Research Ethics and Clearance
Research Ethics and Clearance
Protect your research participants, your institution, and your career — before the first data point is collected.
What Is It?
Think of it as a building permit — for your research.
Research Ethics Clearance (Klirens Etik) is a formal review process conducted by the Research Ethics Committee (Komite Etik Penelitian / KEP) to ensure that any research involving human participants, personal data, or vulnerable groups is conducted safely, honestly, and with full respect for everyone involved. Just like a building permit: no one gets to start construction first and ask for permission later.
At BINUS, what is required is prospective ethics clearance — meaning the application must be submitted before the study begins, before a single respondent is interviewed or any data is collected. This differs from retrospective review, which examines completed studies and is used only in specific, exceptional circumstances.
Expedited Review
Medium to High Risk
Involves human participants, sensitive personal data, vulnerable groups (children under 18, elderly, persons with disabilities), or hazardous materials. Reviewed by the full committee. Estimated timeline: ~12–15 working days.
Exempted Review
Minimal Risk
Anonymous surveys, passive observation in public spaces, analysis of already-published secondary data, or internal classroom programme evaluations. Estimated: ~7 working days. Still mandatory to submit.
Why It Matters
This is not red tape, but real protection.
Career & Publication
International journals require it
Nearly every Scopus and Web of Science indexed journal requires an ethics clearance statement with submitted manuscripts. Without a Letter of Ethical Approval, your research — however rigorous — will be desk-rejected before it ever reaches peer review. This standard applies globally, including most international conferences.
Law & Sanctions
Indonesia’s PDP Law is now fully enforced
Since October 2024, Indonesia’s Personal Data Protection Law (UU PDP No. 27/2022) has entered full enforcement. Research collecting personal data without legally valid consent can result in fines of up to IDR 6 billion and criminal penalties of up to 6 years imprisonment. Ethics clearance is the recognised mechanism to ensure your study is legally protected.
Scientific Credibility
Without trust, findings don’t travel
The Declaration of Helsinki (WMA, last updated 2024) and the Belmont Report establish that protecting research participants is the foundation of modern science. Research without transparent ethical grounding is not only legally risky — its findings will be challenged by the global academic community, no matter how strong the methodology.
Institutional Mandate
Indonesian law is unambiguous
Law No. 11/2019 on the National Science and Technology System (Article 39) and BRIN Regulation No. 22/2022 mandate ethics clearance for all research conducted in Indonesia. For foreign researchers wishing to work in Indonesia, BRIN ethics clearance is even a prerequisite for obtaining a Research Permit — with permit revocation and a 5-year blacklist for violations.
Step by Step
How to Apply for Ethics Clearance at BINUS
Total estimated timeline: 2–3 working weeks. Never submit close to your data collection deadline.
Complete the Online Application Form
Access the form at forms.office.com/r/CUN97r6tE1. The form has four sections: Basic Research Information, Research Information & Methodology, Research Type, and Integrity Declaration. Write “N/A” for any field that does not apply to your study.
Prepare Your Supporting Documents
All of the following must be ready before submitting:
| # | Document | Notes |
|---|---|---|
| 1 | Application Form | Required for all review types |
| 2 | Research Proposal | Required for all review types |
| 3 | Research Instruments | Questionnaire/interview guide/FGD script — must be in Bahasa Indonesia |
| 4 | Conflict of Interest Statement | Select: potential conflict present or absent |
| 5 | Informed Consent Form | Must contain all 8 mandatory elements (see below) |
| 6 | Parental/Guardian Consent Letter | Only if participants are under 18 years old |
Submit to the Ethics Committee Secretariat
Submit your documents to the Research & Technology Transfer (RTT) Office, Kampus Anggrek Room 700. The secretariat will check administrative completeness within 2 working days. If documents are incomplete, you will be notified to revise. If the researcher does not respond within 5 working days, the application is considered withdrawn.
Review Type is Determined
The secretariat classifies your submission as either Expedited or Exempted Review within 2 working days, based on the nature of the research and data being collected. If there is any document mismatch, you will be asked to correct before proceeding.
Committee Review
Expedited: The committee reviews within 5 working days. If revisions are required, the researcher has 2 working days to respond. Final approval by the Committee Chair within 5 working days after revisions are accepted. Exempted: Administrative confirmation within 2 working days, final approval within 5 working days. If the application does not meet requirements, a Rejection Letter is issued.
