ࡱ> xzwg Fbjbj 8~r\r\a>X8lLH( HHHHHHH$zJ0M)H""")H>Ht$t$t$"FHt$"Ht$t$6_BEԤ[%L"^?CGTH0H[CM"M8EMEL5 6t$k , o)H)Hz#H""""M> R: [INSERT ELECTRONIC DEPARTMENT LETTERHEAD ON PAGE 1] Treatment Use Template v. 03/11/2019 RSRB Requirements: Information highlighted in yellow is guidance. Ensure ALL HIGHLIGHTED TEXT is deleted before submitting. Use of 2nd Person: The consent form must be written in the 2nd person (e.g., You are being asked to take part in this treatment program for). 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. CONSENT FORM Treatment Use of [insert name of Investigational Drug/Device] Treating physician: [Insert name] This consent form describes a treatment program, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully. The treatment team will explain this program to you. Please ask questions about anything that is not clear before you agree to participate. You may take this consent form home to think about and discuss with family or friends. Key Information [The 2018 changes to the Common Rule (45CFR46) require that consent forms must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate... Below is guidance for key elements that should be addressed as appropriate modify accordingly.] Being in this treatment program is voluntary it is your choice. You are being asked to take part in this treatment program because [Specify condition, situation, circumstances or other reason for recruitment]. The purpose of this treatment program is [INSERT brief description of purpose]. Your participation in this treatment program will last for about [INSERT timeframe, e.g., hours, months.] Procedures will include [INSERT primary activities]. Some of these procedures may be optional. There are risks from participating. The most common risk is [INSERT]. One of the most serious risks is [INSERT]. See the Risks of Participation section in this consent form for more information. You should discuss these risks in detail with your treating physician. You might not benefit from this treatment. It is hoped that the treatment will [insert potential benefit (e.g., improve your X, stop/slow its progression, etc.)], but this cannot be guaranteed. If you do not want to take part in this treatment program [discuss appropriate alternative treatments or courses of treatment that might be available to the patient (e.g., standard treatment, no treatment, or comfort care or participation in another study or treatment program)] [Delete if no alternatives] (If applicable)If you are the parent of a child or the authorized representative of an adult patient who will receive this treatment, the use of the word you in this form refers to the patient receiving the treatment. Introduction You have been diagnosed with [insert], which is a serious or life-threatening illness. The purpose of this form is to explain your options for treatment with an investigational drug [or device] called [insert name of product]. An investigational drug [or device] is one that has not been approved by the Food and Drug Administration (FDA). This treatment is being recommended for you because there either are no appropriate alternative treatments available for you or because alternative treatments for this condition have been tried and have failed. Purpose of the Treatment The purpose of this treatment is toDescribe the general purpose of the treatment, state why the treatment was chosen and include relevant background information in lay terms. Description of the Treatment Describe, in plain language, step-by-step how the treatment will be provided. As appropriate include: Any screening procedures (e.g., medical history review, physical examination, laboratory or diagnostic testing) How the drug is given (e.g., oral, IV, IM), its dose, when it will be given and for long it will be given [or how the device is used and how long it is used]. Any additional tests/procedures that the patient may need to undergo as part of their treatment (e.g., pregnancy testing, laboratory work-ups, diagnostic testing, etc.). Risks and Discomforts Describe, in plain language immediate and long-term physical, psychological, social, legal and economic risks/discomforts of both the investigational drug/device and any additional tests/procedures that the patient may need to undergo as part of their treatment. If appropriate, include information on the probably of the risk and the magnitude and reversibility of harmful effects (categorizing side effects as Likely, Less Likely and Rare is helpful). Describe how the risks/discomforts will be minimized. Because this treatment is considered investigational, there may also be risks or side effects that we do not know about at this time. Please let your doctor know about other medications (including supplements) you are currently taking and any new medicines you may begin during your treatment so that they can determine whether they are safe to take with this treatment. Benefits You might not benefit from this treatment. It is hoped that the treatment will [insert potential benefit (e.g., improve your X, stop/slow its progression, etc.)], but this cannot be guaranteed. Costs Choose or modify ONE of the following sentences as appropriate: [Insert drug/device] will be provided free of charge. You and/or your medical insurance company are responsible for payment of your hospital stay and regular doctors visits. - OR - The treatment including the [cost of the drug/device, laboratory tests and diagnostic tests] you receive will be charged to you or your insurance company just as any other medical care would be. Your insurance may or may not pay for this treatment. You should check with your insurance company to find out what costs they will pay. If your insurance company will not pay for this treatment, you will be billed for the cost of the treatment and all other related expenses. Alternative Treatments (If applicable) Use this section to discuss appropriate procedures or courses of treatment, if any, that might be advantageous to the patient (e.g., standard treatment, no treatment, comfort care or participation in another study or treatment program). In Case of Injury If you get ill or injured from being in this treatment program, the University of Rochester will help you to get medical treatment. The University of logo however, has not set aside any money to pay you or to pay for this medical treatment. In addition, no funds have been set aside to pay for such things as lost wages or expenses. If you receive medical treatment for your illness or injury, your insurer will be billed for your treatment costs. If you do not have insurance, or if your insurer does not pay, then you will have to pay these costs. If you have Medicare or Medicaid, the government agencies that run these programs may need information about your identity and your treatment. Your insurer may be told that you are receiving this treatment and that is not approved by the FDA. Costs You will/will not have to pay for the costs of this treatment program (INSERT any costs as appropriate). You and/or your insurance company will be responsible for paying for any tests/procedures/exams that are done as part of your standard care. You are encouraged to discuss your coverage with your insurance provider. New Information (If applicable) If we discover anything that might make you change your mind about continuing with this treatment, we