ࡱ> x{stuvw Fbjbj f}c}cP> " " " " "$-"-"-"P}"Y(-"X*:71"Y1Y1Y12 ?Sl \ikkkkkk$B "ca22caca " "Y1Y14nnnca "Y1 "Y1incainn9hMY1ښr-#bVNU0^kgM"o " Hcacancacacacacakcacacacacacacacacacacacacacacaca : Saint ˻ֱ University Institutional Review Board Biomedical (Clinical) Informed Consent Template GUIDELINES FOR PREPARING AN INFORMED CONSENT DOCUMENT INFORMED CONSENT MODEL TEMPLATE: Always use the current version of the informed consent model template when preparing your consent form. In order to make sure that you are using the current version, go to the SLU IRB website and click on Forms and Instructions. Note: ˻ֱ that involves the collection, use, or disclosure of Protected Health Information (PHI) is subject to HIPAA requirements. A separate authorization for use of PHI must be obtained using the SLU model  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hipaa_authorization_form.doc" HIPAA Authorization Form. FORMAT: The informed consent document should meet the following format requirements: Use the SLU Consent template, even if the study is multi-center. Sponsor consent language can be copied and pasted into appropriate sections of the SLU template consent/SLU section headers. Documents should be typed using a black 12 point font (preferably Arial or Times New Roman). If your research study population requires a larger font, adjust the font accordingly. Number all pages of the consent document. Include the version date in the footer in the lower left corner. Place each section heading directly above the text to which it refers. Do not let headings stand alone at the bottom of the page, or with only part of a sentence attached. Before submitting the consent form to the IRB for review, please print and review the document for print errors, spelling and grammar, font sizes, floating headings, etc. Delete any instructions/instruction boxes. CONSENT FORM 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 and emotional stress, it is important that your consent document is easy to understand. Studies have shown that understanding decreases with the length of the text, the consent document should be written at an 8th grade reading level. Below are some helpful hints for writing a consent form that is 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 drug rather than medication, 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-medical) in place of medical terminology. If a medical term is essential, include a lay language definition ( HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/plain_language_thesaurus_health_communications.pdf" Click here for a glossary of lay terms). For example, bruise should be used instead of hematoma. GENERAL INSTRUCTIONS FOR USING THIS FORM: This Model Consent Form template includes shaded boxes providing brief instructions for completing the required elements of an informed consent document. Sample consent language is provided at the end of the template, and also linked by topic within the instructional boxes. 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 SLU 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 SLU IRB jurisdiction) in which research will take place below SAINT LOUIS UNIVERSITY. (This does not include various departments involved in the research unless they are located at a different site.) List any SSM Health sites and list SSM Health Saint ˻ֱ University Hospital if in-patient. The model consent should be printed on Saint ˻ֱ University letterhead when appropriate. Insert the IRB # obtained from eIRB before uploading consent in the system. 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 ˻ֱ Study Consent Form STUDY TITLE: [Title from protocol]  This consent form contains important information to help you decide whether to participate in a research study. The study staff will explain this study to you. Ask questions about anything that is not clear at any time. You may take home an unsigned copy of this consent form to think about and discuss with family or friends. Being in a study is voluntary your choice. If you join this study, you can still stop at any time. No one can promise that a study will help you. Do not join this study unless all of your questions are answered. After reading and discussing the information in this consent form you should know: Why this research study is being done; What will happen during the study; Any possible benefits to you; The possible risks to you; Other options you could choose instead of being in this study; How your personal health information will be treated during the study and after the study is over; Whether being in this study could involve any cost to you; and What to do if you have problems or questions about this study. Please read this consent form carefully. RESEARCH STUDY CONSENT FORM Participant: IRB #:First Name / Last NamePrincipal Investigator (PI)Contact Phone #First Name / Last Name CredentialsTitle of Project:  INSTRUCTIONS: The first paragraph of your consent form is to introduce the research study to the participant. Modify the paragraph below to fit your research study. For samples of text that can be cut/pasted into this section of the consent form, click here: HYPERLINK \l "introduction"INTRODUCTION You refers to the person who takes part in the research study. You are being asked to take part in a research study conducted by name of principal investigator and colleagues because include a reason for why the subject is being asked to participate in the research study,.e.g., you are being asked to participate in a research study because you have been diagnosed with high blood pressure. This consent document may contain words that you do not understand. Please ask the research study doctor or research staff to explain anything that you do not understand. INSTRUCTIONS: This section of the informed consent document is required for studies approved by the SLU IRB on or after 1/21/19. This section may be deleted if this informed consent document as a whole is 5 pages or less in length, at 12 point font. The federal regulations require that informed consent documents contain a concise and focused presentation of key study information. The intention of this section is to provide potential research participants with a better understanding of the projects scope, including major risks and benefits, so they can make a more fully informed decision about whether to participate. The key information must be presented first and should be limited to 1 page in length, and then the information may be discussed in greater detail later in the informed consent document. Examples of key information sections may be found  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_key_information_examples.docx" HERE.  Key Information for You to Consider Purpose. The purpose of this research is [provide a brief description of why the research is being conducted, no more than 2-3 sentences]. Duration. It is expected that your participation will last [expected duration]. Study Procedures. You will be asked to [briefly highlight the key research procedures]. Risks. Some of the foreseeable risks or discomforts of your participation include [describe the most important and significant risks to the participant. Consider those most probable and/or highest magnitude of harm]. Benefits. Some of the benefits that may be expected include [insert direct benefits, or if no direct benefit to subject state there is no direct benefit, but the researchers hope to learn/gain xyz]. Alternatives. You may choose not to be in this research study. As an alternative to participation, you could [note appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective participant. If there are no alternatives, state, Participation is voluntary and the only alternative is to not participate.].  WHY IS THIS RESEARCH STUDY BEING DONE? INSTRUCTIONS: This section of the informed consent should briefly describe: Main purpose of the research study Background information in lay language that informs and justifies why the research is being done so the participant can understand why the research is important. Include how this research differs from the accepted standard of care and/or standard practice at SLU for the condition/disease/situation being studied. If this research study involves use of a drug or device, name the drug or device and explain whether or not it is approved for use by the Food and Drug Administration (FDA). If the test article has been approved by the FDA, but is being studied for an unapproved use, this should be stated. If this is a multi-center research study, indicate the number of sites involved and the total number of participants expected to be accrued from all sites for this research study. Indicate the maximum number of participants expected to be involved at SLU for the duration of the research study. If more than one site is recruiting at SLU, state the total number to be recruited at SLU and the total number to be recruited study wide (an approximate number for study wide is acceptable if that is what the sponsor gives). This number should match the number stated in your protocol. Click on the following options below if it applies to your research:  HYPERLINK \l "Deception" Study involves deception  HYPERLINK \l "HumanGeneTransfer" Study involves Human Gene Transfer WHAT AM I BEING ASKED TO DO? INSTRUCTIONS: This section of the informed consent should clearly describe for the participant their involvement in the research study. Include the following information, when applicable: Describe the research study visits and procedures that the participant will undergo. Include the length of the visits. If possible, organize this information in chronological order, and use headers and bullet points to list different procedures. The use of tables and charts may also be helpful for the participant. Include each table or chart on an individual page if possible or as an appendix page. Identify which procedures are standard of care and which procedures are experimental and would not take place other than for purposes of this research study. Include information about the research study design, i.e., randomization, placebo, blinding. If randomization will occur, explain that the participants will be assigned to one of the groups by chance and state what the chances are of being in each group (give the number or a percentage). If a placebo is being used, indicate and describe what a placebo is in lay language (e.g. a sugar pill, an inactive substance). List special requirements, e.g.., stopping current medications, fasting before tests Reasons for early withdrawal from the research study, e.g., stopping points, failure to follow protocol, final research study visit, altering medication dosage, etc. Include that if there is a conversation with a minor regarding sexual activity, it will be held separate from the parents. Also that if a pregnancy test is done the results will be shared with parents. Sending data/specimens to collaborators outside of SLU If the storage of data or biospecimens for future use is mandatory, state; if optional, include opt in / opt out with signature/initial lines. Permission to contact subjects for future research projects should be requested in this section if applicable. For example, May researchers contact you to invite you to take part in future studies? Yes/No and include signature/initial lines. Sponsor use of identifiable information for additional research For samples of consent form language that can be cut/pasted into the PARTICIPATION section, click on one of the following options:  HYPERLINK \l "ParticipatinginOtherStudies" Participating in Other Studies  HYPERLINK \l "Screeningprocedures" Screening Procedures  HYPERLINK \l "blooddraw" Blood Drawing  HYPERLINK \l "followup" Follow-Visits  HYPERLINK \l "futureuse" Future Use of Blood, Tissue, or Data  HYPERLINK \l "GeneticTestingProcedures" Genetic Testing/Whole Genome Sequencing  HYPERLINK \l "HIV" HIV Testing/Reporting of Communicable Diseases  HYPERLINK \l "interviewquestionnaire" Interviews/Questionnaires  HYPERLINK \l "PhotographsAudiotapesVideotapes" ˻ֱ Involving Photographs/Audiotapes/Videotapes  HYPERLINK \l "placebo" Placebo, Randomization  HYPERLINK \l "pregminor" Pregnancy Tests involving Minors For studies that involve the collection of identifiable data or identifiable biospecimens, one of the following statements MUST be included: Identifiers might be removed from your data (and/or samples) collected in this research, and used for future research studies or distributed to other researchers for future research studies (with/without) your additional permission. Your data (and/or samples) collected as part of this research, even if identifiers are removed, will not be used or distributed for future research studies. 3. HOW LONG WILL I BE IN THE RESEARCH STUDY? INSTRUCTIONS: This section should explain: The anticipated time commitment expected from the participant. (Provide duration such as hours, days, months, years, followed for life; or give a range, e.g., 2-5 years). Total time expected for researchers to complete the research activities (if known).  The time you may spend on this research study is The research study should be completed by WHAT ARE THE RISKS? INSTRUCTIONS: In this section of the consent document, risks to the participant should be addressed. This information should be limited to those risks and discomforts associated with the procedures or activities done for research purposes, and should not include those risks and discomforts related to participants routine medical care. Include the following information in this section: Reasonably foreseeable and significant risks, side effects, or discomforts resulting from the research. List risks and discomforts in order of most common and most likely to occur, with least likely to occur listed last. Also, list any rare, but serious risks. If there are many risks, use a bulleted format. If known, provide the percentage or range of occurrence for the risks. When appropriate, state that there may be risks that are unforeseen or unknown at this time. The possibility of ineffective treatment due to the use of placebo, embarrassment, loss of privacy, financial burdens, adverse impact on employment, etc. should be considered as risks and included. Indicate how side effects or discomforts will be minimized or indicate that they will be treated by medically appropriate therapy. Add what specific arrangements, if any for medical treatment, if needed, have been made. For cancer studies, the disease and the treatment may be considered serious and even life-threatening. Below are a few samples that may be used for the RISKS section of the consent document. EXAMPLE 1 Common Risks for all drugs or drugs used in combination Drug A unique risks Drug B unique risks EXAMPLE 2 Common risks for all drugs or drugs used in combination Severity of side effects for Drug A verses Drug B For clinical studies, the risks from the investigator brochure and/or package insert should be adequately reflected in this section. If such risks are omitted, an adequate explanation must be provided in the protocol. For samples of consent form language that can be cut/pasted into the RISKS section, click on one of the following options:  HYPERLINK \l "Allergic" Allergic-type Adverse Reaction  HYPERLINK \l "blooddrawrisk" Blood Drawing  HYPERLINK \l "breach" Breach of Confidentiality-Sensitive Issues  HYPERLINK \l "combination" Combination Drug Therapy HYPERLINK \l "GeneticTestRisks"Genetic Testing/GINA Language  HYPERLINK \l "HIVrisk" HIV Status  HYPERLINK \l "interview" Interviews/Questionnaires  HYPERLINK \l "investigationaldrug" Investigational Drug  HYPERLINK \l "ObservationalSOCrisks" Observational Study Drug/Device Risks  HYPERLINK \l "placeborisk" Placebo  HYPERLINK \l "reproductiverisks" Reproductive Risks  HYPERLINK \l "radiation" Radiation Exposure  HYPERLINK \l "seriouswithsurgery" Serious Side Effects There are certain risks and discomforts that may occur if you take part in this research study. They include If side effects or discomforts occur, insert name of investigator will try to help these by... As this study involves the use of your personal information, there is a chance that a loss of confidentiality will occur. The researchers have procedures in place to lessen the possibility of this happening, as described in section 7 of this form. The research team is willing to discuss any questions you might have about these risks and discomforts. ARE THERE BENEFITS TO BEING IN THIS RESEARCH STUDY? INSTRUCTIONS: In this section, describe the benefits, or lack of benefits, to the individual as well as to society. The first sentence should indicate that the participant may not or will not benefit from the research study as applicable. NOTE: Compensation for time or reimbursement for expenses are not considered benefits and should be included in the Cost section (section 8 of the consent document). For samples of text that can be cut/pasted into this section of the consent form, click here:  HYPERLINK \l "benefits" BENEFITS  You (may not/will not) benefit from this research study. Your condition may get better, stay the same, or worsen. The possible benefits to you are Even though you may not receive any benefit, (society / other people with / other people who) may benefit in the future because of what the researchers learn from this research study. WHAT OTHER OPTIONS ARE THERE? INSTRUCTIONS: This section of the consent form should include (if applicable): The standard procedure or treatment for the participant's medical condition; when applicable, address the alternative of other research studies. If the research study drug is available outside of the research study, include the alternative of taking the research study drug by doctors prescription without participating in research. List other treatment(s) available, including participating in other research studies  You may choose not to be in this research study. WILL MY INFORMATION BE KEPT PRIVATE? INSTRUCTIONS: It is a federal requirement to describe the extent, if any, to which confidentiality of records identifying the participants will be maintained. In this section, describe the following: Specific method for assuring confidentiality (this section should match the IRB application form (eIRB Biomedical form section 11). Indicate where research study records will be kept, how they will be maintained, and how the principal investigator will be responsible for them. If