Receive Your Letter of Ethical Approval & Begin Research
The Letter of Ethical Approval is issued via official email from the BINUS Ethics Committee, within a maximum of 5 working days after the decision is approved. Keep a copy — it is mandatory to attach to every publication, final report, and grant submission. If your study changes significantly (title, methodology, instruments, sample), you must submit an amendment before continuing.
Key Component
What Is Informed Consent?
An Informed Consent form ensures every research participant fully understands — and voluntarily agrees to — their involvement in the study. It is the ethical heart of participant protection: without valid informed consent, no research is ethically or legally defensible, regardless of how valuable the findings are.
8 mandatory elements in a BINUS Informed Consent (per 21 CFR §50.25 & GDPR Art. 7):
Important Notes
Key Rules & Common Mistakes
⚠️ Avoid these common pitfalls:
- Starting research before the Letter of Approval is issued — data collected in advance cannot be retroactively legitimised.
- Instruments not finalised at the time of submission — any revision to your questionnaire after submission triggers a formal amendment, adding 1–2 more weeks.
- Underestimating your review category — a survey that “feels safe” but collects names, email addresses, or photos falls under Expedited, not Exempted.
- Incomplete Informed Consent — this is the single most common reason for revision requests from the committee.
- Not submitting an amendment when your study changes — changes to title, sample, or methodology must be amended before the study continues.
- Research instruments not in Bahasa Indonesia — all instruments used with participants must be in Indonesian, regardless of the study language.
💡 Real Example: When Do You Need an Amendment?
You have an Ethical Approval Letter for a study on student consumer behaviour using an anonymous online survey. Mid-study, you decide to add 10 in-depth interviews with selected respondents. This means: (1) your study now involves identifiable data (interviewee names), (2) the method has shifted from quantitative to mixed-method, and (3) the review category may move from Exempted to Expedited. You must submit an amendment before the first interview session takes place.
Legal Framework
Regulations That Require Ethics Clearance
Ethics clearance at BINUS is not just an internal policy — it is backed by interlocking national regulations and internationally adopted standards:
| Regulation | Scope | Relevance |
|---|---|---|
| Law No.11/2019 Sisnas Iptek Art.39 | Indonesia | Mandates an Ethics Committee at every research institution |
| BRIN Regulation No.22/2022 | Indonesia | National ethics clearance mechanism; prerequisite for foreign researcher permits |
| PDP Law No.27/2022 | Indonesia | Criminal sanctions for data collection without valid consent; fully enforced since Oct 2024 |
| Declaration of Helsinki (WMA 2024) | International | Global standard for medical and social research ethics; adopted by international journals |
| 21 CFR Part 50 (US FDA) | International | Benchmark for informed consent in clinical and behavioural research |
| EU GDPR & APPI (Japan) | International | Leading data protection benchmarks — increasingly relevant for international research collaborations |
Practical Tips
Make Your Application Go Smoothly
🗓️ Start 4 weeks early
The full process can take 3–4 weeks. Never apply when your data collection window is just around the corner.
📋 Finalise instruments before submitting
Revising a questionnaire after submission triggers a formal amendment — adding at least 1 extra week to your timeline.
✅ Be honest in self-assessment
Use the 10-question self-assessment in BINUS Panduan Edisi 1 to determine your review type. Don’t underestimate the risk profile of your study.
💾 Archive all correspondence
Keep all emails from the Ethics Committee. If a journal reviewer or grant body questions your clearance, this is your evidence trail.
Get Started
Your research deserves the strongest protection.
Submit your ethics clearance application through the online form. Need guidance? The RTT Secretariat is here to help you through every step.
Research & Technology Transfer Office — Kampus Anggrek R.700 | tech.transfer@binus.edu
Kaji Etik Penelitian
Lindungi subjek penelitianmu, institusimu, dan karirmu — sebelum data pertama dikumpulkan.
Apa Itu Kaji Etik?
Izin mendirikan bangunan — untuk risetmu.
Kaji Etik (Klirens Etik / Ethical Clearance) adalah proses telaah resmi oleh Komite Etik Penelitian (KEP) untuk memastikan sebuah riset dilakukan secara aman, jujur, dan menghormati hak-hak semua pihak yang terlibat — terutama manusia sebagai subjek penelitian. Seperti IMB (Izin Mendirikan Bangunan): tidak ada yang boleh memulai konstruksi dulu, baru mengurus izin belakangan.
