THE GENETIC PRIVACY ACT

Sec. 121. IDENTIFICATION OF DEAD BODIES

Notwithstanding any other provisions of this Act, a person may provide access to an individually identifiable DNA sample, or to data derived from DNA typing, to assist in the identification of a dead body, provided further that the analysis of any sample so provided and the analysis of a DNA sample from the dead body is limited to that which is necessary to determine the identity of the dead body.

Sec. 122. IDENTIFICATION FOR LAW ENFORCEMENT PURPOSES

Nothing in this Act shall be construed to prohibit federal, state or local law enforcement authorities from collecting, storing or typing DNA samples, when:

(a) the collection, storage and typing of DNA samples is authorized under federal or state law;

(b) collection, storage and typing of such samples is limited to the purpose of matching DNA samples in criminal investigations; and

(c) access to such DNA samples is limited to authorized law enforcement agencies, prosecutors, defense counsel, defendants, accused individuals, suspects, and their authorized agents.

Sec. 123. COLLECTION AND ANALYSIS OF DNA SAMPLES PURSUANT TO COURT ORDERED ANALYSIS

(a) IN GENERAL.-- Nothing in this Act shall be construed to prohibit the collection or analysis of an individually identifiable DNA sample pursuant to Rule 35 of the Federal Rules of Civil Procedure or comparable rules of other courts or administrative agencies in connection with litigation or proceeding to which the sample source is a party and in which the genetic condition of the sample source has been placed at issue, provided that the conditions in section (b) have been met.

(b) ISSUANCE OF ORDERS. -- An order under Rule 35 of the Federal Rules of Civil Procedure or comparable rules may only be made:

(1) upon motion for good cause shown and upon notice to the sample source or the sample source's representative and all parties; and

(2) the order must specify:

(A) the manner of collection of the DNA sample;

(B) the person or persons authorized to collect and analyze the sample;

(C) the purpose of the genetic analysis;

(D) that the genetic analysis is limited to that which is necessary to fulfill the purpose of the order; and

(E) that the person conducting the analysis destroy the sample at the earliest possible opportunity consistent with the purpose of that order.

PART D - - RESEARCH ACTIVITIES

Sec. 131. RESEARCH INVOLVING GENETIC ANALYSIS

(a) CONDITIONS FOR A GENETIC ANALYSIS. -- Except as provided in section 133 no individually identifiable DNA sample shall be analyzed as part of a research project unless an Institutional Review Board has determined that:

(1) use of individually identifiable DNA samples is essential to the research project;

(2) the potential benefit of the research project outweighs the potential risks to the subjects including psychosocial risks and intrusion into the privacy of the subjects that would result from analysis of individually identifiable samples;

(3) the research protocol

(A) contains adequate safeguards to protect against disclosure of private genetic information that is generated by the research;

(B) requires that research subjects will be given the applicable information set forth in section 101 of this Act in addition to the informed consent requirements contained in 45 CFR 46.116 (1992) as such regulation may be amended;

(C) requires the written authorization of research subjects that includes the applicable requirements of section 103 of this Act; and

(D) prohibits inclusion of research records in medical records unless the sample source or the sample source's representative authorizes such inclusion in writing.

(b) SAFEGUARDS AGAINST DISCLOSURES OF PRIVATE GENETIC INFORMATION. -- For purposes of subparagraph (3)(A) of subsection (a) of this section, adequate safeguards against disclosure of private genetic information include but are not limited to:

(1) obtaining a certificate of confidentiality from the Secretary of Health and Human Services as provided in 42 U.S.C.  241(d) as such statute may be amended;

(2) ensuring that research subjects will not be identifiable in any report or publication which results from the research; and

(3) having procedures to remove or destroy at the earliest opportunity consistent with the purposes of the project, information that would enable a sample source to be identified.

(c) FURTHER LIMITATIONS ON RESEARCH INVOLVING INDIVIDUALS UNDER 18. -- No research shall be conducted on individually identifiable DNA samples when the sample source is under 18 years of age unless:

(1) a parent or guardian is given the applicable information set forth in section 101 of this Act;

(2) a parent or guardian executes an authorization that includes the applicable requirements of section 103 of this Act and which specifically states that the parent or guardian understands and agrees that unless the analysis reveals a genetic condition which in reasonable medical judgment can only be effectively ameliorated, prevented or treated while the sample source is under 18 years of age, the results of the analysis will not be disclosed to the parent or guardian of the sample source; and

(3) any provisions for soliciting the assent of minors as contained in 45 CFR  46.408 as such regulation may be amended which the Institutional Review Board determines to be applicable are met.

(d) DESTRUCTION OF DNA SAMPLES OR IDENTIFIERS.

(1) GENERALLY.-- In the absence of a specific authorization to maintain an individually identifiable DNA sample, individually identifiable DNA samples collected, stored or analyzed in connection with a research project shall be destroyed upon completion of the project or withdrawal of the sample source from the project, whichever occurs first.

