[Federal Register Volume 75, Number 108 (Monday, June 7, 2010)]
[Notices]
[Pages 32195-32199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13516]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Procedures and Costs for Use of the Research Data Center
AGENCY: National Center for Health Statistics, Centers for Disease
Control and Prevention (CDC), Department of Health and Human Services
(HHS).
ACTION: Notice and request for comments.
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Authority: Section 306 of the Public Health Service Act, as
amended (42 U.S.C. 242k) and Public Law 103-333.
SUMMARY: This notice provides information about the Research Data
Center (RDC) operated by the National Center for Health Statistics
(NCHS) within the Centers for Disease Control and Prevention (CDC). The
Research Data Center was established in 1998 to provide a mechanism
whereby researchers can access detailed data files in a secure
environment, without jeopardizing the confidentiality of respondents.
Historically, the data files accessed in the RDC have consisted of NCHS
survey data and vital statistics. RDC has recently begun accepting data
files that were not produced from NCHS survey data. In order to assure
that all data files are processed in a consistent manner, the original
guidelines for accessing files in the RDC are being reviewed and
revised as necessary. As part of the revision process, potential users
are being given the opportunity to provide input on how the procedures
of the RDC can best serve their research needs. This notice describes
how to submit proposals requesting use of the data, mechanisms to
access the RDC, requirements, use of outside data sets, costs for using
the RDC, and other pertinent topics. We are seeking comments on these
procedures and will post the final procedures on the NCHS Web site.
ADDRESSES: Send comments concerning this notice to Peter Meyer,
National Center for Health Statistics, 3311 Toledo Road, Room 4113,
Hyattsville, MD 20782, or e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Peter Meyer, telephone 301-458-4375.
SUPPLEMENTARY INFORMATION:
Operational Procedures for Use of the Research Data Center; National
Center for Health Statistics; Centers for Disease Control and
Prevention
Table of Contents
Background
Methods of Access to Data
Submission of Research Proposals Using NCHS Data
Proposal Review
Researcher Supplied Data
General Procedures for Onsite Access
General Procedures for Remote Access
Confidentiality and Human Subjects Protection
Disclosure Review Process
Costs for Using the RDC
National Center for Health Statistics Research Data Center Procedures
Background
The National Center for Health Statistics (NCHS) releases and hosts
a range of statistical data products on the health and well-being of
the nation and its health care system. Statistical tabulations (tables)
present data in predetermined categories such as age, race, sex or
geographic region that are important to describe health status and
trends. In addition, statistical microdata containing health and
related variables are published so that outside analysts may conduct
original research and special studies to address issues of public
health science and policy. Section 308 (d) of the Public Health Service
Act and the NCHS Staff Manual on Confidentiality do not permit the
release of data that are either identified or identifiable to persons
outside of NCHS. In order to preserve privacy and confidentiality,
details that might identify or facilitate the identification of persons
and entities participating in NCHS surveys and data systems either
owned or hosted by NCHS are not released in published data products.
Examples of data elements that might be abridged or suppressed to
prevent reidentification are geographic identifiers, genetic data,
details of sample design, and variables such as age or income that
might exist in other databases.
Despite the wide dissemination of NCHS data through publications,
Web releases, etc., the inability to release files with these sensitive
variables limits the utility of NCHS data for research, policy, and
programmatic purposes and sets a boundary on one of the Department of
Health and Human Service's goals: to increase our capacity to provide
state and local area estimates. In pursuit of this goal and in response
to the public research community's interest in restricted data, NCHS
established the NCHS Research Data Centers (RDCs), a place where Guest
Researchers can access detailed data files in a secure environment,
without jeopardizing the confidentiality of respondents. Access for
Guest Researchers is regulated by the Confidential Information
Protection and Statistical Efficiency Act (CIPSEA) and other Federal
statutes. The RDCs provide restricted access to NCHS data and non-NCHS
data. Guest Researchers function under the supervision of NCHS
employees and are subject to the same provisions of law with regard to
confidentiality as NCHS employees. Instructions for developing a
research proposal can be found in Appendix II. Special requirements for
use of non-NCHS data can be found in Appendix III, Project-Specific
Requirements.
Methods to Access Data
Restricted NCHS data or data hosted by NCHS can be made accessible
through the RDC. To gain access to these data, Guest Researchers must
submit a proposal for review and approval. Once the proposal is
approved, Guest Researchers meeting certain criteria are allowed
access, under strict supervision, to restricted statistical microdata
file(s). There are four modes of access: (1)
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NCHS RDC, (2) Remote Access System, (3) Census RDC, (4) Staff-Assisted.
