HSREB Letter of Information and Consent Form ChecklistBased on TCPS2 (2014) ONLY
TCPS2 / Description of Element / Additional Guidance / Possible Language
☐ / Study Title / Title must be same title on all research documents.
☐ / Name of Researcher(s)
☐ / Name of Supervisor(s) / All students must include their supervisor(s).
☐ / A statement that the participant is being invited to take part in a research study / Use plain language / I/We are asking you to take part in a research study…
☐ / A statement about why this research is being done (research purpose) / Use plain language
☐ / Describe the research methods, including what participants need to know and what they will be asked to do in plain language / Use plain language / The purpose of our research project is to…
In our research study we plan to…
As a participant you will be asked to/will be responsible for…
☐ / Describe the time commitment required for participation during all phases of the research study / You will be interviewed for one hour…
You will be asked to come to the lab three times for thirty minute sessions…
☐ / Describe what information will be collected about participants and for what purpose and any anticipated uses of data / Personal Information is any information or combination of information that may identify or lead to the identification of a participant such as name, gender, date of birth, student number, and address.
Confidentiality is an extension of privacy, as it pertains to the security of the data. / I/We will be collecting… [type of information including video/audio recording(s)]
I/We will be using this information for… [include anticipated uses of data]
☐ / Describe all reasonably foreseeable risks or inconveniences, to participants, and in general, that may arise from research participation and any plans to mitigate the risks as applicable / Research would be classified as ‘Minimal risk’ if the probability and magnitude of possible harms, related to participating in the research, is no greater than those encountered in aspects of everyday life. Anything greater than minimum risk needs to be communicated to participants. / The risks for you in this research include…
I/We plan to minimize these risks by…
There are no known risks for taking part in this study.
Element from
TCPS2 / Description of Element / Additional Guidance / Possible Language
☐ / Describe all potential benefits, both to participants and in general, that may arise from participation. If no benefits, explicitly state so / Human participant research may result in benefits that positively affect the welfare of society as a whole through the advancement of knowledge for future generations, for participants themselves or for other individuals; however, most research offers no direct benefit to participants. For additional guidance, see TCPS2 (2014) Chapter 2: / The benefits for participating in this research may include…
There are no direct benefits for participating in this research…
☐ / A statement that the participant does not have an obligation to say yes / There is no obligation for you to say yes…
☐ / A statement that the participant is free to stop participating at any time without penalty / You can stop participating at any time without penalty…
You do not have to answer any questions you don’t want to…
☐ / Outline how the participant can withdraw from the study, and include information about the withdrawal of data and any limitations the withdrawal of data / It may not be possible for withdrawal of data in some circumstances (e.g., completion of anonymous surveys). If withdrawal of data is not possible, outline this fact, or the time point at which withdrawal of data is no longer possible / You have the right to request the withdrawal of your data/up until…by contacting me at…
☒ / Explain to participants what aspects of their data will be revealed in presentations/publication of the findings / I hope to publish the results of this study…
I will include quotes from some of the interviews when presenting my findings. However, I will never include any names with quotes, and I will do my best to make sure quotes do not include information that could indirectly identify participants. During the interview, please let me know if you say anything you do not want me to quote…
Element from
TCPS2 / Description of Element / Additional Guidance / Possible Language
☐ / Describe how confidentiality will be protected. Include who will have access to data during all phases of research (collection, analysis, publication and dissemination, archiving) / The ethical duty of confidentiality includes obligations to protect information from unauthorized access, use, disclosure, modification, loss, or theft. For additional guidance, see TCPS2 (2014) Chapter 5: / I/We plan to protect your information by…
☐ / A statement that all data must be retained for a minimum of five years / I/We will keep your data securely for at least five years…
☐ / Information about payments, including any incentives for participating and reimbursement for participation-related expenses / Describe incentives/compensation/reimbursement. For additional guidance refer to “Incentive Guidelines for Human Participant Research”, which is posted on the HSREB website. / For participating in this research you will be …
☐ / The name and contact information for the individual(s) to contact about the research study / All students must include their supervisor(s) contact information / If you have any questions about the research study please contact…
☐ / The contact information for any ethics concerns / Must include:
- HSREB Chair email:
- Contact number: 1-844-535-2988 (Toll free in North America)
☐ / A statement that the participant has read the Letter of Information/Consent Form (LOI/CF), has all of their questions answered, and that they should keep a copy of the LOI/CF and return a copy to the Researcher / By signing below, I am verifying that: I have read the Letter of Information and all of my questions have been answered. I will keep one copy of the Letter of Information for my record and I will return one copy to the researcher.