videotaping or audio taping is done, indicate how confidentiality of the tapes will be maintained and when they will be destroyed. Address who will have access to the confidential information. For samples of consent form language that can be cut/pasted into the CONFIDENITALITY section, click on one of the following options (if applicable):  HYPERLINK \l "resereccontid" ˻ֱ Records Containing Identifiers  HYPERLINK \l "datasharing" Data Sharing (should be consistent with section 11 of the IRB application)  HYPERLINK \l "releaseofresearchresults" Release of Individual ˻ֱ Results  HYPERLINK \l "MandatedReport" Mandated Reporter Language  HYPERLINK \l "COC" Certificates of Confidentiality (REQUIRED language if this is NIH funded research) The results of the research study may be published but your name or identity will not be revealed and your record will remain private. In order to protect your information, name of the investigator will... The Saint ˻ֱ University Institutional Review Board (the Board that is responsible for protecting the welfare of persons who take part in research), (insert hospital name officials) and other University officials may review your research study records. The Food and Drug Administration (FDA) or Sponsor (list name) may also review your research study records, including your medical record. State laws or court orders may also require that information from your research records be released. For studies that may produce clinically relevant research results, including individual research results, consistently with section 3g of the IRB application, describe whether the results will be given to the participants: As this research study involves medical tests, the research team could find out information that affects your health during the course of this study. The researchers (plan/do not plan) to provide you with this information. (Please modify this statement, and include under what conditions the participant would/would not be given the research results). For studies that record research information in the medical record, consistently with section 11h of the IRB application, the following statement must be included: Some information about your participation in this study will be kept in your medical record. Authorized Saint ˻ֱ University and Hospital staff have access to this information. Systems are in place to keep medical record information confidential. It is possible this information could be shared with insurance or healthcare providers who are authorized to have your medical records. For  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/nih_clinical_trial_definition.docx" applicable clinical trials, the following statement must be included: Note - For each clinical trial conducted or supported by a Federal department or agency, an IRB approved consent form must be posted on the Federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol A description of this study and study results will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. You can search this website at any time. WHAT ARE THE COSTS AND PAYMENTS? INSTRUCTIONS: In this section of the consent form, please describe the following (where applicable): State who will be responsible for the costs of drugs, devices, procedures, treatment side effects, follow-up tests, office visits, hospital stays, etc. relating to research activities Differentiate between costs resulting from standard of care and costs resulting from research (that are additional). When costs to a patient or participant for research study related procedures are high and may not be covered by insurance, an estimate of the costs and/or financial counseling should be provided to the subject. State whether or not the subject is receiving an incentive/compensation (i.e. payments, gift cards, travel reimbursements, etc.) For research involving more than one interaction, payment must be prorated. State how and when participants will be paid. Payments must comply with the Universitys Policy on Participant Payments within ˻ֱ and/or Sponsored Activities (Participant Payment Cards should be used for single payments greater than $25 or total payments exceeding $100 in a calendar year unless an exception was granted). For samples of consent form language that can be cut/pasted into the COSTS AND PAYMENTS section, click on one of the following options:  HYPERLINK \l "costsandpayment" Sponsor Covers all Costs  HYPERLINK \l "costsdependuponcomm" Costs Contingent upon Commercial Availability  HYPERLINK \l "StandardOfCareBilling" Standard of Care to be Billed to Insurance  HYPERLINK \l "FinancialCounseling" Studies Offering Financial Counseling  HYPERLINK \l "payment" Sample Payment Language In this study, you will/will not be paid (include payment amount, payment method and payment schedule information). For studies using Participant Payment Cards (i.e. CCPay, ClinCard) include: Payments for taking part in this research study will be put onto a participant payment card. The participant payment card is managed by an external company. Your personal information, such as your name, date of birth, and social security number will be shared with this company to put study payments onto the card. While a participant payment card is not a credit card, the company may use your information like a credit card company would. You should review the terms and conditions of the participant payment card when deciding whether to take part in this study. Include if the study enrolls SLU employees ( HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_addendum_employee_payment.docx" see optional employee payment form): If you are a Saint ˻ֱ University employee, you have the option of being paid via a participant payment card or the payroll system. You can ask the research staff for more information in order to make a decision about how you want to receive payments. Note: student workers can only receive payment through the payroll system. For payments other than Gift Card payments (i.e., Participant Payment Card/Payroll) include: To receive payment for participation in this study, you will be asked to provide your home address and social security number.If you receive $600 or more for participation in this research study, or a combination of studies at Saint ˻ֱ University in one tax year, you will be sent an IRS Form 1099 for tax purposes. WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS RESEARCH STUDY? If you believe that you are injured as a result of your participation in the research study, please contact the research study doctor and/or the Chairperson of the Institutional Review Board as stated in section 10. For studies that are more than minimal risk, add the following paragraph. Note: SLU does not generally allow modification to this language/section of the consent. If the study sponsor proposes modifications to this language, please contact the Office of the General Counsel (OGC) at  HYPERLINK "mailto:ogccontracts@slu.edu" ogccontracts@slu.edu to request an exception prior to IRB submission. Please upload the approval correspondence in the Attachments section of the IRB application.  You will receive necessary medical treatment in the event that an injury results because of your participation in this research. The University will have the right to determine whether an injury is related to your participation in this study or happened because of your medical condition or other reasons which are not related to this study. If the injury is due to participation in the research, you will not have to pay for the cost of this treatment unless your injury is due to your own failure to follow the study doctors instructions. There are no plans for Saint ˻ֱ 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 ˻ֱ University General Counsel's office at HYPERLINK "tel:314-977-5767" \t "_blank" 314-977-5767. WHO CAN I CALL IF I HAVE QUESTIONS? INSTRUCTIONS: In this section of the consent form, provide the PI or research staff contact information for the participant.  