When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval. Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically.

1. Navigating Research in
Pediatric Populations
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4

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5

6. About Quorum Review IRB
Accredited
• Fully Accredited by the Association for Accreditation of Human
Research Protection Programs (AAHRPP) through 2014
• Fully compliant with FDA and OHRP requirements
International capabilities
• Boards available for the review of US and Canadian Studies
Strong Framework
• Approx. 200 employees – one of the largest IRBs in the US
Certified IRB Professionals (CIP)
• 60% of Affiliated IRB members, 40% of Regulatory staff and 20% of
study management & study support positions
6

7. The Quorum Advantage
• 13 Board meetings each week
• 24-hour site turnaround, 36-hour amendment review,
and same day site changes
• One time CV and audit documentation submission
• Support available 8am-8pm ET
• Dedicated Study Manager
7

8. The Quorum Advantage
• Secure portal with Smart Forms, status reports, and
approval documents
• Customized Phase I and Post-Marketing processes
• Flexible, customized process for AMCs
• 100% Quality Control on all documents
8

9. About the Presenter
Regulatory Attorney
Mitchell Parrish, JD, CIP
IRB Experience
• Joined Quorum Review IRB in January 2010
• Regulatory Counsel with WIRB prior to Quorum
• Former Regulatory Advisor to the National Cancer Institute Central IRB
• CIP certified
Legal Background
• Juris Doctor from the University of Oregon School of Law
• Member of the Washington State and American Bar Associations
• Member of the Health and Corporate Law Sections of the WSBA
9

10. Webinar Overview
Description of Topic Page
Importance of Research in Pediatric Populations 11
Regulatory Landscape 21
Research Permitted in Pediatric Populations 24
Recruiting Pediatric Populations 32
Consenting Pediatric Populations 40
Conducting Research in Pediatric Populations 64
Key Take Aways 74
10

11. Importance of Research in
Pediatric Populations

12. Importance of Research in Pediatric Populations
The evolving view of children in research
has changed from protecting children
from research to protecting children
through research
12

13. Importance of Research in Pediatric Populations
Old View New View
Protect children from research Protect children through research
• Result = Children not subjected to • Result = Children subjected to
the potential harm from research potential harm, but such harm is
mitigated by ensuring ethically and
scientifically sound research that
includes additional protections
• End Result = A limited number of
medical products evaluated for use • End Result = The development of
in children medical products appropriately
evaluated for use in children
13

14. Importance of Research in Pediatric Populations
Supporting the New View
Why it’s necessary to develop medical products evaluated for children
Without medical products approved for children, certain harms may
occur:
Denial of a potential treatment
o Physicians refusing to use a drug or device approved for
adults “off label”
The wrong dose
o Dose too high (harmful)
(Ex. Use of the Antibiotic Chloramphenicol in the 1950s)
o Dose too low (ineffective)
14

15. Importance of Research in Pediatric Populations
Supporting the New View
Why it’s necessary to develop medical products evaluated for children
Children are not small adults. Simply adjusting a drug’s dose or
modifying a device according to a child’s weight is not always
sufficient or appropriate due to additional considerations:
o dynamics of growth
o maturation of organs
o changes in metabolism throughout infancy and childhood
o changes in body proportion
o other developmental changes that affect how drugs are
metabolized
15

16. Importance of Research in Pediatric Populations
Supporting the New View
Why it’s necessary to develop medical products evaluated for children
Drugs may behave in a qualitatively different manner based on
age. There may also be quantitative differences including:
o dose-response relationships
o pharmacokinetic parameters
o magnitude of effect
o risk of an adverse event
o other variables that require defining based on the study population
Basing conclusions on the effects observed in adults is not always
useful, or feasible, because responses in pediatric patients may be
different from those reported in adults
16

17. Importance of Research in Pediatric Populations
Supporting the New View
Why it’s necessary to develop medical products evaluated for children
• Potential harms
• Children are not small adults
• Products behave qualitatively and quantitatively based on age
Therefore, medicinal products should be studied in children who
are representative of the range of patients likely to receive the
product once it’s marketed
17

18. Importance of Research in Pediatric Populations
Examples of demonstrated SUCCESS in conducting research in children:
Changing Drug Labels
• Ibuprofen: Studies in infants established safe and effective
dosing information for children ages 6 months to 2 years
• Zantac (ranitidine): Studies in infants established accurate
dosing information for safer and more effective use of the
drug to manage gastroesophageal reflux in seriously ill
infants
• Claritin (loratadine) syrup: Treats allergies and hives.
Studies established that patients ages 2 to 5 require a lower
dose compared to older children and adolescents
FDA Web Article, Drug Research in Children
18

