邢唷��>� oq��n��欹�� 揘bjbj�� 1z辝辝�?��,,��j0D��XXX8�T�\XQ9�@@(hhh��8�8�8�8�8�8�8$7;��=X�8� �*�"��8��hhO9�!�!�!/v�h�h�8�!��8�!�!�$6��7h��愋<宀笙��6�8!90Q9�6A>�A>,�7A>�6�7��!��8�8�!��Q9��A>��, L: GENERAL FORMATTING GUIDELINES FOR INFORMED CONSENT FORMS (ICF) Please note that a well presented ICF that is in accordance to HREB standards will facilitate the approval process. ICFs that do not adhere to HREB standards will be returned to the researcher. Please adhere to the following formatting requirements: Consent forms should be written at a Grade 8 level of understanding. Use simple lay language explaining medical terms and jargon. Use non-scientific terminology and remove emotive terms. Type size should be no smaller than the type on this page. e.g. Times New Roman 12 point can be used. Use headings, small paragraphs and spaces between the paragraphs Regarding the use of DRUG TRADE NAMES in Consent Forms: Exclusive use of drug trade names in consent forms is not allowed. Acceptable forms of designation of drug names are: 揼eneric name� or 揼eneric name (Trade name)� or define as 搕he study drug�, 搕he study treatment� Exception to 1: Where a drug product contains multiple ingredients which makes use of their generic names impractical, the trade name for the combination product may be used. When reference is made to regulatory authorities having access to information please include Health Canada before other foreign regulatory agencies like FDA. Write out all acronyms the first time they appear in the consent form. Include a footer ON EACH PAGE with the version date and pagination (page 1 of X). All information required by the participant must be included in the informed consent form (i.e., references to additional information found in ancillary drug information sheets is not acceptable). Spelling, grammar and formatting must be corrected before it is submitted for review. Use second person pronouns for the information letter part of the consent form (you/your). Use first person pronoun (揑�) for only the final 揷onsent statement� portion of the form. Use 憄articipant� throughout the consent form rather than 憄atient� or 憇ubject�. Blue font: instructions Red font: required language Black: (insert as applicable or suggested language) In each section, replace the instructions (in blue) with information from your study. In some cases sample language is listed (in black), you may use this language, or replace with your own explanation. Any required language is listed in red. Throughout the consent form, use simple, non-technical terms, and address potential participants directly, with second-person language throughout. To be on INVESTIGATOR Letterhead PARTICIPANT CONSENT FORM Title of Study: Principal Investigator: [include phone number] Research/Study Coordinator: Why am I being asked to take part in this research study? Describe, at a 6th-8th grade reading level why this person might qualify for the research study. (i.e. You are being asked to be in this study because you have XX) Also provide a brief explanation about why the research is being done so that the participant can understand why a particular health problem/intervention needs to be studied. For example, this can include non-technical information on the incidence of a disease, on the problems associated with a disease, on the poor outcomes for other treatment methods, etc. A brief statement about the 損urpose� of the Information Sheet can be listed here, such as: Before you make a decision one of the researchers will go over this form with you. You are encouraged to ask questions if you feel anything needs to be made clearer. You will be given a copy of this form for your records. What is the reason for doing the study? Describe the purpose of the study at a 6th � 8th grade reading level. Clearly state what the purpose of this SPECIFIC study is and what the study hopes to answer. Key points to include in this section, when applicable, include the following: Clearly explain what the standard treatment(s) is/are and why there is a need for the experimental intervention (ie the study rationale); If placebo controls are being used, explain why it is appropriate to use such controls; Indicate if the research is being carried out for the first time in humans; Include if study drug has approval in Canada for use in the disease under study, Indicate if the research is part of a larger multi-site clinical trial and when appropriate, also include the approximate number of participants in the study (overall and at this site). What will happen in the study? The first part of this section should describe the study OVERALL, including the following information: how long each study visit will take and overall duration of the study; explain the difference between standard therapy and the study procedures; if participants will be assigned to different treatment arms � what this means and how will this be done. You will be assigned at random, (like flipping a coin OR like rolling a dice), to one of XX number groups. You will have a [specify 1 in 2, 3 in 4, 50%, etc] chance of being in the group that receives Drug A and [specify 1 in 2, 3 in 4, etc] chance of being in the group that receives Drug B. if the study is double blind � an explanation of what this is. The study is double blind which means neither you nor your study doctor will know which treatment you are getting. However, in the case of an emergency we can find out. if applicable � a lay explanation of the use of a placebo arm. A placebo is something that looks exactly the same as the study medicine, but does not have any real medicine in it. THEN: Describe the procedures chronologically using simplistic language, short sentences (1-3) lines and short paragraphs (less than 6 sentences). The use of subheadings may help to organize the section and increase readability. Explain study procedures ONLY ONCE, and then represent what will happen at each