roda_attributions.txt

** Open Targets; version 2020_06 --
https://www.targetvalidation.org/downloads/data

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* For Open Targets see also this required NOTICE:
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------

** BindingDB; version 2019_11 --
https://www.bindingdb.org/bind/chemsearch/marvin/SDFdownload.jsp?all_download=yes
Citation: Michael K. Gilson, Tiqing Liu, Michael Baitaluk, George Nicola, Linda
Hwang, Jenny Chong, BindingDB in 2015: A public database for medicinal
chemistry, computational chemistry and systems pharmacology, Nucleic Acids
Research, Volume 44, Issue D1, 4 January 2016, Pages D1045–D1053,
https://doi.org/10.1093/nar/gkv1072

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------

** ChEMBL; version 2.7 --
https://chembl.gitbook.io/chembl-interface-documentation/downloads
Copyright © EMBL-EBI 2018 | EMBL-EBI is part of the European Molecular Biology
Laboratory

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------

** Genome Tissue Expression Database; version v8 --
https://www.gtexportal.org/home/datasets
The Genotype-Tissue Expression (GTEx) Project was supported by the Common Fund
of the Office of the Director of the National Institutes of Health, and by NCI,
NHGRI, NHLBI, NIDA, NIMH, and NINDS. The data used for the analyses described
in this manuscript were obtained from: [insert, where appropriate] the GTEx
Portal on 08/19/2020.

NIH Genomic Data Sharing Policy
Notice Number: NOT-OD-14-124

Key Dates
Release Date:   August 27, 2014

Related Announcements
NOT-OD-17-110
NOT-HG-15-038
NOT-OD-15-086
NOT-OD-15-083
NOT-OD-15-027
NOT-OD-14-111
NOT-OD-13-119
NOT-OD-12-136
NOT-HG-10-006
NOT-OD-08-013
NOT-OD-07-088
NOT-OD-07-088
NOT-MH-19-033
NOT-HG-20-011
Issued by
National Institutes of Health (NIH)

Purpose

Summary
The National Institutes of Health (NIH) announces the final Genomic Data
Sharing (GDS) Policy that promotes sharing, for research purposes, of
large-scale human and non-human genomic1 data generated from NIH-funded
research. A summary of public comments on the draft GDS Policy and NIH’s
responses are also provided.

Introduction
NIH announces the final Genomic Data Sharing (GDS) Policy, which sets forth
expectations that ensure the broad and responsible sharing of genomic research
data. Sharing research data supports the NIH mission and is essential to
facilitate the translation of research results into knowledge, products, and
procedures that improve human health. NIH has longstanding policies to make a
broad range of research data, in addition to genomic data, publicly available
in a timely manner from the research activities that it funds.2,3,4,5,6

NIH published the Draft NIH Genomic Data Sharing Policy Request for Public
Comments in the Federal Register on September 20, 2013,7 and the NIH Guide for
Grants and Contracts on September 27, 2013,8 for a 60-day public comment period
that ended November 20, 2013. NIH also used websites, listservs, and social
media to disseminate the request for comments. On November 6, 2013, during the
comment period, NIH held a public webinar on the draft GDS Policy that was
attended by nearly 200 people and included a question and answer session.9

NIH received a total of 107 public comments on the draft GDS Policy. Comments
were submitted by individuals, organizations, and entities affiliated with
academic institutions, professional and scientific societies, disease and
patient advocacy groups, research organizations, industry and commercial
organizations, tribal organizations, state public health agencies, and private
clinical practices. The public comments have been posted on the NIH GDS
website.10 Comments were supportive of the principles of sharing data to
advance research. However, there were a number of questions and concerns, and
calls for clarification about specific aspects of the draft Policy. A summary
of comments, organized by corresponding sections of the GDS Policy, is provided
below.

Scope and Applicability
Several commenters stated that the draft Policy was unclear with regard to the
types of research to which the Policy would apply. Some commenters suggested
that the technology used in a research study (i.e., array-based or
high-throughput genomic technologies) should not be the focus in determining
applicability of the Policy. They suggested instead that the information gained
from the research should determine the applicability of the Policy. Many other
commenters expressed the concern that the Policy was overly broad and would
lead to the submission of large quantities of data with low utility for other
investigators. Several other commenters suggested that the scope of the Policy
was not broad enough. Additionally, some commenters were uncertain about
whether the Policy would apply to research funded by multiple sources.

NIH has revised the Scope and Applicability section to help clarify the types
of research to which the Policy is intended to apply, and the reference to
specific technologies has been dropped. The list of examples of the types of
research projects that are within the Policy’s scope, which appeared in
Appendix A of the draft GDS Policy (now referred to as “Supplemental
Information to the NIH Genomic Data Sharing Policy”11), has been revised and
expanded, and examples of research that are not within the scope have been
added as well. Also, the final GDS Policy now explicitly states that smaller
studies (e.g., sequencing the genomes of fewer than 100 human research
participants) are generally not subject to this Policy. Smaller studies,
however, may be subject to other NIH data sharing policies (e.g., the National
Institute of Allergy and Infectious Diseases Data Sharing and Release
Guidelines12) or program requirements. In addition, definitions of key terms
used in the Policy (e.g., aggregate data) have been included and other terms
have been clarified.

The statement of scope remains intentionally general enough to accommodate the
evolving nature of genomic technologies and the broad range of research that
generates genomic data. It also allows for the possibility that individual NIH
Institutes or Centers (IC) may choose on a case-by-case basis to apply the
Policy to projects generating data on a smaller scale depending on the state of
the science, the needs of the research community, and the programmatic
priorities of the IC. The Policy applies to research funded in part or in total
by NIH if NIH funding supports the generation of the genomic data.
Investigators with questions about whether the Policy applies to their current
or proposed research should consult the relevant Program Official or Program
Officer or the IC’s Genomic Program Administrator (GPA). Names and contact
information for GPAs are available through the NIH GDS website.13

Some commenters expressed concern about the financial burden on investigators
and institutions of validating and sharing large volumes of genomic data and
the possibility that resources spent to support data sharing would redirect
funds away from research. While the resources needed to support data sharing
are not trivial, NIH maintains that the investments are warranted by the
significant discoveries made possible through the secondary use of the data. In
addition, NIH is taking steps to evaluate and monitor the impact of data
sharing costs on the conduct of research, both programmatically through the Big
Data to Knowledge Initiative14 and organizationally through the creation of the
Scientific Data Council, which will advise the agency on issues related to data
science.15

Data Sharing Plans
Some commenters pointed out that the Policy was not clear enough about the
conditions under which NIH would grant an exception to the submission of
genomic data to NIH. Some also suggested that NIH should allow limited sharing
of human genomic data when the original consent or national, tribal, or state
laws do not permit broad sharing.

