Video-Assisted Informed Consent for Neonatal Lumbar Puncture
Phase: NA
Conditions: Lumbar Puncture, Pediatrics, Emergency Department Patient, Informed Consent
Sponsor: University of Texas at Austin

Title: Study Protocol with Statistical Analysis Plan 
NCT number: Pending 
Document date: 09/26/2023  

 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
11/1/2022 
 
 
Page 1 of 20 
 
GENERAL STUDY INFORMATION 
 
Study Title  
 
Include the study title below.  
 
Video-Assisted Informed Consent for Neonatal Lumbar Puncture 
 
 
1 
Review Type (Choose one) 
 
Please choose which level of review best fits your research. This is an investigator’s assessment of review and 
does not preclude the IRB from alternate determinations. In cases where the investigator and the IRB’s 
determination of review conflict, the IRB’s determination will be considered the official determination.  
Note: Expedited review does not refer to the timeliness of the review of your protocol, but specific categories of 
research defined by OHRP. If you would like help determining which type of review best fits your research study, 
please contact the IRB staff in the Office of Research Support & Compliance: 
https://research.utexas.edu/ors/human-subjects/get-help/  
a ☐ 
Full Board Review – Greater than Minimal Risk Research 
b ☒ 
Expedited Review – Minimal Risk Research  
 
2 
Research Hypotheses 
Please describe the research aims and hypotheses in the box below. To input text, click in the box below and 
start typing. Note: Procedures will be explained in a separate section below. 
 
We hypothesize that having a visual aid (animated video) in addition to the verbal information 
presented in the consent process will lead to increased parent/guardian comprehension, decision-
making, and satisfaction with the consent process for neonatal lumbar puncture. 
 
3 
Study Background 
Provide the rationale and the scientific or scholarly background for the proposed activity, based on existing 
literature (or clinical knowledge). Describe the gaps in current knowledge that the project is intended to address. 
 
A neonatal lumbar puncture (LP), also known as a spinal tap, is a critical diagnostic procedure for 
detecting and managing serious infections such as meningitis in newborns¹. Ensuring that parents and 
caregivers fully understand the procedure, its risks, and its benefits is an essential aspect of the 
informed consent process. Traditionally, healthcare providers have relied on verbal and written 
methods to communicate this information to parents, aiming to facilitate comprehension and obtain 
consent for the procedure². However, there is growing evidence that these traditional methods may 
not always be sufficient in providing parents with a comprehensive understanding of the procedure, 
which could potentially impact the decision-making process and overall satisfaction with the care 
provided3,4. After conventional consent discussions, parents are still often not aware of what the 
procedure will entail, the risks, how long the procedure will take, and what outcomes to expect. 

Page 2 of 20 
 
Language barriers can also contribute to misunderstandings during the consent process, even with the 
assistance of translation services. 
 
Despite the importance of obtaining informed consent for neonatal LPs, there is a notable lack of 
research on the effectiveness of alternative methods for communicating this information, such as 
video-assisted consent. Video-based interventions have been shown to improve patient understanding 
and satisfaction in other medical contexts5 and may provide a more engaging and easily accessible 
means of conveying complex information related to the neonatal lumbar puncture procedure. 
Integrating video-assisted consent into the process could potentially enhance parent comprehension, 
decision-making, and satisfaction with the consent process. 
 
The purpose of this study is to explore the effectiveness of video-assisted neonatal lumbar puncture 
consent processes against a conventional consent discussion to inform parents about pediatric lumbar 
puncture in the pediatric ED. We hypothesize that having a visual aid in addition to the verbal 
information presented in the consent process will lead to increased parent comprehension, decision-
making, and satisfaction with the consent process. Furthermore, the findings from this study may have 
broader implications for improving the informed consent process for other medical procedures and 
interventions in pediatric settings. 
 
1. Leazer RC. Evaluation and Management of Young Febrile Infants: An Overview of the New AAP 
Guideline. Pediatrics In Review. 2023;44(3):127-38. 
2. Katz AL, Macauley RC, Mercurio MR, et al. Informed Consent in Decision-Making in Pediatric 
Practice. Pediatrics. 2016;138(2): 
3. Sherlock A, Brownie S. Patients' recollection and understanding of informed consent: a literature review. ANZ 
J Surg. 2014;84(4):207-10. 
4. Richardson V. Patient Comprehension of Informed Consent. Journal of Perioperative Practice. 2013;23(1-
2):26-30. 
5. Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent 
in a Pediatric Emergency Department. Pediatric Emergency Care. 2015;31(8):572-6. 
 
