minimal risk and how the participant’s welfare will be protected during participation in the research.

5.9.2    If an authorized third party has consented on behalf of a person who lacks legal capacity but that person has some ability to understand the significance of the research, the Researcher ascertains the wishes of that individual with respect to participation.

5.9.3    Assent from a participant is not sufficient to permit them to participate in a research project in the absence of consent by an authorized third party; however, their expression of dissent is respected.

5.9.4    Prospective participants who may be capable of verbally or physically assenting to, or dissenting from, participation in research include:

• Those whose capacity is in the process of development, such as children whose capacity for judgment and self-direction is maturing,
• Those who were once capable for making an autonomous decision regarding consent but whose capacity is diminishing or fluctuating, and
• Those whose capacity remains only partially developed, such as those living with permanent cognitive impairment.

5.9.5    If assent for research is required, the Researcher must submit to the REB the proposed procedures for obtaining consent from the capable substitute decision maker and assent from the research participant. The Researcher must submit an assent form or summary of the assent process to the REB for approval as per the organization’s guidelines.

5.9.6    When authorization for participation was granted by an authorized third party, and the participant acquires or regains capacity during the research, the Researcher will seek the participant’s consent as a condition of continuing participation.

5.9.7    If an individual signed a research directive indicating their preference for ongoing and/or future research participation, if the individual loses capacity or upon their death, an authorized third party may be guided by these directives during the consent process.

5.10    Other Individuals and Groups who may be Vulnerable in the Context of Research

5.10.1    The REB will determine appropriate protections for individuals and groups who might be inappropriately excluded from research on the basis of attributes such as culture, language, sex, race, ethnicity, age and disability, and who require additional protections. For these individuals and groups, the REB will consider the risks and benefits of the research, protections afforded by organizational policies, and provincial and federal law.
Other individuals or groups whose circumstances may make them vulnerable in the context of research should not be inappropriately included or automatically excluded from participation in research on the basis of their circumstances;

5.10.2    In addition, when the REB regularly reviews research involving individuals, groups or populations who may be vulnerable in the context of research, consideration shall be given to including one or more individuals who are knowledgeable and experienced in working with these participants.

Participants may include, but are not limited to:

• Children,
• The Elderly,
• Individuals with mental illness,
• Pregnant women,
• Individuals with limited language skills,
• Indigenous individuals and communities,
• Prisoners.

 
5.10.3        Suppose research involves prisoners, children, pregnant women, fetuses and/or neonates, and is funded or supported by the US Federal Government. In that case, the REB shall apply the requirements of 45 CFR 46, including Sub-Parts, B, C and D as appropriate.

5.11    Consent for Research in Health Emergencies

5.11.1    The REB establishes the criteria for the conduct of research involving medical emergencies prior to approval of the research. The Researcher must justify to the REB the reasons why an exception to obtaining informed consent from participants is required.

5.11.2    The REB allows research that involves health emergencies to be carried out without the free and informed consent of the participant or of his/her authorized third party if ALL of the following apply:

• A serious threat to the prospective participant requires immediate intervention.
• Either no standard efficacious care exists, or the research offers a real possibility of direct benefit to the participant in comparison with standard care.
• Either the risk of harm is not greater than that involved in standard therapeutic care, or it is clearly justified by the potential for direct benefit to the participant.
• The prospective participant is unconscious or lacks capacity to understand risks, methods and purposes of the research project,
• Third-party authorization cannot be secured in sufficient time, despite diligent, and documented efforts to do so, and
• No relevant prior directive by the participant is known to exist.

5.11.3    When a previously incapacitated participant regains capacity, or when an authorized third party is found, free and informed consent is sought for continuation in the project and for subsequent research-related procedures.

5.12    Consent and Secondary Use of Identifiable Information and/or Human Biological Materials for Research Purposes

5.12.1    The REB allows the secondary use of identifiable information and/or human biological materials for research purposes without obtaining consent from research participants if the Researcher is able to satisfy the following conditions:

• Identifiable information/materials is essential to the research,
• The use of identifiable information/materials without the participant’s consent is unlikely to adversely affect the welfare of individuals to whom the information relates,
• The Researchers will take appropriate measure to protect the privacy of individuals, and to safeguard the identifiable information/materials,
• The Researchers will comply with any known preferences previously expressed by individuals about any use of their information/materials,
• It is impossible or impracticable to seek consent from individuals to whom the information relates/materials were collected, and
• The Researchers have obtained any other necessary permission for secondary use of information/materials for research purposes.

5.12.2    In cases where the secondary use of identifiable information/materials without the requirement to seek consent has been approved by the REB, if the Researcher proposes to contact individuals for additional information and/or materials, REB approval must be obtained before contact.

5.13    Incidental Findings

5.13.1        Within the limits of consent provided by the participant, researchers shall disclose any material incidental findings discovered during research. The Researcher’s plan to identify and disclose incidental findings must be submitted to the REB and approved before implementation.

6.0 REFERENCES

See References.