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Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

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Abstract

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP’s which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, “financial gain” and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

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Abbreviations

AD:

Alzhemiers disease

BTB:

Banks—Brain/tissue/Bio banks

EBBN:

European Brain Bank Network

SOP:

Standard Operating Procedure

MTA:

Material Transfer Agreement

QMS:

Quality Management System

TubaFrost:

European Human Frozen Tumour Tissue Bank

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Acknowledgements

The author would like to thank the Netherlands Brain Bank (NBB) for supplying the means and the samples to perform the experiments needed to crystallize the above findings and recommendations. I also like to thank Dr. P. Van t Klooster for his support, W. Verweij for secretarial assistance and T. Put for graphical assistance. I am deeply grateful to my colleague, Dr. W. Kamphorst who opened for me the window to the mysteries of the neuropathology of the human brain and helped me with his wisdom and common sense to establish the methodological and ethical guidelines for a well-operating Brain bank.

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Authors and Affiliations

  1. Netherlands Institute for Neurosciences, Royal Dutch Academy of Science, Meibergdreef 47, 1105 BA, Amsterdam, The Netherlands

    Rivka Ravid

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  1. Rivka Ravid
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Correspondence to Rivka Ravid.

Additional information

This article has been previously published in Cell and Tissue Banking 9:121–137. doi:10.1007/s10561-007-9055-y.

Appendices

Appendix 1: Proposed model Code of conduct (‘The Code’) for Brain/Tissue banks (Referred to as ‘The Bank’)

Whenever ‘The Bank’ is engaged in the process of recruiting and disseminating human biological material for scientific research it abides by the local law for procuring and sharing human tissue for research and adheres to the following Code of Conduct. In order to provide safe specimens of reliable quality, good practice standards must be applied; the proposed Code addresses these issues, bringing together the generally accepted methodological, legal and ethical guidelines. ‘The Code’ does not limit newly developed technologies, e.g. tissue engineering and cell cultures; once tested, validated and accepted by international concensus, they can be added to the Code.

‘The Bank’ will make sure to promote transparancy and probity with all parties involved, as shown in Figs. 1 and 2 and will make all information available to the public and researchers concerning the organization, funding resources, SOPs and Code of Conduct. This can be done through information flyers, website, annual financial accountant report and scientific publications.

Consent/Authorization

  1. 1.

    The specimens collected by ‘The Bank’ are obtained with informed consent of the donor or the next-of-kin (or a designated confidant in absence of family) for the following:

    1. (a)

      Brain or whole body autopsy during which the brain, the spinal cord and dorsal root ganglia are removed.

    2. (b)

      The subsequent use of the material for scientific research.

    3. (c)

      Access to clinical/genetic data/donor’s medical records.

  2. 2.

    In case a power of attorney has been given by a person, the holder of this power of attorney can give the authorization and sign the consent forms on behalf of the person who for reasons of mental of physical health is no longer capable to give the permission in person. This is also the case for surgical specimens or biological materials obtained from minors.

    The consent of the holder of the power of attorney also covers sub 1(a–c).

  3. 3.

    ‘The Bank’ will provide the donors/next of kin/person/legal authority who give the authorization with all relevant information concerning the consent beforehand.

  4. 4.

    The potential donor or the person/legal authority who gave an authorization can always withdraw their/consent/authorization and the participation in a donor-program.

Handling of specimens

‘The Bank’ formulates the general scope, aims, regulations and SOPs, which will be used for collecting and handling the obtained specimens. The overall scope and regulations of the bank should be open to the public, transparent and well known to the donors and recipients of the specimens.

  1. 1.

    ‘The Bank’ will anonymize the collected specimens during the handling, storage and sharing with researchers.

  2. 2.

    The obtained specimens should be registered, documented, handled and stored according to specific SOPs. Each specimen is registered by ‘The Bank’ as a coded Bank-number which is linked to the autopsy number; ‘The Bank’ is the only one who can break the code.

  3. 3.

    All specimens are prepared for pathological validation and the pathology report is stored in the D-base together with all the clinical/genetic data.

  4. 4.

    Quality control is performed on all collected specimens to guarantee their suitability for research. All samples which do not match the parameters for quality control will be either discarded or used for different purposes (e.g. teaching, internal use within ‘The Bank’).

Safety

  1. 1.

    ‘The Bank’ informs all tissue recipients on the possible hazardous nature of the specimens and asks the recipient to sign for handling all material with the necessary safety methods. ‘The Bank’ will not be liable to any health risk/damage resulting from unsafe handling of the specimens.

  2. 2.

    All those potentially exposed to human specimens should be vaccinated against possible risks and regularly checked for the level of immunity.

  3. 3.

    Sharing data with applicants is performed under data protection.

  4. 4.

    All tissue recipients are responsible to return unused specimens to ‘The Bank’ and dispose of rests according to local legal, ethical and safety rules for disposal of human remains.

Sharing of specimens

  1. 1.

    ‘The Bank’ supplies specimens for peer-reviewed, ethically approved scientific projects. Applicants are subject to an accreditation process and have to fulfill a minimal set of criteria before their application is approved. These criteria are published by ‘The Bank’ and know in advance to each applicant.

  2. 2.

    The internal review committee of ‘The Bank’ will evaluate and approve the request based on availability of specimens, the feasibility and scientific merit of the proposed project.

