COLLECTION AND ANALYSIS OF DNA SAMPLES Sec. 101. COLLECTION OF DNA SAMPLES
(a) REQUIREMENT OF WRITTEN AUTHORIZATION. -- Except as otherwise provided in sections 121, 122, and 123, no person may collect or cause to be collected an individually identifiable DNA sample for genetic analysis without the written authorization of the sample source or the sample source's representative.
This section sets forth the general prohibition against collection of identifiable DNA samples without the written authorization of the sample source or that person's representative. In addition, this section requires that particular information be verbally communicated before an authorization is obtained. These requirements are designed to foster a knowledgeable and voluntary decision to proceed with the collection and analysis of a DNA sample. A perfunctory recitation should be discouraged, despite the fact that mere delivery of the information would technically satisfy the requirement of this section. Those who collect DNA samples should be encouraged to expand upon the minimum information required by providing additional information they believe to be beneficial to individuals who plan to have their DNA analyzed.
The information that must be provided under this Act is similar to the kind of information that must be disclosed before obtaining consent for diagnostic tests that reveal highly private and sensitive information. For example, several state laws require that anyone undergoing an HIV test must first be told about the information that the test can yield, the reliability of the test, and how the information can be used by the individual that is tested, in addition to how the information may be used by others who become aware of it. Such requirements are warranted because, if disclosed, information on HIV status could result in economic, social or psychological harm. Similarly, genetic information may be used to preclude the sample source from obtaining an economic or social service benefit.
Disclosure of genetic information can also have a harmful effect because it can also indicate the presence or absence of a stigmatizing condition or disease. The sample source should therefore be told that others may ask if the sample source has had a DNA analysis, and the results obtained.
An additional disclosure, required by section 101(b)(8), is intended to address the fact that the results of genetic analysis can reveal that others are likely to be affected by the same genetic condition or disease as the individual whose DNA is to be analyzed. This section, therefore, also requires that the person be informed:
that the genetic analysis may result in information about the sample source's genetic relatives which may not be known to such relatives but could be important and if so the sample source will have to decide whether or not to share the information with relatives.
DNA analysis may reveal that other relatives are likely to be gene carriers, to have a gene that codes for disease, or to be predisposed to developing a particular disease or condition by reason of their genetic relationship to the sample source. In effect, the uncollected DNA of family members is indirectly analyzed. This aspect of genetic analysis raises questions about whether such family members should be told about their possible risks and if so, by whom and how? One suggestion is that access to genetic testing in some circumstances be made conditional on a prior agreement to disclose information to other family members who become identified as at risk. This suggestion, however, has not been widely supported for several reasons, including the fact that it would deter individuals from seeking information about themselves.
Creating either a contractual or statutory obligation for individuals to share such information with their family members would be not only unprecedented, but inadvisable. The creation of new substantive rights or duties of family members is not our intention and is beyond the scope of this Act. However, because the Act creates rules that govern the use and disclosure of information, it is imperative that individuals be informed of the fact that by seeking genetic information about themselves through genetic analysis, they may also become privy to information about other family members who would also want and/or need such information. A person seeking genetic analysis will not always be able to anticipate the nature of the information that can result and must therefore be informed of this possibility before the analysis is authorized. While it will be an individual choice as to whether or not to share that information with others, this disclosure should instigate discussion between the sample source and the collector of the sample.
For example, if as a result of the analysis of the DNA of the sample source it could be determined that the person's sibling is also the carrier of a genetic condition, and could pass the condition to offspring, or could suffer in the future from a genetic condition that can be ameliorated or treated, the sample source must be informed that he or she will have to decide whether or not to share that information with the sibling once the results are known. Despite the absence of a legal obligation to do so, the sample source should be encouraged out of moral obligation to share as much of the information as would provide the sibling, or other relatives, with the opportunity to obtain information about their own condition or risk. Since this is a foreseeable and a relatively common burden resulting from DNA analysis, its disclosure is necessary. This issue is discussed in more detail in the Appendix.
