Material Transfer Agreements Research Articles

The Protection of Indigenous Peoples’ Seed Rights during Ethnobotanical Research

Recognition of the importance of biodiversity for global food security and the community food sustainability movement has helped increase awareness of seed rights. International treaties created to ensure the world’s access to seed biodiversity address access to seed banks for breeding purposes. Ethnobotanists are often required to deposit research plant specimens with government seed banks or herbariums. If Indigenous Peoples’ plants are then used developing patented varieties, are their rights recognized? These rights depend upon recognition of Indigenous Peoples as plant breeders, prior informed consent (PIC) protocols, access and benefit sharing (ABS) agreements via material transfer agreements, and benefits returned to Indigenous and local communities per the Nagoya Protocol. To ensure such rights to genetic material and associated intellectual property rights, documentation of these agreements and links to the people and communities from which they originated needs to occur at first collection and throughout subsequent research, conservation, and breeding programs.

Global Genome Biodiversity Network – Infrastructure for genomic research

Genomic research depends upon access to DNA or tissue collected and preserved according to high-quality standards. At present, the collections in most natural history museums do not sufficiently address these standards. In response to these challenges, natural history museums, culture collections, herbaria, botanical gardens and others have started to build high-quality biodiversity biobanks. Unfortunately, information about these collections remains fragmented, scattered and largely inaccessible. Without a central registry of relevant institutions, it is difficult and time-consuming to locate the needed samples. The Global Genome Biodiversity Network (GGBN) was created to fill this gap by establishing a central access point for locating samples meeting quality standards for genome-scale applications, while complying with national and international legislations and conventions (e.g. the Nagoya Protocol). The GGBN is rapidly growing and currently has 70 members and works closely together with GBIF, SPNHC, CETAF, INSDC, BOLD, ESBB, ISBER, GSC and others to reach its goals. Knowledge of biodiversity biobank content is urgently needed to enable concerted efforts and strategies in collecting and sampling new material and making ABS a reality. GGBN provides an infrastructure for making genomic samples discoverable and accessible. While respecting national law, GGBN requires that its members comply with the provisions of the Nagoya-protocol. Thus researchers, collection-holding institutions, and networks should adopt a common Best Practice approach to manage ABS, as has been developed by GGBN. A Code of Conduct; recommendations for implementing the Code of Conduct (the Best Practices), and implementation tools, such as standard Material Transfer Agreements (MTA) and mandatory and recommended data fields in collection databases, are tools which will aid compliance. This talk provides an overview of GGBN and comprises updates on GGBN’s best practices on ABS and the Nagoya Protocol, with examples of their use and applicability.

The Amsterdam ReBus progressor cohort: identification of 165 Barrett's surveillance patients who progressed to early neoplasia and 723 nonprogressor patients.

Patient selection is suboptimal in most studies focused on identifying biological markers for neoplastic progression in Barrett's esophagus (BE). This study aims to describe a stringently selected community-based case-control cohort of non-dysplastic BE (NDBE) patients who progressed to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) and BE patients who never progressed to be used for future biomarker studies. We identified all patients referred for endoscopic work-up of BE neoplasia at three tertiary referral centers for treatment of BE neoplasia between 2000 and 2013. We performed a detailed registration of any endoscopic surveillance history before neoplastic progression. Controls were selected from a retrospective BE surveillance registration in 10 community hospitals. A total of 887 patients were referred for endoscopic work-up of BE neoplasia. Based on predefined selection criteria, we identified 165 progressor patients (82% men; mean age 55 years ± 10.4) with a baseline endoscopy demonstrating NDBE > 2 years before neoplastic progression. Using the same predefined selection criteria, 723 nonprogressor patients (67% men; mean age 57 years ± 11.3) with >2 years of endoscopic surveillance were identified. Median length of the BE segment was 5 cm (IQR 4-7) in progressors and 4 cm (IQR 2-6) in controls. Median duration of surveillance was 89 months (IQR 54-139) in progressors and 76 months (IQR 47-116) in nonprogressors. Paraffin embedded biopsies are available for biomarker research in all patients. Ethical approval was obtained and material transfer agreements were signed with all 58 contributing pathology labs. This is the largest community-based case-control cohort of BE patients with and without progression to early neoplasia. The stringent selection criteria and the availability of paraffin embedded biopsy specimens make this a unique cohort for biomarker studies.