(2) EXCEPTION.-- Whenever the authorization for collection, storage or analysis of an individually identifiable DNA sample does not contain a prohibition against research use of the sample when it is no longer linked to any individual identifier, the person in possession of the sample may destroy all individual identifiers linking the sample to the sample source instead of destroying the sample as required by subsection (1).

(e) PEDIGREE ANALYSIS AND FAMILY LINKAGE STUDIES. -- When a research project includes analysis of DNA from family members for pedigree analysis or linkage analysis--

(1) the Institutional Review Board, in addition to making the determinations required in subsection (a) of this section, shall also require--

(A) that education and counseling regarding how pedigree analysis is conducted and the kind of information that results from such analysis is provided to research subjects;

(B) that as far as practicable separate records are maintained on each subject.

(2) Prior to their participation, and in addition to the disclosures required by section 101 of this Act, subjects shall be--

(A) informed that one risk of their participation is that by the end of the project other family members may learn private genetic information about them;

(B) informed of what will be done with records and data generated during the project;

(C) informed that the project may determine that some members of their family are not genetic relatives.

(f) SUBJECTS RIGHT TO OBTAIN INFORMATION. -- When complying with the provisions of section 113 of this Act, no person shall provide an individual in the pedigree with private genetic information about another person without that other person's authorization.

(g) USE OF UNIDENTIFIABLE DNA SAMPLES NOT PROHIBITED. -- Nothing in this Act shall be construed as prohibiting or limiting research on a DNA sample that cannot be linked to any individual identifier.

Sec. 132. DISCLOSURE OF PRIVATE GENETIC INFORMATION FOR RESEARCH PURPOSES

(a) IN GENERAL. -- Any person who, in the ordinary course of business, practice of a profession, or rendering of a service, stores or maintains private genetic information is prohibited from allowing access to such information to researchers unless:

(1) an Institutional Review Board has approved the conduct of the research program or study; and

(2) the sample source or the sample source's representative has specifically consented to the access or disclosure of such information in an authorization that meets the requirements of section 112 of this Act.

(b) LIMITED ACCESS FOR STATISTICAL USE. -- Notwithstanding the provisions of subsection (a), a person who stores or maintains private genetic information may grant access to such information solely for the purpose of inspection or review of records containing the information provided that

(1) the inspection or review is for the purpose of compiling data for statistical or epidemiological studies and private genetic information is not to be copied, removed from the records, or redisclosed in any way; and

(2) the person conducting the inspection or review certifies in writing:

(A) that these limitations will be complied with; and

(B) to an awareness of their liability for violations of this Act.

Sec. 133. EXCEPTION FOR DNA SAMPLES PREVIOUSLY COLLECTED FROM DECEASED PERSONS

(a) ANALYSIS PERMISSIBLE. -- Notwithstanding the provisions of section 131, an individually identifiable DNA sample which was collected from a sample source who died prior to the effective date of this Act may be analyzed as part of a research project, but no individually identifiable genetic information may be disclosed without the authorization of the sample source's representative.

(b) DISCLOSURE TO RELATIVES. -- If the analysis of a DNA sample permitted by subsection (a) determines that a relative of a deceased sample source is at risk for a genetic disease which in reasonable medical judgment can be effectively ameliorated, prevented, or treated, nothing in this Act shall be construed as prohibiting researchers from contacting such relatives and informing them of such risk provided that private genetic information about the sample source is not disclosed.

PART E - - MINORS AND INCOMPETENT PERSONS

Sec. 141. AUTHORIZATION FOR COLLECTION AND ANALYSIS OF DNA FROM MINORS

(a) INDIVIDUALS UNDER 16. -- Except as provided in sections 131(c) and 151, the individually identifiable DNA sample of a sample source who is under 16 years of age shall not be collected or analyzed to determine the existence of a gene that does not in reasonable medical judgment produce signs or symptoms of disease before the age of 16, unless:

(1) there is an effective intervention that will prevent or delay the onset or ameliorate the severity of the disease; and

(2) the intervention must be initiated before the age of 16 to be effective; and

(3) the sample source's representative has received the disclosures required by section 101 of this Act and has executed a written authorization which meets the requirements of section 103 of this Act and which also limits the uses of such analysis to those permitted by this section.

(b) INDIVIDUALS AGE 16 OR 17. -- Except as otherwise provided in sections 131(c) and 143, the individually identifiable DNA sample of a sample source who is 16 or 17 years of age may be collected and analyzed provided that--

(1) the sample source receives the information required by section 101 of this Act while accompanied by a parent or other adult family member; and

(2) the sample source executes a written authorization which meets the requirements of section 103 of this Act.

(c) DESTRUCTION OF DNA SAMPLES OF INDIVIDUALS UNDER 16. -- A sample source's representative may, on behalf of a sample source who is under 16 years of age, order the destruction of a DNA sample collected pursuant to subsection (a) of this section.

