ࡱ> o bjbjjj dJjdJj}}}}}x!<"l2a#6$4$$$%&T',lllllll/qsl}+%%++l}}$$4ln:n:n:+F}$}$ln:+ln:n:ate$"|+Hc,ll0ltct0ztXtetet}fx='#(n:(K)g='='='llD6*='='='l++++t='='='='='='='='='Y C: IRB NUMBER: [insert LU#] LOYOLA UNIVERSITY CHICAGO HEALTH SCIENCES DIVISION MAYWOOD, ILLINOIS DEPARTMENT OF [insert department name] INFORMED CONSENT Participants Name: _________________________________________________________ Medical Record Number: _____________________________________________________ PROJECT TITLE: [insert project title] THE APPROVAL FOR THIS PROJECT EXPIRES ON xx/xx/xxxx. (OPTIONAL LAR LANGUAGE REMOVE IF NOT APPLICABLE): You are being asked to consider enrolling the patient in a research study. The patient is too ill to given consent right now. When the word you appears in this consent form, it refers to the ill person. You can only consent for the patient if you are the patients guardian, spouse, parent or you hold the power of attorney for healthcare. If the patient regains his or her ability to make decisions, he or she will be informed about the study and asked for a decision about continued participation. If you are a parent or guardian of a patient younger than 18 years old and have been asked to read and sign this form, the you in this document refers to the patient. (This applies only when children are involved. If this text is selected for your ICD, please delete these instructions in italics; otherwise, delete this entire paragraph.) Participant Information About this research study Scientists do research to answer important questions which might help change or improve the way we do things in the future. You are being asked to participate in a research study. Taking part in this research study is voluntary You may choose to not take part in this study or may choose to leave the study at any time. Deciding not to participate, or deciding to leave the study later, will not result in any penalty or loss of benefits to which you are entitled and will not affect your relationship with  FORMTEXT [Insert name of participating sites - Loyola University of Chicago, Loyola University Medical Center]. This consent form will give you information about the study to help you decide whether you want to participate. Please read this form, and ask any questions you have, before agreeing to be in the study. Overview and Key Information This information gives you an overview of the research. More information about these topics may be found in the pages that follow. Why am I being asked to take part in this research study? We are asking you to take part in this research study because [insert the reason why the patient is eligible for participation]. Why is this research being done?  FORMTEXT [Insert a short, 1-2 sentence summary of the purpose of the research] Explain the purpose of the study in language understandable to the participant (i.e., eighth grade level). Explain whether the study involves an investigational drug, device, or biologic, state that investigational means that it is not approved by the Food and Drug Administration (FDA). Explain if the agent is approved for other indications. What will happen to me during the study?  FORMTEXT [Insert a short summary of the procedures] For more information, please see the Description and Explanation of Procedures section below. How long will I participate? Your participation in this study may last up to  FORMTEXT [Insert maximum duration]. You will be asked to complete  FORMTEXT [Insert total number of visits] study visits  FORMTEXT [If applicable - state whether the visits will occur over a month, year, etc.]. Each visit will last approximately  FORMTEXT [Insert the approximate length of time each visit will last in minutes, hours, etc.]. Will I benefit from the study? [Insert one of the following:] You will not benefit from participating in this study. OR We do not know if you will benefit from participating in this study. For more information, please see Benefit section below. What are the risks? [Insert one of the following [For greater than minimal risk research:] Taking part in this research may expose you to significant risks. We may not know or understand all the risks at this time. Some people may experience side effects or discomfort, some of which may be serious. It is very important that you understand the known risks in this research study before you decide whether to participate. For details and a list of risks you should know about, please see the Risks/Discomforts section below. OR [For minimal risk research:] This research is considered no more than minimal risk, which means that there is no more expected risk to you than what you might experience during a typical day or during a routine physical exam. For details and a list of risks you should know about, please see the Risks/Discomforts section below. Do I have other options besides taking part in this study? Participation in research is completely voluntary. You decide whether or not to participate. If you choose to not participate, there will be no penalty to you or loss of benefit to which you are entitled. [Insert the following if this is a treatment study] There may be other options for treatment of your  FORMTEXT [Insert applicable condition], including creating a treatment plan with your doctor. Will I be paid to participate? [Insert one of the following:] You will not receive any payment for taking part in this study. OR Payment for your time or travel is available if you decide to take part in this study. For more information, please see the Financial Information section below. Will it cost me anything to