[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-307039-105":3,"detail-sidebar-cat-1-en-105":81,"doc-detail-307039-en":126},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","icf-informed-consent-form-template","ICF - Informed Consent Form Template","","WHO ERC-informed consent form (ICF) template designed to support principal investigators in drafting study-specific informed consent documents. The ICF includes two required parts: an Information Sheet and a Certificate of Consent, with guidance on clearly identifying the target participant group and the roles of key study stakeholders. 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Please note that this is a template developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF) . It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study.  \n2. The informed consent form consists of two parts: the information sheet and the consent certificate.  \n3. This template includes examples of key questions that may be asked at the end of each section that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.  \n4. Please do not delete any sections. If any portion is not relevant to your study, please mark it as NA.  \n5. ICF should be drafted in simple language (language used throughout form should be at the level of a local student of class 6th/8th)– English, Hindi and other vernacular languages as applicable  \nTEMPLATE ON FOLLOWING PAGE   \n\n|  |  | Page No. | Page 2 of 8 |\n| --- | --- | --- | --- |\n\nInformed Consent Form for   [Study Title]  \nPlease delete the instructions marked in BLUE before submitting the proposal for review  \nName the group of individuals for whom this informed consent form is written. Because research for a single project is often carried out with a number of different groups of individuals-for example healthcare workers, patients, and parents of patients - it is important that you identify which group this particular consent is for.  \nName of Principal Investigator  \nName of Organization  \nName of Sponsor  \nName of Proposal  \nThis Statement of Consent consists of two parts:  \n● Information Sheet (to share information about unused samples with you)  \n● Certificate of Consent (to record your agreement) You will be given a copy of the full Statement of Consent  \nPART I: Information Sheet  \nI. Introduction  \nBriefly state who you are and explain that you are inviting them to participate in the research you are doing.  \nII. Purpose of the research  \nExplain in layman terms why you are doing the research.  \nIII. Type of Research Intervention  \nBriefly state the type of intervention that will be undertaken. This will be expanded upon in the procedures section.  \nIV. Participant selection  \nState why this participant has been chosen for this research. People often wonder why they have been chosen to participate and may be fearful, confused or concerned.  \n\n|  |  | Page No. | Page 3 of 8 |\n| --- | --- | --- | --- |\n\nV. Voluntary Participation  \nIndicate clearly that they can choose to participate or not. State, what the alternative- in terms of the treatment offered by the clinic -will be, if they decide not to participate. State, only if it is applicable, that they will still receive all the services they usually do whether they choose to participate or not.  \nVI. Include the following section only if the protocol is for a clinical trial:  \nA. Information on the Trial Drug [Name of Drug]  \n1) give the phase of the trial and explain what that means. Explain to the participant why you are comparing or testing the drugs.  \n2) provide as much information as is appropriate and understandable about the drug such as its manufacturer or location of manufacture and the reason for its development.  \n3) explain the known experience with this drug  \n4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse effects of all the other medicines that are being used in the trial  \nB. Procedures and Protocol  \nDescribe or explain the exact procedures that will be followed on a step-by-step basis, the tests that will be done, and any drugs that will be given. Explain from the outset what some of the more unfamili","cbCainy9eoAwFhzC","https://ap.wps.com/l/cbCainy9eoAwFhzC","pdf",489652,8,"English","# PART I: Information Sheet\n## I. Introduction\n## II. Purpose of the research\n## III. Type of Research Intervention\n## IV. Participant selection\n## V. Voluntary Participation\n## VI. Clinical trial section (if applicable)\n### A. Information on the Trial Drug\n### B. Procedures and Protocol\n#### a) Unfamiliar Procedures\n#### ● Randomization or blinding / placebo\n#### ● Rescue medicine (if applicable)\n#### ● Clinical research/biopsy and anesthesia guidance\n#### ● Blood sample collection guidance","[{\"question\":\"What are the two parts of the informed consent form in this template?\",\"answer\":\"The ICF consists of two parts: the Information Sheet and the Certificate of Consent. The template also notes that the participant will be given a copy of the full Statement of Consent.\"},{\"question\":\"How should investigators handle sections that are not relevant to their study?\",\"answer\":\"Do not delete any sections. If any portion is not relevant, mark it as NA.\"},{\"question\":\"What language level should be used when drafting the ICF?\",\"answer\":\"The ICF should be drafted in simple language, aligned to the level used by a local student of class 6th/8th, and it should be in English, Hindi, and other vernacular languages as applicable.\"}]","ICF - Informed Consent Form Template | PDF",1789843448]