Di BINUS, yang diwajibkan adalah kaji etik prospektif — artinya pengajuan dilakukan sebelum riset dimulai, sebelum satu pun responden diwawancarai atau data dikumpulkan. Ini berbeda dari kaji etik retrospektif yang meninjau riset yang sudah selesai (umumnya lebih jarang dan untuk tujuan khusus).
Expedited Review
Risiko Sedang–Tinggi
Melibatkan subjek manusia, data pribadi sensitif, kelompok rentan (anak <18 tahun, lansia, penyandang disabilitas), atau bahan berbahaya. Ditinjau oleh komite penuh. Estimasi: ~12–15 hari kerja.
Exempted Review
Risiko Minimal
Survei anonim, observasi pasif di ruang publik, analisis data sekunder yang sudah dipublikasi, atau evaluasi internal program kelas. Estimasi: ~7 hari kerja. Tetap wajib diajukan.
Mengapa Penting?
Bukan birokrasi — ini perlindungan nyata.
Karir & Publikasi
Jurnal internasional mensyaratkannya
Hampir semua jurnal berindeks Scopus dan Web of Science mewajibkan pernyataan klirens etik dalam naskah yang dikirimkan. Tanpa Surat Layak Etik, risetmu — sebagus apa pun — akan ditolak editor sebelum masuk peer review. Ini berlaku global, termasuk untuk konferensi internasional.
Hukum & Sanksi
UU PDP No.27/2022 sudah berlaku penuh
Sejak Oktober 2024, UU Pelindungan Data Pribadi Indonesia sudah memasuki fase penegakan. Penelitian yang mengumpulkan data pribadi tanpa consent yang sah dapat dikenai denda hingga Rp 6 miliar dan hukuman pidana hingga 6 tahun penjara. Kaji etik adalah cara resmi untuk memastikan risetmu terlindungi secara hukum.
Kepercayaan Publik
Tanpa kepercayaan, risetmu tidak berguna
Deklarasi Helsinki (WMA, terakhir diperbarui 2024) dan Belmont Report menegaskan bahwa perlindungan subjek penelitian adalah fondasi ilmu pengetahuan modern. Riset tanpa etika yang jelas tidak hanya berisiko hukum — hasilnya juga akan dipertanyakan validitasnya oleh komunitas akademik global.
Kewajiban Institusi
Regulasi Indonesia sudah tegas
UU No. 11 Tahun 2019 tentang Sisnas Iptek (Pasal 39) dan Peraturan BRIN No. 22 Tahun 2022 mewajibkan seluruh kegiatan riset di Indonesia memiliki klirens etik. Bagi peneliti asing yang ingin bekerja di Indonesia, klirens etik BRIN bahkan menjadi syarat penerbitan Research Permit.
Langkah demi Langkah
Proses Pengajuan Kaji Etik di BINUS
Estimasi total: 2–3 minggu kerja. Jangan ajukan mepet deadline penelitian!
Isi Formulir Permohonan Online
Akses formulir di forms.office.com/r/CUN97r6tE1. Formulir terdiri dari 4 bagian: Informasi Penelitian Dasar, Informasi Riset & Metodologi, Jenis Penelitian, dan Pernyataan Integritas. Kolom yang tidak relevan diisi “N/A”.
Siapkan Semua Dokumen Pendukung
Pastikan semua dokumen wajib (formulir, proposal, instrumen Bahasa Indonesia, surat konflik kepentingan, informed consent, dan surat izin orang tua jika ada peserta di bawah 18 tahun) sudah siap sebelum penyerahan berkas.
Serahkan ke Sekretariat Komite Etik BINUS
Berkas diserahkan ke Research & Technology Transfer Office (RTT), Kampus Anggrek R.700. Sekretariat akan memeriksa kelengkapan administratif dalam 2 hari kerja. Jika tidak ada respons dari peneliti dalam 5 hari kerja setelah notifikasi kekurangan, pengajuan dianggap batal.
Penentuan Tipe Review
Sekretariat mengklasifikasikan pengajuanmu ke dalam Expedited atau Exempted Review dalam 2 hari kerja berdasarkan sifat penelitian dan jenis data yang dikumpulkan.
Proses Telaah oleh Komite Etik
Expedited: Komite menelaah dalam 5 hari kerja. Jika ada catatan revisi, peneliti punya 2 hari kerja untuk merespons. Persetujuan final Ketua Komite dalam 5 hari kerja setelah revisi diterima. Exempted: Konfirmasi administratif 2 hari kerja, persetujuan final 5 hari kerja.