If you have any questions or concerns about this research study, or if you have any problems that occur from taking part in this research study, you may call (insert name of PI/designated physician) at (insert PI/physicians phone number). For Studies that are more than minimal risk: include a phone number for after hours. For questions after hours, you may call (list the phone number) and ask for (insert name). Indicate the name of someone who is on the research team or knows how to contact a member of the research team. If you have questions, concerns or complaints about your rights as a research participant and would like to talk to someone not on the research team, please contact the Saint ˻ֱ University Institutional Review Board (IRB) at 314-977-7744 or  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu. WHAT ARE MY RIGHTS AND WHAT ELSE SHOULD I KNOW AS A RESEARCH STUDY VOLUNTEER? INSTRUCTIONS: This section of the consent form should include the following: The required statement that participation in this research is voluntary and the participant has the right to withdraw at any time. Disclosure if the researcher may withdraw a subject during the research study without the subjects consent when, in the investigators judgment, it is in best interest of the subject to do so, or under certain circumstances. Required statement for studies that collect biospecimens of the potential use for commercial profit, and whether the subject will share in the commercial profit. Required statement of any financial support on sponsored studies. Add any financial disclosures the Investigator may have in relation to the sponsor of this study. If a product, substance, or material of economic value is anticipated to be developed out of the research, disclose whether proceeds will be shared with participants. If a sponsor requires clarity/understanding statements at the end of the consent they must be included in this section, not section 12. In addition they should still speak to the reader in active voice You understand you must. The IRB will not approve I statements (I understand that I must.) Your participation in this research is voluntary. You may choose not to be a part of this research. There will be no penalty to you if you choose not to take part. You may leave the research study at any time. The research study doctor or research study staff will let you know of any new information that may affect whether you want to continue to take part in the research study. The use of your samples and/or data may result in commercial profit, such as a product, material, or process. You will not be compensated for the use of your samples and/or data other than what is described in this consent form. (This statement may be removed only if no specimens are collected as part of this research). The investigator may take you out of the research study if something happens to make this necessary. (If applicable, please list the potential reasons for early withdrawal of subject participation). If the study is funded outside of the university, include: Saint ˻ֱ University is receiving financial support from [insert sponsor name] to assist in the conduct of this research study. The amount of payment is enough to cover the research study doctors and/or institutions expenses to perform the research study. 12. AM I SURE THAT I UNDERSTAND? I have read this consent document and have been able to ask questions and state any concerns. 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. The research team has responded to my questions and concerns. I believe I understand the research study and the potential benefits and risks that are involved. Statement of Consent INSTRUCTIONS: For ˻ֱ Involving participants 7-17 years of age, Use an age appropriate assent information sheet. See Information Sheet templates on the IRB website. For ˻ֱ Involving Participants Whose Ability to Give Consent is in Question/Use of LARs: If a study is being proposed with adults who may be unable to provide consent, this should be described in the IRB Application and LAR signature lines should be retained, below. Please refer to the  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_lar.docx" LAR Guidelines for instructions on how to determine who should act as LAR and how to document LAR consent. SIGNATURE INSTRUCTIONS: Delete the signature lines/sections below that are not applicable (LAR/Witness/Assent) Potential signature lines and text to be deleted are in blue. Note that placebo-controlled pediatric clinical trials and other studies with minors may require a signature line for both parents. Delete the 2nd signature line if appropriate (the IRB will notify researchers if ultimately required). Whenever possible, the IRB stamp should appear on the same page as the participant signature line. [OPTIONAL] If used, the witness signature should be signed by an individual who witnesses the research participant sign and date the consent form document. ICH guidance for Good Clinical Practice defines the impartial witness as a person who is independent from the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subjects legally acceptable representative cannot read, and who reads the consent form and any other written information supplied to the subject. See HYPERLINK "http://ichgcp.net/48-informed-consent-of-trial-subjects"ICH 4.8.9. The witness should not be the person to discuss or obtain consent. The only time a witness signature is required by FDA federal regulations is with the use of a Short Form consent document used in studies with non-English proficient subjects. The IRB adheres to DHHS and FDA regulations. However, in some cases, the IRB, the Sponsor or ˻ֱer may request the use of a witness signature. The use of signature line is permitted as long as it is used as defined above. The Principal Investigator or ˻ֱ 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 ˻ֱ 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 subject/patient has received a copy of this signed consent document. If this study involves participants who are minors: I have explained all 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 be in the research. I believe the minors decision to enroll 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 ˻ֱ Team MemberDate First Name / Last Name CredentialsPrinted Name of Consenting ˻ֱ Team Member NOTE: The Principal Investigator or ˻ֱ Team Member that signs here must be authorized in the IRB-approved protocol to obtain informed consent and must sign at the SAME time on the same day as the above signatures are obtained. DO NOT SUBMIT THE FOLLOWING SECTION TO THE IRB. SAMPLES OF CONSENT FORM LANGUAGE The italicized and underlined text below are instructions. The bulleted text below can be modified and cut/pasted into the consent form document if applicable. INTRODUCTION: Examples of text for Introduction paragraph: Review the introduction paragraph of the consent document. Modify any of the statements below to complete the introduction paragraph of the consent form for your research study. The statements below can be cut and pasted into the consent form document. You are being asked to take part in a research study because you have been diagnosed with high blood pressure. You are being asked to take part in a research study because the research study doctor needs a blood specimen from someone who is healthy. This research is not intended to diagnose or treat any medical problems not stated in section 1 of this form. Taking part in a research study does not take the place of routine physical examinations or visits to your own doctor. Unless you require treatment right away, you may take home an unsigned copy of this consent document in order to think about this research study and to discuss it with family or friends before making your decision.  HYPERLINK \l "INTRO" Back to Consent Document PURPOSE: Additional instructions for the WHY IS THIS RESEARCH STUDY BEING DONE? section: Studies involving Deception If the researcher is using deception (misleading communication about the purpose of the research and/or the procedures employed in the research), please follow these guidelines for the consent document: Do NOT include any information that is untrue in the consent form. The consent form should not be part of the deception. Include as many details as possible regarding research study procedures without invalidating the integrity of the research. Include all significant aspects that would affect an individuals willingness to participate (physical risks, discomforts, unpleasant emotional experiences, etc). NOTE: ˻ֱers must discuss the full details of the research study to participants at the earliest point possible, preferably at the conclusion of the participants role in the study, but no later than at the conclusion of the research study at large. Any waiver of this debriefing requirement will require IRB approval.  HYPERLINK \l "PUR" Back to Consent Document  Studies involving Human Gene Transfer If the study involves human gene transfer as defined below, please go to  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_ibc_language.docx" Human Gene Transfer Informed  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_ibc_language.docx" Consent Guidelines for specific consent considerations. Experiments involving human gene transfer is the deliberate transfer into human research participants of either: 1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, OR 2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid moleculesthat meet any one of the following criteria: a. Contain more than 100 nucleotides; or b. Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or c. Have the potential to replicate in a cell; or d. Can be translated or transcribed.  HYPERLINK \l "PUR" Back to Consent Document  PARTICIPATION: Examples of text for the WHAT AM I BEING ASKED TO DO? section: Participating in Other Studies It is important that you tell the investigator if you have been in another research study in the past year or are currently in another research study. There are safety reasons such as fill in with relevant examples (e.g. potential medication interactions, too much radiation exposure) that will let the research study doctor know if you can take part in this research study. You may not be in any other medical research study while you are in this research study. -OR- If you are a subject in another medical research study, it is important that you discuss the nature of that research study with study doctors.  