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BMC Med Ethics. 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.

Author information

1
Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. karbwangj@nagasaki-u.ac.jp.
2
Department of Pharmacology, Faculty of Medicine, Chiang Mai University, 110 Muang Chiang Mai, Chiang Mai, 50200, Thailand. nut.koonrung@cmu.ac.th.
3
Forum for Ethical Review Committees in the Asian and Western Pacific region, WHO-TDR Clinical Coordination and Training Center, Thammasat University, Pathum Thani, Thailand.
4
National Institutes of Health, University of the Philippines Manila, Manila, Philippines.
5
Selangor State Health Department, Ministry of Health, Putrajaya, Malaysia.
6
ICMR Bioethics Unit, National Centre for Disease Informatics and Research, Bangalore, India.
7
Department of Pharmacology and Therapy, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.
8
Forum for Ethics Review Committees in Sri Lanka and Faculty of Medical Sciences, University of Sri Jayewardanepura, Nugegoda, Sri Lanka.
9
Department of Anesthesiology, Cathay General Hospital, Taipei, Taiwan.
10
Academic Clinical Research Office, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
11
Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.
12
Sultanah Nur Zahirah Hospital, Kuala Terengganu, Terengganu, Malaysia.
13
Sultan Ismail Hospital, Johor Bahru, Johor, Malaysia.
14
Melaka Hospital, Melaka, Malaysia.
15
Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
16
Seri Manjung Hospital, Seri Manjung, Perak, Malaysia.
17
Sungai Buloh Hospital, Sungai Buloh, Selangor, Malaysia.
18
Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
19
Sarawak General Hospital, Kuching, Malaysia.
20
Medical and Health Research Ethics Committee, Faculty of Medicine Universitas Gadjah Mada, Dr. Sardjito General Hospital, Yogyakarta, Indonesia.
21
Taiping Hospital, Taiping, Malaysia.
22
Seberang Jaya Hospital, Perai, Pulau Pinang, Malaysia.
23
Raja Perempuan Zainab II Hospital, Kota Bharu, Malaysia.
24
Department of Pediatric, Faculty of Medicine Universitas Gadjah Mada, Dr. Sardjito General Hospital, Yogyakarta, Indonesia.
25
Division of Epidemiology, National Institute of Cholera & Enteric Diseases, Kolkata, India.
26
Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
27
Ampang Hospital, Ampang, Malaysia.
28
Duchess of Kent Hospital, Sandakan, Malaysia.
29
Likas Hospital, Kota Kinabalu, Sabah, Malaysia.
30
Department of Operational Research, National Institute for Research in Reproductive Health, Mumbai, India.
31
National Institute for Research in Tuberculosis, Chennai, India.
32
Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
33
Sibu Hospital, Sibu, Sarawak, Malaysia.
34
Raja Permaisuri Bainun Hospital, Ipoh, Malaysia.
35
Tengku Ampuan Afzan Hospital, Kuantan, Malaysia.
36
University of the Philippines Manila Research Ethics Board, Manila, Philippines.
37
Sultanah Bahiyah Hospital, Alor Setar, Kedah, Malaysia.
38
Putrajaya Hospital, Putrajaya, Malaysia.
39
Faculty of Medicine, University of Jaffna, Jaffna, Sri Lanka.
40
Tengku Ampuan Rahimah Hospital, Klang, Malaysia.
41
Tuanku Jaáfar Hospital, Seremban, Malaysia.
42
Tuanku Fauziah Hospital, Kangar, Perlis, Malaysia.
43
Department of Biochemistry, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.
44
Pulau Pinang Hospital, George Town, Malaysia.
45
Queen Elizabeth I Hospital, Kota Kinabalu, Sabah, Malaysia.
46
Selayang Hospital, Shah Alam, Malaysia.
47
Miri Hospital, Miri, Sarawak, Malaysia.
48
Sultan Abdul Halim Hospital, Sungai Petani, Kedah, Malaysia.
49
Endocrinology and Metabolism Unit, Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand.
50
Sultanah Aminah Hospital,, Johor Bharu, Malaysia.
51
Institute of Forensic Medicine and Toxicology, Colombo, Sri Lanka.
52
Department of Microbiology, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.
53
Department of Opthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
54
Department of Endocrinology, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI), Lucknow, Uttar Pradesh, India.

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

PMID:
30219106
PMCID:
PMC6139128
DOI:
10.1186/s12910-018-0318-x
[Indexed for MEDLINE]
Free PMC Article

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