approval of research notification

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University of Maryland, Baltimore Institutional Review Board (IRB)

Phone: (410) 706-5037Fax: (410) 706-4189Email: [email protected]

APPROVAL OF RESEARCH NOTIFICATION

Date: May 24, 2015

To: Deborah SteinRE: HP-00064197Type of Submission: Initial ReviewType of IRB Review: Expedited

Approval for this project is valid from 5/11/2015 to 5/10/2016

This is to certify that the University of Maryland, Baltimore (UMB) Institutional Review Board (IRB) approved the above referenced protocol entitled, “Use of Targeted Temperature Management in Hanging-Induced Cardiac Arrest and Asphyxia ”.

The IRB has determined that this protocol qualifies for expedited review pursuant to Federal regulations 45 CFR 46.110, 21 CFR 56.110, & 38 CRF 16.110 category(ies): (5) - Research involving materials (data, documents, records, or specimens) that have been collected for any purpose, or will be collected solely for non-research purposes.

The IRB made the following determinations regarding this submission:- A waiver of consent has been approved per 45 CFR 46.116(d).- A waiver of HIPAA authorization for release of the PHI identified in the CICERO application has been reviewed and approved for this research study.

Below is a list of the documents attached to your application that have been approved:Eligibility Checklist for HP-00064197 v4-9-2015-1428602712425

In conducting this research you are required to follow the requirements listed in the INVESTIGATOR MANUAL. Investigators are reminded that the IRB must be notified of any changes in the study. In addition, the PI is responsible for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.103(4)(iii)). The PI must also inform the IRB of any new and significant information that may impact a research participants' safety or willingness to continue in the study and any unanticipated problems involving risks to participants or others.

DHHS regulations at 45 CFR 46.109 (e) require that continuing review of research be conducted by the IRB at intervals appropriate to the degree of risk and not less than once per year. The regulations make no provision for any grace period extending the conduct of the research beyond 5/10/2016. You will receive continuing review email reminder notices prior to this date; however, it is your responsibility to submit your continuing review report

mailto:[email protected]

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in a timely manner to allow adequate time for substantive and meaningful IRB review and assure that this study is not conducted beyond 5/10/2016. Investigators should submit continuing review reports in the electronic system at least six weeks prior to this date.

Research activity in which the VA Maryland Healthcare System (VAMHCS) is a recruitment site or in which VA resources (i.e., space, equipment, personnel, funding, data) are otherwise involved, must also be approved by the VAMHCS Research and Development Committee prior to initiation at the VAMHCS. Contact the VA Research Office at 410-605-7000 ext. 6568 for assistance.

The UMB IRB is organized and operated according to guidelines of the International Council on Harmonization, the United States Office for Human Research Protections and the United States Code of Federal Regulations and operates under Federal Wide Assurance No. FWA00007145.

If you have any questions about this review or questions, concerns, and/or suggestions regarding the Human Research Protection Program (HRPP), please do not hesitate to contact the Human Research Protections Office (HRPO) at (410) 706-5037 or [email protected].

mailto:[email protected]

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EAST MULTICENTER STUDY

DATA COLLECTION TOOL

Multicenter Study: Role of Targeted Temperature Management in Hanging-Induced Cardiac Arrest Enrolling Center: _______________________ Enrolling Co-investigator: _______________________ Demographics / Injury Variables: Admission Date:_______________ Admission Time:______________ Age: _________ Sex: _____________ Race: _____________ Pre-morbid conditions: ______ Coronary heart disease _______ Psychiatric disorder ______ Diabetes _______ Prior suicidal attempt ______ Alcohol abuse _______ Unknown ______ Tobacco use _______ None ______ IV drug abuse Mechanism of injury: Hanging ISS: _______ AIS Head: _______ Prehospital Variables Location of injury: ______ Home _______ Psychiatric institution ______ Public building _______ Other ______ Prison _______ Unknown Total scene time: ________ minutes ________ unknown Total transport time: _______ minutes ________ unknown Prehospital GCS: Eye: _________ Verbal: ____________ Motor: _________ Cardiac arrest: YES NO Initial cardiac rhythm: _______ Ventricular fibrillation or pulseless ventricular tachycardia _______ Pulseless electrical activity (PEA) _______ Asystole _______ Unknown Bystander CPR: YES NO

2

Time to ROSC: ________ minutes _______ unknown Total hanging time: ______ minutes ______ unknown Admission Variables Admission GCS: Eye: _________ Verbal: ____________ Motor: _________ Admission vital signs: Blood pressure: __________ Heart rate:__________ Pulse Ox: ________ Temperature (°C): _________ Lowest systolic blood pressure during initial 5 hours: ___________ Admission lab values: pH: __________ Lactate: __________ Base Excess: __________ Diagnostic Studies Cerebral anoxia: YES NO Cervical spine bony injury: YES NO Spinal cord injury: YES NO Blunt cerebrovascular injury: YES NO Upper airway injury: YES NO Targeted Temperature Management (TTM) Variables: TTM induced? YES NO Date of TTM induction: ____________ Time of TTM induction: _________ Starting temperature (°C): __________ Target temperature (°C): _________ Date of achieving target temperature: ________ Time of achieving target temperature: _________ TTM method: ________ Cold saline ________ Ice pack ________ External cooling device ________ Intravascular catheter ________ Cold lavage/irrigation ________ Other ________ Unknown Duration of TTM: _______ hours Rate of rewarming (°C/hour): ________ TTM-related complications during hospital days 1 to 7: (check all that apply) _______ Seizure _______ Arrhythmia

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_______ Electrolyte derangement _______ Bleeding _______ Hemodynamic instability _______ Pneumonia _______ Sepsis

Operative procedures:

Was a tracheostomy required? YES NO Was surgical feeding access required? YES NO

Discharge Outcomes:

Discharge GCS: Eye: ___________ Verbal: ____________ Motor: ____________ Hospital LOS: __________________ ICU LOS: __________________ Duration of Mechanical Ventilation (days): __________________ Mortality: YES NO Organ donor? YES NO Cause of death: _______ Brain death _______ Withdrawal of life-sustaining measures _______ Multiple organ dysfunction syndrome _______ Other _______ Unknown Date of death: ___________________ Time of death: ____________________ Discharge date:__________________ Discharge time:____________________ Discharge destination: _______ Home _______ Prison _______ Long-term vent facility _______ Inpatient Psychiatry _______ Rehab/SNF _______ Morgue Cerebral Performance Category (CPC) score at hospital discharge: _____CPC 1 – Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychological deficit. _____CPC 2 – Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment. _____CPC 3 – Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis. _____CPC 4 – Coma or vegetative state _____CPC 5 – Brain death Length of survival after hospital discharge: _____ <1 month _____ 1 to 6 months _____ 6 month to 1 year _____ > 1 year _____ Unknown

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EAST MULTICENTER STUDY

DATA DICTIONARY

Targeted temperature management on hanging-induced cardiac arrest – Data Dictionary

Data Entry Points and appropriate definitions / clarifications:

Entry space Definition / Instructions

Standard Study Questions Admit Date Free text entry for the admission date of patient enrolled Admit Time Free text entry for the admission time of patient enrolled Case Information Age Free text entry for age of patient enrolled Sex Drop down menu of the sex of patient enrolled. Male or female Race Drop down menu of the race of patient enrolled. Race or ethnicity is defined by the US Office of Management and Budget (OMB)

American Indian or Alaska Native: A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment.

Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.

Black or African American: A person having origins in any of the black racial groups of Africa.

