PUBLIC HEALTH SERVICE POLICY RELATING TO DISTRIBUTION OF UNIQUERESEARCH RESOURCES PRODUCED WITH PHS FUNDING

 

NIH GUIDE, Volume 25, Number 23, July 12, 1996

 

P.T. 36



Keywords:

  Grants Administration/Policy+ 

  RESEARCH RESOURCES 

 

Public Health Service

 

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

NIH Guide for Grants and Contracts, Vol. 23, No. 26, July 15, 1994.

 

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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