While NIH encourages investigators to seek consent for broad sharing, and some
ICs may establish program priorities that expect studies proposed for funding
to include consent for broad sharing, exceptions may be made. The final Policy
clarifies that exceptions may be requested in cases where the submission of
genomic data would not meet the criteria for the Institutional Certification.

Some commenters expressed concern that it would be difficult to estimate the
resources required to support data sharing plans before a study is completed.
Others asked for additional guidance on resources that should be requested to
support the data sharing plan. Several commenters suggested that NIH should
allow certain elements of the data sharing plan, such as the Institutional
Certification and associated documentation, to be submitted along with other
“Just-in-Time” information. For multi-year awards, one commenter suggested that
the data sharing plans should be periodically reviewed for consistency with
contemporary ethical standards. Another suggested that data sharing plans
should be made public.

Under the GDS Policy, investigators are expected to outline in the budget
section of their funding application the resources they will need to prepare
the data for submission to appropriate repositories. NIH will provide
additional guidance on these resources, as necessary. The final Policy
clarifies that only a basic genomic data sharing plan, in the Resource Sharing
Plan section of grant applications, needs to be submitted with the funding
application and that a more detailed plan should be provided prior to award.
The Institutional Certification also should be provided prior to award, along
with any other Just-in-Time information. Guidance on genomic data sharing plans
is available on the NIH GDS website.16 Data sharing plans will undergo periodic
review through annual progress reports or other appropriate scientific project
reviews. Further consideration will be given to the suggestion that data
sharing plans should be made public.

Non-human and Model Organism Genomic Data
The draft GDS Policy proposed timelines for data submission and data release
(i.e., when data should be made available for sharing with other
investigators). For non-human data, the draft Policy proposed that data should
be submitted and made available for sharing no later than the date of initial
publication, with the acknowledgement that the submission and release of data
for certain projects may be expected earlier, mirroring data sharing
expectations that have been in place under other policies.4 Some commenters
suggested that the data submission expectations for non-human data were
unclear. One commenter suggested that NIH should consider a more rapid timeline
than the date of first publication for releasing model organism data, while
other comments supported the specified data release timeline. Other commenters
were concerned that the specified timeline was too short.

The final GDS Policy does not change the timeline for the submission and
release of non-human and model organism data. The timeline is based on the need
to promote broad data sharing while also accommodating the investigators
generating the data, who often must make a significant effort to prepare the
data for sharing. The Policy points out that an NIH IC may choose to shorten
the timeline for data submission and release for certain projects and expects
investigators to work with NIH Program or Project Officials for specific
guidance on the timelines and milestones for their projects.

There was broad support for the Policy’s flexibility of allowing non-human and
model organism data to be deposited in any widely used data repository. One
commenter requested that a link or reference to non-NIH-designated repositories
be included in the Policy. Further information about NIH-designated
repositories, including examples of such repositories, is available on the GDS
website,17 and additional information about non-NIH-designated data
repositories will be incorporated in outreach and training materials for NIH
staff and investigators and made available on the GDS website. NIH has
clarified the final Policy to state that data types that were previously
submitted to widely used repositories (e.g., gene expression data to the Gene
Expression Omnibus or Array Express) should continue as before, while data
types not previously submitted may go to these or other widely used
repositories as agreed to by the funding IC.

Human Genomic Data
The Supplemental Information to the NIH GDS Policy10 establishes timelines for
the submission and subsequent release of data for access by secondary
investigators based on the level of processing that the data have undergone. A
number of commenters expressed concern about these timelines, suggesting that
they were too short and could limit an investigator’s ability to perform
adequate quality control and publish results within the provided timeline. Many
commenters proposed that the timeline for data release be extended to 12 or 18
months or be the date of publication, whichever comes first. Others were
concerned that the timelines were too long and that they should reflect the
longstanding principle of rapid data release as articulated in the Bermuda and
Ft. Lauderdale agreements.5 Some commenters were concerned that the elimination
of the embargo period, (i.e., the period between when a study is released for
secondary research and when the submitting investigator first publishes on the
findings of the study) would adversely affect the goal of rapid data release.
One commenter was concerned that data would be released before investigators
could discuss consequential findings with participants.

NIH has modified the Supplemental Information to clarify that the 6-month
deferral for the release of Level 2 and Level 3 human genomic data does not
start until the data have been cleaned and submission to NIH has been
initiated, which is typically about three months after the data have been
generated. Because there will be significant variation in research projects
generating Level 2 and Level 3 human genomic data, the timeline for submission
is project-specific and will be determined in each case by the funding NIH IC
through consultation with the investigator, and the Supplemental Information
has been clarified accordingly. Under the GWAS Policy,6 a publication embargo
period was used as a way of making data more rapidly available. In exchange for
immediate data access, secondary users were not permitted to publish or present
research findings until 12 months after the data were released. NIH did not
adopt this approach for the GDS Policy because in practice, the publication
embargo dates were difficult for secondary users to track, especially for
datasets that had multiple embargo periods for certain types of data, raising
the risk of unintentional embargo violations. Regarding the concern that human
genomic data will be made available before investigators can notify
participants of consequential findings, such data would be considered Level 4
data and would not be expected to be released before publication, which NIH
believes will provide sufficient time to discuss consequential findings with
participants.

Many commenters called for the Policy to include technical data standards for
the submission of human genomic data, such as platform information, controlled
vocabulary, normalization algorithms, data quality standards, and metadata
standards. NIH agrees with the importance of developing and using standards for
genomic data and is aware that there are numerous initiatives underway to
develop and promote such standards.18 NIH has revised the Supplemental
Information by adding a section on resources for data standards. It provides
references to instructions for data submission to specific NIH-designated data
repositories, which include data standards. Additional resources for data
standards will be incorporated in the Supplemental Information as they are
developed and become appropriate for broad use.

Several commenters asked for a definition of an NIH-designated data repository
and for guidance on determining which non-NIH repositories are acceptable as
well as examples of such repositories. Commenters also expressed interest in
additional details regarding the use of Trusted Partners, which are third-party
partnerships established through a contract mechanism, to provide
infrastructure needs for data storage and/or tools that are useful for genomic
data analyses. A definition of an NIH-designated repository is now included in
the final Policy. Additionally, further information about non-NIH-designated
repositories that accept human genomic data will be made available on the GDS
website and incorporated in outreach and training materials for NIH staff and
NIH-funded investigators. Additional information about Trusted Partners,
including the standards required for trusted partnerships, is also available on
the NIH GDS website.16

Regarding informed consent, the GDS Policy expects investigators generating
genomic data to seek consent from participants for future research uses and the
broadest possible sharing. A number of commenters were concerned that
participants would not agree to consent for broad sharing and that enrollment
in research studies may decline, potentially biasing studies if certain
populations were less likely to consent to broad use of their data. Some
commenters also raised a concern about the competitiveness of an application
that proposed to obtain consent for more limited sharing of data. Several
commenters suggested that NIH permit alternative forms of informed consent
other than broad consent, such as dynamic consent or tiered consent.

