• Has Parental Consent Become a Dispensable Safeguard?
  • June 15, 2007 | Author: Jennifer L. Cairns
  • Law Firm: McGuireWoods LLP - Pittsburgh Office
  • From participation in athletics to the administration of Tylenol to an ailing teenager at school, parental consent is ordinarily needed for almost every activity or process a minor child is involved in. Unless a child’s injuries or illnesses are life threatening, healthcare providers usually cannot treat the child without clear and direct parental consent under existing law.

    Given the stringent nature of the parental consent requirement, some healthcare providers have begun to actively encourage parents to designate a responsible adult who may authorize treatment of the child in the parent’s/parents’ absence. The suggested form must be completed for each child in the family and on each occasion that either the parent(s) or child is traveling. The form is to be left with the designated adult so that the adult may present it as evidence of parental consent at the time of treatment.

    In light of the above, one might assume that a healthcare provider would also be obligated to obtain informed parental consent before enrolling a minor child in a research study. Under a recent decision by the National Institutes of Health (“NIH”) and the Food and Drug Administration (“FDA”), however, this is no longer the case in at least some circumstances.

    Historically, research studies were not immune to parental consent requirements. In fact, federal research study guidelines require pediatric study subjects and their guardians to be fully informed of the processes, procedures and risks associated with the intended study so that they (pediatric patient included) may assent to participation before enrollment.[1] Informed consent has been debated in various ethics committees, prompting research studies designed to assess and improve methods of obtaining such consent.[2]

    On May 23, 2007, the landscape of parental consent changed. The NIH announced that, upon arrival at an emergency room in eleven (11) major metropolitan areas[3] epileptic children in status epilepticus (sometimes called “status seizures” or just “status”) will be automatically enrolled in a drug research study without informed consent.[4] In status epilepticus, the patient suffers a series of rapidly repeated seizures without regaining consciousness between them. The trial is intended to assess how epileptic minors in status react to diazepam and lorazepam, two well-known and long-used anti-seizure medications. Parents and the minors involved will receive details associated with the study, but not until after the study medications have been administered. Only then may either the parent and/or minor child raise an objection to participating in the study. Although proceeding in this fashion represents a departure from past practice, the FDA has given its blessing.

    The rationale for this approach is based on timing concerns. At present, there are no data on which a physician can base a choice between the two agents under study. Hence, a head-to-head comparison is desirable. The time needed to explain the risks and benefits of each agent, however, and to obtain formal consent in traditional fashion, is time when the untreated child may continue to seize. Since brain damage can ensue from protracted seizures, prompt initiation of treatment is necessary. If physicians merely continue to use either of these drugs without the data the study is designed to provide, we may never know which is superior, and some patients may be deprived of an opportunity for improved outcomes.

    To ameliorate the consequences of treatment without traditional consent, FDA requires public meetings in the targeted metropolitan areas, at which parents will be given an opportunity to learn about the study and to ask questions concerning it. They will also be informed of their ability, by giving advance notice to the hospitals in their area, to opt out of the study. The children of parents so electing will be treated as they are now.

    If a child remains enrolled in the study, an independent review board or committee at each hospital will oversee the study to ensure that all procedures and protocols comply with safety and ethical standards. Overall trends in study data will be assessed by another group of independent reviewers. Should these reviewers find clear indications that one drug is more effective at treating seizures, the study will end early.

    Both the FDA and the NIH reference the Best Pharmaceuticals for Children Act (“BPCA”)[5] as further grounds for this decision. Critics, however, point out that Section twelve (12) of the BPCA calls for review of the processes and procedures undertaken to secure informed consent as defined in subpart A of part 46 of title 45 of the Code of Federal Regulations. Given the tension between traditional notions of consent and the practical difficulties of securing it in relevant circumstances, a tension that arises in the management of cardiac arrest as well, among other settings, it will be interesting to follow the residual affects of this decision going forward.


    NOTES:

    1. Federal regulations require the consent from both the parent and the child who is considering participating in a research study. Such regulations empower both the parent and the child to veto the decision to participate in the research study, even though the regulations call the child’s decision "assent." “Assent” is defined as the child’s “affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as consent.” (See 45 C.F.R. §§ 46.402, 46.408)

    2. The Cleveland Clinic’s Department of Ethics, e.g., has undertaken multiple studies geared toward developing a scientific understanding of the informed consent process for pediatric cancer patients. (See Information available at www.clevelandclinic.org; last visited on June 4, 2007).

    3. Philadelphia, PA, Washington, DC, Ann Arbor, MI, Baltimore, MD, Boston, MA, Buffalo, NY, Davis, CA, Detroit, MI, Milwaukee, WI, Rochester, NY and Salt Lake City, UT.

    4. See Davis, Robert, USA TODAY, Drug study on kids won’t require consent (May 24, 2007); last visited on June 4, 2007.

    5. Public Law 107-109 (Jan. 4, 2002).