Global Glossary of Terms and Definitions on Donation and Transplantation

WHO/HTP/EHT/CPR/2009.01

Geneva, November 2009

1 2 Global Glossary of terms and definitions on donation and transplantation

The lack of a globally recognized terminology and definitions as well as the need for a uniform collection of data and information for the Global Database on Donation and Transplantation (1), triggered off the unification of terms and basic definitions on cell, tissue and organ donation and transplantation in order to create a Global Glossary. The aim of this Glossary is to clarify communication in the area of donation and transplantation, whether for the lay public or for technical, clinical, legal or ethical purposes. In 2007 WHO, together with The Transplantation Society (TTS), and the Organizacion Nacional de Trasplantes (ONT) in Spain, initiated a harmonization process and held the "Data Harmonization on Transplantation Activities and Outcomes: Editorial Group for a Global Glossary Meeting", gathering together experts from the six WHO Regions, professionals and representatives of government authorities. Existing official definitions were selected whenever deemed appropriate. Furthermore, the Editorial Group either adapted existing definitions or produced new definitions. A draft resulting from this process was posted on the WHO Website for several months for comments. The present document "Global Glossary on Donation and Transplantation" is the outcome of this process. It is anticipated that the Glossary will be completed and adapted with the progress of global consensus. Users are invited to refer to the WHO/transplantation website and to indicate the date of consultation if they quote the Glossary. Suggestions and comments are welcome and should be sent to [email protected].

(1)The Global Observatory on Donation and Transplantation is a collaborative effort of the World Health Organization and the Organizacion Nacional de Trasplantes (ONT) of Spain.

The World Health Organization is grateful to the Spanish Government and The Transplantation Society for their support.

3 4 CONTENTS

1. Actual Organ Donor26 ...... 8 2. Allocation ...... 8 3. Allogeneic ...... 8 4. Amniotic membrane...... 8 5. Bank72 ...... 8 6. Bone Marrow...... 8 7. Brain Death...... 8 8. Cardiac Death...... 8 9. Cells...... 8 10. Cell Manipulation ...... 8 11. Certification of Death 7,8 ...... 8 12. Compatibility testing...... 8 13. Confidentiality ...... 9 14. Consent to donation...... 9 15. Cord blood ...... 9 16. Cord blood Bank15,72 ...... 9 17. Cornea...... 9 18. Culture Expansion ...... 9 19. Death Diagnosis 7,8 ...... 9 20. Deceased Donor 7,8...... 9 21. Distribution...... 9 22. Domino Donor...... 9 23. Domino Transplant ...... 9 24. Donation ...... 9 25. Donation processing registries ...... 10 26. Donor...... 10 27. Donor evaluation...... 10 28. Donor maintenance ...... 10 29. Donor safety ...... 10 30. Encephalic Death 7 ...... 10 31. Ethics Committee...... 10 32. Explicit consent...... 10 33. Exported / Export...... 10 34. Follow up...... 10 35. Follow up Registry ...... 10 36. General National Transplantation Manager...... 10

5 37. Grafted77 ...... 11 38. Haematopoietic Progenitor Cells (HPC) ...... 11 39. Heart Beating Donor 7,20 ...... 11 40. Heart Valve...... 11 41. Human cells and tissues for transplantation (HCTT): ...... 11 42. Imported / Import ...... 11 43. Incompetent person...... 11 44. Informed Consent...... 11 45. Irreversible cessation of brain / brain function7 ...... 11 46. Irreversible cessation of cardio respiratory function 8 ...... 11 47. Living Donor...... 12 48. Musculoskeletal ...... 12 49. Non-Heart Beating Donor8,20...... 12 50. Not for profit = Non - profit ...... 12 51. Organ...... 12 52. Potential Deceased Donor 20 ...... 12 53. Potential deceased donor identification20 ...... 12 54. Pre-stated acceptance / Permission / Authorisation ...... 12 55. Pre-stated refusal (of permission for removal of Human Cells, Tissues and Organs)...... 12 56. Presumed consent...... 12 57. Processing...... 12 58. Procurement ...... 13 59. Recipient...... 13 60. Regulatory oversight...... 13 61. Retrieval or recovery...... 13 62. Serious Adverse Event ...... 13 63. Serious Adverse Reaction ...... 13 64. Skin...... 13 65. Split-liver...... 13 66. Storage ...... 13 67. Surveillance ...... 13 68. Surveillance System (for Human Cells, Tissues and Organs for transplantation) 67,62...... 13 69. Technical Committees / Advisory Boards ...... 13 70. Time on Waiting List81...... 14 71. Tissue ...... 14 72. Tissue Establishment...... 14 73. Traceability ...... 14 74. Trafficking (Cells, tissues or organs) ...... 14 75. Transplant Commercialism ...... 14

6 76. Transplant Tourism...... 14 77. Transplantation...... 14 78. Travel for transplantation...... 14 79. Urgency ...... 14 80. Vascular Tissues ...... 14 81. Waiting List (WL ) ...... 15 82. Waiting List Management 81...... 15

Annex: Data Harmonization on Transplantation Activities and Outcomes: Editorial Group for a Global Glossary - meeting report...... 16

1 In all definitions in the Glossary the use of "cells, tissues and /or organs" has been standardized, whenever was applicable.

