SAMPLE ASSENTS FOR CHILDREN
OBTAINING THE PERMISSION OF MINORS TO PARTICIPATE IN RESEARCH: ASSENT AND CONSENTIn the past, researchers and regulatory bodies assumed that the age of consent for research was the age of majority. People who are not adults because they are under 18 years of age are known as “minors”. When researchers seek the participation of minors in their research, they have sought consent from the adult parents or guardians; from the minors, themselves, they have sought assent. Yet the most recent version the Tri-Council Policy Statement (2014) has taken a new direction suggesting that, for some minors, it is appropriate for the researcher to ask for consent. The TriCouncil advocates that researchers should adopt a decision-making capacity approach when determining whether they should seek assent or consent from minors.The following guidelines developed by the Conjoint Health Research Ethics Board aim to assist researchers in determining when they should seek consent from minors, and when seeking assent is more appropriate.Research decision-making capacity assessmentAs a general rule, when proposed participants are minors under 14 years of age, the investigator should seek assent from the child and consent from the parent(s) or legal guardian.When the proposed participants are minors 14 years and older, researchers must assess the child’s capacity to make a decision about his or her research participation. To have research decision-making capacity requires that:The minor is competent in the sense that he or she has the ability to reason, and can understand and appreciate the risks and benefits of participating and of not participating;The minor has the benefit of full information about the risks and potential benefits of participating and of not participation; andThe minor feels no compulsion, and fears no reprisal, for accepting or refusing to participateTo assess the minor regarding the first criterion, the researcher must generally consider these factors:the intelligence of the minor;the minor’s ability to appreciate the reasonably foreseeable consequences of his or her actions;the stage of the minor’s ’s physical, emotional and mental development;the degree of responsibility the minor has assumed in his/her life; andthe inherent risk level of the research protocol.Alberta Health Services has drafted a document to guide the assessment of mature minor status in the clinical setting. This additional information might be useful to guide such assessment in the research setting. Please see (Procedure: Minors/Mature Minors; 1. Summary Sheet for the Minors/Mature Minors Procedure) When researchers have found that minors have research decision-making capacity, then the minors’ consent for study participation should be obtained using the CHREB standard consent template. Please note that the reading level of a consent form should be appropriate for Grades 6-8 regardless of the age of the intended participant.Assent forms – minors without research decision-making capacityResearchers typically use assent forms with children who are 7 to 14 years of age. Therefore, the target language level is the reading level of pupils in Grade Four. Researchers will need to read the assent form to some very young children. For these reasons, the biggest challenge in writing assent forms is to keep the language and concepts appropriately simple.Children 15 years of age and older who do not have research decision-making capacity are generally expected to give assent by signing the consent form used by their parents. However, an investigator may choose to use an assent form for this age group if he or she believes it appropriate because of the complexity of the study or the nature of the study population.ConfidentialitySexuality and use of illegal substances are two areas in which adolescents may struggle to be truthful if they believe information will be shared with their parents; nevertheless, such information can be essential to the treating physician/physician investigator. Under the Health Information Act of Alberta (s 104), adolescents with capacity are entitled to control the release of their health information. It can be difficult for parents to understand or accept that they will not be privy to information that their child gives to another adult. One approach described later in this document, is to discuss the study with the teen first, informing him or her of any limits to confidentiality. If a teen declines to participate in the study, then the researcher should not approach the parent(s) with the information. If investigators are concerned about the challenges of keeping a minor’s health information private, then the investigators should seek guidance/assistance from the Chair of the CHREB or a delegate.Elements of the Assent FormThere are no formal requirements for the elements that must be present in an assent form, (though this is not true for consent forms). This means that the investigator can propose assent content that he/she believes will best inform the 7 to 14 year old participants about the study. The length of the assent form should be proportionate to the complexity of the study and the age of the participants. The signature block needs lines only for the child to write his/her name and for the person obtaining assent to sign his/her name. The person who seeks assent from the minor must be the Principal Investigator or someone delegated by the Principal Investigator. If the child is not able to read the assent form, and oral assent is obtained using the content in the assent form, then the person who received assent should place in the chart or research record a statement with the following content:I have discussed this research study with [name of child] using language that is understandable and appropriate for the participant. I believe that I have fully informed him/her of the nature of the study and its possible risks and benefits. I believe the participant understood this explanation and appreciates the risks and benefits of agreeing or refusing to agree to participate. I do not believe that the child feels obligated to participate or fears any negative consequences for refusing to participate.Below are two templates that researchers may use as a basis of developing an age appropriate assent. The first is more suitable for a younger child. The second may be more suitable for an older child; researcher should use the second assent form example also for those girls who are approaching sexual maturity. Example #1 – Assent for Younger Child (7-10 years old)Project Title:Principal Investigator:We want to tell you about a research study we are doing. A research study is a way to learn more about something. We would like to find out more about [insert topic and describe goals in simple language]. You are being asked to join the study because [insert name of condition or other reason(s) for inclusion].If you agree to join this study, you will be asked to [describe procedures, (e.g., questionnaires, activities) in words a child would know and understand. Also include number of visits and time frame in words easily understood by a child]. Describe possible risks (e.g., discomforts) in simple