University licensing and the flow of scientific knowledge

As university involvement in technology transfer and entrepreneurship has increased, concerns over the patenting and licensing of scientific discoveries have grown. This paper examines the effect that the licensing of academic patents has on journal citations to academic publications covering the same scientific research. We analyze data on invention disclosures, patents, and licenses from the University of California, a leading U.S. academic patenter and licensor, between 1997 and 2007. We also develop a novel “inventor-based” maximum-likelihood matching technique to automate and generalize Murray's (2002) “patent-paper pairs” methodology. We use this methodology to identify the scientific publications associated with University of California patents and licenses.Based on a “difference-in-differences” analysis, we find that within our sample of patented academic discoveries, citations to licensed patent-linked publications are higher in the three years after the license, although this difference is not statistically significant. We then disaggregate our sample into (a) patented discoveries that are likely to be used as “research tools” by other researchers (based on the presence of material transfer agreements (MTAs) that cover them) and (b) patented discoveries not covered by MTAs. Citations to publications linked to licensed patents in the latter subset (not covered by MTAs) are higher for publications linked to licensed patents, and this difference is statistically significant. In contrast, licensing of patented discoveries that are also research tools is associated with a reduction in citations to papers linked to these research advances, raising the possibility that licensing may restrict the flow of inputs to “follow-on” scientific research.

The Use of MTAs to Control Commercialization of Stem Cell Diagnostics and Therapeutics

While much of the commentary on obstacles to stem cell research focuses on patents, material transfer agreements (MTAs) governed by state contract and property law present equal if not greater challenges to researchers. This Article argues that the life sciences in general, and the stem cell field in particular, are increasingly employing a lease-license model - similar to that used by the software industry - such that end users only license and/or lease both patent rights and the biological materials themselves. The absence of a sale allows owners of patents and physical biological materials to impose greater restrictions on end users than the owners could impose in the context of even a conditioned sale. At the same time, owners can often weave together their intellectual property rights and physical property rights in contracts such as MTAs to allow each type of property right to reinforce the other. However, the control afforded by such a model can be used for both positive as well as negative purposes. The Article uses the case of the control of stem cell patents and stem cell lines by Wisconsin Alumni Research Foundation (WARF) and its affiliate, the WiCell Research Institute, to illuminate this new trend in the life sciences. While the current stem cell research landscape is dominated by WARF's position, the Article offers ways that the California Institute for Regenerative Medicine (CIRM) and other public entities may use de facto research use exemptions to patent infringement to evade some of the reach of WARF's patents. The Article concludes by recommending that CIRM, and other stem cell research facilitators, initiate a comprehensive title chain plan that would govern biological materials from their original collection from donors through the materials' transfer first to non-commercial research entities and ultimately to commercialization firms. In this way, CIRM could play a role in encouraging positive uses of the lease-license model that could reduce the confusion and conflict currently surrounding the ownership, control, and use of biological materials in the life sciences.

Methodology for tissue sample collection within a translational sub-study of the CHHiP trial (CRUK/06/016), a large randomised phase III trial in localised prostate cancer

BackgroundThis article presents the methodology for tissue sample collection in Trans-CHHiP, the main translational study within the CHHiP (Conventional or Hypofractionated High dose intensity modulated radiotherapy in Prostate cancer, ISRCTN 97182923) trial. The CHHiP trial randomised 3216 men with localised prostate cancer to 3 different radiotherapy fractionation schedules. Trans-CHHiP aims to identify biomarkers of fraction sensitivity. MethodsWe outline the process of tissue collection, including central review by a study-specific specialist uropathologist and comparison of the centrally-assigned Gleason grade group with that assigned by the recruiting-centre pathologist. Results2047 patients provided tissue from 107 pathology departments between August 2012 and April 2014. A highly motivated Clinical Trials Unit chasing samples and a central Trans-CHHiP group that regularly reviewed progress were important for successful sample collection. Agreement in Gleason grade group assigned by the recruiting centre pathologist and the central study-specific uropathologist occurred in 886 out of 1854 (47.8%) cases. Key lessons learned were the need for prospective consent for tissue collection when recruiting patients to the main trial, and the importance of Material Transfer Agreement (MTA) integration into the initial trial site agreement. ConclusionsThis methodology enabled collection of 2047 patient samples from a large randomised radiotherapy trial. Central pathological review is important to minimise subjectivity in Gleason grade grouping and the impact of grade shift.