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  Screening Procedures If participants will be asked questions about medical history, etc. to determine eligibility for the research study, this should be stated. Basic inclusion or exclusion criteria may be listed in the consent document; however, if there are several research study entry criteria, it would be more appropriate to provide a detailed list to the potential participant on a separate sheet. You will be asked questions about your medical history to help the investigator decide if you can take part in this research study. You cannot take part if(list reasons).  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  Blood Drawing You will have about (state in teaspoons, tablespoons, or ounces) of blood taken from a vein every (state frequency) on (insert number of occasions). The total amount of blood taken during the research study will be about (state in tsp. tbsp. or oz.).  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document Follow-up Visits You will be asked to return to the (clinic) every (state the frequency) for (state the duration). (State the test procedures and how often they will be performed). Note: When a participant withdraws from a research study before completion of participation, it is often desirable to have a final follow-up visit and test procedures performed. The investigator may encourage the participant to do so; however, the participant may choose to withdraw without returning for a final follow-up visit. Include appropriate language in the consent document.  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  Future Use of Data or Specimens When subjects agree to participate in research, they must be informed of whether or not data/specimens will be collected and stored for future research use. FUTURE USE OF SAMPLES OR DATA FOR FUTURE RESEARCH MUST include one of the following statements if the research study involves the collection of identifiable data or identifiable biospecimens: Identifiers might be removed from your data and/or samples collected in this research, and used for future research studies or distributed to other researchers for future research studies with/without your additional permission. -OR- Your data and/or samples collected as part of this research, even if identifiers are removed, will not be used or distributed for future research studies. If future use is anticipated, the consent should include any foreseeable risks and benefits associated with the collection, storage and future research use of their data/specimens. Some studies may have separate consents for future use. Otherwise, researchers may include the following text as appropriate. Remember the italicized text is instructional. You may delete sections if they do not apply to your research study. Description of specimens to be collected/used for future use No extra blood or tissue will be taken for future research purposes. OR Extra blood and tissue (provide amounts) will be taken for this part of the research study. (Describe when and how it will be collected). Description of specific future use or broad use if will be used for unspecified future research Future studies may provide additional information that will be helpful in understanding (describe the disease/condition/area of future research OR state that you are keeping the samples/data for any type of future research). It is likely that what we learn from the future research will have no direct benefit to you. Description of confidentiality measures If coded: Samples/data will be kept with coding, meaning that all direct identifiers like your name will be removed from the sample and/or data and replaced with a research number. A listing of your name and associated research number will be kept separately for privacy protection. -OR- If anonymous: All information that identifies you will be removed from your samples/data to be used for future research. How will my samples and/or data be shared? The researchers may share your samples/data with other people doing research at SLU or other research centers. Other researchers will not have access to your name or other identifying information. Potential to develop a product with economic value In this research study, a valuable product, material, or process (such as a book, new drug, or new cell line) may be developed. A cell line is a family of cells grown in a laboratory. Cell lines used for research sometimes result in the development of new products. Should a product be developed, there are no present plans to share any monies obtained from the sale of the product with you, and you give up ownership of the samples/data. Withdrawing future use specimens/data If you choose to withdraw your samples/data in the future, you can contact the study doctor at the number provided in this consent document. Your samples/data will be removed for any future uses, but we cannot remove them from studies that were already conducted. OR if anonymous: Because your name will not be associated with the samples/data to be used in the future, we will not be able to remove them should you change your mind in the future. Sample Language to Capture Decision about Participating in Optional Future ˻ֱ Use: This section can be revised to include tiered options (like only allowing certain kinds of research) Please write your initials by the statement you agree with, below: ___ I do want to take part in the future research use of my samples/data. ___ I do not want to take part in the future research use of my samples/data. INCLUDE IF DOING GENETIC RESEARCH ˻ֱ testing may/will include genetic research. We will collect and store information about your genes. Specifically, we will be include description and whether genotypic/phenotypic data are included. The DNA contained in your genes holds the instructions that your body uses to grow and function. Your genes are responsible for your physical features such as eye color, blood type, and how your body breaks down medications. Genes can also be responsible for some medical conditions. Certain genetic research may reveal that you are a carrier of a genetic disorder. This could mean that you or members of your extended family may be more likely to have a disorder, or may be carriers of the gene that causes the disorder. See the risks section of this form for information you should consider when taking part in genetic research. MUST INCLUDE IF DOING WHOLE GENOME SEQUENGING: A genome is a persons complete set of DNA, including all of his/her genes. An exome is a small part of this DNA that makes proteins, which are essential for a healthy body. Much of what we currently understand about your DNA is based on the exome or the DNA that makes proteins. This research will/may include DNA sequencing of both somatic (non-reproductive) and germline (reproductive) specimens with the intent to generate a complete (genomic) DNA sequence or partial (exome) DNA sequence of that specimen. This means researchers may look at your entire DNA. INCLUDE IF SUBJECT TO NIH GENOMIC DATA SHARING POLICY For more information about consent considerations when studies are subject to the policy, see HYPERLINK "https://www.niaid.nih.gov/research/genomic-data-submission-and-release-guidelines"Genomic Data Submission and Release Guidelines. In addition, please reference the HYPERLINK "https://osp.od.nih.gov/wp-content/uploads/NIH_Guidance_on_Elements_of_Consent_under_the_GDS_Policy_07-13-2015.pdf"NIH Guidance on Consent for Future ˻ֱ Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the NIH Genomic Data Sharing Policy or the  HYPERLINK "https://www.genome.gov/27559024/informed-consent-elements-considerations-for-genomics-research-and-sample-language/" NHGRI Special Considerations for Genome ˻ֱ. NIH Genomic Data Sharing Policy We will collect and store information about your genes. The DNA contained in your genes holds the instructions that your body uses to grow and function. Your genes are responsible for your physical features such as eye color, blood type, and how your body breaks down medications. Genes can also be responsible for some medical conditions. Genomic information relates to the structure and function of all of the genetic material in the body. We will submit your genomic information to a public repository. A repository contains many peoples information. There are many different kinds of scientific repositories; some are maintained by the federal government, and some are maintained by private companies. ˻ֱers all over the world can take information from the repository and use it in their studies. Their studies may be similar to this one or may be completely different. Because this research receives funding from the National Institutes of Health (NIH), we will submit your genomic information to a public repository approved by NIH. NIH is a national research agency and is part of the federal government. The National Institutes of Health (NIH) has developed data (information) banks that collect study data. The NIH will label your genomic information with a code, instead of your name or other information that people could use to directly identify you. Even so, there is a possibility