Access to Cancer Registry Data
Policies and Procedures Interim Revised: March, 1999
June, 2000
I. PURPOSE
This set of policies and procedures defines the types of data that
can be obtained from Cancer Epidemiology Services; criteria, conditions,
and limitations for access; procedures to be followed in accessing
the data; format of data released; and the fees for such access. This
policy is designed to be consistent with the "Statement of Policy
on Release of Health Data" adopted in 1998 by the New Jersey Department
of Health and Senior Services. Definitions under that policy are found
as Appendix A of this document.
II. BACKGROUND
The New Jersey State Cancer Registry (NJSCR) is the central cancer
registry for all of New Jersey's eight million residents. With the
passage of NJSA 26:2-104 et seq. in October 1978, the NJSCR was established
as a population-based cancer incidence registry. Data on cases have
been collected since January 1, 1979. New Jersey regulations require
the reporting of all newly diagnosed cancer cases to the Registry within
three months of hospital discharge or six months of diagnosis, whichever
comes first. Reports are filed by hospitals, diagnosing physicians,
dentists, and independent clinical laboratories. Approximately 40,000
incident cases are reported each year. Data items collected by the
NJSCR are listed in Table 1. It should be noted that due to the time required for the submission
of case reports by reporting facilities and for validation by the Registry,
data are not available for the current calendar year. The data are
updated continually and the most recent years of data may be considered
incomplete and not yet useful. Please contact Cancer Epidemiology Services
prior to making a formal request for data to ascertain whether the
data you need are complete.
III. POLICY
It is the policy of Cancer Epidemiology Services (CES) to encourage
research use of Registry data for the purpose of determining the incidence
and etiology of malignant neoplasms and/or evaluating measures designed
to eliminate, alleviate, or reduce the impact of cancer. It is the
policy of CES to adhere to the provisions of NJSA 26:2-107 which states: Release of data will be permitted for medical and epidemiologic research,
for use by reporting facilities and to individuals seeking review of
their own records.
The reports made pursuant to this act are to be used only by the State Department
of Health and Senior Services and such other agencies as may be designated
by the Commissioner of Health and Senior Services and shall not otherwise be
divulged or made public so as to disclose the identity of any person to whom
they relate; and to that end, such reports shall not be included under materials
available to public inspection pursuant to P.L. 1963. c.73 (C.47.1A-1 et seq.). It is CES's policy that all requests for access to data be handled
equitably within the constraints of the statute and that decisions
affecting conflicting priorities be handled in a manner that places
the State's best interest first. It is, furthermore, the policy that
confidential data will be released in as non-specific form as possible
to accommodate the legitimate needs of the researcher requesting cancer
registry information, while safeguarding the confidentiality of the
patients. Therefore, it is the policy of the NJSCR that data from a
specific institution or minor civil division, or data that might reveal
an individual's identity, will not be released without adequate justification. It is also recognized that complex data elements, such as those involving
cancer treatment and diagnostic procedures, require an expert level
of technical sophistication to interpret. Thus, it is the policy that
sensitive and confidential data will be released only after assurances
are obtained that the data shall be analyzed in an epidemiologically
competent manner. Epidemiological competence includes, but is not limited
to, the researchers' awareness and understanding of the effects of
bias that are subject to occur during the processes of data collection,
classification and coding, and statistical analysis. Further, it is
the policy of CES that any publication of findings conform to rigorous
epidemiologic standards and may be subject to review by CES prior to
submission for publication. It is the policy of CES that no information
that might identify a patient, physician, or reporting facility shall
be presented in the results of analyses or other reports or in releases
of information concerning such reports. The New Jersey Department of Health and Senior Services periodically
reviews its privacy policy and reserves the right, at its discretion,
to modify or remove portions of the policy at any time. IV. RESPONSIBILITIES Cancer Epidemiology Services (CES) of the New Jersey State Department
of Health and Senior Services (NJDHSS) is located within the Public
Health Protection and Prevention Programs.
- The New Jersey State Commissioner of Health and Senior Services
adopts policies for the Department. It is his/her intent that
Cancer Epidemiology Services comply with applicable statutes
and regulations
and that the actions of the Cancer Epidemiology Services are
in conformance with established ethical standards and with sensitivity
to the rights
of all participants. The Commissioner of Health & Senior
Services has the final authority to release confidential data.
- The Senior Assistant Commissioner, Public Health Protection and
Prevention Programs, is responsible for overseeing the operations
of the Cancer Epidemiology Services, for ensuring that established
Departmental policies are executed, and for formulating and adopting
policies for the Public Health Protection and Prevention Programs.
