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Dartmouth College and Dartmouth
-
Hitchcock Medical Center

Committee for the Protection of Human Subjects


CPHS Study Plan
for Expedited Review











Template v.
9.8
.2009


Instructions:

The following information in the format provided below is an applic
ation for CPHS review. Read
through each section and respond to each item (even if to indicate NA
-

not applicable). Please also
review the CHECKLIST for Expedited Submission. We have provided some guidance
information under each question.


Please defi
ne all acronyms at first use and attach a glossary if more than 3 acronyms are used in
this application.


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isplay the forms and reviewing toolbars.

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Attachments:

Complete and submit Attachment(s) if applicable to the research study.

Attachments are downloadable from this webpage:
http://www.dartmouth.edu/~cphs/tosubmit
/forms/StudyPlanAttach


Attachment D: Employees and Students


Attachment E: Illiterate Participants


Attachment F: Research Involving Children


Attachment H: Request for Waiver of Par
ticipant Consent


Attachment I: Request for Waiver of Participant

Signed Consent Form


Attachment L: International Research

==================================================================

Local Principal Investigator
:
Kent

P.

Hymel,

MD





Department:


Pediatrics


Study Title:
Abusive

Head

Trauma

(AHT)

Probability

Study

Funding Source (Sponsor):

Internal


CPHS Study Plan Version Date:
2
-
8
-
2010


1.

Abstract.

P
rovide an abstract of the proposed research
in language that can be understood by a
non
-
scientist
. The abstract should summarize the objectives of this project and the procedures to
be used, with an emphasis on what will happen to the subjects.

(Maximum 2
50 words)


Pediatric abusive head trauma primarily affects infants and very young children. Over
-
diagnosis of
pediatric abusive head trauma can compromise the doctor
-
patient relationship and potentially lead to
inappropriate loss of parental rights or to
imprisonment. Under
-
diagnosis creates significant risk for a
child returning to an abusive environment. Unfortunately, physicians struggle to define a “reasonable
medical certainty” of abuse and have demonstrated biases regarding abuse related to race,
s
ocioeconomic and marital status.


Physicians caring for acutely head
-
injured infants and young children need evidence
-
based diagnostic
tools that can facilitate enhanced recognition of suspected abuse and a more consistent medical
response.


A clinical pre
diction rule is a decision
-
making tool that quantifies and then combines the contributions
of specific clinical variables to predict the probability of a diagnosis, prognosis, or response to treatment
in an individual patient.


We propose: (1) To conduct a

prospective, multicenter study of children under 3 years of age
hospitalized with acute, nonpenetrating, traumatic cranial injuries; (2) To identify clinical variables that
are significant and independent predictors of abuse in our study population; and (
3) To use these
variables to derive (and later validate) a clinical prediction rule for pediatric abusive head trauma.


This is strictly an observational protocol. “Standard of care” treatment protocols will give all required
data to derive the clinical p
rediction rule. No treatments will be given, questions asked, consultations
completed, tests conducted, data captured, or reports of suspected abuse made that would not normally
be accomplished by treating physicians.



2. Objectives & Hypotheses:

List y
our research objectives and hypotheses.


Our primary research objective:

To derive a clinical prediction rule for pediatric abusive head trauma that will someday facilitate rapid
and simple calculation of an evidence
-
based estimate of the probability of ab
use for any hospitalized,
acutely head
-
injured child less than 3 years of age.


Our primary research hypothesis:

We hypothesize that acute respiratory and circulatory compromise, loss of consciousness for more than
24 hours, and subcortical brain injury wi
ll each be highly predictive of abusive head trauma in our target
patient population.



3
.

Introduction:

a) Explain the background of this project so that we will understand why it is
important to perform this research project. b) Summarize previously p
ublished data and pilot
studies. Be sure to include a discussion of any data that do not support the study hypothesis. If a
study similar to the one being proposed has already been completed, explain why the proposed
study is necessary. c) For studies d
esigned to compare or evaluate therapies, there should be a
statement of the relative advantages or disadvantages of alternative modes of therapy. d) If not
obvious, explain why human subjects are necessary. Include references for all published data
cite
d.


Background:

According to the most recent data, more than 900,000 children are victims of child maltreatment in the
United States every year, with more than 16% suffering physical abuse.[1] The annual incidence of
physical abuse in childhood is approxi
mately 1:500. By comparison, the incidence of diseases most
commonly tested by uniform newborn screening is typically lower that 1 in 5,000.[2]


Inflicted injury is the most important cause of traumatic death during infancy.[3
-
5] In 2004, more than
1,500

children died from abuse or neglect.[1] In 2003, homicide was the third leading cause of death
among children between 1 and 4 years of age.[6]


According to the Agency for Healthcare Research and Quality, the annual short
-
term costs of medical
and legal
consequences of child maltreatment are $24 billion, with long
-
term costs exceeding $69
billion.[7] Those who survive are likely to suffer serious, permanent morbidity limiting their future
productivity and quality of life.[8
-
12] Decreasing the morbidity
and mortality of inflicted injuries is
cited as a major goal of the National Institutes of Health and the Institute of Child Health and Human
Development.[13,14]


During infancy, abusive head trauma is the leading cause of traumatic death and disability[4]
,
accounting for nearly one quarter of pediatric hospital admissions for head trauma[15
-
17] and two thirds
of infant homicides[5]. The incidence of abusive head trauma in the first 1 or 2 years of life has been
estimated in various studies to range from 1
6.1 to 33.8 cases per 100,000 infants per year.[18
-
22]


Abusive acts directed against infants and young children have been linked to intracranial and retinal
hemorrhages[23
-
27], focal traumatic injuries in the region of the craniocervical junction, acute
r
espiratory and/or circulatory compromise[28
-
31], and diffuse brain hypoxia
-
ischemia or
swelling[31,33
-
35]. Many survivors of abusive head trauma during infancy will manifest devastating,
long
-
term, sensory, cognitive, motor and/or behavioral deficits.[33,
36
-
41]


Diagnosing child abuse requires objectivity. Unfortunately, physicians struggle to define “a reasonable
medical certainty” of abuse[42,43] and demonstrate inherent biases regarding abuse related to race,
socioeconomic and marital status.[44
-
47] P
ediatricians and pathologists have revealed significant
differences in their initial forensic impressions regarding abusive versus nonabusive head trauma.[48]
Despite these challenges, very few investigators have proposed an evidence
-
based approach to the

diagnosis of child maltreatment.[49
-
51]


Diagnosing child abuse can make some physicians uncomfortable. Faced with a need to question
families about abuse, to justify a diagnostic workup for abuse, or to explain a decision to report
suspected abuse to ch
ild protection authorities, these physicians may opt to ignore the possibility of
abuse.[52,53] When abusive head trauma is “missed” or “misdiagnosed,” the cost can be very high. In
their landmark 1999 study, Jenny and colleagues reported that 28% of vic
tims of abusive head trauma
were reinjured and 9% died from repetitive abusive trauma during the period of diagnostic delay.[44]


With this observational study, we propose to derive a clinical prediction rule for pediatric abusive head
trauma that will ult
imately facilitate rapid and simple calculation of an evidence
-
based estimate of the
probability of abuse for any hospitalized, acutely head
-
injured child less than 3 years of age. We predict
that future, routine use of a (subsequently) validated clinical

prediction rule for pediatric abusive head
trauma will decrease the number of missed cases and improve the consistency of physicians’ medical
response to suspected abuse.




Pilot Study Data:

In 2006, participants in the Pediatric Brain Injury Research Ne
twork (PediBIRN) completed a
multicenter, prospective, cohort study of “Determinants of Outcome from Head Trauma during
Infancy.” Subjects were enrolled at 9 participating sites, and extensive historical, clinical, radiological,
investigative and outcome

data regarding 54 hospitalized, acutely head
-
injured children under 3 years of
age was captured.[17]


In a recent secondary analysis of this captured data, we eliminated victims of motor vehicle crashes
(n=4) and thereafter sorted the remaining subjects (
n=50) into 3 comparison groups, categorized as
abusive (n=11), nonabusive (n=26) or undetermined (n=13). The criteria used for this sorting were
specifically written to minimize circular reasoning and inherent biases, to be free of references to
specific
cranial injuries or to injury severity, and to reflect an emerging consensus regarding such
criteria.[16,17,25,48]


We categorized cases as “abusive” IF: (1) the caregiver admitted abusive acts, (2) the caregiver’s
abusive acts were independently witnessed
, (3) the caregiver specifically denied trauma even though a
perambulatory child in his/her care became clearly and persistently ill with signs linked to acute
traumatic cranial injuries, (4) the caregiver’s account of the child’s head injury event was cle
arly
historically inconsistent with repetition over time, OR IF (5) the head
-
injured child revealed multiple
categories of noncranial injuries considered moderately or highly suspicious for abuse.


We categorized cases as “nonabusive” IF: (1) the child’s a
ccidental head injury event was independently
witnessed, OR IF (2) the caregiver’s account of the child’s accidental head injury event was
developmentally consistent, historically consistent with repetition over time, and the child failed to
reveal any non
cranial injuries suspicious for abuse.


We categorized cases as “undetermined” IF: (1) the child met criteria for both abusive
and

nonabusive
head trauma; (2) the child failed to meet criteria for either abusive
or

nonabusive head trauma; OR IF (3)
the chi
ld’s caregiver at the time of child’s head injury (or at the time of acute onset of clinical signs
linked to the child’s unexplained head injuries) could not be interviewed.


Thereafter, we created a list of 39 clinical variables that we theorized might di
scriminate between
abusive and other (nonabusive or undetermined) etiologies of head trauma in hospitalized, acutely head
-
injured children under 3 years of age. From these 39, we identified a subset of 23 clinical variables that
discriminated significantl
y (
P
<.05 by Fisher exact testing) between study cases of abusive head trauma
(n=11) and all other study subjects (n=39), categorized as nonabusive (n=26) or undetermined (n=13).
[NOTE: Equivalent statistical analysis revealed that only 1 of 39 clinical v
ariables discriminated
significantly between study cases categorized as nonabusive (n=26) and those categorized as
undetermined (n=13).]


Next, we calculated the study pre
-
test probability of abusive head trauma (that is, 11 of 50 = 0.22).
Finally, for ea
ch of the 23 statistically significant “discriminators” of head trauma etiology, we
calculated sensitivity and specificity for abuse, positive and negative predictive values for abuse,
positive and negative likelihood ratios for abuse, and positive and neg
ative post
-
test probabilities of
abuse for our study population. As summarized in the table that follows, study post
-
test probabilities of
abuse, adjusted from our study baseline or pre
-
test probability of abuse (that is, 11 of 50 cases or 0.22),
ranged f
rom 0.03 to 0.93 for our 23 statistically significant “discriminators” of head trauma etiology.




Table: Positive and negative study post
-
test probabilities of abuse for 23 statistically significant
(
P
<.05 by Fisher exact testing) “discriminat
ors” of pediatric head trauma etiology.


