Legally Authorized Representatives Under Federal and Texas Law

Legally Authorized Representatives Under Federal and Texas Law[1]

The following information is provided to clarify the regulatory policy on legally authorized representatives and informed consent in research conducted at the University of Texas Health Science Center at San Antonio.

Links to guidance on children (Section 1):

Who is a child?

When may minors give consent without a surrogate?

Who may serve as a surrogate for a child who cannot consent on his own?

Who may give consent for research involving immunizations?

Is consent required under emergency circumstances?

Who may give consent, and to what types of research, if the child is a ward of the state or other agency, institution, or entity?

Who may give consent, and to what types of research, for foster children?

Who can consent for children in a Texas Youth Commission facility?

Under what circumstances can the IRB waive consent for a child’s participation?

Do you have a unique situation not adequately covered in this policy?

Links to guidance on adults (Section 2):

Who can serve as the Legally Authorized Representatives (LAR) for Adult Patients in a Non-Emergent Situation?

What consent is needed, if any, for “emergency research”? What if it is not “emergency research” but the patient is in an emergent condition?

What about patients undergoing outpatient or voluntary inpatient mental health treatment?

Who can be a surrogate for research that is “pure” VA research that involves UTHSCSA only by the use of the UTHSCSA IRB?

Who can provide surrogate consent for research for adult incompetent patients in research involving both the VA and UTHSCSA?

Do you have a unique situation regarding an incapacitated adult which is not adequately covered in this policy?

Section 1 – Children and Consent to Research in Texas

The Common Rule and FDA regulations require parental or guardian consent for a child to participate in research, as well as the assent of the child.[2]

Who is a child?

The regulations define children as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”[3] This definition requires that one understand state law defining who is an adult, and also know when state law authorizes those who are not adults to make their own health care decisions.

Under Texas law, the following are considered adults, and thus are not children:[4]

(1)one who is 18 years of age or older; or

(2)someone under age 18 who has had the disabilities of minority removed by court order (what is commonly referred to as being “emancipated” though that word is not used in the statute). [Note: If there is a question as to whether a potential participant is emancipated, or whether the removal of disabilities was limited and does not include health care decision-making, the researcher should read the actual court order.]

Since a minor who is emancipated is legally considered an adult, any subsequent reference to the term “minor” is referring to a minor who is not emancipated.

Note that while the statues authorizing surrogates or a minor to consent on one’s own speak in terms of treatment, these statutes also apply in the research setting since Texas does not have specific laws addressing consent for research (other than for foster children, as discussed infra). Special caution must be given before enrolling minors in research that imposes more than minimal risk but does not benefit, or offer the potential to benefit, the patient. Seek the guidance of the Director, Institutional Review Board, in such situations.

When may minors give consent without a surrogate?

There are times when minors can legally consent to medical care without a surrogate. While still considered children under state law, they are not “children” as that term is defined in the federal regulations since these individuals have reached the age (or are under other circumstances) to give legal consent to care for treatment, so they will be referred to as “minors” rather than “children.” To be clear, minors in these situations are not emancipated; they simply have statutory authority to provide consent.

In Texas, a minor may consent to medical, dental, psychological, and surgical treatment for him or herself, and hence may also consent to research for the same circumstances/treatment, if the minor is:[5]

(1)is on active duty with the armed services of the United States of America;

(2)is:

1. 16 years of age or older, and
2. residing separate and apart from the his/her parents, managing conservator, or guardian (with or without consent and regardless of duration), and
3. managing his/her own financial affairs (regardless of the source of the income);

(3)is seeking the diagnosis and treatment of an infectious, contagious, or communicable disease that is required by law or a rule to be reported by the licensed physician or dentist to a local health officer or the Texas Department of Health, including all diseases within the scope of Section 81.041, Health and Safety Code;

(4)is unmarried and pregnant and consents to hospital, medical, or surgical treatment, other than abortion, related to the pregnancy;[6]

(5)is seeking an examination and treatment for drug or chemical addiction, drug or chemical dependency, or any other condition directly related to drug or chemical use; or

(6)is serving a term of confinement in a facility of the Texas Department of Criminal Justice.[7]