4 
Design and Methodology 
 
Provide a brief description of the study design or data collection methodologies. Details regarding protocol 
specific research procedures will be discussed in a later section. 
 
A video-assisted informed consent intervention will be implemented in the Dell Children’s Medical 
Center (DCMC) Emergency Department (ED). Parents whose children are recommended for LP will be 
randomly selected to receive either standard informed consent procedures or video-assisted informed 
consent.  We plan to enroll 100 participants. The intervention group (n=50) will receive procedure 
information via a video and the control group (n=50) will receive standard procedure explanation. The 
2-minute video (available in English or Spanish) will use animation to explain the neonatal LP 
procedure, benefits, and risks.  
 
All participants will complete brief knowledge surveys after the intervention and will be asked to 
provide feedback on their satisfaction with the informed consent process. Pediatric emergency 
medicine physicians at Dell Children's collaborated to create the knowledge surveys using the Delphi 
method. The primary outcome to be assessed is the efficacy of the video intervention on parents' 

Page 3 of 20 
 
comprehension compared to the conventional discussion. Secondary outcomes will focus on parental 
satisfaction with the informed consent process and the rate of consent refusal.  
 
5 
Data Analysis 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
Data collection and analysis will be performed by the study physicians with the support from research 
personnel and faculty at DCMC.  Summary statistics of patient variables will be performed using means 
with standard deviations (normally distributed data), and medians with interquartile ranges (non-
normal data).  Categorical data will be presented as percentages.  An independent sample t-test will be 
used to analyze the differences between the survey scores, and the Wilcoxon rank-sum test will be 
used to compare each groups satisfaction with the discharge process. If significant differences in 
baseline variables are observed between the groups, multivariate logistic regression modeling of the 
data will be utilized to adjust for potential confounders.   
STUDY ELEMENT IDENTIFICATION 
6 
Study Elements 
 
Check each research procedure included in your study. A full description of all study procedures should be 
provided in the Procedures (Details) section below. Procedures denoted with “*” below have supplemental forms. 
Navigate to the UTRMS-IRB Library, Templates tab to download the applicable supplemental form.  
 
☐ 
Bio-specimens* 
☐ Biometrics 
☐ Registry or Repository* 
 
☐ 
Focus Group 
☐ Genetic Analysis 
☐ Genomic Data Sharing 
 
☐ 
International Research* ☒ Interview/Survey 
☐ MRI 
 
☒ 
 
Protected Health 
Information* 
☐ 
 
Observation 
☐ 
 
Radioactive Material/PET/Nuc. 
Med 
 
☒ 
Record Review 
☐ Sensors (Inserted) 
☐ Sensors (Externally Placed) 
 
☐ 
Audio (only) Recording ☐ Video Recording 
☐ 
X-Ray/CT/DEXA 
 
 
7 
Study Intervention 
 
Click on the check box (or double click and type an “X” if using Google Docs) if you will implement any of the 
following interventions. 
A full description of all study interventions should be provided in the Procedures (Details) section below.  
* Interventions denoted with “*” below have supplemental forms. Navigate to the UTRMS-IRB Library, 
Templates tab to download the applicable supplemental form. 
 
☒ Behavioral 
☐ Device* 
☐ Drug/Biologic* 
 
8 
Clinical Trial  
 
Click on the following check box (or double click and type an “X” if using Google Docs) if the research meets the 
below definition of a clinical trial.  
 

Page 4 of 20 
 
 
☒ 
This study meets the definition of a clinical trial according to clinical trials.gov in that it 
involves one or more human subjects who are prospectively assigned to one or more 
interventions (which may include placebo or other control) to evaluate the effects of 
those interventions on health-related biomedical or behavioral outcomes. 
 
9 
Additional Oversight  
 
Check the box(es) below if you are implementing research procedures that require oversight from additional UT 
committees. 
 
