SF 1478

1st Engrossment - 86th Legislature (2009 - 2010) Posted on 02/09/2010 02:21am

A bill for an act
relating to health; changing provisions for handling genetic information from
newborn screening; requiring a report; amending Minnesota Statutes 2008,
sections 13.386, subdivision 3; 144.125, subdivision 3.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2008, section 13.386, subdivision 3, is amended to read:

Subd. 3.

Collection, storage, use, and dissemination of genetic information.

new text begin (a)
new text end Unless otherwise expressly provided by law, genetic information about an individual:

(1) may be collected by a government entity, as defined in section 13.02, subdivision
7a, or any other person only with the written informed consent of the individual;

(2) may be used only for purposes to which the individual has given written
informed consent;

(3) may be stored only for a period of time to which the individual has given written
informed consent; and

(4) may be disseminated only:

(i) with the individual's written informed consent; or

(ii) if necessary in order to accomplish purposes described by clause (2). A consent
to disseminate genetic information under item (i) must be signed and dated. Unless
otherwise provided by law, such a consent is valid for one year or for a lesser period
specified in the consent.

new text begin (b) Notwithstanding paragraph (a), the Department of Health's collection, storage,
use, and dissemination of genetic information and blood specimens for testing infants for
heritable and congenital disorders are governed by sections 144.125 to 144.128.
new text end

Sec. 2.

Minnesota Statutes 2008, section 144.125, subdivision 3, is amended to read:

Subd. 3.

deleted text begin Objection of parents to test deleted text end new text begin Information provided to parents new text end .

deleted text begin Persons
with a duty to perform testing under subdivision 1 shall advise parents of infants (1) that
the blood or tissue samples used to perform testing thereunder as well as the results of
such testing may be retained by the Department of Health, (2) the benefit of retaining the
blood or tissue sample, and (3) that the following options are available to them with
respect to the testing: (i) to decline to have the tests, or (ii) to elect to have the tests but to
require that all blood samples and records of test results be destroyed within 24 months
of the testing. If the parents of an infant object in writing to testing for heritable and
congenital disorders or elect to require that blood samples and test results be destroyed,
the objection or election shall be recorded on a form that is signed by a parent or legal
guardian and made part of the infant's medical record. A written objection exempts an
infant from the requirements of this section and section 144.128.
deleted text end

new text begin (a) Prior to collecting a sample, persons with a duty to perform testing under
subdivision 1 must provide parents or legal guardians of infants with a document that
provides the following information:
new text end

new text begin (1) the blood sample will be used to test for heritable and congenital disorders, the
blood sample will be retained by the Department of Health for a period of at least two
years and that the blood sample may be used for public health studies and research;
new text end

new text begin (2) the data that will be collected as a result of the testing;
new text end

new text begin (3) the alternatives available to the parents set forth in paragraph (b) and that a form
to exercise the alternatives is available from the person with a duty to perform testing
under subdivision 1;
new text end

new text begin (4) the benefits of testing and the consequences of a decision to permit or refuse
to supply a sample;
new text end

new text begin (5) the benefits of retaining the blood sample and the consequences of a decision to
destroy the blood sample after two years or to permit or decline to have the blood sample
used for public health studies and research;
new text end

new text begin (6) the ways in which the samples and data collected will be stored and used at the
Department of Health and elsewhere; and
new text end

new text begin (7) the Department of Health's Web site address where the forms referenced in
paragraph (b) may be obtained.
new text end

new text begin This document satisfies the requirements of section 13.04, subdivision 2.
new text end

new text begin (b) The parent or legal guardian of an infant otherwise subject to testing under this
section may object to any of the following:
new text end

new text begin (1) the testing itself;
new text end

new text begin (2) the maintenance of the infant's blood samples and test result records for a period
longer than 24 months; and
new text end

new text begin (3) the use of the infant's blood samples and test result records for public health
studies and research.
new text end

new text begin If a parent or legal guardian elects one of the alternatives, the election shall be recorded
on a form that is signed by the parent or legal guardian. The signed form shall be made
part of the infant's medical record and shall be provided to the Department of Health. The
signature of the parent or legal guardian is sufficient and no witness to the signature, photo
identification, or notarization shall be required. When a parent or legal guardian elects
an alternative under this subdivision, the Department of Health must follow the election
and section 144.128. A written election exempts an infant from the requirements of this
section and section 144.128.
new text end

new text begin (c) For purposes of this subdivision, "public health studies and research" includes
calibrating newborn screening equipment, evaluating existing newborn screening tests to
reduce the number of false positive and false negative results, studying the development
of new newborn screening tests for heritable and congenital disorders, and other
population-based health studies.
new text end

Sec. 3. new text begin NEWBORN SCREENING REPORT.
new text end

new text begin By January 15, 2010, the Department of Health shall report and make
recommendations to the legislature on its current efforts for ensuring and enhancing how
parents of newborns are fully informed about the newborn screening program and of their
rights and options regarding: (1) testing; (2) storage; (3) public health practices, studies,
and research; (4) the ability to opt out of the collection of data and specimens related to
the testing; and (5) the ability to seek private testing.
new text end