Cancer Epidemiology Services

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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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

  1. Published data
  1. 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.

  2. 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.

  3. 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:

  1. the qualification of the organization (individual) conducting the research;
  2. whether the study will duplicate other research in progress using NJSCR data; and
  3. 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:

  1. 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.
  2. 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.
  3. Individuals (or their legitimate representatives) requesting access to their own personal records.
  4. Reporting facilities requesting access to the data on a patient they reported to NJSCR (with the exception of current mailing address).
  5. 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

 


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