Current through Reg. 49, No. 38; September 20, 2024
(a) An application for access to any
confidential data elements for individual patients identified as part of the
operation of the central registry must contain a protocol and be submitted to
the program manager. The protocol shall explain the applicant's "valid
scientific interest" by describing, at length:
(1) the name and qualifications of the
principal investigator, professional staff, and every person who will review,
analyze, or access the data;
(2)
the background justification for the study;
(3) the goals and aims of the proposed
study;
(4) the health outcomes of
interest;
(5) the methodology for
measuring exposures;
(6) the
methodology for measuring and adjusting for confounding variables;
(7) the precise statistical techniques to be
used in the analysis of data, including power and methods to address biases
inherent in the study design and data;
(8) the time tables and feasibility for
completion of the study;
(9) the
level and sources of funding for the study;
(10) an explanation of the potential benefits
and disadvantages involving human subjects;
(11) the plans to maintain the
confidentiality of the information provided by the department; and
(12) a discussion of the project's pertinence
to the fields of medical research, medical care, public health, epidemiology,
biostatistics, or maternal and child health
(b) After the program manager receives the
completed request for information, the protocol will be reviewed by a program
review panel. The panel shall consist of the program manager, the unit manager,
and a departmental epidemiologist. Upon approval by the program panel, the
protocol shall be evaluated and judged by the department's institutional review
board. Final approval of the protocol shall require the approval of both the
program panel and the institutional review board and shall be based on an
evaluation of the criteria listed in subsection (c) of this section. The
department's institutional review board shall evaluate the research based on
federal regulations found in Title 45, Code of Federal Regulations, Chapter
46.
(c) The evaluation criteria for
approval by the program review panel shall include the following.
(1) The key investigators shall have
significant training and experience in biomedical research as demonstrated by a
history of prior research and publication of results in peer-reviewed journals.
For bona fide student proposals, faculty committee members should possess these
qualifications.
(2) The background
reasons for conduct of the proposed study shall be compelling, as judged by the
importance of the scientific question being asked, relative to the fields of
epidemiology, medicine, public health or other medical research.
(3) The goals and aims shall be clearly
stated, consistent with the scientific question, and relevant to the
field.
(4) If appropriate, the
methods for measuring or estimating exposure shall be scientifically
valid.
(5) The roles of other
factors (that might be related to both the exposures and the birth defects
studied) shall be considered, and the methods for measuring and adjusting for
these factors shall be clear and scientifically valid.
(6) If appropriate, power calculations shall
indicate a reasonable chance of identifying expected differences between
groups.
(7) The statistical
techniques to be used in data analysis, including methods to address biases in
the study design shall be clear and appropriately used.
(8) The potential benefits and disadvantages
of working with human subjects must be clearly described.
(9) Plans of how the investigators propose to
maintain the confidentiality and integrity of the information provided by the
department shall be clearly detailed.
(10) The hypothesis or topic to be studied
must not already be under investigation.
(d) Modification to the protocol or other
terms and conditions may be required before releasing any data.
(e) If the applicant intends to contact
individuals whose names were provided by the program, the protocol must contain
strong methodologic support for the need for such contact.
(f) If the protocol is approved by both the
program panel and the institutional review board, then the researcher shall be
considered to have established a valid scientific interest as required. The
program manager shall so advise the Commissioner. The researcher will be
required to comply with the conditions of subsections (g) and (h) of this
section before any data will be released.
(g) If permission is granted, the applicant
shall be responsible for costs incurred by the program in making the data
available in compliance with established procedures for handling requests for
public information. The applicant shall incur the cost of the program to
monitor all contact with human subjects. The date of delivery of data shall be
determined by the program manager based on workload and the nature of the
request.
(h) Prior to release of
any data, the program manager shall receive from all applicants, including the
principal investigators, staff, and consultants who will receive access to any
confidential central registry data, a signed written statement guaranteeing
that:
(1) the applicant shall not allow any
person other than those identified in the protocol, to access, use, or
otherwise review the data supplied by the program;
(2) there shall be no deviation from the
protocol without explicit advance review and approval by the program panel, the
department's institutional review board, and the Commissioner;
(3) information obtained in the course of
activities undertaken or supported using the data from the program shall not be
used for any purpose other than the exact purpose for which it was
supplied;
(4) all data, data tapes
and disks, hard copy output, interview questionnaires or other materials
provided by the program are considered the property of the department and shall
be returned to the department at the completion of the study. Any confidential
information which is copied or otherwise transferred, electronically or through
other means, shall be destroyed at the completion of the research unless
otherwise stated in the research protocol;
(5) the program shall be acknowledged as a
source of birth defects or other data in all written reports, data tabulations
or publications that are produced by use of these data;
(6) the applicant agrees to notify the
program manager immediately upon receiving any request for access to data in
the applicant's possession;
(7) the
applicant shall notify the program manager on receiving notice of any legal
action that might affect disclosure of the data, either by subpoena, discovery,
or other means; and
(8) the
applicant must agree to reimburse the program for reasonable costs it incurs in
protecting patient information from legal disclosure.
(i) While the program utilizes some vital
records information, that information is the responsibility and property of the
department's Vital Statistics Unit (unit). Investigators who request vital
records information from the unit must obtain approval according to the
policies of the unit.