VARIABLE










PPTP


NPTP

Isolated inertial injuries








0.93


0.09

Subcortical ‘greatest depth’ of visible injury on neuroimaging



0.89


0.07

Diffuse axonal injury on CT imaging







0.86


0.17

Impairment o
r complete LOC >24 hours, decerebrate, decorticate or flaccid

0.80


0.16

Bilateral brain hypoxia
-
ischemia or swelling






0.78


0.10

Delayed impairment or complete LOC, onset after admission



0.75


0.17

Bilateral subdural hemorrhage







0.73


0.08

Sign
(s) of circulatory compromise prior to admission




0.73


0.08

Sign(s) of respiratory compromise prior to admission




0.67


0.08

Brain herniation or shifting








0.67


0.16

Interhemispheric subdural hemorrhage






0.58


0.11

Brain contusion(s)









0.55


0.11

Any impairment or complete LOC prior to admission, duration not specified

0.48


0.03

Any inertial injuries










0.48


0.03

Single density, hyperdense subdural hemorrhage on CT imaging



0.44


0.09

Any abnormal subdural hemorrhage(s) or coll
ection(s)




0.41


0.07

Craniofacial soft tissue injuries







0.12


0.44

Any contact injuries









0.11


0.58

Any skull fracture(s)









0.07


0.45

No brain hypoxia
-
ischemia or swelling






0.05


0.75

Isolated contact injuries








0.04


0.38

Is
olated, unilateral, linear, parietal, nondiastatic skull fracture



0.03


0.31

Scalp, skull or epidural ‘greatest depth’ of visible injury on neuroimaging


0.03


0.34


Abbreviation
s and Definitions
: PPTP=positive post
-
test probability (that is, the study p
robability of
abuse if the specific finding was present); NPTP=negative post
-
test probability (that is, the study
probability of abuse if the specific finding was absent); LOC=loss of consciousness; CT=computed
tomography


Because our sample size was small
, these results may not be generalizable. A larger study is required.
On the other hand, the range of study post
-
test probabilities of abuse (from 0.03 to 0.93) is sufficiently
broad to suggest that some combination of these 23 variables can be used to d
erive a clinical prediction
rule that is both a sensitive and specific predictor of abuse

or
suspected

abuse

in our target
population of hospitalized, acutely head
-
injured children less than 3 years of age.


References Cited:

1.

US Department of Health and Hu
man Services, Administration of Children youth and Families,
Child maltreatment 2006, US Department of health and Human Services, Editor. 2008,
Government Printing Office, Washington DC.

2.

Watson M, et al. Newborn Screening: toward a uniform screening panel
and system. Report for
public comment. 2005, Federal Register.

3.

Brenner RA, Overpeck MD, Trumble AC, DerSimonian R, Berendes HW. Deaths attributable to
injuries in infants, United States, 1983
-
1991. Pediatrics 1999;103:968
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974.

4.

Duhaime AC, Christian CW, R
orke LB, Zimmerman RA. Nonaccidental head injury in infants:
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baby syndrome.” N Engl J Med 1998;338:1822
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Overpeck MD, Brenner RA, Trumble AC, Trifiletti LB, Berendes HW. Risk factors for infant
homicide in the United States. N Engl J M
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6.

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Russo CA, Hambrick MM, Owens PL. Hospital stays related to child maltreatment, 2005. HCUP
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8.

Barlow KM, Thomson E, Johnson D, Minns RA. Late neurologic and cognitive sequelae of
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185.

9.

Makoroff KL, Putnam FW. Outcomes of infants and chil
dren with inflicted traumatic brain injury.
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502.

10.

Keenan HT, Runyan DK, Nocera M. Child outcomes and family characteristics 1 year after severe
inflicted or noninflicted traumatic brain injury. Pediatrics 2006;117(2):317
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324.

11.

Keenan HT, Runyan DK, Marshall SW, Nocera MA, Merten DF. A population
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based comparison
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traumatic brain injury. Pediatrics 2004;114(3):633
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639.

12.

King WJ,

MacKay M, Sirnick A. Shaken baby syndrome in Canada: Clinical characteristics and
outcomes of hospital cases. CMAJ 2003;168(2):155
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159.

13.

NICHD. About NICHD. 2006 09/13/2006 [cited 2008 March, 12]; Available from:
http://www.nichd.nih.gov/about/org/crmc/cdb/prog_sadcmv/index.cfm
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14.

Nicholson CE. Research Agenda, in Inflicted Childhood Neurotrauma, Reece RM and Nicholson
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sda, MD; p. 285
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287.

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postacute care. J Head Trauma Rehabil 1997;12:1
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10.

16.

Duhaime AC, Alario AJ, Lewander WJ, Schut L, Sutton LN, Seidl TS, Nudelman S, Budenz
D,
Hertle R. Tsiaras W, Loporchio S. Head injury in very young children: mechanisms, injury types,
and ophthalmologic findings in 100 hospitalized patients younger than 2 years of age. Pediatrics
1992;90(2 Pt 1):179
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185.

17.

Hymel KP, Makoroff KL, Laskey AL,

Conaway MR, Blackman JA. Mechanisms, clinical
presentations, injuries, and outcomes from inflicted versus noninflicted head trauma during
infancy: results of a prospective, multicentered comparison study. Pediatrics 2007;119:922
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929.

18.

Keenan HT, Runyan D
K, Marshall SW, Nocera MA, Merten DF, Sinal SH. A population
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based
study of inflicted traumatic brain injury in young children. JAMA 2003;290:2542
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2543.

19.

Sills MR, Libby AM, Orton HD. Prehospital and in
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hospital mortality: a comparison of intentional
and

unintentional traumatic brain injuries in Colorado children. Arch Pediatr Adolesc med
2005;159:665
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670.

20.

Ellingson KD, Levanthal JM, Weiss HB. Using hospital data to track inflicted traumatic brain
injury. Am J Prev Med 2008;34:S157
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162.

21.

Minns RA, Jones

PA, Mok JY. Annual incidence of shaken impact syndrome in young children.
Am J Prev Med 2008;34:S126
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133.

22.

Barlow KM, Minns RA. Annual incidence of shaken impact syndrome in young children. Lancet
2000;356:1571
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1572.

23.

Reece RM, Sege R. Childhood head i
njuries: accidental or inflicted? Arch Pediatr Adolesc Med
2000;154(1):11
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15.

24.

Bechtel K, Stoessel K, Leventhal JM, Ogle E, Teague B, Lavietes S, Banyas B, Allen K, Dziura K,
Duncan C. Characteristics that distinguish accidental from abusive injury in hos
pitalized young
children with head trauma. Pediatrics 2004;114:165
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168.

25.

Feldman KW, Bethel R, Shugerman RP, Grossman DC, Grady MS, Ellenbogen RG. The cause of
infant and toddler subdural hemorrhage: a prospective study. Pediatrics 2001;108(0):636
-
646.

26.

K
eenan HT, Runyan DK, Marshall SW, Nocera MA, Merten DF. A population
-
based comparison
of clinical and outcome characteristics of young children with serious inflicted and noninflicted
traumatic brain injury. Pediatrics 2004;114:633
-
639.

27.

Levin AV. Retina
l hemorrhage and child abuse. In: Recent Advances in Pediatrics, David TJ,
editor. Churchhill Livingstone

2000; London; p. 151
-
219.

28.

Geddes JF, Whitwell HL, Graham DI. Traumatic axonal injury: practical issues for diagnosis in
medicolegal cases. Neuropa
thol Appl Neurobiol 2000;26(2):105
-
116.

29.

Geddes JF, Vowles GH, Hackshaw AK, Nickols CD, Scott IS, Whitwell HL. Neuropathology of
inflicted head injury in children. II. Microscopic brain injury in infants. Brain 2001;124(Pt 7):
1299
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1306.

30.

Geddes JF, Hacks
haw AK, Vowles GH, Nickols CD, Whitwell HL. Neuropathology of inflicted
head injury in children. I. Patterns of brain damage. Brain 2001;124(Pt 7):1290
-
1298.

31.

Johnson DL. Boal D, Baule R. Role of apnea in nonaccidental head injury. Pediatr Neurosurg
19
95;23(6):305
-
310.

32.

Karandikar S, Coles L, Jayawant S, Kemp AM. The neurodevelopmental outcome in infants who
have sustained a subdural hemorrhage from non
-
accidental trauma. Child Abuse Review
2004;13:178
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187.

33.

Duhaime AC, Christian C, Moss E, Seidl T. Lo
ng
-
term outcome in infants with the shaking
-
impact syndrome. Pediatr Neurosurg 1996;24(6):292
-
298.

34.

Duhaime AC, Bilaniuk L, Zimmerman R. The “big black brain”: radiographic changes after
severe inflicted head injury in infancy. J Neurotrauma 1993;10(Supp
l 1):S59, abstract.

35.

Zimmerman RA, Bilaniuk LT, Bruce D, Schut L, Uzzell B, Goldberg HI. Computed tomography
of craniocerebral injury in the abused child. Radiology 1979;130(3):687
-
690.

36.

Anderson V, Fenwick T, Manley T, Robertson I. Attentional skills fol
lowing traumatic brain
injury in childhood: a computational analysis. Brain Inj 1998;12(11):937
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939.

37.

Barlow K, Thompson E, Johnson D, Minns RA. The neurological outcome on non
-
accidental
head injury. Pediatric Rehab 2004;7:195
-
203.

38.

Bonnier C, Nassogne M
C, Evrard P. Outcome and prognosis of whiplash shaken infant syndrome:
late consequences after a symptom
-
free interval. Dev Med Child Neurol 1995;37(11):943
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956.

39.

Ewing
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Cobbs L, Kramer L, Prasad M, Canales DN, Louis PT, Fletcher JM, Vollero H, Landry SH,
Cheung K. Neuroimaging, physical, and developmental findings after inflicted and noninflicted
traumatic brain injury in young children. Pediatrics 1998;102:300
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307.

40.

Ewing
-
Cobbs L, Prasad M, Kramer L, Landry SH. Inflicted traumatic brain injury: relation
ship of
developmental outcome to severity of injury. Pediatr Neurosurg 2000;31:251
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258.

41.

Hymel KP. Inflicted traumatic brain injury in infants and young children. Infants and Young
Children 2002;15(2):57
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65.

42.

Levi BH, Brown G. Reasonable suspicion: a stu
dy of Pennsylvania pediatricians regarding child
abuse. Pediatrics 2005;116:e5
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e12.

43.

Lindberg DM, Lindsell CJ, Shapiro RA. Variability if expert assessments of child physical abuse
likelihood. Pediatrics 2008;121:e945
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e953.

44.

Jenny C, Hymel KP, Ritzen A, R
einert SE, Hay TC. Analysis of missed cases of abusive head
trauma. JAMA 1999;281:621
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626.

45.

Flaherty EG, Sege R. Mattson CL, Binns HJ. Assessment of suspicion of abuse in the primary
care setting. Ambul Pediatr 2002;2:120
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126.

46.

Lane WG, Rubin DM, Monteit
h R, Christian CW. Racial differences in the evaluation of fractures
for pediatric physical abuse. JAMA 2002;288:1603
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1609.

47.

Hampton RL, Newberger EH. Child abuse incidence and reporting by hospitals: significance of
severity, class and race. Am J Pub H
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60.

48.

Laskey AL, Sheridan MJ, Hymel KP. Physicians’ initial forensic impressions of hypothetical
cases of pediatric traumatic brain injury. Child Ab Negl 2007;31:329
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342.

49.

Kemp KM, Kemp KW, Evans R, Murray L, Guildea ZES, Dunstan FDJ, Siber
t JR. Diagnosing
physical abuse using Bayes’ theorem: a preliminary study. Child Ab Rev 1998;7:178
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188.

50.

