Home   About Us   Contact
 


DELAWARE

http://www.delcode.state.de.us/title16/c012/sc01/index.htm#TopOfPage

TITLE 16
Health and Safety
PART II
Regulatory Provisions Concerning Public Health
CHAPTER 12. INFORMED CONSENT AND CONFIDENTIALITY
Subchapter I. HIV-Related Tests

Re: HIV

§ 1202. Informed consent.

(a) No health facility, health care provider or other person shall test or shall cause by any
means to have tested, any specimen of any patient for HIV-related tests, without the
informed consent of the subject of the test or the subject's legal guardian. A health care
provider shall ensure that informed consent has been received prior to ordering testing by a
laboratory or other facility.

(b) Informed consent to an HIV-related test shall consist of a voluntary agreement executed
by the subject of the test or the subject's legal guardian. If the agreement is oral, the facts
pertaining thereto must be documented by customary practice. Informed consent shall consist
of at least the following:

(1) An explanation of the test, including its purpose, potential uses, limitations and the
meaning of its results;

(2) An explanation of the procedure to be followed, including that the test is voluntary, that
consent may be withdrawn and the extent and limitations of the manner in which the results
will be confidential;

(3) An explanation of the nature of AIDS and other manifestations of HIV infection and the
relationship between the test result and those diseases; and

(4) Information about behaviors known to pose risks for transmission of HIV infection.

(c) Notwithstanding subsection (a) of this section the provisions of subsections (a) and (b) of
this section do not apply when:

(1) Knowledge of such test results are necessary for medical diagnostic purposes to provide
appropriate emergency care or treatment and the subject of the test is unable to grant or
withhold consent.

(2) The testing is done for the purposes of research; provided that the test is performed in a
manner by which the identity of the test subject is not known and may not be retrieved by the
researcher.

(3) A health care provider or health care facility procures, processes, distributes or uses (i)
blood, (ii) a human body part donated for a purpose specified under the Uniform Anatomical
Gift Act [Chapter 27 of this title] or (iii) semen provided prior to July 11, 1988, for the purpose
of artificial insemination, and such test is necessary to assure the medical acceptability of such
gift or semen for the purposes intended.

(4) The health of a health care worker has been threatened during the course of a health care
worker's duties, as a result of exposure to blood or body fluids of the patient in a manner
known to transmit HIV.

(5) Necessary to control the transmission of HIV infection as may be allowed pursuant to
Chapter 7 of this title as it relates to sexually transmitted diseases, or § 6523(b) of Title 11 as
it relates to the Department of Correction.

(6) Testing is ordered by a court of competent jurisdiction within the confines of civil or criminal
litigation where the results of an HIV-related test of a party, or a person in the custody or
under the legal control of another party, is relevant to the ultimate issue of culpability and/or
liability. Said order must be issued in compliance with the following provisions:

a. No court of this State shall issue such order unless the court finds that there is a compelling
need for such test results which cannot be accommodated by other means. In assessing
compelling need, the court shall weigh the need for testing and disclosure of the test results
against the privacy interest of the test subject and the public interest which may be disserved
by disclosure which deters future testing or which may lead to discrimination.

b. Pleadings pertaining to ordering of an HIV-related test shall substitute a pseudonym for the
true name of the subject of the test. The true name shall be communicated confidentially, in
documents not filed with the court.

c. Before granting any such order, the court shall provide the individual whose test result is in
question with notice and a reasonable opportunity to participate in the proceedings if the
individual is not already a party.

d. Court proceedings as to disclosure of test results so ordered shall be conducted in camera
unless the subject of the test agrees to a hearing in open court or unless the court
determines that a public hearing is necessary to the public interest and the proper
administration of justice.

(d) Any person on whom an HIV-related test was performed without first having obtained
informed consent pursuant to subsections (c)(1), (4) and (5) of this section shall be given
notice promptly, personally and confidentially that a test sample was taken and the results of
such test may be obtained upon request.

(e) At the time of learning the test result, the subject of the test or the subject's legal
guardian shall be provided with counseling for coping with the emotional consequences of
learning the result, for understanding the interpretation of the test result, for understanding
measures for preventing infection to others and to urge the voluntary notification of sexual
and needle-sharing partners of the risk of infection.

(f) Notwithstanding any other provision of law, a minor 12 years of age or older may consent
or refuse consent to be a subject of HIV-related testing and to counseling relevant to the
test. The consent or refusal of the minor shall be valid and binding as if the minor had
achieved majority, and shall not be voidable, nor subject to later disaffirmance, because of
minority. (66 Del. Laws, c. 336, § 1; 70 Del. Laws, c. 186, § 1.)

TITLE 16
Health and Safety
PART II
Regulatory Provisions Concerning Public Health
CHAPTER 12. INFORMED CONSENT AND CONFIDENTIALITY
Subchapter II. Genetic Information

http://www.delcode.state.de.us/title16/c012/sc02/index.htm#TopOfPage

Re: Genetic Information

(4) "Informed consent"

a. For the purpose of obtaining genetic information, means the signing of a consent form
which includes a description of the genetic test(s) to be performed, its purpose(s), potential
uses, and limitations and the meaning of its results, and that the individual will receive the
results unless the individual directs otherwise;

b. For the purpose of retaining genetic information, means the signing of a consent form which
includes an description of the genetic information to be retained, its potential uses and
limitations;

c. For the purpose of disclosing genetic information, means the signing of a consent form
which includes a description of the genetic information to be disclosed and to whom.

d. For the purpose of obtaining insurance, there may be a single signing which shall allow the
obtaining, retaining and disclosure of genetic information, which, in addition to the
requirements of paragraphs a. and b. of this subsection, shall:

1. Be written in plain language;

2. Be dated;

3. Name or identify by generic reference the persons authorized to disclose information about
the individual;

4. Specify the nature of the information authorized to be disclosed;

5. Name or identify by generic reference the person to whom the individual is authorizing
information to be disclosed, or subsequently redisclosed;

6. Describe the purpose for which the information is collected;

7. Specify the length of time such authorization shall remain valid; and,

8. Be signed by:

A. The individual;

B. Such other person authorized to consent for such individual, if such individual lacks the
capacity to consent; or;

C. The claimant for the proceeds of an insurance policy. (71 Del. Laws, c. 458, § 2.)

§ 1221. Informed consent required to obtain genetic information.

(a) No person shall obtain genetic information about an individual without first obtaining
informed consent from the individual.

(b) The requirements of this section shall not apply to genetic information obtained:

(1) By a state, county, municipal or federal law enforcement agency for the purposes of
establishing the identity of a person in the course of a criminal investigation or prosecution;

(2) To determine paternity;

(3) Pursuant to the DNA analysis and data bank requirements of § 4713 of Title 29;

(4) To determine the identity of deceased individuals;

(5) For anonymous research where the identity of the subject will not be released;

(6) Pursuant to newborn screening requirements established by state or federal law; or

(7) As authorized by federal law for the identification of persons. (71 Del. Laws, c. 458, § 2.)

 


Copyright 2006-2008 Medical Accountability Network  All Rights Reserved
Technical consultant:
Living Philosophy, LLC
English French German Italian Japanese Spanish Traditional Chinese