• The Journal of KAIRB
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• v.6 no.1
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• pp.5-16
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• 2024

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.43
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• pp.25-52
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• 2009

An acceptance is effected by a statement or other conduct of the offeree indicating assent. Silence or inactivity does not in itself amount to acceptance. An acceptance of an offer becomes effective at the moment the indication of assent reaches the offeror. It uses in stating rules on whether an acceptance is too late to form a contract and an offeree may withdraw an acceptance after transmission. The offeree may indicate assent by performing an act such as one relating to the dispatch of the goods or payment of the price without notice to the offeror. The acceptance by action also is to be performed within the time fixed between the parties or within a resonable time. However, an oral offer must be accepted immediately by an offeree. After an acceptance by action, the offeree avoid revocation of an offer by giving the offeror prompt notice to that effect. Even if a reply an offer contains additions, limitations or other modifications is a rejection of the offer and constitutes a counter offer, the reply to an offer contains additional and different terms which do not materially alter the terms of the offer constitutes an acceptance unless the offeror objects to the discrepancy or to that effect. Additional or different terms relating to the price, payment, quality & quantity of the goods, time & place of delivery, a party's liability or the settlement of disputes are considered to materially alter the terms of the offer.