APPLICATION FOR REVIEW BY RESEARCH ETHICS BOARD



How to prepare an Information/Consent Form (ICF)Required formsIf 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 childIf your study involves adults who cannot consent for themselves, prepare an ICF for “ “Authorized Third Party”If your study involves genetic research, prepare a separate ICF for this part of the studyGeneral requirementsAn 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 toneDescribe the study in second person (e.g., “We are inviting you to participate…”)FormattingUse a font that is easy to read (minimum 12 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. <, >, ~, +)You may use graphics, colour, etc., to make the document more visually appealing and readableInclude a footer with this information:Specify a ‘version number and date’ for the form (this is how the HiREB tracks changes)Include page numbers formatted as (page x of y)ContentEvery study is unique and the content of an ICF should be tailored to the particular studyPlease use the information on the following pages as a guide to what should be includedIf something does not apply to your study, do not include itLogos At the top of the first page include logos (or text) to identify institutions participating in the studyIf you have any questions about consent requirements, please contact the:Research Ethics OfficerHamilton Integrated Research Ethics Board905.521-2100 x 44574sancan@hhsc.ca Consent/Document TitleInformation/Consent Form Specify who the form is for (i.e., Participant, Parent, Authorized Third PartyTitle of Study: Provide the full title of the studyDo not include any study acronyms Local Principal Investigator: Include name, degree, and institutional affiliationCo-investigators: Listing co-investigators is optionalIf you list them, provide name, degree, and institutional affiliationIf a co-investigator is a student, they should be named as “Student Co-Investigator”Sponsor: Identify sources of funding/support for the studyDeclare any conflict of interest (if applicable)Invitation to participate in research:Extend an invitation to participateExplain why the participant is eligible for this studyExplain that participation in research is voluntaryExplain that choosing not to participate will not have any negative consequences for the participantIf this is a student project, say so, and explain who will supervise the studyWhy is this study being done? Provide some background information on the problem being studiedExplain what you are trying to learn by doing this studyHow many participants will be in this study?Explain how many participants will be involved locallyIf this is a multi-centre 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 studyInclude 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 researchIf participants will be randomized or assigned to groups, explain how this will be doneIf a placebo will be used, explain what a placebo is, and explain the chances of receiving the placeboIf study will involve blinding, explain who will know what is happeningIf 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 anythingIf the study includes genetic testing, prepare a separate consent form for this part of the researchIf surveys, questionnaires, interviews or focus groups will be used, indicate how much time would be required to complete the given taskAre 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 soIf there are no foreseeable risks, say soInclude any reproductive risks to women, men, embryo, fetus, nursing infants Include any requirements for birth control As a Catholic institution, studies conducted at St. Joseph’s Healthcare Hamilton sites require a different approach in the reference to pregnancy/conception-related risks. Acceptable statements are found in the Sample Consent Template #2. For qualitative studies using focus groups, indicate that there is no guarantee that group members will maintain the group confidentialityFor qualitative studies, indicate that even though individuals are not identified, one may be recognized by the stories or references they make, and that should be considered when participating Are there any benefits?Describe any potential benefits to participants If there is no direct benefit to participants, say soIf the research may benefit others in the future, say soIf 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 soIf 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 collectExplain that personal information will be kept confidential (except as required by law)Explain who will have access to this informationExplain how long this information will be kept and how it will be protectedExplain how, and when, study data will be de-identified For qualitative studies explain when data will be de-identified; indicate if direct quotes may be usedExplain how long this information will be kept and how it will be protectedExplain 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 conditionsIf the sponsor can stop the study, explain the conditionsExplain that the participant can withdraw for any reasonExplain that participants will be informed of any new information that might influence their decision to continueExplain what a participant should do if they want to withdrawExplain 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 involvedExplain any relevant alternativesExplain that choosing not to participate will not affect current or future careExplain that choosing not to participate will not affect current employment/staff performance/course evaluation (as applicable)What happens if I have a research related injury? Include this only if there is a foreseeable chance of injuryIf compensation is available for research related injuries, explainIf compensation is not available, explain who will cover the cost of medical care (remember that standard health care in Ontario is provided through OHIP)No language should waive legal rights Provide contact information for research related injuries Include name, degree, institution, 24-hour telephoneIf I have questions about this study, who should I call?This should be someone who can address any aspect of study design and participationInclude name, degree, institution, telephoneConsent Not all of the following signature lines are requiredPlease select the signature lines that are appropriate for your studyParticipant: (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.NameSignatureDatePerson 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 StudySignatureDateAuthorized Third Party (required if child is under 16 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 ParticipantSignatureDateWitness: (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 SignatureDateInclude the following HiREB statement at the end of the signature pageThis statement may not be altered in any wayThis 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. ................
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