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SPECIAL ISSUES IN THE REGULATIONS AND ETHICS OF RESEARCH INVOLVING CHILDREN

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Subpart D Additional DHHS Protections for Children Involved as Subjects in Research ... 1896: Hospitalized children used as subjects to test lumbar punctures ... – PowerPoint PPT presentation

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Title: SPECIAL ISSUES IN THE REGULATIONS AND ETHICS OF RESEARCH INVOLVING CHILDREN


1
SPECIAL ISSUES IN THE REGULATIONS AND ETHICS OF
RESEARCH INVOLVING CHILDREN
  • Harold Y. Vanderpool, Ph.D., Th.M.
  • Professor in the History and Philosophy of
    Medicine
  • Institute for the Medical Humanities
  • University of Texas Medical Branch

2
Subpart D Additional DHHS Protections for
Children Involved as Subjects in Research
3
EXAMPLES OF ABUSES OF CHILDREN AS SUBJECTS OF
RESEARCH
  • 1896 Hospitalized children used as subjects to
    test lumbar punctures a new procedure at the
    time and without therapeutic value for the
    children.
  • 1935 Thousands of children involved in trials
    with live polio vaccine virus, later declared
    unsafe by the APHA
  • 1950s-1970s Children in the Willowbrook State
    School in New York intentionally infected with
    hepatitis.

4
HISTORY OF REGULATIONS INVOLVING CHILDREN
  • The main Code of Federal Regulations was
    published and required of researchers in 1974.
  • Called into existence by the U.S. Congress in
    1974, the National Commission for the Protection
    of Human Subjects published its special study of
    research involving children in the Federal
    Register in 1978.
  • Drawn from the National Commissions
    recommendations, Subpart D of the CFR went into
    effect 5 years later in June of 1983.

5
46.403 IRB Duties
  • In addition to other responsibilities assigned
    to IRBs under this part, each IRB shall review
    research covered by this subpart and approve only
    research which satisfies the conditions of all
    applicable sections of this subpart.

6
THE FIRST AND SECOND CATEGORIES
CFR 46.404 Research Involving No More than
Minimal Risk CFR 46405 Greater than Minimal
Risk, but with the Prospect of
Direct Therapeutic Benefit to
the Individual Child
7
THE THIRD AND FOURTH CATEGORIES
CFR 46.406 Greater than Minimal Risk with
No Prospect of Direct Therapeutic
Benefit, but Likely to Yield
Generalizable Knowledge about
Subjects Condition CFR 46407
Research Not Approvable by the
Conditions Set Forth in 1st Three
Categories, but May Lead to
Understanding a Serious Problem
Affecting the Health or Welfare of
Children
8
CONCERN 1 THE ASSENT OF CHILD SUBJECTS A
CONCERN THAT RAISES 4 QUESTIONS
1. When is the childs assent required? 2.
What does assent involve/mean? 3. Which
children have to assent to be involved
before being enrolled as research
subjects? 4. What do researchers need to do
What should IRBs require of researchers
to ensure that the assent of prospective
child subjects is valid?
9
CONCERN 2 UNDERSTANDING THE MEANING OF
MINIMAL RISK WE NEED SPECIFIC AND CLEAR
PERIMETERS/EXAMPLES OF WHAT THIS INCLUDES AND
SHOULD NOT INCLUDE
10
CONCERN 3 PROBLEMS INHERENT TO THE 3rd CATEGORY
OF RESEARCH 46406
1. Meaning of minor increase over minimal
risk. 2. Meaning of research procedures
that are reasonably commensurate with the
childs medical situation. 3. Meaning of
knowledge that is of vital importance to
research subjects conditions.
11
CONCERN 4 WHY IS IT MORALLY ACCEPTABLE OR
MORALLY UNACCEPTABLE TO CONDUCT NON-BENEFICIAL,
BUT MINIMAL RISK RESEARCH ON CHILDREN/ I.E., WHAT
MAKES THE FIRST CATEGORY OF RESEARCH (46.404)
ACCEPTABLE FOR CHILDREN WHEN, WITHOUT FULLY
INFORMED CONSENT, MUCH OF THIS RESEARCH WOULD BE
IMMORAL FOR COMPETENT ADULTS?
12
CONCERN 5 THE 3rd RESEARCH CATEGORY INVOLVING
CHILDREN (46406) ALLOWS FOR MORE THAN MINIMAL
RISK RESEARCH ON SICKER CHILDREN Children who
are already experiencing various interventions
that are similar to the riskier
procedures/interventions in the research. Is
this somewhat perverse for regulations designed
to offer additional protections for children?
13
CONCERN 1 THE ASSENT OF CHILD SUBJECTS A
CONCERN THAT RAISES 4 QUESTIONS
1. When is the childs assent required? 2.
What does assent involve/mean? 3. Which
children have to assent to be involved
before being enrolled as research
subjects? 4. What do researchers need to do
What should IRBs require of researchers
to ensure that the assent of prospective
child subjects is valid?
14
1. WHEN IS A CHILDS ASSENT REQUIRED?
  • In the first 3 categories of research involving
    children, i.e., all the categories that IRBs have
    a mandate to review and approve 46.404
    Research Not Involving Greater than
    Minimal Risk This category of research is
    permissible only if the IRB finds that adequate
    provisions are made for soliciting the assent of
    the children….

