**The Prospective Investigation of Pulmonary Embolism Diagnosis
(PIOPED)**

**Data Distribution Agreement**

The National Heart, Lung, and Blood Institute (NHLBI) and (Name of
Recipient Organization) hereby enter into this Distribution Agreement as
of the date specified on the final page hereof.

PRELIMINARY STATEMENT

The National Heart, Lung, and Blood Institute (NHLBI) has supported
collection of data from participants in the Prospective Investigation of
Pulmonary Embolism Diagnosis (PIOPED), hereafter referred to as "Study".
This well-characterized population provides a unique scientific
resource. Promoting optimal use of it on a national scale will require a
large and concerted effort that may exceed the research capacity of
currently available Study investigators. The NHLBI and the researchers
it supports have a responsibility to the public in general, and to the
scientific community in particular, to encourage as rapid scientific
progress as possible using this resource, subject to appropriate terms
and conditions. In order to take full advantage of the resources and
maximize its research value, it is important that the data that were
collected with public funds be made available, on appropriate terms and
conditions, to the largest possible number of qualified investigators in
a timely manner.

Although data collected by the Study have been stripped of all personal
identifiers, the wealth of data available on individual participants
might make possible their identification. To protect the confidentiality
and privacy of Study participants, Recipients who are granted access to
Study data must adhere to the requirements of this Distribution
Agreement and obtain IRB approval for their project. IRB approval may be
from an expedited or convened review, but a simple IRB letter granting
an exemption is not sufficient. Failure to comply with this Distribution
Agreement could result in denial of further access to Study Data.
Violation of the confidentiality requirements of this agreement is
considered a breach of confidentiality and may leave requesting
investigators liable to legal action on the part of Study participants,
their families, or the U.S. Government.

The Study Investigators have made a substantial long-term contribution
in establishing and maintaining the clinical database. The NHLBI
encourages appropriate collaborative relationships by outside
investigators with the Study Investigators and proper acknowledgement of
the contributions of the Study Investigators.

DEFINITIONS

Data: For purposes of this agreement, "Data" refers to the following
information that has been collected and recorded from Study participants
through the periodic examinations and follow-up contacts conducted
pursuant to the Study Investigators' contracts or awards with the NHLBI
and through associated ancillary studies (where available):

Data from the Prospective Investigation of Pulmonary Embolism Diagnosis
(PIOPED).

PIOPED Investigator: A "PIOPED Study Investigator" is a research
investigator with a current and active contract or consulting agreement
with the NHLBI or one of its contractors to work on the PIOPED study.

RECIPIENT: Recipient is (check one):

a non-profit organization organized under the laws of the State of
(State Name) OR

a for-profit corporation organized under the laws of the State of (State
Name) OR

a government agency organized under the laws of the (United States or
State Name).

Principal Investigator:

 (Name of PI)    , with a principal address at        (**"**PI")
requests access to Study data at his/her sole risk and at no expense to
the Study or the NHLBI.

AGREED TERMS AND CONDITIONS

It is mutually agreed as follows:

Number range CHAPTER1. [Research Project]{.underline}.

1.1 The PI, for the Requestor requests (check one)

Non-Commercial Purpose Data Set

Commercial Purpose Data Set

> 1.2. These Data will be used by the PI in connection with the
> following research project (\"Research Project\"), specifically
> described in an attached Exhibit A. The Project description should
> include: project title, a 1-2 paragraph description of the objectives
> and design, and a brief description of the analysis plan.
>
> Note: If the PI is requesting a Genetic/Pedigree Data Set, the
> Research Project description must describe a specific need for it.
> Investigators using these data are strongly discouraged from
> publishing individual pedigree structures and are prohibited from
> investigating issues such as non-paternity.
>
> 1.3. The Research Project (check one) \[does\]\[does not\] involve
> PIOPED Study Investigator(s) as co-investigator(s). If the Project
> does involve PIOPED Study Investigator(s), their names are: (Study
> investigator name(s) if project involves a collaboration with Study
> investigators) and the work they will perform is described below or in
> an attached Exhibit B:
>
> (Brief description of the role of Study investigators named above in
> the proposed research project)
>
> 1.4. Recipient will promptly notify the NHLBI of any substantive
> changes to the proposed Research Project or of any new projects to be
> initiated from the requested Data. Such notification will consist of a
> new project description as described in paragraph 1.2. Data will be
> used solely for Research Projects disclosed to the NHLBI.
>
> 1.5. This Agreement will terminate three (3) years from the effective
> date of this agreement. Continued use of the Data will require
> execution of a new Distribution Agreement as specified in paragraph 6.