NIH recognizes that consent for future research uses and broad sharing may not
be appropriate or obtainable in all circumstances. ICs may continue to accept
data from studies with consents that stipulate limitations on future uses and
sharing, and NIH will maintain the data access system that enables more limited
sharing and secondary use. With regard to the competitiveness of grant
applications that do not propose to utilize consent for broad sharing, this
Policy does not propose that applications be assessed on this point during the
merit review, but investigators are nonetheless expected to seek consent for
broad sharing to the greatest extent possible. The breadth of the sharing
permitted by the consent may be taken into consideration during program
priority review by the ICs. Regarding the alternative forms of consent, the
Policy does not prohibit the use of dynamic or tiered consents. It promotes the
use of consent for broad sharing to enable the greatest potential public
benefit. However, NIH recognizes that changing technology may enable more
dynamic consent processes that improve tracking and oversight and more closely
reflect participant preferences. NIH will continue to monitor developments in
this area.

Several commenters were unsure whether the GDS Policy would apply to research
in clinical settings or research involving data from deceased individuals.
Research that falls within the scope of the GDS Policy will be subject to the
Policy, regardless of whether it occurs in a clinical setting or involves data
generated from deceased individuals.

Several commenters also expressed concern that the Policy is unclear about the
ability of groups, in addition to participants, to opt-out or withdraw informed
consent for research and whether the ability to withdraw could be transferred
or inherited. The Policy states that investigators and institutions may request
that NIH withdraw data in the event that individual participants or groups
withdraw consent for secondary research, although some data that have been
distributed for research cannot be retrieved. Institutions submitting the data
should determine whether data should be withdrawn from NIH repositories and
notify NIH accordingly.

Many commenters urged NIH to develop standard text or templates for informed
consent documents so that investigators would be assured that their consent
material would be consistent with the Policy’s expectations for informed
consent and data sharing. One of these commenters noted the challenge of
conveying the necessary information (e.g., broad future research uses) without
adding to the complexity of consent forms. Developing educational materials or
tools to guide the process for obtaining informed consent was also suggested.
Other commenters expressed concern about the burden of rewriting and
harmonizing existing informed consent documents. NIH appreciates the suggestion
to develop template consent documents and plans to provide guidance to assist
investigators and institutions in developing informed consent documents.

Many comments questioned the proposal to require explicit consent for research
that is not considered humans subjects research under 45 CFR Part 46 (e.g.,
research that involves de-identified specimens or cell lines). There were also
several comments about the draft GDS Policy proposal to grandfather data from
de-identified clinical specimens and cell lines collected or generated before
the effective date of the GDS Policy. The reason the Policy expects consent for
research for the use of data generated from de-identified clinical specimens
and cell lines created after the effective date of the Policy is because the
evolution of genomic technology and analytical methods raises the risk of
re-identification.19 Moreover, requiring that consent be obtained is respectful
of research participants, and it is increasingly clear that participants expect
to be asked for their permission to use and share their de-identified specimens
for research.20,21,22 The Policy does not require consent to be obtained for
research with data generated from de-identified clinical specimens and cell
lines that were created or collected before the effective date of the Policy
because of the practical and ethical limitations in recontacting participants
to obtain new consent for existing collections and the fact that such data may
have already been widely used in research.

The draft GDS Policy included an exception for “compelling scientific reasons”
to allow the research use of data from de-identified, clinical specimens or
cell lines collected or created after the effective date of the Policy and for
which research consent was not obtained. Commenters did not object to the need
for such an exception, but they asked for clarification on what constitutes a
“compelling scientific reason,” and the process through which investigators’
justifications would be determined to be appropriate.

The funding IC will determine whether the investigators’ justifications for the
use of clinical specimens or cell lines for which no consent for research was
obtained are acceptable, as provided in their funding application and
Institutional Certification. Further guidance on what constitutes compelling
scientific reasons will be made available on the GDS website and will likely
evolve over time as NIH ICs, the NIH GDS governance system, and program and
project staff acquire greater experience with requests for research with such
specimens.

For clinical specimens and cell lines lacking consent for research and
collected before the effective date of the Policy, several commenters were
concerned that the Policy was unclear about whether data from such specimens
can be deposited in NIH repositories. This provision of the Policy is intended
to allow the research use of genomic data derived from de-identified clinical
specimens or cell lines collected or created after the Policy’s effective date
in exceptional situations where the proposed research has the potential to
advance scientific or medical knowledge significantly and could not be
conducted with consented specimens or cell lines. The draft GDS Policy stated
that NIH will accept data from clinical specimens and cell lines lacking
consent for research use that were collected before the effective date of the
Policy, and this remains unchanged in the final Policy.

A concern shared by several commenters was that the risks posed to the privacy
of individuals with rare diseases, populations with higher risk of
re-identification by the broad sharing of data, or populations at risk of
greater potential harm from re-identification were not adequately addressed.
Several commenters were particularly concerned that no additional protections
were specified for these populations, and a subset suggested that research
subject to the GDS Policy that involves these populations should be entirely
exempt from the Policy’s expectations for data sharing.

Currently, NIH requests Institutional Review Boards (IRBs) to consider ethical
concerns related to groups or populations when determining whether a study’s
consent documents are consistent with NIH policy.23 In addition, NIH has
clarified in the final GDS Policy that exceptions may be requested for the
submission and subsequent sharing of data if the criteria in the Institutional
Certification cannot be met (e.g., an IRB or equivalent body cannot assure that
submission of data and subsequent sharing for research purposes are consistent
with the informed consent of study participants). If a submitting institution
determines that the criteria can be met but has additional concerns related to
the sharing of the data, the institution can indicate additional stipulations
for the use of the data through the data use limitations submitted with the
study.

Several commenters suggested that return of medically actionable incidental
findings should be included in the consent or that re-identification of
participants should be allowed in order to return such incidental results. NIH
recognizes that, as in any research study, harms may result if individual
research findings that have not been clinically validated are returned to
subjects or are used prematurely for clinical decision-making. The return of
individual findings from studies using data obtained from NIH-designated
repositories is expected to be rare, because investigators will not be able to
return individual research results directly to a participant as neither they
nor the repository will have access to the identities of participants.
Submitting institutions and their IRBs may wish to establish policies for
determining when it is appropriate to return individual findings from research
studies. Further guidance on the return of results is available from the
Presidential Commission for the Study of Bioethical Issues’ report, “Anticipate
and Communicate: Ethical Management of Incidental and Secondary Findings in the
Clinical, Research, and Direct-to-Consumer Contexts.”24

Several commenters were concerned that the draft GDS Policy was unclear about
which standard should be used to ensure the de-identification of data. Another
issue raised by a number of comments related to identifiability of genomic
data. Several commenters were concerned that de-identified genotype data could
be re-identified, even if these data are de-identified according to Health
Insurance Portability and Accountability Act (HIPAA) and the Common Rule.
Others asserted that genomic data could not be fully de-identified. A number of
commenters suggested that the GDS Policy should explicitly state that risks
exist for participant privacy despite the de-identification of genomic data and
should require informed consent documents to include such a statement. Others
suggested that the Policy should state that genomic information cannot be
de-identified. Commenters suggested that the risks of re-identification were
not adequately addressed in the draft Policy.

