ࡱ> PRO _bjbj11 84SSchh8DR$}2v(1111111$s4%7"2   "272$$$ p1$ 1$$r8/T80םr2] ^/1M20}2/7 780780Z@$)4]"2"2"}2    7h : [INSERT ELECTRONIC DEPARTMENT LETTERHEAD ON PAGE 1] Consent Addendum Template v. 2/01/2016 The information that is highlighted in yellow is being provided as guidance. DELETE THIS AND ALL OTHER HIGHLIGHTED INSTRUCTIONS BEFORE SUBMITTING. RSRB Requirements: Use of Subject: The consent must use the term research subject rather than participant or volunteer. Use of 2nd Person: The consent form must be written in the 2nd person (e.g., You are being asked to take part in a research study about). Pagination: Maintain page numbering already inserted in the footer (e.g., 2 of 4). Version Date: Manually type the date in the footer, rather than selecting Insert Date from the toolbar to avoid automatic logo each time the document is opened. Margins: Maintain the bottom margin of at least 2 inches to provide space for watermarking upon approval. Sample Language: Sample language for certain types of procedures and risks (e.g., CT, MRI, x-ray, randomization, placebo, screening tests and biospecimens) is provided in the  HYPERLINK "http://www.rochester.edu/ohsp/rsrb/docTemplates/consentFormTemplates.html" Consent Document Sample Language guide. CONSENT FORM ADDENDUM [Insert Title of Study] Principal Investigator: [Insert] You are participating in the research study named above. Some of the information provided when you originally agreed to participate has changed. This consent addendum describes [new information, procedures and/or risks] that are now part of the study, and provides important information to help you decide if you want to continue to participate in this study. All other aspects of the study remain the same. Please read this form carefully and ask questions about anything that is not clear before you agree to continue participating or at any time. Describe any new information, procedures and/or risks. If multiple items are being addressed, use headings for each item as appropriate (e.g., New Procedures, Additional Risks of Participation, Alternatives to Participation). Contact Persons For more information concerning this research or if you feel that your participation has resulted in any research related injury, emotional or physical discomfort, please contact: [insert contact persons name (for research related injury contact person must be a clinician)] at [telephone number] Please contact the University of Rochester logo Subjects Review Board at 265 Crittenden Blvd., CU 420628, logo NY 14642, Telephone (585) 276-0005 or (877) 449-4441 [insert country code (001) if applicable] for the following reasons: You wish to talk to someone other than the research staff about your rights as a research subject; To voice concerns about the research; To provide input concerning the research process; In the event the study staff could not be reached. If there are additional informational sources related to the study (e.g., client representatives, subject advocate or individuals at other study sites as appropriate), list here with contact information. Voluntary Participation Continuing to take part in this study is voluntary. You are free to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. In the event that you do withdraw from this study, the information you have already provided will be kept in a confidential manner. If you agree to continue taking part in this study, please sign and date this consent form below. ** Insert any checkbox options for future use of biological specimens or research data, future contact, audio/video recording, etc. If possible, checkbox options & signature blocks should appear all on one page. SIGNATURES/DATES Subject Consent I have read (or have had read to me) the contents of this consent addendum and have been encouraged to ask questions. I have received answers to my questions. I agree to continue participating in this study. I have received (or will receive) a signed copy of this form for my records and future reference. Subject Name (Printed by Subject) Signature of Subject Date Person Obtaining Consent I have read this form to the subject and/or the subject has read this form. I will provide the subject with a signed copy of this consent form. An explanation of the research was given and questions from the subject were solicited and answered to the subjects satisfaction. In my judgment, the subject has demonstrated comprehension of the information. I have given the subject adequate opportunity to read the consent addendum before signing. 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