Provenance and Risk in Transfer of Biological Materials

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

SeedStor: A Germplasm Information Management System and Public Database.

SeedStor (https://www.seedstor.ac.uk) acts as the publicly available database for the seed collections held by the Germplasm Resources Unit (GRU) based at the John Innes Centre, Norwich, UK. The GRU is a national capability supported by the Biotechnology and Biological Sciences Research Council (BBSRC). The GRU curates germplasm collections of a range of temperate cereal, legume and Brassica crops and their associated wild relatives, as well as precise genetic stocks, near-isogenic lines and mapping populations. With >35,000 accessions, the GRU forms part of the UK’s plant conservation contribution to the Multilateral System (MLS) of the International Treaty for Plant Genetic Resources for Food and Agriculture (ITPGRFA) for wheat, barley, oat and pea. SeedStor is a fully searchable system that allows our various collections to be browsed species by species through to complicated multipart phenotype criteria-driven queries. The results from these searches can be downloaded for later analysis or used to order germplasm via our shopping cart. The user community for SeedStor is the plant science research community, plant breeders, specialist growers, hobby farmers and amateur gardeners, and educationalists. Furthermore, SeedStor is much more than a database; it has been developed to act internally as a Germplasm Information Management System that allows team members to track and process germplasm requests, determine regeneration priorities, handle cost recovery and Material Transfer Agreement paperwork, manage the Seed Store holdings and easily report on a wide range of the aforementioned tasks.

Pathogens collections, biobanks and related-data in a One Health legal and ethical perspective.

Research on emerging infectious diseases calls for a work on collections of pathogens (including hosts or vectors from which the pathogens were isolated), related to human and animal health, to wildlife or on the environmental material. In this respect, the adoption of a One Health perspective is determined by the need for a common approach to consider the collection, storage and use of pathogens coming from human or non-human sources, and particularly when the same pathogen is taken from different environments. In response to this development, our purpose is to delineate a flexible regulation framework concerning collections of pathogens from various origins or hosts and their associated data in order to facilitate scientific work and research partnerships. The legal and ethical cutting-edge research on Biomedical Big Data is particularly stimulating when it comes to address challenges related to collections or biobanks of pathogens such as prior informed consent and accessibility, Material Transfer Agreement or benefit sharing.

Challenges to developing cultivars in the public sector

Photo courtesy of Dean Calma/IAEA New plant cultivars are developed in both the private and public sector. Much of the work done in the private sector is focused corn, soy, and other high-value crops. Researchers in the public sector are more likely to deal with minor crops, perennials, or specialty crops within a specific geographical region and are typically based at land grant universities or with the USDA. Although public breeding programs have a high return on investment, there has been an overall decline in funding for them in recent decades. As funding has decreased, there has been an increase in intellectual property protections for cultivars developed at public universities. Intellectual property protection may provide a revenue stream for the university but can also limit the use of germplasm in further research and development. William Tracy, a plant breeder at the University of Wisconsin–Madison, and colleagues are interested in how increased intellectual property protections are impacting plant breeding in the public sector. Tracy is a co-author on a recent article in Crop Science (http://bit.ly/2wVzP5b) summarizing results of a survey that asked plant breeders how intellectual property and material transfer agreements (MTA) affect their work. Survey questions were developed with input from an intellectual property symposium. Focusing on the responses of plant breeders actively releasing finished cultivars, the article provides information about restrictions put on shared germplasm and the current status of plant breeding programs from across the U.S. The authors report that more than 50% of respondents indicated the most common source of new genetic material used in their own breeding programs is germplasm from other programs. In addition, almost all respondents reported sharing germplasm with others. However, approximately 60% of respondents indicated sharing germplasm under a material transfer agreement, and 70% of respondents indicated most or all of their cultivars had some form of intellectual property protection. Given the prevalence of intellectual property protection, it is not surprising that greater than 55% of respondents indicated intellectual property restrictions on germplasm from public breeding programs have a negative impact on their work. This suggests that the short-term gain in revenue from intellectual property protections could result in a long-term barrier to the development of new cultivars in the public sector. One way to alleviate some of the MTA restrictions, according to Tracy, would be if researchers could develop a set of agreed-upon best practices among public plant breeders. Currently, individual researchers and their universities set up MTAs, leading to wide variation in MTA restrictions from one institution to the next. With widely accepted guidelines, universities could balance the need for intellectual property protection, and researchers could gain greater access to germplasm sources to advance plant breeding programs. The survey also revealed how demographics could lead to a setback in public cultivar development and release in near future. More than 55% of respondents had been in the field for 21 or more years. As these individuals retire, cultivar release is likely to decline until early career breeders establish programs. Making the situation worse is the fact that almost a quarter of respondents said that there was no plan for their position to be maintained, and another third were unsure if their position would be continued. This would affect not only cultivar development, but also limit the potential for students to gain hands-on training in plant breeding, a skill that will still be in demand. One area of focus in public breeding could be to develop crops resilient to a more variable climate, Tracy says, such as, “profitable forage crops or perennial crops because perennial crops can better resist severe weather events and come back and grow quickly, perhaps getting the farmer some profit.” Tracy and his co-authors hope to bring the issues raised in this article to the attention of plant breeders and university administrators, who can help find a way to balance intellectual property with cultivar development and look for new opportunities for public-sector breeding programs in the future. Dig Deeper Read the full study in Crop Science: http://bit.ly/2wVzP5b.

