How to prepare an Information/Consent Form (ICF)

Required forms

·  If your study involves individuals who can consent for themselves, prepare an ICF for “Participants”

·  If your study involves children under age 7, prepare only one ICF for “Parents”

·  If your study involves children between ages 7-15, prepare an ICF for “Parents” and prepare a separate “Assent” for the child

·  If your study involves adults who cannot consent for themselves, prepare an ICF for “Legally Authorized Representative”

·  If your study involves Genetic research, prepare a separate ICF for this part of the study

General requirements

·  An ICF should be easy to read (Grade 8 level)

·  Words or concepts that are technical or unfamiliar should be explained (e.g. placebo)

·  Write in a professional but conversational tone

·  Describe the study in second person (e.g., “We are inviting you to participate…”)

Formatting

·  Use a font that is easy to read (minimum 10 pt)

·  Use headings to highlight different sections (we recommend our headings, but they are not mandatory)

·  Present the information in a simple format (e.g. use bulleted lists or tables)

·  Do not use symbols that participants may not understand (e.g. <, >, ~, +)

·  Include a footer with this information:

·  Specify a ‘version date’ for the form (this is how the REB tracks changes)

·  Include page numbers formatted as (page x of y)

·  Include a line for participant initials (clinical trials only)

Content

·  Every study is unique and the content of an ICF should be tailored to the particular study

·  Please use the information on the following pages as a guide to what should be included

·  If something does not apply to your study, do not include it

If you have any questions about consent requirements, please contact the:

Research Ethics Officer

Hamilton Integrated Research Ethics Board

905.521-2100 x 44574


Logos

·  At the top of the first page include logos (or text) to identify institutions participating in the study

Information/Consent Form (Participant)

·  Specify who the form is for (i.e., Participant, Parent, Legally Authorized Representative)

Title of Study:

·  Provide the full title of the study

·  Do not include any study acronyms

Local Principal Investigator:

·  Include name, degree, and institutional affiliation

Co-investigators:

·  Listing co-investigators is optional

·  If you list them, provide name, degree, and institutional affiliation

·  If a co-investigator is a student, list the degree of study, followed by (Student)

Sponsor:

·  Identify sources of funding/support for the study

·  Declare any conflict of interest (if applicable)

Invitation to participate in research:

·  Extend an invitation to participate

·  Explain why the participant is eligible for this study

·  Explain that participation in research is voluntary

·  Explain the choosing not to participate will not have any negative consequences for the participant

·  If this is a student project, say so, and explain who will supervise the study

Why is this study being done?

·  Provide some background information on the problem being studied

·  Explain what you are trying to learn by doing this study

How many participants will be in this study?

·  Explain how many participants will be involved locally

·  If this is a multi-center study, mention where else it is being conducted, and give the expected number of participants (total and local)

What will happen to participants in this study?

·  Provide a chronological outline and a brief explanation of what participants will have to do during the study

·  Include information like:

Where will the research take place?

What procedures/tests will be done?

How many visits will the study require?

How long will each visit take?

How long will each participant be in the study?

·  If medical treatment is involved, state which procedures are standard care and which are for research

·  If participants will be randomized or assigned to groups, explain how this will be done

·  If a placebo will be used, explain what a placebo is, and explain the chances of receiving the placebo

·  If study will involve blinding, explain who will know what is happening

·  If samples will be collected, explain why they are necessary and if participants will be given test results

·  If you would like to store samples for future use, explain the possible uses and give participants options to say yes/no

·  If samples may lead to commercial gain, explain if participants will receive anything

·  If the study includes genetic testing, prepare a separate consent form for this part of the research

Are there any risks?

