The replication of results is one of the basic tenets of the scientific method. But if discoveries are made with unique model organisms or other materials that no one else can use, reproducibility becomes more difficult and expensive, if not impossible.
Although the National Institutes of Health has required recipients of its grants to share these unique resources, a new policy that went into effect October 1 requires researchers to include in grant applications specific plans for sharing model organisms and related materials.
Despite the fact that sharing is required by many funding agencies and journals, many researchers still refuse to share data and resources. For example, a survey of academic life scientists published in the Journal of the American Medical Association in 2002 by Eric Campbell, Ph.D., found that 34% of those surveyed had been denied a request for data or materials and 8.9% admitted to denying a request in the previous 3 years.
"We've structured science not to be a sharing environment. It's a competition," said Campbell, an assistant professor in the Institute for Health Policy at Harvard Medical School in Boston. Among the reasons researchers cited for not sharing were the desire to protect the ability of junior scientists or themselves to publish, the intent to commercialize the work, and industry agreements that prohibit giving materials to a third party. The most common reason, however, was the effort it would take to produce the materials. "Sharing, especially of biomaterials, is expensive," said Campbell.
But, he added, "This issue is not whether people are sharing or not sharing. It's what are the consequences." Not only does the failure to share materials erode the ability of the scientific enterprise and prevent science from being done, he said, but it also affects the education of students by preventing them from doing cutting-edge research and leads to the creation of a new generation of scientists who are more likely to withhold data and materials themselves.
NIH had decided to develop the new sharing policy because of reports from members of the mouse research community "that, despite the fact that there was ample precedence for sharing, and the guidelines from NIH for sharing unique research resources had been around for quite awhile, some investigators would never produce or share models," said Joe Ellis, acting director of the NIH Office for Policy on Extramural Research Administration.
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Administrators eventually extended the policy to include all model organisms, including mammalian models, such as mouse and rat, and nonmammalian models, such as yeast, roundworm, fruit fly, zebrafish, and frog. The policy also covers related resources, including the actual organisms, sperm, embryos, protocols for genetic and phenotypic screens, mutagenesis protocols, and genetic and phenotypic data for all mutant strains.
All extramural grant applications in which the development of model organisms is expected should include a description of a plan "for sharing and distributing unique model organism research resources generated using NIH funding" or "state appropriate reasons for why such sharing is restricted or not possible," according to the new policy.
Applications that do not include a sharing plan at the time of submission will not be returned without review, said Ellis, although he expects that, when appropriate, a plan will be integrated into any award by the time it is finalized. Only applications in which the production of model organisms is an integral part may be rejected outright for failure to include a sharing plan, he said.
Researchers who do not follow an agreed-upon plan for sharing will be dealt with by the individual institute or center that funded an award, which will determine an appropriate response. Investigators who are having difficulty obtaining resources from NIH-funded scientists are advised to first request materials in writing and then go through their own institution's technology transfer office or office of sponsored programs to try to obtain the materials. The NIH program that funds their work or the work that generated the material being requested may also be able to help get the materials.
Although there is general agreement among the research community that sharing of materials and data is an essential part of doing research, the new NIH policy did meet with some initial resistance. Shortly after the policy's release in May, the Council on Government Relations (COGR)an association of research universitiessent a letter to NIH objecting to the new policy. Among their complaints were that the policy did not state how third-party rights would be dealt with or what instructions grant reviewers would get from NIH. They also asked if simple statements of intention to commercialize a resource or deposit it in a repository would be sufficient.
In response, NIH worked with COGR to develop a Web site (http://grants.nih.gov/grants/policy/model_organism/index.htm) released in September that includes frequently asked questions and examples of plans for sharing model organisms and resources. "They [COGR] were very useful in helping us clarify our policy and make it more clear for the community and provide additional resources because they pointed out some areas that we really did need to clarify and expand upon," said Ellis.
Despite their dialogue with NIH, COGR still has several issues with the new sharing policy, including the enforcement, as both the researcher and institution may be penalized for violations. In addition, although researchers can request funds to cover costs associated with sharing plans, there is "no assurance that additional NIH support would be forthcoming," said Robert Hardy, director of contracts and intellectual property management for COGR.
COGR is also concerned about third-party rights and that some institutions may not be able to renegotiate some materials transfer agreements to comply with the new policy, said Hardy.
Agreements that restrict sharing may need to be revisited and made more flexible, Ellis said. "The thing that we need to keep in mind when we're working with the NIH projects and the support we provide is that we have an expectation that when you engage in agreements that they don't conflict [with] the principles and expectations of NIH funding."
Another COGR criticism is that the policy applies only to extramural scientists. Intramural NIH researchers are not required to develop advanced sharing plans, and this is "a burden on the extramural community," Hardy said. Researchers who have problems obtaining materials from NIH intramural researchers will have some help soon, however, because the agency plans release two Web pages that specifically address this issue, Ellis said.
Both COGR and NIH plan to wait for feedback from the research community before revisiting the sharing policy. The research community "has been surprisingly quiet so far," said Ellis, "so we're hoping it won't be a major transition for [them] to deal with this." Over time, the new policy should become ingrained in the community, he said, and "once that does happen, I think things will go much more smoothly."
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