study visit with a study chart of procedures � as opposed to repeating each procedure multiple times in different visit captions. What are the risks and discomforts? Include information on any known risks or discomforts that may result from the study drugs and/or procedures that will be performed for the study, listing the most likely and/or most severe first. Give some context to the risks by grouping risks into those that are common, occasional or rare. QUANTIFY these GROUPINGS (i.e. common >50%, rare <1%). DO NOT USE a % after each individual risk. Explain the ramifications of some risks (for example, what is the importance to the participant if liver enzyme tests indicate an abnormality?); If animal data is provided by the Sponsor, its use should be minimized and attention drawn to the fact that its applicability to human participants is UNKNOWN. Any drugs and/or procedures that are given as standard of care do not need to be fully explained in the consent form. The risks should be limited to those that are related to the study interventions. Studies that present real and potential risks of fetal or reproductive harm should have a description of this risk. If reproductive risk exists, participants should be advised not to become pregnant (or to father a baby) while in this study. If the risk of fetal harm is not known, then indicate it is not known. If there are no risks associated with the research, then indicate no known risks. If applicable, add a statement that, 揟here may be risks in this study that are currently not known. If we find out anything new during the course of this research which may change your willingness to be in the study, we will tell you about these findings.� What are the benefits to me? If direct participant benefits can reasonably be anticipated as a result of participating in the study, then describe these benefits; however, DO NOT OVERSTATE any potential benefits. Conclude with the following standard clause: 揌owever, you may not get any benefit from being in this research study.� If direct participant benefits are not expected, then use the following standard clause: 揧ou are not expected to get any benefit from being in this research study.� You may also state the possible benefits to society in terms of advancement of knowledge, and/or benefits to people with the participant抯 particular circumstance. 揟his study may help other people with XX in the future.� What will I need to do while I am in the study? This section is sometimes entitled 揝ubject Responsibilities�, but we would prefer it be entitled as above. It should list any specific requirements of the study that the participant must agree to comply with in order to participate (i.e., not taking certain medications, telling the study doctor of any adverse events within a certain amount of time). As well this section should list any specific instructions on avoiding becoming pregnant. What happens if I am injured because of this research? (Include this section only if more than minimal risk, or otherwise applicable) Possible approved wording: 揑f you become ill or injured as a result of being in this study, you will receive necessary medical treatment, at no additional cost to you. By signing this consent form you are not releasing the investigator(s), institution(s) and/or sponsor(s) from their legal and professional responsibilities.� Do I have to take part in the study? This section should stress the voluntary nature of the study. 揃eing in this study is your choice. If you decide to be in the study, you can change your mind and stop being in the study at any time, and it will in no way affect the care or treatment that you are entitled to.� Can my participation in the study end early? (Include only if applicable) Describe in lay terms any reason why a participant may be removed from the study, i.e., 揑n addition to you being able to stop the study at any time, the study doctor or the sponsor of the study (if applicable) may withdraw you from this study (list reasons why here i.e. if you don抰 show up for your study visits, if they feel it is in your best interest, if the approval for the study is withdrawn卐tc)�. Are there other choices to being in this research study? Ensure that the participant understands clearly what treatment/options they would have if they were not in the study 揑f you choose not to be in this study, the following treatment options may be available to you厰, If there are no alternatives to treatment, then you do not need to state that the option is to NOT participant. Just leave this section out. What will it cost me to participate? (Include only if applicable) A clear statement must be made about any costs for participation in the study. Will I be paid to be in the research? (Include only if applicable) A clear statement must be made about any reimbursement the participant will receive for being in the study (i.e. parking costs, food, $$ for time, extra credit etc.) Be sure to indicate if these amounts are to be pro-rated for study visit completion. NOTE: The HREB will take into consideration the nature and amount of compensation (i.e., the compensation alone should not serve as sufficient inducement for the participant to volunteer). Will my information be kept private? Describe whether or not records will be kept confidential. If records will not be confidential, describe how records will be presented, and if they will be archived. 