2\. [Non-transferability]{.underline}. This Distribution Agreement is
not transferable. Recipient agrees that appointment by Recipient of
another Principal Investigator to complete the Research Project will
require execution of a new Distribution Agreement in which the new
Principal Investigator is designated. Recipient also agrees that it will
recover from the PI all Data received under this agreement should the
PI's employee relationship with the Recipient terminate for any reason.

3**.** [Publication]{.underline}. Prompt publication or other public
disclosure of the results of the Research Project is encouraged.
Recipient agrees to provide to the NHLBI a copy of any manuscript or
other disclosure document thirty (30) days in advance of submission for
publication, in order to ensure compliance with the confidentiality
requirements set forth in paragraphs 4,5,6,7,and 8 of this Agreement.

Number range CHAPTER4. [Acknowledgments]{.underline}. Recipient agrees
to acknowledge the contribution of the Study Investigators in any and
all oral and written presentations, disclosures, or publications
resulting from any and all analyses of Data.

4.1. [Collaborations/Acknowledgments]{.underline}. If the Research
Project involves collaboration with Study Investigators (see paragraph 1
above), then the PI will comply with all policies established by the
Study's publications committee. In addition, the Recipient will
acknowledge the source of the data by including language similar to the
following either in the acknowledgment or in the text of the manuscript:
'This manuscript was prepared using a limited access dataset obtained
from the NHLBI'.

4.2. [Other Studies/Acknowledgments]{.underline}. If the Research
Project does not involve collaboration with Study Investigators (see
paragraph 1 above), all manuscripts or other disclosure documents should
be submitted to the NHLBI thirty (30) days in advance of submission for
publication. In addition, the PI will use the acknowledgment printed
below. \[The process for review of manuscripts by NHLBI is described in
Attachment 1.\]

"The Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED)
is conducted and supported by the NHLBI in collaboration with the PIOPED
Study Investigators. This Manuscript was prepared using a limited access
dataset obtained from the NHLBI and does not necessarily reflect the
opinions or views of the PIOPED or the NHLBI."

5\. [Non-Identification]{.underline}. Recipient agrees that Data 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 Data were obtained.

6\. [Use Limited to Three (3) Years]{.underline}**.** Recipient agrees
that Data will be removed or destroyed when three (3) years have elapsed
from the effective date of this Agreement. Further use of the Data
beyond that time requires completion of a new Distribution Agreement
along with a current IRB approval resulting from either IRB review of a
new research protocol or continuing review of the existing research
protocol.

7**.** [No Distribution]{.underline}. Recipient agrees to retain control
over Data, and further agrees not to transfer Data, with or without
charge, to any other entity or any individual.

8\. [Non-Data]{.underline}. Notwithstanding the definition of "Data" or
the agreed Terms and Conditions of this Distribution Agreement,
Recipient's obligations under this Distribution Agreement shall not
extend to any information:

(a) that can be demonstrated to have been publicly known at the time of
    disclosure; or

(b) that can be demonstrated to have been in the possession of or that
    can be demonstrated to have been readily available to Recipient from
    another source prior to the disclosure; or

(c) that becomes part of the public domain or publicly known by
    publication or otherwise, not due to any unauthorized act by
    Recipient; or

(d) that can be demonstrated as independently developed or acquired by
    Recipient without reference to or reliance upon Data provided under
    this Agreement; or

(e) that is required to be disclosed by law, provided the Recipient
    takes responsible and lawful actions to avoid and/or minimize such
    disclosure.

9\. [Non-Endorsement, Indemnification]{.underline}. Recipient agrees not
to claim, infer, or imply endorsement by the United States government or
any of its agencies of the Research Project, the entity, or personnel
conducting the Research Project or any resulting commercial product(s)
except as described in paragraph 4. To the extent permitted by law,
Recipient agrees to hold the United States Government, Study
Investigators, and all other investigator(s) who generated Data and the
agents and employees of each of them, harmless and to defend and
indemnify all such parties for all liabilities, demands, damages,
expenses, and losses arising out of Recipient\'s use of Data for any
purpose.

10\. [Recipient\'s Compliance with IRB Requirements]{.underline}.
Recipient acknowledges that the conditions for use of Data are not
exempt from review and have been approved by the Recipient\'s
Institutional Review Board (IRB) operating under an Office of Human
Research Protections (OHRP) - approved Assurance and in accordance with
Department of Health and Human Services regulations at 45 CFR Part 46.
Recipient agrees to comply fully with all such conditions. Recipient
agrees to report promptly to the NHLBI any proposed change in the
research project and any unanticipated problems involving risks to
subjects or others. This Agreement is made in addition to, and does not
supercede, any of Recipient's institutional policies or any local,
State, and/or Federal laws and regulations that provide additional
protections for human subjects.

11\. [Amendments]{.underline}. Amendments to this Agreement must be made
in writing and signed by authorized representatives of all parties.

