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Instruction to PI/Coordinator: Instructions are printed in ‘red’, with actual text in ‘black’. Sections highlighted yellow indicate words you should choose/information required based on your study design (e.g. [study drug/device]).Please delete any parts of the consent template that are not relevant to your particular study. The instructions should be deleted in the final version of the consent form. Use the Guidance Document for Writing the ‘Participant Informed Consent Form’ document when writing your consent form as it contains additional instructions. (Template version Sept 23, 2015)PARTICIPANT INFORMED CONSENT FORMTitle of Study:Local Site Principal Investigator (PI): Add Name and 10 digit phone numberSponsor (or Funding Agency): See guidance document for information on how to complete this section. Participation in this study is voluntary. Please read this Participant Informed Consent Form carefully before you decide if you would like to participate. Ask the study doctor and study team as many questions as you like. We encourage you to discuss your options with family, friends or your healthcare team. Why am I being given this form? You are being asked to participate in this research study because reason why you’re asking person to participate.Why is this study being done?Explain the study purpose/background, why it is being doneFor interventional studies you should include the following:This [study drug/device] is considered investigational. This means that the [study drug/device] used in this study has not been approved for sale or use by Health Canada. However, it has been approved for use in this research study. For multicentre sites use:This study is taking place at a number of sites across [Canada/North America/the world]. We estimate that [number] participants will be enrolled in the study, including [number] participants from [Institution]. For single-centre sites use:We estimate that [number] participants will be enrolled in the study from [Institution].How is the study designed?Section should include the following information (if applicable to your study): number of arms, comparators, placebos/active controls, randomization, blinding, etc.Sample wording for study design descriptions that has previously been accepted by the Board: If the study uses a placebo: This study compares the effects of the study drug with a placebo. A placebo is an inactive substance that looks exactly like the study drug. If it is not made of sugar, it is not a sugar pill.If the study is randomized: Whether you get the study drug (or other product or device as applicable to the study) or the placebo/comparison will be decided randomly. Randomization means that you are put into a group by chance. If the study has two arms, define randomization as “similar to flipping a coin”. If the study has three or more arms, define randomization as “like pulling a number out of a hat”.If the study is single-blinded:This study will be blinded, which means that you will not be told if you will be taking the study drug or the placebo/comparison. Your study team will know what you are receiving. Blinding helps to remove any bias or pre-conceived notions from affecting the outcome of the study. You may be told once the study is finished.If the study is double-blinded:This study will be double-blinded. That means you will not be told if you will be taking the study product or the [placebo/comparison]. Your study team will also not know. Blinding helps to remove any bias or pre-conceived notions from affecting the outcome of the study. However, in an emergency this information can be obtained quickly. You may be told once the study is finished.What is expected of me?Go to the consent guidance document for instructions on describing study procedures.If the study involves frequent repeated measures a table outlining study procedures/tests may be helpful to avoid repetition of procedures/tests:Table 1 Study Visits and Procedures Boxes marked with an X show what will happen at each visit.VisitScreeningRandomizationVisit 1(Month 1)Visit 2(Month 6)Visit 3(Month 12)Length of time needed3 hours1 hour1 hour1 hourMedical HistoryXPhysical ExaminationXVital SignsXXXXElectrocardiogramXXXXBlood TestXXXXQuestionnaireXXXXTable should fit all on one page (portrait or landscape) If using the table format you do not need to discuss each individual visit and every test and/or procedure in the table. Only discuss the tests/procedures requiring explanation. Some suggested sample wording for study procedure descriptions: If the study includes a screening visit: The first study visit will be a screening visit. The results of the tests and/or questions at the screening visit will help the study team decide whether you can continue in this study. If the study includes a baseline visit, in addition to a screening visit (often they are combined): The study team needs to find out about your [condition or health] before you begin receiving the study [product/agent/tablets/device]. This is called the baseline visit. In addition to the results from the screening visit, the results of the tests/questions at the baseline visit will help the study team to decide whether you can continue in this study.If Blood samples will be drawn:You will have [xx] blood samples drawn to [provide purpose for blood collection(e.g. safety, biomarkers, pharmacokinetic, genetic research, etc) and indicate if it will be stored or destroyed]. Each sample will require approximately [xx tsp/tbsp or xx ml]. (1 tsp = 5 ml, 1 tbsp = 15 ml) If an Intravenous (IV) is required, for drugs or as part of a test (imaging):An intravenous is a small plastic tube inserted into a vein, typically used to give fluid and medication.If administering Questionnaires, focus groups or interviewing: You will be asked