[Federal Register Volume 63, Number 162 (Friday, August 21, 1998)]
[Notices]
[Pages 44942-44944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22463]
=======================================================================
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
Announcement of Service to Epidemiological Researchers to Provide
Vital Status Data on Subjects of Health Research
AGENCY: Social Security Administration.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Section 311 of the Social Security Independence and Program
Improvements Act of 1994 directed the Social Security Administration
(SSA) to provide support to health researchers involved in
epidemiological research. Specifically, when a study is determined to
contribute to a national health interest SSA will furnish information
regarding whether a study subject is shown on the SSA administrative
records as being alive or deceased (vital status).
DATES: This service is available as of this date by contacting the
Associate Commissioner for Research, Evaluation and Statistics. The
mailing address is Social Security Administration, Office of Research,
Evaluation and Statistics, 4-C-15 Operations Building, 6401 Security
Building, Baltimore MD 21235. The fax number for the Associate
Commissioner is 410-965-3308.
FOR FURTHER INFORMATION CONTACT: Ms. Cheryl Williams, Office of
Research, Evaluation and Statistics, 4-C-15
[[Page 44943]]
Operations Building, 6401 Security Boulevard, Baltimore MD 21235;
telephone 410-965-5540.
SUPPLEMENTARY INFORMATION:
A. Background
Historically, SSA had made disclosures of vital status data under
the provisions of the Freedom of Information Act (FOIA, 5 U.S.C.
552(a)(3)). However, as a result of the Supreme Court decision in
United States Department of Justice v. Reporters Committee for Freedom
of the Press 489 U.S. 749 (1989), SSA discontinued the process of
providing such data. The enactment of Section 311 of the Social
Security Independence and Program Improvements Act of 1994 established
the legal authority for SSA to release vital status data except for
death data obtained from a State under section 205(r) of the Social
Security Act, which data may only be released for statistical and
research purposes to State and Federal agencies at the discretion of
the Commissioner of Social Security. Accordingly, when the research in
question has been determined to contribute to a national health
interest SSA will furnish vital status data on study subjects. The
researcher must submit the study subject's Social Security Number, full
name (first, last and middle name), date of birth (month, day, century
and year) and sex. SSA, in-turn, will furnish one of the following
vital status determinations for each study subject so long as the
researcher has provided adequate assurances that information relating
to presumed living will be kept confidential:
Death information (except information obtained under
section 205(r)) (the date of death and State where a claim was filed,
or the State of residence at the time of death) if available;
Presumption that the individual is living (There is
sufficient information in SSA administrative records to support this
determination);
Status unknown (SSA has no record of death, nor sufficient
information within the SSA administrative records to support a
determination that the subject is alive);
Social Security Number (SSN) verification failed (the SSN
and name furnished to SSA did not match or the date of birth furnished
for an SSN/name did not match the information in the SSA administrative
records); or
The SSN was impossible or had never been issued.
A companion change to the Internal Revenue Code (26 U.S.C. section
6103) permits SSA to release ``presumption of living'' data based on
reports of earnings obtained from the IRS.
B. Application Process
Please submit requests for this service in memorandum format
addressed to the Associate Commissioner for Research, Evaluation and
Statistics, Social Security Administration. For each request for
services, the following specific areas must be covered in separately
numbered paragraphs:
1. The name, address and phone number of the study's Principal
Investigator. Also include the name and phone number of another person
who can be contacted if SSA has questions about the request.
2. The title of the study or project.
3. Attach a one page summary of the study protocol or the project
activities. Include specific purpose(s) of the research to be
undertaken and the outcomes expected.
4. The organization or institution supporting the research and the
specific person who will sign agreements to reimburse SSA for expenses
incurred in supplying data.
5. An explanation of how data provided by SSA will be used. That
is, will the data only be used to determine the subjects' vital status
or will it also be used to obtain death certificates to determine the
causes of death or to obtain additional information from next-of-kin,
physicians, or hospitals.
6. A specific statement that vital status data obtained from SSA
under the category, ``presumed living'' will only be used for the
purposes described in the request and will not be used for
administrative or legal purposes.
7. Procedures to ensure the confidentiality of the vital status
data supplied by SSA under the category, ``presumed living''.
8. Plans to publish or release the research results including
whether any supporting documentation will be made available in
identifiable form under the category, ``presumed living''.
9. Final disposition of SSA data to include the location of files
and full disclosure of who will have access to the identifying data
under the category, ``presumed living'' and for how long.
10. In addition to the staff of the requesting organization,
identify, ``other parties'' receiving (or have contractual or other
rights to) vital status information provided by SSA under the category
``presumed living''. ``Other parties'' would include consultants,
collaborators, nosologist, contractors, subcontractors, and sponsoring
or participating agencies or organizations.
Note: If the applicant indicates that other organizations or
individuals will receive identifying SSA vital status data under the
category ``presumed living'', that organization must also be a party
(signatory) to the applicant's memorandum or must submit a separate
supporting memorandum. In this supporting documentation each third
party must indicate (1) their role in the study and the activities
they will perform, (2) how they will store and maintain
confidentiality of the identifying data under the category
``presumed living'', and (3) how and when the identifying data on
the ``presumed living'' will be destroyed.
An evaluation team comprised of staff members from SSA's Office of
Research, Evaluation and Statistics and the National Center for Health
Statistics (NCHS) will review each application for services. The team
will not attempt to determine the scientific merit of the study. It is
understood that the merit of the study has been (or will be) determined
by the sponsoring agency and/or the organization performing the study.
The team's purpose will be to reach a consensus that the results of the
study could be expected to advance the public's knowledge in a health
area of importance to a segment of the United States population.