19. Importance of Research in Pediatric Populations
Examples of demonstrated SUCCESS in conducting research in children:
Changing Drug Labels
• Pepcid (famotidine) tablets, capsules, and oral solution:
Studies revealed patients up to 3 months require a lower dose
to treat gastroesophageal reflux disease because their ability to
get rid of drug is less than that of older children and adults
• Midazolam hydrochloride syrup and injection: Used as a
sedative. Studies showed a higher risk of serious and life-
threatening adverse events for children with congenital heart
disease and pulmonary hypertension and identified the need to
begin therapy with doses at the lower end of the dosing range to
prevent respiratory problems in pediatric populations
FDA Web Article, Drug Research in Children
19

20. Importance of Research in Pediatric Populations
Supporting the New View
Ethically and Scientifically Sound Research
• While products specifically evaluated in children will
help protect children, there are undoubtedly still
risks from participating in research
• To mitigate these risks, all parties (sponsor, CROs,
investigators, research staff, IRB) must ensure
research is ethically and scientifically sound
20

21. Regulatory Landscape

22. Regulatory Landscape
United States
FDA DHHS
21 CFR 50 (Protection of Human Subjects) 45 CFR 46 (Protection of Human Subjects)
• Subpart D – Additional Safeguards
for Children in Clinical Investigations • Subpart D – Additional Protections
for Children Involved as Subjects in
21 CFR 56 (Institutional Review Boards) Research
FDASIA (FDA Safety and Innovation Act,
title V)
FDAAA (FDA Amendments Act of 2007,
Pediatric Tracking Requirements)
PREA (Pediatric Research Equity Act of
2007)
BPCA (Best Pharmaceuticals for Children
Act of 2007)
22

23. Regulatory Landscape
Canada
• Tri-Council Policy Statement (TCPS 2) (Ethical
Conduct for Research Involving Humans)
• ICH-E11 (Clinical Investigation of Medicinal
Products in the Pediatric Population)
• Health Canada Addendum to the ICH-E11
23

24. Research Permitted in Pediatric
Populations

25. Research Permitted in Pediatric Populations
IRBs may only APPROVE research in children that falls into one of
the following four categories:
1. Research not involving greater than minimal risk
(21 CFR 50.51/ 45 CFR 46.404 )
o Permission of parent/guardian and assent of participant
2. Research involving greater than minimal risk but presenting the
prospect of direct benefit to individual participants
(21 CFR 50.52/ 45 CFR 46.405 )
o Risk is justified by the anticipated benefit to participant
o Risk to benefit is at least as favorable to participant as available
alternatives
o Permission of parent/guardian and assent of participant
Definition of Minimal Risk = the probability and magnitude of harm or discomfort anticipated in
the research are not greater in and of themselves than those ordinarily encountered in daily life
or during the performance of routine physical or psychological examinations or tests
25

26. Research Permitted in Pediatric Populations
3. Research involving greater than minimal risk and no prospect of
direct benefit to individual subject, but likely to yield generalizable
knowledge about the subjects’ disorder or condition
(21 CFR 50.53/ 45 CFR 46.406 )
o The risk represents a minor increase over minimal risk
o Study presents experiences that are similar to actual non-research medical,
dental, psychological, social, or educational situations
o Study is likely to yield generalizable knowledge about the participant’s
disorder or condition that is vital to understanding or ameliorating the
disorder or condition
o Permission of both parents/guardians and assent of participant
Note: To enroll a “ward” research must be 1) related to child’s status as a ward or
conducted in setting where majority of children are not wards (schools, hospitals)
and 2) each ward must have an advocate
26

27. Research Permitted in Pediatric Populations
4. Research not otherwise approvable that presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the
health or welfare of children
(21 CFR 50.54/45 CFR 46.407)
IRB may not approve unless
27

28. Research Permitted in Pediatric Populations
 IRB finds and documents that study will further the understanding,
prevention, or alleviation of a serious problem affecting children
 The DHHS Secretary or FDA Commissioner in consultation with a
panel of experts and following opportunity for public review and
comment, determines:
o the study presents an opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting children
o the study will occur with sound ethical principles, and
o There are adequate provisions for obtaining both
parents/guardians permission and participant assent
Note: To enroll a “ward” research must be 1) related to child’s status as a ward or
conducted in setting where majority of children are not wards (schools, hospitals)
and 2) each ward must have an advocate
28

