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NIH Data Sharing
§<=
span
style=3D'font-family:Arial;font-size:75%'>Dr. Belinda Seto, Deputy
Director
<=
b>National
Institute of Biomedical Imaging and Biomedical Engineering (NBIB=
)
§<=
span
style=3D'font-family:Arial;font-size:75%;display:none'>
§<=
span
style=3D'font-family:Arial;font-size:75%;display:none'>
§<=
span
style=3D'font-family:Arial;font-size:63%'>February 12, 2004=
Collaborative Meeting
“Data
should be made as widely and freely
available as possible while safeguarding
the privacy of participants, and
protecting confidential and proprietary
data.”
-- Final NIH Statement =
on
Sharing Research Data
February 26, 2003
NIH Viewpoint
PHS Grants Policy Statement
April 1994
“Restricted availability of unique resourc=
es upon
which further st=
udies
are dependent can impede the advancement
of research and the delivery of medical
care. Therefore, when these resources are developed with PHS funds and the associated research findings have been published or after t=
hey have been provided to the agencies under contrac=
t, it is important that they be made readily availa=
ble for research purposes to qualified individuals <=
/span>within the scientific community. This policy applies to grants, cooperative agreements, and <=
/span>contracts.”
•=
NIH expects timely release and sharing of final research data for use by other researchers.
•=
NIH expects grant applicants to include a plan for data sharing or to state why data sharing is not possible, especially if $500K or more of direct cost is requested in any single year
•=
NIH expects contract offerors to address data sharing regardless of cost
=
Effective with
October 1, 2003 receipt
date for NIH
applications
NIH Data Sharing Policy
Cave=
ats for
Studies Including Human
Research Participants
•Investigators need to carefully consi=
der
–Studies with very small sample=
s
–Studies collecting very sensit=
ive
data
•
•However, even these data can be share=
d if safeguards exist=
to
ensure confidentiality and protect the identity of subjects<=
/b>
•In general, no later than the accepta=
nce for publication=
of
the main findings from the final dataset
•No timeline
specified—will vary <=
/span>depending on na=
ture
of the data collected
•First and continuing use, but not prolonged exclu=
sive
use
–Investigators w=
ho
collected the data have a legitimate interest in benefiting from
their investment of time and effort
§=
What=
Is
Meant by Timely?
How =
to
Share Data
•Provide in publications
•Share under the investigator’s own
auspices
•Place datasets in public archives
•Place in restricted access data centers =
or data enclaves
<=
/span>
•Other ways?
•In application—budget and =
budget justification
=
<=
span
style=3D'font-family:"Times New Roman"'>•Administrative supplements
Will=
NIH
Provide Support
for Data Sharing= ?
for Data Sharing= ?
Examples of Current
NIH Data Sharing Activities
National Human Geno=
me
Research Institute (NHGRI)
<=
span
style=3D'font-family:Arial'>Ø Release of genomic sequence
data
National Library of Medicine
(NLM)
Ø
Genome sequence submission and distribution
=
Ø
Enhanced access to other research data/tools
Ø=
Outreach to research community
Ø Possible support for resear=
ch and
development related
to data sharing
The National
Longitudinal Study of Adolescent Health (Add Health):=
An Example of
Sensitive Data and Multi-Tiered Access
Examples of Current
NIH Data Sharing Activities
The
National Longitudinal Study of Adolescent
Health (Add Health)
§<=
span
style=3D'font-family:Arial;font-size:69%'>20,745 adolescents enrolled =
in
grades 7-12, followed between 1994 and 2002.
§<=
span
style=3D'font-family:Arial;font-size:69%'>Data from:
–adolescents and parents;
<=
/div>
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–90,118 students attending sample schools;
–school administrators;
– independent data on
neighborhood/community =
§<=
span
style=3D'font-family:Arial;font-size:69%;color:black'>Data collected i=
n three
waves, 1994 - 2002.
§<=
span
style=3D'font-family:Arial;font-size:69%;color:black'>Measures of:
=
;
–health
–health-related behaviors (e.g., sex,
drugs)
–determinants of health at the individ=
ual,
family, school, peer group, and community level.
<=
/span>
§
Reasons for Sharing Data
§Scope
§Potential
§Cost
Add Health:
Sensitive
Data Sharing =
Example
Challenges to Sharing Data
=
§Data sensitivity
§Need to protect =
confidentiality
§Danger of deductive disclosureAdd Health:
Sensitive
Data Sharing =
Example
A further challenge…
§<=
span
style=3D'font-family:Arial;mso-ascii-font-family:Arial;mso-bidi-font-fami=
ly:
"Times New Roman";mso-hansi-font-family:Arial;font-size:88%'>The timely
release of these public use samples is essential. Reviewers understand
this to mean that investigators outside of the Carolina Population Center will have
ready access to the data as soon as investigators inside the
center have such access.&nbs=
p;
Procedures for the guarantee of confidentiality … should <=
/span>apply to =
all
users, both the general public and those at University of North Carolina.
