Procedure of Ethical Review Submissions

 

 

 

Procedure of Ethical Review Submissions

Prospective researchers access the KEPK-FFUP website at the following link: https://kepk.farmasi.univpancasila.ac.id/index.php/kepk, then register an account and download the required document template. Once filled in, the document is submitted to KEPK-FFUP via the Send Article link on the KEPK-FFUP website using a previously registered account.

The proposal must be signed by the head of the institution where the research is conducted. For research related to education, namely research by undergraduate, master's or doctoral students, the proposal must be signed at least by the supervisor.

The proposal must be accompanied by a curriculum vitae of the principal investigator and co-investigator, and if it is clinical trial research, it must be accompanied by an informed consent form consisting of:

  1. information for research subjects dan  
  2. subject consent form (signature sheet). 

 

Procedure of First Submissions

Procedure of Revision Result Submissions

Procedure of Amendment Submissions

Procedure of Ethical Approval Extension Submissions

Procedure of Serious Adverse Events (SAE) Reports

Procedure of Final Report Submissions

 

Ethics Approval

KEPK-FFUP will issue recommendations no later than 2 weeks after submission, unless the meeting day coincides with a holiday. KEPK-FFUP recommendations can be in the form of:

 

All research that includes humans as research subjects needs to obtain Ethical Clearance or Certificate of Passing Ethical Review. In Indonesia, research ethical standards are regulated in Health Law no. 23/1992 and PP no. 39/1995 concerning Health Research and Development. The research in question is biomedical research related to pharmaceutical products, medical devices, radiation and photography, surgical procedures, medical records, biological samples, as well as epidemiological, social and psychosocial research.