Sec. 142. AUTHORIZATION FOR DISCLOSURE OF PRIVATE GENETIC INFORMATION ABOUT INDIVIDUALS AGE 16 OR 17

(a) AUTHORIZATION REGARDING INDIVIDUALS. -- Except as provided by section 144, private genetic information about an individual who is age 16 or 17 shall not be disclosed unless the sample source has executed a written authorization which meets the requirements of section 112.

(b) AUTHORIZATION REGARDING INDIVIDUALS UNDER 16. -- Except as provided in section 152, private genetic information about a minor who is under 16 years of age shall not be disclosed unless a parent or other sample source's representative has executed a written authorization that meets the requirements of section 112.

Sec. 143. AUTHORIZATION FOR COLLECTION AND ANALYSIS OF DNA SAMPLES FROM INCOMPETENT PERSONS

(a) LIMITATIONS ON COLLECTION AND ANALYSIS. -- The individually identifiable DNA sample of a sample source who lacks the ability to understand the information disclosed pursuant to section 101 and the information contained in an authorization under section 103 shall not be collected or analyzed unless--

(1) the analysis is necessary:

(A) to diagnose the cause of incompetence; or

(B) to diagnose a genetic condition which in reasonable medical judgment can only be effectively ameliorated, prevented or treated while the sample source is incompetent; or

(C) to diagnose a genetic disease of a parent, sibling, child or grandchild of the sample source provided that the disease in reasonable medical judgment can be effectively ameliorated, prevented, or treated;

(2) the analysis is limited to that which is necessary for such diagnosis; and

(3) the sample source's representative has executed an authorization which meets the requirements of section 103 of this Act.

(b) DESTRUCTION OF SAMPLES COLLECTED PRIOR TO INCOMPETENCY. -- Whenever a sample source while competent has, either in an authorization under section 103 of this Act, or in an exercise of the sample source's rights under section 104(b) of this Act, ordered the destruction of a DNA sample, and the sample source becomes incompetent before the occurrence of the date or event which was designated by the sample source to cause the destruction of such sample, the sample source's representative may order the earlier destruction of such sample, but is not empowered to cancel or override any such destruction unless the postponement of the destruction is to enable an analysis of the DNA sample for a purpose provided for in subsection (a) of this section.

Sec. 144. AUTHORIZATION FOR DISCLOSURE OF PRIVATE GENETIC INFORMATION ABOUT INCOMPETENT PERSONS

Private genetic information about an incompetent person shall not be disclosed unless:

(a) the information--

(1) is necessary for the diagnosis of a genetic condition which in reasonable medical judgment is effectively ameliorated, prevented or treated while the person is incompetent; or

(2) is necessary for the purpose of genetic counselling for a relative of the person;

(b) the information disclosed is limited to that which is necessary to conduct such treatment or counselling; and

(c) the sample source's representative executes an autho-rization that meets the requirements of section 112 of this Act.

PART F - - PREGNANT WOMEN, FETUSES, AND EXTRACORPOREAL EMBRYOS

Sec. 151. AUTHORIZATION FOR COLLECTION AND ANALYSIS OF DNA FROM PREGNANT WOMEN AND FETUSES

Regardless of her age, a pregnant woman shall have all the rights and authority of an adult sample source in regard to her DNA sample and the DNA sample of her fetus unless she is otherwise incompetent under the provisions of section 143.

Sec. 152. AUTHORIZATION FOR DISCLOSURE OF PRIVATE GENETIC INFORMATION ABOUT PREGNANT WOMEN AND FETUSES

Regardless of her age, a pregnant woman shall have all the rights of an adult sample source in regard to records containing private genetic information as provided in section 113, 114, and 115 of this Act, and in regard to disclosure of genetic information resulting from an analysis of her DNA sample or the DNA sample of her fetus, unless she lacks the ability to understand the information contained in an authorization under section 112.

Sec. 153. AUTHORIZATION FOR COLLECTION AND ANALYSIS OF DNA FROM EXTRACORPOREAL EMBRYOS

(a) RELINQUISHMENT OF DONOR'S RIGHTS. -- Whoever donates a gamete for the reproductive purposes of a person or persons other than the gamete donor relinquishes all rights regarding the collection and analysis of a DNA sample of an embryo subsequently created using the donated gamete.

(b) CONDITIONS FOR COLLECTION AND ANALYSIS. -- Prior to the collection and analysis of a DNA sample from an extracorporeal embryo created for reproductive purposes, the person collecting or causing to be collected the DNA sample of such embryo shall:

(1) make the disclosures required by section 101 of this Act to the person or persons who intend to use the embryo for reproduction; and

(2) shall obtain the written authorization of such person or persons that meets the requirements of section 103 of this Act.

(c) DISCLOSURE OF RESULTS. -- The results of a genetic analysis of a DNA sample of an extracorporeal embryo shall be disclosed to the person or persons who intend to use the embryo for reproductive purposes.

Proceed to next section.

File posted May 1995.

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