 
☐ 
Energy introduced to 
the subject 
(electrical, magnetic, 
light) 
☐ Human embryonic, human 
induced pluripotent, or 
human totipotent stem cells; 
or human gametes or 
embryos 
☐Radiation exposure 
without direct clinical 
benefit 
 
☐ 
Biological Samples, Biohazards, Recombinant DNA, or Gene Transfer  
 
 
If biological samples are used and stored on UT campus UT IBC approval is needed. 
 
a 
☐ 
UT IBC has (or will have) oversight.  
 
 
Provide UT IBC Number:  
 
 
      
 
 
 
 
b 
☐ 
Biological samples collected will not be stored at UT Austin and another 
agency has responsibility for biospecimen safety. 
 
10 Alternatives to Participation in This Study 
Provide a description of alternatives to participation in this study, as applicable.  
 
Participation in the study is voluntary. All patients will be treated for their presentation. Parents of 
patients who choose not to participate will receive standard hospital informed consent procedures.  
 
 
STUDY PROCEDURE DESCRIPTION 
11 Procedure Description 
 
Describe all study procedures, including a step-by-step outline of what participants will be asked to do or how 
data will be used. Be sure to describe all of the following in detail, as applicable:  
• Description of all research procedures being performed and when they are performed, in sequential order.  
• Describe/list all research measures/tests that will be used [NOTE: upload copies of all measures, surveys, 
scripts, data collection forms, etc., in “Other Attachments” in UTRMS-IRB].  
• Secondary data or specimens that will be obtained, how they are collected, how are they used.  
• Where research activities will take place and duration (include expected time commitment of participants).  
• Study elements checked in #6 above should be described here.  
Note: if this is a multi-site or collaborative study include the following:  

Page 5 of 20 
 
• This is a “Multi-site Study that involves more than one site performing ALL aspects of the research 
procedures as outlined above.” OR “This is a collaborative study that involves UT Austin researchers 
working with external researchers who are engaged in performing the following study activities (list 
activities).”  
• For assistance with multi-site/collaborative research, download HRP-UT932 Request to Rely Assessment 
Form from the UTRMS-IRB Library and email irbreliance@austin.utexas.edu. 
 
All English- or Spanish-speaking parents/guardians of patients, 0-7 months of age, who are 
recommended for lumbar puncture during the study period will be approached to participate. 
Following consent, patients will be randomized to receive standard hospital informed consent 
procedures for neonatal LP or video-assisted informed consent. Computerized randomization 
functions and opaque envelopes will be used to achieve random assignment and allocation 
concealment.   
 
The control group will be given the standard conversation informed consent along with Q&A time. 
The form used for this discussion and consent process is a form provided by Ascension Seton/DCMC 
titled “Disclosure and Consent for Lumbar Puncture.” The intervention group will also be given the 
standard conversation informed consent (with the “Disclosure and Consent for Lumbar Puncture” 
form) and will also be shown a 2-minute video in either English or Spanish with information on the 
procedure, risks, and benefits and then given an opportunity to ask their provider any questions. The 
video is pending being created until all IRB and administrative approvals of the protocol are obtained; 
the video will be submitted to the IRB as a modification once created and finalized.  
 
Both groups will sign and receive the hardcopy consent form and information form (per Ascension 
Seton and DCMC protocol) and will have the opportunity to ask their provider questions as much as 
needed. No script exists for the standard consent process as providers use the “Disclosure and 
Consent for Lumbar Puncture” form and their own words to describe the process. As we only want to 
assess whether including the video in the consent process makes a difference in parent/guardian 
understanding and satisfaction, we are not providing a formal script for providers to use in either the 
control or intervention group.  
  
Both groups will receive a survey to assess knowledge about the procedure after the informed 
consent process. The surveys will also be offered in either English or Spanish depending on the 
caregiver’s preference. The survey will also contain questions about satisfaction with the way 
information about the procedure was presented.    
 
The time required for each group is approximately 30 minutes: 15 minutes for the consent procedure 
(with or without the video) including Q&A, and 15 minutes to complete the post-consent survey.  
 
PHI that will be collected as part of the study includes: medical record number (MRN), visit date, 
race/ethnicity, diagnosis precipitating the need for the LP, and date of birth (to calculate age at visit).   
SUBJECT POPULATION 
12 
Protected Subject Populations 
Click on the check box for each population, if they are specifically studied for this research. 

