Evaluation of The Health Research Ethics Management Information System using The RE-AIM Framework in Indonesia

Abstract

Increased global awareness of research ethics has encouraged many countries to develop an accountable review process. A recent development in Indonesia is the implementation of the Health Research Ethics Management Information System (SIM-EPK), which digitizes the ethics review by an Institutional Review Board (IRB) that can be monitored nationally. This study aimed to evaluate SIM-EPK using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A total of 30 informants including applicants, reviewers, and the IRB secretariat were involved. Data were collected using the Zoom meeting platform on 26 August 2022 and analyzed using NVivo software version 12. The respondents reported that the SIM-EPK is easily accessible and helpful. However, challenges were identified, including applicants’ lack of thoroughness when filling out the submission forms, unfamiliarity with the application, and technical problems such as lengthy CAPTCHA requirements for login and non-automated reminders. Concerns regarding data security, the complexity of submission forms, and institutional support were raised by several respondents. In conclusion, the SIM-EPK is well-received and considered as an effective and efficient digital tool that facilitates the ethical review. For the sustainability of this application, enhanced institutional support and improved data security measures are recommended.

Keywords: ethical review, SIM-EPK, RE-AIM, institutional review board, research ethics committee.

Evaluasi Sistem Informasi Manajemen Etik Penelitian Kesehatan Menggunakan RE-AIM Framework di Indonesia

Abstrak

Meningkatnya kesadaran global terhadap etik penelitian mendorong banyak negara untuk mengembangkan proses peninjauan yang akuntabel. Perkembangan terkini di Indonesia adalah penerapan Sistem Informasi Manajemen Etika Penelitian Kesehatan (SIM-EPK) yang mendigitalisasi tinjauan etik oleh Institutional Review Board (IRB) dan dapat dipantau secara nasional. Penelitian bertujuan mengevaluasi SIM-EPK menggunakan kerangka Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Sebanyak 30 informan terdiri atas pengusul, peninjau, dan sekretariat IRB. Data dikumpulkan melalui Zoom meeting pada tanggal 26 Agustus 2022 dan dianalisis dengan software NVivo versi 12. Para responden melaporkan SIM-EPK mudah diakses dan bermanfaat. Tantangannya adalah kurangnya ketelitian pelamar saat mengisi formulir pengajuan, ketidakpahaman terhadap aplikasi, CAPTCHA yang panjang untuk login, dan pengingat yang tidak otomatis. Kekhawatiran mengenai keamanan data, kompleksitas formulir pengajuan, dan dukungan kelembagaan juga disampaikan oleh beberapa responden. Disimpulkan bahwa SIM-EPK diterima dengan baik serta dianggap sebagai aplikasi digital efektif dan efisien yang memfasilitasi proses tinjauan etik. Untuk keberlanjutan aplikasi ini, diperlukan dukungan kelembagaan dan peningkatan keamanan data.

Kata kunci: tinjauan etik, SIM-EPK, RE-AIM, institutional review board, komite etik penelitian.