A provider may rely on the written statement of the child containing the grounds on which the child has capacity to consent to the medical treatment.[8]

The statute that authorizes a minor to consent contains an additional situation which can sometimes be the cause of confusion. A minor who is unmarried, is the parent of a child, and has actual custody of his or her child, may consent to medical, dental, psychological, or surgical treatment for the child – but not necessarily for him or herself.[9] Unless the minor’s circumstances fall into one of the categories in the list above, or the minor is emancipated, he/she is in the unique situation of being able to consent to the medical care for his/her child, but not for himself. Simply being a parent does not in and of itself make one an adult or give one the authority to make health care decisions for oneself.

While not a consent issue, it is important to note that even though minors under these circumstances can consent to their own treatment, a health care provider may advise the minor’s parent, managing conservator, or guardian of the treatment given and/or needed, even without the consent of the minor.[10]

Who may serve as a surrogate for a child who cannot consent on his own?

If the research is not of the type where a minor can consent on his own, then the minor is a “child” under the federal regulations, and a surrogate must give consent.[11] The federal regulations allow a “parent” or “guardian” to serve as the surrogate.[12]

State law defines a “parent” as:

“the mother, a man presumed to be the father, a man legally determined to be the father, a man who has been adjudicated to be the father by a court of competent jurisdiction, a man who has acknowledged his paternity under applicable law, or an adoptive mother or father.[13]

The term “guardian” in the federal regulation means anyone who is authorized to consent on behalf of a child to general medical care under state or local law.[14] Do not be confused by this unconventional use of the term; it does not limit surrogacy to only those who are court-appointed guardians of a minor ward, which is to whom that term typically refers.

Parents:

Parents always have the highest “priority” in terms of who may act as a surrogate. A parent has the right to consent to medical care, absent a court order affecting rights of the parents with regards to health care decisions; relinquishment of parental rights; or an affidavit by the parent designating another as the managing conservator.[15]

For research involving no greater than minimal risk to participants,[16] or in which the research has greater than minimal risk but presents the prospect of direct benefit to the individual participant,[17] the IRB may find that the permission of one parent is sufficient.[18] This is generally consistent with state law, although in situations where divorced parents are appointed as joint managing conservators, they share all rights and duties with regard to the children, and thus the consent of both parents should be obtained if feasible.[19]

For research involving greater than minimal risk with no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the participant’s disorder or condition,[20] both parents must give their consent.[21] Likewise, for research not otherwise approvable but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children,[22]both parents must give their consent.[23] The consent of just one parent will be sufficient for these categories of research when the other parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.[24] In situations where the parents are divorced or otherwise have a judicial determination of their rights and responsibilities, the research team should ask the parent about the nature of his custodial relationship. If there is doubt as to the authority of a parent to consent on behalf of the child, the research team may need to review the court order establishing conservatorship. A parent who is appointed as sole managing conservator of a child has the exclusive right to consent to medical, dental, and surgical treatment, including treatment involving invasive procedures, and psychiatric and psychological care, unless limited by court order.[25] A parent appointed as a “possessory” conservator of a child (one who has a “standard possession order”) has the right during the period that the parent has possession of the child to consent to medical and dental care which does not involve invasive procedures.[26] Note that this authority does not extend to psychiatric or psychological care. The possessory conservator, unless restricted by court order, may also consent to medical, dental, and surgical treatment during an emergency involving an immediate danger to the health and safety of the child.[27] If the parents are appointed as joint managing conservators, they share all rights and duties, and the research team will need the consent of both parents.[28]

Other surrogates:

If the child does not have a living parent, or if the parent is not able to give consent, then other surrogates potentially may be available.