that when your genomic information is combined with other information available to researchers, either now or in the future, they may be able to identify a group you belong to (like an ethnic group or a disease population) or, less likely, you personally. NIH prohibits people from trying to identify individuals whose genomic information is in an NIH-designated repository. If data are to be added to Unrestricted access databases: The information from this study will be freely available in an unrestricted public national database that anyone can use. [For example], the public database will include information on hundreds of thousands of genetic variations in your DNA code, as well as your ethnic group and sex. The only health information included will be whether you had [disease X] or not. This public information will not include your name or other information that could be used to easily identify you. However, it is possible that the information from your genome, when combined with information from other public sources could be used to identify you. We believe it is unlikely that this will happen. If data are to be added to Controlled access databases: Your individual genomic data and health information will be put in a controlled-access national database. This means that only researchers who apply for and get permission to use the information for a specific research project will be able to access the information. Your genomic data and health information will not include your name or other information that could be used to identify you. However, it is possible that the information from your genome, when combined with information from other public sources could be used to identify you. ˻ֱers approved to access information in the database will agree not to try to identify you. [Include if participants will not receive results] You will not receive any individual medical information or findings from allowing your data to be placed in the NIH data banks. [Include this language if participants will be given the option of receiving results] In general, you will not receive any individual medical information or findings from future research conducted with information placed in the NIH data banks, but in rare circumstances researchers may find something that may be of medical importance. If this happens, do you want to receive these results? Please write your initials by the statement you agree with, below: ___ I do want to receive these results ___ I do not want to receive these results  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  HIV Testing You will receive an HIV test as part of this research. The result of your test may or may not become part of your medical record depending on where testing takes place. Per your request, the results of the HIV testing will be forwarded to your physician. As a volunteer in an approved research study, a confirmed positive HIV result may be reported to the Missouri Department of Health, but your identity will not be revealed. Note: To protect research participants' confidentiality, investigators should use only a code number when sending blood specimens for HIV testing to the laboratory. See the  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_hiv_testing_reporting.doc" SLU IRB Guidance for HIV Testing. Discovery of Reportable Disease (non-HIV): In this study, we may find out you have a disease that could be spread to others [for example, Hepatitis or Tuberculosis]. If this occurs, a report to the Missouri Department of Health that includes your name is required.  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  Interviews/Questionnaires Describe the nature of the interview. Give examples of the nature of the questions (e.g., social, occupational, sexual, domestic, and other behaviors). You will be asked to complete several brief questionnaires about your mental and physical health. For example, you will be asked if you are experiencing any physical challenges or changes in mood.  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  ˻ֱ Involving Photographs/Audiotapes/Videotapes Using the following language as a guide, describe the recording being done, including whether images will be retained or destroyed. Signature lines can be added to this section if being recorded is optional. As part of the research study, the researcher willrecord your [image and/or voice] in a [videotape/audio recording/photograph]. The [recording/photo] may be used in a presentation or publication about this research study. The use of the [recording/photograph] may include news releases, professional conferences, websites and exhibits related to this research study. Also, the [recording/photograph] may be kept for future research studies or educational purposes.[Alternatively, if not retaining the video/audio tape: After the researcher has taken notes from the recording, it will be destroyed to protect your identity.] The [recording/photograph] will include [a picture of your face/sound of your voice], but the researcher will not reveal your name or other identifying information.  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  Placebo, Randomization You will be assigned by chance to receive either the research study drug or a placebo. This process is called randomization. A placebo is a substance (like a pill or liquid) that looks like the research study drug but contains no active drug. No one (including you and the research study staff) will know who is receiving the drug or the placebo. This way the results of the research study will not be favored one way or another. If it becomes necessary for your care, the investigator will be able to find out whether you are taking the placebo or research study drug. If a treatment for your condition is proven helpful while you are on this research study, the placebo may be stopped and replaced with the helpful treatment.  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  Pregnancy Tests involving Minors A positive pregnancy test result for a minor will be reported to the parents and/or legal guardians of the minor.  HYPERLINK \l "whatamibeingaskedtodo" Back to Consent Document  RISKS: Examples of text for the WHAT ARE THE RISKS? section: Include any of the following statements as appropriate Allergic-type Adverse Reaction There is a rare possibility of an allergic-type adverse reaction to _________________. You many experience __include possible side effects of the allergic reaction_. These reactions may be serious or life threatening. Blood Drawing You may experience pain, bruising, and/or bleeding where the needle goes into your vein. Sometimes people become dizzy or feel faint.  HYPERLINK \l "RIS" Back to the Consent Document Breach of Confidentiality Sensitive Issues Please modify as necessary, for instance, if there is no reason the subject will be at risk with the law, remove that part. (Modify as necessary for the study) Taking part in this research study, if it became known outside the research, could place you at risk with the law, harm your reputation, or hurt your ability to keep your job or get a new one. It also may harm your ability to have insurance (health, life, auto, etc.). Every effort will be made to protect your research study data. There is, however, always the possibility of a breach of confidentiality. Breach of Confidentiality when ˻ֱ Involves Sensitive Issues Requiring a Certificate of Confidentiality Please modify as necessary, for instance, if there is no reason the subject will be at risk with the law, remove that part. Taking part in this research study, if it became known outside the research, could place you at risk with the law, harm your reputation, or hurt your ability to keep your job or get a new one. It also may hurt your ability to have insurance (health, life, auto, etc). Although there is always the possibility of a breach of confidentiality, every effort will be made to protect your research data. The research team has obtained a Certificate of Confidentiality from a government agency to further protect your data. This Certificate is explained in detail in section #7, Will My Information Be Kept Private?  HYPERLINK \l "RIS" Back to the Consent Document Combination Drug Therapy These drugs given together may cause more serious side effects than when given alone.  