15
1. WHEN IS A CHILDS ASSENT REQUIRED?
46.405 Category 2 Greater than Minimal
Risk with Prospect of Direct
Benefit This research is permissible only if
the IRB finds that (c) adequate provisions are
made for soliciting the assent of the children
and permission of their parents or guardians, as
set forth in 46.408. 46.408 says that the
assent of the children is not a necessary
condition for proceeding with the research if
the research promises direct benefit to health of
the children that is available only in the
context of the research.
16
1. WHEN IS A CHILDS ASSENT REQUIRED?
46.406 Category 3 Greater than Minimal Risk,
No Prospect of Direct Benefit, but the Promise of
Generalizable Knowledge about Subjects Disorder
or Condition This research is permissible only
if the IRB finds that (d) adequate provisions
are made for soliciting assent of the children.
17
DO THE ABOVE QUOTES MEAN THAT CHILDREN WHO ARE
TOO YOUNG TO ASSENT SHOULD BE EXCLUDED FROM THESE
CATEGORIES OF RESEARCH?!
No. CFR 46.408 (a) says that the assent of
children is required when in the judgment of the
IRB the children are capable of providing
assent. This underscores two things (1) IRBs
are commissioned to determine when the
children are capable of providing assent. (2)
When IRBs judge that children are capable of
assent, the research should not be done
unless researchers do, in fact, secure the
assent of the children subjects they plan to
recruit.
18
1. WHEN IS A CHILDS ASSENT REQUIRED?
  • In all the categories of research IRBs are
    commissioned to review as just indicated.
  • When IRBs decide that the children who are being
    recruited are capable of assent. This takes us
    to our second and third questions.

19
QUESTION 2 WHAT DOES ASSENT INVOLVE/MEAN?
Definition in the Regulations 46.402(b)
Assent means a childs affirmative agreement
to participate in the research. Mere failure to
object should not, absent affirmative agreement,
be construed as assent. This affirmative
agreement to participate in the research is
non-sensible if the children capable of assent do
not understand what the research is and are not
allowed to choose or not to choose to participate
in the research.
20
THE MEANING OF ASSENT
The standard for assent requires that the
subject knows that procedures will be performed
in the research, choose freely to undergo those
procedures, communicate this choice
unambiguously, and be aware that subjects may
withdraw from participating. This standard for
assent is intended to require a lesser degree of
comprehension of the subject than would generally
support informed consent.
21
DEGREES OF ASSENT
  • Obviously, children of different ages and levels
    of maturity will differ in their levels of
    understanding, ability to choose unambiguously,
    and comprehension of the notion that they can
    withdraw from participation at any timemore
    about this later.
  • Assent, is neither cognitively nor legally
    equivalent to informed consent. At the same
    time, (1) the elements of assent include all the
    elements of informed consent (disclosure of
    information, comprehension, and voluntarism), but
    at lesser degrees of completeness or magnitude,
    and (2) the ethical foundations of assentrespect
    for maturing personsare the same as those of
    informed consentrespect for mature persons.

22
WHY THE ABOVE UNDERSTANDING OF ASSENT APPEARS TO
REFLECT THE INTENT OF SUBPART D
  • A childs assent is the closest ethical
    equivalent to the fully informed consent of
    competent adults or their proxies.
  • Assent in the above sense combined with the
    permission of one or both parents offers children
    subjects an additional layer of protection
    Subpart D intends to provide.
  • The use of the wording and concept of parental
    permission rather than consent indicates that
    the Commissioners did not want parents to be
    regarded as agents of proxy consent for children
    capable of assent.

