Please pay attention to the following Frequently Asked Questions (FAQ) before you ask a question about KEP:

Section 1: Human Subjects Research Ethics Training

1. I would like to take the CITI Program course as a proof of credentials for research involving human subjects. Is the course I must take called “Social and Behavioral Research”?

Answer:
Yes, you can simply complete the course “Social Behavioral Research.”

However, you can take other CITI Program classes if you wish.

2. I have already completed the CITI Program class, do I have to take it again?

Answer:
Make sure the class you have taken is “Social and Behavioral Research.”
Make sure your CITI Program certificate has not expired.

3. Are researchers from outside of UI affiliations also required to include proof of CITI credentials?

Answer:
Other credentials of research training with human subjects can be proven in addition to the CITI Program certificate.

 

Section 2: New Applications

1. Does undergraduate and graduate student research require KEP ethics approval?

Answer:
If a postgraduate student’s research falls within the definition of research involving human subjects, then the research requires KEP’s ethical approval.

Currently, KEP has not yet opened submissions for undergraduate students. However, KEP strongly encourages undergraduate students from the University of Indonesia to take human subjects training from the CITI Program. CITI Training program is free for the entire University of Indonesia academic community.

2. Can researchers from outside of the University of Indonesia apply for KEP ethics approval?

Answer:
Yes, they can. Please attach a cover letter from the relevant institution/university when submitting.

3. Who should be included in the “Personnel List” document for new applications?

Answer:
The Personnel List contains a list of all members of the research team involved in the research in any role (Principal Researcher, Associate Researcher, to Research Assistant) and from any institution. All individuals listed on the Personnel List are required to attach proof of their human subjects research training credentials.

4. Does KEP provide a special format for consent forms?

Answer:
KEP does not provide a specific consent form format, but KEP does provide examples of consent forms (currently only available in Bahasa Indonesia) that can be used as a reference as well as a guide (currently only available in Bahasa Indonesia) to understand the important elements that must be included in a consent form.

5. If the research is conducted in English, do the documents sent to KEP (such as questionnaires, consent form) have to remain in Bahasa Indonesia?

Answer:
Please attach a questionnaire/list of questions/consent form in the language that will be used for the interview process with the subjects.

6. What is the Waiver or Alteration of Informed Consent Form?

Answer:
Informed consent form is an integral part of the study where the subject declares consent to participate in the study. However, there are studies where the research team does not use informed consent form for some reason. If the research team has a clear reason and justification for not using consent form, please include the Waiver or Alteration of Informed Consent Form in the application.

7. The research team is in the process of submitting to another IRB. Do I need to inform KEP?

Answer:
Please attach evidence (in any document or form) that the research is also in the process of being submitted to another IRB.

8. If my research has a sponsor, does the sponsor have to prepare certain consent documents?

Answer:
If the research is sponsored by an external party, please attach a copy of the funding proposal to the submission.

 

Section 3: Application Fee

1. Is there a fee for applying for KEP’s ethics approval?

Answer:
Currently there is no charge for applying for KEP’s ethics approval.

 

Section 4: Request for Amendment

1. My research has received KEP approval and is ongoing, but I would like to remove some questions from the questionnaire instrument. Do I still have to submit an amendment request to KEP?

Answer:
Yes, you do. Please submit all types of research protocol changes to KEP.

 

Section 5: KEP Membership

1. I am interested in becoming a KEP Member. How can I register to become one?

Answer:
Please send an email to KEP (kep@lpem-feui.org) with the subject “KEP Member Registration – (your name)” and attach your CV/resume.

2. I am a member of KEP LPEM FEB UI. Can I apply for human subjects research ethics approval to KEP LPEM FEB UI?

Answer:
KEP members can apply for ethics approval. However, the said member may not be involved in the protocol review process and the discussion and voting for the relevant protocol at the Full Board meeting.

 

Section 6: Additional FAQs

1. What kinds of research are required to be reviewed and approved through ethics review by an Institutional Review Board (IRB)?

Answer:
All research involving human subjects must be reviewed and approved by an Institutional Review Board (KEP is an IRB). The involvement of human subjects includes direct or indirect interventions or interactions (e.g. collection of identified secondary data). Written approval from KEP must be obtained before research activities involving human subjects (e.g. subject recruitment) are initiated.

2. How long does it take for KEP to review and approve my research protocol?

Answer:
It depends on the level of research risk and the type of review being conducted. The estimated time required by KEP is 3-7 weeks from the deadline of the submission cycle each month. Therefore, KEP recommends researchers to submit an ethics review 2 months before conducting the research. Further provisions regarding the estimation of the review process and the steps for ethical review of new applications can be accessed at: New Applications.

3. Do I need to get KEP LPEM FEB UI approval if my research is conducted in another country but I am still a University of Indonesia student?

Answer:
You may submit an ethics review to KEP LPEM FEB UI. We recommend that you also submit an application to the local IRB in the country where your research is being conducted.

4. Are all communications with KEP LPEM FEB UI during the application submission process only conducted via email? Does KEP LPEM FEB UI provide certain boxes or links for submission of new applications?

Answer:
You can contact KEP by email. KEP’s working hours are 09.00 – 17.00 WIB every working day.

Researchers can also check the progress of their application in the Submission Status page (only available in Bahasa Indonesia).