Availability of genetic counseling can also provide the sample source with help in deciding how and when to initiate discussion with relatives, and in determining how much information about their own status they are comfortable sharing with others. Consequently, in addition to disclosing the nature and scope of the information that the analysis will produce, section 101(b)(11) requires that the person who collects the sample must provide information on the availability of such counseling. This requirement can be fulfilled by telling the individual about the existence of genetic counselors whose expertise is to help individuals understand what genetic information that can be derived from DNA analysis means, and plan in light of such information. The person could suggest how a genetic counselor could be located by those who decide a consultation would be desirable. The person collecting the sample is not, however, required to provide such counseling, nor would they be obligated to take any steps to ensure that the individual is referred to a specific counselor.
This limited requirement will not be burdensome, since it would be rare for anyone who regularly collects and analyzes DNA samples not to have information about genetic counseling services. Research and clinical programs that conduct DNA analysis often utilize such services, receive references from such services or at least recommend that subjects or patients take advantage of the assistance counselors can give. Anyone collecting and analyzing DNA samples as a regular part of their business or practice should have some awareness of this emerging field, and requiring some discussion about the availability of genetic counseling is consistent with present practices of many programs.
This requirement is supported by the recommendations of other experts who have studied the effects of genetic information. Research and experience with Huntington Disease linkage studies and other genetic testing has demonstrated that pre-test counseling as well as post-test counseling is needed for those who face the choice of having DNA analyzed and the possibility of sharing such information with others. Test results can have an impact, not only on the self perception of the individual who has been tested, but on family relationships as well. Particular attention has been focused on the effect of information about the inheritance of this disease on family relationships and personal identity. Although Huntington Disease is an extreme example because the disease itself is devastating, it presents issues that are typical in genetic testing and analysis.
Sec. 102. ANALYSIS OF DNA SAMPLES
(a) ANALYSIS PROHIBITED WITHOUT AUTHORIZATION. - Except as otherwise provided in sections 121, 122 and 123, genetic analysis of an individually identifiable DNA sample is prohibited unless specifically authorized in writing by the sample source or the sample source's representative.
(b) ASCERTAINMENT OF AUTHORIZATION. - No person may analyze an individually identifiable DNA sample without ascertaining that written authorization for the analysis has been obtained.
This section prohibits conducting any analysis of an individually identifiable DNA sample without specific written authorization. When DNA is collected in a clinical setting for diagnosis of disease or determination of an appropriate course of treatment, the collection process will not differ from taking blood or other specimens for other types of testing or screening. Consequently, the collection of a sample may begin with a physician ordering that the sample be taken by other personnel, such as a phlebotomist, and sent to a lab for analysis. Under the provisions of the Act, even if the physician is the one responsible for informing the sample source and obtaining the written authorization, if he fails to do so, a laboratory may not proceed with conducting the analysis. This is because section 102(b) prohibits DNA analysis, unless the person conducting the analysis ascertains that the authorization has been obtained. If they fail to do so, they, as well as the person who initiated collection of the sample without written authorization, face the penalties for noncompliance with the statutory requirements. How this "person" verifies that the authorization has been obtained is, however, not dictated by the statute, but will be governed by the person's own administrative policies and procedures.
This section does not require the phlebotomist who draws blood under orders from a physician, or a lab technician who receives a sample for analysis to obtain the sample source's consent. This would be unrealistic and disruptive to established roles and protocols in which the collection or analysis of DNA might take place. Instead, the Act requires everyone to refrain from proceeding with their role in the process until proper authorization has been obtained.