1. NCHS RDC--Guest Researchers conduct their research on-site at
one of the NCHS RDCs. The NCHS RDCs are secure research facilities
located at NCHS headquarters in Hyattsville, MD and at the Centers for
Disease Control and Prevention in Atlanta, GA, where Guest Researchers
meeting certain criteria are allowed access, under strict supervision,
to restricted statistical microdata file(s). The NCHS RDC workstations
are ``stand alone'' and have no link to the NCHS network, the CDC-NCHS
mainframe, or the internet. There is sufficient storage on the
workstations. PC-SAS, SUDAAN, and STATA are installed on the
workstations and additional programming/analytic languages can be added
as needed. Drives on the workstations for removable media such as USB
ports are configured so as to be inaccessible to users. The
workstations are configured such that users are given read only access
to requested data files and can write only onto the local workstation's
hard drive. These restrictions ensure that users cannot remove
information that has not been subjected to a review for
confidentiality. Guest Researchers are able to take the results of
their analyses off-site only after disclosure review by an NCHS RDC
Analyst.
2. Remote Access--Through remote access Guest Researchers are able
to electronically submit analytical computer programs using SAS and
SUDAAN. After their proposals are approved, Guest Researchers are
registered with the RDC remote access system and are required to accept
the procedures and programming limitations to be followed in accessing
data. For example, users cannot use PROC TABULATE or PROC IML, nor are
functions allowed that are capable of producing listings of individual
cases such as LIST and PRINT. Additionally, functions which may select
individual cases are not allowed (R--, FIRST., LAST., and others).
Guest Researchers send programs to, and receive output from, the remote
system through a secure communication network. Their programs execute
on a computer in the RDC. Both submitted programs and output are
subjected to a programmed disclosure review and may also be subjected
to a manual review. For example, the output is scanned for cells
containing less than five observations. If any are found, not only is
that cell suppressed, but several additional cells will also be
suppressed (complementary suppression). The .log file is also scanned
with particular attention to certain types of error conditions that may
spawn case listings. Some projects are not suitable for the remote
access method. Researchers should consider the programming limitations
of the remote access system when choosing this method of access.
However, the data stewards and RDC staff may also deem the project
inappropriate for remote access during the review process.
3. Census RDC--Guest Researchers can have the same access that is
available to them at NCHS at one of the Census RDCs. Analytic data sets
are constructed at the NCHS RDC according to specifications included in
the research proposal and are then securely transferred to the Census
data processing facility in Bowie, Maryland. Users can then view the
data using ``front end dumb terminals'' at a Census RDC. The data do
not leave the Bowie facility. The Guest Researcher's output is sent via
a secure communication network to RDC staff for disclosure review. Once
the output has been approved for release, it is sent via email to the
Guest Researcher. A listing of available Census RDC locations can be
found here: http://webserver02.ces.census.gov/index.php/ces/researchlocations.
4. RDC Staff-Assisted Research--This is mainly useful for those
planning to use statistical software programming languages other than
SAS or who are not able to travel to the RDC facility. Under this
method, an approved researcher e-mails a statistical software program
to the assigned RDC Analyst who runs the program and, after disclosure
review, provides the output to the researcher via a secure
communication network. More extensive programming services are also
available.
Each of the access modes has an associated cost which offset
equipment, space rental, and staff overhead. The staff overhead
includes the time and resources necessary for creating the analytical
file, monitoring progress, setting up equipment and data files,
disclosure limitation review, and file management. Since these reflect
varying demands on resources, accurate cost estimates cannot be given
without complete knowledge of the proposed research.
Submission of Research Proposals Using NCHS Data
To access restricted data through the RDC, researchers must first
submit a proposal. The proposal serves four main purposes:
1. To make sure that researchers have a defined research question.
2. To determine what restricted variables are needed to complete
the project.
3. To assess disclosure risk based on the types of output and
requested restricted variables.
4. To determine the mode of access and the required software.
Researchers must submit proposals that are detailed enough in their
data specifications to permit RDC staff to easily determine what data
elements are required. Prospective researchers are encouraged to check
with RDC staff prior to writing their proposals to ensure that the data
of interest can be made available to them. Researchers should develop
their proposals in a way that facilitates the ability of the RDC staff
to create the analytic files required by the project. Proposals should
be explicit regarding the variables needed as well as any case
selection required. Only those data items required to conduct the
proposed analyses will be included in the analytic data file and the
proposals should address why the requested data are needed for the
proposed study. Overly large and complex projects, or poorly defined
projects will require extensive communication between RDC staff and the
researchers proposing the project, and this can cause the process to
move slowly. The RDC allows researchers to supply external sources of
data to be merged with RDC data. These external sources of data
supplied by the researcher may consist of proprietary data collected
and ``owned'' by the researcher or other publicly available data
obtained by the researcher such as Census data.
