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D403 Organization Policy on Research Involving Children

April 2016

It is the policy of the Organization to require adherence to federal regulations regarding the additional findings included in r DHHS regulations (45 CFR 46 Subpart D) and FDA regulations (21 CFR 50 Subpart D), for research involving children.  For the purpose of applying Subpart D of the federal regulations, children are defined 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.

Maryland law defines children as individuals under 18 years of age unless one of the exceptions listed below applies:

A) A person under the age of 18 who is married;
B) A person under the age of 18 who is the parent of a child; or
C) A person under the age of 18 who seeks treatment for one of the following conditions (provided that the research is directly related to one of these conditions and involves minimal risk or involves more than minimal risk and offers the prospect of direct benefit to the subject from the specific treatment):

1.    Drug abuse;
2.    Alcoholism;
3.    Mental or emotional disorder (if age 16 or older);
4.    Venereal disease;
5.    Pregnancy;
6.    Contraception other than sterilization;
7.    Physical examination and treatment of injuries from an alleged rape or sexual offense;
8.    Physical examination to obtain evidence of an alleged rape or sexual offense; or
9.    Initial medical screening and physical examination on and after admission of the person into a detention center.

The IRBs are authorized to review research involving children and may approve research that satisfies the conditions of all applicable sections of Subpart D.  If the IRB determines that Subpart D applies to the protocol, the PI must clearly indicate at what point in the protocol applicable parental permission will be obtained from each child participant’s parents or guardians*, in addition to the child’s assent.  IRB determinations under Subpart D will be documented in the OHSR records.

*Under DHHS regulations “guardian” means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care; and under FDA regulations “guardian” means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes participation in research.  For purposes of Subpart D, a guardian also means an individual who is authorized to consent on behalf of a child to participate in research.  In the State of Maryland guardians are appointed by the Social Services Administration.  Guardians are not authorized to provide consent for foster children.  Inclusion of foster children in research requires adherence to MD Circular Letter SSA #08-25 dated April 17, 2008.  See, Guidance for Research Projects Involving Social Services Administration of the State of Maryland Department of Human Resources Department of Social Services (Foster Children)

The Organization will follow the regulatory criteria found in DHHS 45 CFR 46 Subpart D, section 46.409 “Wards” and in FDA 21 CFR 50 Subpart D, section 50.56 “Wards.”  The IRBs are authorized to approve research involving foster children (or wards of the state) that meet the regulatory criteria for involving children in research found at 45 CFR 46.404, 405, and 406; and 21 CFR 50.51, 52, and 53.  When a JHM IRB determines a project meets the classification of research approvable under 45 CFR 46.406 and/or 21 CFR 50.53, the IRBs are authorized “to appoint an advocate for each child who is a ward, in addition to any other individual or entity acting on behalf of the child as guardian or in loco parentis” as a condition of approval in accord with federal regulations.

The IRBs are authorized to make regulatory determinations for assent by children.   The IRBs may determine that adequate provisions are made for soliciting assent.  The IRBs will determine how assent will be solicited, obtained and documented. The determination will take into account the ages, maturity, and psychological state of the population.  This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate.  If the IRBs determine that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, then the IRBs may determine assent of the children is not a necessary condition for proceeding with the research.  Even where the IRBs determine that the participants are capable of assenting, the IRBs still may waive the assent requirement in accord with 45 CFR 46.116.  Under 45 CFR 46.408(e), when the IRB determines that assent is required it shall also determine whether and how assent must be documented.  See Policy 117.1, regarding requirements for signing an assent document.

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