§
Add Health:
Sensitive
Data Sharing =
Example
Solution: a multi-tiered system=
§Public
use data
§Contractual
data sets
§Cold room for on-site data use
§=
Add Health:
Sensitive
Data Sharing =
Example
Public use data
§=
Made available through <=
/span>Sociometrics, a small busine=
ss data
archive
§=
Contains only a subset of ca=
ses (6,504)
§=
Rare over-samples not includ=
ed
§=
Contains most data on includ=
ed cases
=
§=
Potentially identifying info=
rmation
redacted
Add Health:
Sensitive
Data Sharing =
Example
Restricted-use contractual data
§=
Full data set available only=
under contract
§=
Available to researchers wit=
h:
–IRB- and UNC-approved data security plan
<=
/div>
–Signed agreement to maintain confidentiality
–Fee covering costs of providing data & user support; monitoring
compliance
§=
Requires annual progress rep=
ort and renewal after 3 years
Add Health:
Sensitive
Data Sharing =
Example
Cold room for on-site use
§Initial plan required access to some data only on-site at UNC
=
§Cold room constructed at UNC
=
§Limited use to date
Add Health:
Sensitive
Data Sharing =
Example
Data security caveats
§Security requirements require periodic updating as technology advances
§IRBs often lack understanding of security needs
§Smaller institutions handicapped in creating secure environments for restricted data
Add Health:
Sensitive
Data Sharing =
Example
New Concepts Introd=
uced by
the Privacy Rule
§=
An individual’s written
Authorization is required for use or disclosure of protected =
health information unless waive=
d or
excepted.
§=
Authorization waivers can be gr=
anted
by IRBs =
or Privacy Boards.
§=
Decedent’s information is
protected but Authorization is not required.
§=
Accounting and reporting of
disclosures are required.
Special topic=
: Data
Sharing and HIPAA Privacy Rule
Key Points about Research
§=
In general, the Privacy Rule re=
quires
an individual’s
written Authorization before
the use and disclosure of PHI.
=
§=
For research, the Privacy Rule =
permits
covered
entities to use and disclose PHI for research conducted:
–with individual authorization, =
or
–without individual authorization under limited circumstances.
Special topic=
: Data
Sharing and HIPAA Privacy Rule
Authorizations for Research
§Must
be for a specific research study – Authorization for futu=
re,
unspecified research is NOT permitted but authorization may be used to create a repository or
database
§=
Review/approval by IRB/Privacy Board=
NOT needed
§Different
from, but may be combined with, informed consent
§=
Must contain “core elements=
221;
& “required statements”
Special topic=
: Data
Sharing and HIPAA Privacy Rule
Research Use and
Disclosure of PHI Without Authorization
=
1.De-identify PHI&#=
13;
2.Limited Data Set =
with
Data Use Agreement &#=
13;
3.IRB or Privacy Board waiver of =
Authorization requirement
=
=
4.Activity preparatory to researc=
h
=
5.Research is on decedent’s
information
6.Research qualifies for the Tran=
sition Provisions
7.Disclosure to a public health
authority or as required by law
Special topic=
: Data
Sharing and HIPAA Privacy Rule
Option 1: De-identified Health Information=
§=
Completely de-identified inform=
ation
(18 elements
removed) and no knowledge that remaining information can ident=
ify the
subject. OR
§<=
span
style=3D'font-family:Arial;font-size:88%'>Statistically
“de-identified” information where a statistician certifies that the=
re is a
“very small” risk that the information could be used to identify the subject.
§The Privacy Rule defines 18
identifiers
–Names
–Geographic info (including city=
,
– sta=
te, and
zip)
–Elements of dates
–Telephone #s
=
–Fax #s
–E-mail address
–Social Security #
–Medical record, prescription #s=
–Health plan beneficiary #s
=
–Account #s
=
–Certificate/license #s
–VIN and Serial #s, license plate #s
Special topic=
: Data
Sharing and HIPAA Privacy Rule
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=
–Device identifiers, serial #s&#=
13;
=
–Web URLs
=
–IP address #s
–Biometric identifiers (finger <=
/span>prints)
–Full face, comparable photo images
=
–Unique identifying #s
Option 2: Limited D=
ata Set
with Data Use Agreement
§=
The Privacy Rule permits limited types of =
identifiers to be released with health =
information (referred to as =
a Limited Data <=
/b>Set=
) -- City, State, Zip; Eleme=
nts of
Date; Unique
identifiers not listed as one of 16 direct identifiers
<=
/span>
§
§=
Limited Data Sets can only b=
e used
and released
in accordance with a Data Use Agreement between the covered entity a=
nd the recipient.
For =
More
Information
<=
b>NIH
Office of Extramural Research (OER)
<=
b>Web
site on Data Sharing Policy:
<=
b>http://grants.nih.gov/grants/policy/data_sharing
<=
b>Office
for Civil Rights Web site
<=
b>with
Departmental guidance on HIPAA:
<=
b>Educational
information from NIH
http://privacyruleandresearch.nih.gov
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‹#›
The NIH Statement on Data Sharin=
g is
entirely consistent with the PHS Grants Policy Statement of April 1994, w=
hich
states the following…
Originally presented by Dr. Christine Bachrach,
Demographic and Behavioral Sciences Branch, NICHD, May 23, 2003
Note this is in the handout
Cold room constructed in 2002; c=
an be
used by people who want access to romantic pair data and geocoding techno=
logy
and software to append contextual data to individual-level data.
Not all research uses and disclosures require subject Authorization.
There are at least 7 ways that PHI can be accessed without getting subjec=
t authorization.
I’m going to go over each of these 7 briefly..
To get to OER home page on data =
sharing
-- Or do an advanced google search for Data Sharing under nih.gov and it =
will
be among the top hits.
The web offerings include the Final Statement =
on
Data Sharing that was published in the NIH Guide on Feb 26, and implement=
ation
guidance, and FAQs.
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