HYPERLINK \l "RIS" Back to the Consent Document Genetic Testing Informational Risk There can be risks in learning about your own genetic information. Genes carry information about you, including health issues that you have or you or your blood relatives may get. Information like this may be found during this study. Sometimes medical findings are upsetting to families or they wish they didn't know the information. Because of this, you may want to discuss this study with your family before you decide to take part. Genetic information is unique to you. There is an unlikely, but possible risk that someone could trace the genetic information we obtain in this study back to you. This risk may increase in the future with new technologies. We have safeguards in place to help prevent this from happening. Genetic Information Nondiscrimination Act (GINA) Consent template language for GINA must be used when studies involve personal genetic testing. This language need not be used when only investigating genetic mutations of a strain of bacteria or virus. There is a possible risk that loss of confidentiality with regard to or misuse of genetic information could lead to discrimination against participants. The chance of this happening is remote. Importantly, a US Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate based on your genetic information. Under this law, health insurance companies and group health plans may not ask for genetic information obtained during this research study; health insurance companies and group health plans may not use genetic information when making decisions about eligibility for insurance or your premiums; and employers with 15 or more employees may not use your genetic information obtained during this research study when making decisions to hire, promote, or fire, or when setting the terms of employment. GINA, however, does NOT protect against discrimination by companies that sell life, disability, or long-term care insurance. HIV/Other Reportable Disease Testing If test results show you have (HIV or Hepatitis or another shared disease), it could affect your ability to obtain future life, disability or health insurance. In rare circumstances, a positive HIV test has led to discrimination in employment and housing.  HYPERLINK \l "RIS" Back to the Consent Document Interviews/Questionnaires Some questions in the (interviews or questionnaires) may make you feel uncomfortable. You may choose not to answer any question with which you feel uncomfortable. Indicate whether the responses to the research questions will be coded to protect confidentiality. The survey you are given is coded so that we will know when you return the survey to us without having to put your name on the survey. When all of the surveys have been returned, the list with names and numbers will be destroyed. Investigational Drug Because the research study drug is being researched, there may be risks that are unknown at this time. Observational/Standard of Care Risks This language can be used if this is an observational study of medical drug/devices. The medical risks and side effects of drug/device are no different than if you were not taking part in this study. You already have those medical risks and possible side effects. This study is about information gathering, so it does not change your medical risks and side effects. Your doctor will discuss with you the risks and side effects of drug/device.  HYPERLINK \l "RIS" Back to the Consent Document Placebo If you receive a placebo, you will not receive an active treatment for your condition. Your condition might not improve or it could get worse during the course of this study.  HYPERLINK \l "RIS" Back to the Consent Document Reproductive Risks: Pregnancy/Woman of Childbearing Potential If you are a woman of childbearing potential, please read and sign below. Some research medications or procedures can cause severe birth defects, mental disability in an unborn baby, or loss of an unborn baby. If you take part in a research study that includes a drug or medical procedure, you must be willing to have a pregnancy test done before beginning your participation and you must avoid becoming pregnant while you take part in the research study. If you are pregnant or breast feeding a baby, you cannot take part in this research study. If you become pregnant during the study you will be removed from the study. If you are pregnant or think you are pregnant, it is important for you to tell the study doctor immediately. If you are sexually active during your participation in the research, you must use effective measures (chosen in consultation with your health care provider) to avoid becoming pregnant. Your signature below indicates you agree to these requirements.  FORMCHECKBOX  Check this box if this section does not apply to you (no signature needed). Signature Date Note: Because Saint ˻ֱ University is a Catholic institution, the above statement should be used and specific methods of contraception should not be listed in the consent document. However, in some studies, the harmful effects of a research study drug (e.g., thalidomide, or drugs with known teratogenic effects) on a fetus can be quite severe. In such cases, the study sponsor (via the protocol) or the IRB may require that specific measures including abstinence are listed; if so, the following phrase should be added: according to ones own conscience, after careful reflection. Sexually Active Male If you are a sexually active male, please read and sign below. There is concern that some research medications or procedures may cause severe birth defects, mental disability in an unborn baby, or loss of an unborn baby. If you take part in a research study that includes a drug or procedure, you and your partner must be willing to use effective measures (chosen in consultation with your health care provider) to avoid pregnancy. Your signature below indicates you agree to these requirements.  FORMCHECKBOX  Check this box if this section does not apply to you (no signature needed). Signature Date  HYPERLINK \l "RIS" Back to the Consent Document Radiation Exposure Note: If a participant in a research study will be exposed to radiation that is not part of standard clinical care, a radiation risk statement MUST be included in the consent document. Per IRB Guidelines, the proposed language will either be drafted by IRB staff or drafted by the research team and then verified by IRB staff at the time of submission. For protocols that involve non-standard of care radioactive materials and require review by the Radiation Safety Committee (RSC), IRB staff must draft or verify the proposed language prior to submission for RSC review. Click on the link, below, to access the template radiation risk language.  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_radiation_language.docx" Radiation risk language for insertion into the Informed Consent, Section 4: What are the Risks?  HYPERLINK \l "RIS" Back to the Consent Document Serious Side Effects (Please modify this statement as necessary). Indicate how side effects or discomforts will be minimized or indicate that they will be treated by medically appropriate therapy. Add what specific arrangements, if any for medical treatment, if needed, have been made. It is not necessary to address how confidentiality risks will be minimized in this section as they should be stated in section 14. Taking part in this research study may cause all or some of the side effects listed above which may be serious or even life threatening. In addition, there is always the risk of developing side effects which are not known at this time. This includes the possibility of complications that may require surgery, which has its own risks and complications. The research study doctor is willing to discuss any questions you might have about the severity and frequency of these risks and discomforts.  HYPERLINK \l "RIS" Back to the Consent Document BENEFITS: Examples of text for the ARE THERE BENEFITS TO BEING IN THIS RESEARCH STUDY? section: Donated tissue By agreeing to take part in this research study, you are allowing the use of your specimen for research that may benefit others. The research study of your tissue may one day result in new tests or treatments, or may help to prevent or cure diseases. In the future, medical or scientific products may result from research with your tissue. Should this occur, you will not receive financial compensation related to those medical or scientific products.  HYPERLINK \l "Section5" Back to the Consent Document  CONFIDENITALITY AND PRIVACY: Examples of text for the WILL MY INFORMATION BE KEPT PRIVATE? section: ˻ֱ Records Containing Identifiers Your research record will contain identifiers such as (give examples, such as name, date of birth, social security number, etc). Study doctors will keep your research record protected by (list hard copy protections listed in the eIRB application, such as locked cabinet in locked file room, etc).  HYPERLINK \l "CONF" Back to Consent Document Data Sharing Information collected for this research study may be shared with other researchers. If this information about you (your child/adolescent) is shared, it will not include names, addresses, or other identifying information. Release of Individual ˻ֱ Results/Incidental Findings Examples of language that can be used, below. If you ask for the results of the research-related medical tests before finishing the research study and share this information with your primary care physician, he/she may intervene (e.g., put you on drug or treatment). If this happens, you may be withdrawn from the research study. -OR- In the course of this study, doctors may find out information about your health that was unplanned. Doctors do not plan to give you this information. -OR- In the course of this study, doctors may find out information about your health that was unplanned. If this information is valid, can impact your health and can be treated, you will be told. Otherwise, doctors do not plan to give you this information. -OR- In the course of this study, doctors may find out information about your health that was unplanned. Doctors are willing to tell you information that is valid, can impact your health and can be treated. Please indicate below if you want to receive this information: ___ I want to be told about medical information. ___ I do not want to be told about medical information.  