It is his/her responsibility to determine the disposition of requests
for sensitive, confidential or unusual data release.
- The Director of Cancer Epidemiology Services is responsible for
the formulation and implementation of adopted policies and procedures
for the Services and for monitoring compliance.
- The Director and the Program Managers of Cancer Epidemiology Services
are responsible for the daily operations and for staff compliance
with these policies and procedures.
- The Program Managers and professional staff are responsible for
evaluating the merits of proposed research and for recommending the
priority for research recommended for approval.
- The New Jersey State Department of Health and Senior Services
Institutional Review Board (IRB) is responsible for determining whether
the potential risks to subjects' planned participation in research
is outweighed by the benefits derived from that research. They are
also responsible for reviewing requests involving sensitive or confidential
data.
- Each Principal Investigator (PI) is required to be knowledgeable
regarding the policy and procedure statements herein, and to ensure
that they are strictly followed by every person accessing the data.
- Each employee with access to confidential data is required
to be knowledgeable regarding the policy and procedure statements
herein,
and to strictly follow them. Each employee must sign the "Confidentiality
Assurance Form".
V. PROCEDURES FOR SUBMITTING A REQUEST FOR DATA
A. REQUESTS FOR NON-SENSITIVE DATA
Requests for published aggregated data may be made over the
telephone, in person, or in writing. CES staff will provide this
information as quickly as possible. Charges for materials and
handling will be made in accordance with State policy. (See VII.
FEES.)
Alternatively, the DHSS's website may be accessed for state-level aggregated
data. The website is http://www.state.nj.us/health.
-
Special requests for non-published data
Requests for non-published aggregate data (e.g.
incidence rates, number of cases by site or county, etc.) may also
be initiated
by telephone or in writing. For any data requiring computer
programming, request Form A [PDF 26k]
[Word 31k] must be completed.
This request should specify exactly what information is needed,
the purpose of the request and the date by which the data are
needed. Such requests will be reviewed at the program level for
feasibility and ability to meet the request without interfering
with program activities. The applicant will be notified of any
charges prior to processing the request. These requests need
not be reviewed by the Institutional Review Board.
-
Requests for Data for Research
CES has prepared a Researchers' Database with individual records
created specifically for academic and government researchers
to use for planning, prevention, and research. Users of the data
must sign an agreement to comply with CES provisions regarding
the use of the data. The use of this database does not require
IRB approval. This database does not contain "confidential" data.
(See Table 1 for a list of "confidential" variables.)
Contact CES for more information, to determine if this database
meets your needs, and to request it.
Other non-sensitive data, not in the Researchers' Database, also may be
made available to researchers. This data does not include "sensitive" or "confidential" data
elements. (See Table 1 for a list of non-sensitive variables.) Requests
for such data must be made in writing using Form A [PDF 26k]
[Word 31k]. A limited technical
review will evaluate the Program's ability to provide the requested data,
to ensure
the confidentiality of the data, to ensure that the data is relevant to
the research question, and to assure the appropriate application of the
principles of epidemiology and statistics to the proposed analysis.
B. REQUESTS FOR SENSITIVE DATA
Sensitive data are defined as any data which may supply
enough information to identify a particular individual as having
cancer, including any
request involving access to municipality of residence, date of birth,
or other specific non-name data. It may also include more general
data which result in 5 or fewer individuals in a category from which
individual identities might be surmised. (See Table 1 for the list
of "sensitive" variables.)
Requests for sensitive data must be made in writing
using Form B [PDF 44k] [Word 83k].
In addition to the technical review criteria mentioned above, a
technical review will ascertain the necessity of sensitive-level
access. Experts/consultants will be contacted if necessary to participate
in the review. The purpose of the technical review is not to critique
the investigator's analytic methods, but rather, to be an assessment
of the potential benefit derived from the study and the feasibility
of the study design in achieving the stated goals and objectives.
The review will include an evaluation of the applicability of the
requested data for the stated purposes. The review may include
a meeting or consultation with the principal investigator if there
are any questions or reservations about the release of data.
The technical review will also consider:
- the qualification of the organization (individual) conducting
the research;
- whether the study will duplicate other research in progress using
NJSCR data; and
- the ability of the NJSCR staff to expeditiously provide the requested
data, including an estimation of the staff time and costs involved.
CES will estimate the computer costs involved for any data processing
services which are required. The researcher will be provided with
a written disposition of the review and notification of estimated
costs for data processing.
C. REQUESTS FOR CONFIDENTIAL DATA
Confidential data include personal identifiers such as name, social
security number, or street address which directly link an individual
with a diagnosis. (See Table 1 for a list of "confidential" data
fields.)
