Sharing Materials Integral to Published Findings
Sharing of materials integral to a published work is a responsibility of authorship. For consistency with the spirit of the uniform principle for sharing integral data and materials expeditiously (UPSIDE), materials described in a scientific paper should be shared in a way that permits other investigators to replicate the work described in the paper and to build on its findings. Sharing facilitates new scientific and commercial advances, eliminates duplicative efforts by others to recreate materials, and speeds the progress of science.
Making publication-related materials available begins logically with providing readers with information about them. For example, authors might anticipate which materials integral to their publications are likely to be requested and state in the “Materials and Methods” section or elsewhere how to obtain them. (It is appropriate, in this context, for scientific reviewers of papers submitted for publication to help to identify such materials.)
Some authors find that providing access to publication-related data and material is increasingly time-consuming and expensive. Creative solutions to solve these problems need to be found, and requestors of materials should accept some responsibility for the cost of distribution. A frequently requested reagent could be made reasonably available by an author’s laboratory for a modest fee to cover the costs of production, quality control, and shipping. Repositories are another option. For example, plant germplasm can be deposited in distribution
centers, cell lines could be submitted to the American Type Culture Collection, and mutant mice and the means to re-derive them could be sent to the Mouse Mutant Regional Resource Center or the Jackson Laboratory. In some fields, the use of repositories is a mandatory requirement of publication. Vouchers for studies in systematic and evolutionary biology, including paleontology, are deposited in museums and similar facilities, where they are available for further study and reinterpretation. Without the deposited vouchers, it would be impossible to verify and build on the results of papers in those fields.
Distribution centers are desirable, but not every reagent or biological material can be disseminated through them. Although the community pays a premium when an author uses a commercial licensee to distribute materials, as long as the materials are provided at a reasonable cost, this method of distribution is generally acceptable. Public granting institutions should be receptive to requests for supplemental funds to support the distribution of materials in high demand. An author has an obligation to anticipate requests and make arrangements for responding to them over time, but if this proves impossible, an author should provide requestors with information on how to reconstruct the material or on how the material was obtained.
When publication-related materials are requested of an author, it is understood that the author provides them (or has placed them in a repository) for the purpose of enabling further research. That is true whether the author of a paper and the requestor of the materials are from the academic, public, private not-for-profit, or commercial (for-profit) sector. Authors have a responsibility to make published materials available to all other investigators on similar, if not identical, terms. Prospective authors should be aware that publishing implies an obligation to share patented or copyrighted materials for research purposes. Therefore, if intellectual property rights are associated with a material, a research license should be made available to investigators who request it. If an author does not have rights to distribute the material, the contact information for its original source should be supplied.
The act of publishing information related to a patented material or
process should not destroy the commercial interests of an author. However, an author (and an author’s institution) must be willing to enable the community to use and build on that information by conducting further research. A good example is MIT’s patented process for small interfering RNAs (siRNAs). Individual investigators can seek a research license for the process directly from MIT but can also obtain one by purchasing RNA oligonucleotides from vendors commercially licensed by MIT to incorporate a research license for MIT’s process in the vendor’s product. MIT is also considering whether to negotiate commercial licenses with companies that wish to use process in the development of new therapeutic products (as opposed to research reagents).
MATERIAL TRANSFER AGREEMENTS
Since the 1980s, transfers of materials between investigators (and between investigators’ institutions) in the life sciences have been routinely accompanied by material transfer agreements (MTAs). An MTA defines the rights of the recipient to the use of a material, such as the right to undertake modifications, explore new uses of the material, and seek new inventions by using the material. It also defines how rights to intellectual property resulting from use of the material, if any, are apportioned between the material provider and the recipient.
Transfers of materials between parties are not always related to requests to authors after publication of a scientific paper. The terms of MTAs negotiated for transfers unrelated to publication may be, for various reasons, complex and far-reaching. Such MTAs may contain extreme restrictions on the use of a material, give the provider title to any new inventions that result from its use, include requirements to review the recipient’s research progress related to use of the material, and have other terms. MTAs of this kind are often negotiated in the transfer of (unpublished) materials between companies and universities, but also occur in other contexts—for example, countries that grant permission to allow the export of biological samples for scientific study often prohibit their subsequent use for commercial purposes or distribution to commer-
cial entities. Transfers of that type between two institutions outside the publication process were not discussed at the workshop and are beyond the scope of this report. They stand in contrast with MTAs that are negotiated as a direct consequence of a request for material related to a published work.