Page 6 of 20 
 
 
 
☐ 
 
Active Military 
Personnel 
☒ 
 
Children/Minors 
☐ 
 
Decisionally Impaired Adults 
 
☐ 
 
Emancipated Minors ☐ 
 
Fetuses 
☒ 
 
Individuals with Limited 
English Proficiency 
 
☐ 
 
Neonates (Uncertain 
Viability) 
☐ 
 
Neonates (Non-
Viable) 
☐ 
 
Prisoners 
 
☐ Pregnant Women 
☐ UT Staff/Employees 
☐ 
UT Students 
13 Research Participant Information 
Describe the general characteristics of the subject populations or groups including gender, health status, and 
any other relevant characteristics. If you have multiple research populations (e.g., teachers and students), 
clearly outline characteristics for each group. 
 
Parents/guardians of children 0-7 months old who are recommended for a lumbar puncture will be 
put into two groups to receive either: 
1) standard consent conversation or 
2) video-assisted consent  
 
 
b Minimum Age 
Include the minimum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state the minimum age for each group.  
Minimum age of child = 0 days (both groups) 
Minimum age of parent/guardian = 18 years old (both groups) 
 
c Maximum Age 
Include the maximum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state maximum age for each group. 
Maximum age of child = 7 months (both groups) 
Maximum age of parent/guardian = 85 years old (both groups) 
 
d Inclusion Criteria 
Describe the specific criteria that will be used to decide who will be INCLUDED in the research from interested or 
potential subjects. Define technical terms in lay language, as applicable. 
Children, age 0-7 months old who are recommended for lumbar puncture procedure during an ED 
visit.  
Caregiver fluent in English or Spanish 
 
e Exclusion Criteria 
Describe the specific criteria that will be used to decide who will be EXCLUDED from the research. Define 
technical terms in lay language, as applicable.  
Previous enrollment in the study, i.e., the patient has been previously part of the current LP study. 
This will be confirmed by the study coordinator, PI, or co-I.   
Parent/guardian unwilling to complete surveys 

Page 7 of 20 
 
 
 
SCREENING AND RECRUITMENT 
 
17 
Identification and/or Screening Procedures 
Describe the identification and/or screening procedures below. 
 
Providers (MDs and DOs) who are part of the Pediatric Emergency Medicine Fellowship at DCMC will 
be trained on eligibility criteria for the study and asked to identify potential study candidates who are 
under their care. Patients are triaged upon arrival at the ED by nursing staff and a preliminary 
diagnosis and acuity level is assigned to the patient before they are seen by the ED provider. While 
this triage information is available to all providers on call in the ED and patients are assigned to a 
provider based on acuity level of the patient, use of electronic medical records/PHI will not be used to 
identify potential participants. If they are not part of the research team, ED providers will reach out to 
research personnel to approach the patient about the study if, in the provider’s clinical judgment, a 
lumbar puncture will be part of the patient’s treatment plan. A trained enrolling researcher will 
approach patients and their parent/guardian to introduce the study. If a patient agrees to participate, 
the enrolling researcher will communicate this to the patient’s designated provider. Research studies 
are common in the DCMC ED, and this process has been used for other studies, as well. IRB-approved 
studies where this recruitment method has been used includes:  
• 00002014 - MeMed BV™ to Aid in the Reduction of Inappropriate Antibiotics in Pediatric 
Community Acquired Pneumonia 
14 Total Sample Size 
Enter the total target sample size below.  
 
100 children and their parent/guardian will be part of the study (50 in each group) 
15 
Sample size rationale 
Describe your sample size rational below.  
 
Since this is a pilot study, we do not have the necessary background information to conduct a formal 
sample size calculation. Given our current rate of lumbar punctures in this target population, we 
expect to enroll 100 subjects (50 per arm) over a one year period.  
16 
Identification and Screening 
 
Check the box below if this study involves a screening process prior to the informed consent process.   
 
☐ This study involves obtaining information or biospecimens for the purpose of 
screening, recruiting or determining eligibility of prospective subjects prior to 
informed consent by either: 
1. Oral or written communication with the prospective subject or LAR 
2. By accessing records containing identifiable private information or stored 
identifiable biospecimens. 