will let you know. Circumstances for Discontinuation (If applicable) List the circumstances, if any, under which the patients participation may be stopped without their consent. For example: Your treatment according to this program may be stopped without your consent for any of the following reasons: If you develop severe side effects. If your disease becomes worse or if the doctor feels that staying in the program is harmful to your health. Further treatment would be discussed at that time. If new scientific developments occur that indicate that this program is not in your best interest. If the sponsor decides to stop or cancel the program. Early Termination (If applicable) List any consequences for patient self-withdrawal (e.g., adverse health/welfare effects) and procedures for orderly termination of participation (e.g., To ensure your safety after you have stopped the drug, you will be asked to return approximately 2 weeks after your last dose to complete a physical and neurological exam. Future Use of Information/Samples Choose or modify ONE of the following sentences: Your [information / samples] collected as part of this treatment program will not be distributed or used for future research studies. -OR- Your [information / samples] might be distributed or used for future research studies without additional informed consent. All identifiers will be removed before your [information / samples] are used or distributed. You will be given the option at the end of this consent form to decide if you would like your [information / samples] used for future research. [INSERT LAST SENTENCE IF APPLICABLE] Confidentiality of Records and Authorization to Use and Disclose Information The University of Rochester makes every effort to keep the information collected from you private. In order to do so, we will [insert protection measures]. Sometimes, however, physicians need to share information that may identify you with people that work for the University, regulators or the treatment sponsor. If you have never received a copy of the University of Rochester Medical Center (URMC) and Affiliates Notice of Privacy Practices, please ask the treating physician for one. [Note to Treating Physician: the Notice must be provided and receipt documented if this is the first contact with URMC and Affiliates (copies available on web).] What information may be used and given to others? The doctor will get your personal and medical information. For example: Medical records Results of medical tests Observations made while you undergo the treatment Who may use and give out information about you? Your doctor and the treatment team URMC and Affiliates Your information may be given to: The Department of Health and Human Services The University of Rochester [Include every organization or individual where data is shared (i.e., sponsors, sponsor agents [e.g., CRO], data monitoring committees, government agencies, foreign government regulatory agencies, companies) The U.S. Food and Drug Administration (FDA) may also need to inspect the treatment records at some point during your treatment or even after it has been completed. In the event that this should occur, every effort will be made to keep identifying information about you private. Why will this information be used and/or given to others? To conduct the treatment To measure the effects and safety of the treatment To see if the treatment was done right If the results of this treatment program are made public, information that identifies you will not be used. What if I decide not to give permission to use and give out my health information? Then you will not be able to receive this treatment. May I review or copy my information? Yes, but only after the treatment program is over. How long will this be permission be valid? This permission will last indefinitely. [If you will destroy the records at a definite point that should be stated instead and should be consistent with what is listed in both your protocol and application.] May I cancel my permission to use and disclose information? Yes. You may cancel your permission to use and disclose your health information at any time. You do this by sending written notice to your doctor. Upon receiving the written notice, the treatment team will no longer use or disclose your health information and you will not be able to stay on this treatment program. Information that has already been gathered may need to be used and given to others for the validity of the treatment. May I withdraw from the treatment program? Yes. If you withdraw your permission to be in the treatment program, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others. Is my health information protected after it has been given to others? No. There is a risk that your information will be given to others without your permission. Voluntary Treatment Taking part in this treatment program is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefits to which you are entitled. In the event that you decide to discontinue your treatment, the information you have already provided will be kept in a confidential manner. For safety reasons, it is important to tell your treating physician if you are thinking about discontinuing your treatment. If applicable: You may need to be tapered off the drug or have follow-up physical examination(s) and laboratory tests to monitor your health. Contact Person(s) If you have any questions about the treatment, or you feel you have had a treatment-related injury or bad reaction to the treatment contact [insert treating physicians name] 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] if you have any questions, concerns or complaints about your treatment. If there are additional informational sources related to the program (e.g., client representatives, patient advocate or individuals at other sites as appropriate), list here with contact information. ** Insert any checkbox options for future use of biological specimens or data, future contact, etc. If possible, checkbox options & signature blocks should appear all on one page. SIGNATURES/DATES After reading and discussing the information in this consent form you should understand: Why this treatment is being offered; What will happen during the treatment; Any possible risks and benefits to you; Other options you may have instead of being a part of this treatment program; How your personal information will be protected; What to do if you have problems or questions about this treatment program. Patient Consent I have read (or have had read to me) the contents of this consent form and have been encouraged to ask questions. I have received answers to my questions. I agree to this treatment. I have received (or will receive) a signed copy of this form for my records and future reference. Patient Name (Printed by Patient) Signature of Patient Date Person Obtaining Consent: I have read this form to the patient and/or the patient has read this form. An explanation of the treatment was given and questions from the patient were solicited and answered to the patients satisfaction. In my judgment, the patient has demonstrated comprehension of the information. I have given the patient adequate opportunity to read the consent before signing. I have (or will) provide a signed copy of this consent form to the patient. 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