Terima Surat Layak Etik & Mulai Riset
Surat Layak Etik diterbitkan via email resmi dari Komite Etik BINUS, maksimal 5 hari kerja setelah keputusan. Simpan salinan surat ini — wajib dilampirkan di setiap publikasi, laporan akhir, dan pengajuan grant. Perubahan signifikan pada riset wajib diamandemen sebelum dilanjutkan.
Komponen Kunci
Apa Itu Informed Consent?
Lembar Informed Consent (Persetujuan Berdasarkan Informasi) adalah dokumen yang memastikan setiap subjek penelitian memahami sepenuhnya dan menyetujui secara sukarela keterlibatan mereka. Ini adalah inti perlindungan etis: tanpa informed consent yang valid, riset apapun tidak layak secara etika dan hukum.
8 elemen wajib dalam Informed Consent BINUS (sesuai 21 CFR §50.25 & GDPR Art. 7):
Hal Penting
Aturan Kunci & Kesalahan Umum
⚠️ Jangan sampai terjebak kesalahan ini:
- Mulai riset sebelum Surat Layak Etik terbit — data yang sudah dikumpulkan tidak bisa “dilegitimasi” belakangan.
- Instrumen penelitian belum final saat diajukan — revisi kuesioner = amandemen = tambah waktu 1–2 minggu lagi.
- Meremehkan jenis review — survei yang “terasa aman” tapi memuat nama, email, atau foto termasuk Expedited, bukan Exempted.
- Informed Consent tidak lengkap — ini poin pertama yang diperiksa Komite Etik dan penyebab terbanyak revisi.
- Tidak mengajukan amandemen saat riset berubah — perubahan judul, sampel, atau metodologi wajib diamandemen sebelum dilanjutkan.
- Instrumen tidak dalam Bahasa Indonesia — seluruh instrumen yang bersentuhan dengan subjek wajib berbahasa Indonesia.
💡 Contoh Nyata: Kapan Butuh Amandemen?
Kamu sudah punya Surat Layak Etik untuk penelitian perilaku konsumen mahasiswa melalui survei online anonim. Di tengah jalan, kamu memutuskan untuk menambah sesi wawancara mendalam dengan 10 responden terpilih. Ini berarti: (1) risetmu kini melibatkan data identitas, (2) metode berubah menjadi mixed-method, dan (3) kategori review bisa bergeser ke Expedited. Kamu wajib mengajukan amandemen sebelum sesi wawancara pertama dimulai.
Dasar Hukum
Regulasi yang Mewajibkan Kaji Etik
| Regulasi | Lingkup | Relevansi |
|---|---|---|
| UU No.11/2019 Sisnas Iptek Ps.39 | Indonesia | Mewajibkan Komite Etik di setiap lembaga riset |
| Peraturan BRIN No.22/2022 | Indonesia | Mekanisme klirens etik riset nasional, termasuk peneliti asing |
| UU PDP No.27/2022 | Indonesia | Sanksi pidana; berlaku penuh sejak Okt 2024 |
| Declaration of Helsinki (WMA 2024) | Internasional | Standar etika riset medis & sosial yang diadopsi jurnal global |
| 21 CFR Part 50 (FDA/AS) | Internasional | Standar informed consent; acuan 8 elemen wajib |
| EU GDPR & APPI (Jepang) | Internasional | Benchmark perlindungan data lintas negara |
Tips Praktis
Biar Pengajuanmu Lancar
🗓️ Mulai 4 minggu lebih awal
Proses total bisa makan 3–4 minggu. Jangan mengajukan saat seminggu sebelum data collection mulai.
📋 Finalkan instrumen sebelum submit
Revisi kuesioner setelah pengajuan = amandemen = tambah waktu minimal 1 minggu.
✅ Self-assessment jujur
Gunakan 10 pertanyaan self-assessment di Panduan BINUS Edisi 1 untuk menentukan tipe review dengan tepat.
💾 Arsipkan semua komunikasi
Simpan semua email dari Komite Etik. Berguna jika ada pertanyaan dari reviewer jurnal atau lembaga grant.
Mulai Sekarang
Risetmu layak mendapat perlindungan terbaik.
Ajukan klirens etikmu sekarang melalui formulir online. Butuh bantuan? Sekretariat RTT siap memandumu.
Research & Technology Transfer Office — Kampus Anggrek R.700 | tech.transfer@binus.edu