Guidelines on the use of Human Biological Samples for Research
Human biological tissues or organs, removed in the course of medical procedures / treatment or excess samples left over after diagnostic investigations, are rich resources for immediate or future research.
Generally, patients undergoing surgery do not have their consent obtained nor are informed regarding the further use or handling of their biological materials. To protect the rights and fundamental freedom of these patients and in view of the increasing flow of biological materials across countries and borders, there is a need to standardise practices amongst the various Institutional Review Board / Independent Ethics Committee (IRB/IEC) and institutions in the country in the collection, storage and use of such materials for research.
Clear guidelines must be established particularly on the principle of requesting consent, be it at the time of collection of the materials or after, and the introduction of a layered consent. This is extremely important as more researchers and institutions are leveraging on the vast research potential of human tissues made available through routine medical procedures and investigations. These guidelines aim to draw attention to important ethical issues that should be considered when:
- Conducting research on stored/archived human biological samples which had been collected during routine investigation/treatment;
- Conducting research on biological samples prospectively collected from patients undergoing routine investigation or treatment.
- Conducting research involving planned prospective collection of human biological samples including those for the purpose of bio-banking.
These guidelines are not intended to cover the use of such biological tissues for medical diagnostic purposes, disease surveillance, teaching or stem cell research.
It serves to advise the IRB/IEC on the general principles and approaches to address issues on using human biological samples for research. While the IRB/IEC is expected to comply with these general guidelines, there may be a need for adaptations to suit the individual institutions’ environment and/or the requirements of a particular study.