Hispanic/Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

Unknown Pre-morbid conditions Drop down menu of the patient’s pre-existing medical, social, or psychiatric conditions. May select multiple options

Coronary heart disease

Diabetes

Alcohol abuse

Tobacco use

IV drug abuse

Psychiatric disorder

Prior suicidal attempt

Unknown

None

2

ISS Free text entry for the numerical value for calculated ISS (ISS = Injury Severity Score) AIS Head Free text entry for the numerical value for AIS body region = head (AIS = Abbreviated Injury Score) Prehospital Variables Location of injury Drop down menu for the location where injury occurred

Home

Public building

Prison

Psychiatric institution

Other

Unknown Total scene time Free text entry for the total amount of time in minutes that the prehospital staff spent at the location of injury Total transport time Free text entry for the total amount of time in minutes that the prehospital staff spent transporting the patient from the location of injury to the hospital Prehospital GCS Drop down menu. Eye = 1 to 4, Verbal = 1 to 5, Motor = 1 to 6. The patient’s Glasgow Coma Scale at the scene. Cardiac arrest Drop down menu. Yes or No. Did the patient sustain an out-of-hospital cardiac arrest? Initial cardiac rhythm Drop down menu of the initial prehospital cardiac rhythm obtained at the time of cardiac arrest

Ventricular fibrillation or pulseless ventricular tachycardia

Pulseless electrical activity (PEA)

Asystole

Unknown Bystander CPR Drop down menu. Yes or No. Did the patient receive out-of-hospital CPR performed by a bystander? Time to ROSC Free text entry for the total amount of time in minutes required for the patient to achieve return of spontaneous circulation (ROSC). May select

unknown. Total hanging time Free text entry for the total amount of time in minutes during patient’s hanging. May select unknown. Admission Variables Admission GCS Drop down menu. Eye = 1 to 4, Verbal = 1 to 5, Motor = 1 to 6. The patient’s Glasgow Coma Scale at the time of hospital admission. Admission vital signs Free text entry for the first set of vital signs upon arrival to the emergency department or trauma bay

Blood pressure (systolic pressure/diastolic pressure, mm Hg)

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Heart rate (beats/minute)

Pulse Ox (%)

Temperature (°C) Lowest systolic blood pressure Free text entry for the lowest systolic blood pressure in mm Hg during during initial 5 hours the initial 5 hours of the patient’s hospital course Admission lab values: pH Free text entry for the admission pH value (arterial preferred, but venous value acceptable if no arterial value available) Lactate Free text entry for the admission lactate (mmol/L) Base Excess Free text entry for the admission base excess (mmol/L) Diagnostic Studies Cerebral anoxia Drop down menu. Yes or No. Was there evidence of cerebral anoxia on the patient’s CT scan or MRI of the brain? Cervical spine bony injury Drop down menu. Yes or No. Was there evidence of cervical spine bony injury on the patient’s CT scan or MRI of the cervical spine? Cervical spinal cord injury Drop down menu. Yes or No. Was there evidence of cervical spinal cord injury on the patient’s CT scan or MRI of the cervical spine? Blunt cerebrovascular injury Drop down menu. Yes or No. Was there evidence of blunt cerebrovascular injury on the patient’s CT angiogram or MRI of the cervical spine? Upper airway injury Drop down menu. Yes or No. Was there evidence of tracheolaryngeal injury on the patient’s CT scan, MRI, or clinical exam? Targeted Temperature Management Variables Targeted Temperature Management Targeted temperature management is a medical treatment that lowers a (TTM) patient's body temperature to a predetermined target temperature Date of TTM induction Free text entry for the date when TTM was initiated in the hospital Time of TTM induction Free text entry for the time when TTM was initiated in the hospital Starting temperature (°C) Free text entry for the starting temperature of the patient prior to TTM induction Target temperature (°C) Free text entry for the target temperature identified for the patient Date of achieving target temperature Free text entry for the date when the target temperature (+/- 0.5 °C) was reached when inducing TTM Time of achieving target temperature Free text entry for the time when the target temperature (+/- 0.5 °C) was

reached when inducing TTM TTM method Drop down menu of the medical methods by which TTM is induced. May

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select multiple options.

Cold saline

Ice pack

External cooling device

Intravascular catheter

Cold lavage/irrigation

Other

Unknown Duration of TTM (hours) Free text entry for the total number of hours patient spent at target temperature Rate of rewarming Free text entry for the rate in °C per hour that rewarming was performed TTM-related Complications: Defined as TTM-associated adverse events that occurred during hospital days 1 to 7 when the patient was in the intensive care unit Seizure Drop down menu. Yes or No. Was there any seizure activity requiring treatment? Arrhythmia Drop down menu. Yes or No. Was there any cardiac arrhythmia requiring treatment? Arrhythma is defined as severe bradycardia, recurrent ventricular fibrillation, or bradytachy arrhythmia Electrolyte derangement Drop down menu. Yes or No. Was there was any hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypomagnesemia, or hypermagnesemia requiring treatment? Bleeding Drop down menu. Yes or No. Was there new hemorrhage requiring transfusion of ≥ 2 units of packed red cells? Hemodynamic instability Drop down menu. Yes or No. Was there any hypotension (systolic pressure < 90mm Hg for ≥ 30 minutes) requiring treatment? Pneumonia Drop down menu. Yes or No. Did the patient develop hospital acquired

(HAP) or ventilator associated pneumonia (VAP) as defined by the definitions below?

Hospital Acquired Pneumonia: Confirmed by the presence of the following after 48 hours of hospitalization:

1. Purulent sputum 2. Associated systemic evidence of infection:

i. WBC > 11,000 or < 4,000 ii. Fever > 100.4 degrees F / 38 degrees Celsius

3. Two or more serial chest radiographs with new or progressive and persistent infiltrate, consolidation or cavitation.

4. BAL, mini-BAL or sterile endotracheal specimen with: i. Limited number of epithelial cells ii. WBC (2-3+) iii. Dominant organism(s) identified on gram stain or culture with quantitative culture >

100,000 cfu/mL Ventilator Associated Pneumonia: Hospital acquired pneumonia (as defined above) occurring in a patient who was intubated and ventilated at the time of or within 48 hours before onset of pneumonia. Sepsis Drop down menu. Yes or No. Did the patient develop sepsis as defined

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by below definitions? Sepsis: Has a confirmed infectious process AND two or more of the following: 1. Body temperature < 36 degrees Celsius (97 °F) or > 38 °C (100 °F) 2. Heart rate > 100 bpm 3. Respiratory rate > 20 breaths per minute or, on blood gas, PaCO2 of less than 32 mm Hg 4. White blood cell count > 4,000 cells/mm

3 or > 12,000 cells/mm

3 or greater than 10% and forms

(immature wbc) Operative Procedures Was a tracheostomy required? Drop down menu. Yes or No. Did the patient undergo trachesotomy? Was a surgical feeding access required? Drop down menu. Yes or No. Did the patient undergo surgical feeding

access? Discharge Outcomes Discharge GCS Drop down menu. Eye = 1 to 4, Verbal = 1 to 5, Motor = 1 to 6. The patient’s Glasgow Coma Scale at the time of hospital discharge Hospital LOS (days) Free text entry for number of consecutive days patient hospitalized at initial admission (Day of admission = hospital day #1) LOS = Length of Stay ICU LOS (days) Free text entry of number of consecutive days patient required ICU admission (ICU = Intensive Care Unit, LOS = Length of Stay). Day of admission = hospital day #1 Duration of Mechanical Free text entry for total number of days patient required mechanical Ventilation (days) ventilation (Day of admission = hospital day #1) Mortality Drop down menu. Yes or No. Did patient expire during the initial hospitalization? Organ donor? Drop down menu. Yes or No. Did patient become an organ donor? Cause of death Drop down menu for the cause of death with choices listed below.

Brain death - fulfilled criteria of brain death as per individual institution’s protocol

Withdrawal of life-sustaining measures

Multiple organ dysfunction syndrome – the presence of usually two or more altered organ functions in an acutely ill patient such that homeostasis cannot be maintained without intervention

Other

Unknown Date of death Free text entry for the date when the patient expired Time of death Free text entry for the time when the patient expired Discharge date Free text entry for the date when the patient was discharged from the hospital Discharge time Free text entry for the time when the patient was discharged from the hospital Discharge destination Drop down menu for the patient’s discharge destination.

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Home

Prison

Long-term vent facility

Inpatient psychiatry

Rehabilitation/Skilled Nursing Facility

Morgue Cerebral Performance Category Drop down menu. CPC of 1 to 5. The patient’s Cerebral Performance (CPC) score at hospital discharge Category (CPC) score at the time of hospital discharge based on the below criteria

CPC 1 – Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychological deficit.

CPC 2 – Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.

CPC 3 – Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.

CPC 4 – Coma or vegetative state

CPC 5 – Brain Death Length of survival after hospital Drop down menu for the total length of time that the patient was alive discharge after hospital discharge with choices listed below

<1 month

1 to 6 months

6 month to 1 year

>1 year

Unknown

Form "EAST Multicenter Study Proposal"

Details #13 (submitted 11/01/2015)

Study TitleOutcome of suicidal hanging patients and the role of targeted temperature management in

hanging-induced cardiac arrest

Primary investigator /

Senior researcherDeborah M. Stein, MD, MPH

Email of Primary

investigator / Senior

researcher

[email protected]

Co-primary investigator Cindy H. Hsu, MD, PhD

Use this area to briefly

(1-2 paragraphs only)

outline the burden of the

problem to be examined

Hanging is the second most common suicide method behind firearms in the United States,

resulting in over 10,000 annual deaths during the recent years. Globally, it is the most

common suicide method in countries such as South Korea, Japan, and Australia. Suicidal

hanging frequently affects the younger population with an estimated 77% - 88% mortality. To

date, no specific treatment is available for hanging-induced cardiac arrest (CA).

