Japanese Society of Laboratory Medicine


The use of residual samples for methodological study, teaching and research in the clinical laboratory

－Views of the Japanese Society of Laboratory Medicine (JSLM)－

The concept of informed consent in clinical research was first incorporated in the 1947 Nuremberg Code and was adopted as the Declaration of Helsinki by the World Medical Association in 1964. After being revised a total of five times, this Declaration was confirmed at the Association’s Edinburgh meeting in October 2000. The basis of the Declaration is that no actions detrimental to the life, health, privacy or dignity of an examinee shall be taken against his/her will.

In Japan, the practice of informed consent is well established for HIV testing. Furthermore, Ethical Guidelines1) concerning research on the human genome and genetic analysis have been implemented since April, 2001 and researchers working in these areas are obliged to adhere to the guidelines. In line with these trends, the Japanese Society of Laboratory Medicine established the Ethics Committee in December 2000 to discuss a variety of ethical problems related to clinical laboratory testing . The issue currently under discussion is the handling of residual samples after the requested examinations , and it has been decided to make public the Association’s views on this matter as early as possible.

The residual samples after the completion of the requested laboratory tests2) (hereafter referred to as 'residual samples) are stored for a certain period in case there is a need for retesting, and are then disposed of as medical wastes. However, these residual samples have traditionally been retained for use for in methodological study3), teaching4) and research, playing an important role in enhancing the reliability and usefulness of laboratory test results .

Additionally, much new knowledge has been gained from research on residual samples that originally yielded abnormal data, not only facilitating clarification of the patient's disease condition, but also contributing significantly to advances in clinical medicine. It should be noted that this has been made possible through the goodwill and understanding of examinees who also hope to see advances in medicine. In the long history of clinical laboratory testing, the use of residual samples in this way has almost certainly benefited the examinees who have supplied specimens, and it is hard to imagine that any　examinee has suffered as a result. However, in recent years, there have been increasing calls for better medical practice that is more clearly aligned with patients' interests, making it necessary to establish a clear guideline about the handling of residual samples.

The basic views of the Ethics Committee are set out below. However, concerning hereditary and genetic testings, in addition to the Ethical Guidelines1), a separate set of guidelines has been established 5), 6) covering tests to be performed at medical institutions and commercial independent laboratories. There are also guidelines covering the use of histopathology specimens in research and the teaching7) and the disposal of residual samples at commercial laboratories8), and these guidelines should also be followed.
1. The laboratory director and all persons responsible for laboratory testing and research should keep confidential any personal information and data relating to the examinee and do nothing that would be detrimental to the interests of the subject. Each facility will consider and determine the administrative structure necessary to fulfill this duty.

2. Where residual samples are to be used in laboratory methodological study, they will normally be pooled9) and/or anonymized10). In such cases, while it is not necessary to obtain consent from each and every one of the examinees, the laboratory director shall take responsibility for handling their specimens. Where residual samples are used in teaching, similar actions and control measures should be exercised as in laboratory methodological study.

3. In principle, when residual samples are to be used for research purposes, it is necessary to obtain the consent of the examinee in writing11). However, this does not apply to cases in which the research is directly associated with laboratory methodological　study to be conducted with the aim of improving testing methods or clarifying abnormal laboratory data provided that the samples are pooled and/or anonymized without linking. When specimens and/or samples are anonymized with linking, the researcher and laboratory director are obliged to maintain the confidentiality of the examinees , and the laboratory director is responsible for handling the specimens. In the case of research that is not directly related to laboratory methodological study, in principle, an ethics committee of the respective facility is recommended to rationalize the judgment of each researcher and laboratory director.

4. The laboratory director is responsible for the allocation12) and disposal of residual samples.

May 25, 2002
Japanese Society of Laboratory Medicine





1) Guidelines Relating to Analysis and Research on Human Genome and Genes
(Ministry of Education and Science; Ministry of Health, Labor and Welfare; Ministry of Economy, Trade and Industry, March 29, 2001)
URL:http://www.mext.go.jp/a_menu/shinkou/seimei/genomeshishin/index.htm (in Japanese only)

2) Clinical specimens: blood, urine, stool, cerebral spinal fluid, body fluids and secreted material, organs and tissue, cellular material and etc. Isolated microbes are not included.

3) Laboratory methodological study: precision control, determination of reference intervals, comparison of new reagents against existing reagents, improvement and evaluation of measurement procedures, etc.

4) Teaching: lectures, practical training in laboratory testing for students of hospital-affiliated teaching organizations and for employees of medical facilities. This includes qualifying examinations.

5) Guidelines Regarding Genetic Testing (draft)
(Japan Society for Genetic Counseling, The Japanese Society for Gene Diagnosis and Therapy, Japan Society of Obstetrics and Gynecology, Japan Society of Pediatric Genetics, Japan Society of Human Genetics, Japanese Teratology Society, Japanese Society for Inherited Metabolic Diseases,
Japan Society for Familial Tumors) (March 27, 2001)
URL:http://www.congre.co.jp/gene/contents/f_kanren.htm (Japanese only)

6) Ethical Guidelines for Outside Laboratories Conducting Human Genetic Tests (Japan Registered Clinical Laboratories Association) (April 10, 2001)
URL:http://www.jrcla.or.jp/210410.pdf (Japanese only)

7) Views Regarding Use of Pathology Specimens in Academic Research and Medical Teaching (The Japanese Society of Pathology) Autumn General Meeting 2001 (November 27, 2001)

8) Unified View on Disposal of Used Laboratory Specimens
(Japan Registered Clinical Laboratories Association) Nichieikyo Dayori No. 102 (5) (March 20, 2000)

9) Pooling: collection and blending of multiple samples ? the resultant mixture is used as a single sample

10) Anonymization: total or partial removal of information that would enable identification of an individual and the replacement of such information with a code or number that has no relationship with the person
a. Anonymization with linking:
Maintenance of a cross-reference table to enable the individual’s identity to be discerned from the code or number in case there is a need for identification
b. Anonymization without linking: Creation of no cross-reference table (as described in a.) that would enable the individual’s identity to be discerned
(Extracted from Guidelines Relating to Analysis and Research on Human Genome and Genes1))

11) Obtaining consent: Methods include obtaining across-the-board consent when the patient is first seen as an outpatient or is hospitalized, or obtaining consent for each individual procedure through the attending physician.

12) Allocation of samples: Provision of a portion of specimens to researchers in other facilities for teaching, research or national survey purposes.
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