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The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be \u0027moderately important\u0027 to \u0027very important\u0027 for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.", "subitem_description_type": "Abstract"}]}, "item_2_description_63": {"attribute_name": "引用", "attribute_value_mlt": [{"subitem_description": "BMC Medical Ethics, 19(1), art.no.79; 2018", "subitem_description_type": "Other"}]}, "item_2_publisher_33": {"attribute_name": "出版者", "attribute_value_mlt": [{"subitem_publisher": "BioMed Central Ltd."}]}, "item_2_relation_12": {"attribute_name": "DOI", "attribute_value_mlt": [{"subitem_relation_type": "isIdenticalTo", "subitem_relation_type_id": {"subitem_relation_type_id_text": "10.1186/s12910-018-0318-x", "subitem_relation_type_select": "DOI"}}]}, "item_2_rights_13": {"attribute_name": "権利", "attribute_value_mlt": [{"subitem_rights": "c The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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What information and the extent of information research participants need in informed consent forms: a multi-country survey
http://hdl.handle.net/10069/38623
http://hdl.handle.net/10069/3862346c3b283-d0ca-4ac5-bb8d-fb17b7534939
名前 / ファイル | ライセンス | アクション |
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BMCME19_79.pdf (1.5 MB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2018-10-16 | |||||
タイトル | ||||||
タイトル | What information and the extent of information research participants need in informed consent forms: a multi-country survey | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Consent forms | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Informed consent | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Disclosure | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Information | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Research subjects | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Karbwang, Juntra
× Karbwang, Juntra× Koonrungsesomboon, Nut× Torres, Cristina E.× Jimenez, Edlyn B.× Kaur, Gurpreet× Mathur, Roli× Sholikhah, Eti N.× Wanigatunge, Chandanie× Wong, Chih-Shung× Yimtae, Kwanchanok× Abdul, Malek Murnilina× Ahamad, Fouzi Liyana× Ali, Aisyah× Chan, Beng Z.× Chandratilake, Madawa× Chiew, Shoen C.× Chin, Melvyn Y. C.× Gamage, Manori× Gitek, Irene× Hakimi, Mohammad× Hussin, Narwani× Jamil, Mohd F. A.× Janarsan, Pavithra× Julia, Madarina× Kanungo, Suman× Karunanayake, Panduka× Kollanthavelu, Sattian× Kong, Kian K.× Kueh, Bing-Ling× Kulkarni, Ragini× Kumaran, Paul P.× Kumarasiri, Ranjith× Lim, Wei H.× Lim, Xin J.× Mahmud, Fatihah× Mantaring, Jacinto B. V.× Md, Ali Siti M.× Mohd, Noor Nurain× Muhunthan, Kopalasuntharam× Nagandran, Elanngovan× Noor, Maisarah× Ooi, Kim H.× Pradeepan, Jebananthy A.× Sadewa, Ahmad H.× Samaranayake, Nilakshi× Sri, Ranganathan Shalini× Subasingha, Wasanthi× Subramaniam, Sivasangari× Sulaiman, Nadirah× Tay, Ju F.× Teng, Leh H.× Tew, Mei M.× Tharavanij, Thipaporn× Tok, Peter S. K.× Weeratna, Jayanie× Wibawa, Tri× Wickremasinghe, Renu× Wongwai, Phanthipha× Yadav, Subhash |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF. | |||||
書誌情報 |
BMC Medical Ethics 巻 19, 号 1, p. 79, 発行日 2018-09-15 |
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出版者 | ||||||
出版者 | BioMed Central Ltd. | |||||
EISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 14726939 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1186/s12910-018-0318-x | |||||
権利 | ||||||
権利情報 | c The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | BMC Medical Ethics, 19(1), art.no.79; 2018 |