**Number range CHAPTER**

**The Honolulu Heart Program (HHP)**

**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 Honolulu Heart Program
(HHP), hereafter referred to as "Study". This well-characterized
population provides a rare and valuable scientific resource. Promoting
optimal use on a national scale of such a resource will require a large
and concerted effort which 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 these resources, subject to appropriate terms and
conditions. In order to take full advantage of such resources and
maximize their research value, it is important that data collected with
public funds be made available, on appropriate terms and conditions, to
the largest possible number of qualified investigators in a timely
manner.

Data collected by the Study have been stripped of all personal
identifiers but the wealth of data available on them might make possible
the individual identification of some subjects. To protect the
confidentiality and privacy of these participants, the Recipient who is
granted access to these data must adhere to the requirements of this
Distribution Agreement. 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 seeks
to encourage appropriate collaborative relationships by outside
investigators with the Study Investigators and to ensure that the
contribution of the Study Investigators is appropriately acknowledged.

DEFINITIONS

For purposes of this agreement, "Data" refers to the following
information, which has been collected and recorded from Study
participants through the periodic examinations and follow-up contacts
conducted pursuant to the Study Investigators' contract with the NHLBI:

Data from the Honolulu Heart Program (HHP).

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

RECIPIENT ORGANIZATION is (check one):

A \_\_\_ non-profit OR \_\_\_\_ for-profit corporation organized under
the laws of the State of \_\_\_\_\_. Or a government agency governed
under the laws of .

Principal Investigator requests access to Study data at its sole risk
and at no expense to the Study and NHLBI.

Principal Investigator:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
, with a principal address at
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
(**"**PI") requests access to Study data at no expense to the Study and
NHLBI.

AGREED TERMS AND CONDITIONS

It is mutually agreed as follows:

1\. [Research Project]{.underline}.

> 1.1. These Data will be used by Recipient\'s Principal Investigator
> solely in connection with the following research project (\"Research
> Project\"), specifically described below or in an attached Exhibit A:
>
> 1.2. The Research Project (circle one); \[does\]\[does not\] involve
> HHP Study Investigator(s) as co-investigator(s). If the Project does
> involve HHP Study Investigator(s), their names are: and the work they
> will perform is described below or in an attached Exhibit B:
>
> 1.3. This Distribution Agreement covers only the above-described
> Research Project. Recipient will submit a completed Distribution
> Agreement (this document) for each research project for which Data are
> requested.

2\. [Non-transferability]{.underline}. This Distribution Agreement is
not transferable. Recipient agrees that substantive changes made to the
Research Project described above, and/or appointment by Recipient of
another Principal Investigator to complete the Research Project, require
execution of a new Distribution Agreement in which the new Principal
Investigator and/or new Research Project are designated.

3**.** [Publication]{.underline}. Prompt publication or any public
disclosure of the results of the Research Project is encouraged.
Recipient agrees to provide to 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, and publications
resulting from any and all analyses of Data.

4.1. [Collaborations/Acknowledgments]{.underline}. If the Research
Project involves a collaboration with Study Investigators (see paragraph
1 above), then the manuscript will be reviewed by NHLBI and Recipient
will acknowledge Study Investigators and/or participants as required 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 a collaboration with Study Investigators (see
paragraph 1 above), then the manuscripts or other disclosure documents
should be submitted to the NHLBI thirty (30) days in advance of
submission for publication. The manuscripts will be reviewed by NHLBI
and Recipient will use the acknowledgment printed below. \[The process
for review of manuscripts by NHLBI is described in Attachment 1.\]

"The Honolulu Heart Program (HHP) is conducted and supported by the
NHLBI in collaboration with the HHP Investigators. This Manuscript was
prepared using a limited access dataset obtained by the NHLBI and does
not necessarily reflect the opinions or views of the HHP 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 Research Project]{.underline}**.** Recipient agrees
that Data will not be used in any research that is not disclosed and
approved as part of the Research Project.

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 Governmental endorsement 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
for any purpose of Data.