The final GDS Policy has been clarified to state that for the purpose of the
Policy, data should be de-identified to meet the definition for de-identified
data in the HHS Regulations for Protection of Human Subjects25 and be stripped
of the 18 identifiers listed in the HIPAA Privacy Rule.26 NIH agrees that the
risks of re-identification should be conveyed to prospective subjects in the
consent process. This is one of the reasons why NIH expects explicit consent
after the effective date of the Policy for broad sharing and for data that will
be submitted to unrestricted-access data repositories (i.e., openly accessible
data repositories, previously referred to as “open access”). NIH will provide
further guidance on informing participants about the risks of re-identification
through revisions to guidance documents such as the NIH Points to Consider for
IRBs and Institutions in their Review of Data Submission Plans for
Institutional Certifications Under NIH’s Policy for Sharing of Data Obtained in
NIH Supported or Conducted Genome-Wide Association Studies.24

Several commenters were particularly concerned about the cost and burden of
obtaining informed consent for the research use of data generated from clinical
specimens and cell lines collected or created after the effective date of the
GDS Policy. NIH recognizes that these consent expectations for data from
de-identified clinical specimens collected after the effective date will
require additional resources. Given growing concerns about re-identification,
it is no longer ethically tenable simply to de-identify clinical specimens or
derived cell lines to generate data for research use without an individual’s
consent. In addition, NIH anticipates that obtaining consent for broad future
research uses will facilitate access to greater volumes of data and ultimately
will reduce the costs and burdens associated with sharing research data.

Some commenters expressed concern that the draft Policy’s standards for consent
are more restrictive than other rules governing human subjects protections
including the Common Rule27 and revisions proposed to the Common Rule in a 2011
Advance Notice of Proposed Rule Making (ANPRM).28 Some commenters sought
greater clarification regarding regulatory differences or the regulatory basis
for the draft Policy’s protections.

NIH has the authority to establish additional policies with expectations that
are not required by laws or regulations but advance the agency’s mission to
enhance health, lengthen life, and reduce illness and disability. The GDS
Policy builds on the GWAS Policy, which established additional expectations
that were not required by the Common Rule for obtaining consent for, handling,
sharing, and using human genotype and phenotype data in NIH-funded research.
NIH expects that in addition to adhering to the GDS Policy, investigators and
institutions will also comply with the Common Rule and any other applicable
federal regulations or laws. In response to the concern that the draft Policy
is inconsistent with the ANPRM for revisions to the Common Rule, NIH will
evaluate any inconsistencies between the GDS Policy and the Common Rule when
the Common Rule revisions are final.

Responsibilities of Investigators Accessing and Using Genomic Data
Commenters asserted that the draft GDS Policy did not do enough to protect
against the misuse of the data by investigators accessing the data. They
suggested that the Policy state that responsibilities outlined in the Policy
for data users should be “required” rather than “expected” and should state
that there will be penalties for noncompliance with the Policy and rigorous
sanctions for the intentional misuse of data. There was also a comment
proposing that a submitting institution should be able to review and comment on
all data access requests (DARs) to NIH before NIH completes its internal review
process and proposed that NIH notify submitting institutions and research
participants of any policy violations reported by users of genomic data.

NIH Data Access Committees (DACs) review DARs on behalf of submitting
institutions by using the data use limitations provided by the institutions to
determine whether the DAR is consistent with the limitations to ensure that
participants’ wishes are respected. As part of its ongoing oversight process,
NIH reviews notifications of data mismanagement or misuse, such as errors in
the assignment of data use limitations during data submission, investigators
sharing controlled-access data with unapproved investigators, and investigators
using the data for research that was not described in their research use
statement. To date, violations have been discovered before the completion of
the research, and no participants have been harmed. When NIH becomes aware of
any problems, the relevant institution and investigators are notified, and NIH
takes appropriate steps to address the violation and prevent it from recurring.
To ensure that the penalties for the misuse of data are clear for all data
submitters, users, and research participants, the GDS Policy has been revised
to clarify that secondary users in violation of the Policy or the Data Use
Certification may face enforcement actions. In addition, a measure to protect
the confidentiality of de-identified data obtained through controlled access
has been added by encouraging approved users to consider requesting a
Certificate of Confidentiality.

Several comments were submitted by representatives or members of tribal
organizations about data access. Tribal groups expressed concerns about the
ability of DACs to represent tribal preferences in the review of requests for
tribal data. They also proposed new provisions for the protection of
participant data, for example, including de-identification of tribal membership
in participant de-identification and revision of the Genomic Data User Code of
Conduct to reference protocols for accessing, sharing, and using tribal data,
such as de-identification of participants’ tribal affiliation.
The final Policy has been modified to reference explicitly that tribal law, in
addition to other factors such as limitations in the original informed consents
or concerns about harms to individuals or groups, should be considered in
assessing the secondary use of some genomic data.

Some commenters proposed changes to controlled access for human genomic data.
Some commenters thought controlled access unnecessarily limited research, and
many provided a range of suggestions on how to improve the process of accessing
the data, such as: allowing unrestricted access to de-identified data;
developing standard data use limitations for controlled-access data;
streamlining and increasing transparency of data access procedures and
processing time; and modifying the database of genotypes and phenotypes (dbGaP)
to facilitate peer-review and collaboration.

The final GDS Policy permits unrestricted access to de-identified data, but
only if participants have explicitly consented to sharing their data through
unrestricted-access mechanisms. Standard data use limitations have been
developed by NIH and are available through the GDS website.29 With regard to
improving transparency on data access procedures, NIH plans to make statistics
on access publicly available on the GDS website,30 including the average
processing time for NIH to review data access requests. From its inception,
dbGaP has solicited feedback from users and worked to improve data submission
and access procedures, for example, the creation of a study compilation that
allows investigators to submit a single request for access to all
controlled-access aggregate and individual-level genomic data available for
general research use.31,32 NIH will continue to seek user feedback and track
the performance of the dbGaP system.

Several comments expressed concern that the GDS Policy will increase
administrative burden for NIH DACs, potentially resulting in longer timeframes
to obtain data maintained under controlled access. NIH is aware of the burden
that may be imposed on DACs by additional data access requests and will
continue to monitor this possibility and, as needed, develop methods to
decrease DAC burden and improve performance for investigators, institutions,
and NIH ICs.