·  Describe any reasonably foreseeable risks, discomforts and inconveniences (e.g., physical, psychological, social, financial)

·  Group risks into common, occasional and rare (and give percentages for each category)

·  If the risks are unknown, say so

·  If there are no foreseeable risks, say so

·  Include any reproductive risks to women, men, embryo, fetus, nursing infants

·  Include any requirements for birth control

Acceptable statement for studies conducted at St. Joseph’s Healthcare Hamilton sites:

You must not become pregnant while you are in this study. You will need to decide on the best way to avoid pregnancy by talking to your physician about different methods of birth control.

Are there any benefits?

·  Describe any potential benefits to participants

·  If there is no direct benefit to participants, say so

·  If the research may benefit others in the future, say so

·  If the results of the study can be made available to participants, please explain how this will be done

Will I be paid to participate in this study?

·  If participants will not be paid, say so

·  If participants will be paid, explain (i.e., How much? When? Any pro-rating?)

Will there be any costs to me in this study?

·  If participants will incur study related expenses, explain (e.g. parking)

·  If participants will be reimbursed for study related expenses, explain (e.g. parking)

What will happen to my personal information?

·  Describe what personal information you will collect

·  Explain that personal information will be kept confidential (except as required by law)

·  Explain who will have access to this information

·  Explain how long this information will be kept and how it will be protected

·  If study data will be anonymized, explain what this means and when it will happen

·  Explain how long this information will be kept and how it will be protected

·  Explain any access to a participant’s medical record in case of death (if applicable)

Can participation end early?

·  If the investigator can stop the study, explain the conditions

·  If the sponsor can stop the study, explain the conditions

·  Explain that the participant can withdraw for any reason

·  Explain that participants will be informed of any new information that might influence their decision to continue

·  Explain what a participant should do if they want to withdraw

·  Explain the options a participant has with respect to any information/samples already collected

Are there any alternatives I should know about?

·  Include this only if medical treatment is involved

·  Explain any relevant alternatives

·  Explain the risks and benefits of the alternatives

·  Explain that choosing not to participate will not affect current or future care

What happens if I have a research related injury?

·  Include this only if there is a foreseeable chance of injury

·  If compensation is available for research related injuries, explain

·  If compensation is not available, explain who will cover the cost of medical care

·  No language should waive legal rights

·  Provide contact information for research related injuries

·  Include name, degree, institution, 24 hour telephone

If I have questions about this study, who should I call?

·  This should be someone who can address any aspect of study design and participation

·  Include name, degree, institution, telephone


Consent

·  Not all of the following signature lines are required

·  Please select the signature lines that are appropriate for your study

Participant: (required for participants capable of consent)

I have read the preceding information thoroughly. I have had an opportunity to ask questions and all of my questions have been answered to my satisfaction. I agree to participate in this study. I understand that I will receive a signed copy of this form.

Name / Signature / Date

Person obtaining consent: (required for all studies)

I have discussed this study in detail with the participant. I believe the participant understands what is involved in this study.

Name, Role in Study / Signature / Date

Investigator: (required for studies that include a medical act)

In my judgment, this participant has the capacity to give consent, and has done so voluntarily.

Name, MD / Signature / Date

Legally Authorized Representative: (required if child is under 15 or participant is incapable of consent)

I have read the preceding information thoroughly. I have had an opportunity to ask questions and all of my questions have been answered to my satisfaction. I understand that I will receive a signed copy of this form.

I give my permission for ______to participate in this study.

Name, Relationship to Participant / Signature / Date

Witness: (required if participants are unable to read, or if translation is necessary)

I was present when the information in this form was explained and discussed with the participant. I believe the participant understands what is involved in this study.

Name / Signature / Date

·  Include the following statement at the end of the signature page

This study has been reviewed by the Hamilton Integrated Research Ethics Board (HIREB). The HIREB is responsible for ensuring that participants are informed of the risks associated with the research, and that participants are free to decide if participation is right for them. If you have any questions about your rights as a research participant, please call the Office of the REB Chair, HIREB at 905.521.2100 x 42013

Version date: Dec 2012 Page 5 of 5