**Principles of Data Sharing: A Best Practices Document for Preparation
of Agreements to Enable Data Sharing via the caBIG™ Infrastructure**

**[Background]{.underline}**

Biomedical research is becoming an increasingly collaborative
undertaking. Parallel advances in biotechnology and informatics are
creating new possibilities for discovery as well as increased demands
for information sharing and exchange capabilities. To date, most
existing databases and analytical tools have been developed
independently, with tremendous variability in data rules, processes,
vocabularies, and representations. Overall, there has been a lack of any
unifying architectures to support interoperability among these
databases, knowledge stores, and software tools. An overarching
infrastructure is urgently needed to support the technological and
lexical standards upon which such interoperability critically depends.

In particular, the need to accelerate the translation of basic research
discoveries into new clinical therapies demands that the channels for
communication, data exchange, and collaboration---among cancer centers
along all points of the basic-to-clinical spectrum---must be
significantly expanded. Recognizing the major national impact that a
true networking of cancer centers can achieve, the National Cancer
Institute (NCI) has introduced the [ca]{.underline}ncer
[B]{.underline}iomedical [I]{.underline}nformatics [G]{.underline}rid
(caBIG(tm)) initiative to address these issues in the cancer research
community.

The caBIG(tm) initiative will expedite access of the cancer research
communities to key bioinformatics platforms. In partnership with the
cancer research community, caBIG(tm) will create a common, extensible
informatics platform that integrates diverse data types and supports
interoperable analytic tools. This platform will allow research groups
to tap into the rich collection of emerging cancer research data while
supporting their individual investigations. The participation of
multiple cooperating Cancer Centers in the earliest pilot stages of this
effort ensures that the user community's needs will be appropriately
addressed, and, that the stakeholders in the enterprise will embrace the
emerging vocabulary harmonization and data exchange standards.

In the pilot phase of caBIG(tm), the NCI defined three domain workspaces
representative of the scientific focus of the different participating
cancer centers, including:

-   The Clinical Trial Management Systems Workspace (CTMS WS)

-   The Integrative Cancer Research Workspace (ICR WS)

-   The Tissue Banks and Pathology Tools Workspace TBPT WS)

In addition to these domain-specific workspaces, two cross-cutting
workspaces are also defined whose purposes are to provide unifying
frameworks, methodologies, representations, and terminologies. Topics in
the cross cutting Architecture Workspace (ARCH WS) will include:
middleware, application and data access application program interfaces
(APIs), data transmission formats, web services components, grid
computing services, and security architecture. The primary purpose of
the Architecture Workspace is to ensure consistent application of the
caBIG(tm) development principles in the distributed groups doing the
actual integration and implementation activities throughout the
caBIG(tm) project.

The goal of the Data Sharing and Intellectual Capital (DSIC) Work Space
is to first identify and then propose solutions to potential barriers to
the sharing of data and materials across the caBIG(tm) community. The
Workspace consists of representatives from fourteen funded participating
institutions, and seeks input from those organizations' lawyers,
researchers, software developers, patient advocates, and representatives
from technology transfer offices and institutional review boards (IRBs).
The Regulatory Special Interest Group (SIG) is focused on policy matters
and best practices relating to study participant consent, IRB and Health
Insurance Portability and Accountability Act (HIPAA) authorization, and
confidentiality and data security. The Proprietary SIG is concerned with
intellectual property matters relating to software licensing, data and
biospecimen sharing and "intellectual capital" (e.g., authorship and
attribution). The DSIC WS seeks to provide the caBIG™ community with
guidance regarding these issues.

By creating a virtual web of interconnected data, individuals and
organizations, caBIG™ will redefine the conduct of research, the
provision of care, patient participation in research studies, and
researcher interactions in the biomedical research enterprise. Core
caBIG™ principles support the development of this virtual web through
principles of open source, open development, open access and federation.
caBIG™ is stimulated by and is an expression of the dreams and
aspirations of society to use information to benefit mankind. As noted
by Michael Dertouzos in his visionary book, [What Will Be, How the New
World of Information Will Change our Lives:]{.underline} "People value
greatly the ability to form a community bound by the sharing of
information and are willing to readily integrate new information-driven
activities into their daily lives\" (p.30)[^1]

**[Purpose]{.underline}**

This White Paper is intended to develop resources and guidance, and
present principles and sample language for data sharing agreements that
reflect best practices and support effective sharing of data in the
research community. Its primary audience is the caBIG™ community. The
language offered here is for guidance only. Each institution must
determine what elements are most appropriate to be included in data
sharing agreements they distribute; and it is recommended that the final
document be the work product of the investigator who wishes to share the
data and general counsel for the institution. The objective is a work
product (an agreement) that is informative, understandable, complete and
provides a proper framework and guidance for the exchange of data while
protecting patient privacy.

Framing useful data agreement models is challenging. By identifying best
practices in data sharing and materials transfer agreements, and
providing resources to the community, the DSIC WS intends to lower the
transaction costs inherent to creating data sharing and materials
transfer agreements and promote collaborative research.

Numerous factors create barriers to the sharing of data and/or the
biological materials associated with data. These factors include
concerns about patient privacy, proprietary rights of researchers and
organizations in the materials and data they produce; prior contractual
obligations to public and private research partners and funders; and
expectations of academic institutions and federal, state and local
governments that the application and use of knowledge, including
materials and data, will be used to create economic good. Data and
materials can be more or less sensitive as regards information uniquely
personal to patients. While the benefits of data and material sharing
are broadly appreciated, technology transfer offices (TTO's) in research
organizations are required to balance the demands of many stakeholders
in transferring research data and materials while simultaneously
producing the highest possible good. Despite a broad philosophical
recognition of the benefit of sharing, entrenched mechanisms and ways of
thinking about data and materials as intellectual property can slow the
creation of new ways of sharing knowledge while protecting proprietary
goals.

While this guidance document is concerned primarily with data sharing,
data is frequently and inextricably bound to underlying biospecimens.
Community standards flow from the general principle that science
progresses when both data and related materials are shared, enabling
others to verify and replicate published findings. Where appropriate,
reference will be made to language appropriate for sharing both data and
related biospecimens.

