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Regulations and guidelines on handling human materials obtained from medico-legal autopsy for use in research
Legal Medicine 5 (2003) S76–S78 www.elsevier.com/locate/legalmed
Regulations and guidelines on handling human materials obtained from medico-legal autopsy for use in research Mitsuyasu Kurosu a,*, Toshiji Mukai b, Youkichi Ohno a a
Department of Legal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyouku, Tokyo 113-8602, Japan b Department of Legal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Abstract Human materials obtained from medico-legal autopsy have been used for research without consent from surviving relatives in majority of the cases in Japan. In recent years, however, informed consent has become a key principle in medical practice, and protection of privacy has been emphasized. We investigated the regulations and guidelines in Japan regarding handling of human materials obtained from medico-legal autopsy for use in research. The Autopsy Law, enforced in 1949, does not provide access of human materials for research, although preservation of such materials as specimens for medical education or research is legally approved. The Ethics Guidelines for Human Genome/Genetic Analysis Research, enforced in 2001, provide specific requirements: (1) the deceased had no intention of refusing organ donation during life; (2) consent of surviving relatives; (3) approval from the ethics review committee; and (4) Permission from the director of the institution. The guidelines officially announced in 2002 by the Ethics Committee of the Japanese Society of Legal Medicine provide that one of the fundamental ethical rules is to obtain consent from surviving relatives. However, if that is difficult, approval from the institutional or academic society’s ethics committee is required. In conclusion, no domestic law exists for handling of human materials obtained from autopsy for use in research. New legislation on this issue should be enacted to protect human rights and dignity as well as to promote medical research as soon as possible. q 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Law; Guidelines; Human material; Research; Autopsy; Informed consent
1. Introduction Human materials obtained from medico-legal autopsy [1,2], pathological autopsy or surgery [3] have been used for research without informed consent from surviving relatives or patients in majority of the cases for research using human materials in Japan. In recent years, however, informed consent has gained greater recognition as one of the key principles in medical practice, and protection of personal information has been emphasized with the development of * Corresponding author. Tel.: 181-3-3822-2131; fax: 181-35814-5680. E-mail address: [email protected] (M. Kurosu).
genetic diagnostic techniques [4]. We therefore investigated the existing regulations and guidelines of various academic societies in Japan with regard to the handling of human materials obtained from medico-legal autopsy for use in research. 2. Regulations and guidelines of the Japanese Government The Autopsy Law was enforced in 1949 to regulate autopsies other than judicial autopsy. This law does not provide for the use of human materials for research, although it approves their preservation as specimens for medical education or research. Speci-
1344-6223/03/$ - see front matter q 2003 Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S134 4- 6223(02)0009 7-4
M. Kurosu et al. / Legal Medicine 5 (2003) S76–S78
mens are not defined in this law. For more than 50 years this law was enacted. We, therefore, think that specimens mean samples for the purposes of education and research of morphology, and consent from surviving relatives should be required for the use of human materials in research outside of the purposes of each autopsy. The Law Concerning Transplants of the Cornea and the Kidney, enforced in 1980, provided that any part of an organ that had not been used in an organ transplant must be disposed of by incineration. Organs removed for transplantation were therefore not used for research. This law was repealed in 1997 and a new law, The Law concerning Human Organ Transplants, was enforced in 1997, which provides that any part of an organ that has not been used in an organ transplant must be disposed of by incineration. That organ therefore cannot be used for research. The Law concerning Donation of Deceased Human Bodies for Medical or Dental Education, enforced in 1983, provides that donated human bodies must be used in dissection for anatomical education, not for research purposes. The department of anatomy of some universities has obtained donor consent for the use of organs for research after death through donor registration of their body [5]. The Guideline Regarding Pathological Autopsy, enacted in 1988, provides that: (1) a pathologist must perform the pathological autopsy, after obtaining consents from surviving relatives for pathological autopsy and for obtaining human materials from the deceased; and (2) consent from surviving relatives is necessary when human materials that have been removed from the deceased and preserved are used as human materials for investigating anything other than cause of death, cause of disease or pathological state of disease. The Ethics Guidelines for Human Genome/Genetic Analysis Research, enforced in 2001, provide the requirements for donation of human materials that are removed from the deceased: (1) the deceased had no intention of refusing organ donation during life; (2) consent from surviving relatives; (3) approval from the ethics review committee; and (4) permission from the director of the institution. These guidelines recommend that at least half the members of the ethics review committee should be outside members. The Ethics Guidelines for Research of Epidemiol-
S77
