MINORS AND INCOMPETENT PERSONS
Sec. 141. AUTHORIZATION FOR COLLECTION AND ANALYSIS OF DNA FROM MINORS
(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.
The collection and genetic analysis of DNA from minors is governed by different standards depending on the circumstances, which fall into these general categories and are summarized in Table 1.
1. Rules that govern genetic analysis in the context of research and which apply to all minors (previously discussed and set forth in section 131);
2. Rules that govern genetic analysis in a non-research context and which apply to minors under the age of 16 [section 141(a)];
3. Rules that govern genetic analysis in a non-research context and which apply to minors age 16 and 17 [section 141(b)]; and
4. Rules that govern genetic analysis of DNA of pregnant minors (sections 151, 152).
The Act forbids the genetic testing of children for conditions that will not be manifested until after the child becomes an adult. This accords with the positions of others who have commented upon this topic. For example, the Institute of Medicine's report on Assessing Genetic Risks states:
Similarly, other commentators have said, "The only justification for doing predictive testing in childhood is if an advantage can clearly be demonstrated for the child.[44] These statements and the prohibition of such childhood testing are controversial because they remove authority from parents who may wish to have their offspring tested.
There are two reasons for this prohibition on the exercise of parental discretion. First, if someone learns that the child is a carrier of a gene that disposes the child to some condition later in life, this finding may subject the child to discrimination and stigmatization by both the parents and others who may learn of this fact. Second, a child's genetic status is the child's private genetic information and should not be determined or disclosed unless there is some compelling reason to do so.
Parents have an enormous amount of discretion and authority when it comes to making child rearing decisions. Indeed, such authority has constitutional dimensions.[45] Parents are given this authority because it is assumed that they will act in the best interests of their children. However, there are social policies that deprive parents of discretion in a number of areas. For example, child labor laws and mandatory education laws forbid parents from sending their young children to work or from withholding basic educational opportunities from their children. Even in circumstances in which parents have a religious objection to mandatory education, the state may require that children receive enough instruction so that children learn basic reading, writing and math skills.[46]
Parents have broad discretion, but not absolute discretion, in making health care decisions for their children. For example, the state may require that children receive certain services, such as vaccination, even over parental objections. When a child is ill parents can choose between alternative suggested remedies and can choose to use no remedies in most cases. However, parents may not refuse to provide children with care that is necessary to sustain the child's life, because in such an instance there can be no argument that the parent is acting in the child's best interest.
Parents also have access to their children's medical records and other medical information as a general rule. This is because parents need to have such access to make informed medical decisions about their children's care. But when parents are not in the position to make health care decisions for their children there is no justification for parents to have access to these records. Thus, when minor children are authorized to make treatment decisions for themselves as a result of emancipation or maturity, their medical records are confidential and their parents are not authorized to obtain access to this private medical information.[47]
It is increasingly recognized that children have rights independent of parent's rights. Thus minor women have a constitutional right to obtain abortions without their parents' consent or knowledge because minors have a constitutional right to privacy.[48] Likewise, minors have a constitutional right to obtain contraceptives without parental involvement.[49] The exercise of these rights by minors is dependent upon their maturity to make the decisions necessary to use these services.