Berkoff MC, Zolotor AJ, Makoroff KL, Thackeray JD, Shapiro RA, Runyan DK. Has this
prepubertal girl been sexually abused? JAMA 2008;300:2779
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2792.

51.

W
ells RG, Vetter C, Laud P. Intracranial hemorrhage in children younger than 3 years. Arch
Pediatr Adolesc Med 2002;156:252
-
257.

52.

Flaherty EG, Sege R, Binns HJ, Mattson CL, Christoffel KK. Health care providers’ experience
reporting child abuse in the pri
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493.

53.

Saulsbury FT, Campbell RE. Evaluation of child abuse reporting by physicians. Am J Dis Child
1985;139:393
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395.



4
.

Design, procedures, materials and methods:

Use a level of detail similar
to what would be used
when submitting an article for publication in a peer reviewed journal. Explain the study
procedures and data collection and analysis process. Please define terms and explain concepts
which might be confusing to reviewers who are not

expert in the area of the study.


Study Design, Procedures, Materials and Methods:

We propose to conduct a prospective, multicenter, observational study of hospitalized, acutely head
-
injured children less than 3 years of age.


Investigators and sites wi
ll be recruited for study participation from the “Pediatric Acute Lung and
Sepsis Investigators” (PALISI) research network, from a network of child abuse pediatricians
conducting the “Examining Siblings to Recognize Abuse” (ExSTRA) collaborative study, and

also from
the Ray E. Helfer Society, an honorary society of child abuse pediatricians. Participating sites will be
asked to commit to complete data capture regarding every patient meeting study inclusion criteria [see
“Inclusion and Exclusion Criteria” b
elow] admitted to their local pediatric intensive care unit (PICU).
Information about new sites will be sent to the Dartmouth CPHS and will be added to the list of sites in
the CPHS study plan as a revision to this document.


At this point in time, we can
not predict how quickly sites and investigators will be recruited, or how
many sites will be recruited. For this reason, we request an indefinite ‘end point” for this observational
study. Sites and investigators will be asked to commit to study participa
tion for a minimum of 1 year.


Every participating site will be required to verify and to facilitate the active collaboration of at least 3
local investigators. These investigators must include, at a minimum: (1) a research nurse coordinator,
(2) a pedi
atric intensivist, and (3) a child abuse medical specialist (that is, a pediatrician, pediatric nurse
practitioner, family practice physician, emergency medicine physician, physician assistant, or other
licensed medical provider who routinely completes inp
atient medical evaluations or consultations
regarding suspected child physical abuse). Additional local investigators are welcome. Every
participating site will be required to designate a Site Principle Investigator (other than their local
research nurse

coordinator) who will assume primary responsibility for all site
-
specific research
activities.


At every participating site, the research nurse coordinator will screen PICU admission logs daily (or
frequently enough) to identify new PICU patients meetin
g study inclusion criteria [see “Inclusion and
Exclusion Criteria” below] prior to their hospital discharge. These screening activities must be
documented on a screening log.


The data to be captured prospectively regarding every eligible patient, at ev
ery participating site, is
listed in its entirety on the attached data forms 1 through 4. To maximize efficiency, these web
-
based
data capture forms will utilize embedded “branching logic” that facilitates skipping of some data fields
when appropriate. I
nvestigators who participate in this study will be required to acknowledge that the
data represented on these data forms is data routinely captured as “standard care” for hospitalized,
acutely head
-
injured children less than 3 years of age.


Form 1 will be

used to document subject screening and to capture demographic data. Form 2 will be
used to capture data regarding the 23 statistically significant “discriminators” of head trauma etiology.
Form 3 will be used to capture historical information that will
facilitate subsequent categorization of
study subjects into 2 comparison groups, defined as “abused” or “not abused” [see “Data Analysis”
below]. Form 4 will be used to capture data regarding the subjects’ diagnostic evaluations for abuse and
the health c
are team’s overall forensic impression and response.


For every patient meeting study inclusion criteria [see “Inclusion and Exclusion Criteria” below]: (1)
Form 1 should be completed ASAP after hospital admission; (2) Forms 2 and 4 should be completed 3
t
o 5 days after hospital admission (if hospital discharge or death has not yet occurred), when more
complete clinical and radiological data has become available; and (3) Form 3 should be completed at or
near the time of hospital admission and/or initial chi
ld abuse consultation (if obtained).


Optimally, form 1 will be completed by the research nurse coordinator, form 2 will be completed by a
pediatric intensivist treating the head
-
injured child, and forms 3 and 4 will be completed by a child
abuse medical

specialist, if/when he/she has completed a child abuse evaluation. Data capture and entry
after hospital discharge (or death) is acceptable, though suboptimal. For each head
-
injured child, study
participation will end when all required data has been cap
tured.



This protocol does not require investigators to ask any questions, order any tests, request any
consultations, capture any data, or make any reports of suspected abuse that, in their own clinical
judgments, fall outside the scope of their “standar
d care.” Because this is strictly an observational
protocol, we respectfully seek a waiver of the informed consent process [see “Attachment H”].



Data Security:

Data will only be captured electronically. There will be no written records associated with
data
collection. Study investigators will enter data online, using access
-
controlled, password
-
protected,
standardized data capture forms. S
ite
-
specific data that has been entered online will become part of the
network's pooled data.


Th
e network’s
poo
led data will be
stored
in a password
-
protected, access
-
controlled, HIPAA
-
compliant,
database
.
This database will not be accessible via the internet. Instead, c
ommunication between study
investigators’ user interface and this database will be conducted o
ver a private network specifically
reserved for this unique purpose. This private network will operate in compliance with PCI standards.
No other systems will communicate via this private network.
All data transmissions will be SSL
encrypted.

Access co
ntrols and password protections will prevent study investigators from accessing
any pooled data that was contributed from another site.


The server that will contain the network’s pooled data and its database is physically located at Cogent
Data Center sit
e in Tyson's Corner, VA (Address: 1921 Gallows Road, Vienna, VA 22182). Physical
access to this server requires entrance and passage through 2 secure areas of the building, each requiring
a biometric authentication from the person seeking access. Server
racks have a physical lock requiring a
key. MicroMed Strategies, Inc. will set up and maintain the servers and their access firewalls. Neither
Cogent nor any other entity has or will have access to patient data.




5. Inclusion/Exclusion Criteria:

Pl
ease provide a detailed description of inclusion and exclusion
criteria for study participants:


Inclusion Criteria:

1.

Age less than 36 months on the day of hospital admission,

2.

Acute, nonpenetrating, traumatic cranial injuries confirmed by CT or MR imaging,

and…

3.

Hospitalization in a pediatric intensive care unit for evaluation and/or treatment of the same,
acute, nonpenetrating, traumatic cranial injuries.


Exclusion Criteria:

1.

Any radiological evidence of pre
-
existing brain defect, malformation, disease, inf
ection, or
hypoxia
-
ischemia.



6
.

Data Analysis
:

Describe the plan for analysis of the study data.


All analyses of pooled data captured specifically for this study will be conducted at Dartmouth.


In an ongoing manner as data is captured, the Study Prin
ciple Investigator will apply a priori criteria to
sort subjects with complete data into subject comparison groups categorized as “abused” or “not
abused.”


Subjects will be categorized as “abused” IF: (1) the caregiver admitted abusive acts, (2) the careg
iver’s
abusive acts were independently witnessed, (3) the caregiver specifically denied trauma even though a
pre
-
ambulatory child in his/her care became clearly and persistently ill with signs linked to acute
traumatic cranial injuries, (4) the caregiver’s

account of the child’s head injury event was clearly
developmentally inconsistent; (5) the caregiver’s account of the child’s head injury event was clearly
historically inconsistent with repetition over time, OR IF (6) the head
-
injured child revealed mult
iple
categories of noncranial injuries considered moderately or highly suspicious for abuse. [NOTE:
Categories of noncranial injuries considered moderately or highly suspicious for abuse are listed in data
field Q4.1.3 of data form #4.] All remaining sub
jects will be categorized as “not abused.”


Analysis of aggregate data will begin when we have captured complete data regarding a sufficient
number of “abused” subjects to conduct multivariate analysis with sufficient power to identify clinical
predictors
of abuse that are both significant and independent. Our statistician estimates that this will
require: (1) complete data capture regarding 100 additional “abused” subjects; (2) complete data capture
regarding 400 additional (“abused” or “nonabused”) child
ren meeting study inclusion criteria (assuming
the study pre
-
test probability of abuse among all children meeting study inclusion criteria equals 0.22);
and (3) the active participation of 20 sites for 2 years (estimating complete data capture regarding 10

subjects meeting study inclusion criteria per site per year). If fewer sites participate, this study will take
longer.


When complete data has been captured regarding 100 additional “abused” subjects, we will apply 2
different multivariate analyses to ou
r aggregate data. Logistic regression will be used to identify
independent and significant variables that predict the likelihood of the binary outcome (that is, “abused”
versus “not abused”). This probability will be given as the odds ratio and thereafte
r as a likelihood ratio
for abuse. Logistic regression analyses tend to lead to clinical prediction rules with greater accuracy
(that is, the rule correctly categorizes more patients as “abused” versus “not abused”), but may also
result in less than optim
al sensitivity (that is, the rule correctly categorizes <100% of “abused” children
as “abused”). For this reason, in an effort to derive an optimal clinical prediction rule with very high
sensitivity, we will also apply recursive partitioning analysis to
our aggregate data.


Recursive partitioning analysis progressively divides the patients into a subpopulation that includes only
patients with a particular outcome (for example, “abused” or “not abused”). This approach is
appropriate when the objective is
to derive a clinical prediction rule with a very high sensitivity (that is,
the rule correctly categorizes 100% of “abused” children as “abused”). Ultimately, we will: (1) derive 1
or more clinical prediction rules for pediatric abusive head trauma (using

logistic regression and/or
recursive partitioning); (2) apply our derived clinical prediction rule(s) to every study subject; (3)
calculate each rule’s sensitivity and specificity as a diagnostic test for pediatric abusive head trauma;
and (4) identify a
specific clinical prediction with optimal sensitivity and specificity.


Thereafter, we will: (1) calculate the study baseline prevalence or pre
-
test probability of abuse; and (2)
use our derived clinical prediction rule with optimal sensitivity and specifi
city to calculate the likelihood
ratio and post
-
test probability of abuse for every study subject.


Independent verification of complete enrollment of eligible subjects is necessary to eliminate sampling
bias associated with enrollment of an incomplete (th
at is, a convenience) sample of eligible subjects. To
accomplish this: (1) at the beginning of every month, the research nurse coordinator at every
participating site will be required to report (via email to the network coordinator) the total number of
el
igible subjects identified by local screening activities during the prior month; and (thereafter) (2) the
medical record number (MRN) will be used locally at each participating site to compare lists of “eligible
subjects with complete data captured” versus

“eligible subjects with complete data not yet captured.”
Data entered from sites that fail to capture complete data regarding at least 90% of their eligible subjects
will be eliminated from subsequent aggregate data analysis.


To identify potential “pr
edictors” of abuse that are difficult to interpret (and therefore likely to be
misinterpreted or interpreted inconsistently), we will measure interobserver reliability of data capture.
To accomplish this, at every participating site, for every fifth patie
nt with complete data captured: (1)
the research nurse coordinator will complete a redundant copy of form 1; and (2) other local
investigator(s)

blinded to the patient
-
specific data captured previously

will complete redundant
copies of forms 2, 3 and 4. T
his redundant data will be captured online in a separate but identical
database (also at www.pedibirn.com). Potential “predictors” of pediatric abusive head trauma with poor
interobserver reliability (that is, simple or weighted Kappa values < .6) will no
t be included in the final
derived clinical prediction rule.



