Reforming Procedures for Assessing Research Protocols During Covid-19 Pandemic

Tri Nugraha Susilawati, Erindra Budi Cahyanto, Usman Sudarmaji

Abstract

: Covid-19 pandemic has caused dramatic changes in daily activities. In particular, human interactions were limited, and most daily duties were directed into an online environment. This study aimed to describe the characteristics of research protocols submitted to the Research Ethics Committee (REC), Faculty of Medicine, Universitas Sebelas Maret (UNS), and evaluate the effectiveness of ethical review procedures implemented during the pandemic era. The following data were retrieved: protocol identity, researcher's institution, researcher's educational background, type of study, the date of protocol submission, and the date when the ethical clearance (EC) certificate was issued. Two hundred seventeen research protocols were submitted to the REC from 1 January 2021 until 30 June 2022. Most researchers were university students, lecturers, physicians, and service providers. Observational studies were more prevalent than interventional studies. The ethical reviews were usually completed within 2-3 weeks unless a few protocols required major revisions. Most applicants and reviewers were satisfied with the process of online review. The REC secretariat played a crucial role in keeping everyone working on schedule. In conclusion, restricting direct human interactions during the COVID-19 pandemic does not affect the ethical review process. With familiar tools, online review becomes more effective than face-to-face meetings.

Keywords

Ethical review, ethics committee, research ethics, ethics protocol, Covid-19 pandemic

Full Text:

PDF

References

Bloomberg. Retrieved July 20, 2022, from https://www.bloomberg.com/news/articles/2022-07-04/indonesia-pushes-for-covid-boosters-with-cases-at-two-month-high

Burhan, E. & Rachmadi, R. A. (2022). Omicron surge and the future of COVID-19 vaccinations. Medical Journal of Indonesia, 31, 80–84.

Byerly, W. G. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy, 66(2), 176–184. https://doi.org/10.2146/ajhp070066

Cahyanto, E. B., Susilawati, T. N., & Sudarmaji, U. (2022). Transisi Layanan Kaji Etik Penelitian di Era Digital. Kebidanan, 02(Desember 2022), 136–144.

Chandra, C. E. & Abdullah, S. (2022). Jakarta COVID-19 forecast with Bayesian PIRD multiwave model. ASEAN Journal of Science and Engineering, 3, 227–242.

Chu, D. T., Vu Ngoc, S. M., Vu Thi, H., Nguyen Thi, Y. V., Ho, T.T., Hoang, V.T., et al, (2022). COVID-19 in Southeast Asia: current status and perspectives. Bioengineered, 13, 3797–3809.

Kementerian Kesehatan Republik Indonesia (Kemkes RI). Retrieved July 20, 2022, from https://sim-epk-keppkn.kemkes.go.id/

Lapid, M. I., Clarke, B. L., & Wright, R. S. (2019). Institutional Review Boards: What Clinician Researchers Need to Know. Mayo Clinic Proceedings, 94(3), 515–525. https://doi.org/10.1016/j.mayocp.2019.01.020

Liberale, A. P., & Kovach, J. (2017). Reducing the Time for IRB Reviews: A Case Study. Journal of Research Administration, 48(2), 37–50.

Liputan 6. Retrieved July 20, 2022, from https://www.liputan6.com/news/read/5001016/penerima-vaksinasi-booster-di-indonesia-capai-508-juta-per-sabtu-2-juli-2022

Millum, J., & Menikoff, J. (2010). Streamlining Ethical Review. Ann Intern Med, November 1(153), 655–657. https://doi.org/10.7326/0003-4819-153-10-201011160-00008.

Nugraha, R. R., Miranda, A. V., Ahmadi, A., Lucero-Prisno III, D.E. (2021). Accelerating Indonesian COVID-19 vaccination rollout: a critical task amid the second wave. Tropical Medicine and Health, 49, 76.

Shekhani, S., Iqbal, S., & Jafarey, A. (2021). Adapting the ethical review process for COVID-19 research: reviewers’ perspectives from Pakistan. Eastern Mediterranean Health Journal, 27(11), 1045–1051. https://doi.org/10.26719/emhj.21.053

Susilawati, T. N., Cahyanto, E. B., & Sudarmaji, U. (2022). Digitalisasi Layanan Kaji Etik: Sebuah Studi Tata Kelola Komite Etik Penelitian. Jurnal Etika Kedokteran Indonesia, 5(2), 57.

Refbacks

  • There are currently no refbacks.