7 Glossary of Terms and Definitions

1. Actual Organ Donor Deceased or living person from whom at least one solid organ or part of it has been recovered for the purpose of transplantation. Editorial Group

2. Allocation Allocation is the assignment of human cells, tissues and organs to a transplant candidate, based on a set of rules. Editorial Group

3. Allogeneic Cells, tissues and organs donated by one person for transplantation to another person. Modified from First Global Consultation on Regulatory Requirements for Human Cells and Tissues

4. Amniotic membrane A thin membrane surrounding the fetus during pregnancy. Editorial Group

5. Bank See Tissue Establishment

6. Bone Marrow Tissue at the center of large bones. It is the place where new blood cells are produced. Bone marrow contains two types of stem cells: haematopoietic (which can produce blood cells) and stromal (which can produce fat, cartilage and bone). EUROCET

7. Brain Death Irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in the brain, blood flow to the brain, and brain function as determined by clinical assessment of responses. A brain dead person is dead, although his or her cardiopulmonary functioning may be artificially maintained for some time. Glossary of UNOS

8. Cardiac Death Death resulting from the irreversible cessation of circulatory and respiratory function; an individual who is declared dead by circulatory and respiratory criteria may donate tissues and organs for transplantation. Editorial Group

9. Cells The smallest transplantable and functional unit of living organisms. Editorial Group

10. Cell Manipulation Preparation of retrieved cells to make them suitable for transplantation. Editorial Group

11. Certification of Death Formal standardized documentation of death. Refer to both cardiac death and brain death. Editorial Group

12. Compatibility testing Testing for the presence or absence of recipient antibodies to HLA antigens and to blood group antigens present on the transplant cells, tissues or organs. Editorial Group 8 13. Confidentiality Regards the treatment of information an individual has disclosed in a relationship of trust. This relationship implies the expectation that the disclosed information will not be divulged without prior permission. Recognized exceptions in the medical context may be justified by a country's laws. Editorial Group

14. Consent to donation Legally valid permission for removal of human cells, tissues and organs for transplantation. Editorial Group

15. Cord blood Haematopoietic progenitor cells collected from placental vessels and umbilical cord blood vessels after the umbilical cord is clamped and/or severed. Extracted from JACIE standars

16. Cord blood Bank Is a facility or organization regulated by authorities, where haematopoietic progenitor cells collected from the placental and umbilical cord blood vessels are processed, cryopreserved, and / or stored. It may also be responsible for procurement, testing or distribution. Modified from JACIE standards

17. Cornea The dome-shaped window structure covering the front of the eye. Modified from EUROCET

18. Culture Expansion In vitro, proliferation of retrieved cells for the purpose of transplantation. Editorial Group

19. Death Diagnosis Confirmation of death from evidence acquired through clinical investigation / examination, meeting criteria of brain or cardiac death. Editorial Group

20. Deceased Donor A human being declared, by established medical criteria, to be dead and from whom cells, tissues or organs were recovered for the purpose of transplantation. The possible medical criteria are: - Deceased Heart Beating Donor (Donor after Brain Death): Is a donor who was declared dead and diagnosed by means of neurological criteria. - Deceased Non-Heart Beating Donor (Donor after Cardiac Death) = Non-heart beating donor (NHBD): Is a donor who was declared dead and diagnosed by means of cardio-pulmonary criteria. Editorial Group

21. Distribution Transportation and delivery of cells, tissues or organs intended for human applications, after they have been allocated. Modified from EU Directive 2004

22. Domino Donor A person who by receiving an organ transplant donates the removed organ to another recipient. Editorial Group

23. Domino Transplant A procedure in which an organ is removed from one transplant candidate and immediately transplanted into a second patient, with the first patient receiving a new organ from a deceased donor. Glossary of UNOS

24. Donation Donating human cells, tissues or organs intended for human applications. Modified from EU Directive 2004

9 25. Donation processing registries A repository of data collected of aspects concerning to the donation process and activities. Editorial Group

26. Donor A human being, living or deceased, who is a source of cells, tissues or organs for the purpose of transplantation. Modified from FDA. Human Tissue Intended For Transplantation.