Proposal Review
Upon receipt, the RDC Director will assign the proposal to an RDC
Analyst who will review the proposal for completeness and feasibility.
Then the RDC Analyst will distribute the proposal to the Review
Committee which consists of (at minimum) the Director of the NCHS RDC,
the RDC Analyst, the NCHS Confidentiality Officer, and a representative
of the data producing program. The review takes 6-8 weeks.
The following criteria apply to proposal review:
1. Risk of disclosure of restricted information.
2. Appropriate use of the data and concurrence with the intended
use for which it was collected. Including assurance that the use of the
data is in accordance with the informed consent procedures associated
with the collection of the data.
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3. Scientific and technical feasibility of the project.
4. Availability of resources at the RDCs.
For projects using NCHS data, whether the proposed project is in
accordance with the mission of the NCHS ``* * * to provide statistical
information that will guide actions and policies to improve the health
of the American people.''
The Review Committee can make one of three decisions: approve,
revise/resubmit, or disapprove. Guest Researchers should note that
approval of their application does not constitute endorsement by NCHS
of the substantive, methodological, theoretical, or policy relevance or
merit of the proposed research. Rather, NCHS approval constitutes a
judgment that this research, as described in the application, is not an
illegal or unethical use (as determined by the informed consent and
original reason for collecting the data) of the requested data file and
does not jeopardize the confidentiality of the data. Approval of a
proposal does not explicitly or implicitly guarantee that all output
generated by the analysis will be released. Output that poses a
disclosure risk will be suppressed.
Researcher Supplied Data
The Guest Researcher may supply two types of data: (1) Publically
available NCHS data and (2) external non-NCHS sources of data.
Researchers must supply these data at prior to when they intend to
access it, regardless of method. The RDC Analyst will accept Guest
Researcher data files in SAS, STATA, or ASCII format (flat files) with
variables either column delimited or column specific. Other formats may
also be proposed. The merging of Guest Researcher-supplied data with
NCHS in-house data will be done by an NCHS RDC Analyst prior to the
arrival of the Guest Researcher. Depending on the variables used to
merge the data, they may or may not be removed from the final
analytical data set. For instance, if state and county are used to add
Census variables to an NCHS data set, state and county will be removed
after the merge unless otherwise specified.
Most projects involving NCHS data will require the Guest Researcher
to download the public files from the internet and create an extract
that includes only the variables required for this project. There are a
few exceptions that the RDC Analyst will discuss as needed with the
Guest Researcher.
The public-use file can only include those variables
required for analysis. Please do not send the entire public-use files.
Original NCHS Variables must have the name they are given
in the public-use data set. If the Guest Researcher wants to rename the
variables, please include the original variable name in the variable
description.
Derived Variables must be labeled with the variables from
which they were derived and any arithmetic manipulation must be
explained.
Public-Use Mortality Variables: Please do not include any
public-use mortality variables or variables derived from the public-use
mortality data if the project involves restricted mortality variables.
Any attempt to include variables that may lead to re-
identification of subjects or establishments is considered a disclosure
violation and will result in the cessation of your project and possible
legal actions.
The non-NCHS data may consist of proprietary data collected and
owned by the Guest Researcher or other publicly available data obtained
such as Census data. Guest Researchers are responsible for interacting
with RDC Analyst to ensure that their data can be merged with the NCHS
supplied data and the format of the data is consistent with it. Guest
Researchers are also responsible for ensuring that the data they
provided has been consented for merging.
The RDC may retain copies of datasets but they will not be made
available to anyone other than the Guest Researcher without written
permission.
General Procedures for Onsite Access
1. Guest Researchers may work at the NCHS RDCs only under
supervision of RDC staff and only during normal working hours (Monday-
Friday, 9:00 a.m.-5:00 p.m.). Admittance to the RDC is limited to the
Guest Researchers included in the Research Proposal. Guest Researchers
are required to show photo identification before admittance. A maximum
of 3 collaborating Guest Researchers can sit at a computer station in
the RDC.