If the transfer of a material described in a scientific publication requires an MTA, an author should provide, in the appropriate section of the paper, the URL of a Web site where the MTA can be viewed. According to the principle of publication, an author has an obligation to ensure that material will be provided to other investigators under terms that do not block their ability to engage in the research necessary to replicate the author’s work or build on the publication’s findings. MTAs can support the objectives of publication and sharing by incorporating a minimal set of straightforward terms that do not interfere with the conduct of research. Terms that are consistent with the spirit of sharing publication-related materials and that acknowledge the provider’s contribution of a material include
A requirement that the provider be acknowledged as a source of the material in any publication by the recipient.
A prohibition against use of the material for work with human subjects, including diagnostic testing, if the material has not been approved for use with human subjects.
An acknowledgment that transfer of the material does not affect the legal title to it.
A requirement that the recipient not disseminate the material to others outside his or her laboratory without the provider’s permission.
A requirement that the material be used only for research purposes; that is, where the primary intention of the research is the fundamental increase in knowledge. This excludes its manufacture for sale, licensing to others, or contract research undertaken for a commercial concern.
A general description of the research for which the recipient
intends to use the material (to eliminate frivolous or irresponsible requests).
A provision that disclaims any warranties on the material and excludes the provider from any liability for damages that arise from the use, storage, transport, or disposal of the material by the recipient, including liability related to the recipient’s infringement of any third-party intellectual property rights.
Terms that burden the recipient with unnecessary requirements or impede the transfer of materials are inappropriate in an MTA associated with publication-related materials and defeat the intention of sharing them. Unacceptable terms include
Requirements for periodic reporting of research findings related to the use of the material.
Ownership by the provider of the recipient’s data or other research results.
Limitations on the recipient’s ability to publish research results.
Limitations on the recipient’s ability to discuss research results with his or her laboratory members before publication.
Automatic coauthorship rights for the provider.
Terms like those slow the progress of science by unfairly extending the provider’s rights beyond the material into the recipient’s work and by interfering with a recipient’s participation in research-related activities. For example, a recipient of materials may through their own research arrive at conclusions that differ from those published by the provider of the materials; if required to collaborate or coauthor downstream publications, they would be inhibited from communicating their contrary findings, much to the detriment of the scientific process. Requiring prepublication review—a common term in MTAs currently used by many institutions—is inappropriate if the transfer involves only materials related to a published paper, as opposed to a situation in which additional confidential information about the material will be provided to the
recipient. It is a courtesy to send the provider of a material a copy of a paper before publication, but it should not be a requirement of the MTA. Similarly, it is a courtesy, but should not be a condition of sharing, to require the recipient to notify the provider if patent applications will be filed on new inventions related to the material or its use.
RIGHTS TO NEW INVENTIONS
MTAs that accompany transfers of a publication-related material that might have commercial potential raise more complex issues. Those MTAs will inevitably focus on the provider’s rights to the potential fruits of research realized through the recipient’s use of the material. These include what are called new inventions: improvements of the material, new uses of the material, and new substances created through the use of the material. Specific terms related to those types of new inventions are often a source of contention during the negotiation of MTAs.
The UPSIDE principle can be used to resolve some issues raised in MTAs by identifying clearly unacceptable terms that intrinsically block the recipient of a material from doing research to replicate and build on the author’s findings. For example, it is not acceptable for an author to demand an exclusive license to commercialize a new substance that a recipient makes with the material. A recipient’s ability to conduct research might require the use of multiple materials from different providers, and as a matter of logic, the recipient cannot grant multiple exclusive commercial licenses to providers of all the materials used in making the new substance. Therefore, a provider’s demand for an exclusive license to a new substance effectively blocks the recipient from assembling the materials needed to build the edifice of science.
There is currently no community standard that addresses a provider’s request for a commercial license to the recipient’s improvements to or new uses of a publication-related material. Transfers between academic institutions of materials created with National Institutes of Health (NIH) funding do not generally include any provisions granting the
provider a license to commercialize inventions made with transferred materials. NIH has put forward a uniform biological MTA and simple letter agreement as templates for transfers of materials arising from NIH-funded research (NIH, 1999). Although not necessarily appropriate for MTAs negotiated outside the context of NIH-funded research, those models are considered to be reasonable vehicles for the transfer of most published materials.