Targeted temperature management (TTM) has been shown to improve the survival and

neurologic outcome of CA survivors with shockable and nonshockable rhythms, but its effect

on hanging-induced CA is unknown. Recent case reports and small retrospective studies

have suggested that TTM may lead to good neurologic outcome for survivors who sustained

asphyxial CA. Furthermore, studies in animals and newborns have demonstrated beneficial

effects of TTM in reducing hypoxic encephalopathy caused by asphyxia. A retrospective

study of 138 patients from our institution’s trauma registry suggests that CA is associated

with higher severity of injury and mortality in suicidal hanging survivors, and that TTM may

improve the survival and functional outcome of hanging-induced CA patients at hospital

discharge. We propose to conduct a multicenter retrospective study to determine the impact

of TTM on the survival at hospital discharge, one-year survival, and functional outcome of

hanging-induced anoxic injury and CA.

Primary aimTo determine whether TTM improves the overall survival of hanging-induced CA at hospital

discharge.

Secondary aims

To determine whether TTM improves the neurologic outcome of hanging-induced CA

survivors at hospital discharge.

To determine whether TTM improves the one-year survival of hanging-induced CA survivors.

Inclusion Criteria

Patients age 18 years or older with hanging as primary injury type.

Any above patients who received targeted temperature management during post-arrest care.

Exclusion CriteriaPatients with age less than 18 years, with asphyxia from other causes, or with cardiac

arrests from other causes.

Therapeutic

Interventions

Retrospective study only. Patients would have been managed according to the discretion of

their surgeons and intensivists.

Primary Outcome Survival at hospital discharge

Secondary Outcomes

Neurologic outcome at hospital discharge as measured by Cerebral Performance

Category.**

Survival at 1-month, 6-month, and 1-year after hospital discharge

**Cerebral Performance Category (CPC) is one of the more widely used assessments of the

functional status of patients who have undergone cardiac arrest. Its score ranges from 1

(good cerebral performance) to 5 (brain death), with CPC 1 and 2 generally categorized in

earlier investigations as good neurologic outcome and 3–5 as poor outcome.

List specific variables to

be collected & analyzed

**Demographics/Injury Variables: Admission date and time, age, sex, race, pre-morbid

conditions (coronary artery disease, diabetes, alcohol abuse, tobacco use, IV drug abuse,

psychiatric disorder, prior suicidal attempt, unknown), ISS, AIS Head

**Prehospital Variables: Location of injury (home, public building, prison, psychiatric

institution, others, unknown), total scene time, total transport time, prehospital GCS, cardiac

arrest, initial cardiac arrest rhythm (ventricular fibrillation, pulseless ventricular tachycardia,

PEA, asystole, unknown), bystander CPR, time to return of spontaneous circulation (ROSC),

total hanging time

**Admission Variables: Admission GCS, admission vital signs, lowest systolic blood pressure

during initial 5 hour, admission lab values (pH, lactate, base deficit)

**Diagnostic studies: Evidence of cerebral anoxia, cervical spine injury, spinal cord injury,

blunt cerebrovascular injury, or airway injury on CT or MRI studies

**Targeted Temperature Management (TTM) Variables: Date and time of TTM initiation,

starting temperature (°C), goal temperature (°C), date and time of achieving goal

temperature, TTM method (ice pack, external cooling device, intravascular catheter, cold

lavage/irrigation, unknown), duration of TTM, rate of rewarming (°C/hour)

**TTM-related Complications: Seizure, arrhythmia, electrolyte derangement, bleeding, VAP,

sepsis

**Operative procedures: Tracheostomy, surgical feeding access, others

**Discharge outcomes: Discharge GCS, hospital LOS, ICU LOS, ventilator days, mortality,

organ donation, cause of death (brain death, withdrawal of life-sustaining measures, other),

discharge date and time, discharge destination (home, long-term vent facility, rehab/SNF,

prison, inpatient psychiatry, morgue), Cerebral Performance Category score at hospital

discharge, alive after hospital discharge ( 1 year, unknown)

Outline the data

collection plan and

statistical analysis plan

succinctly

Continuous variables will be compared using Student’s t-test or Wilcoxon rank-sum test. The

Chi-squared tests or Fisher’s exact test will be used to compare categorical variables. All

variables with a p value <0.2 on univariate analysis will be entered into a multivariable

logistic regression analysis to identify independent risk factors for in-hospital mortality and

poor neurologic outcome. Multiple-logistic regression model analyses will be performed to

estimate the odds ratios (ORs) of the neurologic outcomes with 95% confidence intervals

(CIs). Data analysis will include comparisons between the patient characteristics, survival,

and functional outcome of suicidal hanging patients who suffered out-of-hospital CA to those

who did not suffer CA, and between CA patients who received TTM to those who did not

receive TTM.

For long-term outcome analysis, the 1-month, 6-month, and 12-month survival after hospital

of CA patients will be determined by reviewing hospital records. Survival time will be

calculated as the difference between date of death and discharge date. Nonparametric

Kaplan-Meier survival analysis will be used to compare survival between the groups. The

association of unadjusted and adjusted long-term survival with TTM will be calculated. For

the adjusted model, we will adjust for age, sex, race, shockable rhythm, hanging time, time

to TTM initiation, time to ROSC, and withdrawal of life-sustaining measures. Data will be

reported as adjusted odds ratios with 95% confidence intervals. Statistical significance will

be set at a p<0.05.

Outline consent

procedures here, if

applicable

N/A - retrospective chart review with de-identified data collection

Succinctly outline a

risk/benefit analysis

The incidence and natural history of suicidal hanging and hanging-induced cardiac arrest

remain largely unknown. There is no benefit for the subjects who have undergone treatment;

however, information learned from this analysis has potential to benefit future patients in

helping to understand the impact of targeted temperature management on hanging-induced

anoxic brain injury and cardiac arrest. This study qualifies as minimal risk research.

Cindy Hsu

Sticky Note

insert "discharge" after "hospital"

Include a brief listing of

key references

1. CDC’s WISQARS™ (Web-based Injury Statistics Query and Reporting System). Centers

for Disease Control and Prevention.

2. Baldursdottir S, Sigvaldason K, Karason S, et al. Induced hypothermia in comatose

survivors of asphyxia: a case series of 14 consecutive cases. Acta Anaesthesiol Scand

2010;54:821–826.

3. Borgquist O, Friberg H. Therapeutic hypothermia for comatose survivors after near-

hanging—a retrospective analysis. Resuscitation 2009;80:210–212.

4. Lee BK, Jeung KW, Lee HY, Lim JH. Outcomes of therapeutic hypothermia in

unconscious patients after near-hanging. Emerg Med J 2012;29:748–752.

5. Wee JH, You YH, Lim H, et al; Korean Hypothermia Network Investigators. Outcomes of

asphyxial cardiac arrest patients who were treated with therapeutic hypothermia: a

multicentre retrospective cohort study.

6. Shin J, Lee H, Kim J, et al. Outcomes of hanging-induced cardiac arrest patients who

underwent therapeutic hypothermia: a multicenter retrospective cohort study. Resuscitation.

2014 Aug;85(8):1047-51.

7. Salim A, Martin M, Sangthong B, et al. Near-hanging injuries: a 10-year experience. Injury

2006;37:435–439.

8. Azzopardi DV, Strohm B, Edwards AD, et al. Moderate hypothermia to treat perinatal

asphyxial encephalopathy. N Engl J Med 2009;361:1349–58.

9. Logue ES, McMichael MJ, Callaway CW. Comparison of the effects of hypothermia at 33

degrees C or 35 degrees C after cardiac arrest in rats.

10. Hypothermia after Cardiac Arrest Study Group: Mild therapeutic hypothermia to improve

the neurologic outcome after cardiac arrest. N Engl J Med 2002; 346:549–556

11. Bernard SA, Gray TW, Buist MD, et al: Treatment of comatose survivors of out-of-

hospital cardiac arrest with induced hypothermia. N Engl J Med 2002; 346:557–563

12. Nielsen N, Wetterslev J, Cronberg T, et al; TTM Trial Investigators:Targeted temperature

management at 33°C versus 36°C after cardiac arrest. N Engl J Med 2013; 369:2197–2206

13. Nolan JP, Hazinski MF, Aickin R, et al. Part 1: Executive summary: 2015 International

Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care

Science with Treatment Recommendations. Resuscitation. 2015 Sep 12. pii: S0300-

9572(15)00360-3.