This section does not describe these responsibilities as applying to specific personnel because, in the future, collection and analysis of DNA samples might take place outside a clinical setting, such as a commercial facility or free standing laboratory, where the person collecting samples is not a health care professional. DNA can be extracted from different kinds of specimens, including strands of hair, so collecting a DNA sample does not always involve technical medical skills or knowledge. These requirements are applicable to all collection situations and mandate that the necessary disclosures are made and written authorization is obtained from all sample sources. Since these responsibilities have been delegated to the "person" who collects the sample or causes the sample to be collected, and to the "person" who performs an analysis, regardless of whether the facility in which this takes place is a health care facility, this "person" will have to establish procedures and protocols to ensure compliance with these requirements. The effect of the Act should be the same in all instances and settings, regardless of who ultimately obtains the written authorization.
Compliance with the rules in sections 101 and 102 prevents secret collection and analysis of DNA and ensures that before an individual authorizes an analysis he or she should know: why the analysis is being suggested, required or recommended; what information will likely result from the analysis; how the information can be useful to them; and that genetic counselors can be consulted for help in making a decision to go ahead with an analysis, or in understanding the results of the analysis.
Sec. 103. AUTHORIZATION FOR COLLECTION AND STORAGE OF INDIVIDUALLY IDENTIFIABLE DNA SAMPLES FOR GENETIC ANALYSIS
(b)RETENTION OF AUTHORIZATION. -- The authorization for the collection and analysis of an individually identifiable DNA sample shall be retained at least as long as the DNA sample is retained.
(c)COPY. -- A copy of the authorization shall be provided to the sample source or the sample source's representative.
An authorization which includes the details set forth should facilitate compliance with the requirements and goals of section 101. Any forms which are drafted to meet the requirements of this section should contain clear language and not undermine the purposes or process of obtaining informed authorization. Those who develop authorization forms are urged to include additional details and information that they believe to be helpful.
The person who collects the sample, the person who will analyze the sample, and the person who will store the DNA sample, must all be identified in the authorization [section 103(a)(2)-(4)]. Because the individual has the right to order the destruction of a DNA sample that has been collected [section 104(b)] and to inspect records containing information that results from an analysis [section 113], it is important for the individual to know who is, or may be, in possession of the DNA sample and the information that is developed through analysis.
The form must also indicate the manner in which the sample will be collected, describe all authorized uses of the sample, and indicate whether or not the sample source permits storage of the individually identifiable sample after the analysis is completed. [section 103(a)(5)-(8)] These requirements are intended to give the individual maximum control over their DNA. They also provide a mechanism for documenting that authorization to conduct particular tests, or to store samples for a specific period of time, has been obtained.
Finally, the authorization must allow for the inclusion of a prohibition against use of the sample, even in non-identifiable form, for research or commercial use so that individuals who want to prohibit such use can do so. Because individuals have different attitudes toward supporting or participating in research or commercial ventures that utilize human DNA, this provision accommodates the expression of such differences. Admittedly, the Act does not restrict the use of DNA samples which are not linked to any individual identifiers and tracking the use of a sample which is no longer identifiable should be impossible. Consequently, it is not likely that a violation of this directive could be uncovered and inclusion of this item in an authorization form may be more symbolic than effective.
Sec. 104. OWNERSHIP AND DESTRUCTION OF DNA SAMPLES
(a)OWNERSHIP OF THE DNA SAMPLE. - An individually identifiable DNA sample is the property of the sample source.
(b)RIGHT TO ORDER DESTRUCTION OF THE DNA SAMPLE. - Except when a DNA sample has been collected pursuant to section 122 or 123 of this Act, the sample source or the sample source's representative shall have the right to order the destruction of the DNA sample.
Some individuals will want to take maximum advantage of the evolving nature of knowledge about the human genome, and will welcome the opportunity to have their DNA collected, stored or analyzed. Others are wary of the potential harm that can result from information derived from genetic analysis, and will want reassurance that they alone control when their DNA is analyzed and who has access to their samples and information. The provisions of this section are intended to preserve the autonomy of all individuals regardless of their varying views on the benefits and dangers of genetic information.
