ࡱ> z}y y;bjbj 4}c}c2X X 8, ;(cyyyT> +++++++$8.0+N TTN N +yy+R#R#R#N ^yy+R#N +R#R#ro)T'*yZ0ҫ )++0,)V1v!1'*1'*\DhR#TN++X",N N N N 1X e: MODEL CONSENT DOCUMENT for SINGLE USE Should be printed on Saint ֱοƵ University letterhead when appropriate SAINT LOUIS UNIVERSITY Informed Consent for Single Use Treatment Patient: IRB #:First Name / Last NamePhysician:Physician Contact Phone #:First Name / Last Name CredentialsTitle of Project:  You refers to the participant Dr. (insert treating physicians name) and/or colleagues are offering you treatment because (include reason why the participant is considered a candidate). This treatment is being provided under the United States Food and Drug Administrations (FDA) expanded access program. The expanded access program includes an option to use a drug medication not yet approved by the FDA (investigational drug) to treat a patient with a serious or life threatening condition. Investigational drugs have not yet been approved by the FDA as safe and effective. They may or may not be effective in the treatment of a condition. They also may have unexpected serious side effects. It is important for you to consider the possible risks if you are interested in seeking access to an investigational drug. Another way that patients can access an investigational drug is through a clinical trial. You can ask your doctor more about this and other treatment options. This consent document may contain words that you do not understand. Please ask your doctor or staff to explain any words or information that you do not clearly understand. 1. PURPOSE AND BACKGROUND Describe background information in lay language that informs and justifies why the treatment is being performed so the participant can understand clearly why the treatment is important given their current condition. If appropriate, state that the purpose includes evaluation of the safety and effectiveness of the treatment. PROCEDURES Your participation will involve: Describe what the individual is being asked to do in the order that the procedures will take place. Identify those aspects of participation that are standard of care and which aspects are experimental and would not take place other than for purposes of the use of the treatment. RISKS The treatment has not been proven effective for this use. There are certain risks and discomforts that may be associated with this treatment. They include: Describe all reasonably foreseeable risks, side effects, or discomforts resulting from this treatment. When appropriate, state that there may be risks that are unforeseen or unknown at this time. The possibility of loss of privacy, financial burdens, adverse impact on employment, etc. should be considered as risks and included. 4. DURATION Your participation in this treatment, including follow-up, is expected to last (insert anticipated duration such as hours, days, months, years, followed for life; or give a range, i.e., 2-5 years). This section should be for the total duration that the participant will be followed. Please provide a brief description of any individual visits in the procedures section (section 2). 5. BENEFITS You may not benefit from this treatment. Your condition may get better, stay the same, or get worse. The possible benefits to you for receiving treatment with add name of test article are Describe benefits, or lack of benefits, to the individual as well as to society. 6. ALTERNATIVES You may choose not to be treated with the add name of test article. Briefly describe the standard procedure or treatment for the participant's medical condition. 7. CONFIDENTIALITY/PRIVACY Your treatment information will remain private. In order to protect your information, Dr. (insert Treating Physicians name) will... (briefly describe privacy/confidentiality measures) The Saint ֱοƵ University Institutional Review Board (the Board that is responsible for protecting the welfare of persons who take part) and other University officials may review your records. The FDA or drug manufacturer, (insert Manufacturers name), may also review your records. State laws or court orders may also require that information from your records be released. By signing this form, you authorize SLUCare and your attending physician to release medical information concerning your care, including copies of medical records and/or billing information pertaining to your medical care to individuals or representatives of agencies or organizations in connection with obtaining payment for medical services rendered to you by SLUCare and /or independent contractors engaged by them. Saint ֱοƵ University (SLU) requires that private information about you be protected. This is especially true for your personal health information. Protected Health Information (PHI) is any health information that identifies you. To take part in this treatment, you must give permission to use and share your PHI. The treatment team will only use and/or share your information as listed below. The PHI available for this treatment will include your name, address and birth date with your medical history. The PHI will be state the source(s) from which you are obtaining PHI and how the PHI will be obtained (e.g., recorded from your medical record). Your PHI will be maintained by [list appropriate persons] (the Saint ֱοƵ University treatment team) and they will only share the information as described below. SLU may use or share your health information with: The SLU Institutional Review Board and other University personnel in order to provide oversight Federal or state government representatives, when required by law to review quality and safety, including: U.S. government agencies, such as the Food and Drug Administration. [Hospital or representatives (if applicable)] in order to provide oversight [List manufacturer/device provider.] These organizations and their representatives may see your Personal Health Information. They may not copy or take it from your medical records unless permitted or required by law. [INSERT THE FOLLOWING PARAGRAPH IF APPLICABLE.] The manufacturer is not covered by HIPAA. This means that the manufacturer does not have to follow the same