Intellectual Property
The GDS Policy expects that basic sequence and certain related data made
available through NIH-designated data repositories and all conclusions derived
from them will be freely available. It discourages patenting of “upstream”
discoveries, which are considered pre-competitive, while it encourages the
patenting of “downstream” applications appropriate for intellectual property.
Of the several comments received on intellectual property, many supported the
draft Policy’s provisions. However, a few commenters opposed patenting in
general, and one suggested that the Policy should explicitly prohibit rather
than discourage the use of patents for inventions that result from research
undertaken with data from NIH-designated repositories.

As noted above, NIH encourages the appropriate patenting of “downstream”
applications. NIH will continue to encourage the broadest possible use of
products, technologies, and information resulting from NIH funding or developed
using data obtained from NIH data repositories to the extent permitted by
applicable NIH policies, federal regulations and laws, while encouraging the
patenting of technology suitable for private investment that addresses public
needs. As is well known, the Supreme Court decision in Association for
Molecular Pathology et al. v. Myriad Genetics, Inc. et al. prohibits the
patenting of naturally occurring DNA sequences.33 Consistent with this
decision, the NIH expects that patents directed to naturally occurring
sequences will not be filed.

Conclusion
NIH appreciates the time and effort taken by commenters to respond to the
Request for Comments. The responses were helpful in revising the draft GDS
Policy and enhanced the understanding of additional guidance materials that may
be necessary.

Final NIH Genomic Data Sharing Policy
I. Purpose
The National Institutes of Health (NIH) Genomic Data Sharing (GDS) Policy sets
forth expectations that ensure the broad and responsible sharing of genomic
research data. Sharing research data supports the NIH mission and is essential
to facilitate the translation of research results into knowledge, products, and
procedures that improve human health. NIH has longstanding policies to make
data publicly available in a timely manner from the research activities that it
funds.2,3,4,5,6

II. Scope and Applicability
The GDS Policy applies to all NIH-funded research that generates large-scale
human or non-human genomic data as well as the use of these data for subsequent
research. Large-scale data include genome-wide association studies (GWAS),34
single nucleotide polymorphisms (SNP) arrays, and genome sequence1,
transcriptomic, metagenomic, epigenomic, and gene expression data, irrespective
of funding level and funding mechanism (e.g., grant, contract, cooperative
agreement, or intramural support). The Supplemental Information to the NIH
Genomic Data Sharing Policy (Supplemental Information)10 provides examples of
research projects involving large-scale genomic data that are subject to the
Policy. NIH Institute or Centers (IC) may expect submission of data from
smaller scale research projects based on the state of the science, the
programmatic priorities of the IC funding the research, and the utility of the
data for the research community.

At appropriate intervals, NIH will review the types of research to which this
Policy may be applicable, and any changes to examples of research that are
within the Policy’s scope will be provided in the Supplemental Information. NIH
will notify investigators and institutions of any changes through standard NIH
communication channels (e.g., NIH Guide for Grants and Contracts).

NIH expects all funded investigators to adhere to the GDS Policy, and
compliance with this Policy will become a special term and condition in the
Notice of Award or the Contract Award. Failure to comply with the terms and
conditions of the funding agreement could lead to enforcement actions,
including the withholding of funding, consistent with 45 CFR 74.6235 and/or
other authorities, as appropriate.

III. Effective Date
This Policy applies to:

Competing grant applications36 that are submitted to NIH for the January 25,
2015, due date or subsequent due dates;
Proposals for contracts that are submitted to NIH on or after January 25, 2015;
and
NIH intramural research projects generating genomic data on or after January
25, 2015.
IV. Responsibilities of Investigators Submitting Genomic Data
A. Genomic Data Sharing Plans
Investigators seeking NIH funding should contact appropriate IC Program
Official or Project Officer37 as early as possible to discuss data sharing
expectations and timelines that would apply to their proposed studies. NIH
expects investigators and their institutions to provide basic plans for
following this Policy in the “Genomic Data Sharing Plan” located in the
Resource Sharing Plan section of funding applications and proposals. Any
resources that may be needed to support a proposed genomic data sharing plan
(e.g., preparation of data for submission) should be included in the project's
budget. A more detailed genomic data sharing plan should be provided to the
funding IC prior to award. The Institutional Certification (for sharing human
data), should also be provided to the funding IC prior to award, along with any
other Just-in-Time information. NIH expects intramural investigators to address
compliance with genomic data sharing plans with their IC scientific leadership
prior to initiating applicable research and are encouraged to contact their IC
leadership or the Office of Intramural Research for guidance. The funding NIH
IC will typically review compliance with genomic data sharing plans at the time
of annual progress reports or other appropriate scientific project reviews, or
at other times, depending on the reporting requirements specified by the IC for
specific programs or projects.

B. Non-human Genomic Data Sharing Plans
1. Data Submission Expectations and Timeline
Large-scale non-human genomic data, including data from microbes, microbiomes,
and model organisms, as well as relevant associated data (e.g., phenotype and
exposure data), are to be shared in a timely manner. Genomic data undergo
different levels of data processing, which provides the basis for NIH’s
expectations for data submission. These expectations are provided in the
Supplemental Information. In general, investigators should make non-human
genomic data publicly available no later than the date of initial publication.
However, earlier availability (i.e., before publication) may be expected for
certain data or IC-funded projects (e.g., data from projects with broad utility
as a resource for the scientific community such as microbial population-based
genomic studies).

2. Data Repositories
Non-human data may be made available through any widely used data repository,
whether NIH-funded or not, such as the Gene Expression Omnibus (GEO),38
Sequence Read Archive (SRA),39 Trace Archive,40 Array Express,41 Mouse Genome
Informatics (MGI),42 WormBase,43 the Zebrafish Model Organism Database
(ZFIN),44 GenBank,45 European Nucleotide Archive (ENA),46 or DNA Data Bank of
Japan (DDBJ).47 NIH expects investigators to continue submitting data types to
the same repositories that they submitted the data to before the effective date
of the GDS Policy (e.g., DNA sequence data to GenBank/ENA/DDBJ, expression data
to GEO or Array Express). Data types not previously submitted to any
repositories may be submitted to these or other widely used repositories as
agreed to by the funding IC.

C. Human Genomic Data Sharing Plans
1. Data Submission Expectations and Timeline
Investigators should submit large-scale human genomic data as well as relevant
associated data (e.g., phenotype and exposure data) to an NIH-designated data
repository48 in a timely manner. Investigators should also submit any
information necessary to interpret the submitted genomic data, such as study
protocols, data instruments, and survey tools.

