1、Assent Version CMH IRB Approved December 15, 2008CHILDS/ADOLESCENTS ASSENT FORM TEMPLATE Italicized writing is guidance and should not be in the final document. The childs assent form requires the same elements as the parental permission form. However, please modify the words used and length of sent
2、ences and paragraphs, as needed, to make them easily understandable to children Guidance for Assenting Process: You should provide this form to children who are between the ages of 12 and 17 and who have adequate decision-making capacity, in the opinion of the studys principal investigator and/or su
3、bjects treating physician, with an explanation of the procedures they will undergo. Although there is no current legal basis in the state of Illinois for requiring the signature of individuals less than 18 years of age on assent forms, the IRB feels we should accord added protection and respect to c
4、hildren who may become subjects in research projects. Investigators have a special obligation to provide children with the opportunity to express any worries about participating in research or, when appropriate, the opportunity to decline to become a research subject.CHILDRENS MEMORIAL HOSPITALINSTI
5、TUTIONAL REIVEW BOARDAdolescents Agreement to Participate in a Research StudyAges 12- 17We are asking you to be in a research study called: (Title of study)The study is being done by (investigators name) at Childrens Memorial Hospital.WHY IS THIS STUDY BEING DONE?Make sure this information is very s
6、imple and clear. Use the statements below as guides:We want to tell you about a research study at Childrens Memorial Hospital. Research studies help us find better ways to take care and treat children who are sick with a disease, to learn how medicines work, and how our bodies work. Research studies
7、 are voluntary, which means that you only have to participate in the study if you want.We are asking you to be in this research study because you have (condition). AND/ORWe are asking you to be in this research study because we want to learn more about (reason for study). Assent Version WHAT HAPPENS
8、 IN THE STUDY AND HOW LONG WILL I BE IN THE STUDY? If you want to be in the study, this is what will happen: Clearly note the time frame for the whole study and how long each visit will take Describe what happens at the visits, what types of procedures or tests will take place. Describe restrictions
9、 on normal activities; and if relevant the possibility of receiving placebo or other control interventions in a trial. If appropriate, state clearly that the study involves an investigational/experimental drug or device or a marketed drug/device being used in a way for which it is not approved. If o
10、ne (or the only) procedure is blood withdrawal, inform the child how much blood to be withdrawn in understandable words (e.g., tablespoons, teaspoons, ounces). As a general rule of thumb, 5.0 ml or cc equals one teaspoon, 15 ml equals 3 teaspoons or 1 tablespoon (or 1/2 ounce).WHAT ARE THE GOOD THIN
11、GS ABOUT THE STUDY? If there is no direct benefit to the study, include the following information:Although you will not benefit directly from this study, we hope to learn something that could help other children in the future who have (condition).If a treatment is being given, please include the fol
12、lowing information: Being in this study may help you feel better or may make your (insert name for condition) go away, but we do not know this for sure. If the study (medicine/device/intervention) helps you, we do not know how long this will last. We also hope to learn something that could help othe
13、r children or adolescents in the future who have (condition). WHAT ARE THE NOT-SO-GOOD, BAD, OR HARMFUL THINGS THAT COULD HAPPEN TO ME IF I AGREE TO BE IN THIS STUDY? Use simple and general terms to explain the risks and what you will do to decrease them. Please note that there is a fine line and of
14、ten a challenge to give an adolescent sufficient information for him/her to be able to give fully informed assent, while at the same time not overwhelming the adolescent who may have a fatal disease with more information than he/she can digest at the time the assent document is signed. The following
15、 statements may be used or paraphrased, as appropriate, to begin this section:Assent Version You might have some side effects and discomfort while in the study. Some side effects are (state known side effects of the drug, device, treatment, etc.). If you have any of these side effects or feel pain,
16、tell your parents and your study doctor. Your study doctor will check on you and try to help you feel better. The following may be used or paraphrased, regarding blood withdrawal:When we take blood from your arm, the needle might hurt and you might get a bruise but we will (if applicable insert any
17、measures taken such as numbing cream or spray that is applied to the arm or body part) so that it wont hurt as much.The following may be used if appropriate:The questions we ask you as part of the study might seem strange and maybe make you feel sad or embarrassed. If you dont want to, you dont have
18、 to answer these questions. We will tell you if we learn new information that may make you change your mind about being in this study. WHAT OTHER OPTIONS ARE THERE?Describe the alternative courses of action open to the subject (such as usual treatment, no specific therapy, or supportive care, includ
19、ing palliative and hospice care as appropriate) instead of participation in the study. The following statement may be used verbatim or paraphrased to begin this section:If a treatment is being given, please include the following information:You do not have to be in this study if you dont want to. Yo
20、ur doctor may be able to give you other treatments outside of the study. These treatments may include: (list information about other treatment options clearly and in simple terms). If you join the study and then change your mind, it is okay for you to leave this study. Your doctors (health care prov
21、iders) will not be upset with you and will still try to help you feel better. If no treatment is being given, please include the following information:You do not have to be in this study if you dont want to. Your doctors (health care providers) will not be upset with you. If you join the study and t