14. Jennett B, Bond M: Assessment of outcome after severe brain damage. Lancet 1975;

1:480–484

15. Cummins RO, Chamberlain DA, Abramson NS, et al: Recommended guidelines for

uniform reporting of data from out-of-hospital cardiac arrest: The Utstein Style. A statement

for health professionals from a task force of the American Heart Association, the European

Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian

Resuscitation Council. Circulation 1991; 84:960–975

Date: 5/24/2015, 6:20:07 PM

View: v2_Introduction Page

Introduction Page1 * Abbreviated Title:

Use of Targeted Temperature Management in Hanging-Induced Cardiac Arrest and Asphyxia

2 * Full Title:Use of Targeted Temperature Management in Hanging-Induced Cardiac Arrest and Asphyxia

3 * Select Type of Submission:IRB Application

4 Original Version #:

ID: VIEW4DF8709A33C00Name: v2_Introduction Page

View: v2_Research Team Information

Research Team Information1 * Principal Investigator - Who is the PI for this study (person must have faculty status)? Faculty status is defined as being a

full-time (>51% effort) faculty member holding one of the following titles at UM: Professor; Associate Professor;Assistant Professor.Deborah Stein

1.1 * Does the Principal Investigator have a financial interest related to this research?Yes No

2 Point of Contact - Who is the alternative point of contact for the PI? This person can be a study coordinator or any other studyteam member. In case the IRB cannot contact the PI, this person is a secondary person to contact:Cindy Hsu

2.1 Does the Point of Contact have a financial interest related to this research?Yes No

3 Other Team Members - list all additional members of the research team for this study. DO NOT include the PI or POC in thislist:Name Edit Submission cc on Email Research Role Has SFI?

No additional team members specified

IMPORTANT NOTE: All research team members (including PI) must have current CITI and HIPAA training completed.

ID: VIEW4DF85C16F2800Name: v2_Research Team Information

View: v2_Resources

Resources1 * Describe the time that the Principal Investigator will devote to conducting and completing the research:

The Principal Investigator is a committed and active clinical researcher and will devote the necessary time to conduct and complete the research.

2 * Describe the facilities where research procedures are conducted:The R Adams Cowley Shock Trauma Center (STC), located at the University of Maryland Medical Center in Baltimore, cares for nearly 8,000 injured patients each year. It

is the Primary Adult Resource Center (PARC) for Maryland’s emergency medical services system, providing the highest level of trauma care in the state. It also serves as

the Neurotrauma Specialty Referral Center for the State of Maryland and admits approximately 350 patients with moderate and severe TBI each year (GCS≤8). The STC

has a dedicated 14-bed Neurotrauma Critical Care Unit (NTCC) in which over 350 patients per year receives care. There is also a 12-bed dedicated Neurotrauma

Intermediate Care Unit (NTIMC). The STC and University of Maryland Medical Center have a targeted temperature management protocol established to improve the

neurological outcomes in patients after cardiac arrest and to reduce complications related to reperfusion injury. Patients are admitted directly from the scene or in transfer

exclusively through the 13-bed Trauma Resuscitation Unit. Computed tomography scan and MRI is available 24 hours-per-day. Physician staffing consists of 24

hour-per-day in-house board-certified Critical Care Attending, Trauma Surgeon, and Anesthesiologist as well as a Critical Care Fellow and senior Neurosurgical Resident.

There are 6 dedicated trauma Operating Rooms, of which 2 are staffed 24 hours-per-day for emergent operative interventions. In addition to the STC, the University of

Maryland Medical System includes the University of Maryland Rehabilitation & Orthopedic Institute and the University of Maryland Specialty Hospital for sub-acute and

chronic care. Within the Kernan Hospital is a 32-bed TBI rehabilitation unit, as well as a variety of outpatient physiotherapy and support programs. The University

Specialty Hospital includes a coma stimulation program and a long-term ventilator care unit.

3 * Describe the availability of medical and/or psychological resources that subjects might need as a result of anticipatedconsequences of the human research:This is a retrospective chart review study and does not involve any contact with study subjects.

4 * Describe the process to ensure that all persons assisting with the research are adequately informed about the protocol, theresearch procedures, and their duties and functions:

Print: HP-00064197 - Use of Targeted Temperature Management in Hangi... https://cicero.umaryland.edu/Cicero/ResourceAdministration/Project/Pri...

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All persons assisting with the research will have a copy of the approved protocol, including the study schedule, research procedures, and their defined duties and

functions. Research staff are trained and certified with their completion of CITI and HIPAA 125 and 201 research training. Each staff member has access to the protocols

that they are on via CICERO and reviews the approved research protocols regularly.

ID: VIEW4DF83CB976400Name: v2_Resources

View: v2_Sites Where Research Activities Will Be Conducted

Sites Where Research Activities Will Be Conducted1 * Is this study a:

Single SiteMulti-Site

2 * Are you relying on an external IRB (not UM) to be the IRB of Record for this study?Yes No

3 * Are any other institutions/organizations relying on UM to be the IRB of Record for this study?Yes No

3.1 Attach the applicable regulatory documents here (i.e., IRB Authorization Agreement (IAA), FWA, local ethics approval, otherIRB approvals, etc.). Final UM approval will be contingent upon final execution of all required regulatory approvals:Name Created Modified Date

There are no items to display

4 * Is UM the Coordinating Center for this study? (Applicable for multi-site studies. A Coordinating Center is responsible foroverall data management, monitoring and communication among all sites, and general oversight of conduct of the project.)

Yes No

5 * Institution(s) where the research activities will be performed:University of Maryland Medical Center

Shock Trauma Center

ID: VIEW4DF870DF2C000Name: v2_Sites Where Research Activities Will Be Conducted

View: v2_Funding Information

Funding Information1 * Indicate who is funding the study:

Department / Division / Internal

2 * What portion of the research is being funded? (Choose all that apply)Other

3 Please discuss any additional information regarding funding below:There is no external funding source. No additional funding is needed.

ID: VIEW4DF85DF452400Name: v2_Funding Information

View: v2_Research Protocol

Research Protocol1 * Do you have a research protocol to upload?

No, I do not have a research protocol and will use the CICERO application to enter my study information

2 If Yes, upload the research protocol:Name Created Modified Date


ID: VIEW4E00563F8D000Name: v2_Research Protocol

View: v2_Risk Level

Risk LevelWhat is the risk level of your study? (Ultimately, the IRB will determine the appropriate risk level and yourdesignation is subject to change.)

* Choose One:


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Minimal - The probability & magnitude of harm/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 psychologicalexaminations/tests.

ID: VIEW4E02805225800Name: v2_Risk Level

View: v2_Type of Research

Type of Research1 * Indicate ALL of the types of research procedures involved in this study (Choose all that apply):

Data Collection or Record Review (i.e., chart review, datasets, secondary data analysis).

2 * Is this study a clinical trial?A clinical trial is a biomedical or behavioral research study of human subjects designed to answer specific questions abouttherapeutic interventions (drugs, treatments, or devices). Clinical trials are used to determine whether new therapeuticinterventions are safe, efficacious, and effective.

Yes No

ID: VIEW4E0280569E000Name: v2_Type of Research

View: v2_Lay Summary

Lay Summary1 * Provide a summary of the background and purpose of the study in language that can be understood by a person without a

medical degree.Hanging is one of the most common methods of suicide worldwide, and it frequently affects the younger population with an estimated mortality rate of 70-80%. The cause

of death from hanging is usually asphyxia. The transient cerebral ischemia and asphyxiation induced by hanging often times lead to cardiac arrest and functional

incapacitation in the near-hanging survivors. To date, no specific treatment is available for hanging-induced cardiac arrests. Post–cardiac arrest targeted temperature

management (TTM) has been shown to improve survival and neurologic outcome of patients who have undergone cardiac arrest, and it is now a class I and IIb

recommendation for patients resuscitated from shockable and nonshockable rhythms, respectively. However, limited data exists on the role of TTM for cardiac arrests

caused by hanging. This study aims to examine the effects of TTM on the survival and functional outcome of hanging-induced cardiac arrests and asphyxia.

ID: VIEW4E02805CF7000Name: v2_Lay Summary

View: v2_Justification, Objective, & Research Design

Justification, Objective, & Research DesignIf you uploaded a separate research protocol document in the ‘Research Protocol’ page, cite the applicable sectionand page numbers from that document in the answer boxes below.

