| Autor: |
Hartanti W; Center for Bioethics and Medical Humanities, Department of Medical Education and Bioethics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.; Biobank Unit, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia., Wahdi AE; Biobank Unit, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.; Department of Biostatistics, Epidemiology, and Population Health, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia., Prasetiawati T; Ethics and Law Committee, UGM Academic Hospital, Yogyakarta, Indonesia.; Department of Psychiatry, UGM Academic Hospital, Yogyakarta, Indonesia., Izhati QA; Biobank Unit, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia., Fachiroh J; Biobank Unit, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.; Department Histology and Cell Biology, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia. |
| Abstrakt: |
Background: Informed consent (IC) for biobank practice is vital to ensure that sample collection, storage, and utilization are ethical. However, the standard practices in biobanking in upper-middle-income countries such as Indonesia often rely on specific consent, leading to restricted sample use and ethical concerns. This article describes the development of an IC model that meets ethical standards and yet is acceptable for biobanking practice in an Indonesian academic hospital. Method: We conducted a study involving Universitas Gadjah Mada (UGM) Biobank Unit and the UGM Academic Hospital, Yogyakarta, Indonesia, between 2019 and 2021. The IC development process consisted of four stages: (1) conceptualization, (2) preparation, (3) pilot, and (4) evaluation. These activities were part of a more extensive pilot study for an academic hospital-based biobank (Medical Biobank for Research in Indonesia (MBRIO) study). Result: We conceptualized a broad consent model, consisting of an information sheet, comprehension test, agreement sheet, and exit survey. We tested and revised the broad consent document to ensure readability, trained 10 consenting staff (1 surgeon and 9 nurses), and then piloted the IC procedure on 24 patients with elective surgery. The evaluation showed that patients understood the information objectively and subjectively. Consenting staff considered the broad consent model acceptable for the academic hospital setting and suggested improvements to increase the readability of information sheets and have more trained staff for better coordination. Conclusion: The IC development process and model consent are ethically sufficient, acceptable and feasible to be implemented in academic hospital-based biobanks in Indonesia adjusted to the business processes. |