10\. [Recipient\'s Compliance with IRB Requirements]{.underline}.
Recipient acknowledges that the conditions for use of these 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 which provide additional
protections for human subjects.

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

12\. [Termination.]{.underline} NHLBI may terminate this Distribution
Agreement if Recipient is in default of any condition of this
Distribution Agreement and such default has not been remedied within 30
days after the date of written notice by NHLBI's Authorized
Representative of such default.

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 expressly
certifies that the contents of any statements made or reflected in this
document are truthful and accurate.

15\. [Duplication of Research]{.underline}. The recipient of the limited
access data acknowledges that other researchers have access to this data
set, and that duplication of research is a distinct possibility.

**Signatures begin on the next page.**

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

[RECIPIENT]{.underline}:

Name of Recipient Organization:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

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

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

Signature and Date of Recipient\'s Authorized Institutional Business
Official:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}![](media/image1.wmf){width="6.55in"
height="6.25e-2in"}

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

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

[PRINCIPAL INVESTIGATOR]{.underline}:

Principal Investigator\'s Name and Title:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

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

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

Principal Investigator\'s Surface Mail Address:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

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

Principal Investigator\'s E-Mail Address:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}
![](media/image1.wmf){width="6.55in" height="6.25e-2in"}

Principal Investigator\'s Telephone Number:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Principal Investigator\'s Fax
Number:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

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

[NHLBI:]{.underline}

Name and Title of NHLBI\'s Authorized Representative:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

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

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

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

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

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

**ATTACHMENT 1A**: **NHLBI Policies for Review of Manuscripts *without*
NHLBI Staff Authorship** (Revised 3/31/96)

[Manuscript Review Policy]{.underline}

NHLBI reviews manuscripts from large-scale, Institute-initiated studies
and investigator-initiated studies converted to cooperative agreements
prior to their submission for publication. Clarification of criteria and
procedures for this scientific review are being provided for use by
NHLBI staff and investigators in these types of studies.

[Purpose of NHLBI Review]{.underline}

The purposes of NHLBI scientific review are to keep NHLBI staff informed
of activities and results of major research studies, particularly when
findings or their interpretations are likely to be controversial or when
new data conflict with previous reports, and to provide advice which may
be considered helpful.

Almost all collaborative multicenter and complex single-center studies
have a committee in charge of publications (either a Steering Committee
or separate Publications Subcommittee), and NHLBI scientific staff are
usually members of these committees. In this role, NHLBI staff have the
same voice in approving a manuscript or abstract as other committee
members. NHLBI review is a separate process, usually conducted in
parallel with study-specific review**.** It may involve scientific staff
other than the study\'s Project Scientist or Project Officer.

NHLBI review is not intended to duplicate journal review; however, many
NHLBI staff are active reviewers for peer-reviewed journals and major
scientific meetings. Their suggestions may be of assistance to other
investigators and their comments may improve chances of acceptance by
peer-reviewed journals. Such comments, generally identified as
reviewers\' suggestions in the letter summarizing results of the review
or manuscript text rather than as specific requests for revisions,
should be considered matters of collegial advice to be incorporated at
the author(s)' discretion.

[Conduct and Authority of NHLBI Review]{.underline}

NHLBI review applies to manuscripts or abstracts intended for
publication or presentation using data from NHLBI-initiated programs.
Submissions are assigned for initial review to the NHLBI Project
Scientist or Project Officer and other scientific staff based on their
expertise and availability. Reviewed manuscripts are submitted to the
appropriate Division Program Director (for example**,** the Director of
the Clinical Applications and Prevention Program**,** DECA**)** and then
to the Division Director. Manuscript reviews are usually completed and
authors notified of the outcome within three to four weeks. Abstract
reviews are usually completed within one week or less.