7
. Instruments:

Describe the instruments, if any, used to collect data in this study.

Attach copies
of all questionnaires, surveys, interview questions, or other instruments. If the research

involves
interviews that could evolve as the research progresses, include a list of discussion topics and any
“starter” questions for each topic that can reasonably be expected to be covered. If a draft of a
written questionnaire or survey is attached, i
t should be clearly labeled as such and a final version
should be sent to CPHS for review before data collection begins.


The data to be captured prospectively regarding every eligible patient, at every participating site, is
listed in its entirety on the
attached data forms 1 through 4. Investigators will enter this data online
using access
-
controlled, password
-
protected, HIPAA
-
compliant, data capture forms (available at
www.pedibirn.com). To maximize efficiency, these web
-
based data capture forms will u
tilize
embedded “branching logic” that facilitates skipping of some data fields when appropriate.


This is strictly an observational protocol. Investigators who participate in this study will be required to
acknowledge that the data represented on these

data forms is data routinely captured as “standard care”
for hospitalized, acutely head
-
injured children less than 3 years of age. No treatments will be given,
questions asked, consultations completed, tests conducted, data captured, or reports of suspec
ted abuse
made that would not normally be accomplished by treating physicians.



8
. Deception.

Will deception of research participants, including withheld information, be used in
this research?



Yes

No


If yes, compl
ete the following.

a) Describe the deception being used in this study:


NA


b) Explain why deception is necessary in this research:


NA


c) Describe the information being provided to subjects when they decide to participate:


NA


d) Describe how the subjects will be provided with additional pertinent information after
participation (debriefing):


NA



9. Timetables:



a)

Indicate length of participant involvement in the study:


From

hospital admission

until hospital discharge or complete capture of required data.


b)
Estimate how long it will take to enroll enough participants to complete this study:


Unknown,

as we cannot yet predict how many centers will participate. We estimate that the study will
take at least 2 years to complete. We respectfully request an “open ended” study termination date.



10.


Risks:

The purpose of this section is to determine if subjects will be placed "at risk," which in
general means exposed to the possibility of phys
ical, psychological, social, economic, legal, or
dignitary harm as a consequence of any activity proposed in the research project.



a
)

What is the overall risk classification of the research?



Minimal


Greater than mini
mal


Significant


Unknown?


Note: In the federal regulations on human subjects protection, minimal risk means "The probability and magnitude
of harm or discomfort anticipated in the research are not greater in and of the
mselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological examinations or tests."



b
)

Describe any potential risks (physical, psychological, social, legal, financial, or other) and assess
their
likelihood and seriousness. Describe the procedures for protecting against or minimizing
these risks, including risks to confidentiality, and assess their likely effectiveness. Please list risks
from most severe/likely to least severe/unlikely.


This is a
n observational study. Clinical care will not change in any way for subjects.


Study risks are limited to inadvertent disclosure of concerns for abuse. Investigators with access to the
subjects’ identifying information and to concerns regarding child mal
treatment will have obtained this
information in the course of their normal clinical duties. Investigators will include treating physicians,
pediatric intensivists and child abuse specialists with substantial experience in maintaining
confidentiality arou
nd issues of potential abuse. We do not feel that this protocol has the potential to
generate any new mandated reports of suspected abuse.


Data will be stored in a password
-
protected, access
-
controlled, HIPAA
-
compliant, database. Patient
identifiers wil
l not be accessible or displayed to investigators who would not have access to these
identifiers in the course of their normal clinical duties.



11
.
Research Setting


Location of study:

List all study locations. For sites where the CPHS at Dartmouth C
ollege is
NOT the reviewing IRB describe procedures for obtaining IRB approval and permission to
conduct research activities at each site (e.g., for a school the investigator should obtain a letter of
approval from the principal).


(1)

Dartmouth
-
Hitchcock Medi
cal Center; Lebanon NH; Sponsoring Center and Data Coordinating
Center; Kent P. Hymel, MD; Network Coordinator, Study PI, and Site PI.

(2)

The Chidlren’s Hospital at the University of Virginia; Charlottesville, VA; Participating Site;
Douglas F. Willson, D; St
udy Co
-
PI and Site PI.

(3)

The National Children’s Medical Center; Washington DC; Participating Site; Katherine P. Deye,
MD; Study Co
-
PI and Site PI.


Recruitment of other participating sites has not yet begun. All participating institutions will be hospitals

or medical centers with inpatient pediatric care units.
Local investigators from all
future
participating
sites
will be

seeking expedited approval from their local medical centers' IRBs to conduct this research
study in full accordance with their local
institutional IRB requirements.
Information about new sites
will be sent to the Dartmouth CPHS and will be added to this list of sites in the CPHS study plan as a
revision to this document.



If the study involves sites outside of the United States and Ca
nada, please complete International
Research

Attachment L
.



12
. Adequacy of Resources to Protect Subjects:


a
)

Investigator (including co
-
investigators) has sufficient time to conduct and complete the
research.



Yes

No


b
)

Adequately qualified (including experience, training and familiarity with the protocol) staff are
available for this research.




Yes

No


c
)

Describe availability of psychological, social or medical services, in
cluding counseling or social
support services that may be required as a consequence of research participation.



At this medical treatment facility, a social worker or care manager is routinely, actively involved with
the families of children hospitalized
in our pediatric intensive care unit, and/or with the families of
children undergoing evaluation for suspected child physical abuse. These professionals interact
frequently and provide counseling, emotional and psychological support, and assistance in sec
uring
appropriate interventional or supportive services.


d
)

Describe psychological, social, or medical monitoring, ancillary care, and equipment needed to
protect participants (e.g. close proximity to resuscitation equipment or a plan for monitoring of
em
otional state during study procedures).


See response to item 12, c.


e
)

Describe other resources needed for the protection of subjects in the conduct of this research
(e.g. language translation services).


See response to item 10, b. No additional resou
rces are need for the protection of subjects.


f
)

Explain how the Investigator has access to a population that would allow recruitment of the
required number of subjects.


Local investigators will include treating physicians in pediatric intensive care uni
ts and child abuse
consultants who are routinely involved in the care of hospitalized, acutely head
-
injured children under
the age of 3 years.



1
3
. Participant Population:

Certain populations are considered vulnerable to coercion and undue
influence. Th
ese populations are provided with additional protections when participating in a
research study. The populations include:



prisoners








human embryos



fetuses



elderly people



people with an cognitive disability (also see #23 below)



people with a disabling
psychiatric illness



people who are
economically disadvantaged persons



people who are illiterate


Refer to:

Students, Employees
Attachment D


Illiterate Subjects


Attachment E



List vulnerable groups that you plan to involve in this study:

or check

None


NA




Describe additional protections:





or check

N/A



NA




1
4. Gender and Racial/Ethnic distribution
:

NIH guidelines state that research involving human
participation includes minorit
ies and both genders.

Note:

If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in
proposed population
-
based studies, a clear compelling rationale for exclusion or inadequate representation should b
e
provided.


Will eligibility for the study be based on gender, race, or ethnicity?



Yes

No


If yes, explain:


NA




15. Children:

Are children eligible for enrollment into this study? Under state la
w, a child is a
person less than 18 years old.



Yes

No



If yes
, respond to
Ch
ildren Attachment F



16. Recruitment:



Describe how subjects will be recruited for participation in this study:


Eligible participants m
ay be identified from medical record information as a “preparatory to
research” activity under the HIPAA Privacy Rule. Contact with the identified participants,
however, may not occur without prior CPHS approval of the recruitment plan for the study. Thi
s
plan should describe how initial contact with participants will be made and by whom. Protected
health information obtained as a preparatory to research activity may not be removed by a
researcher from DHMC, including on mobile electronic storage devices
.


Please note, in general individuals may not be contacted for recruitment into a research study by
someone unknown to the individual.


a
)

Will subjects be recruited by searching records (e.g., school records, medical records)?



Yes

No


If yes, will this search include paper files?



Yes

No


If yes, where will these paper files be located?

NA



If yes, will this search include electronic files?



Yes

No


If yes, who maintains these electronic files?


CIS

(and

later

EPIC),

and

the

IBEX

system

for

the

ED.



b
)

Will databases be utilized?



Yes

No


If yes, please specify type
s and locations of databases:
NA


c
)

Will fliers or brochures be posted, mailed or otherwise distributed?



Yes

No


If yes, please provide the
fliers and/or brochures

for CPHS review.


d
)

Will letters be
sent to potential participants?



Yes

No


If yes, please provide the letter(s) for CPHS review.


e
)

Will referrals be utilized for recruitment?



Yes

No



If yes, please be a
ware
potential participant
s should first be informed about the study and agree to
the contact before any referral.


f
)

Will any other method be employed?



Yes

No


If yes, please specify, in detail, what those methods

will be:


NA


g) Does the research plan include “finder’s fees” or incentives (bonus payment, gift certificates)
offered to study personnel for enrollment of participants?



Yes

No



Note: As a rul
e, finder’s fees or incentives are not acceptable. Please justify any offered incentives. If incentives
become available during the course of the study, please notify the CPHS.


NA


Attach copies of any proposed flyers, posters, pamphlets,

print advertisements, and scripts for on
-
air advertisements or telephone calls. All recruitment material should be approved by CPHS
prior to use.



Note: Advertising should not use terms such as “new treatment,” “new medication,” or “new drug” without
e
xplaining that the test article is investigational. A phrase such as “receive new treatments” implies that research
participants will be receiving newly marketed products of proven worth. Advertisements should not promise “free
medical treatment,” when th
e intent is only to say participants will not be charged for taking part in the investigation.
The CPHS will determine if the promise of treatment without charge is coercive to participants. Advertisements may
state that participants will be paid, but sh
ould not emphasize the payment or the amount to be paid. The
advertisement should include: the name and address of clinical investigator and research facility; the condition under
study or the purpose of the research; in summary form, the criteria that w
ill be used to determine eligibility for the
study; a brief list of participation benefits, if any (e.g., a no
-
cost health examination); the time or other commitment
required of the participants; and the location of the research activities and the person
or office from whom to obtain
further information.



17. Consent and Authorization


a) Informed consent:


In general, a signed consent form should be obtained from each research participant except in
specific circumstances. Only when certain criteria ar
e satisfied can the CPHS grant a waiver or
alteration to the essential information required for consent to research participation by each
potential participant. Nevertheless, when a waiver is granted, potential research participants
should be informed abo
ut the research procedures and given an opportunity to decline
participation. Most often they should be provided with an information sheet. Please use a
template for a consent form or information sheet from the CPHS website to create the form
specific to

the study.
www.dartmouth.edu/~cphs



Check one and provide explanation below:




A consent form based on the CPHS template is included with this application.


Explain how informed consent t
o research participation will be obtained. Please describe the
consent process, including information about:



Who has been authorized by the PI to obtain consent



The time interval between providing information potential participants about a study and
havi
ng the consent form signed



Any precautions taken to minimize the possibility of coercion or undue influence



Plans for responding to a potential participant or a legally authorized representative who
does not speak English, such as the use of a translator o
r a translated consent form



Any aids used to simplify scientific or technical information, like a diagram



Plans to accommodate the probable literacy level of potential participants



Any aids used to simplify scientific or technical information, like a diagr
am


NA



I intend to obtain consent for research participation but I am requesting a waiver for the use of
a
signed and dated

consent form. Please respond to the criteria listed in
Attachment I

and include
an information sh
eet based on the CPHS template.



