Guideline on the Use of Human Biological Tissues for Research
Guideline on the Use of Human Biological Tissues for Research (0.06MB, PDF )
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 standardize 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 capitalizing on the vast research potential of human tissues made available through routine medical procedures and investigations.
This guideline aims to draw attention to important ethical issues that should be considered when:
- Conducting research on stored/archived human biological tissues which had been collected during routine investigation/treatment
- Collecting biological tissues from patients undergoing routine investigation and treatment which may be used for future research, and
- Conducting research involving planned prospective collection of human tissues including those for the purpose of bio-banking
This guideline is not intended to cover the use of such biological tissues for medical diagnostic purposes, disease surveillance or teaching.
It serves to advise the IRB / IEC on the general principles and approaches to address issues on using human biological tissues for research. While the IRB / IEC is expected to comply with this general guideline, there may be a need for adaptations to suit the individual institutions? environment and/or the requirements of a particular study.
The following ethical principles form the basis for the formulation of this guideline:
- beneficence (doing good)
- non-maleficence (preventing or mitigating harm)
- fidelity and trust within the investigator/participant relationship
- personal dignity of study participants or subjects
- autonomy pertaining to both informed, voluntary, competent decision making (informed consent) and
- privacy of personal information
Download the full guidelines here (0.06MB PDF )
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