12\. [Termination]{.underline}. The NHLBI may terminate this Agreement
if Recipient is in default of any of its conditions and such default has
not been remedied within 30 days after the date of written notice of
such default by an authorized representative of the NHLBI.

13\. [Disqualification, Enforcement]{.underline}. Failure to comply with
any of the terms specified herein may result in disqualification of
Recipient from receiving additional Data. The United States Government
shall have the right to institute and prosecute any proceeding at law or
in equity against the Recipient for violating or threatening to violate
the confidentiality requirements of this agreement, the limitations on
the use of the data provided, or both. Proceedings may be initiated
against the violating party, legal representatives, and assigns, for a
restraining injunction, compensatory and punitive damages, mandamus,
and/or any other proceeding in law or equity, including obtaining the
proceeds from any intellectual property or other rights that are derived
in whole or in part from the breach of the confidentiality requirements
or use limitations of this agreement. In addition, Recipient
acknowledges and agrees that a breach or threatened breach of the
confidentiality requirements or use limitations of this agreement may
subject Recipient to legal action on the part of Study subjects, their
families, or both.

14\. [Accurate Representations]{.underline}. Recipient certifies that
the contents of any statements made or reflected in this document are
truthful and accurate.

15\. [Duplication of Research]{.underline}. Recipient acknowledges that
other researchers are entitled to access to Data on the same terms as
Recipient so that duplication of PI's research may occur.

**Signatures begin on the next page.**

This Agreement is entered into as of
:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ (effective date)

[RECIPIENT]{.underline}:

Name of Recipient :(Name of Recipient Institution)

Name and Title of Recipient\'s Authorized Institutional Business
Official: [\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

Signature and Date of Recipient\'s Authorized Institutional Business
Official: [\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

![](media/image1.wmf){width="6.55in" height="6.25e-2in"}

[PRINCIPAL INVESTIGATOR]{.underline}:

Principal Investigator\'s Name and Title:      

Principal Investigator\'s Surface Mail Address:      

     

     

     

Principal Investigator\'s E-Mail Address:      

Principal Investigator\'s Telephone Number:      

Principal Investigator\'s Fax Number:      

Principal Investigator Signature and Date:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

[NHLBI:]{.underline}

NHLBI Authorized Representative \-- Name and Title:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

![](media/image1.wmf){width="6.55in" height="6.25e-2in"}

NHLBI Authorized Representative \-- Signature and Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

![](media/image1.wmf){width="6.55in" height="6.25e-2in"}

**ATTACHMENT 1**: **Guidelines for Manuscripts and Abstracts from
Investigators Who Use Limited Access Datasets**

[Manuscript Review Policy]{.underline}

The NHLBI reviews manuscripts from PIs who use limited access datasets
only for compliance with the terms of this Data Distribution agreement.
Specifically, manuscripts should not present case studies that describe
the characteristics of individual participants, or of just a small
number of participants. The PI must be a coauthor on all manuscripts and
abstracts, and the acknowledgment as set forth in section 4 must
accompany all manuscripts. Manuscripts and abstracts should be submitted
to the NHLBI authorized representative prior to the end of the three (3)
year limit on use of the data.

Abstracts, in general, can not use the acknowledgment as described in
section 4; therefore, abstracts should clearly indicate within the text
that the source of the data was a limited access dataset obtained from
the NHLBI.

In addition to a review for compliance with the terms of this Data
Distribution Agreement by NHLBI's authorized representative, manuscripts
and abstracts may be forwarded to NHLBI staff familiar with the Study or
to Study investigators for comment. If NHLBI staff or Study
investigators choose to offer additional comments, these are provided to
the Principal Investigator only as courtesy. Limited access
investigators are not obligated to incorporate additional comments from
other NHLBI staff or Study investigators; however, these comments may
provide the investigator with additional insights towards improving the
manuscript.

[Additional Guidelines for Manuscripts/Abstracts using Limited Access
Data]{.underline}

Since many limited access databases are from ongoing studies,
manuscripts and abstracts should not use the name of the study in the
title of the manuscript/abstract unless the title clearly denotes the
source of the data as being from a limited access database (e.g.,
"\...An application from the PIOPED limited access dataset"). The
purpose is to delineate manuscripts from Study investigators who must
obtain prior Study approval and review from those prepared by
investigators who do not have to do so.

Manuscripts submitted to the NHLBI by investigators using limited access
datasets are reviewed within 10-14 days and abstracts are reviewed
within 3-7 days. Expedited reviews can be requested. Additional comments
from NHLBI staff or Study investigators, if any, are forwarded to the
limited access investigator once they are received by the NHLBI
authorized representative. Additional comments from NHLBI or Study
investigators may be forwarded to the Principal Investigator prior to or
after review by the NHLBI authorized representative.