Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

ABSTRACT

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations – risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups’ perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.

KEYWORDS:

• Ethical consideration
• ethics committee
• informed-consent process
• informed-consent form
• perception

Authors‘ contributions

JK and PA discussed and agreed upon the thematic content, contributed to the development and revision of the draft manuscripts, and read and approved the final version. JK analyzed the data and wrote the paper. PA performed the experiments.

Authors‘ information

JK is a biostatistics expert, Chair of the Ethics Committee of the Faculty of Tropical Medicine; Head and Associate Professor in the Department of Tropical Medicine and Hygiene; and Consultant to the Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS). PA is Secretary to FTM-EC, a post held for the past 24 years; she is Head of the Office of Research Services, Faculty of Tropical Medicine, Mahidol University.

Acknowledgments

The authors would like to thank the Faculty of Tropical Medicine, Mahidol University, for supporting the study. Special thanks to the researchers who responded to, and provided comments on, the questionnaires. Thanks to Mr. Paul Adams of the Office of Research Services, Faculty of Tropical Medicine, Mahidol University, for editing the English language of the manuscript.

List of abbreviations

REC: Research Ethics Committee

ICF: Informed Consent Form

ICP: Informed-consent process.

Declarations

Ethics approval and consent to participate

This study was approved by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand. The study participants were informed about the study purpose and answered the questionnaire anonymously; they were free to skip any item they did not wish to answer.

Consent for publication

Not applicable

Availability of data and material

All data are for internal use. The data comprise survey information for specific use in this analysis; comments or notifications can only be accessed by authorized personnel of the Faculty of Tropical Medicine, Mahidol University, Thailand. The data will be available upon reasonable request.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

Not applicable