1. Ethical regulations for health research involving human subjects in Cambodia By Chap Seak Chhay, MD, MPH, MHPEd Public Health and Health Professions Educator Assistant Secretary of the National Ethics Committee for Health Research Involving Human Subjects Deputy Director National Institute of Public Health cschhay@gmail.com

2. Objective of the session  To be familiar with the existing ethical regulations and the process of ethical review for health research involving human subjects in Cambodia 2

3. Introduction  National Ethics Committee for Health Research (NECHR) first established by the MoH in 2002  Upon the request of the MoH, the NECHR re-established by the sub-decree No. 592  Since 2002, the review and approval of NECHR based on the SOPs developed by the committee and with the technical assistant from the WHO  The SOPs was revised with the support from the Forum for Ethical Review Committees for Asian and Western Pacific Region (FERCAP) and WHO in 2006  The revised SOPs published in June 2006 and it has been in effective since November 2008 3

4. NECHR  The Secretariat of the NECHR based at the National Institute of Public Health  The NECHR: 1. Ethical Guidelines for Health Research Involving Human Subjects, December 2002 2. Standard Operating Procedures (SOPs) for NECHR in Cambodia, November 2008 4

5. Ethical guidelines for health research involving human subjects, December 2002  All health research involving human subjects shall conduct in accordance with three basic ethical principles: 1.Respect for rights which requires free choice of the subject and protection of those diminished autonomy 2.Beneficence which requires that good should result, harm should avoid or that benefits should justify the expected risk or harm 3.Justice which requires an equal distribution of burden and benefits 5

6. International guidelines on research ethics  Nuremberg Code  Declaration of Helsinki (1964, 1983, 1989, 1996, 2000, 2006)  Adopted by World Medical Association General Assembly  Belmont Report  WHO-GCP Guidelines  ICH-GCP Guidelines  WHO Operational Guidelines for Ethics Committees that Review Biomedical Research  Surveying and evaluating ethical review practices  A complimentary guideline to the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research, 2002  Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Board  CIOMS Guidelines 2002  Nuffield Council Guidelines on Bioethics  The ethics of research related to health care in developing countries 6

7. Objective and scope of the SOPs  The SOPs is to contribute to the effective functioning of the NECHR in Cambodia to ensure quality and consistent ethical review for health and biomedical research  The scope applies to all procedures related to ethical review of research protocols that submitted to NECHR and its operation and management 7

8. The role of NECHR  NECHR will review and approve all types of research proposals involving human participants with a view to safeguard the dignity, rights, safety and well being of all actual or potential research participants  NECHR will ensure that all the cardinal principles of research ethics: respect for rights (autonomy), beneficence (non-malfeasance) and justice are taken care of in research protocols  For the time being, NECHR is the “only entrance” for all research proposals to be reviewed 8

9. NECHR membership  NECHR chairperson  Two deputy chairpersons  A secretary  15 members from different departments, specialties... 9

10. Type of meeting  There are two types of meeting 1. Regular meeting a. The meeting of the NECHR will be held once in 2 months and the date will be the last Friday afternoon of each designated month b. However, if needed, meetings can be held earlier as decided by the Chairperson 2. Adhoc meetings 3. Quorum requirements a. The minimum of 50% +1 members are required to compose a quorum (absolute majority) 10

11. The process of application submission  All proposals are to be submitted in the prescribed application form, the details of which are given under the Documentation Section  All relevant documents should enclose the application form  20 copies of the proposal along with the application in prescribed format to be submitted  Electronic file of submitted proposal and related documents are required  The date of meeting will be communicated to the researchers  The decision will be communicated in writing. If revision is to be made, the revised document in 20 copies to be submitted. 11

12. Type of review  With the approval from the Chairperson of NECHR, secretariat determines what type of review is required for each protocol received: 1. Expedited review Non-significant risk protocols Protocols that are non-confidential Not likely to harm Involve non-invasive or routine procedures Protocols that use previously collected data or specimens Minor revision of previously approved protocol 2. Full review 12

13. Follow up procedures  Principle investigators are responsible to: Submit regular progress reports Submit final report at the end of study Report any serious side effects, adverse drug reactions and the interventions undertaken to be intimated Report protocol deviation, if any, to be informed with adequate justifications Report any new information related to the study should be communicated Notify the NECHR about premature termination of study with reasons and summary of the studies done 13

14. Communicating the decision  All communication of NECHR’s decision to PIs and their research team done in writing  The secretariat prepares a letter to communicate the decision of the NECHR to the investigator 14

15. Next step  SOPs are being revised so that the online submission and review can be done ... 15

16. Thanks 16