2. Computers will be pre-loaded with the approved datasets by NCHS
staff approximately one day prior to the Guest Researcher's use of the
RDC. Once the analysis is completed, the RDC Analyst will remove the
datasets from the RDC computer. The data will be hosted on the RDC
internal system for one year after the last time it was accessed by the
Guest Researcher.
3. Guest Researchers must be able to conduct their analysis with
the software specified in their research proposal.
4. Guest Researchers are not allowed to bring documents, manuals,
books, etc., that may enable them to identify and disclose confidential
information they access in the RDC. Neither are they allowed to bring
cell phones, pagers, or other devices into the RDC which would enable
them to communicate with persons outside of the RDC.
5. All computer output generated by statistical programs and all
handwritten notes based on such computer output are subject to
disclosure review by NCHS staff before removal from the RDC.
6. Guest Researchers may not save output, files, or programs to
transportable electronic media. RDC staff may copy output or programs
to transportable media, if requested.
7. Guest Researchers' analytic data set will be specified
thoroughly in the research proposal. The analytic data set for a
project may include multiple cycles of a survey or variables from
multiple sources. Under no circumstance will Guest Researchers be
permitted any opportunity to merge datasets on their own.
General Procedures for Remote Access
1. Guest Researchers must register an email address that is
credibly secure.
2. Data requests must be in the form of SAS programs. However,
certain SAS commands/statements are not allowed through remote access.
3. The remote access system does not allow users to write permanent
datasets in its disk space. Jobs that attempt to create permanent
datasets or files are flagged, terminated, and an error message is sent
to the Guest Researcher.
4. The remote access system limits Guest Researchers' time and
storage. No single program is allowed more than one hour to complete
execution or to generate output in excess of 5 MB.
5. Guest Researchers should contact their RDC Analyst immediately
if they have inadvertently produced output that could be used to
identify subjects/respondents or if they cannot complete their analysis
due to automated disclosure protocols. The RDC Analyst will provide
reasonable assistance in completing the analysis while still protecting
confidentiality.
Confidentiality and Human Subjects Protection
In order to access restricted data files in the RDC, Guest
Researchers must sign an NCHS Designated Agent Agreement (Appendix IV),
the Agreement Regarding Conditions of Access to Confidential Data in
the Research Data Center of the National Center for Health Statistics
(Appendix V), and the Researcher Affidavit of Confidentiality (Appendix
VI). All members of the
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research team that work directly with the data must sign these forms.
NCHS reserves the right to terminate any project at any time if it
deems that an investigator's actions may compromise confidentiality,
the ethical standards of behavior in a research environment, and/or
protocols developed by NCHS to protect the data itself. The Guest
Researcher may also be barred from future use of the RDCs.
As mentioned earlier, confidentiality protection at NCHS is
governed by Section 308(d) of the Public Health Service Act, PHSA, and
(42 U.S.C. 242m). Specifically,
No information, if an establishment or person supplying the
information or described in it is identified, obtained in the course
of activities undertaken or supported under Sections 304, 305, 306,
307, or 309 may be used for any purpose other than the purpose for
which it was supplied unless such establishment or person has
consented (as determined under regulations of the Secretary) to its
use for such other purpose and (1) in the case of information
obtained in the course of health, statistical or epidemiological
activities under Section 304 or 306, such information may not be
published or released in other form if the particular establishment
or person supplying the information or described in it is
identifiable unless such establishment or person has consented (as
determined under regulations of the Secretary) to its publication or
release in other form * * *
Having read and familiarized themselves with the Designated Agent
Agreement and understanding the legal framework under which NCHS
operates, including Section 308(d) of the Public Health Service Act,
308d (for all data) and the Confidential Information Protection and
Statistical Efficiency Act (for all data collected, edited, linked,
merged, transformed, or manipulated at NCHS in any way since January 1,
2003), the researchers agree:
1. To make no copies of any files or portions of files to which
they are granted access except those authorized by NCHS Research Data
Center staff.
2. Not to use any technique to circumvent suppression algorithms or
other disclosure minimization protocols developed by the RDC even if
the intent is not to re-identify study subjects or respondents.
3. To return to RDC staff all NCHS restricted materials with which
they may be provided during the conduct of their research at NCHS and
other materials as requested.
4. Not to use any technique in an attempt to learn the identity of
any person, establishment, or sampling unit not identified on public
use data files.
5. To hold in strictest confidence the identification of any
establishment or individual that may be inadvertently revealed in any
documents or discussion, or analysis. Such inadvertent identification
revealed in their analyses will be immediately brought to the attention
of RDC staff.