27. Donor evaluation The procedure of determining the suitability of a potential donor, living or deceased, to donate. Editorial Group

28. Donor maintenance The process and critical pathways used to medically care for donors in order to keep their organs viable until organ recovery can occur. Adapted from UNOS

29. Donor safety A minimization of living donor complications or adverse reactions related to donation Editorial Group

30. Encephalic Death Refer to Brain Death definition

31. Ethics Committee Committee charged with considering ethical issues related to the process of organ procurement, distribution, transplantation, pre and post donation and transplantation care and research for cells, tissues and organs. Such a committee should be at a national level, but can also be at a regional or local level. Editorial Group

32. Explicit consent Legally valid permission for removal of human cells, tissues and organs for transplantation, Otherwise known as “opting in”. Editorial Group

33. Exported / Export Human bodies, body parts, cells, tissues or organs for human application, legally procured inside of the national boundary and transported to another country where it is to be further processed or used. Export must be according local (exporting country) laws, international laws and conventions and receiving country laws. Editorial Group

34. Follow up Subsequent examinations of a patient, living donor or recipient, for the purpose of monitoring the results of the donation or transplantation, care maintenance and initiating post-donation or post-transplantation interventions. Editorial Group

35. Follow up Registry A repository of data collected on cell, tissue and organ donors and /or transplant recipients for the purpose of outcome assessment, quality assurance, health care organization, research and surveillance. Editorial Group

36. General National Transplantation Manager The person responsible for the policy development, management and harmonization of the process of donation & transplantation at a national level of cells, tissues and/or organs. Such responsibilities could also include promotion, public education, waiting list management, quality control and standards of care and follow-up registries. Editorial Group

10 37. Grafted Refer to Transplantation definition

38. Haematopoietic Progenitor Cells (HPC) Include primitive pluripotent haematopoietic cells capable of self-renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage-restricted progenitor cells, unless otherwise specified, regardless of tissue source. Extracted from JACIE standards

39. Heart Beating Donor Refers to Brain Death definition

40. Heart Valve Valves between the chambers of the heart and between the heart and blood vessels around the heart which maintain the unidirectional flow of blood (Aortic Valve, Pulmonary Valve, Mitral Valve and Tricuspid Valve). EUROCET

41. Human cells and tissues for transplantation (HCTT): Means articles containing or consisting of human cells and/or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples of HCTTs include, but are not limited to musculoskeletal tissue (bone, cartilage, meniscus), skin, soft tissue (tendons, ligaments, nerves, dura mater, fascia lata and amniotic membrane), cardiovascular tissue (heart valves, arteries and veins), ocular tissue (corneas and sclera), bone marrow and haematopoietic stem/progenitor cells derived from peripheral and cord blood and stem cells of any tissue, and reproductive cells/tissues. The following articles are not considered HCTTs: (1)Vascularised human organs for transplantation; (2)Whole blood or blood components or blood derivative products; (3) Secreted or extracted human products, specifically, milk, collagen, and cell factors; (4) Cells, tissues, and organs derived from animals other than humans. Adapted and Modified from FDA. Cells, Tissues and Cellular and Tissue-Based Products.

42. Imported / Import Human bodies, body parts, cells, tissues and organs for human application, legally procured outside of the national boundary to which it has been transported for use. Importation must be according local (receiving country) laws, international laws and conventions and supplying country laws. Editorial Group

43. Incompetent person An individual who is unable to make legally valid decisions or is deprived of his/her capacity to decide and/ or to understand the implications of his/her actions (e.g a minor or an individual legally declared unable to manage their own affairs). Editorial Group

44. Informed Consent A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. Glossary of UNOS

45. Irreversible cessation of brain / brain function Refer to Brain Death definition

46. Irreversible cessation of cardio respiratory function Refer to Cardiac Death definition

11 47. Living Donor A living human being from whom cells, tissues or organs have been removed for the purpose of transplantation. A Living Donor has one of the following three possible relationships with the recipient: A/ Related: A1/ Genetically Related: 1st Degree Genetic Relative: Parent, Sibling, Offspring 2nd Degree genetic relative, e.g. grandparent, grandchild, aunt, uncle, niece, nephew, Other than 1st or 2nd degree genetically related, for example cousin A2/ Emotionally Related: Spouse (if not genetically related); in-laws; Adopted; Friend B/ Unrelated = Non Related: Not Genetically or Emotionally Related Editorial Group

48. Musculoskeletal Tissues which are part of the skeletal and/or muscular system such as muscles, bones, cartilage, tendons and ligaments which function in support and movement of the body. Modified from EUROCET

49. Non-Heart Beating Donor Refers to Cardiac Death definition

50. Not for profit = Non - profit Qualifies an organization whose primary objective is to support an issue or matter of private interest or public concern motivated by non-commercial purposes, without concern for monetary profit. Generic definition

51. Organ Differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy. EU Directive 2004

52. Potential Deceased Donor Deceased person without absolute medical contraindications with brain death or cardiac death diagnosis initiated or completed. Modified from DOPKI

53. Potential deceased donor identification The system and processes for identification of potential deceased donors. Editorial Group