I am requesting an alteration of the consent process to exclude certain information that is
ordinarily required. A list of the essential elements of consent to research participation is
available on the C
PHS website:
http://www.dartmouth.edu/~cphs/tosubmit/ConsentElements.html.

Please respond to
Attachment H.



I am requesting a waiver of the entire consent process and use of a consent form. Please
respond to
Attachment H.


Explain why a
ny alteration or waiver to the consent process or form is necessary.


Informed Consent:

We are applying for a waiver of the entire informed consent process and the required use of a consent
form. Criteria for a waiver of informed consent include: (1) no

more than minimal risk to patients, (2)
the waiver or alteration of consent will not adversely affect the rights and welfare of the subjects, and (3)
the study could not reasonable be completed without the waiver. We feel that this study meets all 3
crit
eria.


Regarding Criteria #1:

This is an observational study. Whether or not informed consent is obtained, clinical care will not
change in any way for subjects. The data captured for this study will continue to be captured in its
entirely by study inves
tigators, as their “standard of care.” No additional data will be captured, or
additional tests completed, or additional questions asked, or consultations requested, specifically to
complete this research study.


Were the parents of an eligible child to b
e approached for consent and refuse study participation, there
would be no difference in any interaction between themselves and any member of their care team.
Neither would their refusal change the number or identity of people who have access to their chi
ld’s
protected health information. Conversely, the act of approaching someone for consent to participate in a
study which, by its name, might imply a suspicion of physical abuse has the potential to adversely affect
the doctor
-
patient relationship.


The

only discernable risk for the families of study participants who are suspected victims of abuse
involves inadvertent disclosure of concern for abuse. This risk will exist for all families of suspected
victims of child physical abuse, whether or not their

children become subjects in this research study.
The local investigators with access both to the level of concern for abuse and to the child’s identifying
information will have obtained this information in the course of their normal clinical duties. The

local
investigators at this medical institution (and at other participating sites) will include treating physicians,
pediatric intensivists, and child abuse specialists with substantial experience in maintaining
confidentiality around issues of potential
abuse.


We do not feel that this protocol has the potential to generate any new mandated reports of abuse.


Data will be stored in a password
-
protected database and patient identifiers will not be accessible or
displayed to investigators who would not othe
rwise have access to these identifiers in the course of their
normal clinical duties as treating physicians, pediatric intensivists, or child abuse consultants. All study
data is routinely recorded already in the electronic medical record in hospitals.



Regarding Criterion #2:

Everything that will happen to the families of hospitalized, acutely head
-
injured children, including
suspected victims of child physical abuse, will continue to happen, whether or not parent(s) are given an
opportunity to consent t
o study participation. The study consists only of the collection of data that
would be collected under normal clinical circumstances by the same investigator(s) who will normally
collect the data as part of their routine duties. There will be no loss of
benefits, no loss of rights, no
discernable increased risk of harm, and no changes whatsoever in the clinical care of patients that
become part of this observational study.


Were the parents of an eligible child to be approached for consent and refuse to p
articipate, there would
be no difference in any interaction between themselves and any member of their health care team.
Neither would their refusal change the number or identity of the professionals who have (or will be
granted) access to their child’s p
rotected health information. If abuse is suspected, a report will be made
to child protective services, whether or not parent(s) have consented to research study participation.


The very act of approaching someone for consent to participate in a study whi
ch, by its name, implies
the suspicion of physical abuse, has the potential to adversely affect the doctor
-
patient relationship. On
the other hand, if informed consent is required, a parent who declines participation in this research study
about child abu
se might erroneously assume that their declination precludes physician reporting of
suspected abuse to child protection authorities, thus creating additional confusion and stress for the
doctor
-
patient relationship.


Study data will be stored in a secure d
atabase. Only one patient identifier

the medical record number
(MRN)

will be retained for each patient. This identifier will be accessible and displayed only to the
local investigators from the site that enrolled the patient, and only for the purposes of

data quality
assurance. No one outside the institution enrolling the patient will have access to the MRN or to any
other identifying information about a patient.


MRNs will be purged from the central database at data lock

when all data has been collected

and data
quality assurance has been performed. At no time will investigators use this MRN to obtain information
about patients not initially requested in the data entry form.



Regarding Criterion #3:

As stated previously, the very act of approaching som
eone for consent to participate in a study which, by
its name, implies a suspicion of physical abuse, has the potential to adversely affect the doctor
-
patient
relationship. If child abuse consultants have already become involved in the care of these child
ren, the
doctor
-
patient relationship may already have been compromised. Approaching someone thereafter to
seek consent for study participation can only increase the family’s sense of alienation from their child’s
health care team, without any identifiable

benefit, as the same data will be captured anyway.


Conducting research on child abuse requires study of abused children. It is sometimes impossible to
identify appropriate “surrogate” research subjects for children with suspected physical abuse.


We fee
l that this multicenter study cannot be completed without this waiver of informed consent.
Imaging a moribund child whose sole caretaker has been arrested on suspicion of inflicting the child’s
injuries. If informed consent is required for study particip
ation, this child would be excluded. Imagine
also a child physically abused by a parent who has not “admitted” to inflicting the abuse. If informed
consent is required, this parent will very likely decline participation in a research study specifically
a
bout child abuse. To exclude cases such as these would so bias the results obtained as to render the
data uninterpretable.



b)

Authorization:

Explain how an authorization for research use of protected health information
(PHI) will be obtained. PHI is i
ndividually identifiable health information obtained from a health
care provider or insurance plan. In general, the HIPAA Privacy Rule permits the use or
disclosure of PHI for research purposes only with an authorization from each participant whose
PHI wi
ll be involved. Only when certain criteria are satisfied can the CPHS grant a waiver of
authorization or of the use of a signed and dated authorization form. A waiver of authorization is
necessary for recruitment procedures when patient information is us
ed to identify and contact
potentially eligible research participants. A single form may combine the essential information
for both consent and an authorization. The CPHS consent template contains this combination and
is available on the CPHS website at

www.dartmouth.edu/~cphs
.


Check all that apply:



This study does not involve PHI.



A single form combining an authorization with the consent form and based on the CPHS
temp
late is included with this application.



A separate authorization form is included with this application.



I am requesting a waiver of authorization for only the recruitment procedure. Please respond
to
Attachment H.



I am requesting a waiver of
signed

and dated

authorization. Please respond to

Attachment I.



I am requesting a waiver of authorization for the use or disclosure of PHI in this entire study.
Please respond to
Attachment
H.


In your explanation of the consent process above, please include information about obtaining
authorization for the research use of PHI.



18. Privacy and Confidentiality
: Describe the plans to protect the privacy of subjects and
maintain the confiden
tiality of the data.


a) Will any study activities involve an interaction or reveal information for which protection of
participant privacy is necessary?



Yes

No



If yes, please identify the activities and describe th
e plan to protect the privacy of participants.
For example, a plan for protection of privacy might consist of conducting the assent process for an
adolescent minor in a private setting, rather than in the presence of the minor’s parent.


NA


b) Will the data collected in the course of the study be considered sensitive, e.g., include
information about a mental health disorder, HIV status, or SS#?



Yes

No



If yes, provide the rationale for why these dat
a are needed:


NA


If yes, could any of these data, if disclosed, damage financial standing, employability, insurability,
or reputation?



Yes

No



If yes, will a Certificate of Confidentiality be obtaine
d?



Yes

No


Any person engaged in research collecting information about illegal conduct from human research subjects may
apply for a Certificate of Confidentiality. NIH provides detailed instructions for investigator
s wishing to make an
application at
http://grants.nih.gov/grants/policy/coc/index.htm
.


c) Describe specific physical, administrative, and technical safeguards to be employed to secure
data
, e.g., limitation of access to data, use of locked file cabinets, protection of computer
-
based
data systems.


All data will be entered and stored in a confidential, encrypted, password
-
protected database and will be
available separate from any patient i
dentifiers. Each participating investigator will be issued their own
username and password allowing them access only to information regarding subjects enrolled at their
site, and for which they would need to enter or maintain data.


d)

Will data that iden
tify individual subjects be published or in any way be disclosed to third
parties other than project personnel?



Yes

No


If yes, please explain here and incorporate the information in consent form:


NA



19. Participant Remuneration:

Will participants be paid for their time, reimbursed for travel or meal expenses, or receive any
sort of "gift" for participating in this study?



Yes

No


If yes, please describe in det
ail:


NA


Note: Participant remuneration is not considered a benefit of being in a research study. CPHS will consider the
amount of payment in relation to the time needed and any inconvenience to participants. Payment, reimbursement,
or gif
ts should not be of an amount that would be coercive to the participant population.


If study is to be done at the VA, specific questions need to be answered if a participant is being paid "in excess of
reimbursement for travel." Please contact the CPHS o
ffice if you need more information.



20. Conflict of Interest Review:

Dartmouth College, Dartmouth
-
Hitchcock Clinic, and Mary Hitchcock Memorial Hospital have
adopted a policy on Conflict of Interest in Human Subject Research. Copies of the policy are
a
vailable on the Dartmouth College, Office of Sponsored Projects web site at
http://www.dartmouth.edu/~osp/policies.html.

Definitions:

“Conflict of interest”

occurs when an independent observer may reasonably question whether an
individual's professional ac
tions or decisions are influenced by considerations of the individual’s
private interests, financial or otherwise.

Conflicting financial interests do
not

include:



salary and benefits from Dartmouth College, Dartmouth
-
Hitchcock Clinic, and Mary
Hitchcock Me
morial Hospital;



income from seminars, lectures, teaching engagements, or publishing sponsored by
federal, state, or local entities, or from non
-
profit academic institutions, when the
funds do not originate from corporate sources;



income from service on ad
visory committees or review panels for governmental or
non
-
profit entities;



investments in publicly
-
traded mutual funds;



gifts and promotional items of nominal value; and



meals and lodging for participation in professional meetings.


“Principal investigat
or or other key personnel”

means the principal investigator and any other
person, including students, who is responsible for the design, conduct, analysis, or reporting of
research involving human subjects.

Instructions:

To assist institutional review of t
he proposed research for conflicts of interest, please respond to
the question below.

With regard to this proposed research study, does the principal investigator or other key
personnel, or any of their spouses, domestic partners, or dependent children, ho
ld a financial
interest that would reasonably appear to affect or be affected by the proposed study, including but
not limited to the following interests?

a.

compensation for services (e.g., consulting fees or honoraria), or in
-
kind payments, other
than from
the researcher's primary employer, in the prior calendar year or projected
over the next twelve months;

b.

royalty income or the right to receive future royalties under a patent license or copyright,
when the proposed research is directly related to the licen
sed technology or work;

c.

equity interests (e.g., stocks, stock options or other ownership interests), including equity
holdings where the value cannot readily be determined by reference to public prices;

d.

intellectual property rights (e.g., patents and copy
rights), and royalties from such rights;

e.

gifts or funds available to the researcher from the sponsor of this study beyond the
current project;

f.

funding expected to significantly exceed the projected costs of conducting this study; or

g.

another financial or p
rivate interest that may present a conflict of interest.