Genomic data undergo different levels of data processing, which provides the
basis for NIH’s expectations for data submission and timelines for the release
of the data for access by investigators. These expectations and timelines are
provided in the Supplemental Information. In general, NIH will release data
submitted to NIH-designated data repositories no later than six months after
the initial data submission begins, or at the time of acceptance of the first
publication, whichever occurs first, without restrictions on publication or
other dissemination.49

Investigators should de-identify50 human genomic data that they submit to
NIH-designated data repositories according to the standards set forth in the
HHS Regulations for the Protection of Human Subjects26 to ensure that the
identities of research subjects cannot be readily ascertained with the data.
Investigators should also strip the data of identifiers according to the Health
Insurance Portability and Accountability Act (HIPAA) Privacy Rule.27 The
de-identified data should be assigned random, unique codes by the investigator,
and the key to other study identifiers held by the submitting institution.

Although the data in the NIH database of Genotypes and Phenotypes (dbGaP) are
de-identified by both the HHS Regulations for Protection of Human Subjects and
HIPAA Privacy Rule standards, NIH has obtained a Certificate of Confidentiality
for dbGaP as an additional precaution because genomic data can be
re-identified.51 NIH encourages investigators and institutions submitting
large-scale human genomic datasets to NIH-designated data repositories to seek
a Certificate of Confidentiality as an additional safeguard to prevent
compelled disclosure of any personally identifiable information they may
hold.52

2. Data Repositories
Investigators should register all studies with human genomic data that fall
within the scope of the GDS Policy in dbGaP53 by the time that data cleaning
and quality control measures begin, regardless of which NIH-designated data
repository will receive the data. After registration in dbGaP, investigators
should submit the data to the relevant NIH-designated data repository (e.g.,
dbGaP, GEO, SRA, the Cancer Genomics Hub54). NIH-designated data repositories
need not be the exclusive source for facilitating the sharing of genomic data,
that is, investigators may also elect to submit data to a non-NIH-designated
data repository in addition to an NIH-designated data repository. However,
investigators should ensure that appropriate data security measures are in
place,55 and that confidentiality, privacy, and data use measures are
consistent with the GDS Policy.

3. Tiered System for the Distribution of Human Data
Respect for, and protection of the interests of, research participants are
fundamental to NIH’s stewardship of human genomic data. The informed consent
under which the data or samples were collected is the basis for the submitting
institution to determine the appropriateness of data submission to
NIH-designated data repositories and whether the data should be available
through unrestricted or controlled access. Controlled-access data in
NIH-designated data repositories are made available for secondary research only
after investigators have obtained approval from NIH to use the requested data
for a particular project. Data in unrestricted-access repositories are publicly
available to anyone (e.g., The 1000 Genomes Project56).

4. Informed Consent
For research that falls within the scope of the GDS Policy, submitting
institutions, through their Institutional Review Boards26 (IRBs), privacy
boards,57 or equivalent bodies,58 are to review the informed consent materials
to determine whether it is appropriate for data to be shared for secondary
research use. Specific considerations may vary with the type of study and
whether the data are obtained through prospective or retrospective data
collections. NIH provides additional information on issues related to the
respect for research participant interests in its Points to Consider for IRBs
and Institutions in their Review of Data Submission Plans for Institutional
Certifications.24

For studies initiated after the effective date of the GDS Policy, NIH expects
investigators to obtain participants’ consent for their genomic and phenotypic
data to be used for future research purposes and to be shared broadly. The
consent should include an explanation about whether participants’
individual-level data will be shared through unrestricted- or controlled-access
repositories.

For studies proposing to use genomic data from cell lines or clinical
specimens59 that were created or collected after the effective date of the
Policy, NIH expects that informed consent for future research use and broad
data sharing will have been obtained even if the cell lines or clinical
specimens are de-identified. If there are compelling scientific reasons that
necessitate the use of genomic data from cell lines or clinical specimens that
were created or collected after the effective date of this Policy and that lack
consent for research use and data sharing, investigators should provide a
justification in the funding request for their use. The funding IC will review
the justification and decide whether to make an exception to the consent
expectation.

For studies using data from specimens collected before the effective date of
the GDS Policy, there may be considerable variation in the extent to which
future genomic research and broad sharing were addressed in the informed
consent materials for the primary research. In these cases, an assessment by an
IRB, privacy board, or equivalent body is needed to ensure that data submission
is not inconsistent with the informed consent provided by the research
participant. NIH will accept data derived from de-identified cell lines or
clinical specimens lacking consent for research use that were created or
collected before the effective date of this Policy.

NIH recognizes that in some circumstances broad sharing may not be consistent
with the informed consent of the research participants whose data are included
in the dataset. In such circumstances, institutions planning to submit
aggregate-60 or individual-level data to NIH for controlled access should note
any data use limitations in the data sharing plan submitted as part of the
funding request. These data use limitations should be specified in the
Institutional Certification submitted to NIH prior to award.

5. Institutional Certification
The responsible Institutional Signing Official61 of the submitting institution
should provide an Institutional Certification to the funding IC prior to award
consistent with the genomic data sharing plan submitted with the request for
funding. The Institutional Certification should state whether the data will be
submitted to an unrestricted- or controlled-access database. For submissions to
controlled access and, as appropriate for unrestricted access, the
Institutional Certification should assure that:

The data submission is consistent, as appropriate, with applicable national,
tribal, and state laws and regulations as well as relevant institutional
policies;62
Any limitations on the research use of the data, as expressed in the informed
consent documents, are delineated;63
The identities of research participants will not be disclosed to NIH-designated
data repositories; and
An IRB, privacy board, and/or equivalent body, as applicable, has reviewed the
investigator’s proposal for data submission and assures that:
The protocol for the collection of genomic and phenotypic data is consistent
with 45 CFR Part 46;28
Data submission and subsequent data sharing for research purposes are
consistent with the informed consent of study participants from whom the data
were obtained;64
Consideration was given to risks to individual participants and their families
associated with data submitted to NIH-designated data repositories and
subsequent sharing;
To the extent relevant and possible, consideration was given to risks to groups
or populations associated with submitting data to NIH-designated data
repositories and subsequent sharing; and
The investigator’s plan for de-identifying datasets is consistent with the
standards outlined in this Policy (see section IV.C.1.).
6. Exceptions to Data Submission Expectations
In cases where data submission to an NIH-designated data repository is not
appropriate, that is, the Institutional Certification criteria cannot be met,
investigators should provide a justification for any data submission exceptions
requested in the funding application or proposal. The funding IC may grant an
exception to submitting relevant data to NIH, and the investigator would be
expected to develop an alternate plan to share data through other mechanisms.
For transparency purposes, when exceptions are granted, studies will still be
registered in dbGaP, the reason for the exception will be included in the
registration record, and a reference will be provided to an alternative
data-sharing plan or resource, if available. More information about requesting
exceptions is available on the GDS website.15

7. Data Withdrawal
Submitting investigators and their institutions may request removal of data on
individual participants from NIH-designated data repositories, in the event
that a research participant withdraws or changes his or her consent. However,
some data that have been distributed for approved research use cannot be
retrieved.