54. Pre-stated acceptance / Permission / Authorisation Legal and officially recorded statement of acceptance from the individual to donate cells, tissues and organs after death. Editorial Group

55. Pre-stated refusal (of permission for removal of Human Cells, Tissues and Organs) Legal and officially recorded statement of refusal to donate cells, tissues and organs after death. Editorial Group

56. Presumed consent Legally valid presumption of permission for removal of cells, tissues and organs for transplantation, in the absence of individual pre-stated refusal of permission. Otherwise known as “opting out”. Editorial Group

57. Processing All operations involved in the preparation, manipulation, preservation and packaging of cells or tissues intended for human applications. EU Directive 2004

12 58. Procurement The process that includes donor identification, evaluation, obtaining consent for donation, donor maintenance and retrieval of cells, tissues or organs. Editorial Group

59. Recipient The human being into whom allogeneic human cells, tissues or organs were transplanted. Editorial Group

60. Regulatory oversight The management or supervision of a group by an outside body in order to control or direct according to rule, principle, or law. Editorial Group

61. Retrieval or recovery The procedure of removing cells, tissues or organs from a donor for the purpose of transplantation. Editorial Group

62. Serious Adverse Event Any untoward occurrence associated with the procurement, testing, processing, storage, distribution, transplantation procedure itself or post-transplantation management procedure of cells, tissues and organs that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalization or morbidity. Modified from EU Directive 2004

63. Serious Adverse Reaction An unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement, the transplantation procedure itself or post-transplantation management procedure in the human application of cells, tissues and organs that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalization or morbidity. Modified from EU Directive 2004

64. Skin Strips of skin for grafting and procured as partial or full thickness. EUROCET

65. Split-liver A split liver transplant is defined when a donor liver is divided into parts and transplanted into more than one recipient. Modified from UNOS

66. Storage The maintenance of donor cells, tissues or organs under appropriate controlled conditions until transplantation or disposal. Modified from EU Directive 2004

67. Surveillance The systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary. International Health Regulations 2005

68. Surveillance System (for Human Cells, Tissues and Organs for transplantation) An established process at a local, regional or national level for the reporting of serious adverse events, serious adverse reactions or complications related to donation and transplantation of cells, tissues and organs. Editorial Group

69. Technical Committees / Advisory Boards Specialized professional committees providing recommendations of any aspect of the donation and transplantation process of cells, tissues and organs. Editorial Group 13 70. Time on Waiting List The time from placement on the Waiting List for a transplant until the date of reporting (of a transplant) or until removal (from the Waiting List). Editorial Group

71. Tissue All constituent parts of the human body formed by cells. EU Directive 2004

72. Tissue Establishment A tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells. EU Directive 2004

73. Traceability The ability of an authorized organization to identify and locate all cells, tissues or organs from all specific donors at any time after donation, linked to all specific recipients and vice versa from recipients to donors. This traceability applies to any step of procurement, allocation, processing, including processing agents, storage, distribution or disposal at any time after donation. Editorial Group

74. Trafficking (Cells, tissues or organs) The recruitment, transport, transfer, harboring or receipt of living or deceased persons or their cells, tissues or organs, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of cells, tissues and organs for transplantation. Modified from The Declaration of Istanbul

75. Transplant Commercialism Is a policy or practice in which cells, tissues or organs are treated as a commodity, including by being bought or sold or used for material gain. Modified from The Declaration of Istanbul

76. Transplant Tourism Travel for transplantation when it involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals and transplant centers) devoted to providing transplant to patients from outside a country undermine the country's ability to provide transplant services for its own population. Declaration of Istanbul

77. Transplantation The transfer (engraftment) of human cells, tissues or organs from a donor to a recipient with the aim of restoring function(s) in the body. When transplantation is performed between different species, e.g. animal to human, it is named Xenotransplantation. Editorial Group

78. Travel for transplantation Is the movement of organs, donors, recipients or transplant professionals across jurisdictional borders for transplantation purposes. Declaration of Istanbul

79. Urgency A measure or indicator of a candidate’s relative ability to wait for transplantation compared to that of other candidates. Editorial Group

80. Vascular Tissues Referring to blood vessels. Modified from UNOS

14 81. Waiting List (WL ) The list of candidates registered to receive a human cell, tissue and organ transplant. Editorial group

82. Waiting List Management A system (or method) for maintaining a waiting list accuracy and currency, protecting the privacy and confidentiality of patients in the Waiting List. Editorial Group

15 ANNEX

Data Harmonization on Transplantation Activities and Outcomes:

Editorial Group for a Global Glossary

Geneva, 7-8 June 2007

Report

16 The World Health Organization is grateful to the Spanish Government and The Transplantation Society for their support.