participate? [Insert one of the following:] There is no cost to you for taking part in this study. OR You will not be responsible for any costs related to the research; however, you or your insurance company will still be responsible for the cost of your normal medical care. For more information, please see the Financial Information section below. OR Taking part in this study may lead to additional costs to you or your insurance company. For more information, please see the Financial Information section below. End of Overview and Key Information Please review the rest of this document for details about these topics and additional things you should know before making a decision about whether to participate in this research. PURPOSE OF RESEARCH: You are being asked to participate in this study because [insert text] The purpose of this study is to [insert text] The study is being conducted by [Insert investigator(s) name(s) and University/Departmental affiliation]. It is sponsored by [Insert Sponsor name, if any, and include if the Sponsor is also the manufacturer of the drug/device being studied, if applicable]. Approximately [insert text] people will participate in this research. DESCRIPTION AND EXPLANATION OF PROCEDURES: If you agree to participate in this study, you will be asked to do the following things: [Explain in detail what procedures will be done. This includes all drugs/devices used, hospitalizations, hospital/clinic visits, telephone calls, and any follow-up visits. Include the specific amount of blood to be drawn in teaspoons and the number of times this will occur. Specify where the research related activities are being conducted, which procedures are standard of care and which are research related.] {The following are leading sentences that may or may not be applicable. Delete them if they are not needed.} Neither you nor your doctor will be able to choose which type of treatment you receive [insert text]. Your chances of being assigned to either or any of the treatments are [insert text e.g. 50/50; like the flip of a coin]. If during your participation in the research project new information becomes available which would affect your being in the research project (such as better treatments or the side effects of the treatments), your doctor will discuss this new information with you and will help you make a decision about your continuing in the research. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) A description of this clinical trial will be available at http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) [If the study is NIH funded, you automatically receive a Certificate of Confidentiality, and must include this section. If the study is not NIH funded but the study has obtained or intends to obtain a Certificate of Confidentiality, insert the following as appropriate:] For the protection of your privacy, this research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers may not disclose or use any information, documents, or specimens that could identify you in any civil, criminal, administrative, legislative, or other legal proceeding, unless you consent to it. Information, documents, or specimens protected by this Certificate may be disclosed to someone who is not connected with the research: If there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases); if you consent to the disclosure, including for your medical treatment; if it is used for other scientific research in a way that is allowed by the federal regulations that protect research subjects for the purpose of auditing or program evaluation by the government or funding agency [If FDA-regulated] if required by 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. 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. RISKS/DISCOMFORTS: The treatment you are assigned to receive may not help. The treatment you are assigned to receive may be associated with more problems or may be less effective than the other treatments in this study that you did not receive. While participating in this study, you may experience the following risks, side effect and/or discomforts: (List risks associated with participation.) There may be other side effects that we cannot predict or are currently unknown. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) If you disclose actual or suspected abuse, neglect, or exploitation of a child, or disabled or elderly adult, the researcher or any member of the study staff must, and will, report this to Child Protective Services (i.e. Department of Family and Human Services), Adult Protective Services, and/or the nearest law enforcement agency. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) If the research shows that you have a reportable communicable disease (for example, tuberculosis [TB] or HIV/AIDS), the researchers may report this to the appropriate authorities. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) A new 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 against you based on your genetic information. This law generally will protect you in the following ways: Health insurance companies and group health plans may not request your genetic information that we get from this research. Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums. Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment. All health insurance companies and group health plans must follow this law by May 21, 2010. All employers with 15 or more employees must follow this law as of November 21, 2009. Be aware that this new Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) (If your study needs to be GDPR compliant, you need to identify what data or information that you are collecting may be identifiable, why you are collecting it and for how long you will keep it. Additional information regarding GDPR and its requirements can be found here /gdpr/) (NOTE: If you need to delete the Reproductive Section entirely, check here:  FORMCHECKBOX  It will be removed upon IRB approval.) REPRODUCTIVE AND SEXUAL ACTIVITY INFORMATION: The intervention in this study could affect a developing baby, infant or the sperm and eggs of your reproductive system. Therefore, you cannot participate in this research project if you are pregnant or breast feeding. If you are a woman of childbearing potential, a pregnancy test will be done to make certain that you are not pregnant before beginning the study. You should evaluate your decision to participate if you intend to become pregnant or father a child in the near future. It is strongly recommended that you inquire about counseling and obtain more information about preventing pregnancy from Dr. [insert text] prior to agreeing to participate in this study. Both men and women who are able to have children must use an effective method of preventing pregnancy and also refrain from donating eggs or sperm while participating in this study. Since the study medications or their effects may persist in your body for a period of time after stopping them, the above precautions should also continue for an additional [length of time] for women and [length of time] for men. You are encouraged to discuss your preferred method of preventing pregnancy with Dr. [insert text]. They will answer any questions you have regarding the appropriate and effective methods of preventing pregnancy for this study. It is important that you consult with your physician because some of the study medications may affect the effectiveness of various methods of preventing pregnancy. If you become pregnant, suspect that you have become pregnant, or you have fathered a child during the study, please notify Dr. [insert text] immediately. BENEFITS: (Chose one sentence and delete the other) You will not benefit from participating in this study. OR We do not know if you will benefit from participating in this study. (List any known benefits -- do not overstate benefits.) ALTERNATIVE TREATMENTS: You do not have to participate in this research project to receive care and treatment at Loyola University Medical Center. You can choose the treatments in this project without participating in the project. (If this text is selected, please delete these instructions in italics; otherwise, delete this entire paragraph.) Your doctor has discussed other options with you along with their risks and benefits. FINANCIAL INFORMATION: Taking part in this study may or may not cost your insurance company more than the cost of getting treatment without being in this study. Some health plan insurers will not pay the costs for people taking part in studies. Check with your health plan insurer to find out what they will pay for. Depending on your health insurance coverage, there may be out-of-pocket costs for you like co-payment of the standard visits, co-insurance, or deductibles. You will be responsible for these expenses. (OPTIONAL PARAGRAPH Delete if there are no research-related billable events.) You or your insurance company [will/will not] be billed for the [study drug/device] [INSERT THE STUDY DRUG/DEVICE NAME]. You or your insurance company [will/will not] be billed for the cost of the supplies and the personnel to give you the study [drug/device]. The study sponsor may pay for research-related items or services that are provided only because you are in the study. These will not be billed to you or your insurance. The items or services that will be paid for by the sponsor include: [insert text]. If you receive a total of $600 or more in payment for participating in research at Loyola University of Chicago, personal information about you, including your name, address, and Social Security number, will be released to the Loyola University of Chicago Accounting Office for the purpose of recording the payment and for tax reporting to the United States Internal Revenue Service (IRS). You will be sent a W-9 form which will need to be reported to the IRS. This form will need to be included with your tax forms. RESEARCH RELATED INJURY: Select the most appropriate option Industry-Sponsor (if Sponsor is covering subject injury) If you have an injury or illness that results from your participation in this study, the reasonable medical expenses required to treat such injury or illness may be paid for by the study sponsor. The coverage for such injury or illness would only be available if your study doctor and the study sponsor have decided that the injury or illness is directly related to the study or a portion of the study, for example the study drug or study device. This coverage would not be available if the injury or illness is the result of a pre-existing condition or the normal progression of your disease or because you or your study doctor did not follow the directions of the study. If your insurance is billed because the study sponsor coverage is not available, you may be required to pay some or all of the costs that apply. You should check with your insurance company about any such payments. By signing this form, you are not giving up any legal rights to seek to obtain compensation for an injury. OR (for non-industry trials/investigator initiated) In the event that you are injured or have side effects as a result of participating in this research project, your doctor will take