**[Introduction to and Discussion of Principles of Data
Sharing]{.underline}**

Academic tradition requires publication of all significant research
results. However, it can be a challenge for investigators to harmonize
traditions of openness with the requirements for protecting ownership
rights to intellectual property and/or protection of human subjects. On
May 10, 2002, in its comment on the NIH data sharing proposal at the
time, the AAMC expressed grave concern about the "numerous cultural,
technical, and legal obstacles to a workable uniform federal policy for
data-sharing. "[^2] A degree of compromise is still necessary and
inevitable in some situations. Nevertheless, there is general community
consensus that

1.  Principles of scientific integrity require that ideas be put to a
    test. In order to test ideas about data, they must be exposed to
    others who will either support or challenge those ideas.

2.  Some types of claims can only be tested against large data sets or
    against comparisons of somewhat similar data sets. To make these
    analyses, more and more data is often needed.

3.  Much of the work in science is conducted using public funds.
    Investigators have an obligation to the public to make maximally
    efficient use of these data.

4.  From time to time, there are reasons not to share data. They include
    failure to secure informed consent from subjects of a study and the
    need for scientists to first publish basic findings.Error: Reference
    source not found

5.  Data sharing relies on and presumes robust acquisition and
    recordkeeping. Proper data acquisition and record keeping is an
    essential feature of experimental science and technology. It
    provides the foundation information on which subsequent data
    analysis and generalizations are based. Without good data collection
    and record keeping, all subsequent use of the data is tainted by
    questionable authenticity and accountability. Proper record keeping
    is of vital importance for patentable inventions. Objectivity is a
    basic principle of scientific investigation. It is not easy, even
    for people with the best intentions, to acquire, process, and report
    data in an unbiased way, but that is the goal to which scientists
    aspire. Skill at avoiding bias comes with experience, but depends
    mainly on understanding the goal and carefully thinking through how
    to achieve it.

It is not the intention of caBIG(tm) to establish new principles of data
sharing. Rather, what follows is intended to provide the reader a sense
of current thinking in the academic community and the guidance developed
by a number of institutions, agencies and professional organizations who
have spent considerable time analyzing the issue and offers a broad
range of principles and issues to consider.

***What are the major principles, best practices and standards related
to sharing?***

The academic tradition of openness is supported by federal funding
agencies and professional organizations, but with qualifications related
to protection of subjects or the legitimate interests of investigators.
Institutions across the country have developed policies that echo these
community values and concerns.

A. In 2003, **the NIH** declared: "the **NIH** reaffirms its support for
the concept of data sharing. We believe that data sharing is essential
for expedited translation of research results into knowledge, products,
and procedures to improve human health. The NIH endorses the sharing of
final research data to serve these and other important scientific goals.
The NIH expects and supports the timely release and sharing of final
research data from NIH-supported studies for use by other researchers.
"(Final NIH Statement on Sharing Research Data (2.26.03))

B. The **NSF policy statement** on Sharing of Findings, Data, and Other
Research Products echoes the NIH statement:

1.  NSF expects significant findings from research and education
    activities it supports to be promptly submitted for publication,
    with authorship that accurately reflects the contributions of those
    involved. It expects investigators to share with other researchers,
    at no more than incremental cost and within a reasonable time, the
    data, samples, physical collections, and other supporting materials
    created or gathered in the course of the work. It also encourages
    awardees to share software and inventions or otherwise act to make
    the innovations they embody widely useful and usable.

2.  Adjustments and, where essential, exceptions may be allowed to
    safeguard the rights of individuals and subjects, the validity of
    results, or the integrity of collections or to accommodate
    legitimate interests of investigators.

3.  NSF expects significant findings from research and education
    activities it supports to be promptly submitted for publication,
    with authorship that accurately reflects the contributions of those
    involved. It expects investigators to share with other researchers,
    at no more than incremental cost and within a reasonable time, the
    data, samples, physical collections and other supporting materials
    created or gathered in the course of the work. It also encourages
    grantees to share software and inventions or otherwise act to make
    the innovations they embody widely useful and usable.

4.  Adjustments and, where essential, exceptions may be allowed to
    safeguard the rights of individuals and subjects, the validity of
    results, or the integrity of collections or to accommodate
    legitimate interests of investigators. Data should be made as widely
    and freely available as possible while safeguarding the privacy of
    participants, and protecting confidential and proprietary data."

C. **The National Research Council** offers the following comprehensive
guidance and set of principles in its guidance "Sharing
Publication-Related Data and Materials: Responsibilities of Authorship
in the Life Sciences":

> Community standards for sharing publication-related data and materials
> should flow from the general principle that the publication of
> scientific information is intended to move science forward. More
> specifically, the act of publishing is a quid pro quo in which authors
> receive credit and acknowledgment in exchange for disclosure of their
> scientific findings. An author's obligation is not only to release
> data and materials to enable others to verify or replicate published
> findings as journals already implicitly or explicitly require) but
> also to provide them in a form on which other scientists can build
> with further research. All members of the scientific
> community---whether working in academia, government, or a commercial
> enterprise---have equal responsibility for upholding community
> standards as participants in the publication system, and all should be
> equally able to derive benefits from it.
>
> **Principle 1.** Authors should include in their publications the
> data, algorithms, or other information that is central or integral to
> the publication---that is, whatever is necessary to support the major
> claims of the paper and would enable one skilled in the art to verify
> or replicate the claims. This is a quid pro quo---in exchange for the
> credit and acknowledgement that come with publishing in a
> peer-reviewed journal, authors are expected to provide the information
> essential to their published findings.
>
> **Principle 2**. If central or integral information cannot be included
> in the publication for practical reasons (for example, because a
> dataset is too large), it should be made freely (without restriction
> on its use for research purposes and at no cost) and readily
> accessible through other means (for example, on-line). Moreover, when
> necessary to enable further research, integral information should be
> made available in a form that enables it to be manipulated, analyzed,
> and combined with other scientific data. Because scientific
> publication is intended to move science forward, an author should
> provide data in a way that is practical for other investigators. The
> data might reasonably be provided on-line but should be available on
> the same basis as if they were in the printed publication (for
> example, through a direct and open-access link from the paper
> published on-line). Making data that is central or integral to a paper
> freely available does not obligate an author to curate and update it.
> While the published data should remain freely accessible, an author
> might make available an improved, crated version of the database that
> is supported by user fees. Alternatively, a value-added database could
> be licensed commercially.
>
> **Principle 3**. If publicly accessible repositories for data have
> been agreed on by a community of researchers and are in general use,
> the relevant data should be deposited in one of these repositories by
> the time of publication. The purpose of using publicly accessible data
> repositories is a practical one---to expedite scientific progress and
> provide access to data in a manner that allows others to build on it.
> By their nature, these repositories help define consistent policies of
> data format and content, as well as accessibility to the scientific
> community. The pooling of data into a common format is not only for
> the purpose of consistency and accessibility. It also allows
> investigators to manipulate and compare datasets, synthesize new
> datasets, and gain novel insights that advance science.
>
> **Principle 4**. Authors of scientific publications should anticipate
> which materials integral to their publications are likely to be
> requested and should state in the "Materials and Methods" section or
> elsewhere how to obtain them. Consistent with the spirit and
> principles of publication, materials described in a scientific paper
> should be shared in a way that permits other investigators to
> replicate the work described in the paper and to build on its
> findings. If a material transfer agreement (MTA) is required, the URL
> of a Web site where the MTA can be viewed should be provided. If the
> authors do not have rights to distribute the material, they should
> supply contact information for the original source. A frequently
> requested reagent can be made reasonably available in the commercial
> market or by an author's laboratory for a modest fee to cover the
> costs of production, quality control, and shipping.
>
> **Principle 5**. If a material integral to a publication is patented,
> the provider of the material should make the material available under
> a license for research use. When publication-related materials are
> requested of an author, it is understood that the author provides them
> (or has placed them in an authorized repository) for the purpose of
> enabling further research. That is true whether the author of a paper
> and the requestor of the materials are from the academic, public,
> private not-for-profit, or commercial (for profit) sector.
> Notwithstanding legal restrictions on the distribution of some
> materials, authors have a responsibility to make published materials
> available to all other investigators on similar, if not identical,
> terms.

***3. What are reasonable Access Restrictions?***

-   Temporary restrictions to allow investigators to complete
    experimental protocols and to repeat experiments as judged necessary
    to assure valid results

-   Temporary restrictions to preserve intellectual property or
    copyright claims

-   Temporary restrictions due to requirements of granting agencies or
    contracts with other sponsors

-   Permanent restrictions to ensure privacy of human subjects

***\
4. What about Data Retention and Storage***?

> There is no universal standard for how long raw and processed research
> data should be retained. Some federal agencies require that data be
> retained for three years after completion of the project. In general,
> three years should be considered a minimum in academia. Some experts
> recommend retention of raw and processed data for five years. Many
> companies, however, have shorter retention cycles. When patent or
> other legal issues are involved, advice of an attorney should be
> sought before any records are destroyed.
>
> Proper data retention and storage is the responsibility of the
> Principal Investigator and the Administrator of the unit in which
> he/she works. They should be guided by the answers to the following
> questions:

-   Is the PI confident that the data is accurate and reliable?

-   Is it significant enough to publish?

-   Should negative results be published?

-   Have obligations to granting agencies and project sponsors been
    satisfied?

**[Other data sharing networks:]{.underline}** Issues of data sharing
have been addressed by a broad variety of organizations, some of which
are instructive to members of caBIG™.

A. A **Regional Health Information Organization (RHIO)** is a
nongovernmental, multi-stakeholder organization that enables or oversees
the business and legal issues involved in the exchange and use of health
information, in a secure manner, for the purpose of promoting the
improvement of health quality, safety and efficiency.

Officials from the U.S. Department of Health and Human Services see
RHIOs as the building blocks for the national health information network
(NHIN). When complete the NHIN will provide universal access to
electronic health records. Experts maintain that RHIOs will help
eliminate some administrative costs associated with paper-based patient
records, provide quick access to automated test results and offer a
consolidated view of a patient's history.

RHIO's are described at the website
<http://www.informatics-review.com/wiki/index.php/RHIO>

A.  **The Northwest Data Sharing Network**[^3], by contrast, is a not
    for profit organization in British Columbia in order to provide
    timely, coordinated, co-operative, and innovative use of the
    geo-spatial data sets to reduce ownership data costs and improve
    decision-making about land use in our region. It's values provide
    guidance to any effort in sharing data:

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1.  Owners can reduce costs of data management. Owners will have:\
    - Secure access to shared data sets from themselves and other
    Owners, including: both confidential and open source data sets.

2.  Owners can develop and adopt common data standards and data
    Custodianship policies. Owners will have:\
    - Data Management policies, incorporating Custodianship, data access
    and distribution, data standards, metadata standards, and data
    lifecycle control.

3.  Owners can reduce costs of data stewardship. Owners will have:\
    - Accessible storage of data sets, especially data sets that may be
    lost due to infrequent use.

4.  Owners can improve decisions of land use in our region. Owners will
    have:\
    - Access to a large selection of data sets from which to improve
    their land use plans,\
    - Access to information for land use monitoring, and\
    - A secure information exchange environment with First Nations and
    the public.

-   Owners have greater opportunities to create cost savings through
    innovative co-operative projects. Owners will have:\
    - A community of like-minded data owners to create synergistic
    projects.

**[Considerations when thinking about datasharing
agreements:]{.underline}**

As has been noted, data exists along a continuum of need for privacy or
protection of proprietary rights. Thus, a threshold question to resolve,
when there are no privacy or IP issues, is whether an agreement is
required at all, and, if so, whether a modular agreement based on the
caBIG(tm)™ Standardized "Click-Through Terms and Conditions"
\[hyperlink\] will suffice. In thinking about what document needs to
accompany data, one might consider the following categories:

-   **Category A**: no restrictions on use

-   **Category B**: recipient must sign an agreement with donor\'s
    institution for commercial use

-   **Category C**: no commercial use

-   **Category D**: data has been developed with restrictions by a
    partner whose permission is required prior to transfer.

The UBMTA (Uniform Biological Material Transfer Agreement),adopted by
many nonprofit institutions, may be the simplest solution to the
transfer of data and materials among nonprofit research
institutions.[^4]

The **caBIG(tm)™ Decision-Tree for Privacy/Intellectual Capital Terms
and Conditions** \[embedded hyperlink to matrix\] is offered to assist
the drafter, along with the researcher or end user who controls access
to the data to be shared, come to a decision regarding the appropriate
form of agreement . In the event that an individually negotiated data
sharing agreement is deemed necessary, the following offers potential
elements of such an agreement for consideration.

**[Elements of a Data Sharing Agreement]{.underline}**:

The following is offered in those cases where a simpler solution is not
appropriate. It is intended as a menu allowing the knowledgeable writer
to select what language is appropriate for a given set of conditions.
These paragraphs are intended as guidance to the researcher seeking to
share data with colleague(s), working together with General Counsel or
the Technology Transfer office in the sending institution. Some elements
may not be appropriate to all sets of circumstances and it is possible
that no data sharing agreement may be necessary at all. The skilled
drafter will select the appropriate components of an agreement for a
specific purpose.

I.  Introduction and Intentions of the Parties -- this section puts in
    place the "Whereas'es" that identifies the parties to the agreement
    and describes their general interests in contracting. This section
    should specify that the agreement runs between the provider
    institution (Provider) and recipient institution (Recipient). The
    explicit desire of the institution(s) to share data with one another
    and to comply with all laws particularly as they relate to the
    protection of patient privacy and human subjects could be mentioned
    here as well.

II. Definitions -- each agreement shall contain definitions sufficient
    that the ordinary reader will gain a deeper understanding of the
    meaning of the agreement. Examples of terms that may need to be
    defined are:

> "Clinical Data" refers to data, and associated records, collected and
> recorded from X institutions Study subjects through the periodic
> examinations conducted by X institution.
>
> "Data" means recorded information, regardless of form or the media on
> which it may be recorded. It does not include information incidental
> to contract administration, such as financial, administrative cost or
> pricing, or management information.[^5]

Further refinement of definition may assist understanding and reduce
confusion:

> "Quantitative": Recorded numbers, graphs and charts of numerical raw
> experimental results, and instrument output including photographs and
> digital images from which quantitative date can be derived
>
> "Qualitative": Notes of any type, some types of instrument output,
> photos, movies, and digital images (Original samples in unanalyzed
> form: e.g., biological specimens; Research tools: Protocols; computer
> software)
>
> "Raw data": Information obtained directly from experiments, surveys,
> etc. Includes information in laboratory notebooks and instrument
> output; may include information in computers.
>
> "Processed data": Graphs, equations, tables, descriptions, summaries,
> and conclusions derived from raw data but not yet released to the
> public.
>
> "Published data": Information distributed to people beyond those
> involved in data acquisition and project administration. Theses and
> dissertations are published when they become available to the public
> in a library.
>
> "Disclosure" shall be defined as the release, transfer, provision of
> access to, or divulging in any other manner of information outside the
> entity holding the information. "Disclose" shall have the
> corresponding meaning.[^6]
>
> "Form, fit and Function data" means data relating to items,
> components, or processes that are sufficient to enable physical and
> functional interchangeability as well as data identifying source,
> size, configuration, mating, and attachment characteristics,
> functional characteristics, and performance requirements; except that
> for computer software it means data identifying source, functional
> characteristics, and performance requirements but specifically
> excludes the source code, algorithm, process, formulae, and flow
> charts of the software.
>
> "HIPAA" shall be defined as the Health Insurance Portability &
> Accountability Act of 1996, Public Law 104-191 and related regulations
> promulgated there under, as may be expressly amended from time to time
> or as a result of final interpretations by any applicable regulatory
> agency of an applicable court.Error: Reference source not found

"Human Subjects" are

"Limited Data Set" is a defined set of data

> "Molecular Genetic Data" consists of data derived from analyses of DNA
> samples contained in Biological Materials including but not limited to
> genotyping analysis, anonymous marker polymorphisms, DNA sequence
> information, mutation analysis and other genetic analyses.
>
> "Research" shall be defined as a systematic investigation, including
> research development, testing and evaluation, designed to develop or
> contribute to generalizable knowledge. This includes the development
> of research repositories and databases for research.Error: Reference
> source not found
>
> "Statistical Analysis Data" consists of data derived from statistical
> analyses linking Molecular Genetic Data with Clinical Data including
> but not limited to genetic linkage analysis, transmission
> disequilibrium analysis, haplotype relative risk analysis and other
> statistical genetic techniques.

III. If Protected Health Information (PHI) is distributed to an entity
     that may be defined as a Business Associate under HIPAA, it may be
     desirable to insert language which is commonly used in relation to
     HIPAA requirements for Business Associates such as

     a.  Permitted Uses and Disclosure of PHI

         i.  Except as otherwise limited in this Agreement, Business
             Associate may use or disclose PHI on behalf of, or to
             provide service to, the \[Institution\] for the following
             purposes, if such use or disclosure of PHI would not
             violate the HIPAA Regulations if done by the
             \[Institution\] or the minimum necessary policies and
             procedures of the \[Institution\]

         ii. \[list purposes for which PHI may be used or disclosed by
             Business Associate\]

         iii. \[optional: use only if data aggregation services are part
              o the agreement\] Business Associate may use PHI to
              provide data aggregation services to the \[Institution} as
              permitted by 42 CFR§164.504(e)(2)(i)(B).

         iv. \[optional\]Business Associate may use PHI for the proper
             management and administration of the Business Associate or
             to carry out the legal responsibilities of the Business
             Associate

         v.  Business Associate may use PHI to report violations of law
             to appropriate Federal and State authorities, consistent
             with 42 CFR §164.502(j)(1). Etc. [^7]

IV. Purpose: This section can be used to expand on the Introduction
    and/or state the permitted uses or purpose for which the data is
    shared and restrict the data to that purpose.

V.  Description of data to be transferred: This section describes data
    to be transferred in such a way that the reasonably knowledgeable
    person would know with some precision what is being transferred. Ex:
    "Genetic analysis data that will include genetic marker genotypes,
    genetic map and the relationships among relatives in each pedigree
    for X number of families." The data owner provides background on the
    nature and special characteristics of the data collection which will
    help the recipient understand the general characteristics of the
    data and concerns specific to that data, ie, "Blood samples and
    clinical data collected by the Framingham Heart Study have been
    stripped of all personal identifiers but the confined nature of the
    geographic area from which these subjects were drawn and the wealth
    of data available to them in publicly available records would make
    less difficult the individual identification of some subjects."[^8]

VI. Recipient names and qualifications: Access to data should be
    permitted only to those researchers whose qualifications or role
    within a research project would make them eligible to receive the
    data. Submission of curriculum vitae of the principal investigator
    and all co-investigators is appropriate.

VII. Control of Data. This section should specify who has control over
     the data, a provision that is particularly important in the case of
     large multi-institutional collections. This section can also set
     forth who has responsibility for the security of the data though it
     may also be covered in detail in a separate section.