17 EXECUTIVE SUMMARY

The intention of this report is to provide an overview of the issues discussed and conclusions as a result of the Data Harmonization on Transplantation Activities and Outcomes: Editorial Group for a Global Glossary Meeting, which was organized by WHO in collaboration with The Transplantation Society and the Spanish Organization of Transplants.

The collection of data and information in the Global Database on Donation and Transplantation (GDDT) is being made possible by using a unified global questionnaire. Nevertheless there was a need to work as well for the unification of terms and basic definitions on donation and transplantation and create a global glossary. This glossary would have an impact on the collection and analysis of data, which would improve the results.

As part of the harmonization process to prepare a global glossary, this meeting had the aim of achieving consensus on basic definitions on donation and transplantation.

A document was prepared, including an extensive revision of definitions, coming from different but recognized sources, which was used as a baseline document.

The meeting group, called the Editorial Group, had the opportunity to review some terms and definitions and achieve consensus on them. During the sessions, there were some definitions which led to deep discussions, especially those with ethical and legal connotations, such as living and deceased donor, consent, legally non-competent person, trafficking and transplant tourism. Some of them were revised again after the meeting and even if agreed, they were modified after further consultation.

The definitions agreed during the meeting are presented in the body of this report with some comments whenever necessary. At the end of the meeting it was clear that more work had to be done. The attached document of this report presents all proposed definitions after revision and further consultation by the Editorial Group.

18 OPENING SESSION

Dr Steffen Groth, Director of the Essential Health Technologies Department in WHO, welcomed participants to the Data Harmonization on Transplantation Activities and Outcomes: Editorial Group for a Global Glossary Meeting.

He remarked on the importance of harmonization of terms and definitions and made references to the TTS New Key Opinion Leader Meeting on harmonization of registries which took place before the meeting. Dr Groth acknowledged the TTS and the National Organization of Transplants (ONT) of Spain for their collaboration and support in organizing this meeting.

He expressed his hope for the meeting to produce a globally-agreed baseline to reach a common glossary of definitions on donation and transplantation.

Dr Frank Delmonico (TTS) and Dr Beatriz Dominguez-Gil (ONT) were elected to Co-Chair the meeting and Mr Peter Feldman (TTS) as Rapporteur.

Dr Groth stressed that this was an informal and flexible meeting.

INTRODUCTION

Ms Mar Carmona provided an overview of the background, the sources used to elaborate the background document to work on, and explained what was expected as result of the meeting.

BACKGROUND

WHO, in collaboration with ONT, are working on the Global Database on Donation and Transplantation (GDDT), which compiles information on donation and transplantation activities, legal frameworks and organizational systems. To collect all these pieces of information from every country, a common questionnaire is being used.

In the concrete case of the global questionnaire, it was seen that using it for the collection of data was not enough to obtain harmonized responses. There was also a need for common understanding and interpretation of terms and definitions that would lead to the production of reliable results.

As part of the harmonization process of terms and definitions on donation and transplantation, it was decided to create an agreed upon global glossary which could be included together with the global questionnaire.

The questionnaire was taken as a good base to seek for terms to define.

OBJECTIVE

Ms Carmona explained that the aim of the meeting was to agree on terms and definitions on donation and transplantation, to be used globally.

19 SOURCES

With regard to the material provided for the meeting as a starting working document, Ms Carmona gave some examples of the sources for the terms and definitions proposed. A search was made and the following sources were used:

– Glossary of UNOS

-– European Directive

-– Canadian Standards Association

– US Food and drug Administration (FDA)

– Clinical Research Office

– European projects such as DOPKI, EUROCET and ALLIANCE-O

– First Global Consultation on Regulatory Requirements For Human Cells and Tissue for Transplantation

– IAEA. International Standards on Tissue Banks

– International Society for Stem Cells Research

– JACIE Standards

– National Program of Marrow Donor; etc.

EXPECTED OUTCOMES AND SCOPE

Ms Carmona said that the expected outcome of the meeting had the target of agreeing on definitions for certain proposed terms.

It was clear that a global glossary of donation and transplantation definitions would help to compile harmonized responses and would improve the interpretation of data of the GDDT.

It was noted that the scope of the meeting was intended to cover basic definitions, avoiding adjectives and complexity.

The group of the meeting was called Editorial Group.

MEETING SESSIONS

The Editorial Group used recognized definitions from different sources whenever possible. Nevertheless, in some cases it was necessary to include small modifications in the original source, which was reflected also in the source: “Modified from....”. When the definition was created by the Editorial Group, the source was indicated as: Editorial Group.

20 During the second day of the meeting participants split into small groups to review groups of definitions and then the whole group reviewed the proposals.

Although agreed in the meeting, a few definitions were reviewed and slightly modified after further consultation.

Explanations are provided when necessary for those definitions which created concern or discussion. The terms agreed by the Editorial Group during the meeting are as follows.

DISCUSSIONS

Donor: A Donor is a human being, living or deceased, who is a source of cells, tissues or organs for the purpose of transplantation.

