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Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials

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Abstract

Purpose

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions.

Methods

A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test.

Results

The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001).

Conclusions

The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants’ understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

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Acknowledgments

This study was supported by a grant from Faculty of Medicine, Thammasat University, and partially supported by TDR, the Special Program for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank, and WHO through the Forum for Ethical Review Committees in the Asian and Western Pacific region (FERCAP). Dr. Nut Koonrungsesomboon is a recipient of a scholarship from the Program for Nurturing Global Leaders in Tropical and Emerging Communicable Diseases, Graduate School of Biomedical Sciences, Nagasaki University. We thank Ms. Tasaneeya Chantravekin and Ms. Vanida Jansom for their assistance on the data collection process. We are thankful to Ms. Chotimanee Kaewserm and her colleagues for their assistance in reviewing the SIDCER ICFs from laypersons’ perspectives. We would like to express our gratitude to Prof. Kenji Hirayama for his valuable comments and advice. Thanks are extended to Ms. Junjira Laothavorn for her assistance in editing the manuscript.

Authors’ contributions

NK designed the study, developed the ICF study protocol and related materials, analyzed the data, interpreted the results, and prepared a drafted manuscript. TT designed the study, developed the ICF study protocol and related materials, conducted and collaborated the study, collected the data, and provided comments for manuscript improvement. KP, RV, SM, PC, SS, TP, SK, NT, RY, WC, RK, SN, and PK provided the collaborating study protocols and the conventional ICFs, reviewed the materials, conducted the study, and collected the data. PS reviewed the ICF study protocol and related materials and collaborated the study. JK designed the study, developed the ICF study protocol and related materials, analyzed the data, interpreted the results, and finalized the manuscript.

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Authors and Affiliations

  1. Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan

    Nut Koonrungsesomboon & Juntra Karbwang

  2. Leading Program, Graduate School of Biomedical Sciences, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan

    Nut Koonrungsesomboon

  3. Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand

    Thipaporn Tharavanij, Kittichet Phiphatpatthamaamphan, Ratha-korn Vilaichone, Sith Siramolpiwat, Thanachai Punchaipornpon & Peerapong Kitipawong

  4. Department of Anesthesiology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand

    Sudsayam Manuwong & Parichat Curry

  5. Department of Orthopedics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand

    Supakit Kanitnate & Nattapol Tammachote

  6. Center of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand

    Rodsarin Yamprasert, Ruchirat Kaewkumpai & Soiphet Netanong

  7. Department of Otolaryngology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand

    Waipoj Chanvimalueng

  8. Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand

    Paskorn Sritipsukho

  9. Center of Excellence in Applied Epidemiology, Thammasat University, Pathum Thani, 12121, Thailand

    Paskorn Sritipsukho

Authors
  1. Nut Koonrungsesomboon
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  2. Thipaporn Tharavanij
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  3. Kittichet Phiphatpatthamaamphan
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  13. Ruchirat Kaewkumpai
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  14. Soiphet Netanong
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  16. Paskorn Sritipsukho
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  17. Juntra Karbwang
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Corresponding author

Correspondence to Juntra Karbwang.

Ethics declarations

All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Trial registration

Name of the clinical trial registry: Chinese Clinical Trial Registry

Registration number: ChiCTR-TRC-14004817.

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Koonrungsesomboon, N., Tharavanij, T., Phiphatpatthamaamphan, K. et al. Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials. Eur J Clin Pharmacol 73, 141–149 (2017). https://doi.org/10.1007/s00228-016-2159-1

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