29. Research Permitted in Pediatric Populations
Testing Our Knowledge
A survey study is being conducted to record statistics on illicit drug use in
middle school and high school students. As part of the research, students
are asked to complete a series of questions regarding their drug use, if
any, and are asked to sign and date the questionnaire.
Assuming the study is likely to yield generalizable knowledge about
underage drug use and addiction, which regulatory category
applies?
29

30. Research Permitted in Pediatric Populations
A. 21 CFR 50.51/45 CFR 46.404 Research not involving greater than minimal risk
B. 21 CFR 50.52/45 CFR 46.405 Research involving greater than minimal risk but
presenting the prospect of direct benefit to individual participants
C. 21 CFR 50.53/ 45 CFR 46.406 Research involving greater than minimal risk
and no prospect of direct benefit to individual subject, but likely to yield
generalizable knowledge about the subjects’ disorder or condition
D. 21 CFR 50.54/45 CFR 46.407 Research not otherwise approvable that
presents an opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children
30

31. Research Permitted in Pediatric Populations
Answer:
C. 21 CFR 50.53/ 45 CFR 46.406 Research involving greater than
minimal risk and no prospect of direct benefit to individual subject,
but likely to yield generalizable knowledge about the subjects’
disorder or condition
31

32. Recruiting Pediatric Populations

33. Recruiting Pediatric Populations
Recruiting activities are the beginning of
the informed consent process
Recruiting Study Subjects – Information Sheet:
Guidance for Institutional Review Boards and Clinical Investigators
Most applicable guidance in knowing what to consider when advertising to or recruiting children
33

34. Recruiting Pediatric Populations
Based on FDA guidance, the IRB needs
to review advertising and recruitment to
ensure advertisements to children:
• Are not unduly coercive
• Do not promise or imply a favorable outcome or other
benefits beyond what is contained in the protocol
• Do not communicate that the study product is safe or
effective for the purposes under investigation
34

35. Recruiting Pediatric Populations
• Do not make claims that the study product is known to be
equivalent or superior to any other study product
• Do not include language indicating that regulatory
authorities, such as the FDA and IRB, have approved the
research
• Do not cause therapeutic misconception (e.g. modify the
word “treatment” or “medicine” with a word that does not
imply a benefit)
35

36. Recruiting Pediatric Populations
• Do not promise or imply free medical treatment when the
intent is only to say subjects will not be charged for
participation in the investigation
• Do not emphasize payment
• Provide information limited to that which subjects need to
determine their eligibility and interest
• Do not include statements that are generally misleading
36

37. Recruiting Pediatric Populations
Testing Our Knowledge
A proposed radio advertisement to be played on the local #1 hit music station reads:
Do you suffer from Asthma? Asthma is a chronic disease of the airways that makes
breathing difficult. ABC Health Clinics is conducting a research study to test the
safety and effectiveness of an investigational drug that will cure asthma. If you are
16-22 years old, have asthma, and want $300 to help buy those next concert tickets,
then call 1-800-123-4567 to see if you qualify for the study.
What information in the advertisement would the IRB find most problematic?
What information in the advertisement would the IRB find most
problematic?
37

38. Recruiting Pediatric Populations
A. “that will cure asthma”
B. “want $300 to help buy those next concert tickets”
C. “test the safety and effectiveness of an investigational
drug”
D. A and B
E. A, B and C
38

39. Recruiting Pediatric Populations
Answer:
D. A and B
39

40. Consenting Pediatric Populations

41. Consenting Pediatric Populations
To enroll a child into research there must be
permission AND assent
41

42. Consenting Pediatric Populations
Who Can Give Permission?
Parent
a child’s biological
or adoptive parent
LARor judicial or other body
individual
authorized under applicable law to
Guardian
individual who is consent on behalf of a child
authorized under
applicable state or
local law to consent Note: There is a significant difference
on behalf of a child between having the authority to consent on
behalf of a child for medical care versus
enrollment in research
42

43. Consenting Pediatric Populations
Permission • Explanation of the research
Definition: The agreement of • Any benefits
parent(s) or guardian to the • Confidentiality
participation of their child or ward in
research [21 CFR 50.3(r)/ 45 CFR 46.402(c)] • Contact information
• Foreseeable risks & discomforts
In other words: A parent must
provide their consent consistent • Alternative Procedures
with the consent regulations
• Compensation and Treatment for
injuries
Therefore, for a child to participate
in research the parent must • Voluntary participation and no loss
generally sign a consent form on of benefits
behalf of their child and that • Additional elements found at 21
consent form must contain all CFR 50.25(b)/ 45 CFR 46.116(b)
applicable consent elements (e.g. costs)
43