Abstract 1369: DNA, protein, and cell line reagents to facilitate RAS pathway drug discovery efforts

Abstract The RAS Reagents Core within the NCI RAS Initiative produces and distributes qualified DNA vectors, cell lines, and protein production reagents to the external community to facilitate research into RAS biology and development of RAS cancer therapeutics. DNA vectors representing a variety of RAS mutations, as well as a complete collection of 180 genes in the RAS pathway are available as Gateway-compatible Entry clones. These clones represent the most commonly expressed transcript forms of the 180 genes, many of which were not previously available in full-length, wildtype forms. The vectors can be used with the FNLCR combinatorial cloning library to easily generate a large number of different types of expression clones with various promoters, fusion tags, and plasmid backbones. Cell line reagents include a variety of Ras-dependent mouse embryonic fibroblasts (MEFs) which have a defined mutant allele of KRAS and which serve as isogenic cell lines for investigating allele and mutant specific RAS biology, as well as for valuable screening tools. Protein reagents include E. coli and insect cell constructs and cell lines for production of a variety of Ras-related proteins. In particular, we have materials for the high yield production of properly processed, prenylated KRAS protein using a unique engineered insect cell expression system. This system can also be used to produce other prenylated small GTPases at levels not previously attainable. Many of the resources of the RAS Reference Core are readily available to the academic community through repositories or material transfer agreements, and can be licensed to industry scientists as well. The program is also interested in identifying the needs of the community for additional RAS-related resources, and is developing methods for vetting requests from the outside to provide additional reagents. Citation Format: Dominic Esposito. DNA, protein, and cell line reagents to facilitate RAS pathway drug discovery efforts [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 1369. doi:10.1158/1538-7445.AM2017-1369

Information Intellectual Property and the Global Information System for Plant Genetic Resources for Food and Agriculture

The International Treaty on Plant Genetic Resources for Food and Agriculture (Plant Treaty) establishes a mechanism for the accessing and sharing of some plant materials. An essential element of that accessing and sharing is information about the materials including information (and data) about the characterisation, regeneration and evaluation of the materials. A “Global Information System” (GLIS) will allow much of this information to be made available and shared. This article reviews the information obligations imposed by the Plant Treaty and its associated “Standard Material Transfer Agreement” on the collection and disclosures of information and other legal obligations that will likely shape the form and function of the GLIS. The article concludes that the GLIS will need to carefully distinguish between information that is freely available and information that is subject to legal restrictions.

SeedUSoon: A New Software Program to Improve Seed Stock Management and Plant Line Exchanges between Research Laboratories

