Current through Register Vol. 39, No. 6, September 16, 2024
(a) Individuals other than authorized program
staff requesting access to confidential monitoring program information for
research purposes must establish a valid scientific interest in order to obtain
this information. An application requesting access to monitoring program
information must contain a research protocol and be submitted to the Director.
The protocol shall contain the following information:
(1) The name and qualifications of the
principal investigator, professional staff, and every person who will review,
analyze, or access the data;
(2)
The purpose of the research;
(3)
The research design and statistical methods to be used to analyze the
data;
(4) The proposed benefits to
be derived from such research and the potential risk to human subjects;
and
(5) The plans and procedures to
maintain the confidentiality of information provided by the monitoring
program.
(b) The
criteria to establish a valid scientific interest 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 and research carried out for educational
purposes, faculty committee members should possess these
qualifications;
(2) The purpose of
the research shall be clearly stated, and the hypotheses under investigation
shall be scientifically compelling, as judged by the importance of the question
relative to the fields of epidemiology, medicine, or public health;
(3) The research design shall be
scientifically sound with respect to exposure measurement, assessment and
control of other relevant risk factors, and statistical power. Statistical
techniques to be used in the analysis shall be clearly described and
appropriately applied;
(4) The
benefits of the proposed research, and the potential risk to individuals whose
identity may be disclosed or who are involved as study participants must be
clearly stated;
(5) Plans of how
the investigators propose to maintain the confidentiality and integrity of the
information provided by the monitoring program shall be clearly detailed and
must adequately protect the security of the data;
(6) The hypothesis or topic to be studied
must not already be under investigation; and
(7) If the investigator intends to contact
individuals whose names were provided by the monitoring program, the protocol
must contain strong methodologic support for the need for such
contact.
(c) Before any
data are released, the investigator will be required to submit to the Director
a signed written statement guaranteeing the following:
(1) The investigator has received written
approval of the research protocol from an Institutional Review Board;
(2) The investigator shall not allow any
person other than those identified in the protocol to access, use, or otherwise
review the data supplied by the monitoring program;
(3) There shall be no deviation from the
protocol without explicit advance review and approval by the Director and the
Institutional Review Board;
(4)
Information obtained in the course of activities undertaken or supported using
the data from the monitoring program shall not be used for any purpose other
than the exact purpose for which it was supplied; and
(5) Any confidential or potentially
identifying information supplied by the monitoring program which is copied or
otherwise transferred shall be destroyed upon completion of the study unless
otherwise stated in the research protocol.
(d) Upon completion of the study, the
investigator shall submit one copy of the completed research paper or abstract
to the Director.
Authority
G.S.
130A-131;
Eff. August 1,
2000;
Pursuant to
G.S.
150B-21.3A, rule is necessary without
substantive public interest Eff. December 20,
2015.