Page 8 of 20 
 
• 00000904 - Outcomes of Pediatric Facial Laceration Repair Using 6-0 Fast Absorbing Gut Sutures 
with and without Steri-strips: A Randomized Controlled Trial 
• 00003676 - Effect of Home Nebulized Albuterol vs. Supportive Care on Unscheduled Return Visits 
in Infants with Viral Bronchiolitis 
 
 
19 
Describe the recruitment process, including where recruitment will take 
place. 
Describe recruitment procedures in the box below. Describe all elements checked above to provide a complete 
understanding of the recruitment strategies/methods.  
NOTE: Upload copies of all recruitment materials to UTRMS-IRB in the “Recruitment Materials” section.      
 
Recruitment will take place at the DCMC ED. All patients with an emergency department 
recommendation for LP will be evaluated for study enrollment.  If meeting inclusion and exclusion 
criteria, the patient and caregiver will be approached by an enrolling researcher.  The enrolling 
researcher will inform the family about the study, including providing a written explanation. Refusal 
to participate will not affect the quality of care they will receive. No recruitment materials will be 
used when approaching potential participants.   
OBTAINING INFORMED CONSENT 
 
18 
Recruitment Overview 
 
Check box indicating all recruitment methods utilized for this research. 
 
☐ 
E-mail 
☐ Flyer 
 
☒ 
In-Person 
☐ Letter 
 
☐ 
Social Media 
☐ Research Pool 
 
☐ 
Telephone/Text 
☐ Snowball Sampling 
 
☐ 
Web-post 
☐ Word of Mouth 
20 
Consent Overview 
 
Check the box(es) for consenting procedures that will be used.  
 
☒ 
Obtaining Written Informed 
Consent/Parental Permission 
☐ Requesting a Waiver of Documentation of 
Informed Consent 
 
☐ 
Requesting a Waiver of 
Informed Consent 
☐ Requesting an Alteration of the Required 
Elements of Informed Consent 
 
☐ 
Obtaining Child Assent 
☐ Obtain Consent Using a Short Form with a 
Witness 

Page 9 of 20 
 
 
 
21 
Consent and Assent Processes 
 
Provide a detailed description of consent/assent procedures in the box below. Include: who will obtain consent, 
where will consent be obtained, how is consent obtained, how consent/assent is documented, and when the 
consent process will occur in such a manner that participants will have sufficient time for adequate 
consideration.   
 
Enrollment will take place in the patient’s room at the DCMC ED. An enrolling researcher will explain 
the study objectives, risks, benefits, and alternatives to families in person. If the patient is Spanish 
speaking, a HIPPA-certified video or telephonic translator may be used if a bilingual study coordinator 
is not available. Use of HIPPA-certified video (specifically, the MARTII system) or telephone translator 
is standard procedure for all translation services at DCMC (and Ascension Seton facilities) whether it 
is for clinical, research, or administrative use. Families will be provided a written consent form, with 
similar explanation and be given time to review prior to being given the opportunity for questions. If 
families agree to participation, signed consent will be obtained by research personnel. 
 
Potential participants may be the enrolling researcher’s patient. To minimize the potential for undue 
influence in these cases, the enrolling researcher will reiterate that participation in any research study 
is completely voluntary and that participating or not participating will not have any effect on the level 
of care the child receives at DCMC.  
22 
Electronic Consent  
 
Check the box below if this study involves obtaining consent with an electronic signature. Be sure the section 
above is consistent.  NOTE: This box should NOT be checked participants are responding “yes” or clicking “I 
Agree” on a consent form. This section should only be completed if an electronic signature is being obtained.  
 
☐ 
This study involves documenting informed consent/parental permission using 
an electronic signature.  
 
 
If true, specify method for obtaining e-consent below (e.g., DocuSign): 
 
 
      
23 
Consent and Translation 
Check the box below to indicate that consent documents/scripts will be translated to a language other than 
English.  
 
 
☒ 
The study population will likely include participants whose limited English 
speaking status requires translation of the consent form. 
 
 
Translation Process 
If above is checked, complete the below information describing the translation process. Either A or B 
must be checked. 
 
A 
☐ 
The consent documents will be translated by a certified translator. 
 