ogy, enacted in 2002, provide requirements for epidemiological research using organs removed from the deceased: (1) the deceased had no intention of refusing organ donation during life; (2) consent from surviving relatives; (3) approval from the ethics review committee; and (4) permission from the director of the institution. 3. Guidelines and rules of scientific societies 3.1. Japan Society of Obstetrics and Gynecology The Opinions Concerned with the Use of Organs from a Dead Fetus or Newborn for Research, officially announced in 1987, require that: (1) the Autopsy Law is adhered to; (2) the organs utilized are indispensable for the research; and (3) approval for research must be obtained from parents following comprehensive explanation of the research protocol. 3.2. The Japanese Society of Pathology The Opinions Concerned with the Use of Pathological Specimens for Science Research and Education, officially announced in 2000, urge that consent in writing should be obtained from surviving relatives for use of pathological specimens for education or research. Nippon Medical School decided on a regulation in 2002 that consent from surviving relatives must be obtained for use in research of human materials obtained from the pathological autopsy. 3.3. The Ethics Committee of the Japanese Society of Legal Medicine The Ethical Principles and Considerations for Forensic and Related Research Using Human Organs and Fluids Obtained from Autopsy, officially announced in 2002, states five fundamental ethical principles. (1) Judicial autopsy and administrative autopsy do not legally require to obtain consent for autopsy from surviving relatives; however, obtaining this permission by some methods or other is preferable. Furthermore, surviving relatives should understand that organs and body fluids are obtained, preserved and tested, when autopsy is performed. (2) Anonymity of human materials must be maintained. (3) Consent from surviving relatives should
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be obtained before using preserved human materials for research, and a research protocol using preserved human materials should be approved by the ethics committee. (4) In cases where obtaining consent is difficult, the reason for the difficulty must be accepted and the research protocol must be approved by the institutional or academic society’s ethics committee. (5) Privacy of the deceased and their family must be protected during publication of research in scientific meetings or papers. 4. Recent trials 4.1. The Tokyo Medical Examiner’s Office, Tokyo Metropolitan Government The Office decided the Outlines on Handling of Organs and the Like in 1999. The medical examiner is able to obtain, preserve and use human materials from the deceased for research to investigate the cause of death or pathological state of disease leading to a determination of cause of death. But to use of human materials for research except for these specified purposes, the medical examiner must (1) obtain consent from surviving relatives; (2) submit a research protocol to the director of the Office; and (3) report the results of the research to the director. However, if the whereabouts of surviving relatives are unknown, the director of the Office must decide under advisement from the ethics committee within the Office. We believe that the ethics committee should review all research protocols including those where consent from surviving relatives for use of human materials have been obtained. 4.2. The Department of Legal Medicine, St. Marianna University School of Medicine The Department has been trying to obtain consent from surviving relatives for the use of human materials that have been removed during medico-legal autopsy for research, after the ethics review committee has approved the research protocol. This department has encountered 24 cases of medico-legal autopsies, and requested the use of human materials
in 15 cases. The exceptions included two murder cases, one case of medical malpractice and six cases where the contact addresses of surviving relatives were not updated. In total, four cases refused permission, but 11 cases agreed to the requests. These results revealed that the majority of the surviving relatives donate human materials for research if they are informed of the objectives, significance, and protocol of the research in depth and with sincerity.
5. Conclusion Experts are accountable to laypersons and the society for what they will do or have done. Donor consent, therefore, should be obtained from surviving relatives for the use of human materials removed from the deceased in research. Surviving relatives are not experts of medicine or science but laypersons. They, however, must decide whether to give their informed consent for organ donation of the deceased or not. Ethics committees, therefore, have an important role in regulating medical research. The committees must review medical research from the viewpoint of safety, utility and protections of personal information and human rights. No domestic laws exist for handling human materials obtained from autopsies for use in research. New legislation, therefore, should be proposed and enacted as soon as possible, to protect human rights and dignity as well as to promote medical research [6].
References [1] [2] [3] [4]
The Mainichi Newspaper (in Japanese). June 6; 1999. The Yomiuri Shimbun (in Japanese). August 24; 2000. The Asahi Shimbun (in Japanese). May 19; 1999. Bioethics Committee of the Council for Science and Technology. Fundamental principles of research on the human genome, decided by the Bioethics Committee of the Council for Science and Technology. 2000. [5] Murakami G. Study of clinical autopsy and cadaver for anatomical autopsy. Jpn Med J 2000;4001:24–29. [6] Tuboi E, Kawahara N, Mitsuishi T, Oshima A, Yonemoto S. Data security is crucial for Japanese science. Nature 2002;417:689.
