Mochtar Riady Institute for Nanotechnology Ethics Committee (MRIN EC) Page 1 of 77 Guideline for Application and Submission of Protocol Revision 06/2024 Research involving Human Subjects Mochtar Riady Institute for Nanotechnology Ethics Committee Address : Jln. Boulevard Jend. Sudirman No. 1688 Lippo Karawaci, Tangerang 15811 Telp. 62-21-54210123 Email :
[email protected] www.mrinstitute.org
Mochtar Riady Institute for Nanotechnology Ethics Committee (MRIN EC) Page 4 of 77 3. Procedure for Protocol Submission for Initial Review and Resubmission New research protocol should be submitted for Initial Review by the MRIN EC to obtain ethics approval. Investigation and/ or collection of data on human subjects for research purposes; requires ethics approval by MRIN EC prior to implementation. The Procedure for Protocol Submission for Initial Review or Resubmission is as follows: 1. Complete the Application Form for Clinical Trial (Form AF/01-010/2024/01.6). 2. Complete the Application Form for Health-Related Research including Survey, Registry, Surveillance, Epidemiology, Humaniora, Stored Biological Specimen, Non- Clinical(Form AF/02-010/2024/01.6). 3. Complete the Informed Consent & ChecklistAF/04-010/2024/01.6 4. Application form for Clinical trial or Health-Related Research including Survey, Registry, Surveillance, Epidemiology, Humaniora, Stored Biological Specimen, Non- Clinical should be include the following attachments of: a. Cover Letter from referring Institute b. Research proposal as approved by Advisor or Institutional Head. c. Research Proposal should contain: Title Table of Content Abstract Background Research Problem Aim /Objective, consist of General aim and specific aim Efficacy end point Risk and Benefit (outcome of research) Hypothesis Materials and Methods including a. Theoretical and Conceptual Frame Work
English