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Informed Consent Form – Instructions and Template
Informed consent documentation is required whenever there are human participants involved in research. The following sections are required in all informed consent documents, and this instructions sheet is intended to assist students in the preparation of informed consent documentation. The Office of the Dean, Graduate Studies has created a template which is attached to these instructions, and which students are encouraged to utilize. Wherever necessary, informed consent documents should be modified based on the research being conducted. Informed consent documentation should be developed in conjunction with the research ethics protocol (York University Graduate Student Human Participants Research Protocol).
Study name: Include the study name.
Researchers: Include the names of all researchers here (student(s) and faculty). Include your level of study, graduate program and institution. Include your contact details, including email address and/or office phone number. Do not use a personal phone number or home address.
Purpose of the research: Include a statement about the purpose of the research. Include a statement indicating how the research will be conducted, presented and reported.
What you will be asked to do in the research: Include a statement regarding the role and/or responsibilities of the research participants. Include a statement regarding the estimated time commitment for the participation. If inducements will be offered, indicate them here.
Risks and discomforts: Include a statement regarding any real or perceived risks or potential discomfort that may result from participation in the research. If there is a possibility of harm or discomfort it must be described and the mitigation methods must be indicated.
Benefits of the research and benefits to you: Include a statement regarding any benefits of the research as well as benefits to the research participants.
Voluntary participation: Include the following required text: “Your participation in the research is completely voluntary and that participants may choose to stop participating at any time. Indicate that a participant’s decision not to continue participating will not influence their relationship or the nature of their relationship with researchers or with staff of York University either now or in the future.”
Withdrawal from the study: Include the following required text: “You may stop participating in the study at any time, for any reason, if you so decide. Your decision to stop participating, or to refuse to answer particular questions, will not affect your relationship with the researchers, York University, or any other group associated with this project. In the event that you withdraw from the study, all associated data collected will be immediately destroyed wherever possible.”
If you are offering inducements, the following text is also required: “If you decide to stop participating, you will still be eligible to receive the promised pay for agreeing to be in the project“.
Confidentiality:
Indicate whether or not the interview documentation/recording of the participant will be associated with identifying information. Indicate how the data will be collected (e.g. handwritten notes, video/audio tapes, digital device, etc.). Indicate how the data will be stored, who will have access to it, and that it will be stored securely. Indicate how long the data will be stored and whether or not it will be destroyed after the study, and how it will be destroyed. If the data will not be destroyed, indicate where and how it will be archived.
Include the following required text: “Confidentiality will be provided to the fullest extent possible by law.”
Questions about the research? Indicate that if a research participant has questions about the research in general or their role in the study that they should contact the researcher or their supervisor. Provide the supervisor’s name and telephone number and/or email address. Indicate that the graduate program office may also be contacted. Provide the contact information for the graduate program office.
Include the following required text: “This research has been reviewed and approved by the Human Participants Review Sub-Committee, York University’s Ethics Review Board and conforms to the standards of the Canadian Tri-Council Research Ethics guidelines. If you have any questions about this process, or about your rights as a participant in the study, your may contact the Senior Manager and Policy Advisor for the Office of Research Ethics, 5th^ Floor, York Research Tower, York University, telephone 416-736-5914 or e-mail ore@yorku.ca”
Legal Rights and Signatures: Include the following required text: “I <<fill in the research participant’s name here>>, consent to participate in _<> conducted by <>. I have understood the nature of this project and wish to participate. I am not waiving any of my legal rights by signing this form. My signature below indicates my consent.
Signature Date Participant: name
Signature Date Principal Investigator: name”
Optional: Additional consent If you require additional consent (e.g., for video/audio recording, to waive anonymity, to authorize the use photographs, to use associated data, etc.) include check boxes or request additional signatures.
Withdrawal from the study : You can stop participating in the study at any time, for any reason, if you so decide. Your decision to stop participating, or to refuse to answer particular questions, will not affect your relationship with the researchers, York University, or any other group associated with this project. In the event you withdraw from the study, all associated data collected will be immediately destroyed wherever possible.
Confidentiality
Confidentiality will be provided to the fullest extent possible by law.
Questions about the research?
This research has been reviewed and approved by the Human Participants Review Sub-Committee, York University’s Ethics Review Board and conforms to the standards of the Canadian Tri-Council Research Ethics guidelines. If you have any questions about this process, or about your rights as a participant in the study, your may contact the Senior Manager and Policy Advisor for the Office of Research Ethics, 5th^ Floor, York Research Tower, York University, telephone 416-736-5914 or e-mail ore@yorku.ca
Legal rights and signatures :
I, , consent to participate in
conducted by. I have understood the nature of this project and wish to participate. I am not waiving any of my legal rights by signing this form. My signature below indicates my consent.
Signature Date Participant
Signature Date Principal Investigator
Optional: Additional consent:
