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The Ethical Conduct of Clinical Research Involving Children

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Written information is too complex. Focus is too often on forms not ... Even young children can understand basic information about what will happen in research. ... – PowerPoint PPT presentation

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Title: The Ethical Conduct of Clinical Research Involving Children


1
  • The Ethical Conduct of Clinical Research
    Involving Children
  • Institute of Medicine
  • National Academy of Sciences
  • 2004

2
IOM/Academies Reports
  • Ethical Conduct of Clinical Research Involving
    Children (2004)
  • Responsible Research (2003)
  • Protecting Participants and Facilitating Social
    and Behavioral Sciences Research (2003)
  • View or purchase at www.nap.edu

3
CONTEXT FOR IOM STUDY
  • Incentives for pediatric research
  • 1997 FDA pediatric exclusivity
  • 1998 NIH inclusion of children policy
  • 2002 Best Pharmaceuticals for Children
  • 2003 Pediatric Research Equity Act
  • 1997 to 2001 Estimated tripling of children
    participating in clinical trials
  • Underscores importance of research protections
    for children

4
CHARGE TO IOM COMMITTEE
  • Consider definition of minimal risk for purposes
    of approving research involving children
  • Assess appropriateness of regulations for
    children of different ages
  • Evaluate regulatory compliance
  • Consider IRB roles, responsibilities

5
CHARGE (contd)
  • Examine comprehension of parents and children of
    childs research participation
  • Examine process for obtaining parental permission
    and child assent to research participation
  • Examine appropriateness of payments to parents or
    children

6
REGULATORY FRAMEWORK
  • Common Rule (Subpart A) basic regulations to
    protect human research participants developed by
    DHHS now applies to 17 agencies
  • Subpart D protections for children also adopted
    by Dept of Education, CIA, and SSA but not, e.g.,
    HUD, EPA, etc.
  • FDA similar but separate regulations

7
REGULATORY FRAMEWORK
  • Some research that can be approved for adults
    cannot be approved for children
  • If research with children involves more than
    minimal risk, it must (in brief summary)
  • involve only slightly more risk AND children with
    disorder/condition AND vitally important have
    potential for direct benefit OR
  • knowledge about the disorder/condition OR
  • be approved by DHHS or FDA (rarely)

8
DEFINITION Minimal Risk
  • Definition in Subpart A
  • probability and magnitude of harm or discomfort
    anticipated in research are not greater . . .
    than those ordinarily encountered in daily life
    or . . . in routine physical or psychological
    examinations or tests.

9
DEFINITION Minimal Risk
  • Interpretation What is minimal risk is same for
    healthy and ill children
  • It is not acceptable to approve higher risk in
    research because children to be studied research
    face higher risk in their daily lives (e.g.,
    unsafe homes) or in their medical care (e.g.,
    painful tests or treatments)

10
APPROPRIATENESS OF REGULATIONS Recommendations
  • All research with children should occur under
    umbrella of formal human research participants
    program that incorporates the protections of
    Subpart D.
  • FDA rules should be consistent with other DHHS
    rules allowing waiver of parental permission when
  • Permission not in childs best interests
  • Other safeguards in place

11
COMPLIANCE WITH REGULATIONS Findings
  • Lack of dataespecially on research involving
    childrenmake systematic evaluation impossible.
  • Considerable evidence of inconsistency in
    interpretation.
  • Some evidence of inattention to certain aspects
    of regulations.

12
COMPLIANCE WITH REGULATIONS Recommendations
  • Need for more explicit federal guidance to
    investigators and IRBs to encourage consistency
    and compliance with Subpart D
  • Guidance should be easily located on federal
    IRB web sites
  • OHRP, FDA should collect more data to guide
    education, QI, enforcement

13
COMPREHENSION OF RESEARCHFindings
  • Adultsas parents and in their own rightoften
    misunderstand research
  • Therapeutic misconception believing purpose of
    clinical research is to treat rather than gain
    knowledge
  • Written information is too complex
  • Focus is too often on forms not communication

14
COMPREHENSION OF RESEARCH Findings
  • Even young children can understand basic
    information about what will happen in research.
  • Older adolescents similar to adults in many
    aspects of understanding.
  • Education and discussion usually increase
    understanding.

15
PERMISSION AND ASSENTBasics
  • Instead of informed consent
  • Parents provide permission and
  • Children, when appropriate, provide their assent
    (or dissent)

16
Assent is not informed consent
  • Seeking assent is respectful.
  • My daughter will be nine years old and she needs
    some kind of input in whats going on. Shes
    presently in a study and I need for her to be
    able to understand what shes getting herself
    into . . . Shes at the point where she asks a
    lot of questions.
  • Andrell Vaughn, parent, 2003

17
PERMISSION AND ASSENT Recommendations
  • Focus on process not forms
  • It has to be very interactive process. After I
    was asked this entire list of questions, I began
    to question my own first response. Just giving a
    kid a piece of paper--no matter how
    comprehensible--is not effective. I think the kid
    needs to be prompted with questions.
  • Sarah, research participant at age 13

18
PERMISSION AND ASSENT Recommendations
  • Provide details in protocol on how permission and
    assent will be sought.
  • Try to provide written information at 6th grade
    reading level.
  • Devise ongoing process for families facing
    serious, acute illness.

19
Permission as ongoing process
  • There is never enough time in those situations
    to make an informed decision. We signed the
    form because thats what you do.
  • Its always at the worst time to be reading this
    type of material . . . Parents arent in control
    nor is the child.
  • Joseph Lilly, parent, 2003

20
PAYMENTS TO PARENTS OR CHILDREN
  • Concern some payments may distort parents or
    childs decisions and lead to choices that are
    not in the childs best interests.
  • Findings limited data but evidence of
    considerable variability in practices
  • Findings lack of explicit IRB policies and
    guidance for investigators

21
PAYMENTS TO PARENTS OR CHILDREN Recommendations
  • IRBs should adopt explicit policies on acceptable
    payment practices.
  • To equalize access to research participation,
    IRBs, agencies, sponsors should encourage
    investigators to accommodate parental work and
    family commitments.

22
PAYMENTS TO PARENTS OR CHILDREN Recommendations
  • Okay reasonable reimbursement for expenses of
    being in research
  • Okay tokens of appreciation
  • Scrutinize carefully payments for childs time
    and inconvenience for research w/o prospect of
    benefit
  • Never okay payments to parent or child for
    increased research risk
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