Michiel Verlinden

Access to human tissues for research and product development

Human organs and tissues differ in regard to their clinical and research uses and the regulatory legislation controlling their use. Organs such as livers and hearts are usually taken from donors who are brain‐dead; in addition, kidneys can also come from live volunteers. Organs decay rapidly and need to be transplanted quickly. Surgeons and coordination teams in transplantation centres control the procurement, while dedicated national and international organisations facilitate their allocation. Human tissues such as bone, skin and heart valves are usually removed from cadavers in hospitals, morgues or even funeral homes and, unlike organs, can be stored—sometimes for years—in tissue banks. These tissues can be used in numerous recipients as and when they are needed. In the early days of human tissue banking, not‐for‐profit banks, mostly located in hospitals, dominated the field. The tissues they stored—heart valves and skin, for example—saved many lives. > Human tissues for research are said to be worth more than diamonds, being valued at US

Qualitative study on custodianship of human biological material and data stored in biobanks.

500/g. Since the 1980s, the demand for human tissues has increased dramatically. The first tissue in significant demand was human bone for use in allografts in orthopaedic surgery. In the 1990s, the emerging field of regenerative medicine, which generates human tissue‐engineered products (hTEPs), began to require access to human tissues. Eventually, pharmaceutical companies began using human tissue instead of animals in the early stages of medical product testing. Human tissues for research are said to be worth more than diamonds, being valued at US

Toward a Tiered Model to Share Clinical Trial Data and Samples in Precision Oncology

500/g. ![][1] Inevitably, commercial tissue banks were set up to capitalise on this demand, starting in the USA. Most US tissue bank companies obtain their material through Willed Body Donation programs, run by the bank itself or through offshoots. They are allowed to charge processors and distributors “reasonable fees” for the procurement of cadaver tissue—harvesting, transportation, refrigeration and so … [1]: /embed/graphic-1.gif

IPRs in Biobanking: Risks and Opportunities for Translational Research

BackgroundBalancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials (HBM) and data.MethodsTwenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and applicants with respect to access to HBM and data.ResultsThere was no consensus among the informants on whether the custodian of a biobank should decide upon the scientific merits and the utility of an access request. Nearly all informants agreed that a new request or an amendment to the initial request has to be submitted when an applicant wants to use leftover HBM in a new or follow-up project. Several informants felt that it might be justified to charge higher access fees to external or industrial applicants that did not contribute (directly or indirectly) to the collection of HBM and data. Most informants agreed that a custodian of a biobank could request the sharing and return of research results. It was furthermore argued that some of the benefits of research projects should be fed back into biobanks.ConclusionsThe interviews revealed a rather complex web of rights and obligations allocated to the custodian and the applicant in relation to access to HBM and data stored in biobanks. Some rights and obligations are negotiated on a case-by-case basis, while others are stipulated in access arrangements. We did find a consensus on the attribution of certain general rights to the custodians and the applicant.

Access Rules within Biobank Networks

The recent revolution in science and technology applied to medical research has left in its wake a trial of biomedical data and human samples; however, its opportunities remain largely unfulfilled due to a number of legal, ethical, financial, strategic, and technical barriers. Precision oncology has been at the vanguard to leverage this potential of “Big data” and samples into meaningful solutions for patients, considering the need for new drug development approaches in this area (due to high costs, late-stage failures, and the molecular diversity of cancer). To harness the potential of the vast quantities of data and samples currently fragmented across databases and biobanks, it is critical to engage all stakeholders and share data and samples across research institutes. Here, we identified two general types of sharing strategies. First, open access models, characterized by the absence of any review panel or decision maker, and second controlled access model where some form of control is exercised by either the donor (i.e., patient), the data provider (i.e., initial organization), or an independent party. Further, we theoretically describe and provide examples of nine different strategies focused on greater sharing of patient data and material. These models provide varying levels of control, access to various data and/or samples, and different types of relationship between the donor, data provider, and data requester. We propose a tiered model to share clinical data and samples that takes into account privacy issues and respects sponsors’ legitimate interests. Its implementation would contribute to maximize the value of existing datasets, enabling unraveling the complexity of tumor biology, identify novel biomarkers, and re-direct treatment strategies better, ultimately to help patients with cancer.