to complete [xx] questionnaires, at define when: each, every other, actual number, etc. visit(s). The questionnaires are to assess define: quality of life, your ability to carry out your day to day activities, your level of anxiety, etc. They will take approximately [minutes] to complete. Define each questionnaire separately if appropriate. You may skip any questions that make you uncomfortable or that you do not wish to answer.Will my samples or research data be used in future research?If tissue/blood banking is required, the consent must clearly state the specific, defined reasons the banking is required, and the defined, finite duration for which the samples will be stored. Go to the guidance document for instructions on describing the future use of samples/research data. How long will I be involved in the study?The entire study will last approximately [days/weeks/months]. Your participation in the study will last approximately [days/weeks/months]. Over this time, you will be required to visit the [institution] [number of visits]If applicable insert other details such as number of telephone follow-ups or mailings, etc. Your participation in the study may be stopped for any of the following reasons:The study doctor feels it is in your best interest. If applicable: The sponsor or a government agency such as Health Canada or the U.S. Food and Drug Administration (FDA) cancels the study.You need [additional medication/treatment] that would interfere with the study.You do not follow the study staff’s instructions.If applicable: You become pregnant.What are the potential risks I may experience? Describe all known risks. Go to the consent guidance document for instructions on describing risks/discomforts. This study [drug/treatment/product] has risks, as most [drug/treatment/product] do. However, there is always a chance of risks that we do not know about. The risks we know about are listed below. Drug side effects:Some drug side effects can be managed. Most side effects go away when you stop taking the drugs, but others might be long-lasting or permanent. The risks we know about are:Very likely (21% or more of patients): [describe risks]Less likely (5% to 20%): [describe risks]Rare (1% to 4%): [describe risks]Very rare but serious (less than 1%): [describe risks]For Phase 1 studies, the breakdown on risks into percentages may be difficult, as risks are unknown, or if known, not of sufficient statistical precision to be meaningful. For Phase 1 studies the following text may be more appropriate to use: The study drug [name of drug] is in an early phase of development and so the side-effects in humans are unknown at this time. Animal studies to date show [list as per Investigator Brochure using lay language]. There may be additional risks and side-effects that are currently unforeseen and therefore not listed in this study information and consent form.Some suggested sample wording, for study procedure descriptions: Intravenous risks An intravenous may cause minor bleeding, bruising, redness, or swelling at the site. Less often it may lead to an infection.Blood Sample RisksYou may experience some temporary discomfort when the blood sample is taken. There is a small risk of bruising, infection or swelling at the site where the needle is inserted, and some people may feel faint or dizzy. If the blood samples will be used for genetic research, describe risks associated with risk of insurability and employability (see below) as well as if information received from this testing would affect family members, any risks of identification based on rare genetic marker/disease, etc.If the blood samples will be used for testing for any legally reportable conditions such as hepatitis and HIV, inform the participants that any positive results must be reported to public health. Questionnaires:You might find the interviews and questionnaires [upsetting or distressing or tiring if they are quite lengthy, etc. - specify based on type of questionnaires]. You might not like all of the questions that you are asked. You do not have to answer any questions that make you uncomfortable. Inform participants if information may need to be disclosed and that the participant will be provided with help if the PI believes the participant’s life or another person’s life is at risk (i.e. suicide scales).Risks of Insurability: required for all interventional studies We will take all reasonable steps to keep your research information confidential. Should someone not involved in the research find out that you took part in this research study, or if you choose to share your results (if they are provided to you), there is a possibility that this could affect your insurability under certain policies of insurance, depending on the exclusions in such policies. Is there a concern with pregnancy or breastfeeding?Please note this section is protocol driven. The consent must reflect the risks related to pregnancy and reproduction as described in the protocol. The drugs or procedures used in this study may be harmful to a fetus. For this reason, women must not become pregnant or breastfeed an infant for a period of [days/months] during [and/or] after the study. In the event of pregnancy, or suspected pregnancy, you must tell your study doctor immediately. The study [product/treatment/intervention] may be stopped in order to avoid unknown risks to you or the fetus.If you are a woman of childbearing potential, you will have a pregnancy test to ensure you are not pregnant before the study begins. You may also be given another pregnancy test [during/after/at xx weeks, etc. -specify] the study. Additional pregnancy/reproductive related risks, for males. If there are no concerns with pregnancy for your study then remove this section.The risk to your partner and the fetus is unknown. If your partner becomes pregnant, she