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:
- The Recipient uses the DNA, Clinical Data, and Genetic Analysis Data at its sole risk and at no expense to NIDA.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- NIDA, through the Center, agrees to provide the Recipient's Principal Investigator with Clinical Data, and accompanying documentation.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Amendments to this Distribution Agreement must be made in writing and agreed to by both parties.
- The Recipient expressly certifies that the contents of any statements made or reflected in this Distribution Agreement are truthful and accurate.
- 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