Skip to main content

Currently Skimming:

Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis
Pages 320-387

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 320...
... These protections enable society to reach a reasonable balance between protecting the safety of children and adolescents from research risks and promoting their inclusion in studies to benefit them and future generations. Special federal regulations provide guidance to child and adolescent heath care researchers.
From page 321...
... Also addressed are state laws, regulations, or policies specific to children in state custody (e.g., children in foster care or detention facilities) , when such laws, regulations, or policies are available.1 These guidelines are of particular importance in that they apply to those children who likely have unique medical or psychosocial issues distinct from those of the general population 1A separate project conducted under the auspices of the University of Rochester Medical Center is also pending.
From page 322...
... Directions for state guidance are also provided. SUMMARY OF STATE LAWS RELEVANT TO MEDICAL AND BEHAVIORAL RESEARCH WITH CHILDREN AND ADOLESCENTS Age of Majority As a first issue, the age of majority in each state is important, as it sets forth the age above which Subpart D of the federal regulations, in addition to any special state protections, do not apply.
From page 323...
... In the sections that follow, which discuss emancipation, the mature minor rule, and minor consent to treatment provisions, it should be emphasized that state laws have relevance in two different ways: the application of the definition of "children" and the waiver of parental permission to medical treatment and in other contexts. That is, certain state laws place a minor outside the definition of children (which would seemingly make Subpart D of the federal regulations inapplicable)
From page 324...
... For the purposes of this review, however, emancipation, whatever the causal event, is taken to mean that the child becomes an adult in the eyes of the state; that is, all rules governing parental custody or control are severed, which could include parental permission for research participation, to the extent that states follow a broader range of emancipation effects. Moreover, in this appendix, only those individuals considered adults for all purposes under state law are included in the category "emancipated minors." Mature Minors Although emancipation in effect turns the "child" into an "adult" for the purposes of state law, other events may occur as a result of which the child or adolescent may be seen as sufficiently mature to make (certain)
From page 325...
... with the capacity to understand the risks and consequences of certain decisions and, hence, who have the ability to make those decisions, including, at times, decisions relating to medical treatment (Table B.4) .8 The historical development of the "mature minor" doctrine in common law supports a distinction from emancipation, inasmuch as the former doctrine is of more recent vintage conferring more context-sensitive consent rights in children, for example, to consent to certain medical treatments.9 Age of Consent for Medical Care Some youth, who are still technically "minors" under state law, are allowed to consent to general medical treatment under specific state statutory provisions [19]
From page 326...
... This uncertainty and frequent silence on the matter leaves researchers and IRBs in a position to make a best guess as to whether state laws related to treatment also apply to research, although there are good reasons to believe that they do apply, at least in certain situations [29]
From page 327...
... . Finally, it is also worth clarifying the distinction between emancipation and mature minor status, a distinction not always clearly made in state law.12 In general, emancipation (in this appendix)
From page 328...
... Research-Specific Regulations: Children Under State Custody Of special concern to researchers and policy makers are regulations pertaining to children in state custody, for example, children in foster care, juvenile delinquents, and wards of the state. These children fall under state control under the doctrine of parens patriae, the concept that the states assume a "parental" role to protect children when biological parents are not able to do so, such as in instances of child neglect or abuse or when children enter the juvenile detention system.
From page 329...
... A review of state law, regulation, and case law related to this research suggests that little formal guidance is available. To clarify this, commissioners of each state's child welfare or social services department were recently contacted for further information on state and local policies or other guidance related to research with children under state custody.
From page 330...
... (See Addendum B2 for a discussion of two hypothetical studies proposing to perform research with children in state custody and how states might approach such proposals.) CASE LAW Case Example Researchers at a prominent institute affiliated with an academic medical center propose to study the effects of various types of lead abatement on a group of already affected and at-risk children from an urban inner-city environment.
From page 331...