6. Not to remove any printouts, electronic files, documents, or
media until they have been scanned for disclosure risk by RDC staff.
7. Not to remove from NCHS any written notes pertaining to the
identification of any establishment, individual, or geographic area
that may be revealed in the conduct of their research at NCHS.
8. To the inspection of any material they may bring to or remove
from the NCHS RDC.
9. To submit to NCHS RDC Analyst for disclosure limitation review
any papers or reports submitted for publication.
10. To comport themselves in a manner consistent with principles
and standards appropriate to a scientific research establishment.
Any willful disclosure of confidential statistical information by
the Guest Researcher is punishable under CIPSEA and carries a fine of
up to $250,000 and up to 5 years in prison.
The NCHS RDCs expect that all Guest Researchers will adhere to
established standards and principles for carrying out statistical
research and analyses. Guest Researchers must conduct only those
analyses which received approval. Failure to comply with RDC rules and
regulations will result in cancellation of the research activity and
potential disbarment from future research activities in the RDCs. In
the case where Ethics Review Board (ERB) approval is required to
conduct research, NCHS will notify relevant ERBs of infringements of
protocol approvals.
Disclosure Review Process
All output will undergo disclosure review by an RDC Analyst and/or
the remote access system. In general, disclosure review is consistent
with the guidelines published in the NCHS Staff Manual on
Confidentiality.
RDC staff review data summaries to assure maintenance of respondent
confidentiality. Tables containing cells with fewer than 5 observations
may not be released to the data user. These cells will be suppressed.
If Guest Researchers require output of an intermediary nature that
contains counts of less than five and believes that the release would
not compromise confidentiality, they should contact their assigned RDC
Analyst or the Director. To assure that small cells cannot be
calculated from the other cells in the same row or column, the totals
for the rows and columns containing the small cell are also suppressed.
Once disclosure review is completed, Guest Researchers receive
electronic copies of the final tabulations.
Output generated through RDC access mechanisms will be subject to a
review that will include, but not be limited, to the following
procedures:
1. In no table should all cases of any line or column be found in a
single cell.
2. In no case should the total figure for a line or column of a
cross-tabulation be less than 5. One acceptable way to solve the
problem is to use a statistical disclosure limitation technique such as
rounding.
3. In no case should a quantity figure be based upon fewer than
five cases.
4. In no case should a quantity figure be released to the Guest
Researcher if one case contributes more than 60 percent of the amount.
5. In no case should data on an identifiable case, nor any of the
kinds of data listed in preceding items A-D, be derivable through
subtraction or other calculation from the combination of output on a
given study.
6. Low level geography will not be included in output provided to
the Guest Researchers.
The reviews will all be performed by an NCHS RDC Analyst who is
trained in statistics and statistical disclosure limitation. For more
information consult the Report on Statistical Disclosure Limitation
Methodology: http://www.fcsm.gov/working-papers/wp22.html.
Costs for Using the RDC
Guest Researchers using the NCHS RDCs will be charged for space and
equipment rental and staff time necessary for supervision, disclosure
limitation review, maintenance of computer facilities (including both
hardware and software), and the creation and maintenance of data files
required by the Guest Researcher. The cost per project (or creation of
an analytic file) is given below:
Set-Up
New file creation
There is a minimum setup charge of $750 per day. An additional $750
per day is charged as needed for file creation and for special
handling, such as the merging of additional data or creating custom
file formats. More complex projects may require discussion between the
Guest Researcher and RDC staff to determine the cost of file creation.
On-Site
Daily programming costs
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$300 per day (consecutive 2-day minimum and 10-day maximum, with
extensions negotiated subject to scheduling requirements). Time on-site
in the RDC can be scheduled in daily increments but the minimum
reservation is 2 consecutive days. Scheduling time at the RDC is on a
first-come, first-served basis.
Staff-Assisted
$750 per day.
Remote
$750 per month.
Payment is expected in advance of the use of the RDC. A check,
money order, or Interagency Agreement payable to ``DHHS Statistical
Services'' must be received 7 business days prior to the scheduled
start date of use of the RDC.
Payments should be mailed to: Research Data Center, Attn: Peter
Meyer, National Center for Health Statistics, 3311 Toledo Road, Suite
4113, Hyattsville, MD 20782.
FULL Document with appendices available at: http://www.cdc.gov/nchs/data/r&d/Guidelines_10_14_08c.pdf.
Dated: May 28, 2010.
James Stephens,
Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-13516 Filed 6-4-10; 8:45 am]
BILLING CODE 4163-18-P