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NIDA Distribution Agreement
The National Institute on Drug Abuse supports research projects in which there
is collection by scientific investigators ("Submitters") of blood samples and
clinical data from affected and unaffected individuals and their relatives to
help identify gene variants that confer increased vulnerability to addiction;
Blood samples collected by Submitters, stripped of all personal identifiers
and thus not linked to the individuals from whom they were obtained, are provided
to the NIDA Center for Genetic Studies ("the Center"), as operated under an
NIDA contract to Rutgers University and subcontract to Washington University,
for the production of immortalized cell lines and extraction of DNA (cell lines
and DNA samples are collectively known as "Biomaterials");
Anonymous data on family structure, age, sex, vital status, addiction status,
and other clinically relevant information ("Clinical Data") collected by Submitters,
stripped of all personal identifiers and thus not linked to the individuals
from whom they were obtained, are provided to the Center;
Anonymous data derived from genotyping, mutation analysis, and other genetic
analyses of Biomaterials and Clinical Data ("Genetic Analysis Data") conducted
by Submitters and other scientists, stripped of all personal identifiers and
thus not linked to the individuals from whom they were obtained, are provided
to the Center;
The Center maintains, as a national resource, Biomaterials, Clinical Data,
and Genetic Analysis Data on addiction and related disorders that are distributed
to a receiving Institution ("the Recipient") for analysis by scientific investigators
certified by the NIDA Genetic Data Access Request Committee. Of the Biomaterials
only DNA is available to the Recipient. However, Submitters of the anonymized
blood sample may receive both DNA and immortalized cell lines from the samples
that they submitted;
It is mutually agreed as follows:
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The Recipient uses the DNA, Clinical Data, and Genetic Analysis Data at
its sole risk and at no expense to NIDA.
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NIDA, through the Center, agrees to transfer to the Recipient DNA for exclusive
use by the Recipient's principal investigator ("Recipient's Principal Investigator")
and his or her staff to conduct research.
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The Recipient will submit to NIDA an Access Request using the format specified
by NIDA. In addition, the Recipient will submit to NIDA this signed and
dated Distribution Agreement for each Access Request for Biomaterials, Clinical
Data, and Genetic Analysis Data.
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Biomaterials, Genetic Analysis Data, and Clinical Data received from the
Center will be used exclusively by the Recipient's Principal Investigator
in connection with a specific genetic research project ("Research Project")
for which the Recipient's Principal Investigator has responsibility to administer
and execute through his/her staff, and which is explicitly described on
ATTACHMENT PAGES as part of the Access Request. This description will specify
which Genetic Analysis Data are expected to be produced in the proposed
Research Project.
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Recipients who propose to use Biomaterials in the Research Project described
in the Access Request must request those Biomaterials no later than one
year from the date on which Clinical Data and Genetic Analysis Data are
made available by the Center. If Biomaterials are not requested within that
time period, the proposed Research Project will be deemed terminated. At
that time, the Recipient will notify NIDA and provide written certification
that any and all Clinical Data and Genetic Analysis Data were destroyed
by the Recipient, unless the Recipient obtains NIDA's agreement to an extension
of the agreement. Any such extension must be in writing and in accordance
with the terms and conditions under which NIDA is distributing data and
biomaterials at that time.
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The Recipient agrees to provide NIDA, through the Center, with any and
all Genetic Analysis Data derived from Clinical Data and Biomaterials received
under this Distribution Agreement. The Recipient will provide to the Center
such Genetic Analysis Data twelve (12) months after receipt of Biomaterials
or immediately upon publication of research in which such data were analyzed,
whichever comes first, and, if further analyses are generated, annually
thereafter upon the anniversary of this date or immediately upon further
publication. This will continue until the Research Project is completed.