A “guardian,” as the term is typically used and defined as a person appointed by a court under state law with the authority and duty to care for a ward, has the authority to consent to medical, psychiatric, and surgical treatment, other than inpatient psychiatric commitment (but see also the separate section on wards of state agencies,infra). [29]

A non-parent who is appointed as the sole managing conservator of a child has the right “to consent for the child to medical, psychiatric, psychological, dental, and surgical treatment and to have access to the child's medical records.”[30]

Texas has a statutory list of surrogates who may consent to medical, dental, psychological, and surgical treatment of a child (except immunizations – that’s a separate section infra) when the person having the right to consent as otherwise provided by law (i.e., the parent, guardian, or managing conservator) cannot be contacted and that person has not given actual notice to the contrary. These surrogates should be used with some reservation, however, depending on the nature of the research (i.e., potential for therapeutic benefit in relation to risks involved) and the reason the parent, guardian, or managing conservator is unavailable. The surrogates, in order of priority, are:[31]

1. a grandparent of the child;
2. an adult brother or sister of the child;
3. an adult aunt or uncle of the child;
4. an educational institution in which the child is enrolled that has received written authorization to consent from a person having the right to consent;
5. an adult who has actual care, control, and possession of the child and has written authorization to consent from a person having the right to consent;
6. a court having jurisdiction over a suit affecting the parent-child relationship of which the child is the subject;
7. an adult responsible for the actual care, control, and possession of a child under the jurisdiction of a juvenile court or committed by a juvenile court to the care of an agency of the state or county;
8. a peace officer who has lawfully taken custody of a minor, if the peace officer has reasonable grounds to believe the minor is in need of immediate medical treatment; or
9. The Texas Youth Commission may consent to the medical, dental, psychological, and surgical treatment of a child committed to it under Title 3 when the person having the right to consent has been contacted and that person has not given actual notice to the contrary.

Who may give consent for research involving immunizations?

If the research involves immunizations, there is a different statute and thus a different list of who may give consent for the child and under what circumstances: [32]

(1)A parent;

(2)a guardian of the child (as appointed by court under state law) (but see separate section on wards of the state,infra); or

(3)a person authorized under the law of another state or a court order to consent for the child.

(4)If the persons listed above are not available and the authority to consent is not denied the following may give consent:

1. a grandparent of the child;
2. an adult brother or sister of the child;
3. an adult aunt or uncle of the child;
4. a stepparent of the child;
5. an educational institution in which the child is enrolled that has written authorization to consent for the child from a parent, managing conservator, guardian, or other person who under the law of another state or a court order may consent for the child;
6. another adult who has actual care, control, and possession of the child and has written authorization to consent for the child from a parent, managing conservator, guardian, or other person who, under the law of another state or a court order, may consent for the child;
7. a court having jurisdiction of a suit affecting the parent-child relationship of which the minor is the subject;
8. an adult having actual care, control, and possession of the child under an order of a juvenile court or by commitment by a juvenile court to the care of an agency of the state or county; or
9. an adult having actual care, control, and possession of the child as the child's primary caregiver.

A person otherwise authorized to consent may not consent for the child if the person has actual knowledge that a parent, managing conservator, guardian of the child, or other person who under the law of another state or a court order may consent for the child and hasexpressly refused to give consent to the immunization, has been told not to consent for the child, or has withdrawn a prior written authorization for the person to consent.

As is the case with surrogate consent for research that does not involve immunizations, researchers need to exercise caution when a parent, guardian, or managing conservator is only temporarily unavailable, especially in consideration of the benefits and risks of participation.

Is consent required under emergency circumstances?

No. Consent is not required for a minor who is suffering from what reasonably appears to be a life-threatening injury or illness and whose parent(s), managing or possessory conservator, or guardian is not present.[33]

Who may give consent, and to what types of research, if the child is a ward of the state or other agency, institution, or entity?

Federal regulations define a “ward” as “a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law.”[34]

A “ward” as used in this Section then includes foster children,[35] children residing at a Texas Youth Commission facility,[36] and children who are otherwise in the care and control of the state or a state agency.

For research involving no greater than minimal risk to participants,[37] or in which the research has greater than minimal risk but presents the prospect of direct benefit to the individual participant,[38] there are no additional protections in addition to the standard rules for consent as covered in the sections below for foster children and children in the custody of the Texas Youth Commission apply.

For research involving greater than minimal risk with no prospect of direct benefit to individual subjects, [39] and for research not otherwise approvable but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children,[40] a child who is a ward can only be included if the research is:[41]