No: The Principal Investigator or other key personnel do not have any financial interests
listed in a.
-

g. above.


Yes: The Principal Investigator or other ke
y personnel do have financial interests listed in
items a.
-

g. above.

Only if you have answered yes to the question above about study
-
specific financial interests for a
member of the research team, please provide the following additional information.

Name

of each individual with a listed financial interest:



Each individual on the above list should complete a Conflict of Interest Disclosure Form for
Human Subject Research. The disclosure should include only those financial interests t
hat are
specifically relevant to this research study.

The Conflict of Interest Disclosure Form for Human Subject Research is available on the CPHS
website at the following url:

http://www.dartmou
th.edu/~cphs/tosubmit/forms/


Please complete and sign the Conflict of Interest Disclosure Form for Human Subject Research
form. In an envelope marked "Confidential", send the form to the Director of the Office of
Sponsored Projects, using the following
address:

CPHS/COI
-
HS, Hinman Box 6254.


Attachment F

Children


1. Children as Subjects


a.
What is the age range of the children in this research?


0

to

36

months


b.
Where will the children participate?

Home
School
College or hospital

lab/office

Other Specify:
Hospital


c.
Will any of the research take place in school settings?

Yes
No


If yes, have you obtained the ne
cessary permission from the school district?

Yes
No

If yes, at
tach documentation of permission

If no, explain:
NA


d.
Are any of the children wards of the State or any other agency, institution, or entity
?

Yes
No.

If yes, provide details:

C
hildren

who

are

suspected

victims

of

abuse

may

become

wards

of

the

State.




2.

Designation Risk / Benefit: Check the risk designation you believe appropriate:



Research not involving greater than minimal risk
.

[45 CFR 46.404]


DHHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children
is presented, only if the IRB finds that adequate provisions are made for
soliciting the assent of the
children and the permission of their parent or guardians, as set forth in 46.408.




Minimal risk

means that the probability and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves t
han those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests
.
[45 CFR 46.10
2
(i)]




Research involving greater than minimal risk but presenting the prospect of direct b
enefit.

[45 CFR
46.405]

DHHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
subject, or by a monitor
ing procedure that is likely to contribute to the subject’s well being, only if the
IRB finds that:

a) the risk is justified by the anticipated benefit to the subjects;

b) the relation of the anticipated benefits to the risk is at least as favorable to th
e subjects as that
presented by available alternative approaches
.





Research involving greater than minimal risk and no prospect of direct benefit to individual
participants, but likely to yield generalizable knowledge about the subjects
’ disorder or condition.

[45
CFR 46.406]

DHHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
presented by intervention or procedure that does not hold out the prospect of direct benefit for the
individual su
bject, or by a monitoring procedure which is not likely to contribute to the well
-
being of the
subject, only if the IRB finds;

a) the risk represents a
minor increase over minimal risk;

b) the intervention or procedure presents experiences to participan
ts that are reasonably commensurate
with those inherent in their actual or expected medical, dental, psychological, social or educational
situations;

c) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder o
r
condition which is of vital importance for the understanding of the participants condition
.





Research not otherwise approvable which presents an opportunity to understand, prevent, or
alleviate a serious problem affecting the health
or welfare of children.


[45 CFR 46.407]

DHHS will conduct or fund research that the IRB does not believe meets the requirements of
sections
46.404, 46.405, or 46.406 o
nly if :

a)

the IRB finds that the research presents a reasonable opportunity to furt
her the understanding,
prevention, or alleviation of a significant problem affecting the health and welfare of children; and

b) t
he panel of experts must also find that the research will be conducted in accordance with sound
ethical principles
.



Section
2. Parental permission for research participation.

Please check as appropriate for this
study:



a Permission of only one parent is necessary for research designated 46.404 or 46.405 above.



b. Permission of both paren
ts is necessary. If the research is designated 46.406
or
46.407 above,

both parents
should

give their permission
,
unless one parent is deceased, unknown, incompetent, or
not
r
easonably available, or when only one parent has legal responsibility for the ca
re and custody of
the child
.




c
.
Permission of one parent only

for research designated

46.406
or
46.407 above
,

when
one
parent is deceased, unknown, incompetent, or not
r
easonably available, or when only one parent has
legal respo
nsibility for the care and custody of the child
.




d. Alteration or waiver of p
arental
permission. See Attachment H for alteration or waiver of the
consent process.


2a
. If the research is being conducted in a group setting (e.g., a c
lassroom), explain what
provisions have been made for children whose parents have not given permission for them to
participate:



Section 3. Assent by children
-

In determining whether children are capable of

providing assent, you should

take into account

the ages, maturity, and psychological state of
each child
who will be
involved. If
the CPHS

determine
s

that the research holds out a prospect of direct benefit

to
individuals,
assent of the children
may

not

be

a necessary requirement.


It is important t
o include each child in the discussion of the research as appropriate for his or her
maturity level. A signature line for assent may be included on the consent form when children may be
enrolled. The nature of the study, however, determines if a child’s s
ignature should be obtained in
connection with an assent to study participation. Please indicate below your judgements about
including a signature in the assent process:



a. Assent

signature obtained:

This study does not involve inter
ventions likely to directly benefit the
health or welfare of individual children. They are likely, however, to comprehend and appreciate what it
means to be a volunteer for the benefit of others.



b.

Assent signature
not
obtained:

Child
ren will be included in the discussions about research
participation. The children who will participate in the study, however, either have the prospect of an
important and direct benefit to the health or well
-
being of each child or are unlikely to underst
and
research participation sufficiently to provide meaningful assent.



Attachment H

Request for Waiver of Participant Consent and Authorization


In general, a signed consent form should be obtained from each research participant except in
specific circum
stances. Only when certain criteria are satisfied can the CPHS grant a waiver or
alteration to the essential information required for consent to research participation by each
potential participant.



Part A:
Request for waiver for or alteration of ess
ential information used in the consent process.

Check one:


I am requesting an alteration of the consent process to exclude certain information that is
ordinarily required. A list of the essential elements of consent to research particip
ation is
available on the CPHS website:
http://www.dartmouth.edu/~cphs/tosubmit/ConsentElements.html



I am requesting a waiver of the entire consent process and u
se of a consent form.


Instructions
:

Each of the following regulatory criteria should be addressed for evaluation by the CPHS. Please
respond thoughtfully to each item. Yes and no answers are not sufficient.


(1) Describe why the research involves no mo
re than minimal risk to the subjects.
Minimal risk
means that 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.


This is an observational study. Whether or not informed consent is obtained, clinical care will not
change in any way for subjects. The data captured for this study will continue to be captured in

its
entirely by study investigators, as their “standard of care.” No additional data will be captured, tests
ordered, consultations completed, or questions asked, specifically to complete this research study.


Were the parents of an eligible child to be
approached for consent and refuse study participation, there
would be no difference in any interaction between themselves and any member of their care team.
Neither would their refusal change the number or identity of people who have (or will be granted)
access
to their child’s protected health information. Conversely, the act of approaching someone for consent to
participate in a study which, by its name, might imply a suspicion of physical abuse, has the potential to
adversely affect the doctor
-
patient
relationship.


The only discernable risk for the families of study participants who are suspected victims of abuse
involves inadvertent disclosure of concern for abuse. This risk will exist for all families of suspected
victims of child physical abuse, wh
ether or not their children become subjects in this research study.
The local investigators with access both to the level of concern for abuse and to the child’s identifying
information will have obtained this information in the course of their normal cli
nical duties. The local
investigators at this medical institution (and at other participating sites) will include treating physicians,
pediatric intensivists, and child abuse specialists with substantial experience in maintaining
confidentiality around is
sues of potential abuse.


We do not feel that this protocol has the potential to generate any new mandated reports of abuse.


Data will be stored in a password
-
protected database and patient identifiers will not be displayed to
investigators who would not
otherwise have access to these identifiers in the course of their normal
clinical duties as treating physicians, pediatric intensivists, or child abuse consultants. All study data is
routinely recorded already in the electronic medical record in hospitals
.


(2) Describe why the waiver or alteration of consent will not adversely affect the rights and welfare of
the subjects. Subject rights include:



voluntary participation;



receiving adequate information about the research;



the right to withdraw at any tim
e for any reason;



no loss of benefits and no penalties for a decision not to participate or to withdraw;



minimized risks of potential harms, including to physical, psychological, social, financial, and
reputational well
-
being;



confidential handling of pers
onal information; and



all other legally recognized rights.


Everything that will happen to the families of hospitalized, acutely head
-
injured children, including
suspected victims of child physical abuse, will continue to happen, whether or not parent(s) a
re given an
opportunity to consent to study participation. The study consists only of the collection of data that
would be collected under normal clinical circumstance by the same investigator(s) who will normally
collect the data as part of their routine

duties. There will be no loss of benefits, no loss of rights, no
discernable increased risk of harm, and no changes whatsoever in the clinical care of patients that
become part of this observational study.


Were the parents of an eligible child to be app
roached for consent and refuse to participate, there would
be no difference in any interaction between themselves and any member of their health care team.
Neither would their refusal change the number or identity of the professionals who have (or will be

granted) access to their child’s protected health information. If abuse is suspected, a report will be made
to child protective services, whether or not parent(s) have consented to research study participation.


The very act of approaching someone for co
nsent to participate in a study which, by its name, implies
the suspicion of physical abuse, has the potential to adversely affect the doctor
-
patient relationship. On
the other hand, if informed consent is required, a parent who declines participation in
this research study
about child abuse might erroneously assume that their declination precludes physician reporting of
suspected abuse to child protection authorities, thus creating additional confusion and stress for the
doctor
-
patient relationship.


Stud
y data will be stored in a secure database. Only one patient identifier

the medical record number
(MRN)

will be retained for each patient. This identifier will be accessible and displayed only to the
local investigators from the site that enrolled the pa
tient, and only for the purposes of data quality
assurance. No one outside the institution enrolling the patient will have access to the MRN or to any
other identifying information about this patient.


MRNs will be purged from the central database at data

lock

when all data has been collected and data
quality assurance has been performed. At no time will investigators use this MRN to obtain information
about patients not initially requested in the data entry form.


(3) Describe why the research could not

practicably be carried out without the waiver or alteration of
consent. For example, an epidemiology study with incidence as an endpoint may need to capture data
from an entire population. Inconvenience does not satisfy this criterion.


As stated previo
usly, the very act of approaching someone for consent to participate in a study which, by
definition, implies the suspicion of physical abuse, has the potential to adversely affect the doctor
-
patient relationship. If child abuse consultants have already b
ecome involved in the care of these
children, the doctor
-
patient relationship may already have been compromised. Approaching someone
thereafter to seek consent for study participation can only increase a family’s sense of alienation from
their child’s hea
lth care team, without any identifiable benefit, as the same data will be capture anyway.


Conducting research on child abuse requires study of abused children. It is sometimes impossible to
identify appropriate “surrogate” research subjects for children
with suspected physical abuse.


We feel that this multicenter study protocol cannot be completed without this waiver of informed
consent. Imagine a moribund child whose sole caretaker has been arrested on suspicion of inflicting the
injuries.
If informed

consent is required for study participation, this child would be excluded. Imagine
also a child physically abused by a parent who has not “admitted” to inflicting the abuse. If informed
consent is required, this parent will very likely decline participa
tion in a research study specifically
about child abuse. To exclude cases such as these would so bias the results obtained as to render the
data uninterpretable.


