A P3G generic access agreement for population genomic studies

摘要: The Public Population Project in Genomics and Society (P3G) is a not-for-profit consortium that provides the international research community with access to expertise, resources innovative tools for harmonization of health social sciences research. (www.p3gconsortium.org) This “Generic Access Agreement” tool developed use by population genomic studies (also often called biobanks or resources). Over past decade, anticipation expanding demand researchers industry, large collecting DNA samples worldwide have been developing principles policies ensure ethical legal procedures their resource respect participant consent (see Table 1). These are now being operationalized into agreements clearly stipulate obligations institutions who wish these resources. agreement typically final step request process, following submission successful review an application access.1 Table 1 Existing Agreements, Related Policies Guidelines Reviewed This P3G Generic Agreement attempts address both sharing data materials (i.e. biospecimens). All named 1 provide data, while some may additionally allow biological themselves, under certain conditions. While many aspects apply uniformly between materials, there considerations unique such as limited depletable nature. Our proposed aims foster level uniformity addressing together. Access must be drafted clearly, not only so aware obligations, but also order “the border acceptable unacceptable conduct delineated predictable…”2 Explicit sanctions important respond effectively any breach. balanced: harsh enough deter abuse yet discourage access. We surveyed available literature, policies, attempt identify norms. norms captured Agreement.” Its utility, however, extends beyond suggesting best practices, it enhance procedures. Researchers should encounter completely different procedure each time they study. Mindful national cultural heterogeneity, seeks promote scientific knowledge common good shared, appropriate protections place. adoption this will hopefully improve transparency interoperability samples. It problematic simply rely on existing agreements. First, significant heterogeneity exists studies, reflect peculiarities. harmonize core conditions considered all studies. Second, rarely samples. Third, tend conceived highly legalistic terms. drafting approach because lacks clarity needed communicate clear understandable expectations commitments. offers principled analysis content agreements, explicit clauses comprehensibility among researchers. It essential isolation. Harmonization, at current implementation stage reinforce sample norms, equitable procedures, researcher familiarity simplified Ultimately, bioethical principles3 accompanying them transparent playing field across translation medicine. The has drawn variety sources. A selection material members was reviewed determine elements. Access-related documents from – publication intellectual property forms were coherent integration. General encourage access.4,5,6,7 sources listed 1. From results our review, provisional generic team Centre Policy McGill University. draft then circulated two iterations comments revisions International Steering Committee.8 resulting version discussed approved via consensus Committee Board P3G.9 A few adopted preparation document: brevity; simple language (as read scientists administrators training); limiting template elements uniform treatment applications, reduce negotiation study researchers, customization local needs laws. Certain issues encountered document. There uncertainty concerning commensurability Initially, list “special samples.” require quality, security, liability, disposal upon termination, we found could largely integrated general used agreement. Significant discussion went Intellectual Property definition “Invention” European Parliament Council’s Directive biotechnological inventions.10 reflected tension incentivizing allowing patent protection inventions, promoting valorization future build findings solution protect potential downstream patentability reserving robust, open license sublicense. Thus, inventions explicitly recognized, reference directives judged offer balance interests. Finally, types mentioned included. most reasons overly technical legalistic, too specific type merit inclusion agreement. The success depend ability adequately promotion regulation access. Research suffer if strict; participants liberal. strike balance, Agreement’s member help establish standard Their effective enhanced promoted.