Research Ethics Committee (Human)

Jawatankuasa Etika Penyelidikan (Manusia) - [JEPeM]

 

Background

 

The Human Research Ethics Committee of USM (JEPeM) started as Jawatan Kuasa Etika Penyelidikan (JKEP), established under the medical school [PPSP] administration in 1987. The initial responsibility was to review and vet research proposals for short and long term research grants. Its role was later expanded to include vetting on ethical issues as PPSP embarked on clinical trials in 1994. The committee was initially catering for research proposals from PPSP.

 

In 2002, the Committee was made the only human ethics committee for University Sains Malaysia. This Research and Ethical Committee is listed under the Office for Human Research Protections (OHRP), United States Department of Health & Human Services, since October 2004 as we began to do more clinical trials involving international pharmaceutical companies The Federal-wide Assurance (FWA) identification number is FWA00007718 and the Institutional Review Board (IRB) number is IRB00004494. The term of accreditation is until February 2012. The Committee adopts research ethics guidelines outlined by the Helsinki Declaration agreed by the World Medical Association and Council for International Organizations of Medical Sciences (CIOMS).

 

Clinical Science Research Platform [CSRP] was established in 2004. Its role is to facilitate and mobilize clinical researches. JKEP was then transferred under the administration of CSRP in April 2007 and renamed JEPeM.

 

Terms of Reference of JEPeM

To vet and regulate clinical proposals on;

  • Research involving human subjects [patients or normal people]
  • Research involving human samples
  • Research involving data derived from humans
  • Research using products [biological or non-biological] which will be tested on humans... [ Read More ]

Documents related to Ethical Approval (Human)

How tos: Download Forms:
How to get Ethical Approval Ethical Approval Application Form
How to do Clinical Trial with USM Ethical Approval Application Form (For MMed Student PPSP Only)
  Borang Perundingan USAINS
Other info: Checklist for Clinical Trial
Malaysian R&D Classification System Book Extention of Ethical Approval Form
Members of Research Ethics Committee (Human) Example of good Patient Informed Consent Form
Proposed JEPeM Meeting Schedule for 2011 Example of Gantt Chart / Milestone

 

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