CHEO REB Template Version 4.0 June 19, 2017 (Delete Upon Use)

CHEO REB template version 4.0 June 19, 2017 (delete upon use)

Information & consent form

Protocol Title: Insert Name of Study

Investigator: Name of Dr.

Sponsor: If applicable

Address: CHEO, Department of______,

401 Smyth Road, Ottawa, ON K1H 8L1

Telephone Number: (613) 737-7600 Ext Fax: (613) ______

For more simplicity, the word “you”, when used in this form, means “yourself” or “your child”.

You are being invited to join in a research study about {insert text}. You are being invited to join this study because {insert information}. Before agreeing to take part in this study, it is important that you read and understand this document.

Taking part in this study is voluntary. Your decision to participate or not in this study will not affect the care you receive at CHEO. You are free to withdraw from the study at any time and there will be no penalty to you or your child.

Why is this study being done?

This study is being done because {insert information} and/or we hope to find out {insert information}.

How many people will participate?

At CHEO, we expect to have {x number} of people participate.. The study is expected to be recruitingfor {x timeframe}.

What will I have to do?

Include a step-by-step description of the study procedures to be done.

• Whenever possible, illustrate the procedures in a table or schema.
• List each test/procedure/survey/interview, how often it is to be done (i.e., every month, every day), the number of times it is to be done, and the amount of time it is expected to take to complete each procedure/sample/survey.
• Include whether the test/procedure is different from the current standard of care or part of their typical care (i.e., an ‘extra’ sample of blood will be taken, you will be asked to complete a survey).
• If blood is being drawn, indicate the volume, whether or not this draw will be appended to routine blood sampling and the possible uses of the blood.
• If it is a questionnaire include what types of questions would be asked of them.
• If randomization or sequential assignment is to be carried out, explain the terms and the probability of being assigned to each option (‘you have a 1 in 3 chance of…).
• If audio recordings or video recordings, include this information.
• Review of the patient’s health record for the research project must also be mentioned, if this is part of the trial.

If you decide to participate in this study, you will be asked to {insert information – as a list, as a table, or in sentence form}.

Are there any risks to participating?

Indicate to the participant the reasonable foreseeable risks or inconveniences, discomforts to the subjects.

If there are no known harms:

There are no known risks associated with taking part in this study.

If there are known harms to the participants, clearly state:

• Current knowledge regarding the nature, probability and personal relevance of harms or inconveniences of participating in the research.
• Any knowledge regarding the reversibility of the harm (i.e, bruising or redness that will disappear in a few days).
• Description of any procedures that might be done to offset or minimize harms or inconveniences

Examples:

For surveys/ interviews/questionnaires:

A potential discomfort may include you feeling uncomfortable with some of the questions being asked if they are sensitive or evocative. If you feel uncomfortable, you may choose not to answer a question.

For group interviews/focus groups:

During the group meeting we will remind everyone that the information shared is private and should not be repeated outside the group but we cannot be sure that information about you will be kept private. People in groups may share information with others outside the group.

For blood tests:

Blood drawing causes some pain and may cause bruising, bleeding or infections at the site of the needle stick. Care will be taken to avoid theses complications. Analgesic (numbing or pain blocking) cream can be used to decrease the pain and discomfort of blood tests.

Are there any benefits to participating?

Indicate to the participant the reasonable foreseeable benefits, if any.

If no benefit or questionable benefit:

If you decide to participate, you may or may not benefit from participating in this study; however, we hope to {insert information – i.e., change clinical practice or to take better care of patients in the future.}

If yes to benefit:

• Describe the benefit

Will I be paid to participate?

Describe the compensation or payment if any; and describe if the participant will receive payment if they withdraw.

If no compensation

You will not be paid to take part in this study.

If reimbursement

• You will be reimbursed for {insert – i.e., parking costs, travel, reasonable out of pocket expenses}.

OR

• We will provide you with some compensation {name item or amount}, in recognition of your time and effort.

If you withdraw, you will receive {insert amount} or you will not receive compensation for your time.

If there are potential future developments

It is possible that research conducted may eventually lead to the development of {insert – e.g. new diagnostic tests, new drugs, or other commercial products}. There are no plans to provide payment to you if this happens.

Can I Withdraw?

You can withdraw from the study at any time without any impact to your current or future {insert - care, employment, career, etc} at CHEO. Please discuss with your investigator if you would like to withdraw. If you withdraw your consent, the investigator will no longer collect, and disclose your health information for the purpose of this study. Information that was already collected will still be used by the Investigator orall information collected will be discarded.

{if there are samples collected, indicate the participants ability to withdraw the samples, and/or data generated from those samples}

What if I get injured? (If applicable)

In the event that you or your child suffers injury as a direct result of participating in this study, normal legal rules on compensation will apply. Medical care will be provided to you or your child. By signing this consent form you are in no way waiving your legal rights or releasing the investigator {and name the Sponsor, (if applicable)} from their legal and professional responsibilities.

Will I be told about new information?

We will inform you of any new information that might changeyour decision to continue to participate in this research project. We will ask you again if you still want to be in the study.

You can receive a copy of the study results at the end of the study. Please let the study team know if you like to receive a copy.