(4) Describe whether the subjects will be provided with additional pertinent information af
ter
participation. Examples are if there are incidental findings or if the research plan includes informing
participants about the research after an intervention has occurred.


Subjects will not be provided additional pertinent information after study par
ticipation.



Part B: Request for a waiver

for or alteration of

authorization for research use of protected
health information (PHI
).


NOT APPLICABLE


NO PHI collected in this study.


Definition
: PHI
is individually identifiable health information obta
ined from a health care provider
or insurance plan.


In general, the criteria below mirror the criteria for a waiver or alteration of the consent process.
Safeguards for maintaining confidentiality in the data management plan are especially important
when

a study involves the use of PHI.


Check one:



I am requesting a waiver of authorization for only the recruitment procedure.



I am requesting a waiver for or alteration of authorization for the use or disclosure of

P
HI in this entire study.


Please respond thoughtfully to each of the following

waiver or alteration criteria, unless you intend to
use only de
-
identified health information containing none of the identifiers listed below throughout
all study activities.
If study data contain codes linked to identifiers, the codes should satisfy the
HIPAA Privacy Rule standard for re
-
identification that is also listed below.


Your responses to the following criteria establish that your research use or disclosure of PHI inv
olves
no more than minimal risk of a breach of confidentiality
. If the research use or disclosure of PHI
involves more than minimal risk, the research is not eligible for a waiver or alteration of
authorization. Yes and no answers are not sufficient.


(5
) Describe why the research cannot practicably be conducted without access to and use of PHI.


Independent verification of complete enrollment of eligible subjects is necessary to eliminate sampling
bias associated with enrollment of an incomplete (that i
s, a convenience) sample of eligible subjects. To
accomplish this: (1) At the beginning of every month, the research nurse coordinator at every
participating site will be required to report (via email to the network coordinator) the total number of
eligib
le subjects identified by local screening activities during the prior month; and (thereafter) (2) the
medical record number (MRN) will be used locally at each participating site to compare lists of “eligible
subjects with complete data captured” versus “el
igible subjects with complete data not yet captured.”


(6)
Describe why the research

cannot practicably be conducted without the waiver of participant
permission to use PHI.


Analogous to our rationale for requesting a waiver of the informed consent pro
cess, seeking a waiver to
release PHI

specifically to conduct a research study about child physical abuse

will have the same
potential to adversely affect the doctor
-
patient relationship. Too many families would decline release of
PHI if the request for a

waiver was specifically linked to a research study about child physical abuse. To
exclude so many cases would so bias the results as to render the data uninterpretable.


(7) Describe in detail your plan to protect identifiers from improper use and discl
osure. If this plan is
described elsewhere in the study documents, provide a reference to that description.


Only one patient identifier, the medical record number (MRN), will be retained for each patient. This
identifier will be accessible and displayed

only to the local investigators from the site that enrolled the
patient, and only for the purposes of data quality assurance. No one outside the institution enrolling the
patient will have access to this MRN or to any other identifying information about
the patient.


The medical record number (MRN) will be used locally at each participating site to compare lists of
“eligible subjects with complete data entered” versus “eligible subjects with complete data not yet
captured.” Under no circumstances will th
e MRN be used to obtain or to verify data not specifically
elicited by the initial data abstraction form without prior IRB approval.


All data will be entered and stored in a confidential, encrypted, password
-
protected database and will be
available separa
te from any other patient identifiers. Every participating investigator will be issued their
own username and password allowing them access only to the information regarding subjects enrolled at
their own sites

subjects for which they would need to enter
or maintain data.


(8) Confirm that an adequate plan exists to destroy identifiers at the earliest opportunity, unless there
is a health or research justification, or legal requirement, to retain them. Generally accepted
standards of scientific research
require maintenance of the data to address future challenges to
published conclusions. Describe in detail any justification for retaining identifiers.

Medical records numbers will be purged from the database at data lock, when all data has been collected
and quality assurance has been performed. Study record numbers will be generated by the database for
each subject.


(9) Provide an adequate assurance that PHI will not be reused or disclosed for other purposes other
than to conduct this study, except as
permitted by law.


Under no circumstances will the medical record numbers be used to obtain or to verify data not
specifically elicited by the initial data abstraction form without prior IRB approval. PHI will not be
reused or disclosed to others. Any an
d all paper data forms will remain at the site with the research
nurse coordinator.


De
-
identification standard
:
The following 18 data elements should not be present for health
information to be considered de
-
identified:


Names

All geographic subdivisions
smaller than a state, with certain exceptions

All elements of dates (except year)

Social security numbers





Account numbers

Medical record numbers





Certificate/license numbers

Health plan beneficiary numbers




Device identifiers and serial numbers

Bi
ometric identifiers, including finger and voice prints

Fax numbers

Electronic mail addresses





Web universal resource locators (urls)

Internet protocol (IP) address numbers



Full face images

Vehicle identifiers and serial numbers



Telephone numbers


An
y other unique identifying number, characteristic, or code



Re
-
identification code standard
:

A covered entity (individual or institution originally holding the PHI) may assign a code or other means of record
identification to allow information de
-
identifi
ed under this section to be re
-
identified by the covered entity, provided
that:


1. Derivation. The code or other means of record identification is not derived from or related to information about the
individual and is not otherwise capable of being transl
ated so as to identify the individual; and


2. Security. The covered entity (individual or institution originally holding the PHI) does not use or disclose the code
or other means of record identification for any other purpose, and does not disclose the m
echanism for re
-
identification.


Form 1:

Subject Screening and Enrollment

Who should complete this data form?

The research nurse coordinator


When should this data form be completed?
As soon as possible after hospital admission

to an
inpatient care unit


What is the purpose of this data form?

To document subject screening and to capture demographic
data


Instructions:
Answer every question in order, unless specifically directed otherwise. This data form
utilizes embedded branching logic that facilitates s
kipping of some data fields when appropriate. For this
reason, if you must go backwards to change an answer in a previous data field, the software will require
you to re
-
enter all entries in subsequent data fields. Data entry after hospital discharge is ac
ceptable, but
suboptimal.


Sources of Information:


Caregivers, parents, EMT and ED records, inpatient medical records

1.

Site and Subject Identification

Q1.1.1.

Site number


Assigned by the network coordinator.

Free Text Answer:

Q1.1.2.

Subject ident
ification number


Assigned sequentially at each participating site.

Free Text Answer:

Q1.1.3.

Medical record number


To be entered ONLY to facilitate accuracy of local data
capture. Will be accessible ONLY to researchers at the
specific site where the s
ubject was treated. Will NOT be
accessible to the network coordinator or to researchers from
other participating sites.

Free Text Answer:

2.

Inclusion and Exclusion Criteria

Q1.2.1.

Acute, closed or non
-
penetrating, traumatic cranial
injuries confirmed
by CT or MR imaging?

Choose one:




Yes



No (If selected, patient is not eligible
for study participation.)

[go to:

1.4.2]

Q1.2.2.

Hospitalized
specifically

for evaluation and/or
treatment of the same, acute, traumatic cranial injuries?


Answer 'No
' if the child has only minor traumatic cranial
injuries (not requiring inpatient care) and was hospitalized
specifically for psychosocial assessment and/or intervention.

Choose one:




Yes



No (If selected, patient is not eligible
for study participa
tion.)

[go to:

1.4.2]

Q1.2.3.

Less than 36 months of age at the time of hospital
admission?

Choose one:




Yes



No (If selected, patient is not eligible
for study participation.)

[go to:

1.4.2]

Q1.2.4.

Any radiological evidence of pre
-
existing bra
in defect,
malformation, disease, infection, hypoxia
-
ischemia or
traumatic brain injury?

Choose one:




No

[go to:

1.3.1]



Yes (If selected, patient is not eligible
for study participation.)

[go to:

1.4.2]

3.

Demographics

Q1.3.1.

Age (in months) at

the time of hospital admission?


Expressed in months, 0 to 36, rounded to the nearest whole
month.

Free Text Answer:

Q1.3.2.

Gender?

Choose one:




Male



Female

Q1.3.3.

Ethnicity?


Select
ONLY

one.

Choose one:




Hispanic or Latino



Not Hisp
anic or Latino



Ethnicity unknown, not specified or
refused to answer

Q1.3.4.

Race?


Select
ONLY

one.

Choose one:




White or White
-
Hispanic

[go
to:

1.4.1]



Black, African American or Black
-
Hispanic

[go to:

1.4.1]



Other

Q1.3.5.

Which other
race(s)?


Select
ALL

that apply.

Choose all that apply:




American Indian



Alaskan Native



Native Hawaiian



Other Pacific Islander



Asian (Asian Indian, Chinese,
Filipino, Japanese, Korean, Vietnamese)



Mixed or Other



Race unknown, no
t specified or
refused to answer

4.

Miscellaneous

Q1.4.1.

To which inpatient care unit was this child first
admitted?

Choose one:




To a pediatric intensive care unit



To a general pediatric ward

Q1.4.2.

What medical professional captured and en
tered the
data on this form?


Select
ALL

that apply.

Choose all that apply:




A pediatric intensivist



A pediatric hospitalist or general
pediatrician



The child's treating physician or
medical provider



A child abuse pediatrician or
specialist




A family practice physician



An emergency medicine physician



A research nurse or coordinator


Form

2
:

Potential Predictors of Abusive Head Trauma

Who should complete this data form?

An informed physician or medical provider on the child’s
in
patient health care team


When should this data form be completed?

Three to five days after hospital admission

if death,
transfer or discharge has not yet occurred

when more complete clinical information and follow
-
up
neuroimaging data have become availabl
e


What is the purpose of this data form?

To capture data regarding potential clinical predictors of
abusive head trauma


Instructions:

Answer every question in order, unless specifically directed otherwise. This data form
utilizes embedded branching logi
c that facilitates skipping of some data fields when appropriate. For
this reason, if you must go backwards to change an answer in a previous data field, the software will
require you to re
-
enter all entries in subsequent data fields. Data entry after hosp
ital discharge is
acceptable, but suboptimal.


Sources of Information:


Caregivers, parents, EMT and ED records, inpatient medical records,
consultation reports, neuroimaging studies and/or physical examination

1.

Acute Clinical Presentation

Q2.1.1.

Did

the child manifest a clear impairment or loss of
consciousness at the scene of injury, during transport, in the
ED, or prior to hospital admission?

Choose one:




None was reported, documented or
observed

[go to:

2.1.3]



Yes

Q2.1.2.

How long did th
is impairment or loss of
consciousness last?


Select
ONLY

one.

Choose one:




It resolved before the child was
admitted to the inpatient care unit of the
hospital.



It resolved in the inpatient care unit
within 24 hours of hospital admission.



It l
asted >24 hours after admission,
but WAS NEVER associated with
flaccidity, decorticate or decerebrate
posturing.



It lasted >24 hours after admission,
and WAS associated with flaccidity,
decorticate or decerebrate posturing.

Q2.1.3.

Did the child mani
fest any clinically
-
significant
RESPIRATORY compromise at the scene of injury, during
transport, in the ED, or prior to hospital admission?


'Respiratory compromise' includes infrequent or labored
respirations, apnea, or any requirement for intubation or
assisted ventilation.

Choose one:




Yes



No

Q2.1.4.