V. Responsibilities for Investigators Accessing and Using Genomic Data
A. Requests for Controlled-Access Data
Access to human data is through a tiered model involving unrestricted- and
controlled-data access mechanisms. Requests for controlled-access data65 are
reviewed by NIH Data Access Committees (DACs).66 DAC decisions are based
primarily upon conformance of the proposed research as described in the access
request to the data use limitations established by the submitting institution
through the Institutional Certification. NIH DACs will accept requests for
proposed research uses beginning one month prior to the anticipated data
release date. The access period for all controlled-access data is one year; at
the end of each approved period, data users can request an additional year of
access or close out the project. Although data are de-identified, approved
users of controlled-access data are encouraged to consider whether a
Certificate of Confidentiality could serve as an additional safeguard to
prevent compelled disclosure of any genomic data they may hold.55

B. Terms and Conditions for Research Use of Controlled-Access Data
Investigators approved to download controlled-access data from NIH-designated
data repositories and their institutions are expected to abide by the NIH
Genomic Data User Code of Conduct67 through their agreement to the Data Use
Certification.68 The Data Use Certification, co-signed by the investigators
requesting the data and their Institutional Signing Official, specifies the
conditions for the secondary research use of controlled-access data, including:

Using the data only for the approved research;
Protecting data confidentiality;
Following, as appropriate, all applicable national, tribal, and state laws and
regulations, as well as relevant institutional policies and procedures for
handling genomic data;
Not attempting to identify individual participants from whom the data were
obtained;
Not selling any of the data obtained from NIH-designated data repositories;
Not sharing any of the data obtained from controlled-access NIH-designated data
repositories with individuals other than those listed in the data access
request;
Agreeing to the listing of a summary of approved research uses in dbGaP along
with the investigator’s name and organizational affiliation;
Agreeing to report any violation of the GDS Policy to the appropriate DAC(s) as
soon as it is discovered;
Reporting research progress using controlled-access datasets through annual
access renewal requests or project close-out reports;
Acknowledging in all oral or written presentations, disclosures, or
publications the contributing investigator(s) who conducted the original study,
the funding organization(s) that supported the work, the specific dataset(s)
and applicable accession number(s), and the NIH-designated data repositories
through which the investigator accessed any data.
NIH expects that investigators who are approved to use controlled-access data
will follow guidance on security best practices58 that outlines expected data
security protections (e.g., physical security measures and user training) to
ensure that the data are kept secure and not released to any person not
permitted to access the data.

If investigators violate the terms and conditions for secondary research use,
NIH will take appropriate action. Further information is available in the Data
Use Certification.

C. Conditions for Use of Unrestricted-Access Data
Investigators who download unrestricted-access data from NIH-designated data
repositories should:

Not attempt to identify individual human research participants from whom the
data were obtained;69
Acknowledge in all oral or written presentations, disclosures, or publications
the specific dataset(s) or applicable accession number(s) and the
NIH-designated data repositories through which the investigator accessed any
data.
VI. Intellectual Property
NIH encourages patenting of technology suitable for subsequent private
investment that may lead to the development of products that address public
needs without impeding research. However, it is important to note that
naturally occurring DNA sequences are not patentable in the United States.34
Therefore, basic sequence data and certain related information (e.g.,
genotypes, haplotypes, p-values, allele frequencies) are pre-competitive. Such
data made available through NIH-designated data repositories, and all
conclusions derived directly from them, should remain freely available, without
any licensing requirements.

NIH encourages broad use of NIH-funded genomic data that is consistent with a
responsible approach to management of intellectual property derived from
downstream discoveries, as outlined in the NIH Best Practices for the Licensing
of Genomic Inventions70 and Section 8.2.3, Sharing Research Resources, of the
NIH Grants Policy Statement.71 NIH discourages the use of patents to prevent
the use of or to block access to genomic or genotype-phenotype data developed
with NIH support.