will be asked to sign a consent form to allow access to information on the outcome of her pregnancy. If your partner does not consent to this, it will not affect your continued involvement in the study.If applicable: Some of the drugs used in the study may make you unable to have children in the future. Your study doctor will discuss this with you.If there are known interactions or contraindications with specific birth control methods, they should be included.Can I expect to benefit from participating in this research study?Required language:You [may not/will not] receive any direct benefit from your participation in this study. Your participation may allow the researchers to [explain]. This may benefit future patients. If applicable, you may also add:This study will select by chance which treatment you will receive. Participants in one arm of this study may do better or worse than participants in the [other/another] arm. Do I have to participate? What alternatives do I have?Choose the appropriate paragraph to match your study populationOption 1: When the participants are patients or general public:You can choose not to participate in this study. If you choose not to participate, [describe the options still available to them (e.g. no treatment, standard treatments, supportive care, etc)]. Your study doctor will discuss these options with you.Your participation in this study is voluntary. You may decide not to be in this study, or to be in the study now, and then change your mind later without affecting the medical care, education, or other services to which you are entitled or are presently receiving at this institution. Option 2: When the participants are employees of the hospital:Your participation in this study is voluntary. You may decide not to be in this study, or to be in the study now, and then change your mind later. Your decision will not affect your current or future employment at [institution].Option 3: When the participants are students:Your participation in this study is voluntary. You may decide not to be in this study, or to be in the study now, and then change your mind later. Your decision will not affect your academic standings, current or future placements, or any future employment or potential for employment at [institution]If I agree now, can I change my mind and withdraw later?You may withdraw from the study at any time without any impact on your current or future care at this institution. If you decide to stop your study [drug/treatment/product] you should contact the study doctor or the study team first. They will discuss the related issues or possible safety concerns for you. You may also choose to discontinue your participation in the study. However, a final visit(s) may need to be completed to ensure your safety and well-being. If you withdraw your consent, the study team will no longer collect your personal health information for research purposes, unless it is needed for review of safety. [If applicable: Information given to the sponsor before you cancel this consent may still be used.] Participants should also be given the choice of having their data withdrawn from the study completely, or be provided with the reasons why this option may not be possible. (Example: tissue samples are anonymous so there is no link between the participant and their sample)What compensation will I receive if I am injured or become ill in this study?Required language (delete mention of sponsor if there is no study sponsor)In the event of a study-related injury or illness, you will be provided with appropriate medical treatment and care.? Financial compensation for lost wages, disability or discomfort due to an injury or illness is not generally available.? You are not waiving any of your legal rights by agreeing to participate in this study.? The study doctor, the [Institution], and the sponsor (remove if no sponsor) still have their legal and professional responsibilities. Will I be paid for my participation or will there be any additional costs to me? Required language for study costs if relevant to your study (delete if not applicable) The [drug/intervention/product] will be provided to you free of charge as long as you are participating in the study. The cost of parking/transportation [and any other items] will be paid for any extra visits related to the study.If applicable: You will be paid $[amount] for time taken to participate in the study. Insert description of payment schedule if applicable.Include the following required text:Money received as a result of your participation in this study, may be considered taxable income by Revenue Canada. This does not include money given to you for the reimbursement of study expenses. To receive payment for your participation in this study, you may need to provide the study team with your Social Insurance Number. By the end of February of the following year, the [Institution] will issue a T4A for any amount equal to or over $500 earned in the calendar year. If applicable, include the following text:If the [software development/drug/device] is proven effective, it may be approved for use and available for sale in [Canada/US/Internationally, etc]. If this occurs, the [as applicable: Principal Investigator, [Institution(s)], and/or the Sponsor] may benefit from this development. You will not share in any profits arising from commercialization. How is my personal information being protected?The following statements assume the typical practices for de-identification; if there is a variance from this, it must be fully disclosed to the participants and well justified in the application.If you decide to participate in this study, the investigator(s) and study staff will look at your personal health information and collect only the information they need for this study. “Personal health information” is health