The Act's limitation of parental authorization for genetic testing does not provide minors with decisional rights, but rather provides them with protection from potential harm. In this regard it is similar to the prohibition on parents from consenting to research for their children in which the research presents a risk of harm to the child with no benefit. Not only is such research strictly regulated, there are those who argue that it should be absolutely banned.[50] The further purpose of the limitation of parental authority to authorize collection and analysis is to protect the child's privacy interest in his or her own genetic information. This information will not only exist during the child's minority but will continue to exist when the child becomes an adult. As a result, a parent's curiosity about a child's genetic information should not be sufficient to breach the child's (and later the adult's) privacy interest in this genetic information. If, however, there is sufficient justification, a parent may authorize the collection and analysis of DNA samples. It is for this reason that the Act makes an exception for the collection and analysis of genetic material where it is necessary in order to ameliorate, prevent or treat a condition that will manifest itself prior to the time when the child is authorized to consent to such DNA collection and analysis. This exception enables parents to play their traditional protective role, and provides them with the authority to obtain necessary information when needed for them to act in their child's best interest.[51]
Under the Act 16 and 17 year olds have the same rights as adults in nonresearch settings to authorize genetic analysis [section 141 (b)]. This accords with the increasing recognition that mature minors are entitled to make medical decisions for themselves. Consequently, if a 16 or 17 year old wanted information about carrier status, such screening could be conducted under his or her sole authorization. This information would mostly be relevant to decisions relating to reproduction. Although unlikely, a 16 or 17 year old could seek genetic analysis either prior to becoming pregnant, or in relation to the decision to continue with a pregnancy. Where the young woman is already pregnant, under the Act, no restrictions are placed on her pursuit of such analysis and genetic information regarding herself or her fetus. (sections 151, 152)
In all other nonresearch circumstances, however, the Act requires that the 16 or 17 year old be accompanied by an adult family member at the time that the information required by section 101 (b) is given to him or her. [section 141 (b)(1)] The decision to include an adult family member in this process is not up to the young person, as some state statutes provide regarding abortion counseling.[52] The Act requires an adult's involvement. Although the decision to undergo genetic analysis is a highly personal and private one, it is unlike the decision to continue a pregnancy in that requiring the involvement of a family member does not expose the minor to the same familial repercussions. The goal of this requirement is to provide family support for the minor who is faced with a novel situation which involves obtaining and processing complex information. Since the collector of the sample is likely a stranger, regardless of how skilled this person is in communicating information, he or she may not be aware of, or sensitive to, the burden that such information can place on even a mature minor. A family member will also have a shared interest in protecting family privacy and will be aligned with the minor if issues of disclosure to other family members arise or are anticipated.
The Act does not require the authorization of the adult family member prior to the collection of a sample for analysis. The role of the adult family member in the authorization process is limited to providing support and guidance. The decision not to require dual consent of parent and minor when the minor is 16 or 17 years old is intentional. We want to avoid giving greater deference to the interests of a parent or family member than to the autonomy of the mature minor who seeks genetic analysis. Actual exercise of this authority by a 16 or 17 year old will undoubtedly be rare. In general, those likely to seek such genetic analysis will do so out of a need to know if they are at risk for a specific genetic disease that is known to be present in the family. Unlike adults, 16 and 17 year olds do not generally seek genetic analysis and information in the context of reproductive planning, since few teenage pregnancies are the result of conscious and careful planning.
Sec. 143. AUTHORIZATION FOR COLLECTION AND ANALYSIS OF DNA SAMPLES FROM INCOMPETENT PERSONS
(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.
The question of what tests or procedures can be authorized by a guardian or other legally authorized representative of an incompetent person is not unique to genetics. In the past courts have been asked to determine when consent of a guardian is legally effective in varying circumstances. Several courts have determined that the doctrine of substituted judgment should be applied to effectuate the intentions and preferences of the incompetent individual whenever possible. When such intentions are not known, a decision to authorize or refuse treatment is based on a determination of the best interests of the ward. The rules in this section are consistent with this approach and are intended to prevent exploitation of incompetency to obtain private genetic information about a person.
A person is incompetent for purposes of the Act if the person lacks the ability to understand the information that must be provided under section 101 and the information contained in the authorization [section 143(a)]. The DNA of any individual who is incompetent cannot be collected or analyzed unless the conditions in this section have been met. Such conditions are similar to the restrictions placed on the collection and analysis of the DNA of children because there are similar privacy concerns involved in determining both the best interests of children and incompetent adults whose intentions are unknown.
Consequently, the analysis of the DNA of an incompetent person can only be conducted if it is for one of three permissible purposes. Two are related to the person: for the diagnosis of the cause of incompetence, or the diagnosis of a genetic condition that can be effectively ameliorated, prevented, or treated during the period of incompetency. [section 143(a)(1)(A)] This prevents testing for untreatable genetic conditions (which would have no benefit for the incompetent person), and testing for conditions that do not require intervention during a period of temporary incompetency (which could be postponed until the person can act for themselves).