Giving individuals control over their DNA is accomplished first by establishing that an individually identifiable DNA sample is the property of the sample source. Since the sample source has this property right, control of a sample can be transferred to another individual through a will or other legal instrument. Consequently, individuals who do not want their DNA analyzed during their own lifetime may nevertheless have a sample collected and stored for the benefit of others. Descendants to whom control over DNA samples is transferred could thus benefit from future developments in genetics which require analysis of DNA from multiple generations. Until the complete genome is mapped, locating genes through linkage analysis will be dependent upon the availability of such samples. This provision can promote this availability.
In addition to being able to transfer ownership of a sample, the sample source also has the right, except in limited circumstances, to order the destruction of a sample that has been collected. [section 104(b)] This gives those who want to limit the availability of such samples reassurance that once authorized analysis has been completed, the sample itself can be destroyed, preventing any additional unauthorized analysis. In some circumstances, a sample source's representative, such as the parent of a minor, can exercise this right on behalf of the individual from whom the sample has been collected. However, this right is not exercisable by either the sample source or a sample source's representative when samples have been collected for identification use in law enforcement (section 122), or when the sample has been collected pursuant to a court-ordered analysis (section 123). Requiring that the person analyzing such samples destroy them at the direction of a sample source would directly conflict with the compulsory nature of collection and analysis in these situations.
Finally, section 104 provides for routine destruction of DNA samples or removal of identifiers, after the completion of the authorized analysis. This routine destruction can be overridden by the explicit directions of the sample source or the sample source's representative. [section 104(c)] Routine destruction would not result in an irreplaceable loss, since each individual is the source of an abundant supply of DNA samples. If an individual anticipates having a series of analyses conducted, and wants to avoid what is perceived as the inconvenience of collecting multiple samples, the authorization for collection of a specimen containing DNA can include specific directions for storage of the sample for analysis in the future, provided, of course, that storage services are offered by the collector or analyzer.
Sec. 105. NOTICE OF RIGHTS AND ASSURANCES. -- A person who collects or stores DNA samples for genetic analysis shall provide a sample source or a sample source's representative prior to the collection, storage, or analysis of a DNA sample, and any other person upon request, with a notice of rights and assurances that contains the following information and assurances that:
(a)a DNA sample will only be used as authorized in the written authorization;
(b)an individually identifiable DNA sample is the property of the sample source;
(c)unless specifically prohibited by the sample source or sample source's representative, researchers may be granted access to DNA samples that cannot be linked to individual identifiers;
(d)the sample source or the sample source's representative has the right to order the destruction of the individually identifiable DNA sample at any time;
(e)the individually identifiable DNA sample will be destroyed on the completion of the analysis unless the sample source or the sample source's representative has previously directed otherwise in writing;
(f)the sample source can designate another individual as the person authorized to make decisions regarding the individually identifiable DNA sample after the death of the sample source; and if any person is so designated, the sample source should notify the facility in which the DNA sample is stored;
(g)the sample source or the sample source's representative has the right to examine the records containing private genetic information, to obtain copies of such records and to request correction or amendment of them;
(h)private genetic information may be disclosed to researchers who qualify for such access under this Act;
(i)the collection and analysis of the DNA sample and the private genetic information derived from the analysis is protected by this Act, and anyone whose rights under this Act have been violated can seek civil remedies, including damages, as provided in this Act; and
(j)genetic counseling is available.
Individuals who authorize the collection and analysis of their DNA may not be aware of their rights under this Act and therefore be unable to exercise them. To enhance the knowledge of one's rights, this section requires that persons who collect DNA samples provide written notice to the individual when authorization for collection, storage and analysis of the DNA sample is obtained. This notice is similar in function and content to notices of fair information practices required by other informational privacy statutes. However, since the Act has provisions relating to the collection and analysis of samples, in addition to provisions that govern the information that results from such activities, the notice required by section 105 is more inclusive than other information practices.
A notice prepared under this section does not contain contractual assurances, but will consist of a series of statements regarding the legal responsibilities of those who collect, store and analyze samples, and the legal rights of the sample source.
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File posted May 1995.
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