Abstract
Ethical practice in the field of tissue banking requires the setting of principles, the identification of possible deviations and the establishment of mechanisms that will detect and hinder abuses that may occur during the procurement, processing and distribution of tissues for transplantation. This model of a Code of Ethics has been prepared with the purpose of being used for the elaboration of a Code of Ethics for tissue banks operating in the Latin American and the Caribbean, Asia and the Pacific and the African regions in order to guide the day-to-day operation of these banks. The purpose of this model of Code of Ethics is to assist interested tissue banks in the preparation of their own Code of Ethics towards ensuring that the tissue bank staff support with their actions the mission and values associated with tissue banking.
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Notes
International Ethical Guidelines for Biomedical Research Involving Human Subjects, the Council for International Organisations of Medical Sciences (CIOMS) in collaboration with the World Health Organisation (WHO), Geneva 2002
According to the Declaration of Istanbul, all countries need a legal and professional framework to govern tissue donation and transplantation activities, as well as a transparent regulatory oversight system that ensures donor and recipient safety and the enforcement of standards and prohibitions of unethical practices.
Tissues for transplantation should be equitably allocated within countries or jurisdictions to suitable recipients without regard to gender, ethnicity, religion or social or financial status. Financial considerations or material gain of any party must not influence the application of relevant allocation rules.
For this reason, all promotional activities related to tissue donations should be carried out by the tissue bank respecting all national regulations in force with the purpose of ensuring that the tissue donation will be obtained in a manner that unethical practices are totally excluded.
It is important to single out, in the case of living donors, the following: The ethical issues associated with the donation of human tissues for transplantation from a living donor principally involve concern for the donor: The autonomy and welfare of the donor takes precedence over the needs of the recipient to receive a human tissue.
All States of the EU adhere to the ethical principle that donation of human tissues must be free, and this rule out any payment to the donor. However, the donor may receive compensation for the constraints associated with tissue removal (e.g., travel expenses, loss of earnings, etc.).
Retaliation means harm done to persons in retribution for raising concerns in good faith or violations of the Code of Ethics or any other of the tissue bank’s policy and regulations.
A person is closely related to the tissue bank staff by blood or marriage if they are mother, father, brother, sister, son, daughter, father-in-law, mother-in-law, son-in-law, daughter-in-law, sister-in-law, brother-in-law, grandmother, grandfather, grandson, granddaughter, uncle, aunt, nephew, niece, husband, wife, step-parent, step-child, step-brother, step-sister, guardian or ward.
The term “gift” includes any cash, gratuity, favour, discount, entertainment, admission to sporting and cultural events, hospitality, loan or any other benefit or item having monetary value. Such benefits include services and/or gifts of training, transportation, travel, lodgings and meals, whether provided in-kind, by purchase of a ticket, payment in advance or reimbursement after the expense has been incurred.
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Acknowledgments
I would like to thanks Professor Glyn O. Phillips (UK), Dr. Astrid Lobo Gajiwala (India), and Dr. Saimel Bello Gonzalez (Cuba) for their relevant contributions and support in the preparation of this paper.
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Appendix 1
Appendix 1
Definitions of terms
Unless otherwise defined in the tissue-specific standards or otherwise used in another context in this Code, the following terms shall be defined as follows:
Allograft: Tissue intended for transplantation into another individual of the same species.
Autograft: Tissue intended for implantation, transplantation or infusion into the individual from whom they were recovered.
Deviation: An event that is a departure from a procedure or normal practice.
Distribution: A process that includes receipt of a request for tissues, selection and inspection of appropriate tissues, and inspection, and subsequent shipment and delivery of tissues to another tissue bank, tissue distribution intermediary or tissue dispensing service.
Donor: A living or deceased individual who is the source of tissues for transplantation in accordance with established medical criteria and procedures.
Informed consent: A procedure whereby information concerning the donation process is presented to the donor or donor’s next of kin with an opportunity for them to ask questions, after which specific approval is documented.
Living donor: A donor whose heart is beating at the time of tissue donation.
Next of kin: The person(s) most closely related to a deceased individual.
Procedure: A series of steps, which when followed, is designed to result in a specific outcome.
Processing: Any activity performed on tissues, other than tissue recovery, including preparation, preservation for storage, and/or removal from storage, to assure the quality and/or sterility of human tissues. Processing includes steps to inactivate and remove adventitious agents.
Procurement: See Retrieval
Quality: The conformance of tissues or a process with pre-established specifications or standards.
Quality control: Specific tests defined by the Quality Assurance Programme to be performed to monitor retrieval, processing, preservation and storage, tissue quality, and test accuracy. These may include but are not limited to, performance evaluations, inspection, testing, and controls used to determine the accuracy and reliability of the tissue bank’s equipment and operational procedures, as well as the monitoring of supplies, reagents, equipment, and facilities.
Recipient: An individual into whom tissues is transplanted.
Recovery: Obtaining tissues from a donor that is intended for use in human transplantation.
Resolution: Adjustment, clarification, and/or correction of practices and/or procedures that results in compliance with the SOPs and/or standards.
Retrieval: The removal, acquisition, recovery, harvesting or collection of donor tissues.
Standard operating procedure: A group of standards detailing the specific policies of a tissue bank and the procedures used by the staff/personnel. This includes but is not limited to, procedures to assess donor suitability, retrieval, processing, quarantine, release to inventory, labeling, storage, distribution, and recalling tissues.
Storage: The maintenance of tissues for future use.
Tissue: A functional group of cells.
Tissue bank: An entity that provides or engages in one or more services involving tissues from living or deceased individuals for transplantation purposes. These services include assessing donor suitability, recovery, processing, storage, labeling, and distribution of tissues.
Transplantation: The transfer of tissue to a recipient. This includes musculoskeletal, skin, cardiovascular, and fetal tissues, as well as reproductive tissues used in assisted reproductive procedures.
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Morales Pedraza, J. A model of a code of ethics for tissue banks operating in developing countries. Cell Tissue Bank 13, 607–622 (2012). https://doi.org/10.1007/s10561-011-9279-8
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DOI: https://doi.org/10.1007/s10561-011-9279-8