FKUI Research Ethical Committee
Science and technology of medicine has been swiftly developed these recent years. A qualified research is research with according to scientific method as well as honoring human rights, as written in the Declaration of Helsinki about Good Clinical Practice.
FKUI-RSCM Research Ethical Committee is an independent organization formed to oversee the research done to human is conducted according to the International Convention on Harmonization of Good Clinical Trial Practice (ICH-GCP). This organization functions to judge research proposal that will be conducted in FKUI-RSCM or affiliated hospitals, research centers in Jakarta and surrounding area or research that conducted by FKUI/RSCM staff in other places. Not only judging the ethical aspect, this organization is also assessing scientific aspect and methodology of the proposal. This is because the research that conducted not according to the science and inaccurate methodology would yield misleading conclusion and therefore it would be unethical.
Composition of Member
Membership of FMUI-RSCM Ethical Committee consists of staff from both institutions member from outside those institutions and two members from non-scientific group (layman) in accordance to the ethical commission membership based on ICH-GCP.
Meeting of Ethical Committee
FKUI Research Ethical Committee holds meeting once a week with main agenda to discuss the research proposals. In addition, there is discussion about protocol amendment that requires full board review.
Procedure of Ethical Clearance
Application form for ethical clearance can be obtained in the secretariat of ethical commission in the Ruang Tata Usaha of FKUI level 2 (Ms Subekti). Afterward, the applicant has to fill form, synopsis, and full proposal, each for 20 copies.
Proposal has to be signed by institution’s superior where the research is done.
For research that linked to academic (Specialist, Master, Doctoral, Undergraduate Students), proposal has to be signed by supervisor.
Proposal has to be completed with the curriculum vitae of principal investigator and co-investigator, informed consent which consists of 1) information for research subject, 2) acceptance form for research subject (signature.)
FKUI-RSCM Research Ethical Committee would issue recommendation at least 2 weeks after application (except if the meeting day is coincide with public holiday). Recommendation can be in forms of :
– Suggestion of improvement
– Call for the investigators
Contact person: dr. Nafrialdi, PhD, SpPD, c/o FMUI Department of Pharmacology, or through email:firstname.lastname@example.org
FKUI-RSCM RESEARCH ETHICAL CLEARANCE COMMITTEE, JAKARTA 2009 :
- Prof. Rianto Setiabudy, Farmacologist, MD, PhD – Chairman – Farmacology & Terapeutik
- Muchtarudin Mansyur, MD, SpOK, PhD – Vice Chairman – Medicine Community
- Nafrialdi, Internist, Farmacologist, MD, PhD – Secretary – Farmacology & Terapeutik
- Prof. Rita Sita Sitorus, Opthalmologist, MD, PhD – Committee – Opthalmology
- Kusmarinah Bramono, Dermatovenreologist, MD, PhD – Committee – Dermatovenereology
- Ratna Dwi Restuti, Otolaryngologist, MD, PhD – Committee – Otorhinolaryngology
- Imam Effendi, Internist, MD, PhD – Committee – Internal Medicine
- Murdani Abdullah, Internist, MD, PhD – Committee – Internal Medicine
- Dini Widiarni Widodo, Otolaryngologist, MD, MEpid – Committee – Otorhinolaryngology
- Andri Maruli Tua Lubis, Orthopaedy Surgery, MD, PhD – Committee –
- Suryanto Sidik, Internist, MD, PhD – Committee – RSAL Mintoharjo
- Gatot Purwoto, Obstetric and Gynecologist, MD – Committee – Obstetry and Gynecology
- Drh. Endi Ridwan, MS – Committee – Nutrition Research and Development , Bogor
- Drh. Safarina G. Malik, MS, PhD – Committee – EIJKMAN Institute
- Dra. Dwi Anita Suryandari, PhD, M.Biomed – Committee – Biology Medicine
- Ade Firmansyah, Forensic, MD – Committee – Forensic and Medicolegal
- Nia Kurniati, Pediatrician, MD – Committee – Pediatric
- R. Mgd. Rajeni P. Tolani – Committee
- Sulistyawati Siregar – Committee