Issue Date: October 4, 2004
The idea of sharing resources in biomedical research in a timely way is nothing new at the National Institutes of Health. The agency has a long-standing policy governing the sharing of NIH-funded research. After all, sharing of biomaterials, reagents, and data reduces research costs by avoiding duplication of effort and facilitating more rapid progress in the biomedical field.
Model organisms covered by this policy include both mammalian models, such as the mouse and rat, and nonmammalian models, such as budding yeast, social amoebae, roundworms, fruit flies, zebra fish, and frogs. Research resources include genetically modified or mutant organisms, embryos, protocols for genetic and phenotypic screens, mutagenesis protocols, and genetic data. The policy applies to all applications and proposals for NIH grants, cooperative agreements, and contracts, regardless of budget size.
Although the evaluation of the policy for sharing resources will not generally be included in the evaluation and scoring of the project by peer review, the plan will be reviewed along with the proposal and commented on in an administrative note. Researchers will have to work with NIH program staff to resolve any concerns before an award is made. Grantees who fail to comply with an approved sharing plan risk losing future NIH grants for themselves and their institution.
After Oct. 1, researchers who submit proposals "basically have to address the issue of how they're going to share whatever model organism that would result from their grants," says Norka Ruiz Bravo, deputy director for extramural research at NIH. "There are a number of model plans that researchers might be able to present, from something very simple where they have nothing at the beginning to something quite complex that tries to address some of the relevant intellectual property issues," she notes, adding that three example plans and other important information about this policy are available at http://grants.nih.gov/grants/policy/model _organism/index.htm.
NIH originally issued the policy in May, and then worked with the people who provided input to address their concerns. The results have been incorporated into a set of frequently asked questions (FAQs) available on the website, explains Joseph J. Ellis, acting director of NIH's Office of Policy for Extramural Research Administration. The FAQs serve as a "living document" for interpreting the policy, which is unchanged from the one posted in May.
One group that has voiced its concern over the implementation of the policy is the Council on Government Relations (COGR), an association of research universities. Robert B. Hardy, director of contracts and intellectual property at COGR, explains that, even though NIH has been very responsive to the concerns that the group has raised since release of the policy earlier this year, COGR would like NIH to address a few more issues.
One of these deals with the renegotiation of material transfer agreements (MTAs) with third-party material providers. NIH does include some guidance for dealing with MTAs; however, "it doesn't address the issue of incoming MTAs with terms that may conflict with the NIH sharing policy," Hardy says. "We've been concerned that this might necessitate substantial renegotiation of MTAs so that investigators can comply with this new policy," he notes.
COGR is also concerned that NIH decided that the penalty for noncompliance in this case would be the possible denial of future agency funding for both the researcher and the institution. "Noncompliance with the sharing policy should be treated the same way as noncompliance with any other NIH funding requirement," Hardy says.
In addition, Hardy raises the question of who will pay for the maintenance and distribution of these model organisms and related material. According to Ellis, researchers can write the cost for these activities into their grant, or if the costs arise after the grant is awarded, they can apply for supplemental funds.
"Investigators should take advantage of the available repositories when possible, which would remove a lot of the cost issues for them in sharing," Ellis says. "Also, if they can't secure funds from us, they can provide reasonable charges for sharing," he notes. But for Hardy, this lack of assurance that additional NIH support will be available remains a concern.
Hardy also points out that although extramural scientists will now be subject to this broad policy, intramural scientists are subject to sharing policies only with regard to mice. However, according to Ellis, the issue is being addressed, and there is a plan to draft a complementary policy for intramural scientists.
"We have taken what I hope is a commonsense approach to this policy," Ruiz Bravo says. "We've developed a set of FAQs and will update them as new things arise. We are just going to have to learn as we go along."
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