Organs and cells were added to the original definition (Source: FDA, Cells, Tissue and Cellular and Tissue-Based Products).

Living Donor: A Living Donor is a living human being from whom cells, tissues or organs have been removed for the purpose of transplantation. A Living Donor has one of the following three possible relationships with the recipient:

Genetically Related:

1st degree genetic relative: Parent, Sibling, Offspring

2nd degree genetic relative, E.g. grandparent, grandchild, aunt, uncle, niece, nephew

Other than 1st or 2nd degree genetically related, For example, cousin

Emotionally Related (examples include) Spouse (if not genetically related) In-laws Adopted Friend

Unrelated Not Genetically or Emotionally Related

This definition of the living donor was elaborated by the Editorial Group. However it was seen during the process after the meeting that it could be reclassified into two bigger groups: Related and Unrelated. Related would include Genetically and Emotionally.

21 Deceased Donor: A Deceased Donor is a human being legally declared, by established medical criteria, to be dead and from whom cells, tissues or organs were recovered for the purpose of transplantation; the possible medical criteria are:

Deceased Heart-Beating Donor (Donor after Brain Death): A Deceased Heart-Beating Donor is a donor who was legally declared dead by neurological criteria. Deceased Non-Heart-Beating Donor (Donor after Cardiac Death): Deceased Non-Heart- Beating donor is a donor who was legally declared dead by cardio-pulmonary criteria.

The original definition (Source: EUROCET) referred to be declared dead according to national regulations. Nevertheless it raised the discussion to change those terms by legally. Then, after further consultation, the definition was altered again. The word "legally" was removed because it was seen that was a “clinical” definition, not legal. Some countries may have regulations but not law, and following this definition as it stays, they would not fulfil it. Domino Donor: A person who by receiving an organ transplant donates the removed organ to another recipient.

Procurement: The process that includes donor identification, evaluation, obtaining consent for donation, donor maintenance and retrieval of organs, tissues or cells.

The Editorial Group considered the addition of evaluation, consent for donation and maintenance to the original definition and also applies to organs (Source: Aide-Mémoire. Human Cell and Tissue for Transplantation).

Retrieval (Recovery): The procedure of removing organs, tissues or cells from a donor.

It was suggested to say recovery as well.

Cross Match Compatibility for Organ Transplantation: Absence of recipient antibodies to HLA antigens present on the transplant organ.

Blood group compatibility for Organ Transplantation: Absence of recipient antibodies to blood group antigens present on the transplant organ.

Although both definitions were agreed in the meeting, after further consultation they merged into one term: Compatibility Testing. Those aspects do not apply only to organs but also to tissues and cells. It was also seen that the questionnaire had necessarily to include both cross match and blood group compatibility. Note was well taken in order to make the proper changes.

Processing of Tissues or Cells: All operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human application.

Allocation: Allocation is the assignment of organs, tissues and cells to a transplant candidate, based on a set of rules.

22 Distribution: Transportation and delivery of organs, tissues or cells intended for human applications, after they have been allocated.

The Editorial Group considered the addition of the last part "after they have been allocated" to the original definition (Source: Directive 2004/23/EC of the European Parliament of the Council of Europe).

Recipient: The human being into whom allogeneic human organs, tissues or cells were transplanted

Wait List (WL): The list of candidates registered to receive an organ, tissue or cell transplant

Time on Waiting List: The time from placement on the Waiting List for a transplant until the date of reporting (of a transplant) or until removal (from the Waiting List)

Consent: Legally valid permission for removal of organs, cells and tissues for transplantation.

Due to the legal and also ethical complexity of this term, it was seen that this general definition could be applicable for those involved, i.e. living and/or deceased, next of kin, etc.

Presumed Consent: Legally valid presumption of permission for removal of organs, cells and tissues for transplantation, in the absence of individual pre-stated refusal of permission. Otherwise known as “opting out” law legislation.

Pre-stated Refusal of Permission for Removal of Organs, Cells and Tissues: Legal and officially recorded statement of refusal to donate organs, cells and tissues after death.

Pre-stated Acceptance: Legal and officially recorded statement of acceptance to donate organs, cells and tissues after death.

This definition was agreed by the Editorial Group during the meeting. Nevertheless it was reviewed after consultation and included “of acceptance from the individual”.

Explicit Consent: Legally valid pre-stated individual permission for the removal of organs, cells and tissues for transplantation, otherwise known as “opting in” law.

Although agreed by the Editorial Group, it was modified after further consultation. “Pre- stated individual” was removed.

Informed Consent: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure.

Legally Non-Competent Person: An individual unable to provide legally valid permission for the removal of organs, cells and tissues for transplantation, (e.g., a minor or an individual legally declared unable to manage their own affairs).