References
1. The genome is the entire set of genetic instructions found in a cell. See
http://ghr.nlm.nih.gov/glossary=genome.
2. Final NIH Statement on Sharing Research Data. February 26, 2003. See
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
3. NIH Intramural Policy on Large Database Sharing. April 5, 2002. See
http://sourcebook.od.nih.gov/ethic-conduct/large-db-sharing.htm.
4. NIH Policy on Sharing of Model Organisms for Biomedical Research. May 7,
2004. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html.
5. Reaffirmation and Extension of NHGRI Rapid Data Release Policies:
Large-scale Sequencing and Other Community Resource Projects. February 2003.
See https://www.genome.gov/10506537.
6. NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies (GWAS). See
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html.
7. Federal Register Notice. Draft NIH Genomic Data Sharing Policy Request for
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the Draft NIH Genomic Data Sharing Policy. September 27, 2013. See
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-119.html.
9. Public Consultation Webinar. Draft NIH Genomic Data Sharing Policy. November
6, 2013. See https://webmeeting.nih.gov/p7sqo6avp6j/.
10. Compiled Public Comments on the Draft Genomic Data Sharing Policy. See
http://gds.nih.gov/pdf/GDS_Policy_Public_Comments.PDF.
11. Supplemental Information to the NIH Genomic Data Sharing Policy. See
http://gds.nih.gov/pdf/supplemental_info_GDS_Policy.pdf.
12. National Institute of Allergy and Infectious Diseases. Data Sharing and
Release Plans. See
http://www.niaid.nih.gov/labsandresources/resources/dmid/pages/data.aspx.
13. Roster of NIH Genomic Program Administrators. See
http://gds.nih.gov/04po2_2GPA.html.
14. NIH Big Data to Knowledge.  See http://bd2k.nih.gov.
15. NIH Big Data to Knowledge. Scientific Data Council. See
http://bd2k.nih.gov/about_bd2k.html#sdcmembership.
16. Genomic Data Sharing Website. Resources for Investigators Submitting Data
to dbGaP. See http://gds.nih.gov/06researchers1.html.
17. Genomic Data Sharing Website. Data Repositories. See
http://gds.nih.gov/02dr2.html.
18. See for example the Genomic Standards Consortium, http://gensc.org/; the
Global Alliance, http://www.broadinstitute.org/news/globalalliance; and the NIH
Big Data to Knowledge focus on community-based data and metadata standards,
http://bd2k.nih.gov/about_bd2k.html#areas.
19. Gymrek et al. Identifying Personal Genomes by Surname Inference. Science.
339(6117): 321-324. (2013).
20. Kaufman et al. Public Opinion about the Importance of Privacy in Biobank
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Clinically Derived Biological Samples. British Journal of Cancer. 101(9):
1505-1512. (2009).
22. Trinidad et al. Research Practice and Participant Preferences: the Growing
Gulf. Science. 331(6015): 287-288. (2011).
23. NIH Points to Consider for IRBs and Institutions in their Review of Data
Submission Plans for Institutional Certifications Under NIH’s Policy for
Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association
Studies (GWAS). See
http://gds.nih.gov/pdf/PTC_for_IRBs_and_Institutions_revised5-31-11.pdf.
24. Presidential Commission for the Study of Bioethical Issues. Anticipate and
Communicate: Ethical Management of Incidental and Secondary Findings in the
Clinical, Research, and Direct-to-Consumer Contexts. December 2013. See
http://bioethics.gov/node/3183.
25. Code of Federal Regulations. Protection of Human Subjects. Definitions. See
45 CFR 46.102(f) at
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102.
26. The list of HIPAA identifiers that must be removed is available at 45 CFR
164.514(b)(2). See:
http://www.gpo.gov/fdsys/pkg/CFR-2002-title45-vol1/pdf/CFR-2002-title45-vol1-sec164-514.pdf.
27. Federal Policy for the Protection of Human Subjects (Common Rule). 45 CFR
Part 46. See http://www.hhs.gov/ohrp/humansubjects/commonrule/.
28. ANPRM for Revision to Common Rule. See
http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.
29. Genomic Data Sharing Website. Standard Data Use Limitations. See
http://gds.nih.gov/pdf/standard_data_use_limitations.pdf.
30. Genomic Data Sharing Website.  See http://gds.nih.gov/.
31. dbGaP Compilation of Aggregate Genomic Data for General Research Use. See
http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000501.v1.p1.
32. dbGaP Collection: Compilation of Individual-Level Genomic Data for General
Research Use. See
http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/collection.cgi?study_id=phs000688.v1.p1.
33. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___
(2013) (slip opinion 12-398). See
http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf.
34. GWAS has the same definition in this policy as in the 2007 GWAS Policy: a
study in which the density of genetic markers and the extent of linkage
disequilibrium should be sufficient to capture (by the r2 parameter) a large
proportion of the common variation in the genome of the population under study,
and the number of samples (in a case-control or trio design) should provide
sufficient power to detect variants of modest effect.
35. 45 CFR 74.62. Uniform Administrative Requirements for Awards and Subawards
to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations,
and Commercial Organizations; Enforcement. See
http://www.gpo.gov/fdsys/pkg/CFR-2011-title45-vol1/xml/CFR-2011-title45-vol1-part74.xml#seqnum74.62.
36. Competing grant applications encompass all activities with a research
component, including but not limited to the following: Research Grants (Rs),
Program Projects (Ps), Cooperative Research Mechanisms (Us), Career Development
Awards (Ks), and SCORs and other S grants with a research component.
37. Investigators should refer to funding announcements or IC websites for
contact information.
38. Gene Expression Omnibus at http://www.ncbi.nlm.nih.gov/geo/.
39. Sequence Read Archive at http://www.ncbi.nlm.nih.gov/Traces/sra/sra.cgi.
40. Trace Archive at http://www.ncbi.nlm.nih.gov/Traces/trace.cgi.
41. Array Express at http://www.ebi.ac.uk/arrayexpress/.
42. Mouse Genome Informatics at http://www.informatics.jax.org/.
43. WormBase at http://www.wormbase.org.
44. The Zebrafish Model Organism Database at http://zfin.org/.
45. GenBank at http://www.ncbi.nlm.nih.gov/genbank/.
46. European Nucleotide Archive at http://www.ebi.ac.uk/ena/.
47. DNA Data Bank of Japan at http://www.ddbj.nig.ac.jp/.
48. An NIH-designated data repository is any data repository maintained or
supported by NIH either directly or through collaboration.
49. A period for data preparation is anticipated prior to data submission to
NIH, and the appropriate time intervals for that data preparation (or data
cleaning) will be subject to the particular data type and project plans (see
Supplemental Information). Investigators should work with NIH Program or
Project Officials for specific guidance.
50. De-identified refers to removing information that could be used to
associate a dataset or record with a human individual.
51. Confidentiality Certificate. HG-2009-01. Issued to the National Center for
Biotechnology Information, National Library of Medicine, NIH. See
http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=ConfidentialityCertificate.pdf.
52. For additional information about Certificates of Confidentiality, see
https://grants.nih.gov/grants/policy/coc/.
53. Database of Genotypes and Phenotypes at http://www.ncbi.nlm.nih.gov/gap.
54. Cancer Genomics Hub at https://cghub.ucsc.edu/.
55. dbGaP Security Best Practices. See
http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=dbgap_2b_security_procedures.pdf.
56. The 1000 Genomes Project at http://www.1000genomes.org/.
57. See the roles of Privacy Boards as elaborated in 45 CFR 164 at
http://www.gpo.gov/fdsys/pkg/CFR-2011-title45-vol1/pdf/CFR-2011-title45-vol1-part164.pdf.
58. Equivalent body is used here to acknowledge that some primary studies may
be conducted abroad and in such cases the expectation is that an analogous
review committee to an IRB or privacy board (e.g., Research Ethics Committees)
may be asked to participate in the presubmission review of proposed genomic
projects.
59. Clinical specimens are specimens that have been obtained through clinical
practice.
60. Aggregate data are summary statistics compiled from multiple sources of
individual-level data.
61. An Institutional Signing Official is generally a senior official at an
institution who is credentialed through NIH eRA Commons system and is
authorized to enter the institution into a legally binding contract and sign on
behalf of an investigator who has submitted data or a data access request to
NIH.
62. For the submission of data derived from cell lines or clinical specimens
lacking research consent that were created or collected before the effective
date of this Policy, the Institutional Certification needs to address only this
item.
63. For guidance on clearly communicating inappropriate data uses, see NIH
Points to Consider in Drafting Effective Data Use Limitation Statements,
http://gwas.nih.gov/pdf/NIH_PTC_in_Drafting_DUL_Statements.pdf.
64. As noted earlier, for studies using data or specimens collected before the
effective date of this Policy, the IRB, privacy board, or equivalent body
should review informed consent materials to ensure that data submission is not
inconsistent with the informed consent provided by the research participants.
65. dbGaP Authorized Access. See
https://dbgap.ncbi.nlm.nih.gov/aa/wga.cgi?page=login.
66. For a list of NIH Data Access Committees, see
http://gwas.nih.gov/04po2_1DAC.html.
67. Genomic Data User Code of Conduct. See
http://gds.nih.gov/pdf/Genomic_Data_User_Code_of_Conduct.pdf.
68. Model Data Use Certification Agreement. See
http://gwas.nih.gov/pdf/Model_DUC_7-26-13.pdf.
69. In certain cases, NIH may consider approving research intended to enhance
genomic data privacy protection procedures.
70. NIH Best Practices for the Licensing of Genomic Inventions. See
http://www.ott.nih.gov/sites/default/files/documents/pdfs/70fr18413.pdf.
71. NIH Grants Policy Statement. 8.2.3, Sharing Research Resources. See
https://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch8.htm#_Toc271264950.

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