1. Children in Research: They’re Not Just Small Adults
5/13/2018 4:06 PM
Children in Research: They’re Not Just Small Adults
Kelly O’Berry
IRB Education & Outreach Manager
Human Subjects
Photo by Zachary Scott, 1981, for the New York Times
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2. Overview Pros and Cons of Using Children as Subjects
Ethical Principles
Federal Regulations and Guidance
Consent/Assent
Resources

3. Children as Research Subjects
Pros:
Cons
Risks from taking medication that has not been tested in children
Regulations allow parent/guardian to grant permission
Children’s Health Act of 2000
Diseases only in kids
Risks from investigational medication and study procedures
lack legal authority to consent for themselves
Historic cases of unethical research

4. Ethical Principles: Respect for Persons Beneficence Justice
Provisions for parental permission
Considerations for the child
Beneficence
Discoveries that benefit children
Justice
Research must be done in adults before children, whenever possible
Photo by Zachary Scott, 1981, for the New York Times

5. Regulations & Guidance
Photos by Zachary Scott, 1981, for the New York Times

6. Subpart A (The Common Rule)
Definitions
Legally Authorized Representative
Criteria for IRB Approval (45 CFR )
Minimize Risk to Subjects
Risk/Benefit Evaluation
Informed Consent will be sought and documented
Additional Safeguards for Vulnerable Subjects

7. Common Rule (continued)
Obtaining Informed Consent
From subject or Legally Authorized Representative
Circumstances minimize coercion or undue influence
Language the subject or LAR can understand
Presenting the required information (elements of consent)

8. Expedited Review Limits amount of blood collected, based on subject’s:
Age
Weight
Health

9. Subpart D: Children Definitions Limits on Exempt Research Children
Parent
Guardian
Limits on Exempt Research
NOT surveys or interviews
Observation of public behavior - ONLY if researcher not participating in the activities being observed

10. Subpart D – Risk and Benefit
The IRB Can approve studies that are:
No greater than minimal risk
Greater than minimal risk,
but include the prospect for direct benefit
Greater than minimal risk and no prospect for direct benefit,
but likely to yield generalizable knowledge of subject’s disorder or condition

11. The IRB Cannot Approve:
Studies that are more than minimal risk, no prospect for direct benefit and not likely to yield generalizable results about the subject’s condition,
but opportunity to further understand, prevent or alleviate a serious problem affecting health/welfare of children

12. Approval Process for Studies the IRB Cannot Approve
Department of Health and Human Services (HHS) Posts Protocol in Federal Register
Time for Public Comment
Convene an expert panel
Protocol approved by the HHS Secretary
8-week process

13. Wards of the State Only the first 2 IRB approval categories if:
Research is related to their status as a Ward
Research is done in a setting where the majority of child subjects are not Wards
Requires appointment of an advocate in addition to the Guardian

14. Subpart B: Pregnant Women, Fetuses and Neonates
Scope
Consent/Permission from the Woman
Benefit to herself
Benefit to herself and fetus
No benefit (minimal risk to fetus and purpose to develop important biomedical knowledge)
Permission from Both Parents
Prospect of benefit only for the fetus

15. Subpart B (continued) Pregnant Teens
Follow Subpart D (research with children)
Limitations on what Researchers can do
No inducements
No part in decision-making
No determination about viability

16. Subpart C: Prisoners Definitions
Must comply with requirements of Subpart B and Subpart C

17. Informed Consent & Assent
Photo by Zachary Scott, 1981, for the New York Times

18. Parent/Guardian Permission
Granting permission – not consent
All required elements of consent
Voluntary agreement for child to participate

19. Anticipate and Address Needs
Reluctance to ask questions
Concerns about “experiments” & research
Bad experience with health care/research
Difficulty understanding words/concepts
Confuse healthcare and research (therapeutic misconception
Coercion or undue influence

20. Consent Document Use IRB template Fill in study details
When to use “your child” in place of “you”
Could describe both the parent and child participation in the study
Could collect information about the child from a proxy (parent, teacher, other)

21. Documenting Parent Permission
Valid IRB Approval Stamp
Subject Printed Name
Subject Signature & Date, if applicable
Parent/Guardian Section
Good: Mother, Father, Legal Guardian
Questionable: Step Parent, Foster Parent, Grandparent, Aunt/Uncle, Other…
Record Storage Requirements

22. Assent from the Child Obtain Assent Read and Sign
Read and Verbal Agreement
Verbal Description and Agreement
No Assent
Not capable
Prospect for direct benefit
Waiver of assent

23. Assent Document Template Assent Document
Simpler description of the study
Printed name, signature and date
Edit to reflect the proposed assent process

24. Resources UI Investigator’s Guide Federal Regulations – HHS and FDA
Family Education Rights and Privacy Act (FERPA)
Guidance from the Office of Human Research Protections (OHRP)
Special Protections for Children as Subjects
FAQ on Research with Children
Guidance from the Food and Drug Administration (FDA)
General Considerations for the Clinical Evaluation of Drugs in Infants and Children
Children and Clinical Studies.org

25. Questions/Comments?
Photo by Zachary Scott, 1981, for the New York Times