HYPERLINK \l "CONF" Back to Consent Document Mandated Reporter/Reporting If the study involves mandatory reporting, use the following language. Child can be replaced by elder. Under State law, we cannot keep information about known or reasonably suspected abuse or neglect of a child confidential, including but not limited to physical, sexual, emotional abuse or neglect. If any member of the study team has or is given such information, he or she is required to report it to the appropriate authorities. MUST include if this is NIH funded research or any other research with a Certificate of Confidentiality: For studies that have been issued a Certificate of Confidentiality, NIH has specific criteria for disclosure to participants, per the  HYPERLINK "https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html" NIH Policy for Issuing Certificates of Confidentiality. Studies that involve collection or use of identifiable sensitive information may have a Certificate of Confidentiality through NIH either because: A Certificate of Confidentiality was automatically issued with the terms and conditions of the award (only studies funded on or after December 2016) OR- The research team has applied for and obtained a Certificate of Confidentiality from NIH. NIH expects researchers to tell participants about the protections afforded by the Certificate of Confidentiality. NIH provides the sample language below which should be adapted to the study participants and subject matter of the research and included in the confidentiality section of the informed consent document: Certificate of Confidentiality This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. [Use the following language as applicable] The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by [THE AGENCY] which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it. [language such as the following should be included if researcher intends to disclose information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws.] The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others]. [language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants.] The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research data in the medical record].  HYPERLINK \l "CONF" Back to Consent Document COSTS AND PAYMENTS: Examples of text for the WHAT ARE THE COSTS AND PAYMENTS? section: Include mention of any payment to participants (e.g., time and travel). For research involving more than one interaction, payment must be prorated. Sponsor Covers All Costs There will be no additional costs to you for taking part in this research study. All research study procedures including lab work, tests, doctor visits, and research study drugs/ devices are provided to you free of charge by the sponsor, (insert sponsor name) and will not be billed to you or your insurance carrier.  HYPERLINK \l "COSTS" Back to Consent Document Costs Contingent upon Commercial Availability The costs of procedures/research study drug/research study device used in this research study are provided at no cost to you or your insurance carrier. If, however, the (drug/device) becomes commercially available as standard care for your medical condition while you are in the research study, it may no longer be provided free of charge.  HYPERLINK \l "COSTS" Back to Consent Document Standard of Care Billed to Insurance: Because this research provides standard treatment and follow-up tests for the disease or condition being studied, insurance carriers ordinarily cover the costs.You should check with your insurance company to verify that they cover standard of care procedures.You will be responsible for any costs not covered by your health insurance companyincluding any co-payments and/or deductibles. Studies Offering Financial Counseling: Financial counseling is available to you, which includes meeting with a licensed social worker and/or financial counselor. This social worker/financial counselor will assist you as needed in providing medical information to your insurance company.  HYPERLINK \l "COSTS" Back to Consent Document Payment/Compensation Sample Language You will be paid (insert total amount) for your participation in this research study if you complete the study. If you do not complete this research study, you will be paid (insert amount) for each study visit completed. Explain with specificity the method of prorating the payment(s). You will be paid to participate in this study as follows: Mileage will be determined using an internet-mapping program and reimbursement will be calculated at the current IRS standard business mileage rate Meal Cost Stipend: $xx per study day (x days maximum per study visit) Lodging Stipend: If you live more than xx miles from the study site, you will receive a lodging stipend of $xx per day (x days maximum per study visit You will be reimbursed for the above travel related expenses, up to a maximum of $xx, for each completed annual visit.This means you may receive up to $xxx if you complete the entire study.This money is meant to assist in paying any travel expenses that you may have as a result of participating in this study. You will be paid within a month of your completed study visit.  HYPERLINK \l "COSTS" Back to Consent Document VOLUNTARY PARTICIPATION: Examples of text for WHAT ARE MY RIGHTS AND WHAT ELSE SHOULD I KNOW AS A RESEARCH STUDY VOLUNTEER? section: The investigator may withdraw you from this research study without your consent when, in the investigators judgment, it is in your interest to do so, or under certain circumstances (list relevant examples): Possible examples of circumstances when termination may occur are: Conditions worsen or do not improve and an alternative treatment is medically indicated, A side effect or medical condition occurs that may place you at risk of further complications if research study participation is continued, Inability to take the medication / participate as instructed, Inability to keep scheduled appointments, Cancellation by the research study sponsor or regulatory agency  HYPERLINK \l "rights" Back to Consent Document     IRB Template Date: 10/2019 PAGE   PAGE \* MERGEFORMAT 10 Version Date: IRB Template Date: 10/2019 24?Icdf / 0 񷣕{naPB7h5OJQJ^Jh`hc5OJQJ^J h`hcCJOJQJ^JaJh`h yOJQJ^Jh`hcOJQJ^Jh`hFOJQJ^Jh`hXOJQJ^Jh`hpL5OJQJ^J&h`hX5>*CJOJQJ^JaJh`hX5>*OJQJ^Jh`h5OJQJ^Jh`hh5OJQJ^Jh`h 5OJQJ^Jh`hX5OJQJ^J34ef 8 9 : N O  ^gdK & F ^gd"8^8gdXgdcl h^hgdpLl  & F5$7$8$9DH$gdpL 5$7$8$9DH$gdc$a$gdX0 } ~    5 6 8 9 : @ P Y ` 6 : кު}pcpcpVpIp<h`hOJQJ^Jh`h!ZOJQJ^Jh`h&OJQJ^Jh`hOJQJ^Jh`hXOJQJ^Jh`hX5OJQJ^J h`hGxCJOJQJ^JaJh`h-y5OJQJ^Jh`hc0J5OJQJ^J*jh`hS5OJQJU^Jh`hS5OJQJ^J$jh`hS5OJQJU^Jh`hc5OJQJ^J  o p BC}~|gdX & F 5$7$8$9DH$^gd"8^8gdX^gdXh^hgdpL & F5$7$8$9DH$gdpLgd & F ^gd"h^hgdX & F ^gd"^gdX: m n MNOٵ٨ٚ~p~`~Sšh5BhXOJQJ^Jh`hX>*H*OJQJ^Jh`h>*OJQJ^Jh`hX>*OJQJ^Jh`hn5OJQJ^Jh`hX5OJQJ^Jh`hOJQJ^Jh`hOJQJ^JhOJQJ^Jh`h&OJQJ^Jh`hXOJQJ^Jh`hOJQJ^Jh`h|zROJQJ^JW{|6mr'd678BCHa˾˱˱ˤ˓rcVh`hJOJQJ^Jh`hJ0JOJQJ^J'jh`hSOJQJU^Jh`hSOJQJ^J!jh`hSOJQJU^Jh`h+*OJQJ^Jh`h&OJQJ^Jh`hv?OJQJ^Jh`hXOJQJ^Jh`hX5OJQJ^Jh5OJQJ^Jh`hpL5OJQJ^J'({{{ $Ifgd/ 5$7$8$9DH$gd y 5$7$8$9DH$^gdu$-gdu$ & F 5$7$8$9DH$^gd"h5$7$8$9DH$^hgdX & F 5$7$8$9DH$^gd" 5$7$8$9DH$gdXab5hiHIK~qdWdqG7h`h*95>*OJQJ^Jh`h5>*OJQJ^Jh`hVw!OJQJ^Jh`hz:iOJQJ^Jh`h*9OJQJ^Jh`h>HOJQJ^Jh`hFOJQJ^Jh`h@7OJQJ^Jh`h/5OJQJ^Jh`h8v 5OJQJ^Jh`hL5OJQJ^Jh`hJOJQJ^Jh`h yOJQJ^Jh`hXOJQJ^JhOJQJ^JKReisHIWa%xnaTaGa:axah`h..OJQJ^Jh`h yOJQJ^Jh`hOJQJ^Jh`hVw!OJQJ^JhOJQJ^Jh`h\OJQJ^Jh`h>HOJQJ^Jh`h*95OJQJ^Jh`h y5>*ϴ5>*ϴշ!5>*ϴ5>*ϴ*95>*ϴɳ5>*ϴ%4<Edef̾汤}sfXHh`hSc5CJOJQJ^Jh`h/5OJQJ^Jh`h yOJQJ^JhOJQJ^Jh`h OJQJ^Jh`h?pOJQJ^Jh`hOJQJ^Jh`h(OJQJ^Jh`hJOJQJ^Jh`hHk>*OJQJ^Jh`hHkOJQJ^Jh`h|OJQJ^Jh`hVw!OJQJ^Jh`h\OJQJ^J4defhijkd_WWWW$a$gdWr$a$kd~$$Ifl      ''  t 0      644 l` alp ytu$ & F$IfgdVL & F$Ifgd" fgkоpfpXHX:h`hIOJQJ]^Jh`hWr6OJQJ]^Jh`hWrOJQJ]^JhOJQJ^Jh`hWr5OJQJ\^Jh`h0m5OJQJ\^Jh`hWrOJQJ^Jh`hSc5CJOJQJ^J h`hWrCJ OJQJ^JaJ #h`hWr5CJ OJQJ^JaJ h`hWrCJOJQJ^Jh`h0m5CJOJQJ^Jh`hWr5CJOJQJ^Jk^ykd)$$Ifl40'064 laf4yt x$If]xgd $Ifgd$a$gdWr$a$gdWr ;<lm7Bjz|~B  мyddddddydP&h7WhWr5CJOJQJ\^JaJ)h`hWr5>*CJOJQJ\^JaJ#h`hWr5CJOJQJ^JaJhCJOJQJ^JaJ h`hWrCJOJQJ^JaJ#h`hWrCJOJQJ\^JaJ&h`hWr5CJOJQJ\^JaJh`hxc 5OJQJ\^Jh`hWr5OJQJ\^Jh`hI5OJQJ\^J;<=D|BC $ & F 8h5$7$8$9DH$^`a$gd".H$d %d &d 'd N O P Q ]^Hgdu$gdWr$a$gdWrCji  0 7 E F $Ifgd3m$ !$Ifgd3m$gdu$$a$gdWr$a$gdWrgdWr$ & F hh5$7$8$9DH$^ha$gd" $ & F h5$7$8$9DH$^`a$gd"    / 0 6 7 E F I J M N P f ˹xhxUxFx1)h`hB6CJH*OJQJ\^JaJh`hBCJOJQJ^J%h`hB56CJOJQJ\^Jh`hBCJOJQJ\^J"h`hB5CJOJQJ\^Jh`hBOJQJ^Jh`h5CJOJQJ^J#h`hSc5CJOJQJ^JaJ#h`hxc 5CJOJQJ^JaJ#h`hWr5CJOJQJ^JaJh`hWrOJQJ^J)h`hWr5>*CJOJQJ\^JaJF M N O %kd$$If\  }'z\ 064 apyt $Ifgd3m$ $IfgdBm$O P g h i 4kd$$IfF }' 06    4 apyt $Ifgd3m$ !$Ifgd3m$f g h ͽͧͽ͓~i͓XD5h`hScCJOJQJ^J'h`hB5CJOJQJ^JmH sH  h`hBCJOJQJ^JaJ) *h`hB6CJOJQJ\^JaJ)h`hB6CJH*OJQJ\^JaJ&h`hB5CJOJQJ\^JaJ*h`hB5CJOJQJ\^JmH sH h`hBCJOJQJ\^J"h`hB5CJOJQJ\^Jh`hBCJOJQJ^J"h`hB6CJOJQJ\^J  !$Ifgd3m$ $Ifgd3m$ ;000 $Ifgd3m$kd$$IfU\  }'z\ 064 apyt NCCC $Ifgd3m$kd$$IfF }' 06    4 apyt }!~! 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