VIII. Reservation of Rights: in order to ensure the ability to use data
      following transfer, especially to a company, the institution may
      want to reserve rights for all non commercial, research purposes:
      "\[Institution\] reserves the right to (i) make and use, and grant
      to others non-exclusive licenses to make and use for
      NON-COMMERCIAL RESEARCH PURPOSES within the FIELD the subject
      matter described and claimed in PATENT RIGHTS, and PROPERTY
      RIGHTS, and (ii) provide the BIOLOGICAL MATERIALS to others on a
      non-exclusive basis ,and grant others non-exclusive licenses to
      make and use the BIOLOGICAL MATERIALS, all for NON-COMMERCIAL
      RESEARCH PURPOSES within the FIELD."

IX. Approval of the Credentials of the Recipient's Individual Users.

    a.  If sharing the data does not require approval by the sending
        institution, go on to IX.

    b.  If sharing of the data does require approval of the credentials
        of the recipient by the sending institution, describe here the
        steps required to obtain approval and the Recipient's
        responsibilities after approval.

> What happens after approval: "After access certification, an
> electronic data file, documentation, and pedigree drawings will be
> sent to the principal investigator. Shipping information and an Excel
> file containing an NIMH Repository ID number and NIMH subject ID
> number for each subject for which biomaterial is requested should be
> submitted to the Rutgers University Cell and DNA Repository (RUCDR)
> web portal at heep://rucdr.rutgers.edu. the request will then be
> forwarded for approval to NIMH. Approved projects will be invoiced by
> RUCDR. For problems accessing the RUCDR web portal, please
> contact..."[^9]

X.  Compliance with IRB requirements:

    a.  If no human subjects are involved, go to Section XI.

    b.  If human subjects are involved, use language such as the
        following or an equivalent: "Recipient acknowledges that the
        conditions for use of the data and/or Biological Materials have
        been approved by the Recipient's Institutional Review Board
        (IRB) in accordance with Department of Health and Human Services
        regulations at 45 CFR Part 46. Recipient agrees to comply fully
        with all such conditions and with the subjects' informed consent
        documents, and any additional conditions that may be imposed by
        \[name of Institution\]. Recipient acknowledges that this
        project is not eligible for exemption for IRB review. Recipient
        agrees to report promptly to the \[X\] IRB and the \[granting
        institution\] any proposed change in the research project and
        any unanticipated problems involving risks to subjects or
        others. Recipient remains subject to applicable State and local
        laws and regulations and institutional policies that provide
        additional protections for human subjects."

XI. Term of the Agreement -- this section should indicate how long the
    agreement will be in effect and what will happen to data or
    specimens when it is terminated\...

> "This Agreement shall go into effect on the Effective Date. It is
> expected that the Research Project will be completed within
> approximately \_\_\_\_\_\_ year(s) of the Effective Date. This
> Agreement shall continue in effect until the earlier of
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_ or the completion or termination of the
> Research Project. However, the Company or CSHL may terminate the
> Research Project and this Agreement at any time upon 30 days' written
> notice to the other parties, regardless of whether the Research
> Project has been completed. In addition, in the event of a material
> breach of this Agreement by a party, any other party may terminate the
> Research Project and this Agreement immediately upon written notice to
> both other parties. If the Research Project and this Agreement are
> terminated, Company Materials received pursuant to this Agreement by
> CSHL shall, at the request of the Company, be returned to the Company
> or properly destroyed, and Institution Materials received pursuant to
> this Agreement by the Company shall, at the request of CSHL, be
> returned to CSHL or properly destroyed. The terms of
> paragraphs\_\_\_\_\_\_\_\_\_, and of this sentence and the preceding
> sentence, shall survive any termination of this Agreement."Error:
> Reference source not found

XII. Recipient Responsibilities and Assurances:

     a.  If the Recipient has no further responsibilities to the
         Provider, go on to Section XIII.

     b.  If the Provider needs to impose additional responsibilities on
         the Recipient, list them here as clearly and unambiguously as
         possible. Examples of these assurances are listed below:

     ```{=html}
     <!-- -->
     ```
     1.  Assurance that data will be used in compliance with all
         applicable statutes and regulations.

     2.  Assurance to report any use or disclosure not permitted by the
         agreement

     3.  Assurance that any agent, including a subcontractor, to whom
         the recipient provides the data set has agreed to the same
         restrictions and conditions that apply through the original
         agreement.

     4.  Assurance that no information contained in the data set will be
         given to a third party not authorized by the agreement.

     5.  Assurance that the recipient will maintain an accounting of
         disclosures which can be made accessible to the data owner
         following written request for an accounting

     6.  Assurance that recipient will mitigate any harmful effect that
         use or disclosure of the data may have

     7.  Assurance that recipient will take all necessary steps to limit
         PHI to the minimum necessary to accomplish the intended purpose
         of the use, disclosure or request.

     8.  Recipient will not contact the individuals who are the subject
         of the PHI contained in the Limited Data Set.

     9.  When appropriate, the Recipient agrees not to use any data or
         sets of data to establish the individual identities of any of
         the subjects from whom the data were obtained.

XIII. Reporting requirements --

      a.  If Provider does not require any further communication from
          the Recipient, move on to Section XIV.

      b.  If the Provider would like reports back on the use of data or
          periodic updates or acknowledgement in any publication, list
          those reporting requirements here

XIV. Right to use data. Providers may want to preserve the right to
     receive and redistribute data developed by a recipient.

     a.  If the Provider does not want any rights in further data
         developed by the recipient, move on to Section XV.

     b.  If the Provider wants to be able to examine, use and/or
         redistribute derivative data developed by the recipient, insert
         language such as the following:

> "Recipient will provide to the Center such Genetic Analysis Data
> twelve (12) months after receipt of Biomaterials or upon publication
> of research in which data were analyzed, whichever comes first, and
> annually thereafter upon the anniversary of this date. This will
> continue until the Research Project is completed. The Center may at
> any time distribute these Genetic Analysis Data to qualified
> scientific investigators, subject to any patents or pending patent
> applications of Recipient."Error: Reference source not found

XV. Confidentiality. While publication of data generally is an objective
    of academic institutions, and confidentiality is often impossible to
    assure beyond "best efforts", there may be a rationale for requiring
    confidential treatment in the context of a specific agreement. In
    that case, language such as the following might be considered; If
    possible, specify the need for confidentiality with a brief
    rationale, which may be presaged in Section IV:

> "During the term of this Agreement and for a period of (?) years
> thereafter, each party to this agreement shall cause all information
> that is disclosed to it by the other party in connection with the
> Research Project and is identified in writing as confidential by the
> disclosing party ("Confidential Information") to be treated according
> to the same internal security procedures and with the same degree of
> care regarding its secrecy and confidentiality as the party receiving
> the disclosure treats similar information of its own within its
> organization. Confidential Information does not include information
> that (i) is or later becomes available to the public through no breach
> of this Agreement; (ii) is of the date of disclosure, is already in
> the possession of the party to whom disclosure is made; (iv) is
> required to be disclosed by law, government regulation, or court
> order; or (v) is independently developed, by the party to whom the
> disclosure is made, without use of the disclosing party's Confidential
> Information."Error: Reference source not found

XVI. Costs -- from time to time, costs may be incurred by the database
     owner that may be passed on to the recipient.