rules to protect your privacy. SLU may send information to the manufacturer. This information could contain PHI such as your (list any identifiable information, or state as listed above). In addition, the manufacturer or its agents may review your medical record in order to verify information that is provided to them. SLU agrees to protect your health information by using and/or disclosing it only as you authorize. However, if your PHI is shared with someone outside of SLU and/or if you choose to share this information with others, your health information may no longer be protected by HIPAA. Your permission to use and/or share your PHI does not have an expiration date. If you choose to sign this form: You can change your mind and not allow SLU to use and/or share your PHI (revoke your authorization). If you revoke your authorization, you must send a written letter to: [insert Physicians name and contact information] to inform him/her of your decision. If you revoke your authorization, SLU may only use and/or share your PHI already collected for this treatment. If you revoke your authorization, your PHI may still be used and/or shared should you have an adverse event (a bad effect). If you withdraw your authorization, you may not be allowed to continue in the treatment. If you have questions or concerns regarding your privacy and the use of your personal health information, please contact the University Privacy Officer at (314) 977-5545. You will also be given a copy of the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/slu_notice_of_privacy_practices.pdf"Notice of Privacy Practices (a separate document). 8. COSTS State who will be responsible for any additional costs resulting from receiving the treatment. State which costs are standard of care. 9. TREATMENT RELATED INJURY If you believe that you are injured as a result of your participation in this treatment, please contact the doctor and/or the Chairperson of the Institutional Review Board as stated in section 10. You will receive necessary medical care in the event that an injury results because of your participation in this treatment. The University will have the right to determine whether an injury is related to your participation in this treatment or happened because of your medical condition or other reasons which are not related to this treatment. If the injury is due to participation in the treatment, you will not have to pay for the cost of necessary medical care unless your injury is due to your own failure to follow the doctors instructions. There are no plans for Saint ֱοƵ University to pay for the costs of any additional care. You have not waived your legal rights by signing this form. If you have questions, please call the Saint ֱοƵ University General Counsel's office at HYPERLINK "tel:314-977-5767" \t "_blank" 314-977-5767. 10. CONTACTS If you have any questions or concerns regarding the treatment, or if any problems arise, you may call the treating physician (insert name) at (insert phone number). For questions after hours, you may call (list the number) and ask for (insert name). If you have any questions about your rights as a participant or in the event you believe you have suffered an injury as a result of participation in the treatment, you may contact the Chairperson of the Saint ֱοƵ University Institutional Review Board (314-977-7744), who will discuss your questions with you or will be able to refer you to an individual who will review the matter with you, identify other resources that may be available to you, and provide further information as how to proceed. 11. VOLUNTARY PARTICIPATION Your participation in this treatment is voluntary and refusal to participate will involve no penalty to you or result in the loss of any benefits to which you are otherwise entitled. You may choose to stop treatment at any time. 12. STATEMENT OF CONSENT I have read this consent document and have been able to ask questions and express concerns to which the doctors have responded. I believe I understand the purpose and procedures involved with the treatment as well as the potential benefits and risks that are involved. For pediatric studies, replace the previous statement with the following: I have read this consent document and agree to allow my child to be treated with the understanding that I may withdraw him/her at any time. If my child is 7 years of age or older, the treatment has been explained to him/her and he/she agrees to take part. NOTE: The IRB doesnt require a separate assent form, but the physician can use one if desired. In such cases, the assent form should be submitted for IRB review and approval. If a minor will be assenting, include the Statement of Parent or Guardian section, below. If a minor will not be allowed to decline participation based on the treatment nature, do not use an assent process but do explain the treatment to the minor. For Treatment Involving Participants Whose Ability to Give Consent is in Question: It is recommended that the caregivers signatures be obtained [either on the same consent that the participant signs (modify the signature lines accordingly) or on an addendum consent] indicating they understand their involvement. I give my informed and voluntary consent. I will be given a signed copy of this consent document for my records. __________________________________ ________________ Consent Signature of Patient (18 and over) Date __________________________________ Print Name of Patient __________________________________ ________________ Signature of Parent/Guardian/Legal Representative Date __________________________________ Description of Relationship to Patient Statement of Parent or Guardian: My child appears to understand the treatment to the best of his or her ability and has agreed to take part. __________________________________ ________________ Signature of Parent or Guardian 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 the possible benefit and risks associated with treatment. I have answered any questions that have been raised and the patient has received a copy of this signed consent document. 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