the necessary steps to treat the problem. There are no funds available from Loyola University Medical Center, Gottlieb Memorial Hospital, Loyola University Health System or Loyola University of Chicago to pay for the cost of care of the problem. You will be financially responsible for the cost of care of any problems. By signing this form, you are not giving up any legal rights to seek to obtain compensation of injury. Information collected and what will happen to it: In order to meet the goals of the research study (see Purpose of Research section of this consent), we will collect information on you, your test results, and how you do from you and your Loyola University Medical Center or Gottlieb Memorial Hospital medical records. The information will be collected by [insert text] ASK \* MERGEFORMAT , the study physician(s), the research nurses, data administrators and secretaries. Information about you will be provided to Loyola University of Chicago; [insert text], the research sponsor; data collection and study verification agencies; and/or government regulatory agencies such as the Food and Drug Administration. [Insert text]. (If data or specimens will be retained after the study for future research, explain where the data or specimens will be stored, who will have access to the data or specimens, and how long the data or specimens will be retained. Note that any research conducted on specimens stored for future use must obtain IRB Approval prior to initiating the study.) In this way, we will learn about [insert text]. [INSERT-the safety and effectiveness or briefly restate the major goal of the study]. The information we will collect and send includes: (Select what information, IF ANY, will be sent to the sponsor or the sponsors designee. Place an X beside the sentence if it is applicable; if not, delete the line. When finished, delete these instructions.) ____ DEMOGRAPHIC INFORMATION (e.g., name, address, phone number) ____ BILLING AND PAYMENT INFORMATION ____ MEDICAL RECORD (including, but not limited to, history and physical exam notes, progress notes, consultation reports, laboratory test results, AND/OR operative reports) ____ INFORmation relating to acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection ____ INFORMATION RELATING TO treatment for drug or alcohol abuse ____ INFORMATION RELATING TO mental or behavioral health or psychiatric care excluding psychOTHERAPY notes ____ PHOTOGRAPHS, VIDEOTAPES, OR DIGITAL OR OTHER RADIOGRAPHIC IMAGES ____ TISSUE SAMPLES ____ BLOOD SAMPLES ____ GENETIC INFORMATION We will collect and provide this information about you [insert text]. INDICATE HOW LONG THE INFORMATION WILL BE COLLECTED AND SENT. FOR EXAMPLE, for as long as you are in the study, for your lifetime or until the sponsor terminates the national study. Once the information is disclosed outside of Loyola University Medical Center or Gottlieb Memorial Hospital, it may no longer be protected by federal privacy laws. De-identified data and/or samples from this study may be shared with others for research purposes. We will remove or code any personal information that could identify you before data and/or samples are shared with other researchers to ensure that no one will be able to identify you from the data we share, however this cannot be guaranteed. Once identifying information is removed, the information and samples cannot be withdrawn from further use. You will not be asked to sign an additional consent for this use. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) If a commercial product is developed from the tissue or blood samples collected as part of this research project, the commercial product will be owned by  FORMTEXT [Insert appropriate entity]. You will not profit financially from such a product. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) Cells obtained from your body may be used to establish a cell line which may be shared in the future with other researchers and which may be of commercial value. A cell line is one which will grow indefinitely in the laboratory. . If any human materials (tumor tissue, bone marrow, blood, etc.) are used for establishing a cell line which may be shared with other researchers and which may in the future be of commercial value, the subject must be informed of the fact in the consent form. Any research conducted from specimens/cells/blood/tissue previously collected and stored must have IRB Approval prior to the initiation of the study. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) We may use the specimens collected as a part of this study for whole genome sequencing, which involves mapping all of your DNA. Describe what information will be gained, how the information will be used and stored, any risks of whole genome sequencing, and whether the information will be provided back to the subject, and, if so, whether it may be clinically relevant. It is possible that the sponsor, [insert text], research nurses, data collection and/or study verification agencies, data administrators or staff, [insert text], or the Food and Drug Administration will come to Loyola University Medical Center or Gottlieb Memorial Hospital and view the medical record (see above for description of content) and the research records. They may take notes or copy pages of the medical record. This is done to verify the accuracy of the information Loyola University of Chicago is sending to them. The results of this research study may be published in a journal for the purpose of advancing medical knowledge. You will not be identified by name or by any other identifying information