Regulations and guidelines on handling human materials obtained from medico-legal autopsy for use in research Mitsuyasu Kurosu a,*, Toshiji Mukai b, Youkichi Ohno a a
Department of Legal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyouku, Tokyo 113-8602, Japan b Department of Legal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Abstract Human materials obtained from medico-legal autopsy have been used for research without consent from surviving relatives in majority of the cases in Japan. In recent years, however, informed consent has become a key principle in medical practice, and protection of privacy has been emphasized. We investigated the regulations and guidelines in Japan regarding handling of human materials obtained from medico-legal autopsy for use in research. The Autopsy Law, enforced in 1949, does not provide access of human materials for research, although preservation of such materials as specimens for medical education or research is legally approved. The Ethics Guidelines for Human Genome/Genetic Analysis Research, enforced in 2001, provide specific requirements: (1) the deceased had no intention of refusing organ donation during life; (2) consent of surviving relatives; (3) approval from the ethics review committee; and (4) Permission from the director of the institution. The guidelines officially announced in 2002 by the Ethics Committee of the Japanese Society of Legal Medicine provide that one of the fundamental ethical rules is to obtain consent from surviving relatives. However, if that is difficult, approval from the institutional or academic society’s ethics committee is required. In conclusion, no domestic law exists for handling of human materials obtained from autopsy for use in research. New legislation on this issue should be enacted to protect human rights and dignity as well as to promote medical research as soon as possible. q 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Law; Guidelines; Human material; Research; Autopsy; Informed consent
1. Introduction Human materials obtained from medico-legal autopsy [1,2], pathological autopsy or surgery [3] have been used for research without informed consent from surviving relatives or patients in majority of the cases for research using human materials in Japan. In recent years, however, informed consent has gained greater recognition as one of the key principles in medical practice, and protection of personal information has been emphasized with the development of * Corresponding author. Tel.: 181-3-3822-2131; fax: 181-35814-5680. E-mail address: [email protected] (M. Kurosu).
genetic diagnostic techniques [4]. We therefore investigated the existing regulations and guidelines of various academic societies in Japan with regard to the handling of human materials obtained from medico-legal autopsy for use in research. 2. Regulations and guidelines of the Japanese Government The Autopsy Law was enforced in 1949 to regulate autopsies other than judicial autopsy. This law does not provide for the use of human materials for research, although it approves their preservation as specimens for medical education or research. Speci-
1344-6223/03/$ - see front matter q 2003 Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S134 4- 6223(02)0009 7-4
M. Kurosu et al. / Legal Medicine 5 (2003) S76–S78
mens are not defined in this law. For more than 50 years this law was enacted. We, therefore, think that specimens mean samples for the purposes of education and research of morphology, and consent from surviving relatives should be required for the use of human materials in research outside of the purposes of each autopsy. The Law Concerning Transplants of the Cornea and the Kidney, enforced in 1980, provided that any part of an organ that had not been used in an organ transplant must be disposed of by incineration. Organs removed for transplantation were therefore not used for research. This law was repealed in 1997 and a new law, The Law concerning Human Organ Transplants, was enforced in 1997, which provides that any part of an organ that has not been used in an organ transplant must be disposed of by incineration. That organ therefore cannot be used for research. The Law concerning Donation of Deceased Human Bodies for Medical or Dental Education, enforced in 1983, provides that donated human bodies must be used in dissection for anatomical education, not for research purposes. The department of anatomy of some universities has obtained donor consent for the use of organs for research after death through donor registration of their body [5]. The Guideline Regarding Pathological Autopsy, enacted in 1988, provides that: (1) a pathologist must perform the pathological autopsy, after obtaining consents from surviving relatives for pathological autopsy and for obtaining human materials from the deceased; and (2) consent from surviving relatives is necessary when human materials that have been removed from the deceased and preserved are used as human materials for investigating anything other than cause of death, cause of disease or pathological state of disease. The Ethics Guidelines for Human Genome/Genetic Analysis Research, enforced in 2001, provide the requirements for donation of human materials that are removed from the deceased: (1) the deceased had no intention of refusing organ donation during life; (2) consent from surviving relatives; (3) approval from the ethics review committee; and (4) permission from the director of the institution. These guidelines recommend that at least half the members of the ethics review committee should be outside members. The Ethics Guidelines for Research of Epidemiol-
S77
