211 CMR 36.04 - Informed Consent
(1) Before a
carrier may conduct an HIV test, the individual to be tested must give prior
written informed consent to such testing to the carrier , laboratories and blood
testing centers or agents in compliance with the requirements of 211 CMR 36.04.
Such consent shall be based on an understanding by the individual to be tested
that the test is being performed, of the nature of the test, of the persons or
entities which will or may have access to the test results or to which the
results of that test may be disclosed, of the purpose for which the test
results may be used, and of any reasonably foreseeable risks and benefits
resulting from the test.
(2) Such
informed consent shall include, at a minimum, the following disclosures:
(a) The carrier shall provide to the
individual the following information in writing:
1.notification of the purpose(s) of the HIV
test(s), including whether the test is required as a condition of obtaining an
insurance benefit;
2.information
concerning the effect(s) of the test result(s) on the approval of the
application, or the risk classification of the individual ;
3.information explaining HIV and AIDS,
including without limitation, the following:
a.the nature of the HIV test(s), including
the name(s) of the test(s) to be performed, and the degree of reliability of
each of the tests, including the risks of false negative results and false
positive results;
b.the meaning of
the results of the test(s), including the implication of a positive HIV test
result for developing AIDS, a description of HIV and AIDS, its major risk
groups, symptoms, and the potential for adverse psychological effects to the
individual upon being tested and upon learning of a positive test
result;
4.a description
of the carrier 's confidentiality standards and procedures, including full
disclosure of any potential use that may be made of the test results or
HIV-related information about the individual, and the extent to which the
carrier restricts access to such results and information;
5.a complete description of the persons or
entities which may reasonably be expected to have access to the test results or
any other HIV-related information about the individual as permitted under
211 CMR 36.00 and the
purposes for which such results or information would be provided to such
persons or entities;
6.a statement
concerning the availability of free, anonymous or confidential HIV testing,
with the opportunity for both pre-test and post-test counseling;
7.a statement that the individual may wish to
obtain counseling before undergoing the HIV test because of the serious nature
of HIV and AIDS, and that if an individual waits to sign the consent form for
up to 21 days from the date the test was requested by the carrier or insurance
producer, absent changes in underwriting factors, that delay will not prejudice
the application for insurance benefits;
8.a statement that HIV-related information
concerning the individual maintained by the carrier will be available to the
individual directly, or indirectly through a designated physician if preferred
by the individual, upon his or her written request, and at no more than the
reasonable cost of photocopying; and
9.a statement that if the individual believes
that his or her rights concerning the confidentiality of HIV-related
information have been violated he or she may contact the Division of Insurance.
(b) The carrier shall
furnish the individual with a copy of the notice of HIV testing and
authorization for testing and disclosure, including the signed and dated
authorization in conformity with the requirements of 211 CMR 36.04.
(3)
Content of the
Authorization. An authorization form must contain the following
minimum information:
(a) that the
authorization to conduct an HIV test is valid for a period of not longer than
90 days after the date on which the informed consent form is signed, or for
such lesser period as the carrier may select;
(b) a description of the test protocol,
including the name(s) of the test(s) to be performed, the laboratory or
laboratories which will conduct the test or which customarily conduct such
tests for the carrier , the carrier which will receive the test results, and the
purpose(s) of the test(s);
(c) a
statement that the test results will not be released to any person or entity
other than those described in the consent form (which persons and entities
shall consist only of those persons or entities to which release of such
confidential medical information is lawful), unless the carrier obtains the
specific prior written consent of the individual, which consent may not be
sought in this consent form; further, any statement that information will be
shared with the MIB or any other insurance support organization must describe
that organization, its policy of disclosure to other carriers, its policy
concerning consumer access to information and the process by which consumers
can correct inaccurate information, and include that organization's address and
telephone number;
(d) a statement
that HIV-related information will be disclosed only to persons and entities for
which prior written informed consent to the release has been given, and that in
the event of such a release of HIV-related information concerning the
individual to any person or entity other than the carrier , its employees,
reinsurers, attorneys, and contractors solely on a need to know bases for use
for underwriting, claims or another business purpose in connection with the
insurance transaction, or any insurance support organization, the carrier will
notify the individual in writing of the name and address of such person or
entity, and subject to 211 CMR 36.04(3)(e), upon the request of the individual ,
will promptly provide to the individual a copy of the information released at
no more than the reasonable cost of photocopying; and
(e) a description of the methods by which the
carrier shall notify the individual of a positive HIV test result, and the time
period, which shall be as expeditiously as possible, but in no event later than
45 days after the individual's blood sample is taken, by which such test
results will be conveyed in accordance with
211 CMR
36.05. The description shall offer the
individual the option to receive the information from a physician he or she
designates on the form, or directly from the carrier , and shall inform the
individual that such information sent to the physician may become part of the
physician's permanent medical record concerning that individual. The individual
may change his or her election by so informing the carrier in
writing.
(4) A carrier
shall use a notice of HIV testing and authorization for testing and disclosure
form that contains at a minimum the information specified in 211 CMR 36.04(2)
and (3). Copies of all such forms shall be retained on file by the carrier and
shall be available to the Division upon its request.
Notes
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