language. Use any of the following statements that are appropriate to describe benefits: We do not know if being in this study will help you. We expect that the study will help you by [describe how]. We may learn something that will help other children with [insert name of condition or topic under investigation] some day. This study will help us learn more about [topic under investigation].You do not have to join this study. It is up to you. You can say okay now. You can also say no. If you say okay and then you change your mind later. If you want to stop, then all you have to do is tell us you want to stop. No one will be mad at you if you don’t want to be in the study or if you join the study and then change your mind later and stop. Before you say yes or no to being in this study, we will answer any questions you have. If you join the study, you can ask questions at any time. Just tell the researcher that you have a question.We will also talk to your parents about this study. You can talk this over with them before you decide.If you have any questions about this study please feel free to contact [Insert Study contact name and contact #]Would you like to be in this research study? _____? Yes, I will be in this research study. _____ No, I don’t want to do this.__________________________ ___________________ ____________Child’s name Signature of the childDate__________________________ _______________________________Person who received assent SignatureDateExample #2- Assent for Older Child (11 years or age or older, or female of reproductive potential)Project Title:Principal Investigator:What is a research study?A research study is a way to find out new information about something. Children do not need to participate in a research study if they don’t want to participate.Why are you being asked to be part of this research study?You are being asked to take part in this research study because we are trying to learn more about [Insert name of what is studied here]. We are asking you to be in the study because [state why the child is being asked to participate]. About (enter #) children will be in this study.If you join the study what will happen to you? [describe what takes place from the child’s point of view]We want to tell you about some things that will happen to you if you are in this study. EXAMPLES BELOWYou will be in the study for [insert duration of participation].We will use a needle to take some blood from your arm [#] times.We will need you to take [name of procedure] that will last [duration]. This is [a simple explanation of what will happen]. Your [mother/father/other] can be present in this [location]. We will ask you to sit with us and [talk about some things/look at some pictures]. It will take about 1 hour to do thisWe will ask you to answer some questions about X.Will any part of the study hurt? [describe risks and discomforts using terms a child would know and understand; take into account a child’s fears]Will the study help you? [describe any benefits to the child from participation in the research or if there are none omit this section].Will the study help others? [describe any benefits to society from the research].This study might find out things that will help other children with [insert name of condition being studied] some day.Do your parents know about this study?We will talk to your parents about your participation in this study as well. You can talk this over with them before you decide.Who will see the information collected about you?The information collected about you during this study will be kept safely locked up. Nobody will know it except the people doing the research. The study information about you [will, will not] be given to your parents [or teachers]. The researchers will not tell your friends or anyone elseReproductive Information (please include if applicable)If you are a girl, then it is important that you understand that the medication or medical tests that will be done in this study might harm a baby. We do not make assumptions about any girls’ activities and just have a standard way of doing things. We will be testing you to see if you are pregnant before and at intervals during the study. If you are pregnant, then you cannot take part in the study. If you become pregnant during the study, then you will be withdrawn from the study. If you are, or become, pregnant, then we will do our best to protect your confidentiality. We will tell your parents only that you are not suitable for the study. We will tell you where you can get advice and help with your pregnancy.If you are a girl and having sex with a male, then you will be required to use effective contraception during this study. We would like to discuss the best methods of contraception with you do not become pregnant. Again, we will not give this information to your parents, and we will do our best to protect your confidentiality. If you are a boy, and having sex with a female, then it is important that your partner does not get pregnant. You are required to use effective contraception. If you are sexually active, then we will keep this information confidential. We would like to discuss the best methods of contraception with you so that a pregnancy does not occur. If your partner does become pregnant, then please tell us as soon as possible, because the study medicine may be harmful to your sperm and therefore to the fetus. Again, we will make every effort to keep your information on contraception and pregnancy confidential. What do you get for being in the study?You will get [enter amount or item] for [each visit/entire study].Do you have to be in the study?You do not have to be in the study. No one will be upset if you don’t want to do this study. If you don’t want to be in this study, you just have to tell us. It’s up to you.You can also take more time to think about being in the study.What if you have any questions?You can ask any questions that you may have about the study. If you have a question later that you didn’t think of now, either you can call or have your parents call (insert study telephone number). You can also take more time to think about being in the study and also talk some more with your parents about being in the study.What choices do you have if you say no to this study?There are other ways to help your [insert name of condition being studied] if you don’t want to be in this study. Examples are …….This study is extra, so if you don’t want to do it [nothing else will change/there are no other choices].Other information about the study.If you decide to be in the study, then please write your name below. You can change your mind and stop being part of it at any time. All you have to do is tell the person in charge. It’s okay. The researchers and your parents won’t be upset.You will be given a copy of this paper to keepWould you like to take part in this study?_____ Yes, I will be in this research study. _____ No, I don’t want to do this.__________________________ _______________________________Child’s name Signature of the childDate__________________________ _______________________________Person who received assent SignatureDate ................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.