  3. 3.

    Specimens are to be used solely for the requested/approved project and are not to be passed on to a third party without written permission from ‘The Bank’. The review committee communicates her decision to the applicant.

  4. 4.

    ‘The Bank’ will act as a custodian of specimens (and their derivatives such as cells, RNA and DNA extracts) and there is no ownership.

  5. 5.

    ‘The Bank’ will accompany the specimens with all available clinical/genetic/pathological data in an anonymized form.

  6. 6.

    ‘The Bank’ formulates the terms and contractual obligations of sharing/transfer of specimens/data in a MTA and a Tissue recipient statement.

Financial gain

  1. 1.

    ‘The Bank’ defines the terms for financial compensation and cost-recovery obtained from recipients for the requested specimens.

  2. 2.

    Donated specimens may not be sold by ‘The Bank’ for commercial purposes to a for-profit organization. ‘The Bank’ will not have ‘financial gain’; it operates as a non-profit organization but has the right to recover any legitimate costs made for technical or scientific services used for collecting, handling, management, storage and transport of the specimens.

  3. 3.

    When supplying specimens for the Bio-industry, ‘The Bank’ will sign a written agreement (MTA), which will define the terms of supplying the specimens and the future intellectual property, in case of registered patents, resulting from research performed on the specimens.

Publications

  1. 1.

    Each researcher/recipient of specimens will send an annual report to ‘The Bank’ about the results obtained with the specimens, including a list of published data/filed patent applications/registered patents.

  2. 2.

    In publications, use shall be made exclusively of the specific Bank-coded numbers (not autopsy numbers), in order to fully protect the anonymity of the donors. This also makes it possible for different researchers who were using specimens from the same donors, to get a full picture of the studied cases.

  3. 3.

    ‘The Bank’ will always be acknowledged in the scientific publications for supplying the specimens. Guidelines for authorship will be formulated in advance and make a clear distinction between the cases in which ‘The Bank’ acts as supplier of specimens or the studied in which scientific staff of ‘The Bank’ actively participates in the research project.

Appendix 2: Model standard evaluation protocol for Auditing BTB-banks (Referred to as ‘The Bank’)

  1. 1.

    ‘The Bank’ will undergo a review process biannually in the start-period and once in 5 years to come.

  2. 2.

    The evaluation will be conducted by an external review board, consisting of members who have a high scientific reputation in this field and have no direct contact or a conflict of interest with ‘The Bank’, so the process will be as objective as possible. The impact measures are required to determine the performance of ‘The Bank’ and state whether it is effectively meeting a critical scientific need. The impact of a bank is the most difficult characteristic to measure, although it becomes easier with time as the bank has established its methodological and legal-ethical code of conduct; also, with time, more researchers have been using specimens from the bank and more papers with high impact have been published base on these results. The achievement aspects include the strategic value of the Bank, the performance of the management and all the aspects relevant to scientific standing.

  3. 3.

    ‘The Bank’ will present the audit committee in advance with a report containing all relevant information.

  4. 4.

    ‘The Bank’ will organize a site visit in which the facility will be examined and all topics discussed between the Audit committee and the team of ‘The Bank’.

  5. 5.

    The Audit-committee will evaluate/review various aspects of achievement by checking the following points:

    • What is the overall effective performance of ‘The Bank’?

    • Does ‘The Bank’ operate through a donor program?

    • How many enrolled donors are registered and is there an increase/decrease in donor registration?

    • How many specimens have been provided by ‘The Bank’ for research? (in the current year and an Audit of the past years from the establishment of ‘The Bank’).

    • How many complex projects involving unusual or large quantity requests did ‘The Bank’ handle?

    • Does ‘The Bank’ apply a quality control of the specimens? Which method is used?

    • How many research projects have obtained specimens from ‘The Bank’?

    • What was the quality of the supplied specimens?

    • How many publications resulted from the use of specimens (including bibliometric data analysis related to the number of publications and citation index)?

    • Does ‘The Bank’ circulate survey-questionnaires to request feedback from end-users on its general performance and the number, quality and timeliness of the supplied specimens?

    • How are the technical transfer and the intellectual property issues regulated?

    • Does ‘The Bank’ collaborate or supply specimens to the pharmaceutical industry and under what financial terms?

    • Does ‘The Bank’ claim a compensation for cost recovery from the academic end-users? If yes, under which regulations?

    • Does ‘The Bank’ perform a regular Strength; Weekness; Opportunities; Threats (SWOT) analysis of its operation?

    • Can the team of ‘The Bank’ cope with all the activities?

    • Is the facility appropriate/is there shortage of space/apparatuses?

    • Does ‘The Bank’ perform research on collected specimens? If yes, what are the national/international collaborations?

    • Is ‘The Bank’ still serving a critical need in the scientific community/bio-industry?

    • What are the funding resources of ‘The Bank’?

    • Is ‘The Bank’ self sustainable and is it successful in attracting external funding/resources?

    • How does the management of ‘The Bank’ reach decisions concerning technical investments and personnel management?

    • Is there enough transparency in the presentation of ‘The Bank’ to the public?

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Ravid, R. Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?. Cell Tissue Banking 9, 151–167 (2008). https://doi.org/10.1007/s10561-008-9101-4

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