Using Donated Human Tissue

Obtaining human tissue for testing requires great care to ensure that the material is obtained with fully informed consent and ethical approval for the proposed studies. The general requirements on those in charge of utilizing human material have been enshrined in international guidance such as Good Cell Culture Practice [10] and accords such as the Hinxton Statement ( bioethics/finalsc.doc), which emphasize the need for attention to central generic criteria, including compliance with national laws and "norms", the avoidance of any coercion to donate tissue, and the maintenance of donor anonymity.

The 32nd Workshop of the European Centre for the Validation of Alternative Methods addressed the issue of the availability of human tissue [11]. The report from this workshop made 23 recommendations (see Table 9.1) which, in respect of tissue availability for testing purposes, included:

• the need for governments to facilitate appropriate legislation to permit use of human material for research and testing;

• the important role of tissue banks in provision of tissue; and

• the importance of accreditation for users of human tissue to ensure safe and ethical use.

Making human tissue available for research, with all appropriate approvals in place, can take some considerable time and effort, and it is therefore important to optimize and maximize its use. An important step to achieve this is to put in place a protocol for obtaining tissues that is agreed between user and providers [12]. This will help to ensure that tissues are optimally harvested, stored and

Table 9.1 Recommendations made by the ECVAM Workshop on Availability ofHuman Tissue [12].

General Recommendations

1. Governments and legislators should be kept fully informed about the important contributions to healthcare that the use of human tissue for research purposes can make, as well as contributing to the replacement of animal experiments.

2. Where necessary, changes to the legal frameworks operating in European countries should be sought in conjunction with the relevant authorities, in order to facilitate the procurement of surgically removed human material surplus to medical requirements, and its supply in a suitable form to endusers.

The consent form used by Queen Mary's Hospital, Roehampton, UK, is recommended as a suitable example for obtaining general consent from living donors for the provision of human tissue for research.

The use of tissue banks should be recognized as the most legally and ethically acceptable approach to the procurement and distribution of donated non-transplantable human tissue for research.

A tissue-tracking system should be established to guarantee the anonymity of the donor, the donor's family, and health professionals involved in a donation. This should also involve routes of communication between the researcher and the surgeon, via the tissue bank that originally supplied the tissue in question, when appropriate.

Users of human tissue should undergo a process of accreditation, to ensure that a minimum set of criteria are fulfilled. These criteria will include safety issues, scientific reputation, ethical credibility, proper training, suitable facilities for safe handling and disposal of human tissue, and confidentiality. Wherever possible, this accreditation should be conducted via an appropriately qualified and independent expert group.

Informative articles on the establishment and role of tissue banks, and on the need for a wide variety of human tissue for research, for publication in the medical, scientific and general literature, should be prepared by those interested and involved in this area of work.

The availability for research purposes of human tissue, surplus to medical requirements, should be facilitated by all available means; for example, by distributing newsletters, short articles and instructional videos, to improve communication between end-users and health professionals.

Safety 9. All human tissue should be regarded as potentially biohazardous and should be handled accordingly by appropriately trained personnel. Specific and appropriate precautions should be taken against known hazards, and general precautions against unknown hazards.

10. Tissue banks should ensure that human tissues have been screened for specific biohazards, where possible and as appropriate. Such information should be made available to the end-user as quickly as possible. Ideally, this should be before any exposure of the end-user to the tissue. It is recognized, however, that this might not always be possible. Safety information should be used to modify any risk assessment already undertaken, with subsequent adjustment of handling procedures, or immediate disposal of the material, as appropriate.

Legal and 3. ethical

General Recommendations

11. All those potentially exposed to human tissue should be vaccinated against hepatitis B virus, and should be shown to exhibit the nationally accepted level of immunization before any possible exposure; they should also be regularly checked for level of immunity.

12. All human material, and disposable equipment used in conjunction with human tissue, should be sterilized according to a recommended procedure before transport for incineration.

13. All research facilities involved in the use of human tissue should have relevant, standard protocols for ensuring its safe handling and disposal. Guidelines to be used as a basis for these protocols should be made available.

14. Safety courses should include information specific to the handling of human tissue.

15. National governments and appropriate international agencies should be encouraged by the European Network of Research Tissue Banks to officially recognize and regulate a non-profit research tissue-banking service to academia and industry.

16. The nature and content of such courses, and records of staff attendance, should be documented, and maintained within the relevant establishments.

17. There should be standardization of containers and labeling with respect to the movement of surgical and non-transplantable human tissue for research, so that they are easily recognizable.

18. Information regarding regulations for packaging and national and international transport of human tissue should be collated into a database and made generally available.

Logistics 19. Tissue banks should establish procedures for providing advice to end-users who find themselves with human tissue surplus to their requirements which could be useful to other end-users.

20. Tissue banks and others, including end-users, should undertake research which will enable, as far as possible, the regular and reliable supply of cells from all human tissue of sufficiently high quality for research. Issues requiring further research include isolation, preservation and storage techniques, and suitable conditions for distribution.

Tissue banks should be transparent about the procedures involved in the isolation, storage and sterilization of human tissue. This would be facilitated if staff at tissue banks and end-users visited each others' establishments to view techniques and procedures.

A list of suitable quality control criteria for each type of tissue and use should be drawn up by tissue banks, in conjunction with end-users. This is particularly important where a use is for regulatory purposes, when specific criteria will have to be met to satisfy a particular regulatory guideline. Flexibility in structural and performance criteria for using human tissue for regulatory purposes should be increased where this is possible without compromising scientific output, by dialogue among tissue banks, end-users and regulatory bodies. Attempts should be made to satisfy end-user requirements by standardizing the preparation and quality of specific cell types, and standardizing the transport conditions for their distribution.

End-user 21. requirements

transported to the user's laboratory, and provide good quality tissues for testing purposes. This protocol can specify a number of technical details to promote successful delivery of tissues, as illustrated in Table 9.2. Where tissues are transported across national borders it is important to ensure that the ethical approvals and any other requirements such as provision ofviral marker screening are completed appropriately. Any laboratory receiving such material should be at least able to demonstrate traceability to a system of ethically approved tissue procurement for each sample.

Table 9.2 Key technical details to be agreed for procurement of tissue samples. Preliminary arrangements:

• Consult local and national rules for use of patient cells.

• Establish a specification for the tissues samples required, e.g. type of tissues to be included, time between harvesting and reception at the laboratory, type of labeling.

• Coordination meetings between laboratory and clinical staff to agree protocol for provision of tissue including: tissue specification, description of necessary equipment and consumables, communications and labeling.

• Ensure ethical approval and appropriate consenting procedures are in place.

• Awareness/training for those who are involved in the storage and transfer of tissue.

• Ensure adequate storage facilities are available at appropriate sites in the tissue supply chain.

Routine operation during supply of tissue:

• Points of contact at clinical and laboratory sites.

• Forewarning of sample delivery.

• Assessment process for tissue received to ensure it is appropriate for use.

• Documentation of tissue receipt, evaluation and use.

Monitoring procedures:

• Review of consents for donated tissue.

• Notification of any changes in local practice which may impact on supply.

• Review any proposed change of use or supplementary use for donated tissues to ensure ongoing compliance with ethical approvals in place or activation of new applications for ethical approval.

Closure of protocol:

• All key staff informed.

• All remaining sample tubes and dedicated storage facilities recalled.

• Arrangements made for dealing with residual unused tissues.

• If appropriate, communication with local ethics committees.

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