1 * Describe the purpose, specific aims, or objectives of this research. State the hypothesis to be tested:This study will help to elucidate the impact of TTM on the outcome of hanging-induced cardiac arrest and asphyxia patients. Our hypothesis is that TTM is feasible during

the management of postarrest and comatosed near-hanging patients, and that it improves their survival and functional outcome at hospital discharge and up to one year

after hospital discharge.

2 * Discuss the research design including but not limited to such issues as: probability of group assignment, potential for subjectto be randomized to placebo group, use of control subjects, etc.:This is a retrospective chart review of the trauma registry and patient chart data from the R Adams Cowley Shock Trauma Center. The Social Security Death Index will

also be queried to determine the survival of hanging-induced asphyxia and cardiac arrest survivors up to one year. We will compare the survival and functional outcome

at hospital discharge and at one year of patients who received TTM versus those who did not.

Key data to review for this study will include:

-Type of trauma: Hanging, near-hanging, asphyxia, cardiac arrest

-All images and pertinent studies relevant to the head, brain, and cervical spine

-All concomitant injuries

-All complications

-Age

-Sex

-Race

-Pre-morbid conditions

-Vital signs at admission

-Initial rhythm during cardiac arrest (shockable vs nonshockable rhythm)

-Hanging time

-Total time to return of spontaneous circulation (ROSC)

-Bystander CPR

-Time to TTM initiation

-TTM method

-Initial GCS

-Mortality

-ICU LOS

-HLOS

-Withdrawal of care

-GCS at hospital discharge

-Cerebral performance category (CPC) score at hospital discharge (To be abstracted from patient’s PT/OT assessments and cognitive evaluations)

-Survival at 1-month, 6-month, and 1-year (by querying the Social Security Death Index and outpatient records)

3 * Describe the relevant prior experience and gaps in current knowledge. Describe any relevant preliminary data:Available literature is limited on this topic. No clear consensus exists currently regarding the management of hanging-induced asphyxia and cardiac arrest.


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4 * Provide the scientific or scholarly background, rationale, and significance of the research and how it will add to existingknowledge:This study will help us understand whether TTM improves the survival and functional outcome of hanging-induced asphyxia and cardiac arrest patients. Our results may

also be helpful in determining the role of TTM in other trauma patients.

ID: VIEW4E02805EA0C00Name: v2_Justification, Ob jective, & Research Design

View: v2_Supporting Literature

Supporting Literature1 * Provide a summary of current literature related to the research: If you uploaded a separate research protocol

document in the ‘Research Protocol’ page, cite the applicable section and page numbers from that document inthe answer box below.Our literature review revealed that there is paucity of research on the role of TTM for hanging-induced asphyxia and cardiac arrest. No randomized controlled study exists

that directly compares the outcome of these survivors who received TTM and to those who did not. Recent case reports and retrospective case series suggested that

TTM is feasible and may lead to good neurologic outcome at hospital discharge for survivors who sustained hanging-induced asphyxia and cardiac arrest. However, no

previous studies have examined the effect of TTM on the long term survival of these patients. As such, our findings will help guide the postarrest management of these

challenging patients.

2 If available, upload your applicable literature search:Name Created Modified Date


3 * Provide a list of 3 keywords or search terms (1 per line) relevant to your research that would help potential participants findyour study using search engines:

Keyword 1: Targeted temperature management

Keyword 2: Hanging

Keyword 3: Cardiac arrest

ID: VIEW4E02805A7E400Name: v2_Supporting Literature

View: v2_Study Procedures

Study ProceduresIf you uploaded a separate research protocol document in the ‘Research Protocol’ page, cite the applicable sectionand page numbers from that document in the answer boxes below. If some of the questions below are notapplicable to the research (i.e., chart review), enter “N/A.”

1 * Describe all procedures being performed for research purposes only (these procedures would not be done if individuals werenot in the study) and when they are performed, including procedures being performed to monitor subjects for safety or tominimize risks:This study design is a retrospective, observational, chart review study of existing data. Study staff will review all patient medical records, who were admitted to Shock

Trauma Center from 1/01/1989 to 12/31/2014, for demographic data, past medical history, reason for admission, vital signs, laboratory and diagnostic results,

interventions, clinical status, complications, outcomes, etc. Patient movements (to any location off of the ICU) will also be captured. Data will be de-identified, given a

unique study ID, and entered into a de-identified database for analysis.

2 * Describe all procedures already being performed for diagnostic or treatment purposes (if not applicable to the study, enter"N/A"):N/A. This is a retrospective chart review study. Demographic data, past medical history, reason for admission, laboratory and diagnostic results, interventions, continuous

vital signs monitoring, video in TRU, clinical status, complications, outcomes, etc are part of standard of care. No additional diagnostic or treatment procedures are being

performed.

3 * Describe the duration of an individual participant's participation in the study:N/A. This is a retrospective chart review study.

4 * Describe the duration of the entire study:The study population covers all STC patients admitted during calendar years 1989-2014.

5 * Describe any additional participant requirements:None.

ID: VIEW4E0280585B400Name: v2_Study Procedures

View: v2_Sample Size and Data Analysis

Sample Size and Data AnalysisIf you uploaded a separate research protocol document in the ‘Research Protocol’ page, cite the applicable sectionand page numbers from that document in the answer boxes below.

1 * Provide the rationale and sample size calculations for the proposed target population:This is a retrospective study considering all patients suffered from asphyxia and cardiac arrest due to hanging from January 01, 1989 to December 31, 2014. We will be

attempting to learn the outcomes those who received TTM during post-cardiac arrest care versus those who did not.


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2 * Provide the plan for data analysis. Include in the description the types of comparisons that are planned (e.g., comparison ofmeans, comparison of proportions, regressions, analysis of variance, etc.), which is the primary comparison/analysis, andhow the analyses proposed will relate to the primary purposes of the study:Data analysis will include comparisons between the demograhics, patient characteristics, survival, and functional outcome of hanging-induced cardiac arrest and

asphyxia patients who received TTM to those who did not receive TTM. The 1-month, 6-month, and 12-month survival of these patients will be determined by reviewing

hospital records and querying the Social Security Death Index (via the Genealogy Bank at http://www.genealogybank.com/gbnk/ssdi/?kbid=9064&m=9). Survival time will

be calculated as the difference between date of death and discharge date. Nonparametric Kaplan-Meier survival analysis will be used to compare survival between the

groups. The association of unadjusted and adjusted long-term survival with TTM will be calculated. For the adjusted model, we will adjust for age, sex, race, shockable

rhythm, hanging time, time to TTM initiation, time to ROSC, and withdrawal of care.

ID: VIEW4E02806052800Name: v2_Sample Size and Data Analysis

View: v2_Sharing of Results

Sharing of Results1 * Describe whether results (study results or individual subject results, such as results of investigational diagnostic tests,

genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care physicians) and ifso, describe how it will be shared:Any study results derived from data will be submitted for peer-review in manuscript form, and if accepted, will be made publicly available in a clinical journal.

ID: VIEW4E02808CBD800Name: v2_Sharing of Results

View: v2_Data Collection / Record Review

Data Collection/Record ReviewYou indicated on the "Type of Research" page that your study involves data collection or record review (i.e., chart review, notself-report).

1 * What type of data will be collected/analyzed in this study? (Check all that apply)Retrospective/Secondary Analysis (data has already been collected at the time of initial IRB submission)

2 * Will this study involve adding data to a registry or database for future use?Yes No

3 * Will the data be released to anyone not listed as an investigator on the protocol?Yes No

3.1 If Yes, give name(s) & affiliation(s):

ID: VIEW4E0E25A8CA400Name: v2_Data Collection / Record

Review

View: v2_Retrospective Data

Retrospective DataYou indicated that the study involves the use of retrospective data.

1 *What is the date range that the existing data was collected?

Beginning Date:1/1/1989End Date:12/31/2014

2 * What is the source of the data originally collected? (Check all that apply)Medical records

Medical images

Publicly available records

Other

2.1 If Other, please specify:Trauma Registry, Social Security Death Index

2.2 If you checked “Data collected under a different research study”, please provide the name of study, where the study wasconducted, and the IRB number (if applicable).

3 * What specific data fields will you have access to/collect for the study? For example, name, initials, date of birth, SocialSecurity number, income, demographic information, family units, housing, etc.Please see the attached copy of data fields/variables to be collected for this study.

