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Multicenter Study
. 2018 Sep 15;19(1):79.
doi: 10.1186/s12910-018-0318-x.

What information and the extent of information research participants need in informed consent forms: a multi-country survey

Juntra Karbwang  1 , Nut Koonrungsesomboon  2 , Cristina E Torres  3   4 , Edlyn B Jimenez  4 , Gurpreet Kaur  5 , Roli Mathur  6 , Eti N Sholikhah  7 , Chandanie Wanigatunge  8 , Chih-Shung Wong  9 , Kwanchanok Yimtae  10 , Murnilina Abdul Malek  11 , Liyana Ahamad Fouzi  12 , Aisyah Ali  13 , Beng Z Chan  14 , Madawa Chandratilake  15 , Shoen C Chiew  16 , Melvyn Y C Chin  17 , Manori Gamage  18 , Irene Gitek  19 , Mohammad Hakimi  20 , Narwani Hussin  21 , Mohd F A Jamil  22 , Pavithra Janarsan  23 , Madarina Julia  24 , Suman Kanungo  25 , Panduka Karunanayake  26 , Sattian Kollanthavelu  27 , Kian K Kong  28 , Bing-Ling Kueh  29 , Ragini Kulkarni  30 , Paul P Kumaran  31 , Ranjith Kumarasiri  32 , Wei H Lim  33 , Xin J Lim  34 , Fatihah Mahmud  35 , Jacinto B V Mantaring 3rd  36 , Siti M Md Ali  37 , Nurain Mohd Noor  38 , Kopalasuntharam Muhunthan  39 , Elanngovan Nagandran  40 , Maisarah Noor  41 , Kim H Ooi  42 , Jebananthy A Pradeepan  39 , Ahmad H Sadewa  43 , Nilakshi Samaranayake  26 , Shalini Sri Ranganathan  26 , Wasanthi Subasingha  15 , Sivasangari Subramaniam  44 , Nadirah Sulaiman  45 , Ju F Tay  46 , Leh H Teng  47 , Mei M Tew  48 , Thipaporn Tharavanij  49 , Peter S K Tok  50 , Jayanie Weeratna  51 , Tri Wibawa  52 , Renu Wickremasinghe  18 , Phanthipha Wongwai  53 , Subhash Yadav  54 ; FERCAP Multi-Country Research Team
Affiliations
Multicenter Study

What information and the extent of information research participants need in informed consent forms: a multi-country survey

Juntra Karbwang et al. BMC Med Ethics. .

Abstract

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.

Keywords: Consent forms; Disclosure; Ethics; Information; Informed consent; Research subjects.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol and related documents obtained ethical approval from local ethics committees prior to the commencement of the survey in each center. The full name of ethics committee(s) that approved the study in each country is as follows: India – Institutional Ethics Committee, National Center for Disease Informatics and Research (NCDIR); National Institute for Research in Reproductive Health (NIRRH) Ethics Committee for Clinical Studies; Institutional Ethics Committee, ICMR – National Institute of Cholera and Enteric Diseases; National Institute for Research in Tuberculosis (NIRT) Institutional Ethics Committee; and Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical Sciences; Indonesia – Medical and Health Research Ethics Committee Faculty of Medicine Universitas Gadjah Mada – Dr. Sardjito General Hospital; Malaysia – Medical Research and Ethics Committee (MREC); Philippines – University of the Philippines Manila Research Ethics Board; Lung Center of the Philippines Institutional Ethics Review Board; Makati Medical Center Institutional Review Board; Manila Doctors Hospital Institutional Review Board; National Kidney and Transplant Institute Research Ethics Committee; Philippine Heart Center Institutional Ethics Review Committee; St. Luke’s Medical Center Institutional Ethics Review Committee; and Veterans Memorial Medical Center Institutional Review Board; Sri Lanka – Ethics Review Committee, Sri Lanka Medical Association; Taiwan – Institutional Review Board, Cathay General Hospital; Thailand – Khon Kaen University Ethics Committee in Human Research; and Human Research Ethics Committee of Thammasat University No.1 (Faculty of Medicine). Participants were informed about this survey and consent was obtained by action, i.e., the participants voluntarily answered the questionnaire and returned it to the collection box by themselves.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The element and extent of information that research participants wanted to receive
See this image and copyright information in PMC

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