information about you that could identify you because it includes information such as your name, address, telephone number, date of birth, new and existing medical records, or the types, dates and results of various tests and rmation that identifies you will be released only if it is required by law. All information collected during your participation in this study will be identified with a unique study number (for example participant # AB01), and will not contain information that identifies you. Documents or samples leaving [Institution] will only contain the coded study number. If applicable, explain where the data will be sent/stored/analysed, etc.A Master List provides the link between your identifying information and the coded study number. This list will only be available to Dr. [name] and [his/her] staff and will not leave this site.The Master List and coded study records will be stored securely. For audit purposes only, your original medical records may be reviewed under the supervision of Dr. [name]’s staff by representatives from:the Sponsor, [name],Health Canada and/or US FDA, if applicablethe Ottawa Health Science Network Research Ethics Board (OHSN-REB), and the [Institution (e.g. Ottawa Hospital Research Institute or the Ottawa Heart Institute Research Corporation)].You will not be identified in any publications or presentations resulting from this study.Research records will be kept for [10/25] years, as required by the [OHSN-REB/Health Canada]. At the end of the storage time, all paper records will be shredded and all electronic records will be securely deleted. For clinical trials with U.S. ties (FDA oversight, NIH funding, etc.) you must include the following language unchanged: A description of this clinical trial will be available on , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.This research study can be found on the above listed website by using the clinical trial registration number [insert clinical trial registration number].If a Canadian trial is being sponsored or coordinated elsewhere and is registered on another site, replace the website address (see guidance document for more information). Otherwise for all clinical trials without US ties insert: A description of this clinical trial will be available on [ or name alternate registry site you are using]. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.This research study can be found on the above listed website by using the clinical trial registration number [insert clinical trial registration number].Do the investigators have any conflicts of interest?Examples of wording, for declaring a real or perceived conflict of interest are included below. We cannot provide examples for every type of possible conflict of interest so you may need to alter the text below to match your circumstance:[Principal Investigator] is receiving personal financial payment from [Sponsor/Funding Body(ies) for providing advice on the design of the study]. You may request any details about this payment from [Principal Investigator, department and telephone or pager number].-or- This study is sponsored by [insert]. Although the sponsor will be paying the Principal Investigator (PI) and the [Institution(s)] to conduct the study, the PI and the [Institution(s)] do not otherwise benefit financially from the study. -or-If no conflicts of interest exist, state:There are no conflicts of interest to declare related to this study. If applicable: The Principal Investigator is receiving financial payment from the Sponsor to cover the cost of conducting this study.What are my responsibilities as a study participant?It is important to remember the following things during this study: Ask your [insert applicable study personnel] if you have any questions or concerns.Tell your [insert applicable study personnel] if anything about your health has changed.List out any restrictions or reminders, as applicable to the study, for example: You should not eat for 12 hours before visits. Do not take medications before visits.Return study [product/intervention/treatment] and diaries.Prior to any blood test, you must not eat or drink for at a period of 12 hours and not consume any [provide appropriate information: coffee, chew gum, etc.]Call the study doctor if you experience any side effects, even if you are unsure whether it has anything to do with this study. Will I be informed about any new information that might affect my decision to continue participating?You will be told in a timely fashion of any new findings during the study that could affect your willingness to continue in the study. You may be asked to sign a new consent form.Who do I contact if I have any further questions? If you have any questions about this study, or if you feel that you have experienced a study-related injury or illness, please contact Dr. [principal investigator] at [phone number] or the study staff at [phone number]. If applicable, include a 24 hour contact number, such as an on-call pager.The Ottawa Health Science Network Research Ethics Board (OHSN-REB) has reviewed this protocol. The Board considers the ethical aspects of all research studies involving human participants at the [Institution]. If you have any questions about your rights as a study participant, you may contact the Chairperson at 613-798-5555, extension 16719.If there is a Primary Investigator from another institution, include the same information for that institution. Title of StudyConsent to Participate in ResearchI understand that I am being asked to participate in a research study about [describe]. This study was explained to me by ___________________________. I have read, or someone has read to me, each page of this Participant Informed Consent Form. All of my questions have been answered to my satisfaction. If I decide later that I would like to withdraw my participation