Informed Consent Template - Instructions

 

Investigator(s):

Insert the principal investigator’s name and title (indicate the name and affiliation of the supervisor in the case of a student project). Include the names of any co-researchers and/or research assistants. Example: Principal investigator and co-researchers Dr. John A. Smith, Ambrose University, Principal Investigator Dr. Jane B. Smith, University of Calgary, Researcher Dr. Jack C. Smyth, The Research Institute of Alberta, Researcher Marlene Smith, Ambrose University, Research Assistant Example: Student project Student Q. Student, Ambrose University, Principal Investigator Dr. John A. Smith, Ambrose University, Supervisor

Title of Project:

Insert the title of the project here

This consent form, a copy of which has been given to you, is only part of the process of informed consent. If you would like more details about something mentioned here, or information not included here, you are welcome to ask. Please take the time to read this document carefully and to be sure you understand any and all accompanying information.

The Ambrose University Research Ethics Board has approved this research study.

If the project is funded, identify the funding source here. Otherwise, delete this text.

Purpose of the Study

Describe the purpose of the study in clear and simple language that a layperson will understand. Avoid technical jargon and theoretical concepts that your participants are unlikely to be familiar with. No more than a paragraph of text is necessary here.

What Will I Be Asked to Do?

In plain language, describe what the participant will be asked to do. Remember that participants cannot provide truly informed consent unless it is clearly explained to them what they will be asked to do. Describe the tasks participants will be asked to perform. If participants will be asked to complete a questionnaire or interview, give examples of the types of questions that will be asked, and be very clear when personal and sensitive questions are included. State (approximately) how much time participation will require and, if applicable, the location where they will need to present themselves.

If you are requesting to video- or audio-record participants, state that clearly here and provide the rationale.

If there will be follow up (e.g., a second part to the study), indicate how this will be accomplished (e.g., how will participants be contacted?). Indicate that participation in the follow up is completely voluntary.

End this section by stating that participation is completely voluntary, that the individual may refuse to participate altogether, may refuse to participate in individual components of the study, may decline to answer any and all questions, and may withdraw from the study at any time without penalty or, if applicable, loss of benefits to which s/he is otherwise entitled (e.g., assistance received through Agency “X” will not be affected).

What Type of Personal Information Will Be Collected?

If no personal identifying information is to be collected (e.g., names, social insurance numbers, student ID numbers, email addresses, etc.), and the participant will be completely anonymous, use the following statement: “No personal identifying information will be collected in this study, and all participants shall remain anonymous.”

If information such as gender, age, ethnicity, education level (etc.) is collected, provide a description of the type of information you will be collecting. For example, “Should you agree to participate, you will be asked to provide your gender, age, and academic major.”

If you wish to audiotape or videotape the participant, explain who will have access to the recordings, whether the recordings will ever be shown in public, the location and level of privacy that will be afforded participants during audiotaped or videotaped sessions.

Are there Risks or Benefits if I Participate?

List reasonably foreseeable risks, harms, or inconveniences to the participant. If the research necessitates the provision of rescue mechanisms (e.g., if there is a possibility of identifying distressed individuals), advise the participant what these are, how to access the support, and whether there is any cost to the individual. This information is also usually listed in a handout or debriefing document that is provided to the participant, to supplement the verbal description of these resources.

If the research has the potential to reveal information that is required by law to be reported to a law enforcement officer or other agency (e.g., child abuse), inform your participant of your legal obligations.

If the participant will be paid or compensated for taking part in the research, describe the payment. Describe the partial payment arrangement if the participant withdraws before the study is completed (e.g., participants might be paid $5.00 out of a possible $25.00 if they decide to withdraw). If the participant will incur any costs, describe these.

What Happens to the Information I Provide?

Explain who will have access to the information collected (e.g., principal investigator, research assistants, supervisor, etc.).

State how the participant’s contribution will be treated. For example, will pseudonyms or some other means of ensuring anonymity be used? Explain any limitations to the anonymity/confidentiality that you can offer.

Tell the participant what will happen to their information if s/he decides to withdraw. (Note: in the case that a participant withdraws from a study, the TCPS advises that all data the participant contributed be destroyed unless this is not feasible or there are compelling reasons not to do so).

The following is a suggested statement to include in this section (be sure to adapt the statement for your specific project): “Participation is completely voluntary, anonymous and confidential. You are free to discontinue participation at any time during the study. No one except the researcher and his/her supervisor will be allowed to see or hear any of the answers to the questionnaire or the interview recording. There are no names on the questionnaire. Only anonymous group information will be summarized for any presentation or publication of results. The questionnaires are kept in a locked cabinet only accessible by the researcher and her supervisor. The anonymous data will be stored securely for five years on a computer disk, at which time, it will be permanently erased.”

Permissions

If applicable to your research, describe options available to the participant. To do so, it may be useful to create a check list to enumerate the participant’s choices. For example, you might explain to the participant: “There are several options for you to consider if you decide to take part in this research. You can choose all, some, or none of them. Please review each of these options and choose Yes or No:”

You can revise the following list of choices as necessary to accommodate the circumstances of your research. You can also add choices that are relevant to your circumstances:

I grant permission to be audio recorded:                                 Yes              No

I grant permission to be video recorded:                                 Yes              No

I grant permission to have my company’s name used:            Yes              No

I wish to remain anonymous:                                                   Yes              No

I wish to remain anonymous, but you may refer to me by a pseudonym:       Yes             No                                      

The pseudonym I choose for myself is: ____________________________

I agree to the use of anonymous quotations in the reporting of results:         Yes             No

Signatures

Your signature on this form indicates the following:

1. You understand to your satisfaction the information provided to you about your participation in this research project
2. You agree to participate in this research project of your own free will

In no way does this waive your legal rights nor release the investigators, sponsors, or involved institutions from their legal and professional responsibilities. You are free to withdraw from this research project at any time. You should feel free to ask for clarification or new information throughout your participation.

Participant’s Name (please print): __________________________________________________

Participant’s Signature: _________________________________      Date: __________________

Principal Investigator’s Name (please print): ________________________________________

Principal Investigator’s Signature: ____________________________    Date: ______________

Questions or Concerns?

If you have any additional questions or would like clarification regarding this research project and/or your participation, you are welcome to contact:

Insert name of principal investigator

Department/Faculty

Telephone/Email

(In the case of a student project, provide the supervisor's name, department/faculty, telephone number, and email)

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 If you have any concerns about the way you have been treated as a participant, please contact the Chair of the Research Ethics Board, Dr. Jonathan Goossen, by phone at 403-410-2000 (ext. 5960) or by email at ResearchEthics@ambrose.edu. 

A copy of this consent form has been given to you to keep for your records and reference. The investigator will retain the original, signed copy of this consent form for his/her records.