... . Of particular note was the court's decision to go beyond the issue of negligence to find that, under state law, parental authority to permit their children to participate in research does not extend to nontherapeutic research that carries with it the risk of harm to the health of the child [52]
From page 332...
... After the initial Court of Appeals decision, many believed that Johns Hopkins University and the University of Maryland would push for legislation to address the extent or limits of parental authority to permit research with their children, and a legislative committee hearing was scheduled to talk about what was seen as the crippling effect of the decision on research involving children. However, after a subsequent clarification by the court in its denial of the Kennedy Krieger Institute's motion for reconsideration (in which it
From page 333...
... As we indicated, the determination of whether the study in question offered some benefit, and therefore could be regarded as therapeutic in nature, or involved more than minimal risk is open for further factual development on remand [63]
From page 334...
... . It stands to reason that states which have experienced the ill effects, including bad press, of research cases are more likely to respond with protective statutory and common law approaches.
From page 335...
... Each court interpreted state law as restricting the ability to do nontherapeutic, greater-than-minimal-risk research with children. Furthermore, each did so by explicitly acknowledging the need for state protection, notwithstanding federal regulations or cases in which such regulations do not apply (non-federally funded research)
From page 336...
... Tennessee The Tennessee Supreme Court has also recognized the common law "mature minor exception" by adopting the "Rule of Sevens" [82]
From page 337...
... . It further held that the mature minor exception is part of Tennessee's common law to be applied on a case-by-case basis (i.e., not a bright-line test)
From page 338...
... Researchers might also be well advised to seek agency approval for research with children in or at risk of being under state custody and also to develop research protocols with greater community input, particularly those members of the community from which subjects or families are likely to be drawn [87]
From page 339...
... Additionally, might it also be wise for states to set forth guidance more uniformly and to learn from each other's experiences, in recognition of the growing "multistate" nature of research? Such guidance could, for example, address more precisely what is meant by "emancipated minor" and "mature minor" on the one hand and "greater than minimal risk" and "nontherapeutic research" on the other [92]
From page 340...
... Ann. § 228.093 with written parental consent Georgia None identified Hawaii None identified Idaho None identified Illinois School records may be released with 105 Ill.
From page 341...
... without written parental consent Oklahoma None identified Oregon None identified Pennsylvania None identified Rhode Island None identified South Carolina None identified South Dakota None identified Tennessee Student records are not available Tenn.
From page 342...
... Stat. § 40:1299.56 Maine 18 1 Maine Rev.
From page 343...
... Code Ann. § 41-41-3 states that "adult" means anyone 18+ for the purposes of consent to surgical or medical treatment procedures.
From page 344...
... Ann. § 46b-150b from parents Court order Conn.
From page 345...
... Code Ann. § 2111.18.1 Oklahoma Court order Okla.
From page 346...
... Codified Laws § 25-5-26 and with parents' consent/ acquiescence; managing own financial affairs Military S.D. Codified Laws § 25-5-24 Court order (age 16+)
From page 347...
... § 22-8-4 Minor parent (may consent to Code of Ala. § 22-8-5 child's and own medical treatment)
From page 348...
... Ann. § 577A-2 Idaho Minor parent (may consent to Idaho Code § 39-4303 child's medical treatment)
From page 349...
... Ann. § 214.185 child's and own medical treatment)
From page 350...
... Code § 144.343 Minor parent (may consent for Minn. Code § 144.342 child's and own medical treatment)
From page 351...
... Pub. Health Law § 2504 child's and own medical treatment)
From page 352...
... Code Ann. § 63-6-223 Minor parent (may consent for Tenn.
From page 354...
... 354 121020 § 22-11A-19 Code 6926 6925 6929 6924 44-133.01 20-16-508 20-16-304 20-27-301 20-9-602 § § § § 25-4-402 13-22-105 13-22-105 22-8-6, 22-8-6 22-8-3 § § § § § Safety § § § 25.20.025 25.20.025 § § § § § & Stat.