XVII. Disclaimer of Warranties. The drafter should consider whether it
      is necessary to disclaim warranties of fitness or merchantability;
      if required, the language may be as follows:

> No Warranties: NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO
> THE MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE BIOLOGICAL
> MATERIALS, GENETIC ANALYSIS DATA AND CLINICAL DATA PROVIDED TO
> RECIPIENT UNDER THIS AGREEMENT, OR THAT THE BIOLOGICAL MATERIALS,
> GENETIC ANALYSIS DATA OR CLINICAL DATA MAY BE EXPLOITED WITHOUT
> INFRINGING THE INTELLECTUAL PROPERTY OR PROPRIETARY RIGHTS OF ANY
> THIRD PARTIES. Error
>
> Or,
>
> No Warranties. All research Materials (Data) transferred in connection
> with the Research Project are experimental in nature and shall be used
> with prudence and appropriate caution, since not all of their
> characteristics are known. ALL RESEARCH MATERIALS (DATA) ARE PROVIDED
> WITHOUT WARANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
> OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED. A party providing its
> Research Materials (data) makes not representation or warranty to the
> receiving party that the use of such Research Materials (Data) will
> not infringe any patent or other proprietary right.[^10]

XVIII. Biological Materials Sent with Data:

       a.  If there is no biological material sent with data, move on to
           Section XIX.

       b.  If there is biological material, language should be inserted,
           if appropriate, describing the hazards associated with the
           material and holding the Recipient responsible for the proper
           handling of the material. Provider may also wish to consider
           prohibiting the use of such materials in human subjects or
           for commercial purposes:

> "Recipient acknowledges that Biological Material may carry viruses,
> latent viral genomes, and other infectious agents. The Recipient
> agrees to treat Biological Material as if it were not free of
> contamination, and that Biological Material will be handled by trained
> persons under laboratory conditions that afford adequate biohazard
> containment. By accepting Biological Material, Recipient assumes full
> responsibility for its safe and appropriate handling, or
>
> Limitations: Research Materials transferred under this Agreement are
> provided only for use in animals or in vitro. Research Materials
> transferred under this Agreement will not be used in human, including
> for purposes of diagnostic testing. Any use of Company Materials by
> Institution, or of Institution Materials by the Company, or of Jointly
> Developed Materials by a party, other than in accordance with the
> rights outlined herein, is a material breach of this Agreement for
> purposes of the termination provisions below.Error: Reference source
> not found

XIX. Points of contact: This section should set forth the names of
     individuals who are the official points of contact for each party
     to the agreement, including leaders, the business/legal contacts,
     and the technical/scientific contacts

XX. Security Procedures. This section should specify the need for
    appropriate administrative, technical and physical safeguards with
    explicit designation of standards for transmission, encryption,
    storage, physical handling, etc.

XXI. Security Breaches. This section should specify, as applicable, what
     to do in case of corruption, theft, or loss, inappropriate
     disclosure or compromise of any device or data.

XXII. Rights of Distribution.

      a.  If the Provider has no concern about the data being passed on
          to a third party, go on to Section XXIII.

      b.  If the Provider wishes to restrict distribution to a third
          party, language should be inserted here, as an example: "No
          rights of Recipient under this Distribution Agreement may be
          assigned or otherwise conveyed to any party, including a
          purchaser of Recipient, without the specific written agreement
          of \[the provider/sender\]".[^11]

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

XXIV. Acknowledgements:

      a.  If the Provider does not require the Recipient's
          acknowledgement of the source of data in any publications, go
          on to Section XXV.

      b.  If the Provider wishes to restrict distribution to a third
          party, language should be inserted here.

XXV. Interpretation: If applicable, the drafter should include language
     in the agreement that provides guidance as to how to interpret
     ambiguous meanings. Example: "Any ambiguity in this Agreement shall
     be resolved in favor of a meaning that permits the Institution to
     comply with HIPAA, HIPAA regulations, the requirements of the
     Department of Health and Human Services and the responsible IRB."

XXVI. Third Party Beneficiaries: If applicable, the drafter should
      include language that specifies whether or not third party
      beneficiary rights are conferred under the agreement or not.
      Example: Nothing express or implied in this Agreement is intended
      to confer, upon any person other than the parties hereto any
      rights, remedies, obligations or liabilities whatsoever."Error:
      Reference source not found

XXVII. Disqualification language. If applicable, the drafter should
       consider whether the agreement should state the circumstances by
       which a recipient is disqualified from receiving additional data
       due to unlawful or inequitable behavior: Example: "Failure to
       comply with any of the terms specified herein may result in
       disqualification of Recipient from receiving additional Clinical
       Data, Biological Materials, and/or Genetic Analysis Data. The
       United States Government and \[X\] institution shall have the
       right to institute and prosecute appropriate proceedings 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 or materials provided, or
       both. Proceedings may be initiated against the violating party,
       or legal representatives, or 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 the study subjects, their families,
       or both."

XXVIII. Termination. This section describes what happens when the
        agreement ends; it could also indicate whether any provisions
        survive termination.

XXIX. Primacy: If applicable, the drafter should include a provision
      specifying whether the agreement supersedes any and all previous
      agreements.

XXX. Changes in writing only: If applicable, the drafter should include
     language that stipulates that changes can be made only by a written
     modification of the agreement signed by all the parties.

XXXI. Independent Parties. If applicable, the drafter should include a
      provision specifying that each party is an independent contractor
      and has no authority to bind or act on behalf of another party.

XXXII. Governing Law: If applicable, the drafter should include a
       provision specifying that the agreement is governed by and
       construed in accordance with the law of a particular
       jurisdiction.

XXXIV\. Signatures: The agreement should be signed by individuals who
are authorized to bind their institutions.

