NIH GUIDE, Volume 23, Number 26, July 15, 1994

P.T. 36


  Biomed. Research Resources, Other 

Public Health Service

This announcement is a republication of the one last appearing in the

NIH Guide for Grants and Contracts, Vol. 21, No. 33, September 11,


Investigators conducting biomedical research frequently develop unique

research resources.  Categories of these resources include:  synthetic

compounds, organisms, cell lines, viruses, cell products, cloned DNA,

as well as DNA sequences, mapping information, crystallographic

coordinates, and spectroscopic data.  Some specific examples are:

specialized and/or genetically defined cell lines, including normal and

diseased human cells; monoclonal antibodies; hybridoma cell lines;

microbial cells and products; viruses and viral products; recombinant

nucleic acid molecules; DNA probes; nucleic acid and protein sequences;

certain types of animals such as transgenic mice; and intellectual

property such as computer programs.  The PHS provides the following

statement of policy concerning unique research resources developed

through PHS awards.

A.  Policy on Distribution of Research Resources

The policy of the PHS is to make available to the public the results

and accomplishments of the activities that it funds. Restricted

availability of unique resources upon which further studies are

dependent can impede the advancement of research and the delivery of

medical care.  Therefore, when these resources are developed with PHS

funds and the associated research findings have been published or after

they have been provided to the agencies under contract, it is important

that they be made readily available for research purposes to qualified

individuals within the scientific community.  This policy applies to

PHS intramural investigators as well as extramural scientists funded by

PHS grants, cooperative agreements, and contracts.

Because of concern that some crystallographers are not making their

coordinates available promptly (see Science, Vol. 245, p. 1179), one of

the national advisory councils of the NIH and the executive committee

of another institute recently adopted resolutions affirming the policy

of the International Union of Crystallographers (IUCr) (Acta Cryst.,

A45: 658, 1989).  The PHS has now adopted the IUCr policy that includes

data from publications based on spectroscopic data such as nuclear

magnetic resonance as well as crystallographic coordinates.

The PHS encourages investigators who have such resources to consult the

appropriate Program Administrators who may be of assistance in

determining a suitable distribution mechanism. Such a mechanism should

take into consideration all applicable Federal regulations including,

but not limited to:  those regarding human subjects, animal welfare,

and use and handling of hazardous materials, where applicable.

Investigators requesting materials should provide evidence of having

the proper training, experience, and facilities to make use of the

items they request. Program staff of the agencies will be available to

assist in verification of credentials of requesters where such concern

exists on the part of suppliers.

Investigators who believe that they will be unable to implement this

policy should promptly contact the appropriate PHS Program

Administrator to discuss the circumstances, obtain information that

might facilitate compliance with the policy, and reach an understanding

in advance of the subsequent award.  For research and development

contracts, approval should be obtained from the PHS Contracting Officer

before distribution of unique resources, unless the terms of the

contract permit distribution without prior clearance of the Contracting

Officer.  In order to facilitate the availability of unique or novel

biological materials and resources developed with PHS funds,

investigators may distribute the materials through their own laboratory

or institution or submit them, if appropriate, to entities such as the

American Type Culture Collection or other repositories.  In the case of

unique biological information, such as DNA sequences or

crystallographic coordinates, investigators are expected to submit them

to the appropriate data banks because they otherwise are not truly

accessible to the scientific community.  When distributing unique

resources, investigators are to include pertinent information on the

nature, quality, or characterization of the materials.

Investigators must exercise great care to ensure that resources

involving human cells or tissues do not identify original donors or

subjects, directly or through identifiers, such as codes linked to the

donors or subjects.

The goals of some programs, (e.g., the Human Genome Program) are such

that applicants for certain projects may be required to provide plans

for the sharing of data and materials.  These plans will undergo review

by program staff and the national advisory council prior to award.

B.  Distribution Costs

Institutions and investigators may charge the requester, if necessary,

for the reasonable cost of production of unique biological materials,

and for packaging and shipping,  Such costs may include labor,

supplies, and other directly related expenses. Investigators should

note, however, that such a charge accrues as general program income.

This should not be an impediment to the distribution of materials, but

investigators and institutions are advised that:

a) for grants, the income is governed by 45 CFR Part 74 and it must be

reported on the Financial Status Report.  Questions regarding these

policies and the treatment of income should be directed to the Grants

Management Officer.

b) for contracts, the income is governed by Federal Acquisition

Regulations (FAR) 45.610-3.  Contracting Officers must be contacted

before generating any revenues from the distribution of materials.  Any

contract under which research resources would be sold require specific

contract instructions.  Existing contracts may require an amendment and

specific approval of the Contracting Officer to render them allowable.

C.  Inventions and Commercialization

Federal policy encourages the commercialization of the products of

research developed as a consequence of Federal funding; therefore, the

intent of this policy is to not discourage, impede, or prohibit the

organization that develops unique research resources or intellectual

property from commercializing the products.  Investigators may make

their materials available to others for commercial purposes with

appropriate restrictions and licensing terms as they and their

institution deem necessary.

Institutions are reminded that some of these products may be inventions

subject to the various laws and regulations applicable to patents and

must be reported to the Extramural Inventions Reports Office of the

NIH.  The terms for licensing of unpatented research products, such as

cell lines, monoclonal antibodies, and other materials and products,

should generally be no more restrictive than would have been the case

had they been patented---for example, only if there is full public

disclosure of the invention/discovery, availability through a

repository, and written agreement to end all fees and constraints after

17 years. When reporting is required, it should occur at the earliest

possible time.  (See 37 CFR 401 and NIH Guide for Grants and Contracts,

Vol. 19, No. 6, February 9, 1990.)


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