From page 355...
... 355 Continued 19a-598 19a-582, 19a-216 17a-688 19a-285a 17a-79 577A-2 577A-2 577-26 § §§ § § § § § § 708 708 708 707 709 § § § § § Ann.
From page 356...
... 356 210/4 210/4 10/1 210/4 214.185 214.185 214.185 Ann.
From page 357...
... without if 's parent, ") minor minor minor minor physician harm minor minor minor minor minor minor minor minor minor minor minor parent/guardian minor or of parents "jeopardize health Any 16+ Any Any 17+ Any Minor Any Any Any Any 16+ Any Any Any Any Any 14+ Any Any use believes illness)
From page 359...
... 359 (iii) Continued 33.21 130A-148 90-21.5(a)
From page 360...
... abuse of abuse abuse abuse abuse services care Disorder drug subject use drug drug drug drug or or treatment Health for donation care health or planning or health or or donation donation testing/treatment testing testing/treatment testing testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment Mental except Condition STD HIV Alcohol Blood Medical Health Mental STD HIV Alcohol STD HIV Family Alcohol Blood Mental STD HIV Alcohol Blood STD HIV Alcohol Continued B.5 Island TABLE State Ohio Oklahoma Oregon Pennsylvania Rhode
From page 361...
... in abuse abuse abuse abuse abuse (not abuse treatment drug drug drug drug drug drug treatment or or health donation planning or or or donation planning or illness donation testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment Blood Medical Alcohol STD Alcohol Mental STD HIV Family Alcohol STD Alcohol STD Blood STD Alcohol STD HIV Family Alcohol Blood Mental Carolina Dakota South South Tennessee Texas Utah Vermont Virginia
From page 362...
... Wyo. by or Social or of treatment inpatient if minor if minor minor minor minor minor minor minor minor outpatient, 12+ Department Services Age 14+ 14+ Any 13+ 13+ Any Any Any Any Any 12+ 14+ Any Any Any 18+ treatment treatment treatment abuse abuse abuse treatment care Disorder drug drug drug or planning or health planning or or health planning donation testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment testing/treatment Condition STD HIV Family Alcohol Mental STD HIV Family Alcohol STD Alcohol Mental STD HIV Family Blood Continued B.5 Virginia TABLE State Washington West Wisconsin Wyoming
From page 364...
... 364 ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN TABLE B.6 Regulation of Research with Children and Adolescents in State Custody: Responses from Child Welfare or Social Services Personnel State Contact Alabama Dr. Page Walley, Commissioner, Department of Children's Affairs Delaware Peter S
From page 365...
... policy: Except for identifying information, the OCS State Office must preapprove access to foster care records, records of abuse/ neglect investigations, and child welfare services records by external investigators (the latter cannot be undergraduate students) ­(Policy 1-550)
From page 366...
... 366 ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN TABLE B.6 Continued State Contact Louisiana (continued) Maine Michael Norton, Director, Division of Public Affairs/Quality Assurance, Bureau of Child and Family Services (BCFS)
From page 367...
... . No policies specifically address medical research, but there are policies on confidentiality and medical treatment orders; allows optional disclosure of nonidentifying information for "bona fide" research and identifying information with commissioner's prior approval; cannot contact subject directly without subject's consent through DHS before such contact (MRSA Title 22, sec.
From page 368...
... Williams, Director, Division of Human Services, Department of Social Services South Dakota Virginia Wieseler, Office of Child Protection, Department of Social Services Tennessee Mary Jane Davis, Assistant General Counsel, Department of Children's Services (DCS)
From page 369...
... . No state laws/regulations addressing research with children in state custody.
From page 370...
... 370 ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN TABLE B.6 Continued State Contact Tennessee (continued)
From page 371...
