+62 331 337877 fk@unej.ac.id

Research Ethics

Organizational Structure

Chief
Dr. dr. Rini Riyanti, Sp.PK.

Secretary
dr. Angga Mardro Raharjo, Sp.P.

Staff
dr. Cholis Abrori, M.Kes., M.Pd.Ked.
dr. Muhammad Hasan, M.Kes., Sp.OT.
dr. Desie Dwi Wisudanti, M.Biomed.
dr. Ayu Munawaroh Aziz, M.Biomed
dr. Kristianningrum Dian Sofiana, M.Biomed.
Lilik Maslian, A.Md.
Nurul Istinaroh, A.Md.
Abu Hasanudin, S.Pd.I.
Antonius Agus Prayogi
Rizqi Mardiana

Definition

The Research Ethics Commission is a commission tasked with conducting reviews and providing recommendations for research to be carried out. Medical science and technology has developed very rapidly thanks to good and high-quality research. High-quality research is research that meets the requirements of scientific excellence and upholds human dignity, dignity, and rights as stated in the Helsinki Declaration, and meet the principles of Good Clinical Pactice.
Basically, all research that uses humans as research subjects must get Ethical Clearance or Information Passes Ethical Review. In Indonesia, the research ethics standards are regulated in the Health Law no. 23/1992 and further regulated in PP no. 39/1995 concerning Health Research and Development. The research in question is biomedical research which includes research on pharmaceutics, medical devices, radiation and shooting, surgical procedures, medical records, biologic samples, as well as epidemiological, social and psychosocial research.

  • Review research proposals to provide ethical approval. Without ethical approval from the KPK research should not be started;

  • Supervise research so that it can run according to the protocol that has been approved by KEPK.

     

  • The researcher submits an application for a certificate of ethical approval to the ethics commission of the FK UNEJ by filling out the application form. F.7.6B.00.01;
  • The application is accompanied by 2 copies of a copy of the proposal that has been approved by the supervisor (for the student’s thesis) submitted to the secretariat of the ethics commission;
  • The secretariat of the ethics commission checks the completeness of the file, the incomplete file will be returned to the researcher for completion. The complete dossier will be conducted an ethics review;
  • Members of the ethics commission conduct an internal assessment of a copy of the proposal without the researcher attending to determine eligibility according to the research ethics form. F.7.6B.00.02;
  • The ethics commission determines the criteria for the proposal. The ethics commission gives decisions on intermediate research proposals;
  • For the 5.c criteria proposal, the Ethics Commission invites prospective researchers to discuss the research proposal;
  • The information of approval of the research ethics is signed by the chairman of the ethics commission or who represents with the knowledge of the chairman of the ethics commission;
  • The description of the approval of the research ethics was made in duplicate, one original sheet was given to the researcher and one derivative sheet for the Ethics Commission archives. F.7.6B.00.03;
  • The steps above are also presented in the form of a process flow.