The third permissible purpose for analysis conducted is for the diagnosis of a particular relative (parent, sibling, child or grandchild) for a disease that can be ameliorated, prevented or treated. [section 143(a)(1)(B)] This purpose was included after examination of instances where courts have applied the best interests standard but nevertheless permitted a guardian to consent to procedures which had no therapeutic benefit for the ward, but significant benefit to another individual. Although reluctant to use substituted judgment as a basis for permitting invasive procedures with no direct benefit to the incompetent person, a few courts have nonetheless done so when an indirect psychosocial benefit to the individual has been demonstrated. Such benefit is typically derived from the continuation of a relationship with an individual who has a significant role in the ward's life and when that individual needs something from the ward in order to survive.[53] This benefit has been identified in cases involving kidney transplants and donation of bone marrow from an incompetent person to a close relative.[54]
In contrast to the procedures involved in such situations, the collection of DNA from an incompetent person itself presents little physical risk and is relatively non-invasive. The risks involved the harm that can come from disclosure of highly personal information, and not risk to the physical well-being of the individual. Balanced against this low risk is the indirect benefit that the person may gain when a relative with whom they have a significant relationship needs the information contained in the DNA of the incompetent person and it can be effectively used to help them. To limit creation of private genetic information about the incompetent person to those circumstances where actual benefit will result, the rule specifies that the information must be needed for the diagnosis of a disease which in "reasonable medical judgment can be effectively ameliorated, prevented, or treated." [section 143(a)(1)(B)] Because this purpose is also only permissible when the individual who will benefit is a parent, sibling, child or grandchild of the incompetent person, the Act reflects a presumption that the person would, if competent, choose to help such individuals.
The Act does not take the more stringent approach of requiring a demonstration that no other alternative is available for the diagnosis of the relative.[55] Instead, the determination of the appropriateness of the use of genetic analysis for such diagnosis is left first to the standard of medical care for the relative, and secondly, to the discretion of the sample source's representative whose authorization is required before the analysis can proceed. Until the whole human genome is mapped, there may be no other alternative than linkage analysis which involves the analysis of several family members' DNA to develop reliable information on the inheritance of some genetic diseases. Rather than prohibit the participation of an incompetent person in such a process, this rule accommodates a legitimate need for such participation. The Act does not, however, obligate a sample source's representative to authorize any analysis which would not be appropriate under the doctrine of substituted judgment, either because it would be inconsistent with the prior wishes of the incompetent person, or because it presents a risk to their privacy which is not outweighed by other factors.
Although the incompetent person's representative generally has the same authority in regard to authorizing the collection and analysis of DNA that the sample source would have if competent, there is one additional restriction on what the representative of such a sample source can do. The representative cannot in most circumstances override an order of the sample source made during a period of competency which directs the destruction of a previously collected DNA sample. If postponement of the destruction would, however, avoid collection of an additional sample for an analysis that is currently necessary and permissible, the sample source's representative can authorize such postponement. [section 143(b)] The representative of an incompetent person is obligated to first act in a manner consistent with the person's expressed wishes, and therefore is unlikely to rescind an order made by the person while competent. Nonetheless, this rule gives clear deference to decisions made while the person was competent and prevents a representative from taking advantage of the person's incompetency so as to discover private genetic information.
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.
These rules apply regardless of the age of the pregnant woman, and thus avoid a situation where a pregnant mature minor's independent decision regarding the continuation of her pregnancy would have legal effect, but she would be unable to independently obtain genetic information about herself or her fetus. It is also the woman alone who can consent to any intervention that might be available for a fetus who may have a particular genetic condition, and therefore she has a direct interest in the information that could be derived from the analysis.
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.
(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.
In vitro fertilization may take place with gametes from individuals other than the woman in whom the embryo may be implanted, or the male who is the prospective father. Whose authorization is necessary for collecting and analyzing DNA from the embryo? There are several possibilities. The rules could require authorization of the gamete sources, regardless of whether or not such individuals have any connection to use of the gamete for reproductive purposes. The argument could be made that the individuals who are the source of the gametes are genetically linked to the embryo and therefore have the greatest interest in the information contained in the DNA of the embryo. However, it is not necessarily those individuals who will ultimately be responsible for decisions regarding the fetus that the embryo develops into, or the child that is eventually born. Compared to a gamete donor, it is the prospective parents who have a need for genetic information about the embryo so that they can plan for its future development and the care which will be their responsibility. Consequently, the Act reflects the diminishing interests of a gamete donor once a donation is made, and the increasing interests of the persons who use the resultant embryo for reproduction. Section 153(a) provides that the gamete donor who donates a gamete for reproductive purposes relinquishes all rights regarding the collection and analysis of the DNA of an embryo that is subsequently created with that gamete.
This allocation of authority does not deprive gamete donors of any genetic information about themselves since they are free to have their own DNA tested. Nor does it deny them any information they would need in regard to the possible future development of the resultant embryo, since they would not otherwise have any authority or responsibility in regard to its future. Giving them rights to such information would create the only instance under the Act where an individual could know private genetic information of another simply for the sake of knowing, and without serving any beneficial purpose.
If the embryo is subsequently implanted and develops into a fetus, then any further collection or analysis of DNA is governed by the rules in section 151 and the authorization of the pregnant woman is required.
File posted May 1995.