23 This definition was agreed by the Editorial Group; however it was reviewed and modified after. This term was seen as a legal term and not clinical. Due to the legal and ethical connotations implied, it was suggested to ask some of the departments within WHO for a universal definition. After further consultation the term was changed to “Incompetent Person”, which is recognized legally.

Commercialization (organ, tissues, cells): Handling of Organs, Cells or Tissues for financial profit. Commerce may be conducted legally or illegally.

Trafficking (organ, tissues, cells):

The discussion of this definition led to the use of the United Nations definition of Trafficking in Persons. Although it addresses organs, it is important to note that trafficking refers to not only organs but also to tissues and cells.

55/25 United Nations Convention against Transnational Organized Crime

Annex II Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children, supplementing the United Nations Convention against Transnational Organized Crime

Article 3

The definition of trafficking “Trafficking in Persons” shall mean the recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs; (b) The consent of a victim of trafficking in persons to the intended exploitation set forth in subparagraph (a) of this article shall be irrelevant where any of the means set forth in subparagraph (a) have been used; (c) The recruitment, transportation, transfer, harbouring or receipt of a child for the purpose of exploitation shall be considered “trafficking in persons” even if this does not involve any of the means set forth in subparagraph (a) of this article; (d) “Child” shall mean any person under eighteen years of age.

Transplant Tourism: The travel of prospective transplant recipients or donors across national borders and involving the trafficking of organs, tissues or cells. The travelling of patients or donors across national borders should not be understood as transplant tourism, when organs are not trafficked. Travelling of prospective transplant recipients or donors may be legal and appropriate, such as where travel of a related donor and recipient pair is from a country without transplant services to a country with transplant services.

This definition was reviewed in further consultation. First, the suggestion was not to include trafficking in the definition. Then, it was decided to use the one in the Istanbul Declaration.

24 CONCLUSIONS

At the end of the meeting the Editorial Group had approved 24 definitions and proposed some others.

Dr Luc Noël, Coordinator of the Clinical Procedures Unit in WHO, thanked all the participants for their input to the meeting.

In the light of the discussions, he noted the need to modify some of the questions included in the Questionnaire. It was agreed that explanations would be added as well as the Glossary once agreed, with the purpose of getting harmonized responses. Some adaptations would be necessary in both, the Glossary and the questionnaire, to avoid discrepancies between them.

Dr Noël stressed that the work had to continue in order to reach consensus for all definitions proposed. He said that the next step would be the circulation of the working document among participants and to receive their feedback.

Participants had the opportunity to review all the definitions even if they were already agreed during the meeting or whether the definitions were proposed. Some of them were modified because other factors were contemplated.

After this consultation process, the attached document has been elaborated to include all definitions, the source of each of them and comments if they are appropriate.

25 Annex 1

Data Harmonization on Transplantation Activities and Outcomes: Editorial Group for a Global Glossary

7-8 June 2007, Geneva HQ, Switzerland (Room M.605)

List of Participants

Dr Inés ÁLVAREZ SALDÍAS Director Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos Hospital de Clinicas, Avenida Italia s/n Montevideo, Uruguay E-mail: [email protected] or [email protected];

Dr Mohamed Salah BEN AMMAR Representative, Centre national pour la promotion de la Transplantation d'Organes - Tunisie (CNPTO) Sidi Daoud 2046, Tunisia E-mail: [email protected]

Dr Liliana BISIGNIANO Director, Technique Scientific Direction INCUCAI Ramsay 2250 Buenos Aires 1428, Argentina e-mail: [email protected] / [email protected]

Dr Jeremy CHAPMAN Director, Acute Interventional Medicine Westmead Hospital Westmead, NSW 2145, Australia E-mail: [email protected]

Ms Lisa COSCIA Transplant Registry Research Coordinator Thomas Jefferson University 1025 Walnut Street 605 College Building Philadelphia, PA 19107 E-mail: [email protected]

Dr Razeen DAVIDS Division of Nephrology and Department of Medicine Stellenbosch University and Tygerberg Hospital P.O. Box 19063 Tygerberg 7505, South Africa E- mail: [email protected]

26 Dr Francis DELMONICO (Member of WHO Expert Director of Medical Affairs Advisory Panel on Transplantation) The Transplantation Society Massachusetts General Hospital Dept of Surgery White Bldg 505 55 Fruit Street Boston, MA 02114-2696, USA E-mail: [email protected]

Dr Visist DHITAVAT Director, Organ Donation Centre Thai Red Cross Society 5th Floor, Terd Prakiat Building Henry Dunant Rd, Pathumwan Bangkok 10330, Thailand E-mail: [email protected]

Dr Beatriz DOMINGUEZ-GIL MD, PhD Organización Nacional de Trasplantes C/ Sinesio Delgado 6, Pabellón 3 28029 Madrid, Spain Email: [email protected]

