Cost recovery policies should be developed with key stakeholders of the repository, potential recipients of the collected specimens, and, where appropriate, with study participant advocates. These policies should be reviewed regularly and adjusted as needed. Service fees should be kept within a range that accommodates cost recovery and permits maximum use of the repository. Additional policies should be developed to address the timely collection and non-payment of fees, as well as culling or redistribution of specimen collections that are no longer supported by funding.
- Best Practice: Cost recovery policies should be developed, periodically reviewed, and adjusted as needed to meet the needs of the repository and its stakeholders.
Biobankonomics: Developing a Sustainable Business Model Approach for the Formation of a Human Tissue Biobank. Vaught et al. JNCI Monographs, 42, 24–31 (2011).
Public Biobanks: Calculation and Recovery of Costs. Clement et al., Sci Transl Med 6, 1 – 3 (2014).
The Biobank Economic Modeling Tool (BEMT): Online Financial Planning to Facilitate Biobank Sustainability. Odeh et al., Biopres. Biobanking 13, 421-429 (2015)
Calculator for the costs of using biological samples. Developed by The University of British Columbia (UBC) Office of Biobank Education and Research (OBER) and CTRNet
Material Transfer Agreements
- An MTA or similar agreement should be executed to document the obligations and responsibilities of parties involved in the transfer of materials from a repository prior to shipment. The agreement should be in place before the transfer occurs.
- Repositories that receive or send material should have an MTA and maintain documentation for such transactions. Repositories should have templates of this document that can be used or modified as needed.
- Repositories should execute an MTA that incorporates terms for data transfer or similar agreement with recipients who receive specimen-associated data from the repository.
Use and Misuse of Material Transfer Agreements: Lessons in Proportionality from Research, Repositories, and Litigation. Bubela et al. PLoS Biol 13(2): e1002060. doi:10.1371/journal.pbio.1002060 (2015).
International Charter of principles for sharing bio-specimens and data. Mascalzoni et al. Eur J Hum Genet. 23, 721–728 (2015).
Drafting biological material transfer agreement: a ready-to-sign model for biobanks and biorepositories. Cervo et al. Int J Biol Markers 31, e211 – e217 (2016)
Provenance and risk in transfer of biological materials. Nielsen et al. PLoS Biol 16, e2006031. https://doi. org/10.1371/journal.pbio.2006031 (2018)
Protecting participants in health research: The South African Material Transfer Agreement. Labuschaigne et al. S Afr Med J, 109, 353-356 (2019).
The European IVDR will have major impact on the IVD industry as essentially all devices falling under the scope of the IVDR will require new or re-certification of devices. It will also affect health institutions developing and using in-house devices. In order to demonstrate conformity with the IVDR, data have to be provided on acceptable sample pre-analytical parameters (e.g. ischemia duration, transport duration, fixation condition etc.) for which the performance of an IVDMD has been shown. Dagher et al, New Biotechnology 52, 121-125 (2019).
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, 4.IV.1997. European Treaty Series – No. 164
Article 21 – Prohibition of financial gain.
The human body and its parts shall not, as such, give rise to financial gain.
Explanatory Report to Oviedo Convention
Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.
On article 21: It states in particular that the human body and its parts must not, as such, give rise to financial gain. Under this provision organs and tissues proper, including blood, should not be bought or sold or give rise to financial gain for the person from whom they have been removed or for a third party, whether an individual or a corporate entity such as, for example, a hospital. However, technical acts (sampling, testing, pasteurisation, fractionation, purification, storage, culture, transport, etc.) which are performed on the basis of these items may legitimately give rise to reasonable remuneration. For instance, this Article does not prohibit the sale of a medical device incorporating human tissue which has been subjected to a manufacturing process as long as the tissue is not sold as such. Further, this Article does not prevent a person from whom an organ or tissue has been taken from receiving compensation which, while not constituting remuneration, compensates that person equitably for expenses incurred or loss of income (for example as a result of hospitalisation).
Commentary on the Oviedo Convention
Is the commercialisation of human tissue and body material forbidden in the countries of the European Union? Lenk and Beier. J. Medical Ethics 38. (2012)
The Convention on Human Rights and Biomedicine twenty years later: a look at the past and a step towards the future. Petrini and Ricciardi. Ann Ist Super Sanità 54, 171-173 (2018)
Human Tissue Authority (UK)
HTA’s policy on the sale of human bodies, body parts and tissue.
“Establishments, such as medical schools or research tissue banks, may charge for providing human tissue to other establishments or researchers, including those working for private companies, so that their running costs are recovered. Where cost recovery, or any other charging mechanism, is in place it is important that establishments are able to satisfy themselves the information provided to potential donors is sufficient to ensure they understand that their tissue samples may be shared, subject to a fee being charged. We also recommend that establishments ensure transparency by providing easily accessible information about how and why they charge, and to whom they will supply human tissue. This is important to ensure that the consent sought from donors is fully informed.”
Human Biomedical Research Act 2015 (Singapore)
In some countries like Singapore, commercial trading of human tissue is prohibited by law. To illustrate this fact, section 32 of Singapore’s Human Biomedical Research Act states that:
(1) Subject to subsections (4) and (5), a contract or an arrangement under which a person agrees, for valuable consideration, whether given or to be given to himself or herself or to another person, to the sale or supply of any human tissue from his or her body or from the body of another person, whether before or after his or her death or the death of the other person, as the case may be, is void.
(2) A person who enters into a contract or an arrangement of the kind referred to in subsection (1) and to which that subsection applies shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.