Guidance and guidelines
- Consent and Participant Information Guidance by the UK Health Research Authority (HRA) and Medical Research Council (MRC) – provides guidance on the style and content of PIS, as well as templates and examples.
- World Medical Association (WMA) Declaration of Taipei on ethical considerations regarding health databases and biobanks (2017) – provides a list of information that should be included in the PIS if researchers intend to collect and store any data / biological samples from subjects for multiple uses. (No.12).
- Malaysian Guideline on the use of Human Biological Samples for Research (2015) – provides a list of information that should be included in the PIS for research that involves collection and/or use of human biological samples. (section 3.3.2 and 5).
- Malaysia Guidelines for Stem Cell Research and Therapy (2009) – provides a list of information that should be included in the PIS when acquiring human gametes or blastocysts for human embryonic stem cell research. (pg. 32-34)
- Malaysian Guideline for Health Research involving Minors (2001) – provides a set of criteria for obtaining assent from children, including a list of information that should be included in the assent form.
- Malaysia Mental Health Act 2001 (Section 77) (click to download) – stipulates how consent for clinical trials should be obtained from someone with a mental disorder.
Video
- Clinical trial informed consent video produced by Warwick Medical School – provides examples of situations or questions that recruiters may encounter when obtaining consent.