(c) A report submitted to
the SCR concerning an individual, and any other information maintained by the
SCR, which, because of a personal identifier, can be readily associated with an
individual, shall only be released:
(1) To the
individual upon:
a. Receipt of a written
request which shall be signed by the individual; and
b. Presentation of identification, such as a
driver's license, by the individual;
(2) If the individual is a minor, to a parent
of the individual upon:
a. Receipt of a
written request, which shall be signed by the parent;
b. Receipt of a certified copy of the birth
certificate of the individual; and
c. Receipt of a copy of the parent's
identification, such as a driver's license of the parent;
(3) If the individual has a court-appointed
guardian or if the individual is deceased, to the court-appointed guardian or
to the executor or administrator of the individual's estate upon:
a. Receipt of a written request, which shall
be signed by the court-appointed guardian, executor, or administrator of the
estate;
b. Receipt of a certified
copy of the order or decree which appoints the guardian, executor, or
administrator; and
c. Receipt of a
copy of identification, such as a driver's license, by the guardian, executor,
or administrator;
(4) To
an attorney or other person designated by the individual upon receipt of a
written medical release request which shall be signed by the
individual;
(5) To persons
conducting health related research, upon receipt and approval pursuant to
He-P
304.09 of a written application to the department,
which shall be signed by the applicant and includes:
a. The following information about the
principal investigator:
1. Name, address, and
phone number;
2. Organizational
affiliation;
3. Professional
qualification; and
4. Name and
phone number of principal investigator's contact person, if any;
b. The following information about
the data or record copies being requested:
1.
Type of event or record copies;
2.
Time period of the data or record copies;
3. Specific data items required, if
applicable;
4. Medium in which the
data or record copies are to be supplied by the bureau; and
5. Any special format or layout of data
required by the principal investigator;
c. A research protocol which shall contain:
1. A summary of background and origin of the
research;
2. A statement of the
health-related problem or issue to be addressed by the research;
3. The primary research hypothesis to be
tested;
4. The research design,
which shall include:
(i) Case
definition;
(ii) Method of case
selection; and
(iii) Method of data
analysis;
5. The
research methodology, which shall include:
(i) The way in which the requested data will
be used; and
(ii) The procedures
for follow-back to any persons or facilities named in records, if
applicable;
6.
Procedures to obtain informed consent from the research participants, if
applicable;
7. The procedures that
shall be followed to maintain the confidentiality of any data or copies of
records provided to the requester; and
8. The intended completion date;
d. A statement signed by the
principal investigator agreeing to the following:
1. The investigator shall acknowledge the
department as the source of the data in any and all public reports,
publications, or presentations generated by the requester from these
data;
2. The investigator shall
specify that the analyses, conclusions, and recommendations drawn from such
data are solely those of the requester and are not necessarily those of the
department;
3. Any data or record
copies provided shall not be used for any purpose other than that described in
the application;
4. The principal
investigator and the research staff shall not disclose the identity of
individuals revealed in the data or record copies to any persons except as is
necessary to perform the research described in the application;
5. The data record shall not be further
released to any other person or organization without the written consent of the
commissioner or his designee; and
6. No form of information derived from the
data or record copies that identify any individuals shall be made
public;
e. A written
statement ensuring that the investigator shall hold all information
confidential; and
f. When contact
with patients will occur, submission of an Institutional Review Board (IRB)
approval for the study by an IRB formed in accordance with the requirements of
the U.S. Department of Health and Human Services Code of Federal Regulations
for Protection of Human Subjects, 45 CFR 46, June 23, 2005; or
(6) In association with an audit
as required under Title III of Public Health Services Act, 42 U.S.C. 241 et
seq.