Introduction 678

Research involving human participants, animals or biological materials should be based on a fundamental moral commitment to the individual or animal concerned. The research should also result in advancing human welfare, knowledge and understanding. It is a universal requirement mandated by all research bodies that all institutions should establish an Ethics Committee to monitor research activities.

Anyone employed in Mochtar Riady Institute for Nanotechnology (MRIN), Faculty of Medicine, Universitas Pelita Harapan (FK UPH), Universitas Pelita Harapan or Siloam Hospitals who intends to undertake a research or teaching project involving any form of human participation or animal studies has an ethical responsibility toward the subjects of that project. This includes research carried out on MRIN premises or conducted elsewhere.

The MRIN Ethics Committee is the body that reviews and approves such projects to ensure that the ethical responsibilities are appropriately addressed in the project. Their review is based on details provided by the completion of an ethics application for research involving human subjects or animals.

The following guideline is prepared to assist Researcher/ Principal Investigator (PI) to outline the submission requirements for full or expedited review of new protocols and modification to an approved protocol. As an ethics conduct has to be maintained throughout a study, this guideline describes procedure for additional report mechanism after a protocol is approved.