ogy, enacted in 2002, provide requirements for epidemiological research using organs removed from the deceased: (1) the deceased had no intention of refusing organ donation during life; (2) consent from surviving relatives; (3) approval from the ethics review committee; and (4) permission from the director of the institution. 3. Guidelines and rules of scientific societies 3.1. Japan Society of Obstetrics and Gynecology The Opinions Concerned with the Use of Organs from a Dead Fetus or Newborn for Research, officially announced in 1987, require that: (1) the Autopsy Law is adhered to; (2) the organs utilized are indispensable for the research; and (3) approval for research must be obtained from parents following comprehensive explanation of the research protocol. 3.2. The Japanese Society of Pathology The Opinions Concerned with the Use of Pathological Specimens for Science Research and Education, officially announced in 2000, urge that consent in writing should be obtained from surviving relatives for use of pathological specimens for education or research. Nippon Medical School decided on a regulation in 2002 that consent from surviving relatives must be obtained for use in research of human materials obtained from the pathological autopsy. 3.3. The Ethics Committee of the Japanese Society of Legal Medicine The Ethical Principles and Considerations for Forensic and Related Research Using Human Organs and Fluids Obtained from Autopsy, officially announced in 2002, states five fundamental ethical principles. (1) Judicial autopsy and administrative autopsy do not legally require to obtain consent for autopsy from surviving relatives; however, obtaining this permission by some methods or other is preferable. Furthermore, surviving relatives should understand that organs and body fluids are obtained, preserved and tested, when autopsy is performed. (2) Anonymity of human materials must be maintained. (3) Consent from surviving relatives should
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be obtained before using preserved human materials for research, and a research protocol using preserved human materials should be approved by the ethics committee. (4) In cases where obtaining consent is difficult, the reason for the difficulty must be accepted and the research protocol must be approved by the institutional or academic society’s ethics committee. (5) Privacy of the deceased and their family must be protected during publication of research in scientific meetings or papers. 4. Recent trials 4.1. The Tokyo Medical Examiner’s Office, Tokyo Metropolitan Government The Office decided the Outlines on Handling of Organs and the Like in 1999. The medical examiner is able to obtain, preserve and use human materials from the deceased for research to investigate the cause of death or pathological state of disease leading to a determination of cause of death. But to use of human materials for research except for these specified purposes, the medical examiner must (1) obtain consent from surviving relatives; (2) submit a research protocol to the director of the Office; and (3) report the results of the research to the director. However, if the whereabouts of surviving relatives are unknown, the director of the Office must decide under advisement from the ethics committee within the Office. We believe that the ethics committee should review all research protocols including those where consent from surviving relatives for use of human materials have been obtained. 4.2. The Department of Legal Medicine, St. Marianna University School of Medicine The Department has been trying to obtain consent from surviving relatives for the use of human materials that have been removed during medico-legal autopsy for research, after the ethics review committee has approved the research protocol. This department has encountered 24 cases of medico-legal autopsies, and requested the use of human materials
in 15 cases. The exceptions included two murder cases, one case of medical malpractice and six cases where the contact addresses of surviving relatives were not updated. In total, four cases refused permission, but 11 cases agreed to the requests. These results revealed that the majority of the surviving relatives donate human materials for research if they are informed of the objectives, significance, and protocol of the research in depth and with sincerity.
5. Conclusion Experts are accountable to laypersons and the society for what they will do or have done. Donor consent, therefore, should be obtained from surviving relatives for the use of human materials removed from the deceased in research. Surviving relatives are not experts of medicine or science but laypersons. They, however, must decide whether to give their informed consent for organ donation of the deceased or not. Ethics committees, therefore, have an important role in regulating medical research. The committees must review medical research from the viewpoint of safety, utility and protections of personal information and human rights. No domestic laws exist for handling human materials obtained from autopsies for use in research. New legislation, therefore, should be proposed and enacted as soon as possible, to protect human rights and dignity as well as to promote medical research [6].
References [1] [2] [3] [4]
The Mainichi Newspaper (in Japanese). June 6; 1999. The Yomiuri Shimbun (in Japanese). August 24; 2000. The Asahi Shimbun (in Japanese). May 19; 1999. Bioethics Committee of the Council for Science and Technology. Fundamental principles of research on the human genome, decided by the Bioethics Committee of the Council for Science and Technology. 2000. [5] Murakami G. Study of clinical autopsy and cadaver for anatomical autopsy. Jpn Med J 2000;4001:24–29. [6] Tuboi E, Kawahara N, Mitsuishi T, Oshima A, Yonemoto S. Data security is crucial for Japanese science. Nature 2002;417:689.