You can also upload a copy of the data fields/variables to be collected for the study:Name Created Modified Date

HP-00064197-Data fields to be collected.doc 5/10/2015 5:25 PM 5/10/2015 5:25 PM

ID: VIEW4E0E25AFA4000Name: v2_Retrospective Data


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View: v2_Participant Selection

Participant Selection1 * How many local potential participants (or specimens/charts) do you anticipate will be screened

for this study? Screening includes determining potential participants' initial eligibility for and/orinterest in a study.10000000

2 * How many participants (or specimens, or charts) will be enrolled/used for this study? A localprospective participant is considered enrolled in the study when a UM-approved Informed ConsentDocument (not including separate screening consent forms) is signed.

Local - the number being enrolled at this site:10000

Worldwide - the number being enrolled total at all sites (including local enrollment):10000

3 * Gender:Male

Female

4 * Age(s):18 years and older (Adult)

5 * Race/Ethnicity:All Races Included

6 * Language(s):English

6.1 Specify Other:

7 * Are you excluding a specific population, sub-group, or class?Yes No

7.1 If Yes, indicate your justification for excluding a specific population, sub-group, class, etc.:

ID: VIEW4E0E519C1D000Name: v2_Participant Selection

View: v2_Vulnerable Populations

Vulnerable Populations1 * Will you be including ANY of the following Vulnerable Populations? (Select all that apply)

None of the above

You may not include any members of the above populations as subjects in your research unless you indicate this here.

ID: VIEW4E0E519917800Name: v2_Vulnerab le Populations

View: v2_Eligibility

Eligibility1 * Do you have an existing Eligibility checklist(s) for this study?

Yes No

1.1 If Yes, upload here. If you need a template, you can download it by clicking HERE. The checklists you upload will also beavailable under the Documents tab of this application.Name Created Modified Date


1.2 If No, create an eligibility checklist below:

List inclusion criteria (List each Inclusion Criteria individually, using the ADD button):Number Criteria

View 1 Patient with age 18 years or older

View 2 Patient who suffered from hanging-induced cardiac arrest

View 3 Patients who suffered from hanging-induced asphyxia

View 4 Patients who received targeted temperature management

List exclusion criteria (List each Exclusion Criteria individually, using the ADD button):Number Criteria

View 1 Patient with age less than 18 years

View 2 Asphyxia from other causes


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Number Criteria

View 3 Cardiac arrests from other causes

After entering the inclusion and exclusion criteria above, click the Save link. CICERO will automatically generate a printableEligibility Checklist for you to use in your research. To review the checklist, click on the resulting link below. This checklist isalso available under the Documents tab of this application.

Eligibility Checklist for HP-00064197 v4-9-2015-1428602712425(0.01)

ID: VIEW4E0E5185F9000Name: v2_Eligib ility

View: v2_Recruitment

Recruitment1 * Describe plans for recruitment, including the identification of potential participants (or acquisition of charts/records

/samples) and initial interactions with them:This is a retrospective chart review study. Patients will be identified via the Trauma Registry by the research staff. Patients who meet inclusion criteria and no exclusion

criteria will be included in the study. The eligible subject list will be generated using hospital medical record numbers.

2 * Describe measures that will be implemented to avoid participant coercion or undue influence (if not applicable to the study,enter "N/A"):This is an observational study of data generated by standard of care. A full waiver of consent is being sought for this study; there will be no interactions with the patient or

patient's family.

3 * Who will recruit participants (or acquire charts/records/samples) for this study? (Check all that apply)PI

Study Staff

3.1 If you are using a third party, specify Third Party Recruiters:

4 Upload any recruitment tools such as screening/telephone scripts and introductory letters (do not upload advertisementshere):Name Created Modified Date


ID: VIEW4E0BCAA0A6C00Name: v2_Recruitment

View: v2_Advertising

Advertising1 * Will you be using advertisements to recruit potential participants?

Yes No

ID: VIEW4E0BCCF811000Name: v2_Advertising

View: v2_Research Related Risks

Research Related RisksIf you uploaded a separate research protocol document in the ‘Research Protocol’ page, cite the applicable sectionand page numbers from that document in the answer box below.

1 * Individually list each research-related risk, using a separate line for each. Next to each risk, delineate thelikelihood/seriousness of the risk, and the provisions for minimizing the risk:Confidentiality - There is a slight risk that a breach of confidentiality would occur. This is very unlikely, since all hardcopy data will be stored in a locked cabinet in a

secured research space. Electronic data will be stored in a password protected laptop and computer. Only designated members of the research team have access to the

study office and data storage equipment. All members of the research team are trained in maintaining confidentiality. All patient data will be de-identified and assigned a

study number prior to storage. Patient confidentiality will be maintained to the extent provided by law.

ID: VIEW4E1B52509F000Name: v2_Research Related Risks

View: v2_Potential Benefits and Alternatives

Potential Benefits and AlternativesIf you uploaded a separate research protocol document in the ‘Research Protocol’ page, cite the applicable sectionand page numbers from that document in the answer boxes below.

1 * Describe the potential direct benefit(s) to participants:There is no direct benefit to participants.

2 * Describe the importance of the knowledge expected to result from the study:This study will help us understand whether TTM improves the survival and functional outcome of hanging-induced asphyxia and cardiac arrest patients.

3 * Describe how the potential risks to participants are reasonable in relationship to the potential benefits:The risks are only potential loss of confidentiality. The potential benefits are that the knowledge acquired may improve the care of future trauma patients.


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4 * Describe the alternatives to participation in this study. If there are no alternatives, state that participation is voluntary andthe alternative is not to participate. For intervention studies, describe appropriate alternative clinical procedures or courses oftreatment available to subjects.This is a retrospective study.

ID: VIEW4E1B5251B0400Name: v2_Potential Benefits and Alternatives

View: v2_Withdrawal of Participants

Withdrawal of ParticipantsIf the questions below are not applicable to the research (i.e., chart review), enter "N/A".

1 * Describe anticipated circumstances under which subjects will be withdrawn from the research without their agreement:N/A. This is a retrospective study.

2 * Describe procedures for orderly termination:The entire study may be stopped by the PI, the Institutional Review Board, the facility where the study is being carried out.

3 * Describe procedures that will be followed when subjects withdraw from the research, including partial withdrawal fromprocedures with continued data collection:N/A. This is a retrospective study.

ID: VIEW4E1B52531F800Name: v2_Withdrawal of Participants

View: v2_Privacy of Participants

Privacy of ParticipantsIf the study does not involve interaction with participants, answer “N/A” to the questions below.

1 * Describe how you will ensure the privacy of potential participants throughout the study (privacy refers to persons andtheir interest in controlling access to themselves):N/A. This is a retrospective chart review study and there will be no interaction with the participants.

2 * Describe the location where potential participants will receive research information and detail the specific actions the studyteam will take to ensure adequate privacy areas:N/A. We are requesting a full waiver of consent for this study; therefore potential participants will not receive research information.

3 * Describe potential environmental stressors that may be associated with the research:N/A. This is a retrospective chart review study and there will be no interaction with the participants.

ID: VIEW4E1B525B87C00Name: v2_Privacy of Participants

View: v2_Confidentiality of Data

Confidentiality of Data1 * Will stored research data contain identifiers or be able to be linked to and identify individual participants (either directly or

through a code/research ID)?Yes

2 * Where will research data be kept (address electronic and paper data as applicable)?All hardcopy data will be stored in a locked cabinet in a secured research space. Electronic data will be stored in a password protected Computer. Only designated

members of the research team will have access to the study office and data storage equipment.

3 * How will such data be secured?Research data collected by the PI and research staff will be kept strictly confidential and will be used for research purposes only. All hardcopy data will be stored in a

locked cabinet in a secured research space Electronic data will be stored in a password protected computer. Only designated members of the research team will have

access to the study office and data storage equipment. The subject's name will never be directly connected with data (data sheets) that is collected from his/her or their

medical records. The research data collected will not identify the patient directly. However, the study ID number will be linked and coded which could identify the patient.

The research data that is collected from the subject and his/her medical records will be grouped together with other participants' information for any reporting of the study

findings.

4 * Who will have access to research data?Only designated members of the research team will have access to the study office and data storage equipment.

