Ohio Admin. Code 3701-4-03 - Confidentiality; research
(A) Any information, data, and reports with
respect to a case of cancer which are furnished to, or procured by, the
department shall be confidential and shall be used only for public health
surveillance and research for the purposes of reducing the morbidity or
mortality of cancer.
(B) A person
involved with a research project may be given access to confidential
information if all the following conditions are met and if the research project
is approved by the department's institutional review board:
(1) The person conducting the research
submits verification of his credentials and of the credentials of other
individuals involved in conducting the research;
(2) The person conducting the research
provides written information about the purpose of the research project, the
nature of the data to be collected and how the researcher intends to analyze
it, the records the researcher seeks to review, and the safeguards the
researcher will take to protect the identity of patients whose records the
researcher will be reviewing;
(3)
The proposed safeguards are adequate to protect the identity of each patient
whose records will be reviewed. Safeguards for the protection of the identity
of patients shall include, but are not limited to, provisions to limit access
to identifying data to only those individuals who during the course of the
project need access to such information for research purposes and provisions
for the maintenance and/or destruction of identifying information after the
termination of the project;
(4) An
agreement is executed between the department and the researcher that specifies
the terms of the researcher's use of the records. The agreement will prohibit
the publication or release of protected health information.
(C) Notwithstanding paragraphs (A)
and (B) of this rule, a researcher may, with the approval of the department's
institutional review board, contact individual cancer patients to request
additional information for research purposes or to solicit a patient's
participation in a research project. The researcher shall first notify the
patient's managing physician of the intent to contact the patient. Unless the
patient's managing physician informs the researcher within a reasonable time
that the patient should not be contacted, the researcher may contact the
patient. The researcher shall obtain the patient's verbal or written consent
prior to requesting additional information or including the patient in a
research project.
(D)
Notwithstanding paragraphs (A) and (B) of this rule the department may release
confidential information concerning individual cancer patients who are not Ohio
residents to the cancer registry of the patient's state of residence at
diagnosis.
(E) Nothing in this rule
prevents the release to any person of summary, statistical, or aggregate
information that does not identify individual cancer patients.
Notes
Promulgated Under: 119.03
Statutory Authority: 3701.262
Rule Amplifies: 3701.262
Prior Effective Dates: 05/20/1993, 10/19/2015
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