Requests for confidential data must be made in writing
using Form B [PDF 44k] [Word 83k].
Such requests will be subject to the technical review process described
under section B above. Additionally, a review by the Department
of Health and Senior Services Institutional Review Board (IRB)
is necessary.
Access to confidential data shall be restricted to:
- Those employees or authorized agents of CES involved in data collection,
data processing, quality control, follow-up activities and administration
as appropriate to carry out their work assignments.
- Authorized employees or authorized agents of the New Jersey State
Department of Health and Senior Services involved in public health
investigations and interventions within the scope of applicable State
statutes.
- Individuals (or their legitimate representatives) requesting access
to their own personal records.
- Reporting facilities requesting access to the data on a patient
they reported to NJSCR (with the exception of current mailing address).
- Qualified institutions for qualified research purposes.
D. REQUESTS FOR DATA BY HOSPITALS OR OTHER REPORTING SOURCES
Any reporting source may obtain data on any case they have reported
to the NJSCR, including follow-up and treatment information. However,
the patient's current mailing address will not be released. Standard
requests (e.g. a patient listing, follow-up printout, etc.) may be
made over the telephone. The hospital should contact their assigned
Public Health Representative from the NJSCR. Non-standard requests
should follow the procedures listed above, depending on the type
of information necessary.
E. REQUESTS TO REVIEW PERSONAL RECORDS
All requests by individuals to access and copy their record will
require the presentation of two forms of identification: one of which
is a picture ID, such as a driver's license and a second which may
be a birth certificate, valid credit card, or other identification.
A patient's designated surrogate has the right to view and copy the
patient's record with written permission from the patient or the
individual who has the patient's power of attorney. Charges for retrieval
and photocopying of an individual record will be made in accordance
with State policy. Requests must be made in person. Please telephone
CES at (609) 588-3500 for an appointment. Records previously sent
to long term storage may cause delays in access.
F. RELEASE OF CONFIDENTIAL DATA FOR AUDITS
Requests for this purpose must be approved by CES. Personal identifying
information will only be released if it is vital to the audit. Personnel
conducting the audit must not directly or indirectly identify the
person who is the subject of any record in the report of the audit
or otherwise disclose the individual's identify. Audit personnel
must sign the "Confidentiality Assurances Form."
G. ATTEMPT TO SUBPOENA CONFIDENTIAL RECORDS
The NJDHSS does not permit access to sensitive or confidential data
for reasons other than bona fide research. The press, lawyers, law
enforcement agencies, and agents of the courts will not be given
access to sensitive or confidential data. If an attempt is made to
serve a legal subpoena, the individual attempting to serve the subpoena
will be advised that as custodian of the record, CES is not authorized
to accept subpoenas or to release records to the courts. The individual
will be referred to the Office of Legal and Regulatory Affairs, Office
of the Commissioner of the NJDHSS. CES staff will immediately advise
the Senior Assistant Commissioner of the Public Health and Protection
and Prevention Programs and the Office of Legal and Regulatory Affairs
of the attempt. If legal papers are left at the OCE, staff will courier
them to the Office of Legal and Regulatory Affairs, Office of the
Commissioner.
H. PRESS INQUIRIES
Inquiries by the press must first be cleared through the Press Office
of the NJDHSS. Upon receiving clearance, CES staff will respond to
general questions that can be answered with information available
in published documents and other non-sensitive data.
I. REQUESTS FROM THE LEGISLATURE
Requests from the Legislature must be directed to the Office of
Governmental Relations through the Senior Assistant Commissioner
for Public Health Protection and Prevention Programs.
VI. DATA RELEASE FORMAT
Data can be released in printed form or on magnetic storage media.
A checklist showing the data fields present on the NJSCR analytic file
is presented in Table 1. Documentation of the data file and statements
of known limitations will be supplied to the user. Due to technical concerns related to consistency in summarizing multiple
records on any given cancer case, it will be the operational practice
of CE S to provide summarized individual records rather than multiple
records from multiple reporting sources for each patient. Individual paper records are considered confidential. Due to the cost
and the effort to retrieve and duplicate these forms, it shall also
be the operational practice not to release paper records to researchers.
(Individuals requesting their own records are exempt from this restriction.)
Under compelling reasons, a researcher may be allowed to inspect a
sample of paper records. Note:
Since 1996, most information on cases of cancer has been submitted to CES in
electronic form.
VII. FEES
Fees are charged to anyone outside the DHHS for photocopying records:
First page to tenth page.......................................$0.75 per
page,
Eleventh page to twentieth page...........................0.50 per page,
All pages over 20..................................................0.25 per
page.
