ࡱ>   =bjbj 74@ 66666JJJ8|JV("$$$vu$UUUUUUU$WZU6U66$$Ud6$6$UU[P7T$լ;.R*UU0V9Rf[if[T7Tf[67THhJ_<<UUVf[ : 鶹Ƶ Institutional Review Board GUIDELINES FOR PREPARING AN ADDENDUM TO INFORMED CONSENT DOCUMENTS 1. The addendum consent should only be prepared for subjects who are currently taking part in a study: When subjects need to be informed of any significant new findings developed during the course of participation that may have a bearing on their willingness to continue in the study. When subjects need to be informed of specific changes (rather than having them sign a modified consent). The addendum will facilitate discussion since the changes/new findings are the focus of the document. Do not use the addendum consent document if there are extensive changes subjects should be re-consented with the modified consent document. Format: Informed consent documents should meet the following format requirements: All consent form documents must be typed using a black 12 point font (preferably Arial or Times New Roman). If your research study population requires a larger font, please adjust the font accordingly. Do not exceed 16 point in font size. Number all pages of the consent document. Include version date in the footer in the lower left corner of each page or in the title of the saved document for electronic submissions. Only original signatures are permissible on consent documents. Signature stamps are not acceptable. Before submitting the consent form to the IRB for review, please print and review the document for printing errors, spelling and grammar, font sizes, floating headings, etc. Addendum Consent Template: Always use the current version of the Addendum Consent template. In order to make sure that you are using the current version, go to the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/index.php"鶹Ƶ IRB website, and click on Forms and Instructions. Addendum Consent Language and Readability: The consent document you prepare is a reflection of your communication with your research participants. Because research participants come from a variety of backgrounds and educational levels and may be under physical or emotional stress, it is important that your consent document is easy to understand. Because studies have shown that understanding decreases with the length of the text, the consent document should be written at an 8th grade reading level. Microsoft Word has a readability check (under Tools, Spelling and Grammar, Options, check show readability statistics). Below are some helpful hints for writing consent documents that are easy to read and understand: Speak to your reader. Use you to refer to the subject. Use the active voice to make it clear who will do what. For example, write, You must provide consent not, Consent must be provided. Use words with the fewest number of syllables. For example, use take part rather than participate. Use short, declarative sentences to deliver a clear message. Break long sentences into several shorter ones. Express only one major idea per sentence. Break lengthy paragraphs into multiple, shorter paragraphs. Break long paragraphs into several shorter ones. Express only one major idea per paragraph. Avoid unfamiliar or confusing words or phrases. Avoid jargon. Use lay language (non-technical) in place of scientific terminology. For example, survey or questionnaire should be used instead of instrument or assessment. If scientific terminology is essential, include a lay language definition. GENERAL INSTRUCTIONS FOR USING THIS FORM: This Addendum Consent Form template includes shaded boxes providing brief instructions for creating an addendum consent. The instructions are shaded so you can tell the difference between instructions and required language. All shaded instruction boxes and underlined instructional text must be deleted BEFORE submitting this form to the 鶹Ƶ IRB for review. To delete the instruction boxes, place your curser within the shaded box, right click the mouse, and select Delete Rows. To delete the underlined text, select the text by highlighting with your mouse, and push the delete button on your keyboard. Instructions for the consent form header below: List all sites (under 鶹Ƶ IRB jurisdiction) in which the research study will take place below SAINT LOUIS UNIVERSITY. The model consent should be printed on 鶹Ƶ letterhead when appropriate. Insert IRB Number. The Title of Project should match the protocol title. This title should also match the sponsor contract or grant title if appropriate. SAINT LOUIS UNIVERSITY (List other facilities in which research will take place) ADDENDUM INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES Participant: IRB #:First Name / Last NamePrincipal Investigator (PI)Contact Phone #First Name / Last Name CredentialsTitle of Project:  You refers to the person taking part in the research study. You are currently taking part in the above-named research study. The purpose of this document is to provide you with more information about the study, which will be discussed with you. This form may contain words that you do not understand. Please ask the researcher or the study staff to explain any words or information that you do not clearly understand. Since the time you signed the original consent form for this study, new information related to the study has become available. Fill in information which is applicable to the study, i.e., new safety information, additional procedures, etc. Please include any appropriate language from sections of the Model Informed Consent Document (e.g., participation, duration, risks, benefits, confidentiality, alternatives, etc.). It is not necessary to include information if it is not relevant to the new information or the subjects willingness to continue participation. Your continued participation in this research is voluntary and refusal to take part will involve no penalty to you or loss of any benefits to which you are otherwise entitled. You may withdraw from the research study now or at any time without penalty or loss of benefits to which you are otherwise entitled. You will be informed of any significant new findings developed during the course of participation in this research that may have a bearing on your willingness to continue in the study. The investigator may withdraw you from this research if circumstances