Plant research is supported by an ever-growing collection of mutant or transgenic lines. In the past, a typical basic research laboratory would focus on only a few plant lines that were carefully isolated from collections of lines containing random mutations. The subsequent technological breakthrough in high-throughput sequencing, combined with novel and highly efficient mutagenesis techniques (including site-directed mutagenesis), has led to a recent exponential growth in plant line collections used by individual researchers. Tracking the generation and genetic properties of these genetic resources is thus becoming increasingly challenging for researchers. Another difficulty for researchers is controlling the use of seeds protected by a Material Transfer Agreement, as often only the original recipient of the seeds is aware of the existence of such documents. This situation can thus lead to difficult legal situations. Simultaneously, various institutions and the general public now demand more information about the use of genetically modified organisms (GMOs). In response, researchers are seeking new database solutions to address the triple challenge of research competition, legal constraints, and institutional/public demands. To help plant biology laboratories organize, describe, store, trace, and distribute their seeds, we have developed the new program SeedUSoon, with simplicity in mind. This software contains data management functions that allow the separate tracking of distinct mutations, even in successive crossings or mutagenesis. SeedUSoon reflects the biotechnological diversity of mutations and transgenes contained in any specific line, and the history of their inheritance. It can facilitate GMO certification procedures by distinguishing mutations on the basis of the presence/absence of a transgene, and by recording the technology used for their generation. Its interface can be customized to match the context and rules of any laboratory. In addition, SeedUSoon includes functions to help the laboratory protect intellectual property, export data, and facilitate seed exchange between laboratories. The SeedUSoon program, which is customizable to match individual practices and preferences, provides a powerful toolkit to plant laboratories searching for innovative approaches in laboratory management.

Mouse Models for Drug Discovery. Can New Tools and Technology Improve Translational Power?

The use of mouse models in biomedical research and preclinical drug evaluation is on the rise. The advent of new molecular genome-altering technologies such as CRISPR/Cas9 allows for genetic mutations to be introduced into the germ line of a mouse faster and less expensively than previous methods. In addition, the rapid progress in the development and use of somatic transgenesis using viral vectors, as well as manipulations of gene expression with siRNAs and antisense oligonucleotides, allow for even greater exploration into genomics and systems biology. These technological advances come at a time when cost reductions in genome sequencing have led to the identification of pathogenic mutations in patient populations, providing unprecedented opportunities in the use of mice to model human disease. The ease of genetic engineering in mice also offers a potential paradigm shift in resource sharing and the speed by which models are made available in the public domain. Predictively, the knowledge alone that a model can be quickly remade will provide relief to resources encumbered by licensing and Material Transfer Agreements. For decades, mouse strains have provided an exquisite experimental tool to study the pathophysiology of the disease and assess therapeutic options in a genetically defined system. However, a major limitation of the mouse has been the limited genetic diversity associated with common laboratory mice. This has been overcome with the recent development of the Collaborative Cross and Diversity Outbred mice. These strains provide new tools capable of replicating genetic diversity to that approaching the diversity found in human populations. The Collaborative Cross and Diversity Outbred strains thus provide a means to observe and characterize toxicity or efficacy of new therapeutic drugs for a given population. The combination of traditional and contemporary mouse genome editing tools, along with the addition of genetic diversity in new modeling systems, are synergistic and serve to make the mouse a better model for biomedical research, enhancing the potential for preclinical drug discovery and personalized medicine.

"It's all about trust": reflections of researchers on the complexity and controversy surrounding biobanking in South Africa.

BackgroundBiobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented.MethodsIn-depth qualitative interviews were conducted with a purposive sample of 21 researchers – 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40–60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors.ResultsResearchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements (MTAs) were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust.ConclusionBuilding trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0140-2) contains supplementary material, which is available to authorized users.

Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes.

Modern approaches for research with human biospecimens employ a variety of substantially different types of ethics approval and informed consent. In most cases, standard ethics reporting such as “consent and approval was obtained” is no longer meaningful. A structured analysis of 120 biospecimen studies recently published in top journals revealed that more than 85% reported on consent and approval, but in more than 90% of cases, this reporting was insufficient and thus potentially misleading. Editorial policies, reporting guidelines, and material transfer agreements should include recommendations for meaningful ethics reporting in biospecimen research. Meaningful ethics reporting is possible without higher word counts and could support public trust as well as networked research.

Biobank-based research on digestive peritoneal carcinomatosis (the BIG-RENAPE Biobank)

Access to good quality biological samples is a prerequisite for highlevel translational research. The BIG-RENAPE Biobank has been established by the French hyperthermic intraperitoneal chemotherapy centers involved in the management of peritoneal surface malignancies. The Biobank is a core facility aiming to support researchers who conduct studies with sample collections, both within and outside the Big- RENAPE Network. The Biobank is certified according to NFS 96-900 and has been launched in February 2016 as a service of processing, storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue (formalin-fixed-paraffin-embedded) samples from patients with digestive peritoneal carcinomatosis. Biospecimens are collected at each stage of diagnostic and therapeutic care. The patient and his derivates are anonymized and registered in a web database reporting disease status, treatments, surgical procedures, pathological diagnosis, quality of life’s assessment and long term follow-up. All participants have given their informed consent before any sample. The Biobank was approved by the local Ethical Committee, based on the assessed compliance to French regulatory rules. The Biobank is located in the Centre Hospitalier Lyon (SudBioTech), which is known to be an expert center in the management of the peritoneal carcinomatosis. Research projects that require material stored in the Biobank are submitted by specific form and evaluated by the BIG-RENAPE Scientific Committee. A material transfer agreement is agreed with the recipient before samples are allowed to be sent from the Biobank.

Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts.

Currently, researchers have to apply separately to individual biobanks if they want to carry out studies that use samples and data from multiple biobanks. This article analyzes the access governance arrangements of the original five biobank members of the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) project in Finland, Germany, the Netherlands, Norway, and the United Kingdom to identify similarities and differences in policies and procedures, and consider the potential for internal policy “harmonization.” Our analysis found differences in the range of researchers and organizations eligible to access biobanks; application processes; requirements for Research Ethics Committee approval; and terms of Material Transfer Agreements relating to ownership and commercialization. However, the main elements of access are the same across biobanks; access will be granted to bona fide researchers conducting research in the public interest, and all biobanks will consider the scientific merit of the proposed use and it's compatibility with the biobank's objectives. These findings suggest potential areas for harmonization across biobanks. This could be achieved through a single centralized application to a number of biobanks or a system of mutual recognition that places a presumption in favor of access to one biobank if already approved by another member of the same consortium. Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortia (BBMRI-ERIC), a European consortium of biobanks and bioresources with its own ethical, legal, and social implications (ELSI) common service, could provide a platform by developing guidelines for harmonized internal processes.

Streamlining the MTA Process to Alleviate the Burden on Technology Transfer Offices and Facilitate the Dissemination of Research Tools

Since the signing of the Bayh-Dole Act in 1980, the licensing of technology from academic institutions has become increasingly complex. Material transfer agreements (MTAs), intended to protect the owners of discoveries while promoting the sharing of scientific material, have become more human-resource intense and time-consuming. Technology transfer offices (TTOs), now present at most academic institutions, are tasked with the goal of becoming a profit center while simultaneously needing to facilitate the sharing of materials and data with other institutions, as dictated by the National Institutes of Health (NIH) guidelines for federally funded research. As a result, many TTOs operate without profit. Decreasing the complexity of the MTA process is paramount to not only create a more efficient TTO, but also to make the sharing of research tools easier so that the myriad of materials stored in laboratory freezers may be utilized by other investigators whose research would benefit from their use. For-profit and nonprofit companies and organizations have therefore created a variety of solutions to improve the MTA process. This article will discuss several of these programs, including electronic MTAs, standardized MTAs and repository strategies, and highlight how they have facilitated the sharing of research tools. Keywords: MTA, material transfer agreement, technology licensing, technology transfer, Bayh-Dole act, national Institutes of Health, NIH, research tools, research reagents, licensing.

Drafting biological material transfer agreement: a ready-to-sign model for biobanks and biorepositories.

Due to the scarcity of publications, guidelines, and harmonization among national regulations, biobanks and institutions face practical and theoretical issues when drafting a material transfer agreement (MTA), the fundamental tool to regulate the successful exchange of biosamples and information. Frequently researchers do not execute MTAs because of a general lack of knowledge about this topic. It is thus critical to develop new models to prevent loss of traceability and opportunities both for researchers and biobanks, their exposure to various risks, and delays in transferring biomaterials. Through the involvement of institutional groups and professionals with multidisciplinary expertise, we have drawn up a ready-to-sign MTA for the CRO-Biobank (the biobank of the National Cancer Institute, CRO, Aviano), a standardized template that can be employed as a ready-to-use model agreement. The team identified the essential components to be included in the MTA, which comprise i) permissions, liability and representations; ii) custodianship and distribution limitations; iii) appropriate use of materials, including biosafety concerns; iv) confidentiality, non-disclosure, and publications; v) intellectual property protection for both the provider and recipient. This paper aims to be an unabridged report (among the few works in the existing literature) providing a description of the whole process related to the formation of an MTA. Biobanks and institutions may consider adopting our ready-to-sign form as a standard model. The article discusses the most important issues tackled during the drafting of the document, thus proposing an operative approach for other institutions that face the same problems.