and/or consent from the study, I can do so at any time.I voluntarily agree to participate in this study.I will be given a copy of this signed Participant Informed Consent Form.Remove if not applicable:It is important that your personal doctor be aware you are in a research study, as you may be taking a treatment that could affect your health. With your permission, we will notify him/her that you are taking part in this study.I consent to my personal doctor being notified that I am taking part in this study. YES NO Participant’s Initials_____________________________________ ____________________________ _________________Participant’s Printed Name Participant’s Signature DateInvestigator or Delegate Statement I have carefully explained the study to the study participant. To the best of my knowledge, the participant understands the nature, demands, risks and benefits involved in taking part in this study. _____________________________ ____________________________ _________________Investigator/Delegate’s Printed Name Investigator/Delegate’s Signature DateAssistance Declaration Was the participant assisted during the consent process? Yes No The consent form was read to the participant/substitute decision-maker, and the person signing below attests that the study was accurately explained to, and apparently understood by, and consent was freely given by the participant/substitute decision-maker. The person signing below acted as a translator for the participant/substitute decision-maker during the consent process. He/she attests that they have accurately translated the information for the participant/substitute decision-maker, and believe that the participant/substitute decision-maker has understood the information translated.___________________________ ____________________________ ____________________ Name of Person Assisting (Print) Signature DateIf applicable: This page is not applicable, see attached Substitute Decision Maker addendum. If not applicable to your study, remove the next two pages:The next two pages have been numbered differently. These pages are appendices and should be removed if a SDM is not required. The appendices numbering will allow for their removal without causing page numbering errors. Title of StudyAddendum to [x] page Participant Informed Consent Form for use with a Substitute Decision Maker I understand that as the Substitute Decision Maker (SDM) for _______________________, I am being asked that he/she participate in a research study about [describe]This study was explained to me by _______________________. I have read, or someone has read to me, each page of this Participant Informed Consent Form.All of my questions have been answered to my satisfaction. If I decide later that I would like to withdraw my consent, I can do so at any time.I voluntarily agree to allow participation in this study.I will be given a copy of this signed Participant Informed Consent Form._____________________________ ____________________________ _________________SDM’s Printed Name SDM’s Signature DateInvestigator Statement (or Person Explaining the Consent)I have carefully explained the study to the Substitute Decision Maker (SDM). To the best of my knowledge, the SDM signing this consent form understands the nature, demands, risks and benefits involved in taking part in this study. Consent will be sought promptly for continued consent, if/when the Participant regains his/her capacity. _____________________________ ____________________________ _________________Investigator/Delegate’s Printed Name Investigator/Delegate’s Signature Date Title of StudyParticipant’s Acceptance of Substitute Decision Maker’s Consent Your illness or injury made it impossible for you to participate in the informed consent process, so your substitute decision maker’s (SDM) consent was obtained on your behalf. Your SDM agreed to your participation in this research study. Now that your condition has improved we would like to inform you of the details of the study and obtain your personal decision. The Participant Informed Consent Form will be reviewed with you and then you may agree or disagree with the decision made by your SDM. I understand that I am being asked to continue my participation in a research study about describe…... This study was explained to me by ___________________________. I have read, or someone has read to me, each page of this Participant Informed Consent Form. All of my questions have been answered to my satisfaction. If I decide later that I would like to withdraw my participation and/or consent from the study, I can do so at any time.I will be given a copy of this signed Participant Informed Consent Form. I voluntarily agree with my SDM’s decision and wish to continue my participation in this study OR□ I do not agree with my SDM’s decision and choose not to continue my participation in this study. However, I will allow the information collected about me to remain in the study and be used by the researchers.If the data is not required for safety reasons, and it is possible to withdraw it, also add: OR□ I do not agree with my SDM’s decision and choose not to continue my participation in this study. I request that all information collected about me be withdrawn from the study. _____________________________ ____________________________ _________________Participant’s Printed Name Participant’s Signature DateInvestigator or Delegate Statement I have carefully explained the study to the study participant. To the best of my knowledge, the participant understands the nature, demands, risks and benefits involved in continuing to take part in this study. _____________________________ ____________________________ _________________Investigator/Delegate’s Printed Name Investigator/Delegate’s Signature Date ................
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