Must be printed on institutional letterhead

Project Title:{Put the title of your project here}

Principal Investigator:

{List the Principal Investigator here}

E.g.Jane Smith, MD, Department, Institution

Letter of Information

  1. Invitation to Participate

{Provide an invitation to participate and explain to the potential participant WHY they are being targeted for recruitment}

E.g. You are being invited to participate in this research study {indicate what the research study is about} because you {indicate why they are being asked to participate}.

  1. Purpose of the Letter

{Outline what the purpose of this letter is here}

E.g. The purpose of this letter is to provide you with information required for you to make an informed decision regarding participation in this research.

  1. Purpose of this Study

{Outline what the purpose of this study is here}

E.g. The purpose of this study is to {indicate why the study is being done here and your objectives}.

  1. Inclusion Criteria

{Outline the inclusion criteria from your protocol submission for this study here, providing the information on what age group and any other specific inclusion criteria that is required for the study}

E.g. Individualswho {indicate what the inclusion criterion are} are eligible to participate in this study.

  1. Exclusion Criteria

{Outline whatspecific criteria based on your protocol submission will exclude someone from the study here}

E.g. Individuals who are {indicate what the exclusion criterion are} are not eligible to participate in this study.

  1. Study Procedures

{Outline what activities / procedures that you will be asking the study participants to do / perform here.}

E.g. If you agree to participate, you will be asked to {insert what they will be asked to do here}. It is anticipated that the entire task will take {inset how long here}, over {inset number of sessions here}. The task(s) will be conducted in the {insert location here}. There will be a total of {insert number of local and total participants here as applicable}.

  1. Possible Risks and Harms

{Outline any possible risks and harms here as per your protocol submission, or if none, indicate it here.}

E.g. The possible risks and harms to you include {insert risks and harms here}.

Or

There are no known or anticipated risks or discomforts associated with participating in this study.

  1. Possible Benefits

{Outline any possible benefits to the participants and to society as per your protocol submission here. You may indicate there are no benefits to the participant but there should always be societal benefits}

E.g. The possible benefits to participants may be {insert benefits here}. The possible benefits to society may be {insert societal benefits here}.

OR

You may not directly benefit from participating in this study but information

gathered may provide benefits to society as a whole which include {insert societal benefits here}.

  1. Compensation

{Outline any compensation that will be provided to the research participant}

E.g. You will be compensated {insert what the compensation is, if applicable} for your participation in this study. If you do not complete the entire study you will still be compensated at a pro-rated amount of {indicate the pro-rated amount and how it will be offered}.

OR

You will not be compensated for your participation in this research.

  1. Voluntary Participation

Participation in this study is voluntary. You may refuse to participate, refuse to answer any questions or withdraw from the study at any time with no effect on your future (care/academic status/employment etc).

{Please only select the above choices in the brackets which apply to your study / participants)

  1. Confidentiality

{Describe the protection of the participant’s privacy, method of storing research data, and who may have access to study records.} Examples below marked with a * may not be applicable to your study. Please see the Letter of Information Guidelines to see all forms of required wording for this section of the letter to ensure that you choose the wording applicable to your study.

E.g., All data collected will remain confidential and accessible only to the investigators of this study. If the results are published, your name will not be used. *If you choose to withdraw from this study, your data will be removed and destroyed from our database. *While we will do our best to protect your informationthere is no guarantee that we will be able to do so.The inclusion of your initials and your date of birthmay allow someone to link the data and identify you. *Representatives of The University of WesternOntario Non-Medical Research Ethics Board maycontact you or require access to your study-relatedrecords to monitor the conduct of the research.

  1. Contacts for Further Information

{Instructions on whom (name and phone number)to contact regarding any questions or concerns that may be raised by participating in the study or questions that may be raised by being a research participant.}

E.g. If you require any further information regarding this research project or your participation in the study you may contact {inset name, number, and email for Principle Investigator and, if applicable, Co-Investigators or Administrative Contact here / student researcher.}

You must also include:

E.g. If you have any questions about your rights as a research participant or the conduct of this study, you may contact The Office of Research Ethics (519) 661-3036, email: .

  1. Publication

{Outline the ways in which the results will be published and if appropriate, how the participants will be informed of the results.}

E.g. If the results of the study are published, your name will not be used.If you would like to receive a copy of any potential study results, please contact {insert contact name(s) here}.

OR

E.g. If the results of the study are published, your name will not be used.If you would like to receive a copy of any potential study results, please provide your name and contact number on a piece of paper separate from the Consent Form.

  1. Consent

{Indicate how the participant will be consented to participate in the study}

Alternate method of consent

E.g. Completion of the survey is indication of your consent to participate.

OR

E.g. Completion of the survey is indication of your consent to participate.

OR

E.g. You indicate your voluntary agreement to participate by responding to the questions.

OR

Written Consent

Include a Consent Form with this letter that the participant will sign. This does not need to be indicated in the letter.

This letter is yours to keep for future reference.

Consent Form

Project Title: {Insert the project title here}

Study Investigator’s Name: {Insert name here}

I have read the Letter of Information, have had the nature of the study explained to me and I agree to participate. All questions have been answered to my satisfaction.

Child’s Name:(if applicable)______

Participant’s Name (please print): ______

Participant’s Signature: ______

Date:______

Parent / Legal Guardian / Legally Authorized Representative (if applicable) Print: ______

Parent / Legal Guardian / Legally Authorized Representative (if applicable) Sign: ______

Parent / Legal Guardian / Legally Authorized Representative (if applicable) Date: ______

Person Obtaining Informed Consent (please print):______

Signature:______

Date:______

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