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NFORMED CONSENT FORM (ICF) I GUIDANCE / CHECKLIST (Island Health)

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I
NFORMED CONSENT FORM (ICF)
GUIDANCE / CHECKLIST
Island Health’s HREB (Health Research Ethics Board) and Information Stewardship, Access and
Privacy Office have compiled the following list of requirements when studies include an
informed consent form (ICF). If you have not included the following or justification as to why
not in your research ethics application form, the approval process could be delayed.
The Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS2 (2014))
requires:
☐ Information that the individual is being invited to participate in a research project;
☐ A statement of the research purpose in plain language, the identity of the researcher, the identity of
the funder or sponsor, the expected duration and nature of participation, a description of research
procedures, and an explanation of the responsibilities of the participant;
☐ A plain language description of all reasonably foreseeable risks and potential benefits, both to the
participants and in general, that may arise from research participation;
☐ An assurance that prospective participants:
Are under no obligation to participate; are free to withdraw at any time without prejudice to
pre-existing entitlements;
Will be given, in a timely manner throughout the course of the research project, information
that is relevant to their decision to continue or withdraw from participation; and
Will be given information on the participant’s right to request the withdrawal of data or human
biological materials, including any limitations on the feasibility of that withdrawal;
☐ Information concerning the possibility of commercialization of research findings, and the presence
of any real, potential or perceived conflicts of interest on the part of the researchers, their
institutions or the research sponsors;
☐ The measures to be undertaken for dissemination of research results and whether participants will
be identified directly or indirectly;
☐ The identity and contact information of a qualified designated representative who can explain
scientific or scholarly aspects of the research to participants;
☐ The identity and contact information of the appropriate individual(s) outside the research team
whom participants may contact regarding possible ethical issues in the research;
☐ An indication of what information will be collected about participants and for what purposes; an
indication of who will have access to information collected about the identity of participants, a
description of how confidentiality will be protected (see Article 5.2), a description of the anticipated
uses of data; and information indicating who may have a duty to disclose information collected, and
to whom such disclosures could be made;
☐ Information about any payments, including incentives for participants, reimbursement for
participation-related expenses and compensation for injury;
☐ A statement to the effect that, by consenting, participants have not waived any rights to legal
recourse in the event of research-related harm; and
Version: 1.0 Version Date: 16 MAR 2015 Page 1 of 3
I
NFORMED CONSENT FORM (ICF)
GUIDANCE / CHECKLIST
☐ In clinical trials, information on stopping rules and when researchers may remove participants from
trial.
The Freedom of Information and Protection of Privacy Act (FoIPPA) provides guidance on how to ensure
that the participant is fully informed regarding the use of their personal information during a study. The
ICFs must include:
☐ a. The personal information for which the individual is providing consent (i.e. the type)
☐ b. The organization for which they are authorizing to share their personal information (i.e. Island
Health)
☐ c. The date on which the consent is effective, and if applicable, the date on which it expires
☐ d. Who the information is being shared with and/or collected by
☐ e. The purposes for the collection of the personal information
☐ f. Who may store or have access to the personal information
☐ g. The jurisdiction in which they personal information may be stored / accessed (Canada or other*)
☐ h. The purposes for the storage or and access to the personal information
☐ i. The uses of the personal information
☐ j. To whom the personal information will be further disclosed
☐ k. The purpose of the disclosure of the personal information
☐ l. Who the individual may contact with questions or requests concerning their personal
information in the study
* I
nformation being sent to, accessed from or stored outside of Canada
If participant information is being sent to, accessed from, or stored outside of Canada (e.g. If you
find that the videoconferencing technology does have a server(s) in the United States), you must
provide notice of this to participants. To be FoIPPA compliant, please notify participants by
including the following:
☐ Describe whom the participant is authorizing to use or disclose their personal information
(e.g. Island Health, Providence, UVic, UofM);
☐ Describe who may have access to the personal information after it is disclosed;
☐ Describe the safeguards in place to protect the information while it is being accessed,
sent, or stored;
☐ Describe which country it is being sent to, accessed from, or stored in;
☐ The name(s) of the organization(s) it is being sent to, accessed from, or stored at;
☐ The purpose for which it is being sent to, accessed from or stored outside of Canada;
☐ The safeguards in place to protect the information while it is being sent to, accessed from,
or stored outside of Canada;
☐ A statement that once information is sent to, accessed from, or stored outside of Canada,
it is subject to the laws of that country which may be different from the laws in British
Version: 1.0 Version Date: 16 MAR 2015 Page 2 of 3
I
NFORMED CONSENT FORM (ICF)
GUIDANCE / CHECKLIST
C
olumbia/Canada that govern how information may be collected, accessed, used or
shared/disclosed.
Additional considerations for ICFs include:
o The informed consent process must include adequate time and opportunity for prospective
participants to assimilate the information provided, pose any questions they may have, and
discuss and consider whether they will participate. The time required for this initial phase of the
consent process will depend on such factors as the magnitude and probability of harms, the
complexity of the information conveyed, and the setting where the information is given.
o The key to informed consent is that prospective participants understand the information bein
g
c
onveyed to them by researchers. Researchers and REBs should consider how best to convey
that information to facilitate understanding. For example, written documentation may be
s
upplemented with audio and/or visual aids, or accompanied by video presentations.
o When language barriers necessitate the assistance of an intermediary for communication
between the research team and participants, the researcher should select an intermediary who
has the necessary language skills to ensure effective communication. The involvement of such
intermediaries may raise confidentiality issues.
Guidance regarding the form(s) must also include:
☐
Island Health logo
☐ P
age numbering and a version number and version date included in the footer
☐ Island Health Research Ethics Board contact information. “If you have any concerns about your
rights as a research participant and/or your experiences while participating in this study, or if
you wish to verify the ethical approval of this study, you may email researchethics@viha.ca or
call 250 370-8620.”
Version: 1.0 Version Date: 16 MAR 2015 Page 3 of 3
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Completed 25 November 2020

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