... The draft version gives parents the legal right to consent to medical treatment for their child, unless parental rights are terminated; DCS is authorized to consent to ordinary medical treatment by virtue of court order granting it legal custody, but "best practice is to involve the parent(s) in the child's treatment and to facilitate the parental role in giving informed consent" (draft DCS Policy 20.24)
From page 372...
... 372 ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN TABLE B.6 Continued State Contact Tennessee (continued) Utah Navina Forsythe, Supervisor, Data Research Reporting Unit, Division of Child and Family Services (DCFS)
From page 373...
... . DHS IRB reviews are pursuant to federal regulations and state laws on family educational rights and privacy act (UCA sec.
From page 374...
... 374 ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN TABLE B.6 Continued State Contact Washington Michael Garrick, Ph.D., Executive Secretary, Washington State IRB Wisconsin Kitty Kocol, Administrator, Division of Children and Family Services, Department of Health and Family Services SOURCES: The information presented in the table is drawn from inquiry (by mail, e-mail, and follow-up calls) of state child welfare and related departments.
From page 375...
... No specific state policies on research other than statutes/regulations related to confidentiality and, if applicable, any federal guidelines/regulations under which it is funded. Depending on nature of research request and "type" of children involved, will negotiate with researcher on individual basis for each study: might allow direct access to children or data systems or, alternatively, might permit indirect access through Department.
From page 376...
... Child Abuse & Neglect 26:1179­1199 (study examining protective and vulnerability factors in foster care youth) ; Child Welfare League of America.
From page 377...
... Research Report 2002-R0008 (emancipation of minors under common law)
From page 378...
... 55 (July 1992) (clients served by Delaware Health & Social Services may not be research subjects unless the Human Subjects Review Board approves the research and the research is compatible with DHHS [federal]
From page 379...
... Kennedy Krieger, and public health research involving children. American Journal of Public Health.92(7)
From page 380...
... 2001. Nontherapeutic research minimal risk, and the Kennedy Krieger Lead Abatement Study.
From page 381...
... 75. The court argues that the OMH regulations' surrogate consent provisions are unacceptable for greater-than-minimal-risk nontherapeutic research in light of earlier treatmentrelated holdings and the state's interest in child health and welfare as parens patriae, suggesting such research may lead to the same result at "denial of necessary medical treatment" (Id.
From page 382...
... Government Printing Office, (which suggests that adolescents' legal ability under state law to consent to certain medical treatments without need for parental permission, indicative of adolescent capacity, should extend to research context for same conditions)
From page 383...
... Code Ann. 32.1-162.16 (which defines "nontherapeutic research" as that which holds "no reasonable prospect of direct benefit to the physical or mental condition of the human subject.")
From page 384...
... , may serve to highlight the myriad of approaches applied to research studies involving youth in state custody. They were developed in consultation with researchers focused on the foster care population and were circulated to researchers whose work touches upon these issues in numerous states, as well as representatives of state child welfare departments (or the relevant agencies who regulate such research)
From page 385...
... are scrutinized closely. Informed consent is required: the presumption is in favor of seeking parental consent for children, unless parental rights have been terminated, even though the Department has legal authority for approving "ordinary medical care" for children in its custody.
From page 386...
... As this is far beyond what they consider "ordinary care and treatment" for pediatric populations, they are that much more cautious about enrolling children under their custody, who face their own host of vulnerabilities. Less regulatory or restrictive state State C is also highly concerned by this hypothetical research and would require ample showing of cause or medical justification for the treatment methods contained within the protocol; that is, there must be some physician documentation that the testing is being conducted with all pediatric populations, not simply those in foster care, and that it is medically warranted and not purely an experiment without some data backing AZT's use.
From page 387...
... APPENDIX B 387 The lack of black-and-white approaches is not necessarily a problem; in fact, it likely represents the best course given the need for individualization of studies to match individual or local community needs. Such flexibility is also in keeping with the federal government's emphasis on local review, notably, through the IRB structure.


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.