Ethics Committee

Ethics Committee

Ethics Committee for Health Research, Faculty of Dentistry, Universitas Trisakti

Ethics Committee for Health Research, Faculty of Dentistry, Universitas Trisakti (KEPK FKG Usakti) is independent and free from political influence or pressure, institutions, professions, groups, individuals, industries or markets. This independence includes aspects of member composition, work procedures, review processes, and decision making. KEPK FKG Usakti is tasked with assessing, requesting clarification and modifications, then approving or disapproving a research protocol that is submitted for approval of research ethics. KEPK FKG Usakti also assesses and approves amendments to the protocol that had previously been given ethical approval.KEPK FKG Usakti supports researchers to adhere to ethical principles in clinical trial research, clinical research, surveys, and registries, epidemiological studies, humanities studies, studies using experimental animals, studies using Stored Biological Samples (BBT), genetic materials and other non-clinical activities, including obtaining ethical clearance and monitoring of research activities that have been approved. Research conducted must meet ethical standards including respect for the dignity, rights, safety and welfare of subjects who participate in research.KEPK FKG Usakti is responsible for protecting research subjects, including the risks and benefits to the community in the area where the research is conducted. The primary objective is to promote high ethical standards in health research. The research in question is Dental and Oral Health Sciences, which includes Oral Biology, Oral Pathology, Pharmacology, Biochemistry, Microbiology, Histology, Dental Anatomy, Dental Materials, Conservative Dentistry/Endodontics, Orthodontics, Pedodontics, Prosthodontics, Periodontology, Oral and Maxillofacial Surgery, Oral Medicine, Dental Radiology, and Public Health.

Organization Structure
Health Research Ethics Commission FKG Usakti
No. Dean’s Decree : 076/SK/DEK/FKG/X/2024
Chair : Dr. drg. Sri Ratna Laksmiastuti, Sp. KGA
Secretary : Dr. drg. Johan Arief Budiman, Sp. Ort
Member : 1. Prof. drg. Rahmi Amtha, MDS, Sp.PM., PhD
2. Prof. Dr. drg. F. Loes D. Sjahruddin, M.Kes
3. Prof. drg. Janti Sudiono, MDSc, Sp. PMM(K)
4. Dr. drg. Joko Kusnoto, MSc, Sp.Ort
5. Dr. drg. Tien Suwartini, Sp.KG (K)
6. Dr. drg. Eko Fibriyanto, Sp. KG(K)
7. drg. M. Orliando Roeslan, M.Kes, PhD
8. drg. Carolina Damayanti Marpaung, Sp. Prost. PhD
9. Dr. drg. Didi Nugroho Santosa, M.Sc
10. drg. Abdul Gani Soulisa, MPH
11. Herry Maulana, S.Kom
12. Mega Cahyati, SE

 

Ethical Clearance Submission Flow


Guidelines 

  1. Forum For Ethical Review Committees In Asia & The Western Pacific, POB Handbook For Ethics Committees.
  2. World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research, 2000.
  3. World of Health Organization. Handbook for Good Clinical Research Practice (GCP), 2002
  4. Ethical Guidelines for Biomedical Research on Human Subjects, 2000
  5. Pedoman Nasional Etik Penelitian Kesehatan. Komnas Etik Penelitian Kesehatan, Badan Litbang Kesehatan, Jakarta, 2007.
  6. CIOMS. International Ethical Guidelines for Epidemiological Studies. 2008.
  7. International Ethical Guidelines for Biomedical Research Involving Human Subjects – CIOMS ethical guideline 2016
  8. Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects
  9. Buku Pedoman Cara Uji Klinis yang Baik (CUKB 2016)
  10. Guidelines for Good Clinical Practice – ICH GCP E6 R2_GCP
  11. Guide for The Care and Use of Laboratory Animal
  12. UU no 36 th 2009 tentang kesehatan

Research Ethics Review Form
https://drive.google.com/drive/folders/1eW943H3-7aWKD4ge2gG7B0OtWmThb1I4?usp=sharing

Contact US: 
Sekretariat KEPK FKG Usakti
FKG Universitas Trisakti Kampus B.
Jl. Kyai Tapa No. 260, Grogol Petamburan,
Jakarta Barat 11440

Email: komisietikfkg@trisakti.ac.id

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