NHLBI review is not binding upon non-NHLBI staff, who, as private
citizens, have the right to say or write what they wish. Reviewers\'
comments should be considered as advice. Authors should understand**,**
however**,** that NHLBI staff are frequently called upon by the media to
comment on particularly newsworthy or controversial papers**.**

Upon receiving the outcome of NHLBI review and comments, authors are
asked to consider reviewers\' comments carefully. Authors are encouraged
to discuss comments with the study\'s Project Scientist or Project
Officer, or the Division or Program Director, especially if they believe
a comment has been made in error. Authors should notify the Project
Scientist or Project Officer when a manuscript is accepted for
publication and send a copy of the published manuscript as soon as it is
available. For papers that are particularly newsworthy**,** NHLBI staff
will supply the Public Information Office with a title page and abstract
of the manuscript, and will notify the Office when publication is
imminent and provide it with a copy of the final version.

Questions about the review process may be directed to a study\'s Project
Scientist or Project Officer, the Division Program Director, or the
Division Director.

**ATTACHMENT 1B**: **NHLBI Policies for Review of Manuscripts with NHLBI
Staff Authorship** (Revised 1/11/99)

[Manuscript Review Policy]{.underline}

All manuscripts of which NHLBI staff are authors or co-authors must
undergo scientific review and clearance prior to their submission for
publication. Clarification of criteria and procedures for this
scientific review are being provided for use by NHLBI staff.

[Purpose of NHLBI Review]{.underline}

For collaborative studies supported by contracts, cooperative
agreements, or grants, there is usually a committee in charge of
publications (either a Steering Committee or a separate Publications
Subcommittee), and NHLBI scientific staff are usually members of these
committees. NHLBI review is a separate process, usually conducted in
parallel with study-specific review**.** It may involve scientific staff
other than the study\'s Project Scientist or Project Officer.

NHLBI review is not intended to duplicate journal review; however, many
NHLBI staff are active reviewers for peer-reviewed journals and major
scientific meetings. Their suggestions may be of assistance and their
comments may improve chances of acceptance by peer-reviewed journals.
Such comments, generally identified as reviewers\' suggestions in the
approval letter or manuscript text rather than as specific requests for
revisions, should be considered matters of collegial advice to be
incorporated at the author(s)' discretion.

[Conduct and Authority of NHLBI Review]{.underline}

NHLBI review applies to manuscripts or abstracts with NHLBI staff as
authors or co-authors. Submissions are assigned for initial review to
NHLBI scientific staff based on their expertise and availability.
Reviewed manuscripts are submitted to the appropriate Division Program
Director or Branch Chief (for example**,** the Director of the Clinical
Applications and Prevention Program**,** DECA) and then to the Division
Director. Manuscript reviews are usually completed and authors notified
of the outcome within three to four weeks. Abstract reviews are usually
completed within one week or less. Written approval of the Division
Program Director or Branch Chief and the Division Director is required.

Manuscript disapproval is binding on NHLBI employees, who must have
Institute approval for their names to appear as authors or co-authors.
If such a manuscript is disapproved, it must either be revised so as to
be approved by the Institute or NHLBI staff who are co-authors must
remove their names from it.

Staff are reminded that each author is responsible for everything in the
manuscript, irrespective of his or her involvement in any specific part
of the research effort.

When appropriate, the manuscript should contain a disclaimer, indicating
that what is being reported or claimed does not necessarily reflect the
views of the NHLBI, NIH, or DHHS.

[Criteria for Disapproval]{.underline}

Three primary reasons may cause a manuscript to be disapproved:

> 1\) Concern that the analysis or interpretation may be flawed;
>
> 2\) Inclusion of clinical or public health recommendations that are
> not consistent with or supported by (usually they simply over-extend)
> the data presented; or

3\) Conflict with NHLBI or DHHS policies.

Differences of opinion about the scientific interpretation of results
can be a reason for returning a paper without approval, if reviewers\'
opinions are well-founded and adequately justified. Interpretations that
overstep the data; for instance, implying causality where none can be
inferred, or suggesting the need for intervention when it has not been
proven to be effective, can be highly embarrassing to the authors and
the Institute.