Addenda: This section can be used to provide the technical details
needed to support the agreement and/or describe the process of sharing
data. The responsible exchange of data requires the establishment and
maintenance of appropriate technical standards. As in the example of
multi-centered consortia, it may be appropriate to provide specific
technical descriptions of the data storage requirements and processes in
an addendum. Alternatively or in addition, a description of access to
the network, such as the EDRN, may be included in an addendum or in a
letter of acknowledgement and acceptance of the recipient's request. An
example follows from Fox Chase Cancer Center: [^12]

We recognize that prudent sharing of final data is key to achieving the
goals of this project. FCCC will fully comply with NIH policies on data
sharing. Data generated by FCCC and available for sharing with the
research community will be presented through a portion of the FCCC
website dedicated to EDRN activities. This site will provide an easily
accessible, single point of entry for scientists seeking access to
inventory and project data. Tabular biosample inventory data, and an
easy to use web-based query tool will be available to the research
community though this website. Data transfer between FCCC and the EDRN
Data Management and Coordinating Center (DMCC), other EDRN components,
outside investigators, or the NCI can be accomplished in a number of
different ways. Data can be transferred directly between computers using
ftp (file transfer protocol) or sftp (secure ftp). Alternatively, users
can transfer data through a secure web-enabled, non-browsable,
predetermined directory. Direct transfers of data will require users to
register with the system. In some cases, users may need to agree to
modest and reasonable conditions described by a data-sharing agreement
before receiving permission to access these data. In any case, FCCC will
be happy to transfer data in agreed upon vocabularies and formats (e.g.,
fixed format, delimited, XML, etc.). Due to the sensitive nature of
personal medical information, we will take extensive precautions to
protect the privacy of participants. Study subject information will be
anonymized/de-linked before being made available to non-FCCC
investigators or organizations. Data will also comply with the HIPAA
Privacy Rule and FCCC IRB regulations before being made available for
general distribution. Data dictionaries and other required documentation
will be accessible to the research community.

FCCC staff will collaborate with the DMCC to ensure that eligible data
is submitted in accordance with data management protocols produced by
the DMCC. FCCC will submit (via the internet) information on specimen
collections per the Network's Common Data Elements and register
protocols with the Network's Data Management and Coordinating Center. As
part of this effort, FCCC will work with our collaborators to convert
(or "map") data from our existing information systems to the
EDRN-approved Common Data Elements (CDE) definitions.

When appropriate, FCCC staff will adapt FCCC data management systems so
that they are compatible with EDRN data infrastructures. Ultimately,
FCCC would like to participate in the federation of data resources
across the EDRN network using technologies already developed and
deployed by the DMCC and the Jet Propulsion Laboratory. This will
require installation of the necessary OODT middleware software
components, development of appropriate local data elements and metadata
adhering to ISO/IEC 11179 format, development of local query wrappers
for the query services, and working with the DMCC to develop the
necessary XML-based transforms that drive the OODT "product" service to
produce EDRN-compatible data output. This data, which is represented as
a XML stream, can then be transmitted to the EDRN via a variety of
mechanisms, including Java-RMI or batch uploads using secure File
Transfer Protocol (sFTP).

**[Glossary]{.underline}**

See definitions in "Elements of a Data Sharing Agreement" above.

***Open source***[^13]-

> Open source doesn\'t just mean access to the source code. The
> distribution terms of open-source software must comply with the
> following criteria:

### 1. Free Redistribution

> The license shall not restrict any party from selling or giving away
> the software as a component of an aggregate software distribution
> containing programs from several different sources. The license shall
> not require a royalty or other fee for such sale.

### 2. Source Code

> The program must include source code, and must allow distribution in
> source code as well as compiled form. Where some form of a product is
> not distributed with source code, there must be a well-publicized
> means of obtaining the source code for no more than a reasonable
> reproduction cost preferably, downloading via the Internet without
> charge. The source code must be the preferred form in which a
> programmer would modify the program. Deliberately obfuscated source
> code is not allowed. Intermediate forms such as the output of a
> preprocessor or translator are not allowed.

### 3. Derived Works

> The license must allow modifications and derived works, and must allow
> them to be distributed under the same terms as the license of the
> original software.

### 4. Integrity of The Author\'s Source Code

> The license may restrict source-code from being distributed in
> modified form only if the license allows the distribution of \"patch
> files\" with the source code for the purpose of modifying the program
> at build time. The license must explicitly permit distribution of
> software built from modified source code. The license may require
> derived works to carry a different name or version number from the
> original software.

# The Open Source Definition

### 5. No Discrimination Against Persons or Groups

> The license must not discriminate against any person or group of
> persons.

### 6. No Discrimination Against Fields of Endeavor

> The license must not restrict anyone from making use of the program in
> a specific field of endeavor. For example, it may not restrict the
> program from being used in a business, or from being used for genetic
> research.

### 7. Distribution of License

> The rights attached to the program must apply to all to whom the
> program is redistributed without the need for execution of an
> additional license by those parties.

### 8. License Must Not Be Specific to a Product

> The rights attached to the program must not depend on the program\'s
> being part of a particular software distribution. If the program is
> extracted from that distribution and used or distributed within the
> terms of the program\'s license, all parties to whom the program is
> redistributed should have the same rights as those that are granted in
> conjunction with the original software distribution.

### 9. License Must Not Restrict Other Software

> The license must not place restrictions on other software that is
> distributed along with the licensed software. For example, the license
> must not insist that all other programs distributed on the same medium
> must be open-source software.

### \*10. License Must Be Technology-Neutral

> No provision of the license may be predicated on any individual
> technology or style of interface.

***Wikipedia*** defines ***open source*** as follows: "Open source
describes the principles and methodologies to promote open access to the
production and design process for various goods, products, resources and
technical [conclusions](http://en.wikipedia.org/wiki/Conclusions) or
advice. The term is most commonly applied to the [source
code](http://en.wikipedia.org/wiki/Source_code) of
[software](http://en.wikipedia.org/wiki/Software) that is made available
to the general public with either relaxed or non-existent [intellectual
property](http://en.wikipedia.org/wiki/Intellectual_property)
restrictions. This allows users to create [user-generated software
content](http://en.wikipedia.org/wiki/User_generated_content) through
either incremental individual effort, or
[collaboration](http://en.wikipedia.org/wiki/Collaboration).