B 
☒ 
A non-certified translator will translate the consent documents. 
If selected, complete the next two items below. Section describing qualifications must be 
completed and backtranslation (ii) must be true.  
 
i 
Describe the translator’s qualifications 
To input text, click in the light grey area below. 

Page 10 of 20 
 
 
 
 
The consent form has been translated by the study coordinator Lina Palomares, LMSW. 
Ms. Palomares is fluent in Spanish and has 20 years of experience in survey design and 
translation. 
 
ii 
☒ 
Another individual will confirm that the translation is accurate and 
appropriate  
26 
Waiver of Documentation of Informed Consent  
 
Only complete this section if a waiver of documentation of consent is requested (checked above in #21). To 
approve a waiver of documentation of consent, one of the following options must be appropriate and justified 
by the researcher.  Please choose one waiver option and provide additional information as prompted.  Waiver 
option 2 is most common.  
 
A Waiver Option 1 
 
 
Check the box below for each item (all required – #1-4) and provide protocol-specific information as to 
how the criteria below are met.    
NOTE: This is the only applicable waiver of documentation option for greater than minimal risk 
research. If your study is greater than minimal risk and does not meet Option 1 criteria, you will need 
to obtain written consent.   
1 ☐ 
 
The only record linking the subject and the research would be the consent 
document. 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
2 ☐ 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality. 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
3 ☐ 
 
Each subject will be asked whether the subject wants documentation 
linking the subject with the research, and the subject’s wishes will govern. 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
4 ☐ Describe the mechanism for documenting that informed consent was 
obtained 

Page 11 of 20 
 
  
Briefly explain how the researcher will document that consent was obtained from participants.  
  
     
 
 
 
B Waiver Option 2 
 
Check the box below for each item (all required – 1-3) and provide protocol-specific information as to 
how the criteria below are met.    
1 ☐ The study is minimal risk. 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
2 ☐ Written consent would not be required outside the research context. 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
3 ☐ Describe the mechanism for documenting that informed consent was 
obtained 
  
Briefly explain how the researcher will document that consent was obtained from participants.  
 
i 
     
  
 
C Waiver Option 3 
 
Check the box below for each item (all required – 1-4) and provide protocol-specific information as to 
how the criteria below are met.    
1 ☐ 
 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
 
i 
Describe the cultural group or community. 
 
 
      
 
 
2 ☐ The research presents no more than minimal risk of harm to subjects. 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     

Page 12 of 20 
 
 
 
 
3 ☐ 
 
There is an appropriate alternative mechanism for documenting that 
informed consent was obtained. 
 
i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
4 Describe mechanism for documenting that informed consent was obtained 
To input text, click in the light grey area below 
      
27 
Waiver or Alteration of Informed Consent  
 
Only complete this section if a waiver or alteration of consent is requested. To approve a waiver or alteration 
of consent, all of the following criteria must be appropriate and justified by the researcher. All boxes must be 
checked. SKIP THIS SECTION IF NOT REQUESTING A WAIVER/ALTERATION OF CONSENT 
 
A 
☐ 
The research involves no more than minimal risk to the subjects.  
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below 
 
 
 
      
 
 
 
 
 
B 
☐ 
 
The waiver or alteration will not adversely affect the rights and welfare of 
the subjects.  
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
C 
☐ 
 
The research could not practicably be carried out without the waiver or 
alteration (it is impracticable to perform the research if obtaining consent 
is required and not just impracticable to obtain consent).  
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
D 
☐ 
 
If the research involves using identifiable private information or 
identifiable biospecimens, the research could not practicably be carried 
out without using such information or biospecimens in an identifiable 
format.  
 
 
i 
Provide protocol specific information as to how this criterion is met.  

Page 13 of 20 
 
 
BENEFITS 
29 
Benefits to Society 
Describe the scientific and societal benefit(s) below. 
 
The potential benefit of this trial would be the identification of a superior method for providing 
information on lumbar puncture procedure, risks, and benefits to parents and guardians. Video-
assisted consent could also be adapted for other procedures within the Pediatric ED to improve 
caregiver understanding of procedures.  
 
