Announcer: From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.

Megan Columbus:  Welcome to another edition of All About Grants. I’m your host, Megan Columbus, coming to you from the NIH Office of Extramural Research.  Today, our focus is on All About Sharing, that is, a discussion about NIH sharing policies. With us today, we have J.P. Kim, who is the Director of the Division of Extramural Inventions & Technology Resources in the Office of Extramural Research. Some investigators are puzzled when we mention that the NIH has data sharing and model organism sharing policies. They just assume they have always been able to ask any investigator for animal models, reagents, and other unique research resources.  J.P., can you talk to us about the purpose of NIH sharing policies?

J.P.:  Certainly, NIH sharing policies they actually exist to continue to promote the sharing of research resources that are developed using NIH funds.  It includes reagents, cell lines, animal models, and other research resources. Investigators have always been able to ask any other investigator for research resources, but even when I was a cancer researcher, I was aware that not all investigators shared their research resources as broadly as we had hoped.

Megan:  As applicants are developing their applications, is there anything investigators should consider in addressing the NIH data sharing policy, or the NIH model organism sharing policy, or other NIH sharing policies?

J.P.:  Yes, the best way for an investigator to develop plans and such, is that when developing their sharing plans, investigators they should confer with their institution’s sponsored research office regarding how these expectations should be addressed.  The institutional office knows the NIH policies and rules that they must comply with under NIH funding, as well as their own institution’s rules and policies. 

Megan: So when did NIH sharing policies go into effect?

J.P.:  Well, some people believe the sharing of research resources only began in 1999 with the adoption of the NIH Research Tools Policy, but you have to understand that sharing policies have been in the Grants Policy Statement since before 1976 in one form or another. The NIH has a mission to improve public health through research, and it actually has a longstanding legislative mandate to make available to the public the results of the research activities that it supports and conducts. So sharing policies are not new and have been in place for many years.

Megan:  What exactly do the policies address? What should be shared?

J.P.:  NIH sharing policies broadly address unique research resources that are developed with NIH funding. Different policies provide different examples, but the basic premise is the same, sharing of research resources funded by the NIH. For example, research resources can encompass both data and materials. Among these examples are data, cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools, methods, laboratory equipment and machines, as well as databases, software, materials subject to copyright.


Megan:  Does this include resources for which a patent application has been submitted?

J.P.:  Actually yes, the filing of a patent application does not exclude a research resource from being shared and being subject to NIH sharing policies.

Megan:  Let’s discuss some specific NIH policies. We’ll start with data sharing. What is the NIH data sharing policy?

J.P.:  Well the NIH data sharing policy came out in 2003 and is a policy that expects a sharing plan that needs to be submitted for applications requesting $500,000 or more in direct costs in any given year, or state why data sharing isn’t possible. This does not mean that investigators should not be sharing in other grant applications that don’t get to that threshold 500,000 amount. 

Megan:  What types of data should be shared?

J.P.:  Some examples include recorded factual data, especially unique data such as data collected from large surveys, from unique populations, under unique circumstances, and in the study of rare diseases. Of course, data from human subjects must obey privacy rules and the applicable informed consent forms.

Megan: So can you tell me a little bit now about the NIH model organism sharing policy?

J.P.:  The model organism sharing policy, like the 2003 data sharing policy, expects a sharing plan in any grant application which will develop a model organism. But unlike the data sharing policy, there is no threshold budget amount.

Megan: What types of model organisms does the policy apply to?

J.P.: The policy applies to non-human model organisms and related resources, and some examples include mammalian models, such as mice and rats, and non-mammalian models such as yeast, fruit flies, zebra fish, and worms. Specifically excluded from the policy are human specimens or human cells.

Megan: What do you mean by “related resources”?

J.P.:  Well, in addition to knock-out and transgenic animals, “related resources” would include, for example, genetic and phenotypic data, viral vectors, monoclonal antibodies, computer software and databases, stem cells, and any other resources that would aid in understanding biological systems.

Megan: So does the policy also apply then to the development of viruses, bacteria, and other organisms?

J.P.: Well, the policy specifically addresses eukaryotes, so prokaryote organisms are actually excluded.

Megan:  Okay, so now that you’ve given an explanation of data sharing policies and model organism sharing policies, can you talk to me more generally about what is the best way to comply with NIH sharing policies overall?

J.P.:  The most efficient and effective way to share research resources, whether it be data, model organisms or others, is to put them in a repository that is designed for distributing that type of resource.  NIH-funded repositories are likely the best option for researchers because, as NIH-funded repositories, those repositories’ operations need to comply with NIH sharing policies as a term and condition of their grant.

Megan: Thank you for joining us today, J.P. For NIH and OER this is Megan Columbus.

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