Under the revision, medical institutions are required to verbally explain key details and notify relevant details in writing before collecting human biological materials from patients. (image: Korea Bizwire)
SEOUL, Oct. 16 (Korea Bizwire) — New legislation has made it possible for samples from human biological materials taken for treatment and diagnostic purposes to be used in research.
The Ministry of Health and Welfare said a law enforcement ordinance was approved at a Cabinet meeting Tuesday that requires medical institutions to impose fines for violating their obligation to provide remaining test objects.
Under the revision, medical institutions are required to verbally explain key details and notify relevant details in writing before collecting human biological materials from patients.
Furthermore, the residual samples can now be provided to the human biological material bank if the patient agrees.
Medical institutions are required to set the purpose of providing the remaining samples and methods of anonymity and seek approval from a review board.
The revision also elaborated on the contents of written notice of blood collectors and how one can express rejection intent.
Human biological materials refer to serum, plasma, chromosomes, DNA, RNA and proteins that are separated or collected from the human body including tissues, cells, blood and body fluids.
Residual samples refer to remaining biological materials left by medical institutions after treatment and diagnosis, including leftover tissue, cells, blood and body fluids.
The human biological materials bank is an institution that collects and preserves human origin or genetic information, epidemiological information, and clinical information and uses them directly or provides them to others.
D. M. Park (dmpark@koreabizwire.com)