The negotiation of an MTA in which the provider seeks rights to new inventions made through the use of the material is the most challenging. The lack of standardized terms for dealing with improvements and new uses of publication-related materials is a reflection of the commercial interests of the institutions involved in the transfer, whether they are for-profit or not-for-profit entities. Those interests overwhelm the application of the principle of publication as a means to guide the negotiation of MTAs.
Therefore, other factors have evolved as the basis of what an author can acceptably request in an MTA. For example, when a provider’s material is protected by patents, a request for an exclusive commercial license to improvements and new uses of the material is often deemed acceptable because the provider can often legally block others from exploiting those new inventions anyway. If the material is not patented, requests by the provider of a material for exclusive commercial licenses to improvements and new uses made by the recipient may be accepted or rejected by a recipient’s institution, depending on whether the provider plans to contribute in some way to the recipient’s work with the material. If the provider will not contribute funds or other types of support, such a request is often rejected because it is viewed as an overreaching claim for reward for work neither done nor envisaged. If the provider of a material requests a nonexclusive commercial license to inventions made through the use of the material, negotiations between institutions often focus on the specific facts of the case, such as the true importance of the material provided, how integral it will be to the recipient’s prospective work and whether the new inventions might block the provider of
material from exploiting the original material. Some negotiations may elaborate whether, in exchange for the right to a commercial license, the provider must pay royalties to the recipient.
There are many contrasting views in the technology-transfer community about what is appropriate in an MTA in any given situation and for any particular material. Because there are so many nuances in the negotiation of these issues (the examples given above are not exhaustive), there is a potential for delay in reaching agreement, and sometimes there is an impasse. The proliferation of MTAs with idiosyncratic requirements set by multiple institutions is, in the end, an impediment to sharing publication-related materials.
The purpose of sharing publication-related materials is to enable research—that is, to allow the recipients of material to replicate and build on the work of the authors—and the terms of MTAs and their negotiation should not create a barrier to this goal. All institutions engaged in technology transfer should closely examine the merits of adopting a standard MTA, and efforts to streamline the process need to be championed at the highest levels of universities, private research centers, and commercial enterprises. The NIH guidelines for sharing research resources are useful as a starting point for the discussion (NIH, 1999).
In the meantime, both practicality and expediency should be embraced in procedures for transferring publication-related materials. Commercial and proprietary interests notwithstanding, an author’s fulfillment of the quid pro quo includes ensuring that MTAs related to materials described in the author’s publications are not burdened by protracted negotiations over terms. As a best practice, a period of 60 days for the negotiation of publication-related MTAs would eliminate uncertainty for requesters of materials and remove what is currently perceived as a substantial barrier to the ability of investigators to move forward with their research plans. Institutions should consider whether MTAs are necessary for every material transferred, and universities, in particular, should provide adequate resources to support the effective and expeditious management of MTAs. If sharing publication-related materials in a timely fashion is important to participants in the publication process,
participants should encourage their institutions to commit to achieving that goal.
In its exploration of sharing publication-related materials, the committee identified the following principles of publication:
Principle 4. Authors of scientific publications should anticipate which materials integral to their publications are likely to be requested and should state in the “Materials and Methods” section or elsewhere how to obtain them. If an MTA is required, the URL of a Web site where the MTA can be viewed should be provided. If the authors do not have rights to distribute the material, they should supply contact information for their original source. A frequently requested reagent can be made reasonably available in the commercial market or by an author’s laboratory for a modest fee to cover the costs of production, quality control, updating, and shipping.
Principle 5. If a material integral to a publication is patented, the provider of the material should make the material available under a license for research use.
The following recommendations address actions that, if adopted by the life-sciences community, would expedite the process of sharing publication-related materials:
Recommendation 2. It is appropriate for scientific reviewers of a paper submitted for publication to help to identify materials that are integral to the publication and likely to be requested by others and to point out cases in which authors need to provide additional information on obtaining them.
Recommendation 3. It is not acceptable for the provider of a publication-related material to demand an exclusive license to commercialize a new substance that a recipient makes with the
provider’s material or to require collaboration or coauthorship of future publications.
Recommendation 4. The merits of adopting a standard MTA should be examined closely by all institutions engaged in technology transfer, and efforts to streamline the process should be championed at the highest levels of universities, private research centers, and commercial enterprises.
Recommendation 5. As a best practice, participants in the publication process should commit to a limit of 60 days to complete the negotiation of publication-related MTAs and transmit the requested materials or data.