If there is a possibility of incidental findings:

If this study uncovers information that might be helpful to your current or future health, the investigator would offer to discuss these findings with you. The investigator would first advise you of any risks and benefits of sharing this information with you. If necessary, the investigator will recommend consultation with a genetic counsellor and repeat testing in a clinical (not research) laboratory.

What about confidentiality and privacy?

Your personal information will be kept strictly confidential except as required or permitted by law.[As required:Any information that would indicate that a child was being harmed or at risk of such harm, would not be kept confidential and instead be disclosed as appropriate to the appropriate authorities.]

For this study we will be collecting these personal identifiers {insert patient identifiers – i.e., initials, gender, DOB, postal code} for the research purposes described in this consent form. Your personal identifiers will be kept in a document that links this information with a study ID, called a master list. The study ID will be used in all of the research documents instead of your personal information to protect your privacy. The master list will be stored separately from the research data. It will be stored {insert -where & how}, with access restricted to {insert who – researcher, research team, etc.}.

Representatives from the CHEO research Ethics Board and a quality reviewer from CHEO research institute may look at your records at the site where these records are held, to check that the study is following the proper laws and guidelines.

The research data {and [audio or video] recordings (if applicable)} produced from this study will be stored {insert where and how– i.e., secure, locked location}. Only members of the research team and the individuals described above will have access to the data. Following completion of the study the research data and master list will be kept for {insert timeframe – if secondary use is intended this should be longer then 7 years} after the last publication of this study. They will then be destroyed.You will not be identified in any publication or presentation of this study.

[If the data /information is being sent outside of the site (i.e, SickKids, Study Sponsor), please insert the following language:This study is taking place at multiple sites which means the research data will be shared outside of the hospital. Representatives from {insert outside site}will receive research data including your study ID, for data analysis and/or quality assurance. Any personal information about you that leaves the hospital will be coded with a study ID so that you cannot be identified by name. This is called de-identified data.][If personal identifiers are being sent outside of the hospital, modify these sentences to indicate which identifiers will be sent outside of the hospital and to whom)]. The de-identified research data will be sent securely to {insert where} and stored {insert where, and how} and for {x years -how long}.

[If there is secondary use of the de-identified data set insert:The de-identified data will be used to answer future related research questions about {insert}. Any researcher wishing to use this data will need research ethics board approval, as well as approval from the {insert who – study research team, principal investigator, etc.}. You will not be re-contacted for this use.]

[If a person’s photo is to be published in full, insert the following language:

Although my or my child’s name will not be published, my child’s photo may be published in full. As a result, my child’s identity cannot be protected fully]

A copy of the signed consent form will be provided to you.

Is the research team benefiting from the study(i.e., real or perceived conflict/competing interests)?

It is the responsibility of the primary investigator to identify actual or potential conflicts of interest of members of the research team. A declaration of these three points must be made: 1. Identify of the person with COI , 2.Type of incentive or inducement, 3. Its source.

• {Name specific team members}may benefit personally, financially or in some other way from this study.
• Dr.{X}or a family member or dependent of Dr.{X}
• Has received or may receive for research related in the present study (money, benefits, etc.)
• From{the Sponsor(s)}that have activities related to the present study.

OR

• The research team members are not benefiting personally, financially or in some other way from this study.

What if I have questions?

If you have any questions concerning participation in this study [{if applicable},or if at any time feel that you have experienced a study-related injury or reaction to the study medication,]contact:

Dr. ______613- 737 7600 Ext.___

This study has been reviewed and approved by the CHEO Research Ethics Board. The CHEO Research Ethics Board is a committee of the hospital that includes individuals from different professional backgrounds. The Board reviews all human research that takes place at the hospital. Its goal is to ensure the safety of people taking partin research. The Board’s work is not meant to replace a parent or child’s decisions and choices that are best for them. You may contact the Research Ethics Board, for information regarding a patient’s rights in research studies at (613) 737-7600 (3272), although this person cannot provide any health-related information about the study.

Consent form Signatures

By signing this consent form I agree that: [add or delete as applicable]

• I am voluntarily agreeing to participate in this research study;
• I understand the information within this consent form;
• All of the risks and benefits of participation have been explained to me;
• All of my questions have been answered;
• I allow access to my medical records and/or personal information as described in this consent form; and
• I do not give up my legal rights by signing this form.

A copy of the signed Information Sheet and/or Consent Form will be provided to me.

{If secondary use of the data set is occurring :

I agree to the secondary use of my data to answer future related research questions:

Yes No }

Signatures

Obtain the appropriate signatures, which should be based on capacity.

Printed Participant’s Name / Participant’s Signature / Date
Printed Parent’s Name / Parental Signature / Date
Printed Name of Person Who Conducted Consent Discussion / Signature of Person Who Conducted Consent Discussion / Date

Use this section if a translator or impartial witness is required.

If the consent discussion has been conducted in a language other than English, and an impartial qualified translator is required.

Printed Name of Translator / Translator Signature / Date

The “Signature of the Witness” line is intended for an impartial witness which is necessary when either the subject or the subject’s legally authorized representative (LAR) speaks and understands English, but cannot read and write or is visually impaired

Printed Witness Name / Signature of Witness / Date

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