NIDA, through the Center, may at any time distribute these Genetic Analysis
Data to qualified scientific investigators conducting biomedical research
at recognized institutions, subject to any patents or pending patent applications
of the Recipient. The Recipient will provide Genetic Analysis Data, indexed
by NIDA subject ID number, in the electronic format specified by the Center.
When genotyping has been conducted, DNA marker names and allele sizes in
base pairs or single nucleotide polymorphisms will be provided for each
individual subject, as indexed by NIDA subject ID number. Descriptive information
about each typed marker, including marker name, allele sizes in base pairs
and corresponding frequencies, relative distances in megabases and in centimorgans,
marker heterozygosity, and the source of information used to determine map
location, will also be provided. The Recipient also agrees to submit to
the Center all data relevant to the establishment of family structure as
determined from laboratory analysis, at the time such determinations are
made.
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This Distribution Agreement is not transferable to another Recipient or
to another facility that is not under the control of the Recipient. The
Recipient's Principal Investigator cannot transfer the Research Project
to a different institution unless NIDA agrees to a new Distribution Agreement
with that institution. The Recipient cannot appoint a new Principal Investigator,
conduct the Research Project at a different facility, or make other substantive
changes, unless NIDA agrees to an appropriate amendment of this Distribution
Agreement.
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The Recipient agrees to retain control over Biomaterials, Clinical Data
and Genetic Analysis Data received from the Center and further agrees not
to provide them, with or without charge, to any other entity or any individual
other than the Recipient's Principal Investigator.
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NIDA, through the Center, agrees to provide the Recipient's Principal Investigator
with Clinical Data, and accompanying documentation.
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NIDA, through the Center, agrees to provide the Recipient's Principal Investigator
with periodic updates of Clinical Data, including updates of family structure
as determined from laboratory analysis of DNA samples, if available.
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NIDA, through the Center, agrees to provide the Recipient's Principal Investigator
with periodic updates of Genetic Analysis Data, if available, including
the name and address of the scientists who generated such Genetic Analysis
Data.
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DNA is provided according to the fee structure indicated. This fee is subject to change following written notification from NIDA. The Recipient agrees to pay any and all fees to the Center.
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The Recipient's Principal Investigator will acknowledge the contribution
of scientists who generated Genetic Analysis Data received from the Center,
in any and all oral and written presentations, disclosures, and publications
resulting from any and all analyses of these Genetic Analysis Data. The
Recipient's Principal Investigator will provide to NIDA a list of all such
presentations, disclosures, and publications.
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When the Research Project is completed, the Recipient must notify NIDA
and provide written certification of the destruction of Biomaterials, Clinical
Data, and Genetic Analysis Data received from the Center in accordance with
any applicable laws and/or accepted safety procedures. The Research Project
shall be deemed completed for purposes of this agreement three (3) years
after the effective date of this agreement, unless the Recipient obtains
NIDA's agreement to an extension of the agreement. Any such extension must
be in writing and in accordance with the terms and conditions under which
NIDA is distributing data and biomaterials at that time.
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The Recipient agrees that Biomaterials, Clinical Data, and Genetic Analysis
Data received from the Center will not be used, either alone or in conjunction
with any other information, in any effort whatsoever to establish the individual
identities of any of the subjects from whom Biomaterials, Clinical Data,
and Genetic Analysis Data were obtained.
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The Recipient agrees that Biomaterials, their progeny, and unmodified or
modified derivatives thereof will not be used in any experiments or procedures
that are not disclosed and approved as part of the Research Project, and
will not be used in human experimentation of any kind.
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NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE MERCHANTABILITY
OR FITNESS FOR ANY PURPOSE OF THE BIOMATERIALS, CLINICAL DATA, AND GENETIC
ANALYSIS DATA PROVIDED BY THE CENTER TO THE RECIPIENT UNDER THIS AGREEMENT,
OR THAT THE BIOMATERIALS, CLINICAL DATA, AND GENETIC ANALYSIS DATA MAY BE
EXPLOITED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY OR PROPRIETARY RIGHTS
OF ANY THIRD PARTIES.
