Abstract
Lay members of Human Research Ethics Committees (HRECs) play a crucial role in
representing community perspectives, yet many face challenges in confidently voicing their
opinions on ethical issues, particularly during interactions with expert members. This lack of
assertiveness can compromise the ethical protections afforded to research participants,
undermining the core principles of human research ethics.
The second phase of the Capacity Development Project for laypersons is designed
to cultivate knowledge and comprehension regarding their essential duties. Through targeted
training sessions and resources, this project aims to strengthen the role of laypersons within
Ethics Committees, ultimately leading to more robust protection for human subjects in
research and fostering a more ethical research environment. The successful execution of this
phase will facilitate a deeper understanding of ethical considerations in research among lay
members, enhance their capacity to contribute meaningfully to ethical deliberations and
ensure their voices are heard and considered during the ethical review process.
The implementation of the Phase 2 Capacity Development Project for Layperson
members involved 5 4 participants, all of whom are committee members from Human
Research Ethics Committees (HRECs) nationwide. One participant did not attend the followup sessions due to prior commitments, while another withdrew from the online follow-up and
evaluation meeting as they transitioned to another organization.
The project activities included: (1) reviewing and documenting the roles and
responsibilities of lay members in human research ethics committees, along with creating a
manual for the layperson members; (2) developing an e-learning platform; (3) offering onsite
refresher training for Phase 1 Layperson project; (4) Introduction of ethical principles training
and practical training based on onsite using case studies for 3 days, followed by five online
group meetings in weeks 2-6 after the initial introductory training, with group instructors
providing advice, lecturing, expressing opinions, assigning each group to present a case study,
writing of ICF documents from the given research project examples at each follow-up meeting,
and post-training advice via group LINE or telephone contact, and (5) A final onsite meeting
for comprehensive discussions, A final evaluation via a multiple-choice examination to assess
knowledge gained.
By engaging in these comprehensive activities, the project aimed to enhance the
capacity and confidence of lay members within HRECs, ultimately equipping them to
contribute more effectively to ethical reviews and safeguarding the rights and welfare of
research participants.
Of the participants, forty-eight completed the final examination, achieving a
median score exceeding 75% (25 points). Notably, thirty-seven individuals scored above 80%
(28 points or more). The program received positive feedback, with ninety-five percent of
participants expressing satisfaction and a willingness to recommend the program to other lay
members.
Participants reported significant gains in understanding their roles and
responsibilities and an increase in confidence. The handbook, “Key Highlights for Layperson”
was noted as a valuable resource for their practice, while discussions centered around case
studies emerged as an effective learning strategy. Additionally, they emphasized the
importance of maintaining the network established during the training, which enables ongoing
knowledge sharing and inquiry among peers and mentors.
Despite the training's success, participants expressed a desire to shorten the
project duration and increase on-site meetings to enhance idea exchange and shared
experiences. However, online monthly follow-up evaluations and training should not take
place during weekends. Additionally, a refresher course for laypersons should be organized
annually.
The findings underscore the essential need to empower lay members of HRECs.
To enhance the effectiveness of lay members in protecting research participants, institutions
must prioritize training and workshop opportunities. Such initiatives will not only enable these
members to fulfill their responsibilities more effectively but will also enhance the overall
ethical standards within human research protocols, ultimately resulting in greater protection
for research participants.