Some consider open source as one of various possible design approaches,
while others consider it a critical
[strategic](http://en.wikipedia.org/wiki/Strategy) element of their
[operations](http://en.wikipedia.org/wiki/Business_operations). Before
open source became widely adopted, developers and producers used a
variety of phrases to describe the concept; the term open source gained
popularity with the rise of the
[Internet](http://en.wikipedia.org/wiki/Internet) and its enabling of
diverse production models, communication paths, and interactive
communities.[^\[1\]^](http://en.wikipedia.org/wiki/Open_source#_note-0%23_note-0)
Subsequently, [open source
software](http://en.wikipedia.org/wiki/Open_source_software) became the
most prominent face of open source practices.

The open source model of operation can be extended to [open source
culture](http://en.wikipedia.org/wiki/Open_source_culture) in [decision
making](http://en.wikipedia.org/wiki/Decision_making) which allows
concurrent input of different agendas, approaches and priorities, in
contrast with more centralized models of development such as those
typically used in commercial
companies.[^\[2\]^](http://en.wikipedia.org/wiki/Open_source#_note-1%23_note-1)
\"Open source\" as applied to culture defines a culture in which
collective [decisions](http://en.wikipedia.org/wiki/Decisions) or
[fixations](http://en.wikipedia.org/wiki/Fixation) are shared during
development and made generally available in the [public
domain](http://en.wikipedia.org/wiki/Public_domain)- - - as seen with
[Wikipedia](http://en.wikipedia.org/wiki/Wikipedia). This collective
approach moderates [ethical](http://en.wikipedia.org/wiki/Ethical)
concerns over a \"conflict of roles\" or [conflict of
interest](http://en.wikipedia.org/wiki/Conflict_of_interest).
Participants in such a culture are able to modify the collective
outcomes and share them with the community

***open access*** generally refers to a series of initiatives designed
to make scholarly articles in all fields freely available on the
internet. More information on this movement can be found at
http://www.soros.org/openaccess/

***open development occurs*** when software is worked on, improved, and
distributed by a self-selected group of developers to the benefit of
all. This is not synonymous with open source. Linux is often cited as an
example of software created in an open development environment.[^14]

***Federation:*** is defined at
http://www.thefreedictionary.com/federation as "the act of constituting
a political unity out of a number of separate states or colonies or
provinces so that each member retains the management of its internal
affairs" caBIG(tm) ™ is an example of a federated structure.

OMB defines ***research data*** as "the recorded factual material
commonly accepted in the scientific community as necessary to validate
research findings

***UBMTA***: Universal Biological Material Transfer Agreement. See
<http://www.niehs.nih.gov/techxfer/ubmta.htm> or
http://www3.niaid.nih.gov/about/organization/odoffices/omo/otd/UBMTA.htm

**[Resources]{.underline}**

The website of the American Bar Association at
[**http://www.abanet.org/scitech/**](http://www.abanet.org/scitech/)

American Intellectual Property Law Association at http://www.aipla.org/

Cozzarelli, R. (2001) Proc. Natl. Acad. Sci. USA 98,
8159.[\[Free Full Text\]](http://www.pnas.org/cgi/ijlink?linkType=FULL&journalCode=pnas&resid=98/15/8159)

Cech, T.R. (2003) Sharing Publication-Related Data and Materials:
Responsibilities of Authorship in the Life Sciences. Available at
[www.nap.edu/books/0309088593/html](http://www.nap.edu/books/0309088593/html).

<http://www.codata.org/> ***International Council for Science: Committee
on Data for Science and Technology***

COGR: <http://206.151.87.67/docs/DataRetentionIntroduction.htm>

Cold Spring Harbor Research Collaboration Agreement form, provided
courtesy of Tristan Fiedler, Ph.D.

Journal of Technology Law and Policy at
<http://journal.law.ufl.edu/~techlaw/>

Harvard Journal of Technology and Law at http://jolt.law.harvard.edu/

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

<http://www.rcr.emich.edu/module3/c_21sharing.html>

<http://www.talkbank.org/share/share.html>

Sharing Publication-Related Data and Materials: Responsibilities of
Authorship in the Life Sciences Committee on Responsibilities of
Authorship in the Biological Sciences, National Research Council of the
National Academies of Science, 2003

http://www.informatics-review.com/wiki/index.php/Biobanking_Definition

For signatories to the UBMTA, see the AUTM
site:http://www.autm.net/aboutTT/aboutTT_umbtaSigs.cfm

On RHIO models:
<http://www.naphit.org/global/library/webinars/webinars_06/031506/RHIO-Models-NAPHIT-v4.ppt#18>

David L. Calone, review of [What Will Be: How the New World of
Information Will Change our Lives]{.underline} by Michael L. Dertouzos
[in]{.underline} *Harvard Journal of Law & Technology,* Volume 11,
Number 1 Fall 1997

[^1]: Dertouzos, Michael L. in WHAT WILL BE: HOW THE NEW WORLD OF

    INFORMATION WILL CHANGE OUR LIVES, New *York. N.Y.: HarperCollins
    Publishers, lnc. 1997.*

[^2]: http://www.aamc.org/advocacy/library/research/corres/2002/051102.htm

[^3]: . http://www.nwdsn.org/html/about.htm

[^4]: http://www.autm.net/aboutTT/aboutTT_umbta.cfm

[^5]: RFP NCI NO2-CO-51019-17

[^6]: UNC Data Use Agreement

[^7]: University of Minnesota Business Associate Agreement

[^8]: THE FRAMINGHAM STUDY -- Data and Materials Distribution Agreement
    Form

[^9]: Washington University Center for Collaborative Genetic Studies on
    Mental Disorders information on Access to Data and Biomaterials.
    12/2005

[^10]: Excerpted from Cold Spring Harbor Research Collaboration
    Agreement courtesy of Tristan Fiedler

[^11]: NIMH Center for Collaborative Genetic Studies on Mental Disorders
    Distribution Agreement

[^12]: Language from Fox Chase Cancer Center application to the EDRN
    network

[^13]: Origins: Bruce Perens wrote the first draft of this document as
    \"The Debian Free Software Guidelines\", and refined it using the
    comments of the Debian developers in a month-long e-mail conference
    in June, 1997. He removed the Debian-specific references from the
    document to create the \"Open Source Definition.\"

    Copyright © 2007 by the [Open Source
    Initiative](http://www.opensource.org/index.php)\
    Send questions or suggestions about the website to Steve M.:
    [webmaster at opensource.org](mailto:webmaster@opensource.org)

[^14]: http://wp.netscape.com/browsers/future/whitepaper.html