30 
Potential Direct Benefits to Participants 
Click on the applicable check box. A or B must be checked.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
28 Deception/Incomplete Disclosure and Debriefing 
Only complete the sections below if requesting an alteration of informed consent for research that involves 
deception/incomplete disclosure.  
Deception (as applies to research) means intentionally giving research subjects false information in order to 
establish false beliefs during the course of a research study. 
Incomplete disclosure means that the principal investigator withholds some information about the real purpose of 
the study or the nature of the research procedures. 
See IRB Policies and Procedures Section 15 for a description of deception. 
If this study does not involve deception/incomplete disclosure, skip this section. 
 
A 
☐ It is appropriate to provide additional pertinent information to the subject 
after research activities are complete (e.g., the researcher needed to deceive 
the subject to the nature of the study). 
 
B 
☐ Research participants will have the opportunity to withdrawal their data 
during the debriefing. 
 
C 
Describe the nature of deception/incomplete disclosure and why it is necessary 
to conduct the research. 
To input text, click in the light grey area below. 
 
 
      
 
 
 
 
D 
Describe debriefing procedures. 
To input text, click in the light grey area below. NOTE: Upload the debriefing form to UTRMS-IRB in the 
“Consent Forms” section.  
 
 
      

Page 14 of 20 
 
 
A 
☐ 
There is no anticipated direct benefit to participants. 
 
B 
☒ 
There are anticipated benefits to participants. 
 
 
i 
If applicable, describe the potential direct benefits to participants. 
 
 
 
Describe potential direct benefits to participants below.  
RISKS 
31 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. Note: Risks should also be outlined in the consent form(s).  
 
The greatest risk for participants is loss of confidentiality. Other risks include discomfort watching the 
animated video, completing the study survey, or being provided with the verbal information about 
LPs. The LP procedure itself (whether part of the research study or not) carries risks, as well.  
 
There is no risk the additional time spent watching the video (for the participants randomized to that 
arm) will delay care for patients. Even with the standard consent process, the time spent going over 
the document, answering questions, and clarifying the procedure varies greatly from family to family 
and the procedure is not conducted until the consent is obtained. We do not anticipate that watching 
the video (which will run no more than 2 minutes) will impact the overall time spent on the process 
significantly.   
 
 
32 
Describe how each risk is mitigated/minimized. 
To input text, click in the light grey area below. Note: Risks mitigation should be outlined in the consent form(s), 
as applicable.  
 
The risk of loss of confidentiality does exist but will be minimized with previously mentioned data 
protection procedures and de-identification plans. Risks associated with discomfort will be mitigated 
in the same manner as when explaining invasive procedures in the clinical setting, e.g., allowing the 
parent to ask questions about the procedure to the provider, providing the parent with Child Life 
supportive services, providing parent with other support resources, getting a second opinion about 
the procedure, etc.  
 
Risks involved with the LP procedure are discussed with the parents/guardians irrespective of 
whether it is part of a research study or not. Parents/guardians are given an overview of these risks, 
benefits, other options for care, and are given the opportunity to ask questions and voice concerns 
with their child’s doctor. Social Work and Child Life is also available to help discuss concerns.   
 
 
33 
Data Safety Monitoring 
For additional information regarding data safety monitoring boards and data safety monitoring plans, please 
see Section 21 of our Policies and Procedures. 
One of the following must be checked (A, B, or C).  
 
 
 
If the video-assisted consent procedure provides information on lumbar puncture in a 
more understandable way, parents/guardians in the intervention group may have better 
understanding of the procedure, feel more secure in the procedure their child will 
receive, and have higher satisfaction with the ED visit.  

Page 15 of 20 
 
 
A 
☒ 
 
In the investigator’s opinion, this study is minimal risk and does not 
require a Data Safety Monitoring Plan (DSMP) or a Data Safety 
Monitoring Board (DMSB). 
PLEASE NOTE: The IRB may determine minimal risk studies do require data safety monitoring 
under certain circumstances (e.g., if there is a known risk with an expected frequency).  
 
B 
☐ 
 
This study does not have a Data Safety Monitoring Board, but 
researchers have an internal plan to monitor for safety (Data Safety 
Monitoring Plan (DSMP)). 
Complete Data Safety Monitoring Details  
 
 
C 
☐ 
 
This study has a Data Safety Monitoring Board (DSMB). 
Complete Data Safety Monitoring Details section below or upload this study’s Data Safety 
Monitoring Board’s charter that contains the information below.  
34 
Data Safety Monitoring (Details) 
Complete this section if the study has a Data Safety Monitoring Plan. SKIP this section there is not a 
DSMP/DSMB. If the study has a DSMB, ensure all items below are addressed in the charter (and charted 
uploaded to UTRMS-IRB) or provide additional information below, as needed.  
 