Did the child manifest any clinically
-
significant
Choose one:


CIRCULATORY compromise at the scene of injury, during
transport, in the ED, or prior to hospital admission?


'Circulatory compromise' includes bradycardia, hypotension,
delayed capi
llary refill, cardiac arrest, or any requirement for
urgent volume expansion, chest compressions or vasoactive
therapy.



Yes



No

Q2.1.5.

Did the child manifest seizure(s) at the scene of
injury, during transport, in the ED, or prior to
hospital
admission?

Choose one:




Yes or Probably



No

Q2.1.6.

Did the child manifest a DELAYED impairment or
loss of consciousness, with new onset after hospital
admission to the inpatient care unit?

Choose one:




Yes

[go to:

2.2.1]



No

[go t
o:

2.2.1]

2.

Cranial Injuries

Q2.2.1.

Did the child manifest any craniofacial bruising,
abrasion(s), subgaleal hematoma(s) or cephalohematoma(s)?

Choose one:




Yes



No

Q2.2.2.

Any skull fracture(s)?

Choose one:




Yes



No

[go to:

2.2.4]

Q
2.2.3.

What skull fracture(s) did the child manifest?


Select
ALL

that apply. 'Complex skull fracture(s)' include
skull fractures that are multiple, bilateral, branching or
comminuted, diastatic, stellate or crossing suture line(s).

Choose all that apply:




Only an isolated, unilateral,
nondiastatic, linear, parietal skull
fracture



Complex skull fracture(s)



Other skull fracture(s)

Q2.2.4.

Any epidural hemorrhage(s)?

Choose one:




Yes



No

Q2.2.5.

Any subdural hemorrhage(s) or fluid collect
ion(s)?

Choose one:




Yes



No

[go to:

2.2.8]

Q2.2.6.

How would you characterize the CT appearance of
the child's subdural hemorrhage(s) or fluid collection(s)?


Select
ONLY

one.

Choose one:




Single density, hyperdense



Single density, hypode
nse



Mixed density



Other, unknown, or CT not completed

Q2.2.7.

How would you characterize the location(s) or
distribution of the child's subdural hemorrhage(s) or fluid
collection(s)?


Select
ALL

that apply.

Choose all that apply:




Small, foca
l



Interhemispheric



Unilateral, overlying only a single
cerebral hemisphere



Bilateral, overlying both cerebral
hemispheres

Q2.2.8.

Any subarachnoid hemorrhage(s)?

Choose one:




Yes



No

Q2.2.9.

Any brain parenchymal contusion(s), lacera
tion(s) or
hemorrhage(s)?

Choose one:




Yes



No

[go to:

2.2.11]

Q2.2.10.

How would you characterize these brain
parenchymal contusion(s), laceration(s) or hemorrhage(s)?


Select
ALL

that apply. 'Diffuse traumatic axonal injury' is
defined as CT ev
idence of multiple, small, parenchymal or
intraventricular hemorrhages.

Choose all that apply:




Involving the cortical brain



Involving the subcortical (or deeper)
brain



Compatible with diffuse traumatic
axonal injury

Q2.2.11.

Any brain hypoxia
, ischemia and/or swelling?

Choose one:




Yes



No

[go to:

2.2.14]

Q2.2.12.

How would you characterize the depth of this child's
brain hypoxia, ischemia and/or swelling?


Select
ONLY

one.

Choose one:




Limited to the cortical brain



Involving
the subcortical (or deeper)
brain

Q2.2.13.

How would you characterize the distribution of this
child's brain hypoxia, ischemia and/or swelling?


Select
ONLY

one.

Choose one:




Unilateral, involving only a single
cerebral hemisphere



Bilateral, invo
lving both cerebral
hemispheres

Q2.2.14.

Any brain herniation or shifting?

Choose one:




Yes or Probably

[go to:

2.3.1]



No

[go to:

2.3.1]

3.

Miscellaneous

Q2.3.1.

What medical professional captured and entered the
data on this form?


Select
AL
L

that apply.

Choose all that apply:




A pediatric intensivist



A pediatric hospitalist or general
pediatrician



The child's treating physician or
medical provider



A child abuse pediatrician or specialist



A family practice physician



An
emergency medicine physician



A research nurse or coordinator


Form 3:

History

Who should complete this data form?

The child abuse specialist or consultant, if he/she completed a
child abuse evaluation; Otherwise, an informed physician or medical pro
vider on the child’s inpatient
health care team


When should this data form be completed?

After child abuse evaluation, or whenever complete
historical information about the child’s head injury event has become available


What is the purpose of this data f
orm?

To capture historical information that will facilitate
categorization of study patients into three comparison groups, defined as abused, nonabused or
undetermined


Instructions:

Complete this data form even if the child did not undergo a child abuse evaluation.
Answer every question in order, unless specifically directed otherwise. This data form utilizes
embedded branching logic that facilitates skipping of some data fields when

appropriate. For this
reason, if you must go backwards to change an answer in a previous data field, the software will require
you to re
-
enter all entries in subsequent data fields. Data entry after hospital discharge is acceptable, but
suboptimal.


Sourc
e
s

of Information:


Caregivers, parents, EMT and ED records, inpatient medical records and/or
consultation reports

1.

History

Q3.1.1.

Did the child's acute head injuries result from a motor
vehicle crash or collision?

Choose one:




Yes

[go to:

3.2.1]



No

Q3.1.2.

Was the child's head injury event witnessed and
described thoroughly by an UNBIASED, INDEPENDENT
observer?

Choose one:




Yes, and was described by this
observer as an 'accidental' or
'nonabusive' head injury event

[go
to:

3.2.1]



Yes
, and was described by this
observer as an 'inflicted' or 'abusive'
head injury event

[go to:

3.2.1]



No or Unknown

Q3.1.3.

Was the person responsible for this child when he or
she was head
-
injured
--
or first became clearly and persistently
ill
--
asked
to explain what happened?

Choose one:




Yes



No

[go to:

3.2.1]

Q3.1.4.

Which of the following statements best summarizes
this caregiver's explanation for the child's head injuries and
acute clinical presentation?


Select
ONLY

one.

Choose one:




The caregiver described an 'accidental'
or 'nonabusive' head injury event.



The caregiver clearly admitted
'inflicted' or 'abusive' head trauma.

[go
to:

3.2.1]



The caregiver specifically denied that
the child experienced any head trauma
before he be
came symptomatic.

[go
to:

3.1.7]



The caregiver refused to explain what
happened.

[go to:

3.1.7]

Q3.1.5.

Was the caregiver's explanation
'DEVELOPMENTALLY CONSISTENT' with the child's
known (or expected) gross motor skills?


Select
ONLY

one. 'Developm
entally consistent' means that
the caregiver's explanation did not include a requirement for
the child to have utilized gross motor skills that he or she had
not previously demonstrated.

Choose one:




Yes or Probably



No or Probably Not

Q3.1.6.

Did

the caregiver provide an explanation that was
'HISTORICALLY CONSISTENT' with repetition over time?


Select
ONLY

one. An explanation that was 'historically
consistent' with repetition over time is one that did not change
substantively over time with repet
ition.

Choose one:




Yes or Probably



No or Probably Not

Q3.1.7.

Did the caregiver specifically deny 'inflicted' or
'abusive' head trauma?

Choose one:




Yes



No

Q3.1.8.

Was the child cruising or walking prior to hospital
admission?

Choose one:




Yes

[go to:

3.2.1]



No

[go to:

3.2.1]

2.

Miscellaneous

Q3.2.1.

What medical professional captured and entered the
data on this form?


Select
ALL

that apply.

Choose all that apply:




A child abuse pediatrician or specialist



A pediatric intensivist



A pe
diatric hospitalist or general
pediatrician



The child's treating physician or
medical provider



A family practice physician



An emergency medicine physician



A research nurse or coordinator


Form 4:

Diagnostic Evaluations, Forensic Impressio
ns and Response

Who should complete this data form?
The child abuse specialist or consultant, if he/she completed a
child abuse evaluation; Otherwise, an informed physician or medical provider on the child’s inpatient
桥a汴栠hare⁴敡m


When should this da
ta form be completed?

After child abuse evaluation and/or whenever the child’s
diagnostic evaluations looking for traumatic injuries has been completed


What is the purpose of this data form?

To capture data regarding the child’s diagnostic evaluations


I
nstructions:

Complete this data form even if the child did not undergo a child abuse evaluation.
Answer every question in order, unless specifically directed otherwise. This data form utilizes
embedded branching logic that facilitates skipping of some data

fields when appropriate. For this
reason, if you must go backwards to change an answer in a previous data field, the software will require
you to re
-
enter all entries in subsequent data fields. Data entry after hospital discharge is acceptable, but
subopt
imal.


Sources of Information:


Inpatient medical records, consultation reports, radiological studies and
laboratory reports

1.

Diagnostic Evaluations and Results

Q4.1.1.

Which of the following diagnostic tests were
completed on this child?


Select
ALL

that apply.

Choose all that apply:




Cranial CT scan(s)



Cranial MRI scan(s)



Abdominal CT scan(s)



Complete blood count



Coagulation testing or screening



Liver function tests



Pancreatic function tests



Radiological skeletal survey



Bone scan



Ophthalmology eva
luation

Q4.1.2.

Which of the following traumatic injuries (or
potential 'markers' for traumatic injuries) did this child
reveal?


Select
ALL

that apply.

Choose all that apply:




Classic metaphyseal lesion fracture(s)
or epiphyseal separation(s)



Ri
b fracture(s)



Fracture(s) of the scapula or sternum



Fracture(s) of digits



Vertebral body fracture(s) or
dislocation(s) or fracture(s) of spinous
process(es)



Initial hematocrit (%) <28



Initial PT
-
INR >1



Serum hepatic transaminase (AS
T or
ALT) level >80 IU/L any time after
hospital admission



Any bruising in a child less than 4
months of age



Any bruising in a child not yet
cruising



Any bruising involving the child’s
ear(s), neck or torso (that is, his/her
chest, abdomen, GU
region, back or
buttocks)



Skin bruising, abrasion(s) or
laceration(s) in two or more distinct
locations other than knees, shins or
elbows



Scalding burn(s) with uniform depth,
clear lines of demarcation and paucity of
splash marks



Confirmed intr
a
-
abdominal injuries



Retinoschesis confirmed by an
ophthalmologist



Retinal hemorrhages described by an
ophthalmologist as dense, extensive,
covering a large surface area and/or
extending to the ora serrata



Other traumatic injuries considered
mo
derately or highly suspicious for
abuse



None of the above

2.

Forensic Impression and Response

Q4.2.1.

Which of the following best describes the overall
forensic impression of the physician(s) caring for this child?


Select
ONLY

one.

Choose one:




Definitive abusive head trauma



Probable abusive head trauma



Undetermined



Probable nonabusive head trauma



Definitive nonabusive head trauma

Q4.2.2.

Did any professional from your medical treatment
facility make a report of suspected child
maltreatment
regarding this child to a child protection or investigative
agency?

Choose one:




Yes

[go to:

4.3.1]



No

[go to:

4.3.1]

3.

Miscellaneous

Q4.3.1.

What medical professional captured and entered the
data on this form?


Select
ALL

that a
pply.

Choose all that apply:




A child abuse pediatrician or specialist



A pediatric intensivist



A pediatric hospitalist or general
pediatrician



The child's treating physician or
medical provider



A family practice physician



An emergenc
y medicine physician



A research nurse or coordinator