5 * Will study data or test results be recorded in the participant’s medical records?Yes No

6 * Will any data be destroyed? (Please note that data for FDA regulated research and VA research cannot be deleted)Yes No

6.1 If Yes, what data (e.g., all data, some recordings, interview notes), when and how?

7 * Do you plan to obtain a Certificate of Confidentiality?Yes No


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7.1 If Yes, upload your Certificate of Confidentiality. If you have not yet obtained the Certificate, please note that once it isobtained, you will need to submit an amendment to attach the document, make any needed changes to the submission andmake needed changes to the Informed Consent Document.Name Created Modified Date


8 * Discuss any other potential confidentiality issues related to this study:None

ID: VIEW4E1B5265E0400Name: v2_Confidentiality of Data

View: v2_Monitoring Plan Selection

Monitoring Plan Selection1 * Type of data safety monitoring plan for the study:

Data Safety Monitoring by an Individual

ID: VIEW4E1B00E30D400Name: v2_Monitoring Plan Selection

View: v2_Monitoring Plan - Individual

Monitoring Plan - IndividualYou indicated that the monitoring will be done by an Individual.

1 * Identify the individual who will be performing the safety monitoring:Dr. Deborah Stein

2 * Describe this individual’s role in relation to the protocol:Principal Investigator

3 * What data will be reviewed?Adverse Events

Enrollment Numbers

Patient Charts/Clinical Summaries

Laboratory Tests

Procedure Reports

Raw Data

Outcomes (Primary, Secondary)

3.1 If Other, specify:

4 * What will be the frequency of the review?Other

4.1 If Other, specify:The Principal Investigator will primarily be responsible for monitoring checks for efficacy of data collection, enrollment numbers, as well as

clarification of any questions. This will be done on an as needed basis throughout the study.

5 * Safety monitoring results will be reported to:IRB


ID: VIEW4E1B026A2A400Name: v2_Monitoring Plan - Individual

View: v2_Research Related Costs

Research-Related Costs1 * Is the study's financial supporter (e.g., commercial sponsor, federal or state grant or contract, private foundation, physician-

sponsor) covering any research-related costs?No

1.1 If Yes, check all that apply:There are no items to display

1.2 If No, who is responsible for payment?N/A

2 * Who is responsible for the uncovered research-related costs?There will be no uncovered research-related costs


3 If the participant is responsible for any research-related costs, identify and estimate the dollar amount:


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ID: VIEW4E1B5D9641800Name: v2_Research Related Costs

View: v2_Compensation for Research-Related Injury

Compensation for Research-Related Injury1 * Is this study under a master agreement that includes a provision requiring the sponsor to provide compensation to

participants for research-related injury?Yes No

1.1 If Yes, please provide the date and title of the agreement and upload the portion of the contract language relevant tocompensation for research-related injury:

Name Created Modified Date


1.2 If No (the study is not under a master agreement), is there proposed contract language concerning payment to participantsfor treatment in the event of a research-related injury?

Yes No

1.2.1 If Yes, indicate the status of the contract review/approval with the ORD and upload the proposed language relevant tocompensation for research-related injury:

1.2.2 Name Created Modified Date


ID: VIEW4E1B629EEC000Name: v2_Compensation for Research-Related Injury

View: v2_Payment to Participants

Payment to Participants1 * Will participants receive payment (money, gift certificates, coupons, etc.) for their participation in this research?

Yes No

ID: VIEW4E1C52A5D7800Name: v2_Payment to Participants

View: v2_HIPAA

HIPAA (Health Insurance Portability and Accountability Act)1 * HIPAA applies to the University of Maryland School of Medicine, the University of Maryland School of Dentistry and the VA.

Are you affiliated with, or will be accessing data from, any of these places? Yes No

2 If Yes, will the study view, access, share, collect, use, or analyze health information that is individually identifiable underHIPAA? Yes No

ID: VIEW4E1B0A2114400Name: v2_HIPAA

View: v2_Protected Health Information

Protected Health Information (PHI)You indicated that HIPAA applies and the study will view, access, share, collect, use, or analyze health information that is individually identifiable.

1 * Which PHI elements will be used or disclosed in this study? (Check all that apply)Name

Dates

Ages over age 89

Telephone numbers

Social Security numbers

Medical record numbers

2 * Why is the PHI necessary for this research?If SSNs are going to be used, describe the specific use and type of SSN to be used (real, scrambled, last 4 digits).The PHI will need to be accessed prior to enrollment for patient's demographics, date of birth, past medical history to screen and determine patient's eligibility. The SSNs

will be used to query the Social Security Death Index.

3 * What is the source(s) of the PHI?PHI is obtained from the Trauma Registry and the participant’s medical chart.

4 * Provide written assurance that Protected Health Information will not be reused. (Note: this refers to re-use on another studyor for a purpose which has not been approved, not to the re-use of screening data during the current study).The data collected for this study will not be re-used in another study or for any other purpose that has not been approved.

5 * How will permission to allow the use/disclosure of the individual's protected health information (PHI) be obtained? (Chooseall that apply:)Requesting waiver/alteration of authorization (includes waiver of authorization for recruitment only)


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5.1 If you are using a limited data set (LDS), please attach the Data Use Agreement (DUA):Name Created Modified Date


ID: VIEW4E1B0A24AA400Name: v2_Protected Health Information

View: v2_Waiver/Alteration of Authorization

Waiver/Alteration of AuthorizationYou indicated that a waiver/alteration of authorization is requested.

1 * Provide rationale for how the research presents no more than minimal risk to the privacy of individuals:The research data being collected is from standard of care. No additional information is being collected as part of research. Therefore this study does not increase the

privacy risk to participants.

2 * Describe the plan to ensure the protection of PHI collected during this study from improper use and disclosure:Once enrolled, the subject's MRN will be used to collect and abstract data from the UMMC medical record systems. The dataset entered in the database will not have any

PHI. Each subject will be assigned a unique identifier number (UIN) as data is entered in the database, prior to analysis. The completely de-identified datasets in the

database will then be used for data analysis. No identifying information (MRN, DOB, etc.) will be connected with the UIN on any of the datasets in the database. For

example, demographic information (e.g. gender, age etc.) collected will be linked to the subject's UIN only.

3 * Describe the plan to destroy the PHI collected during this study at the earliest opportunity consistent with the conduct of theresearch. If there is a need to retain PHI, provide a justification:Research data collected by the PI and research staff will be kept confidential and used for research purposes only. All hardcopy data will be stored in a locked cabinet in

a secured research space. Electronic data will be stored in a password protected database. Only designated members of the research team will have access to the study

materials and data storage equipment.

4 * Why could the research not practicably be done without access to and use of this PHI?The PHI will need to be accessed for patient's admission history, past medical history to screen and determine patient's eligibility.

5 * Why could the research not practicably be done without the waiver or alteration?This study is a retrospective chart review with minimal risk to participants and will not adversely affect the patient's rights and welfare. The data to be collected by

research is from standard of care information and will not affect patient care or treatment. All protected health information will be kept private and the rights of the patients

will be of primary concern. Any identifiers collected on the datasheets will be deleted prior to data analysis. The data sheets for analysis will be completely de-identified,

containing no PHIs.

6 * Will the subjects' PHI be disclosed to (or shared with) any individuals or entities outside of UM?Yes No

6.1 If Yes, describe the individuals or entities outside of UM to whom PHI will be disclosed.

ID: VIEW4E1B0A2896400Name: v2_Waiver/Alteration of Authorization

View: v2_Informed Consent Process

Informed Consent ProcessIf the study does not involve interaction with participants or a waiver of consent is being requested , answer“N/A” to the questions below.

1 * Indicate the type(s) of consent that will be involved in this study: (check all that apply)Request to Waive Consent/Parental Permission (Consent is not being obtained)

2 * Describe the Informed Consent process in detail:N/A. This is a retrospective chart review study.

3 * Confirm that the consent process will explain the following:· The ac vi es involve research.· The procedures to be performed.· That par cipa on is voluntary.· The name and contact informa on for the inves gator.

Yes No

4 * Describe who will obtain Informed Consent:N/A. This is a retrospective chart review study.

5 * If obtaining consent from a legally authorized representative (LAR), describe how you will confirm that the individual is theLAR and can provide legally effective informed consent. (Answer "N/A" if not obtaining consent from LARs)N/A. This is a retrospective chart review study.

6 * Describe the setting for consent:N/A. This is a retrospective chart review study.

7 * Describe the provisions for assessing participant understanding:N/A. This is a retrospective chart review study.


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8 * Describe the consideration for ongoing consent:N/A. This is a retrospective chart review study.

ID: VIEW4E1C661D0AC00Name: v2_Informed Consent Process

View: v2_Waiver/Alteration of Consent Process

Waiver or Alteration Consent ProcessYou indicated that a waiver/alteration of consent is requested.

1 * Explain why the research involves no more than minimal risks to the subjects:This is a retrospective chart review study and will involve no more than minimal risk to participants.