Mr Peter FELDMAN GAT Registry Program 64 Rodeo Drive Thornhill, Ontario L4J 4Y3, Canada E-mail: [email protected]

Dr John GILL University of British Columbia - St Paul Providence 6A - 1081 Burrard Street Vancouver, BC V6Z 1Y6, Canada E-mail: [email protected]

Dr Jongwon HA Department of Surgery Seoul National University College of Medicine Seoul National University Hospital 28 Yongon-dong, Chongno-gu Seoul 110-744, Republic of Korea E-mail: [email protected]

Ms HAN Joung-Hee Korean Network for Organ Sharing (KONOS) Division of Organ Transplant Coordination National Medical Center 18-79, Ulgiro 6-ga, Gung-gu Seoul 100-799, Republic of Korea E-mail: [email protected] / [email protected]

Dr Ahmad Adel HASSAN Professor of Nephrology and Renal Transplantation Arab Society of Nephrology Misr 2000 Center 9 Okba Street Dokki, Giza, Egypt E-mail: [email protected]

27 Prof. HE Xiaoshun Organ Transplantation Centre The First Affiliated Hospital of Zhongshan University 58 Zhongshan er Road Guangzhou, People's Republic of China E-mail: [email protected]

Ms JIAO Yahui Programme Officer Department of Medical Administration Ministry of Health No. 1 Nanlu, Xizhimenwai Beijing 100044, People's Republic of China E-mail: [email protected]

Dr Bertram KASISKE Hennepin Country Medical Center Department of Medicine 701 Park Avenue Minneapolis, MN 55415, USA E-mail: [email protected]

Dr Nguyen Ngoc KHANG Senior Medical Officer for Transplantation Health Policy and Systems Development Ministry of Health 138A Giang Vo Street Hanoi, Viet Nam E-mail: [email protected]

Dr Enrique MARTÍNEZ GUTIÉRREZ Director del Registro Nacional de Trasplantes Centro Nacional de Trasplantes (CENATRA) Carretera Picacho Ajusco No. 154 6° piso Colonia Jardines en la Montaña 014210 DF, Delegación Talpan, Mexico E-mail: [email protected]

Unable to attend:

Dr Rafael MATESANZ ACEDOS (Member of WHO Expert Coordinador Nacional de Trasplantes Advisory Panel on Transplantation) Organización Nacional de Trasplantes C/ Sinesio Delgado 6-8 Pabellon 3 28029 Madrid, Spain E-mail: [email protected] / [email protected]

Dr Robert MERION Professor of Surgery University of Michigan Health System 2926B Taubman Center Box 0331 Ann Arbor, MI 48109-0331, USA E-mail: [email protected]

28 Unable to attend:

Dr Philippe MOREL University Hospital of Geneva Chef du Département de Chirurgie Rue Micheli-du-Crest 24 CH-1211 Geneva 14, Switzerland E-mail: [email protected]

Mr Kevin O'CONNOR New England Organ Bank One Gateway Center Newton, MA 02458, USA E-mail: [email protected]

Dr Graeme RUSS The Australia and New Zealand Dialysis and Transplant Registry (ANZDATA) The Queen Elizabeth Hospital 28 Woodville Road Woodville South, Adelaide 5011 Australia E-mail: [email protected] / [email protected]

Dr Naoshi SHINOZAKI Assistant Professor Department of Ophthalmology Ichikawa General Hospital Tokyo Dental College (Executive Director, Cornea Center and Eye Bank) Sugano 5-11-13 Ichikawa City 272-8513, Japan E-mail: [email protected]

Mr Mariano SORATTI Jefe del Departamento de Informática del INCUCAI Ramsay 2250, Ciudad Autonoma de Buenos Aires, C.P. 1428 Argentina E-mail: [email protected] / [email protected]

Dr Yves VAN RENTERGHEM University Hospital Department of Nephrology Herestraat 49 Leuven, Belgium E-mail: [email protected]

WHO Secretariat

Ms Mar CARMONA (Secretary of the Meeting) World Health Organization Technical Officer, Clinical Procedures Essential Health Technologies Health Technology and Pharmaceuticals Avenue Appia 20 CH-1211 Geneva 27, Switzerland E-mail: [email protected]

29 Dr Steffen GROTH World Health Organization Director, Essential Health Technologies Health Technology and Pharmaceuticals 20 Avenue Appia CH-1211 Geneva 27, Switzerland E-mail: [email protected]

Mrs Christine FAIVRE-PIERRET World Health Organization Clinical Procedures Essential Health Technologies Health Technology and Pharmaceuticals 20 Avenue Appia CH-1211 Geneva 27, Switzerland E-mail: [email protected]

Dr Luc NOËL World Health Organization Coordinator, Clinical Procedures Essential Health Technologies Health Technology and Pharmaceuticals World Health Organization 20 Avenue Appia CH-1211 Geneva 27, Switzerland E-mail: [email protected]