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The United States Government and its contractor and subcontractor that
operate the Center are not responsible for the accuracy of Clinical Data
and Genetic Analysis Data, provided by Submitters and other Recipients,
which are distributed by the Center.
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The Recipient acknowledges that Biomaterials have the potential for carrying
viruses such as HIV and hepatitis, latent viral genomes, and other infectious
agents in an unapparent state. The Recipient agrees to treat Biomaterials
received from the Center as if they were not free of contaminations, and
that Biomaterials will be handled by trained persons under laboratory conditions
that afford adequate biohazard containment. By accepting Biomaterials from
the Center, the Recipient assumes full responsibility for their safe and
appropriate handling, to the extent allowed by applicable law.
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The Recipient agrees not to claim, infer, or imply Governmental endorsement
of the Research Project, the institution, or personnel conducting the Research
Project or any resulting commercial product(s). To the extent permitted
by law, the Recipient agrees to hold the United States Government, its contractor
and subcontractor that operate the Center, Submitters, and other Recipients
providing Genetic Analysis Data to the Center harmless and to indemnify
all such parties for all liabilities, demands, damages, expenses, and losses
arising out of the Recipient's use for any purpose of Biomaterials, Clinical
Data, and Genetic Analysis Data received from the Center.
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The Recipient acknowledges that the conditions for use of Biomaterials,
Clinical Data, and Genetic Analysis Data must be approved by the Institutional
Review Board (IRB) of their own institution and the IRB of the NIDA contractor
and subcontractor that operate the Center in accordance with Department
of Health and Human Services regulations at 45 CFR Part 46. The Recipient
agrees to comply fully with all such conditions and to report promptly to
NIDA any proposed changes in the Research Project and any unanticipated
problems involving risks to subjects or others. The Recipient remains subject
to applicable State or local laws or regulations and institutional policies
that provide additional protections for human subjects.
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NIDA may terminate this Distribution Agreement if the Recipient fails to
comply with any of the terms specified herein and if the failure to comply
has not been remedied to the satisfaction of NIDA within 30 days after the
date of written notice by NIDA that Recipient is not in compliance with
the Distribution Agreement. Upon termination of this Distribution Agreement,
the Recipient agrees to return all unused Biomaterials, Clinical Data, and
Genetic Analysis Data to the Center, or provide NIDA with written certification
of their destruction.
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Failure to comply with any of the terms specified herein may result in
disqualification of The Recipient from receiving additional Biomaterials,
Clinical Data, and Genetic Analysis Data from NIDA, as provided by the Center.
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NIDA reserves the right to distribute, through the Center, any and all
Biomaterials, Clinical Data, and Genetic Analysis Data to others and to
use them for its own purposes.
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Amendments to this Distribution Agreement must be made in writing and agreed
to by both parties.
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The Recipient expressly certifies that the contents of any statements made
or reflected in this Distribution Agreement are truthful and accurate.
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This Distribution Agreement shall be construed in accordance with Federal
law as applied by the Federal courts in the District of Columbia.
Name and Title, Recipient's Principal Investigator
Mailing Address, Recipient's Principal Investigator
Telephone Number, Recipient's Principal Investigator
Fax Number, Recipient's Principal Investigator
E-Mail, Recipient's Principal Investigator
Name and Title, Receiving Institution's Authorized Representative
Mailing Address, Receiving Institution's Authorized Representative
Telephone Number, Receiving Institution's Authorized Representative
Fax Number, Receiving Institution's Authorized Representative
E-Mail, Receiving Institution's Authorized Representative
DATED SIGNATURES
Signature and Date, Recipient's Principal Investigator
Signature and Date, Receiving Institution's Authorized Representative
Signature and Date, NIDA Center for Genetic Studies' Authorized Representative
Signature and Date, NIDA's Authorized Representative
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