揇uring the study we will be collecting health data about you. We will do everything we can to make sure that this data is kept private. No data relating to this study that includes your name will be released outside of the study doctor抯 office or published by the researchers. Sometimes, by law, we may have to release your information with your name so we cannot guarantee absolute privacy. However, we will make every legal effort to make sure that your health information is kept private. The study doctor/study staff may need to look at your personal health records held at the study doctor抯 office, and/or kept by other health care providers that you may have seen in the past (i.e. your family doctor). Any personal health information that we get from these records will be only what is needed for the study. During research studies it is important that the data we get is accurate. For this reason your health data, including your name, may be looked at by people from: (list: study sponsor (either a Pharmaceutical Company or the 黑料不打烊 if the study is Investigator Initiated), the 黑料不打烊 auditors and members of the Research Ethics Board, Health Canada, and/or other foreign regulatory agencies) By signing this consent form you are giving permission for the study doctor/staff to collect, use and disclose information about you from your personal health records as described above. After the study is done, we will still need to securely store your health data that was collected as part of the study. Choose one of the following as applicable: If this is a study being conducted under Health Canada: In Canada, the law says we have to keep the data stored for 25 years after the end of the study. OR if not: At the 黑料不打烊, we keep data stored for 5 years after the end of the study. If you leave the study, we will not collect new health information about you, but we will need to keep the data that we have already collected. What if I have questions? If you have any questions about the research now or later, please contact [enter Investigator and/or study coordinator numbers here]. For greater than minimal risk, include 24 hour night/emergency phone numbers. If you suffer a research related injury � please contact the Investigator at this number as well. If you have any questions regarding your rights as a research participant, you may contact the Health Research Ethics Board at 780-492-2615. This office is independent of the study investigators. Declare any actual or potential conflicts of interest with respect to remuneration received from the funding agency for conducting or being involved with any part of the study and/or the possibility of commercialization of research findings. If the study is being 搒ponsored�, list the agency/company that is sponsoring the study, as well as the fact that the Investigator is receiving funding to conduct the study. 揟he study is being conducted/sponsored by the [name of research group, e.g. NCIC/industry sponsor/granting agency/]. The Institution and study doctor are getting money from the study sponsor to cover the costs of doing this study. You are entitled to request any details concerning this compensation from the Principal Investigator.� To be on Investigator Letterhead CONSENT Title of Study: Principal Investigator(s): Phone Number(s): Study Coordinator: Phone Number(s): Yes No Do you understand that you have been asked to be in a research study? ( ( Have you read and received a copy of the attached Information Sheet? ( ( Do you understand the benefits and risks involved in taking part in this research study? ( ( Have you had an opportunity to ask questions and discuss this study? ( ( Do you understand that you are free to leave the study at any time, ( ( without having to give a reason and without affecting your future medical care? Has the issue of confidentiality been explained to you? ( ( Do you understand who will have access to your records, including ( ( personally identifiable health information? Do you want the investigator(s) to inform your family doctor that you are ( ( participating in this research study? If so, give his/her name __________________ Who explained this study to you? _____________________________________________________ I agree to take part in this study: Signature of Research Participant ______________________________________________________ (Printed Name) ____________________________________________________________ Date:______________________________ Signature of Witness ______________________________________________________________ I believe that the person signing this form understands what is involved in the study and voluntarily agrees to participate. Signature of Investigator or Designee ________________________________ Date __________ THE INFORMATION SHEET MUST BE ATTACHED TO THIS CONSENT FORM AND A SIGNED COPY GIVEN TO THE RESEARCH PARTICIPANT MUST INCLUDE A VERSION DATE AND PAGINATION IN THE FOOTER Version: 29 Oct 2014 Page PAGE \* Arabic \* MERGEFORMAT 6 of NUMPAGES \* Arabic \* MERGEFORMAT 7 In accordance with GCP 4.8.10 an ICF is to provide an explanation related to compensation and/or treatment available to the subject in the event of trial-related injury. Our compensation for injury clause is meant to tell participants that if they are injured as a result of being in the study, regardless of the causality of the injury a participant in 黑料不打烊 would be entitled to medical care. In 黑料不打烊 if a subject was injured, medical treatment would be provided through the provincial health care system. The issue related to WHO may pay for the cost of that treatment would ultimately be decided by the courts through a review of the terms of indemnification contained within the contract that is signed between the PI, the sponsor and the Institution and not the consent form. All we want the participant to know, is that they will receive care as a result of an injury and we are in fact remaining SILENT with respect to who would pay for that injury. A Witness line is only required if you anticipate that your participants will be unable to read the consent for themselves. If so, an impartial witness (i.e. not associated with the study team) must be present during the entire informed consent discussion and is witnessing that the participant understood what was discussed (i.e. not just witnessing the signature process). 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