44. Consenting Pediatric Populations
Permission
One or both Parents/Guardians
1. Research not involving greater than minimal risk
(21 CFR 50.51/ 45 CFR 46.404 )
• One parent/guardian
2. Research involving greater than minimal risk but presenting the
prospect of direct benefit to individual participants
(21 CFR 50.52/ 45 CFR 46.405 )
• One parent/guardian
44

45. Consenting Pediatric Populations
Permission
One or both Parents/Guardians
3. Research involving greater than minimal risk and no
prospect of direct benefit to individual subject, but likely to
yield generalizable knowledge about the subjects’ disorder
or condition (21 CFR 50.53/ 45 CFR 46.406 )
• Both parents/guardians
4. Research not otherwise approvable that presents an
opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children (21 CFR
50.54/45 CFR 46.407)
• Both parents/guardians
45

46. Consenting Pediatric Populations
If Permission of both Parents/Guardians is
required then . . .
both parents/guardians must give their permission
unless one is deceased, unknown, incompetent, or
not reasonably available, or when only one has legal
responsibility for the care and custody of the child
46

47. Consenting Pediatric Populations
Testing Our Knowledge
An IRB is reviewing a Phase III study involving an investigational drug
for juvenile diabetes. The drug has some potential significant side
effects.
47

48. Consenting Pediatric Populations
Testing Our Knowledge
An IRB is reviewing a Phase III study involving an investigational drug
for juvenile diabetes. The drug has some potential significant side
effects.
Is permission of one or both parents required?
48

49. Consenting Pediatric Populations
A. One, since the research does not involve greater than minimal risk
B. One, since the research involves greater than minimal risk but presents
the prospect of direct benefit
C. Two, since the research involves greater than minimal risk but presents
the prospect of direct benefit
D. Two, since the IRB determined that while the research presents the
prospect of direct benefit, the drug has potential significant side effects
49

50. Consenting Pediatric Populations
Answer:
D. Two, since the IRB determined that while the research
presents the prospect of direct benefit, the drug has potential
significant side effects
50

51. Consenting Pediatric Populations
Who Must Assent?
Minor Emancipated Minor
a person who, under local law, is under the a person who is recognized to have the full
age of majority. The age of majority is the age legal rights of an adult under local law even
at which the individual is considered an adult. though he/she is a minor. Minors can become
Generally, minors cannot consent to emancipated through certain actions, such as
participate in research marriage, enlistment in the military or living
independently. Emancipation may require a
Child court order. Emancipated minors may be able
defined by federal regulations as a person to consent to research depending on local law
who has not attained the legal age for consent
to treatments or procedures involved in
research under local law Mature Minor
a person who, under local law, may consent
Ward to certain health care treatment or procedures
a minor who is has a guardian appointed by a (such as drug or substance abuse or sexually
court or governmental agency; in other words, transmitted diseases) even though he/she is a
a minor who is under the temporary custody minor. Mature minors may be able to consent
or care of the local jurisdiction in which they to research depending on local law
reside (e.g. a foster child)
51

52. Consenting Pediatric Populations
Mature Minor Emancipated
(consent) Minor (consent)
Minor
Child Ward
(assent) (assent)
52

53. Consenting Pediatric Populations
PA
NE 21
19
MS AL
19
21
Puerto Rico
21
States that are not “18” – see map
53

54. Consenting Pediatric Populations
NU
19
YT
NT
19
19
NL
BC 19
19
NS
NB 19
19
Provinces and Territories in Canada that are not “18” – see map
54

55. Consenting Pediatric Populations
Assent
Definition:
A child’s affirmative agreement to participate in research
(mere failure to object may not be construed as consent)
[21 CFR 50.3/45CFR46.402]
55

56. Consenting Pediatric Populations
Assent
To determine whether Assent is required,
how to administer assent, and how to
document assent the IRB must consider
• age
• maturity
• psychological state
56

57. Consenting Pediatric Populations
Assent requirements Waiver of Assent. Requirement for
Waiver 21 CFR 50.55(c)/45 CFR
Based on 46.408(a)
age
1. The capability of some or all of the
children is so limited that they
cannot reasonably be consulted
below7 2.
or
the study presents the prospect of
direct benefit that is important to
the health or well-being of the
children and is available only in
the context of research (ex. pediatric
oncology trials)
57