in any publication or report about this research. Consent for LUMC to use and disclose your medical information is required in order for you to participate in the study. This authorization does not expire. (check here if not applicable:  FORMCHECKBOX  It will be removed upon IRB approval.) As part of this study, some samples of your blood, urine, tissue biopsy, etc. will be obtained and stored in the Loyola Tissue Repository. You will be presented with an additional consent form that will provide you with more information. Withdrawal of Consent: Your consent to use and disclose your medical information for the purpose of this research study is completely voluntary. You can withdraw your consent to use and disclose your information and your consent to participate in this study at any time without affecting your ability to receive care and treatment at Loyola University Medical Center or Gottlieb Memorial Hospital, as applicable, unrelated to the research study. Withdrawal means that all study procedures and follow-up will stop and we will not send any more information about you to the sponsor of this research or its designees. However, information already used and disclosed to the research sponsor prior to the time of your withdrawal from this study may continue to be used and disclosed by Loyola University of Chicago and the sponsor. [CUSTOMIZE THIS PARAGRAPH IF IT IS NECESSARY FOR PARTICIPANT TO CONTINUE SEEING DOCTOR]. For your safety, we may ask that you return to clinic one more time for [insert text]. We will also ask that you return any unused study medication. If you withdraw from the study, you will need to contact your physician(s) to discuss what other options may be available. If you withdraw from the study, we will ask that you sign the form attached to this consent and send it to [insert text] or give it to the study staff. Your withdrawal from the study will not have any effect on any actions by Loyola University Medical Center, Gottlieb Memorial Hospital, or Loyola University of Chicago taken before the attached form is received by Loyola University of Chicago. Your study doctor, the Institutional Review Board, the regulatory authorities, or the sponsor, [insert text], may terminate the study at any time with or without your consent. [MODIFY THIS PARAGRAPH AS NEEDED OR DELETE ENTIRELY]] Your study doctor may choose to take you out of the study because of unexpected or serious side effects, treatment non-compliance, or because you are not taking the medication as you were instructed. You may also be removed from the study if your study doctor feels that you are not benefiting from the study treatment. CONSENT I have fully explained to ____________________________ the nature and purpose of the above- described procedure and the risks that are involved in its performance. I have answered and will answer all questions to the best of my ability. I may be reached at [insert text]. ________________________________________________Date:____/_____/____ Signature [insert text], the principal investigator for this study, or (Chose one) his her associates will be available to answer any questions you may have. [insert text] can be reached at: [insert text]. If you ever feel that you have been injured by participating in this study, if you have any questions, concerns, or problems regarding your rights as a research participant, or if you would like to obtain information or provide input, you may contact either Robert Wagner, MD, Chair of the Institutional Review Board for the Protection of Human Subjects - ݮ Health Sciences Campus, at 708-526-4139 or Cynthia Tom, MA, CIP, Director of the Human Research Protection Program at 464-220-9665. Although you have the right to revoke this authorization, you accept that such revocation will not apply to any uses and disclosures of your information that are described in the Loyola University Health System Notice of Privacy Practices or otherwise allowable under any Federal or State laws. You will receive a signed copy of this informed consent document. You have been fully informed of the abovedescribed research program with its possible benefits and risks. Your signature below indicates that you are willing to participate in this research study and agree to the use and disclosure of information about you as described above. You do not give up any of your legal rights by signing this consent document. ________________________________________________Date:____/_____/____ Signature: Participant ________________________________________________Date:____/_____/____ (Signature: Witness) [A witness signature line is to be included if the participant lacks the capacity to consent. This may include but is not limited to: individuals requiring a Legally Authorized Representative, Minors or other individuals who lose or may lose the capacity to consent during their participation in the study] (Optional Signature Lines for ICDs with Childs Assents attached. Delete if not needed.) ________________________________________________Date:____/_____/____ (Signature: Parent/Legal Guardian) ________________________________________________Date:____/_____/____ (Signature: Parent/Legal Guardian) ________________________________________________Date:____/_____/____ (Signature: Witness) (If Assent is needed, 1) use the signature lines above, 2) cut the Childs Assent from page 9, 3) paste text here, 4) delete these instructions, and 5) delete the instructions on page 9.) (OPTIONAL REMOVE IF NOT APPLICABLE and IF NOT CONSENTING LEGALLY AUTHORIZED REPRESENTATIVES): ________________________________________________Date:____/_____/____ Signature: Legally Authorized Representative (if applicable) ____________________________________________________________ Legally Authorized Representatives relationship to participant Consent for Continued Participation: At the time that you became ill, you were not able to make a decision about participating in a research project. The person making medical decisions on your behalf during your illness agreed for you to be in this research study. Now that you are again able to make decisions, you can choose whether or not to remain a participant. If you decide to stay in the study, you will be asked to review and sign the full consent form for this research. If you decide to end your participation, your personal and medical information gathered since the start of the research project may still be used for this research. Please check below to indicate your decision: _____ I wish to stay in the study _____ I wish to end my participation in the study ________________________________________________Date:____/_____/____ Signature of Participant ________________________________________________Date:____/_____/____ Signature of Person Obtaining Informed Consent ________________________________________________Date:____/_____/____ Signature of Witness Remote consent: Consent obtained by: _____________________________________ ___________________ Print name of person obtaining consent Date Select how consent was obtained: Phone_______ Zoom ______Videoconference ____ (Required for studies that require a signed consent document for participation. Delete if not needed.) Date the signed consent was received:______________________ Include a brief explanation for performing the informed consent discussion over the Phone/Zoom/Videoconference: PROJECT TITLE: [insert text] REVOCATION OF AUTHORIZATION TO RELEASE PROTECTED HEALTH INFORMATION (PHI) I, _____________________________________, hereby revoke my consent to participate in the study titled, [insert text], at Loyola University Medical Center, Gottlieb Memorial Hospital, or Loyola University of Chicago, as applicable. I also revoke my consent to release information I provided to Loyola University Medical Center, Gottlieb Memorial Hospital, or Loyola University of Chicago, as applicable, that allowed use and disclosure of my medical information to [insert text] as outlined on the consent form, which I signed on ____/_____/____ (insert date consent was signed originally). I understand that this revocation does not apply to any action Loyola University Medical Center, Gottlieb Memorial Hospital, or Loyola University of Chicago, as applicable, have taken in reliance on the consent I signed earlier. ________________________________________________Date:____/_____/____ Signature: Participant Please return this form to: [insert text] Loyola University of Chicago 2160 South First Avenue Maywood, Illinois 60153 INSTRUCTIONS: CHILDS ASSENT TO CONSENT Federal Regulations now require the assent of children for participation in research protocols. Recognizing that the rate of development of many children is different and that their ability to adequately comprehend the implications of participation in research projects varies significantly with age, the ݮ Health Sciences Division Institutional Review Board has drafted the following statement: For children below the age of eight (8), parental consent is all that is required. It is still appropriate that the investigator discuss with the child the mode of therapy in a fashion that may leave the child with some idea of what the plans for his or her therapy are. Between the ages of eight (8) and twelve (12), the investigator must discuss with the child what is involved in the investigational therapy. The types of procedures, medication, side effects and purposes of the investigational protocol should be discussed with the child. While parental consent is still required for children in this age group, formal assent of the child will not be required but it is suggested. Children above the age of twelve (12) should be treated as adult participants in a research project. Full disclosure must be made to them concerning the risks and benefits of the project as well as procedures, drugs, and other factors that may be related to the project. A witness assent in writing is "required" from a child greater than twelve (12) years of age; parental consent is also required. Witnesses to the children's assent should be impartial observers and neither members of the family nor the investigators team. TEXT TO USE FOR ASSENT: Child's Assent to Consent I have been fully informed of the research project and what my part in the project will be. I have also been fully informed of any side effects that may occur during my participation. I give permission to be part of this study. I know that Dr. [insert text] will be available to answer any questions I may have. I understand that I am free to withdraw this Assent to Consent and participation at any time. I have received a copy of this Child's Assent to Consent. ________________________________________________Date:____/_____/____ (Signature: Participant) ________________________________________________Date:____/_____/____ (Signature: Witness)     PAGE   PAGE 2  PAGE 10 Document ID#: Version Date: Document ID#: 10957am8.030404 Version Date: 03/05/2004 .56Oao, 7 8 F H ^ _ ` ÿٸٸ٨}vqjqfa hVhhV *hV6 *hV h7hf h7h)Nh7hG5CJaJh7h\5CJaJh7hgX5CJaJho:5CJaJ h7hgX h7hOho: h7h Es *hZhZ h7h^ h7h\hZh\5 *hZhZ5 hZ5h7h\5&6Oa7 8 _ ` ( ) gdV1$gdV $1$a$gd'1$gd' $1$`a$gd' ( ) t u v ! 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