It may be possible for a person who wishes to copy more than 100 pages
of records to use their own photographic process, upon payment of a fee
not less
than $5 or more than $25.
The fee for documents provided by fax is:
First page..........................................................$3.00,
Second and over...............................................$1.50 per page.
Fees that are charged to produce a data tape, diskette, or print-out
are used to offset the staff and data processing costs incurred in
servicing a request. CES will assist an individual requesting data
in modifying specifications so as to reduce cost. At the discretion
of the Department, the fee may be waived. A standard fee schedule has
not been established since costs vary widely with the complexity of
the request. The cost of each request is estimated individually considering
the programming and data processing time that will be involved. Simple
analytic subfile creation can range from a few hundred to several thousand
dollars. Complex requests that involve extensive programming may cost
more. Data for which there is a fee cannot be released until receipt by
the CES of a check in the appropriate amount made payable to "Treasurer,
State of New Jersey". VIII. STATUS REPORTS AND ERRORS Annual or more frequent investigator-generated progress reports may
be required by CES. A final report also will be requested by CES. Copies
of these reports will be forwarded to the Institutional Review Board.
These reports must describe study progress and include copies of any
analysis submitted for publication. The reports also must contain a
log of complaints (if any) the researcher received from physicians,
study subjects, health professionals, or members of the public regarding
the study. Any data errors discovered by data users must be reported to the CES.
New fields may be used that contain corrections to the errors. Reports
and publications should acknowledge the changes and their relationship
to the source data when more than five errors are noted. IX. APPEAL PROCESS If a request for data is denied, the researcher will receive a written
summary of the proposal review including the reason(s) for denial.
Applications may be resubmitted with the revisions recommended in the
written summary. Alternatively, appeals may be directed to the Senior
Assistant Commissioner of Public Health Protection and Prevention Programs.
APPENDIX A
DEFINITIONS * Confidential information: Information with identifiers about
a living individual, when that individual has not given consent to
make that information public. Confidential record: A paper or electronic record containing
confidential information. Individual identifiers: Those elements of the confidential
record that state the name, address, social security number, or other
information that exactly identify the subject of the record. Confidential data elements: Data elements which by themselves
or in conjunction with other elements in the record could easily lead
to the identification of the subject. In addition to individual identifiers,
these elements may include exact date of birth, municipality, name
of physician, name of hospital, and others; whether these data elements
are considered confidential depends on the data set. Health data files: Electronic or paper files that contain health
and related information about individuals. They may or may not include
confidential data elements. Confidential health data: Health data that include confidential
data elements. Non-confidential health data: Health data which do not include
confidential data elements. Individual elementary data units: The individual records within
health data files. NJDHSS Programs: The administrative units in the NJDHSS with
primary responsibility for collection, maintenance, and release of
health data. Qualified personnel: Those individuals with sufficient training
and experience to carry out the responsibilities connected with collection,
maintenance, release, or utilization of specific health data files. * From "New Jersey Department of Health and Senior Services Statement
of Policy on Release of Health Data".
| TABLE 1 |
|
I. NON-SENSITIVE LEVEL (PUBLIC)
|
|
Age at Diagnosis (SEER recodes, 5-year age groups)
Behavior (SEER recodes)
Cancer Site Group (SEER recodes)
Hispanic Ethnicity
Race (SEER recodes)
|
Sex (male, female)
Stage of Disease
State of Diagnosis
Vital Status
Year of Diagnosis |
| II. SENSITIVE ACCESS LEVEL --
includes all Non-sensitive Level fields plus the following: |
County of Residence at Diagnosis
Date of Diagnosis - Month & Year
Date of Last Contact - Month & Year
Diagnostic Confirmation
Grade
Histologic Type
Laterality
|
Marital Status
Place of Birth
Primary Site
Race
Sequence Number
Type of Reporting Source |
| III. CONFIDENTIAL ACCESS LEVEL --
includes all Non-sensitive and Sensitive Level fields plus the
following: |
Address at Diagnosis - Street, City, Zip
Age at Diagnosis
Alias
Birth Date
Birth Place
Date of Admission/First Contact
Date of Diagnosis
Date of Inpatient Admission
Date of Inpatient Discharge |
Death Certificate State File Number
Edit Override Fields (9)
Maiden Name
Medical Record Number
New Jersey Municipality Code
Patient's Current Address - Street, City, State, Zip
Patient's Name - First, Last, Middle
Reporting Hospital
Social Security Number |
|
Cancer Epidemiology Services