58. Consenting Pediatric Populations
Assent requirements Option 1: Assent form
Based on for ages 7-18 with
reading levels at lowest
age Between age
• participant signs
7 and 18
assent (or assent is
documented in
participant’s chart)
Reminder!
• Different ages of majority
• Whenever a participant turns the age of
majority during a study that participant
must be consented with the consent form
58

59. Consenting Pediatric Populations
Assent requirements Option 2: Assent Form
Based on for ages 7-11 and 12-18
with reading levels at
age Between the lowest age
• participant signs assent
7 and 18
(or assent is documented
in participant’s chart)
Reminder!
• Different ages of majority
• Whenever a participant turns the age of
majority during a study that participant
must be consented with the consent form
59

60. Consenting Pediatric Populations
Assent requirements Option 3: Assent form
Based on 7-15; or assent forms 7-
11 and 12-15; and
age Between consent/assent form for
participants 16-18
•
7 and 18
means the consent form is
written at a level in which a 16
year old could understand and
means that the participant will
provide their written assent on
the actual consent form after
their parent/guardian’s consent
Reminder!
signature
• Different ages of majority
• Whenever a participant turns the age of
majority during a study that participant
must be consented with the consent form
60

61. Consenting Pediatric Populations
Waiving Assent no matter the age, maturity, or psychological state
45 CFR 46.408(a)
The IRB can always waive assent altogether for all
participants if the following criteria are satisfied:
• The clinical investigation involves no more than minimal
risk to the subjects;
• The waiver will not adversely affect the rights and welfare
of the subjects;
• The clinical investigation could not practicably be carried
out without the waiver; and
• Whenever appropriate, the subjects will be provided with
additional pertinent information after participation
61

62. Conducting Research in Pediatric Populations
Testing Our Knowledge
An IRB reviewing a non-Hodgkin’s lymphoma oncology clinical trial (with
the potential for direct benefit) waived the requirement for assent for those
participants under the age of seven. A six-year-old child with non-
Hodgkin’s lymphoma is enrolled in the trial. After three months in the trial,
the child has her seventh birthday.
Must the child be provided with the assent form for participants 7-
11 years old and provide her assent in order to remain in the trial?
62

63. Conducting Research in Pediatric Populations
Testing Our Knowledge
An IRB reviewing a non-Hodgkin’s lymphoma oncology clinical trial (with
the potential for direct benefit) waived the requirement for assent for those
participants under the age of seven. A six-year-old child with non-
Hodgkin’s lymphoma is enrolled in the trial. After three months in the trial,
the child has her seventh birthday.
Must the child be provided with the assent form for participants 7-
11 years old and provide her assent in order to remain in the trial?
NO
63

64. Conducting Research in Pediatric Populations

65. Conducting Research in Pediatric Populations
In order to approve Pediatric research that is permitted under
the regulations an IRB must ensure . . .
• risks to participants are minimized
• risk to benefit ratio is acceptable
• selection of participants is equitable
• informed consent and assent will be sought and documented
• adequate safety monitoring is in place
• adequate privacy protections are in place
• additional safeguards are in place to protect the rights and
welfare of participants
21 CFR 56.111 and 45 CFR 46.111
65

66. Conducting Research in Pediatric Populations
In order to approve Pediatric research that is permitted under
the regulations an IRB must ensure . . .
• risks to participants are minimized
• risk to benefit ratio is acceptable
• selection of participants is equitable
• informed consent and assent will be sought and documented
• adequate safety monitoring is in place
• adequate privacy protections are in place
• additional safeguards are in place to protect the rights and
welfare of participants
21 CFR 56.111 and 45 CFR 46.111
66

67. Conducting Research in Pediatric Populations
In order to approve Pediatric research that is permitted under
the regulations an IRB must ensure . . .
• risks to participants are minimized
• risk to benefit ratio is acceptable
• selection of participants is equitable
• informed consent and assent will be sought and documented
• adequate safety monitoring is in place
• adequate privacy protections are in place
• additional safeguards are in place to protect the rights and
welfare of participants
21 CFR 56.111 and 45 CFR 46.111
67

68. Conducting Research in Pediatric Populations
• Medical facilities are scary and
Minimizing cause distress
Conduct the research in a child friendly
Risks To atmosphere to reduce distress
Participants
ex. play equipment, furniture, age
appropriate food, activities
• Medical procedures hurt
Use procedures to reduce pain
To help understand ex. topical anesthesia to place IV
catheters, indwelling catheters rather than
what it means to repeated venipunctures for blood sampling
minimize risks to • More procedures equal more
children evaluate risks distress and more pain
Be efficient to reduce distress and pain
from the perspective of ex. if possible, conduct interventions at the
a child: same time clinically indicated interventions
are scheduled; utilize staff that is experienced
working with children to ensure they are
skilled and quick at administering procedures,
such as blood draws
68