arise which makes this necessary. If you would like, the information in the original consent form may be reviewed with you. STATEMENT OF CONSENT: I have read this addendum consent form and have been able to ask questions and express concerns, which have been satisfactorily responded to by the study investigator(s). For Clinical Studies Add: I have been asked if I wish to speak directly to the researcher or research study doctor responsible for this research study. All previous statements of informed consent that were contained in the original consent document that I signed are still applicable, including potential benefits and risks. SIGNATURE INSTRUCTIONS: Delete the signature lines/sections below that are not applicable (LAR/Witness/Assent) Potential lines to be deleted are in blue. As much as possible, the IRB stamp should appear on the same page as the participant signature line. A witness signature is required by federal regulations ( HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "46.117" 45 CFR 46.117(b)(2)) with the use of a Short Form consent document, which is most often used in studies that accrue non-English speaking subjects. However, in some cases, the IRB or the Researcher may request the use of a witness signature. The witness line should be signed by an individual who witnesses the research participant sign and date the consent form document. This signature can be a family member, friend, etc. The witness signature should not reflect the signature of the person responsible for obtaining informed consent. For research involving participants whose ability to give consent is in question: It is recommended that the caregivers signatures be obtained (please modify the signature lines below accordingly) indicating they understand their involvement. For research involving children 7 years of age and older, consider modifying the assent form or you may otherwise document that changes or new information has been discussed with them and indicate whether assent was obtained. The Principal Investigator or Research Team Member that signs the consent form must be authorized in the protocol to obtain informed consent and must sign at the SAME time as the participant signature is obtained. Use the following lines for adult participants or remove. (minors section is below) I give my informed and voluntary consent to take part in this research study. I will be given a copy of this consent document for my records. _____________________________________ Print Name of Participant _____________________________________ ________________ Signature of Research Participant (18 and over) Date Use the following lines if an LAR signature is needed or remove. (minors section is below) I give my informed and voluntary consent for the person I represent to take part in this research study. I will be given a copy of this consent document for my records. _____________________________________ Print Name of Participant _____________________________________ Print Name of Guardian/Legal Representative _____________________________________ ________________ Signature of Guardian/Legal Representative Date _____________________________________ Description of Relationship to Participant Use the following lines if a witness signature is needed or remove. Note: the witness should be someone unrelated to the research; a subject relative would qualify. _____________________________________ Print Name of Witness _____________________________________ ________________ Signature of Witness Date Use the following section for research involving minors or remove. Include the text from ASSENT SECTION down to the IRB approval stamp box ONLY if the study requires obtaining minors assent. I have read this consent document and agree to allow my child to be in this research study with the understanding that I may withdraw him/her at any time. If my child is 7 years of age or older, this research study has been explained to him/her and he/she agrees to participate. I will be given a copy of this consent document for my records. _____________________________________ Print Name of Participant _____________________________________ Print Name of Parent/Guardian/Legal Representative _____________________________________ ________________ Signature of Parent/Guardian/Legal Representative Date _____________________________________ Description of Relationship to Participant _____________________________________ Print Name of 2nd Parent/Guardian if required _____________________________________ ________________ Signature of 2nd Parent/Guardian, if required Date _____________________________________ Description of Relationship to Participant ASSENT SECTION: Statement of Parent, Guardian, or Legal Representative: My child appears to understand the research to the best of his or her ability and has agreed to participate. _____________________________________ ________________ Signature of Parent/Guardian/Legal Representative Date SAINT LOUIS UNIVERSITY INSTITUTIONAL REVIEW BOARD APPROVAL STAMP This form is valid only if the IRBs approval stamp is shown below.  I certify that I have explained to the above individual(s) the nature and purpose of the research study and the possible benefit and risks associated with participation. I have answered any questions that have been raised and the participant has received a copy of this signed consent document. If this study involves participants who are minors: I have explained new aspects of the research to the minor to the best of his or her ability to understand. I have answered all the questions of the minor relating to this research. The minor agrees to continue to be in the research. I believe the minors decision is voluntary. The research study doctor and study staff agree to respect the minors physical or emotional dissent at any time during this research when that dissent pertains to anything being done solely for the purpose of this research. Signature of Consenting Research Team MemberDate First Name / Last Name CredentialsPrinted Name of Consenting Research Team Member NOTE: The Principal Investigator or Research Team Member that signs here must be authorized in the IRB approved protocol to obtain informed consent and must sign at the SAME time as the above signatures are obtained.     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