22、hen change your mind, it is okay for you to leave this study. Assent Version WHAT ABOUT MY CONFIDENTIALITY?We will do everything possible to make sure that your medical records are kept private.Unless required by law, only representatives of the following groups or organizations can review your stud
23、y records. Name the study sponsor The Childrens Memorial Hospital Institutional Review Board (IRB): This is the hospitals board that is in charge of protecting the rights of all adults and children who participate in research studies. Government agencies with responsibilities to oversee research stu
24、dies.They are required to keep your personal information private.WILL I RECEIVE ANY PAYMENT OR GIFTS IF I AM IN THIS STUDY? This section should be included when appropriate to clarify if the adolescent will be compensated for his/her inconvenience, discomfort, etc include the form of the compensatio
25、n, such as gift cards, gift certificates, ITunes, etc. WHAT IF I HAVE QUESTIONS? You can ask questions whenever you have them. You can ask your doctor, nurse or other people working with them on the study (insert PI name and study team contact information). You can also ask your parents. Your parent
26、s know about the study and said that it is okay if you want to be in the study. If you dont want to be in the study, that is okay. You can ask (PI name) anything about the study. If you are not happy with this study and want to talk with someone else, not the doctor or the people working with the do
27、ctor, you may contact Philip V. Spina, Senior Vice-President and Chief Operating Officer at Childrens Memorial Research Center, at 773-755-6301 or pspinachildrensmemorial.org. His address is 2300 Childrens Plaza, no. 205, Chicago, Illinois 60614-3394.You will be given a signed and dated copy of this
28、 form.Assent Version SIGNATURESWritten assent must be sought from all adolescents (12-17 years). If written assent is not possible or the principal investigator and parent(s) or guardian(s) do not feel it is in the best interest of the child to obtain written assent, then verbal assent must be obtai
29、ned. If verbal assent is not possible or the principal investigator and parent(s) or guardian(s) do not feel it is in the best interest of the child to obtain verbal assent, the IRB Chair must be consulted for approval of an assent waiver prior to proceeding with the research. An investigator may re
30、quest a waiver of child assent for neurologically (comatose) or mentally incapacitated children at the time the protocol is initially submitted or as an amendment at any time thereafter. Please also see the instructions below regarding how to obtain assent from minors who do not speak English. I hav
31、e read this assent form, and I agree to take part in this study as it is explained in this assent form.Date Signature of Child or Adolescent (only 12-17 years old)_Printed Name of Child/AdolescentCMH requires that the date and the signature of the person (not necessarily the principal investigator)
32、explaining the study to the subject(s) and parent(s) or surrogate(s) appear on the consent or assent document, and that that date be the same or an earlier date to that of the subject/parents/surrogate. The principal investigator also must sign the consent or assent form, if he/she is not the person
33、 explaining the study, but he/she does not necessarily need to do so on the same or prior date. The following paragraph should be used verbatim after the above subject signature:Please indicate how assent was obtained by initialing the applicable line. _ I certify that I have explained the above to
34、this research subject and believe that the signature was affixed freely. I also agree to answer any questions that may arise._ Written assent was not obtainable because _. However, I certify that I have explained the above to this research subject and believe that verbal assent was freely given. I a
35、lso agree to answer any questions that may arise._ Verbal assent could not be obtained because _. (Contact IRB Chair or his/her designee for approval of a waiver of assent prior to proceeding with research).Assent Version Date Signature of Person Obtaining ConsentPrinted Name of Person Obtaining Con
36、sentDate Signature of Principal Investigator (if not listed above)STOP: The following signature lines must be completed if you unexpectedly consent a non-English speaking adolescent research subject and there is no IRB approved translation of the English consent form/assent form into a language unde
37、rstandable to the research subject. . In order to obtain consent, an interpreter must interpret the English assent form for the adolescent research subject and the adolescent research subject must sign the IRB approved short form consent document that has been translated into a language understandab
38、le to the research subject. ,. Copies of several IRB approved translated short form consents are available on the IRB Website. If the short form is not available in a language understandable to the research subject an interpreter must interpret the English assent form for the adolescent research sub
39、ject and the subject signs the English assent form. In addition, the PI must fulfill the IRB requirements regarding parent/guardian consenting. Please see the IRB Policy and Procedures Manual for the complete policy and specific IRB requirements, including signature requirements, when consenting/ass
40、enting non English speaking research subjects.NOTE: If you anticipate that you will enroll non-English speaking subjects on a regular basis, the IRB-approved English language consent/assent form(s) must be translated and be IRB approved before being presented to subjects. Printed Name of Interpreter
41、: _Note: the interpreter may not be a member of the study team (i.e. listed on the study personnel form) or be related to the research subject.Printed Name of Witness: _Signature of Witness: _Assent Version Note: The witness should be fluent in both languages and may be the same person as the interpreter.
