Ohio Admin. Code 3701-57-04 - Confidentiality, research
(A) Any information, data or reports with
respect to a birth defects case that is furnished to, or obtained by, the birth
defects information system or by the director shall be confidential and shall
be used for one or more of the following purposes:
(1) For medical research studies including
demographic, epidemiologic, teratologic, or similar studies related to health
and health care provision;
(2) To
inform parents, guardians and custodians of children with birth defects of
medical care and other services available for the child and family;
(3) To provide data regarding birth defects
in Ohio to the "National Birth Defects Prevention Network"; and
(4) To distribute reports of information as
required by section 3705.36 of the Revised Code.
(B)
Information concerning individuals with birth
defects obtained by the Ohio department of health for the birth defects
information system is for the confidential use of the Ohio department of
health. However, qualified
Qualified
persons or government entities engaged in demographic, teratologic,
epidemiologic or similar studies related to health and health care provision
may be given access to confidential information if
the study meets the standards established in paragraph (C) of this rule
and if all the following conditions are met and if the project is approved by the Ohio department of
health's institutional review board :
(1) The person requesting to access the data
initially meets with the birth defects program administrator or other pertinent
Ohio department of health staff to discuss the proposed study concept and
programmatic data elements requested.
(2) Following the outcome of paragraph (B)(1)
of this rule, the person conducting the study submits a complete application to
the Ohio department of health's institutional review board and provides written
information about:
(a) The purpose of the
study;
(b) The nature of the data
to be collected;
(c) How the
researcher intends to analyze it;
(d) The records the researcher seeks to
review, and;
(e) The safeguards the
researcher will take to protect the identity of the patients whose records the
researcher will be reviewing.
(C) Based on the results from the meeting and
written information submitted to the Ohio department of health's institutional
review board under paragraph (B) of this rule, the director shall determine
that access to confidential information concerning individuals with birth
defects shall be made available to persons engaged in demographic,
epidemiologic, teratologic, or similar studies related to health and health
care provision if the person or government entity signs an agreement to
maintain the confidentiality of the information and the study meets the
following standards:
(1) The study had clearly
defined goals that pertain to birth defects diagnosis, prevention, treatment or
service coordination;
(2) For case
control studies, the research design used in the study will involve a
sufficiently large sample size that any meaningful difference between cases and
controls will be statistically significant. For other projects, the study will
provide enough cases for meaningful analysis of the data for identification of
potential risk factors and intervention strategies for birth defects treatment
and prevention; and
(3) The study
will be conducted by researchers who have the ability to analyze and interpret
data.
(D) The director
may disclose information assembled by the birth defects information system with
the written consent of the parent or legal guardian of the child who is the
subject of the information.
(E) The
director may obtain and merge into the birth defects information system
information reported to the Ohio department of health under another provision
of the Revised Code or Administrative Code.
(F) Notwithstanding paragraphs (A) and (C) of
this rule, the Ohio department of health may release confidential information
concerning individuals with birth defects or congenital anomalies to the birth
defects information system of another state, if the other state has entered
into a written reciprocal agreement with the Ohio department of health and the
agreement provides that the state will comply with the confidentiality
provision of this rule and that information identifying a child will not be
released to any person without the written consent of the individual's parent
or legal guardian.
(G) This rule
does not prevent the release of information assembled by the birth defects
information system in summary, statistical or other form that does not identify
particular individuals or individual sources of information.
Notes
Promulgated Under: 119.03
Statutory Authority: 3705.30, 3705.35
Rule Amplifies: 3705.32, 3705.35
Prior Effective Dates: 6/3/2005, 11/1/10
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