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<p>Broad consent refers to a consent model that permits the collection, storage, and future use of participants’ biospecimens and related data under ethical oversight. Broad informed consent forms (ICFs) are standalone documents used to operationalize this model by recording participants’ permission for such secondary use. Although the 2018 Revised Common Rule and the 2016 CIOMS Guidelines specify the essential elements required in broad ICFs, systematic evaluations of compliance and readability in international multicenter clinical trials remain limited. This study analyzed 54 broad ICFs used between 2019 and 2024 in international multicenter clinical trials involving a research site at the Faculty of Medicine, Chiang Mai University, Thailand. Compliance with ethical and regulatory requirements for essential elements of broad consent was evaluated, and readability of English-language ICFs was assessed using the Flesch Reading Ease (FRE) and Flesch-Kincaid Grade Level (FKGL) metrics. Most ICFs included over 90% of essential elements, with high compliance in consent documentation (100%, <i>n</i> = 54), storage conditions and duration (98.2%, <i>n</i> = 53), and voluntary participation (98.2%, <i>n</i> = 53). However, some elements were frequently incomplete or absent, including explanations of the meaning of broad consent (64.8%, <i>n</i> = 35) and information on commercial profit sharing (51.9%, <i>n</i> = 28). Readability analyses posed additional challenges: average FRE indicated difficult text (55.1 ± 7.0; Median 55.6; IQR 6.8), and mean FKGL exceeded recommended levels for health communication (9.7 ± 1.5; Median 9.7; IQR 1.9). Thai-language versions were consistently longer than English version in both word count (3,020.2 ± 1,442.1 vs. 2,188.0 ± 1,128.4 words) and page length (9.2 ± 3.8 vs. 7.1 ± 2.8 pages). Overall, while most broad ICFs meet relevant regulatory requirement, variation in content completeness, considerable length and limited readability may reduce their effectiveness in supporting participant understanding in research involving the long-term storage and future use of biospecimens. This study addresses an important gap by examining the actual content and readability of broad ICFs used in international multicenter clinical trials in Thailand.</p>

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Analysis of compliance and language use in broad informed consent forms in international multicenter clinical trials after the implementation of the 2018 common rule

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  • 出版模式：

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  • 发表日期：

    2026年5月20日

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  • Pannita Anek,
  • Nahathai Dukaew,
  • Nimit Morakote,
  • Nattharinee Kongta,
  • Mingkwan Na Takuathung,
  • Nut Koonrungsesomboon

摘要

Broad consent refers to a consent model that permits the collection, storage, and future use of participants’ biospecimens and related data under ethical oversight. Broad informed consent forms (ICFs) are standalone documents used to operationalize this model by recording participants’ permission for such secondary use. Although the 2018 Revised Common Rule and the 2016 CIOMS Guidelines specify the essential elements required in broad ICFs, systematic evaluations of compliance and readability in international multicenter clinical trials remain limited. This study analyzed 54 broad ICFs used between 2019 and 2024 in international multicenter clinical trials involving a research site at the Faculty of Medicine, Chiang Mai University, Thailand. Compliance with ethical and regulatory requirements for essential elements of broad consent was evaluated, and readability of English-language ICFs was assessed using the Flesch Reading Ease (FRE) and Flesch-Kincaid Grade Level (FKGL) metrics. Most ICFs included over 90% of essential elements, with high compliance in consent documentation (100%, n = 54), storage conditions and duration (98.2%, n = 53), and voluntary participation (98.2%, n = 53). However, some elements were frequently incomplete or absent, including explanations of the meaning of broad consent (64.8%, n = 35) and information on commercial profit sharing (51.9%, n = 28). Readability analyses posed additional challenges: average FRE indicated difficult text (55.1 ± 7.0; Median 55.6; IQR 6.8), and mean FKGL exceeded recommended levels for health communication (9.7 ± 1.5; Median 9.7; IQR 1.9). Thai-language versions were consistently longer than English version in both word count (3,020.2 ± 1,442.1 vs. 2,188.0 ± 1,128.4 words) and page length (9.2 ± 3.8 vs. 7.1 ± 2.8 pages). Overall, while most broad ICFs meet relevant regulatory requirement, variation in content completeness, considerable length and limited readability may reduce their effectiveness in supporting participant understanding in research involving the long-term storage and future use of biospecimens. This study addresses an important gap by examining the actual content and readability of broad ICFs used in international multicenter clinical trials in Thailand.