2 * Explain why a waiver or alteration of the consent process would not adversely affect the rights and welfare of the subjects:The waiver would not adversely affect the rights and welfare of the subjects as their confidentiality will be maintained at all times. The information to be obtained has

already been collected for standard of care purposes. No interventions will be performed on the participants, all decisions will be taken by attending physician. No

Intervention or decision will be done by the researchers therefore posing no more than minimal risk to patient.

3 * Informed consent is always required unless there is reason to grant a waiver or alteration of the consent process. Explain whyyou cannot carry out the research unless you are granted a waiver or alteration of the consent process:This is a retrospective chart review study. Each subject's data is critical to the outcome of the study. Without a waiver, data from a significant population would not be

available for analysis. Failure to analyze data from all eligible subjects might skew the assessments made in the study and affect the study’s overall validity.

4 In some cases there will be additional pertinent information during the study that should be given to the participating subjects.For those subjects who have not been given informed consent because there is a waiver or alteration of the consent process,explain how the subjects will receive this additional important information. If applicable, please explain why a subject wouldnot receive additional pertinent information.Since this is a full waiver of consent study, the subject and/or LAR will not be approached. There will be no communication of the study with the participant.

5 If you are requesting an alteration of the consent process please explain why this request is necessary for the conduct of theresearch study. Please identify specifically what is being altered or changed in the consent process.N/A.

ID: VIEW4E1C73B344800Name: v2_Waiver/Alteration of Consent Process

View: v2_Consent Forms - Draft

Consent and HIPAA Authorization Forms - Draft1 Upload all of your Consent Forms for approval. Use only Microsoft Word.


No Consent Forms Uploaded

IMPORTANT NOTE: the above list of consent forms (if any) are DRAFT versions. Under no circumstances should copies ofthese be distributed to patients/study subjects. If/when this research submission is approved by the IRB, approved consentforms will be available for download and use from the "Documents" tab of the Submission's workspace (click Exit and then lookfor the Documents tab - approved submissions only)

2 Upload any HIPAA authorization forms here:There are no items to display

Please refer to HRPO’s website for specific instruc ons for preparing informed consent documents and to access current templates:h p://hrpo.umaryland.edu/researchers/consents.html

ID: VIEW4E1C7712D3000Name: v2_Consent Forms - Draft

View: v2_Organization Review Requirements (other than IRB)

Organization Review Requirements (other than IRB)Answer the following questions to determine additional organizational review requirements:

1 Department/Division Review - All research submissions are required to undergo department/division/institutional reviewprior to IRB review. The following entity is listed as the required department/division/institutional review:

Trauma Rsrch-CORE

If this information is incorrect, please notify the HRPO office.

2 RSC Review Criteria - select 'Yes' if the answer is 'Yes' for any of the following questions. Review by the Radiation SafetyCommittee may be required.

* 2.1 Does the research involve the use of ionizing radiation?

2.2 Does the research involve the sampling of radioactive human materials for subsequent use or analysis in alaboratory?

Yes No


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3 IBC Review Criteria - select 'Yes' if the answer is 'Yes' for any of the following questions. Review by the InstitutionalBiosafety Committee may be required.* 3.1 Does the research involve human gene transfer?

-OR-Does the research specifically apply to human studies in which induction or enhancement of an immuneresponse to a vector-encoded microbial immunogen is the major goal, and such an immune response has beendemonstrated in model systems, and the persistence of the vector-encoded immunogen is not expected? Thistype of research is often referred to as recombinant vaccine trials.

3.2 Does the research involve: a) the exposure of human subjects to pathogenic microorganisms, or b) thepotential exposure of UMB research staff to infectious materials through the sampling or processing of materialsfrom patients with known infectious disease or from environmental surfaces?

3.3 Does the research involve the sampling of materials from persons with no known infectious disease andwhere the only risk to study staff is occupational exposure to bloodborne pathogens as defined by the OSHABloodborne Pathogen Standard?

Yes No

4 Cancer Center Criteria - Answer the following to determine if review by the Cancer Center (Hematology-Oncology) maybe required.

* Does the protocol involve in any way studies related to the prevention, treatment, diagnosis, or imaging ofneoplastic diseases?

Yes No

5 General Clinical Research Center Review Criteria - the GCRC offers free and/or cost shared resources for patient-orientedresearch. Click Here for more information.

Answer the following to determine if review by the GCRC may be required.* Will the General Clinical Research Center (GCRC) facility or resources be used to conduct this activity? Yes No

6 VA Review Criteria - Answer the following questions to determine if review by the VAMHCS R&D Committee may be required.

* 6.1 - Will the research be conducted by VA Investigators including PIs, Co-PIs, and Site Investigators on VA time(serving on compensated, WOC, or IPA appointments)?

Yes No

* 6.2 - Will the research utilize VA resources (e.g., equipment, funds, medical records, databases, tissues, etc.)? Yes No* 6.3 - Will the research be conducted on VA property, including space leased to and used by VA? Yes No

PLEASE NOTE that the research may be funded by VA, by other sponsors, or may be unfunded.

ID: VIEW4E1AF91AB2400Name: v2_Organization Review Requirements (other than IRB)

View: v2_Summary of Required Reviews (other than IRB)

Summary of Required Reviews (other than IRB) 1 Additional Committee Reviews - Based on your responses to the previous questions, you have identified the following additional reviews. To complete or view these

additional committees' forms, click on the links below or exit this application and click on the appropriate button on left side of this submission's webpage.

Name of Related Submission

This protocol has no related submissions (RSC, GCRC, IBC, etc)

2 Required Department and Specialty Reviews - Based on the PI's organization (department, division, etc.) affiliation and answers to previous questions (use of Cancer

Center, etc.), the organizations listed below are required to review this application. These reviews are conducted online and no additional forms or steps by the study

team are required.

Name of Organization Review Status

Trauma Rsrch-CORE Complete

SOM Program in Trauma Complete

ID: VIEW4E1C8D9AE4000Name: v2_Summary of Required Reviews (other than IRB)

View: v2_Additional Documents

Additional Documents1 Upload all additional documents here:



ID: VIEW4E0962513A000Name: v2_Additional Documents

View: v2_Final Page of Application

Final Page of ApplicationYou have reached the final page of this application. It is recommended that you click on the "Hide/Show Errors" link on the upper or lower breadcrumb row of this

page. The "Hide/Show Errors" will do a search of your application, and highlight areas that are required or need to be completed prior to submitting.

By submitting this application, you are electronically routing the protocol for departmental scientific review and all other necessary reviews. According to information you

have provided, this application will be routed to the following Departments for review prior to being forwarded to the IRB for review. These reviews are conducted online

and no additional forms or steps by the study team are required.



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Trauma Rsrch-CORE Complete

SOM Program in Trauma Complete

Required Safety Committee Reviews - In addition to the IRB, the following committees must review this submission. Each additional committee has a separate online

form that the study team will be required to fill out. All committee applications (IRB plus those listed here) must be completed properly before the 'package' of applications

can be submitted. The team may complete these additional forms in any order or at any time prior to submission of the IRB Application. To complete or view these

additional committees' forms, click on the links below or exit this application and click on the appropriate button on left side of this submission's Workspace.

Name of Related Submission

This protocol has no related submissions (RSC, GCRC, IBC, etc)

You may check the progress of your application at any time by returning to the Workspace of this submission. A detailed history, including notes, dates, and times of

events, is provided to you for this purpose.

If a reviewer returns the application to you, you must address their concerns and resubmit the protocol for review to all designated departments. After all departments

have reviewed the application, it will automatically be sent to the IRB for review. Changes made to the submission after its approval must be submitted as modifications.

Investigator AttestationBy submitting this application, I, the Principal Investigator (PI), certify that the information provided in this application is complete and correct. Research will be conducted

according to the submission as described, only by the approved principal investigator and study team members.

In addition, I agree to the responsibilities of a PI, including:

Obtaining informed consent (if applicable) from all subjects as outlined in the submission.

Reporting new information to the IRB per the requirements of the Investigator Manual.

Obtaining renewal of the protocol prior to the expiration of the approval period or halt all study activities upon study expiration.

Accepting ultimate responsibility for the protection of the rights and welfare of human subjects, conduct of the study and the ethical performance of the project.

Ensuring performance of all research activities by qualified personnel according to the IRB approved submission.

Ensuring that research personnel have or will receive appropriate training.

Ensuring no changes will be made in the research until approved by the IRB (except when necessary to eliminate apparent immediate hazards to subjects).

Click the "Finish" button and then click "Submit Application" in the submission Workspace.

ID: VIEW4E1B10C500000Name: v2_Final Page of Application


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