69. Conducting Research in Pediatric Populations
•
Minimizing
Minimize risks to children by tailoring
the consent process to children
Design the consent and assent process to ensure
Risks To comprehension, appropriate parental/guardian
involvement, and privacy issues
Participants • Ex. Assent forms written at the appropriate
reading level
• Ex. Inclusion of graphs, charts, or visuals
incorporated into the assent discussion
•
To help understand
Ex. Separate discussions with children and
their parents as necessary
what it means to • Minimize risks to children by
minimize risks to scientifically evaluating risks
Design protocols to protect against adverse
children, evaluate the outcomes that generally only affect minors
protocol and consent • Ex. impairments of cognitive growth or skeletal
development
process specifically for • Ex. reduce the overall amount of blood
required for the study by using sensitive
children assays, pediatric-enabled laboratories, and
population pharmacokinetic approaches
69

70. Conducting Research in Pediatric Populations
Blood Draw
• Type of research in which
Volumes in the child is enrolled
Children • Severity of the child’s
The IRB determines an
condition
appropriate blood draw volume
• Hemoglobin levels
taking into account the following
• Frequency of blood draws
Ex. Various Children’s Hospitals throughout
the United States follow these
recommendations: • Collection procedure
Maximum Allowable Blood Draw Volumes
(Clinical + Research) • Age of population
Maximum of 2.5% of total blood volume in one
blood draw and a maximum of 5.0% of total
• Protocol justification for the
blood volume in a 30 day period. volume
www.seattlechildrens.org/pdf/blood-volume-chart.pdf
70

71. Conducting Research in Pediatric Populations
Testing Our Knowledge
A study in children involves several blood draws over the course of 30
days. The target total amount of blood drawn within that time is 5% of a
participant’s blood volume. The protocol for the study notes that a blood
draw may have to be repeated in the event that a child’s blood sample is
contaminated in the laboratory.
Is the potential blood collection volume acceptable?
71

72. Conducting Research in Pediatric Populations
Testing Our Knowledge
A study in children involves several blood draws over the course of 30
days. The target total amount of blood drawn within that time is 5% of a
participant’s blood volume. The protocol for the study notes that a blood
draw may have to be repeated in the event that a child’s blood sample is
contaminated in the laboratory.
Is the potential blood collection volume acceptable?
NO
72

73. Conducting Research in Pediatric Populations
Additional • Require that each Investigator has
the appropriate training and
Safeguards expertise in pediatric populations
(i.e. use a pediatrician, pediatric
oncologist, pediatric cardiologist,
First, one additional safeguard is
etc.)
ensuring the protocol fits into one of
• More frequent DSMB meetings
the categories of research in children.
Remember, the IRB cannot approve • Omit any discussion of
the research unless it fits into one of compensation from the assent
the four applicable regulatory discussion
categories • Develop documents to periodically
check a child’s willingness to
Second, other examples include: continue in the research (remember,
assent is an active and ongoing
process!)
73

74. Key Take Aways

75. Key Take Aways
• Research in children is important and know how to protect the
rights, safety, and welfare of these young participants
• The key regulatory documents are 21 CFR 50, Subpart D; 45
CFR 46, Subpart D; and in Canada ICH-E11
• The IRB can only approve research in children that falls into one
of four categories and these categories also tell us whether the
consent of one or both parents/guardians is required
• Tailor advertisements appropriately to children when they are
your audience
• Permission and assent are required in order to enroll children
into research and understand how to obtain and document both
• Always ensure the research minimizes risks to children and
includes additional safeguards
75

76. Additional Questions
• You may submit questions during our webinar
survey, or
• You may email your questions to:
clientrelations@quorumreview.com
• We will do our best to follow-up individually or
answer your questions in the Q&A we post on
our website
76

77. Webinar Follow-Up
• The webinar Recording, Slide Deck,
and Q&A will be posted on our website
• We will email you a link to view these
items as they become available
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SURVEY and provide us with feedback
77

78. Connect with us!
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@quorumreview youtube.com/quorumreview
78

79. Thank You for Attending!
79

80. Navigating Research in
Pediatric Populations
fully accredited since 2006