Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Criteria.
The commissioner of health may enter into contracts to conduct
research, using data collected pursuant to parts 4606.3300 to 4606.3309, with
public and private research agencies or with individuals who satisfy all of the
following criteria:
A. the research
proposed to be conducted will assist in improving the diagnosis, treatment, or
prevention of cancer and the public health;
B. there is documented evidence that the
principal investigator for the research proposed is qualified:
(1) by having attained the degree of medical
doctor, doctor of dental surgery, doctor of science, doctor of philosophy, or
equivalent degree from an accredited college or university; and
(2) by specific academic graduate level
training in epidemiology, biomedical research or biometry, or documented
evidence of biomedical or related medical research experience; and
C. there is a written protocol
which includes but is not limited to a complete description of:
(1) the proposed scientific research
hypotheses;
(2) the purpose of the
proposed research;
(3) the specific
methodologies, including data required from the commissioner, to be used in
conducting the research and testing of scientific hypotheses;
(4) the projected or anticipated result of
the research;
(5) the period of
time during which the proposed research will be conducted and when a final
report will be completed;
(6) the
physical facilities to be employed in conducting the research; and
(7) the methods to be used to assure that
privacy of data is maintained in accordance with state law, and that access to
private, nonpublic data is limited to those authorized by the commissioner to
have access.
Subp.
2.
Release of information.
Under no circumstances will researchers be provided access to
personal identifiers that would allow contact of a patient without attempting
to obtain physician consent as described in part 4606.3306. The following
personal identifiers will not be released:
A. last name;
B. first name;
C. middle name or initial;
D. address;
E. county of residence; or
F. social security number.
No researcher operating under contractual agreement with the
commissioner as described in subpart 1 shall release any personal identifier,
mark, or description obtained during an investigation that could be used for
identification of an institution, a physician, or an individual who is or was
the subject of a case report required in part 4606.3303.
Subp. 3.
Evaluation of
proposals.
The commissioner shall evaluate proposals based upon the
criteria in items A to E.
A. The
proposed research has social and scientific merit that is directed primarily
toward improving the diagnosis, treatment, defining of risks, or prevention of
cancer.
B. All coinvestigators are
qualified to undertake the proposed research by means of specific academic
training or demonstrable, related experience in epidemiology, medical,
biomedical, or statistical research.
C. The hypotheses to be tested are explicit,
and are determined to be researchable and feasible by the scientific peer
review committee described in subpart 4.
D. The methods proposed for testing the
hypothesis clearly define:
(1) the population
or cancers to be studied;
(2) the
type and amount of data to be collected;
(3) the source of the data;
(4) the procedures for collecting and
maintaining the data; and
(5) the
specific measurement techniques to be employed in analysis of data, including
discussion of: major variables, statistical methods, methods of testing data
reliability and validity, and required levels of accuracy, precision, or
completeness of the data to be collected.
E. The results of this study will be
interpreted so that the findings can be used or generalized to other
populations and provide a timely, substantive, and important contribution to
the understanding of cancer diagnosis, treatment, or prevention in
Minnesota.
Subp. 4.
Scientific peer review committee.
To assist in evaluating the scientific merits of proposals for
research, the commissioner may appoint up to seven scientists to conduct
scientific peer review who are qualified by having:
A. attained the degree of medical doctor,
doctor of science, doctor of philosophy, or equivalent degree from an
accredited college or university;
B. specific training in medicine,
epidemiology, cancer research, or biometry from an accredited college or
university; and
C. two or more
years of applied experience in epidemiology, medical research, biomedical
research, or biometry.
Statutory Authority: MS s
144.05;
144.671
to
144.69