☐ / Signature and date of signature of the participant (or their substitute decision-maker/legally authorized representative, if applicable) / Signature/date of participant required on Consent Form only
The following elements are only required as applicable.
Element fromTCPS2 / Description of Element / Additional Guidance / Possible Language
☐ / Name of Sponsor(s)/Funder(s). / List as applicable.
☐ / Is there biological specimen collection (mandatory or optional)? / If there is biological specimen collection (mandatory or optional), the recommended statement must be added into the appropriate consent form(s). / If you are a First Nations or an indigenous person who has contact with spiritual 'Elders', you may want to talk to them before you make a decision about this research study. Elders may have concerns about some research procedures including genetic testing.
☐ / Are genetic samples being sent off-site or outside of Canada? / While the risk of re-identification from “de-identified” genetic material may not be high, with advances in genetic testing, there is a risk of re-identification and the associated risks of disclosure is present. In addition, once the genetic material is sent out of Canada, it is no longer under the protection of Canada’s privacy laws. The HSREB requires that a statement about this be included in all Consent Forms. / Though the risk is not high, there is a chance that your genetic blood sample could be re-identified and your identity and information from genetic test results disclosed during storage and shipment of your genetic blood sample.
☐ / Is there a duty to report? / Section 72 of the Child and Family Services Act (CFSA; states that if a person, including a person who performs professional duties with respect to children under the age of 16, has reasonable grounds to suspect a child may be in need of protection, that person has a duty to report suspicions of physical, sexual, and emotional abuse, neglect, and risk of harm, directly to the Children’s Aid Society (CAS). This requirement extends to children already under a child protection order who are 16 and 17 years old.
In research projects that have a reasonable possibility of the disclosure of child abuse, neglect, or risk of harm, it must be clearly stated in the Letter of Information/Consent Form that confidentiality will be breached in those instances. / Members of the research team will receive and have access to confidential information about children and families. Except when required by law, such as when there are reasonable suspicions of child abuse, neglect, or risk of harm, this information will be kept confidential to the extent possible.
☐ / Is there a possibility of commercialization of research findings? / Describe any information on the possibility of making research findings available on the public market.
☐ / Will you be providing compensation for research-related injury? / A description of the compensation, if any, that will be provided to the participant in the event that he/she is injured during the research.
☐ / Do participants need to know that they have not waived any legal rights/rights to legal recourse in the event of research-related harm? / A statement that the participant has not waived any legal rights/rights to legal recourse in the event of research-related harm.
Element from
TCPS2 / Description of Element / Additional Guidance / Possible Language
☐ / Is there a conflict of interest? / Information concerning the presence of any real, potential or perceived conflicts of interest (COI) on the part of the researchers, their institutions or the research sponsors.
A conflict of interest exists if there is a potential benefit to the investigator(s), study staff, or member of their immediate family beyond the professional benefit from academic achievement or presentation of the results. Examples include, but are not limited to, speakers’ fees, travel assistance, consultant fees, honoraria, gifts, and intellectual property rights such as patents. A declaration of conflict of interest should include the identity of the person with the conflict of interest, the type of incentive or inducement, and its source.
☐ / How will new information be communicated to participants that may impact their decision to continue participating in the research? / An assurance that participants 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.
☐ / How can participants be removed from the research without the participant’s consent? / Information on stopping rules and when researchers may remove participants from the research without the participants’ consent.
HSREB Letter of Information and Consent Form Checklist
Based on TCPS2 ONLY v.2016NOV18
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