Peran Komite Etik Penelitian Kesehatan RS dalam Perlindungan Subjek Penelitian Klinik: Perspektif Hak Asasi Manusia

Abstract

Penelitian klinik merupakan kegiatan ilmiah yang memiliki potensi risiko terhadap subjek manusia sehingga memerlukan mekanisme perlindungan yang kuat berbasis etika dan hukum. Komite Etik Penelitian Kesehatan (KEPK) Rumah Sakit berperan sebagai lembaga independen yang menilai, mengawasi, dan menjamin bahwa penelitian klinik berjalan sesuai prinsip bioetika dan Hak Asasi Manusia (HAM). Berbagai regulasi telah mengatur peran Komite Etik Penelitian Kesehatan (KEPK) dalam melindungi subjek penelitian. Namun, penelitian terdahulu masih didominasi kajian normatif dan kepatuhan prosedural, sementara analisis mengenai implementasi peran KEPK Rumah Sakit dalam perlindungan subjek penelitian klinik dari perspektif HAM serta kesenjangan antara norma dan praktik masih terbatas.

Penelitian ini bertujuan menganalisis pengaturan peran KEPK Rumah Sakit dalam perlindungan subjek penelitian klinik dalam perspektif HAM, implementasi perlindungan subjek penelitian klinik oleh KEPK di RS ST. Elisabeth Semarang, dan  kesesuaian implementasi dengan ketentuan normatif. Kebaruan penelitian ini terletak pada analisis integratif antara aspek hukum kesehatan, bioetika, dan HAM melalui pendekatan perbandingan antara das Sollen dan das Sein dalam pelaksanaan fungsi KEPK di lingkungan rumah sakit.

Metode penelitian yang digunakan adalah kualitatif dengan pendekatan yuridis sosiologis. Data diperoleh melalui wawancara, observasi, serta kajian dokumen hukum dan administrasi KEPK. Analisis dilakukan menggunakan interpretasi hukum (gramatikal, sistematis, historis, sosiologis, dan teleologis) untuk menilai kesenjangan antara das Sollen dan das Sein.

Hasil penelitian menunjukkan bahwa kerangka hukum Indonesia meliputi UUD 1945, UU Kesehatan, UU HAM, serta Permenkes terkait KEPK telah mengatur secara jelas kewajiban perlindungan subjek penelitian. KEPK RS ST. Elisabeth Semarang telah menjalankan fungsi telaah etik, validasi informed consent, dan pemantauan penelitian sesuai standar. Namun, ditemukan beberapa hambatan seperti keterbatasan sumber daya manusia, sarana dan prasarana, dan pelatihan etik anggota, serta belum tertanamnya budaya etik penelitian. Kesenjangan antara norma dan praktik menunjukkan perlunya penguatan kelembagaan, peningkatan kapasitas etik anggota KEPK, serta transparansi dalam proses telaah, pemantauan dan pelaporan penelitian. Penelitian ini menegaskan pentingnya peran strategis KEPK dalam menjamin bahwa penelitian klinik tidak hanya sah secara ilmiah, tetapi juga menjunjung tinggi martabat manusia. Penguatan implementasi regulasi dan tata kelola KEPK diperlukan agar perlindungan HAM terhadap subjek penelitian klinik dapat terwujud secara optimal.

Abstract: Clinical research is a scientific activity that carries potential risks for human subjects, thereby requiring strong ethical and legal protection mechanisms. The Health Research Ethics Committee (HREC) of a hospital serves as an independent body responsible for reviewing, overseeing, and ensuring that clinical research is conducted in accordance with the principles of bioethics and human rights. Various regulations have established the role of Health Research Ethics Committees (HRECs) in protecting research participants. However, previous studies have primarily focused on normative and procedural aspects, while limited attention has been given to the implementation of hospital-based HRECs from a human rights perspective and the gap between normative provisions and actual practice.

This study aims to analyse the regulatory framework governing the role of hospital HRECs in protecting clinical research subjects from a human rights perspective, to examine the implementation of such protections by the HREC at ST. Elisabeth Hospital Semarang, and to assess the alignment of its practices with normative standards. This study offers a novel contribution by integrating health law, bioethics, and human rights perspectives to examine the discrepancy between normative standards (das Sollen) and actual practices (das Sein) in the implementation of the functions of Health Research Ethics Committees (HRECs) in hospitals.

This research employs a qualitative method with a socio legal approach. Data were collected through interviews, observations, and reviews of legal documents and HREC administrative records. The analysis was carried out using legal interpretation methods (grammatical, systematic, historical, sociological, and teleological) to identify gaps between das Sollen and das Sein.

The results indicate that Indonesia’s legal framework including the 1945 Constitution, the Health Law, the Human Rights Law, and Ministry of Health regulations governing HRECs provides clear guidelines on the obligation to protect research subjects. The HREC of ST. Elisabeth Hospital Semarang has performed ethical review, validated informed consent, and monitored ongoing research in accordance with established standards. However, several challenges remain, including limited human resources, infrastructure constraints, insufficient ethics training for committee members, and the lack of a strong research ethics culture. The gap between normative provisions and actual practice highlights the need for institutional strengthening, capacity building for HREC members, and improved transparency in review, monitoring, and reporting processes.

This study underscores the strategic role of HRECs in ensuring that clinical research is not only scientifically sound but also upholds human dignity. Strengthening regulatory implementation and HREC governance is essential to achieving optimal human rights protection for clinical research subjects