If such a determination is made and the Associate Commissioner for
Research, Evaluation and Statistics concurs, the applicant will be
notified, in writing, of the methods that may be used to submit data on
study subjects, the exact format to be used in submitting this data and
the cost for developing and transmitting the vital status data from SSA
records. The applicant will be required to sign a memorandum of
understanding which will delineate his/her responsibilities in the use
of the requested vital status data. The applicant will also be required
to sign a contractual agreement to facilitate payment for the service.
C. Service Costs
The service is currently available at a cost of $.16 per record
(data supplied to identify one study subject) up to 25,000 records.
Additional records will be processed at a cost of $.012 per record.
Form SSA-1234-U5 ``Agreement Covering Reimbursable Services'' will be
signed by the applicant and an appropriate SSA representative to
formalize the payment process. As authorized by Pub. L. 97-35, SSA
requires federal agency requestors to provide an advance payment equal
to 50 percent of the SSA costs for this service. Non-federal requestors
are required to provide an advance payment of 100 percent of the SSA
costs for this service.
D. Criteria Used to Approve Requests
The SSA/NCHS team will use the following criteria in formulating
their
[[Page 44944]]
recommendations for the Associate Commissioner for Research, Evaluation
and Statistics:
Use of Data for Statistical Purposes
The request for services should clearly state that the vital status
data supplied will be used to support statistical calculations and/or
study findings. Furthermore, the request must indicate those situations
in which the death data furnished will be used to identify state death
records. A request will be disapproved if it proposes to use the vital
status data or state death data obtained from the vital status data for
administrative, law enforcement or other nonstatistical purposes. The
team can suggest that the applicant be given the opportunity to revise
the application to eliminate any nonstatistical uses of the vital
status data.
Disease Registries
Requests from individuals and or groups working with disease
registries will be accepted. (Disease registry is a roster of persons
diagnosed and/or treated for a particular disease and maintained for
the purpose of morbidity and/or mortality surveillance without any
specific hypotheses to be examined.) Registries usually employ a
standardized methodology, are subject to informal and sometimes formal
controls, and may rely on other methods for follow-up of a majority of
the roster. Such registries deserve special considerations. Applicants
who propose to submit a roster of names deriving from such a registry
should specify the date the registry was founded, the purposes of the
registry, the eligibility criteria for including persons in the
registry, the provisions for internal and external approval of the
registry's quality and methods (including human subject
considerations), and the dates of the last documented internal and/or
external reviews.
SSA will generally approve these submissions provided the requests
give adequate documentation of the registries' activities.
Furthermore, registries will not be required to submit separate
applications for each study. Multiple uses of SSA vital status data are
permitted, provided that: (1) each study is solely used for statistical
purposes in medical and health research, (2) adequate assurances are
given confidentiality of the identifying vital status data under the
``presumed living'' category will be maintained, and (3) vital status
data under the ``presumed living'' category will be kept separate from
any administrative records.
Mortality Follow-Up on Non-Disease Cohorts
Most applicants are required to submit separate requests for
specific studies. However, some organizations conduct mortality
surveillance studies on ``non disease'' cohorts such as industrial
workers, population samples, and members of particular families. Vital
status data on such individuals may be used for multiple
epidemiological studies. Such organizations, in essence, are
maintaining exposure or other non-disease ``registries'' which
facilitate epidemiological studies of groups with particular
experiences. Such organizations will not be required to submit separate
applications to SSA for each study, although they will be required to
describe expected protocols and give specific, current or future
examples.
Multiple uses of vital status data obtained from SSA under the
``presumed living'' category are permitted, provided that (1) each
study is used solely for statistical purposes in medical or health
research, (2) adequate assurances are given the confidentiality of
identifying vital status data under the ``presumed living'' category
will be maintained, and (3) vital status data under the ``presumed
living'' category will be kept separate from any administrative
records.
Use of Data by a Third Party
If the applicant indicates that another organization will receive
identifying SSA vital status data under the ``presumed living''
category, that organization must be a party to the original submittal
or submit a supporting memorandum. In this supporting documentation,
the third party must indicate (1) how they will store data and maintain
the confidentiality of data under the ``presumed living'' category and
(2) how and when data under the ``presumed living'' category will be
destroyed.
Final Disposition of Data
The applicant must indicate if, how and when identifiable data
under the ``presumed living'' category furnished in support of a
request, will be destroyed. If there is no indication that the
identifiable data under the ``presumed living'' category will be
destroyed, then the individual requesting the vital status data must
explain, in some detail, why the data needs to be maintained.
E. Repeated Use of the Service
Once an applicant is approved to obtain vital status data for a
specific study or project, the approval is valid as long as there are
no major changes in the project. Additional records may be submitted
under the approved contract for services. If however, the project
specifications change, the applicant must submit a new request for
services. The following is a list of possible occurrences which would
require the submission of a new request for services:
The project will be supported by a new organization,
A new organization will be receiving the vital status
data,
Confidentiality provisions under the ``presumed living''
category have changed,
Provisions for disposing of data under the ``presumed
living'' category obtained from this request have changed,
Vital status data under the ``presumed living'' category
will be used for legal, administrative or other actions which could
directly affect particular living individuals or establishments,
Changes have been made in the project's research
objectives.
(Catalog of Federal Domestic Assistance Program Number 96.007,
Social Security--Research and Demonstration)
Dated: May 1, 1998.
Jane L. Ross,
Deputy Commissioner for Policy.
[FR Doc. 98-22463 Filed 8-20-98; 8:45 am]
BILLING CODE 4190-29-P
