{"id":500,"date":"2023-08-17T05:23:11","date_gmt":"2023-08-17T05:23:11","guid":{"rendered":"https:\/\/research.iium.edu.my\/irec\/?page_id=500"},"modified":"2026-04-14T02:01:15","modified_gmt":"2026-04-14T02:01:15","slug":"template-guideline","status":"publish","type":"page","link":"https:\/\/research.iium.edu.my\/irec\/?page_id=500","title":{"rendered":"Template & Guideline"},"content":{"rendered":"
\n \n
\n \n \n
\n \n <\/polygon>\n <\/polygon>\n <\/polygon>\n <\/svg>\n <\/div>\n
\n \n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n \n \n

GUIDELINES & TEMPLATES<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n \n \n

Guidelines<\/h2>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \"\"\n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Malaysian Guideline for Good Clinical Practice, Fourth (5th) Edition<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Malaysian Guideline for Safety Reporting of Investigational Product, First (1st) Edition<\/p>\n <\/div>\n <\/div>\n

\n \n
download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

International Ethical Guidelines for Health-related Research Involving Human, 2016<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

75th WMA General Assembly, Helsinki, Finland, October 2024<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Malaysia Decentralised Clinical Trial (DCT) Guidance Document<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Guideline for Herbal Medicine Research, First (1st) Edition<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First (1st) Edition<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

IREC User’s\/Investigator’s Guidelines<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

IREC Standard Operation Procedure Version 2, Revision 5<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

National Institutes Of Health (NIH) Guidelines For Conducting Research In Ministry Of Health (MOH) Institutions & Facilities 3rd Edition<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Guidelines on Stem Cell and Cell-Based Research and Therapy 3rd Edition<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n
\n
\n \n \n \n
<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Malaysian Guidelines On The Use Of Human Biological Samples For Research (2nd Edition)<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n \n
\n \n \n \n
<\/div>\n <\/div>\n <\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n
\n \n \n
\n

Garis Panduan Etika Bioteknologi Di Malaysia<\/p>\n <\/div>\n <\/div>\n

\n \n
Download<\/span><\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n <\/div>\n <\/div>\n <\/div>\n
\n
\n \n \n
\n \n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n \n
\n \n <\/polygon>\n <\/polygon>\n <\/polygon>\n <\/polygon>\n <\/polygon>\n <\/polygon>\n <\/svg>\n <\/div>\n
\n \n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n \n \n

Templates<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n
\n \n \n

Templates for Informed Consent Form<\/h3>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
\n \n
\n \n
\n
\n \n \n
\n \n
\n \n \n
\n

Templates for informed consent forms<\/strong><\/p>\n

Notes to researchers<\/em><\/p>\n

The language used throughout form should be at the level of a local student of class 6th\/8th<\/em><\/p>\n

Please note that these are templates developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline\n and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.<\/strong><\/p>\n

The informed consent form consists of two parts: the information sheet and the consent certificate.<\/p>\n

Do not be concerned by the length of these templates. They are long only because they contain guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to\n participants in your research.<\/p>\n

These templates include examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples,\n and suggestions, and the investigators will have to modify the questions depending upon their study.<\/p>\n

In these templates:<\/p>\n