23
QUESTION 3 REGARDING ASSENT WHICH CHILDREN HAVE
TO ASSENT TO BE INVOLVED BEFORE THEY CAN BE
ENROLLED AS RESEARCH SUBJECTS?
  • Short Answer Given Above All the children
    IRBs judge to be capable of assent.
  • Longer Answer 46.408(a) To make this
    determination, IRBs shall take into account the
    ages, maturity, and psychological state of the
    children involved.

24
SOME ANSWERS TO THE QUESTION WHICH CHILDREN
SHOULD IRBs REGARD AS CAPABLE OF ASSENT?
  • The National Commission Assent should be
    required of children 7 and older. Their dissent
    from involvement should be regarded as binding
    except for category 2 (possibility of direct
    benefit) research.
  • The view that their dissent should be binding was
    reaffirmed by a Bioethics Commission in 1995.
  • Study by Abramaovitch, et al. (1991) 62 of
    children who were 5 to 6 years old in a
    psychological study understood what the research
    was about and were capable of giving voluntary
    assent. 87.5 of the 7 to 8 year olds could do
    this.

25
ANSWERS TO THE QUESTION WHICH CHILDREN SHOULD
IRBs REGARD AS CAPABLE OF ASSENT? (Continued)
  • Weithorn and Campbell (1982) Study of
    ninety-eight 9 to 21 year olds indicated that 9
    year olds can comprehend the purposes,
    procedures, risks, benefits and treatment options
    of research.
  • Broome (2003) Children as young as 6 can
    understand the purpose of research and what is
    expected from them. In general, adolescents (14
    to 15 years old) are cognitively capable of
    informed consent.
  • Several studies Children from 9 to 15 are
    subject to coercive parental dictates and to
    parental and authority figure influence.

26
SUMMARY OF ANSWERS TO FIRST THREE QUESTIONS
  • The CFR views the assent of children who are
    capable of such assent as a pivotal
    threshold/ condition for research involving
    children.

27
SUMMARY OF ANSWERS (Continued)
  • Assent or affirmative agreement to participate
    or not in research is meaningless if children
    have not (1) been informed about the research to
    the extent of their capability of understanding
    it, (2) comprehended this information, and (3)
    affirmed that they themselves are willing to
    participatean impossibility if the decision is
    in response to the pressure or dictate of an
    authority figure.
  • IRBs are commissioned to determine which children
    are capable of assent and that, if capable, to
    see that such assent is a condition for
    approvable research.

28
WHAT DO RESEARCHERS NEED TO DO AND/OR WHAT
SHOULD IRBs REQUIRE OF RESEARCHERS TO ENSURE
THAT THE REQUIREMENTS FOR ASSENT IN CFR SUBPART D
FOR PROSPECTIVE CHILD SUBJECTS ARE DULY
RECOGNIZED AND FOLLOWED?
29
CRITERIA FOR ENSURING THAT THE REQUIREMENTS
REGARDING THE ASSENT OF CHILDREN IN THE CFR WILL
BE UPHELD
  • A clear recognition that morally permissible
    research involving children is predicated on the
    assent of children capable of assent and parental
    permission, not the proxy consent of parent(s) or
    guardian(s).
  • Understanding that, except for lesser degrees of
    comprehension and less experience with personal
    decision making adjusted to the maturity level
    of the child, the elements of assentunderstandin
    g, comprehension, and voluntary choiceare
    similar to those of consent.

30
CRITERIA FOR ASSURING (Continued)
3. An assent process that facilitates
understanding and voluntary choice on the part of
children in their respective developmental
stages. --This means that if researchers plan to
recruit children of widely differing ages into
a single protocol, they would need to develop
age-suitable assent forms. --It also means that
the usual I/my child wording on consent forms
that in all other respects are created for
competent adults reflects a parental proxy
consent approach to recruitment, rather than the
child assent/parental permission directives of
the CFR. --Researchers should consider using
mixed media approaches.
31
CRITERIA FOR ASSURING (Continued)
4. Guidelines regarding assent forms that
reflect the regulations and ethics regarding
assent e.g., when they might take the form of an
oval script and when they should be modeled on
consent forms, but use simpler language and
contain less detail. 5. Given the data from
studies that indicate how parental influence can
be decisive for a childs decision, assent should
be obtained in settings that minimize the
influence of parents and other authority figures.
32
CRITERIA FOR ASSURING (Continued)
6. A childs dissent from participation should
be taken as binding. 7. Minimize financial
incentives to avoid undue influence or coercion.
33
Self Assessment Answers
  • B
  • C
  • C
  • D
  • B
  • F
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