A 
How is safety information collected? 
 
 
      
 
 
 
 
B 
When will safety data collection start (for each participant or for the whole 
study, as applicable)? 
 
 
      
 
 
 
 
C 
How frequently will safety data be collected? 
 
 
      
 
 
 
 
D 
Who will review the data for safety? 
 
 
      
 
 
 
 
E 
How frequently will data be monitored for safety concerns? 
 
 
      
 
 
 
 
F 
What data will be reviewed? 
 
 
      
 
 
 
 
G 
State the frequency or periodicity of the review of cumulative data. 
 
 
      
 
 
 
 
H 
State any conditions that would trigger an immediate suspension of the 
research. 
 
 
      
 

Page 16 of 20 
 
35 
Early Withdrawal 
Only complete this section if there are planned conditions under which a participant will be withdrawn from 
the study. If not applicable, skip to next section. Include this information in your consent form. 
 
A 
List the criteria for withdrawing individual participants from the study (e.g., 
safety or toxicity concerns, emotional distress, inability to comply with the 
protocol, or requirements from study sponsor). 
 
 
      
 
 
 
 
B 
Describe any necessary procedures for ensuring the safety of a participant 
who has withdrawn early. 
 
 
      
 
 
 
36 
Describe any pre-specified criteria for stopping or changing the study protocol due 
to safety concerns. 
 
      
REQUIRED DISCLOSURES 
37 
Required Consent Disclosures  
Identify each element below that may require additional information to be disclosed in the consent form. 
 
A 
☐ It is reasonable that researchers could discover or suspect child or elder abuse. 
Add appropriate disclosure in consent form(s). 
 
B 
☐ It is reasonable that researchers could learn of an incident that could require 
reporting under Title IX. 
Add appropriate disclosure in consent form(s). See Title IX and Research Guidance for information and 
download the Title IX Reporting Form on the Special Topics page.  
 
C 
☐ It is reasonable that researchers could discover incidental findings or other 
information of medical interest about a participant's previously unknown 
condition. 
Add appropriate language to consent form(s).  
 
i 
Articulate methods for addressing and reporting incidental findings, if 
applicable. 
Ensure appropriate information is in consent form(s), as applicable.  
 
 
      

Page 17 of 20 
 
PRIVACY AND CONFIDENTIALITY 
 
38 
Privacy 
Describe how you will protect the identity and privacy of study participants during each phase of research. 
Privacy focuses on the individual participants rather than data. In this section, researchers should focus on 
issues such as where research activities take place and how participant involvement is protected from non-
participants. Describe methods to ensure participants’ privacy during identification, recruitment, screening, the 
consent process, the conduct of the study, and dissemination of data. 
All initial research interactions with the patient will take place in a private room within the DCMC ED. 
Patients will only be approached once a trained ED provider has verified the patient’s eligibility for 
research personnel to approach. We will collect private information (e.g., name, medical record 
number) to be able to review the patient’s visit history after discharge from the ED.  
 
All post-study activities, including chart review and data analysis will occur in a confidential location, 
specifically the PEM Fellows offices at Dell Children’s Medical Center. The suite has individual offices, 
including a private office for the study coordinator, that ensures that phone conversations cannot be 
overheard, and data being assessed on a computer monitor cannot be seen by others. 
 
All data will be analyzed in a de-identified format. Upon study closure, identifiers will be destroyed. 
The data from this study may be published, but the subject identities will not be disclosed. 
39 
Confidentiality and Data Security Plan 
Provide general information below regarding confidentiality and data security plan. Provide additional details 
regarding how you will protect the confidentiality of data or address confidentiality concerns.  
Include the following, as applicable:  
• 
If identifiers will be coded to protect confidentiality describe how and where identifiers are stored.  
• 
Describe where and how data is stored and maintained. 
• 
Include details regarding storage of consent forms, if applicable. 
Research personnel will have access to identifiable data, specifically MRN, visit date, date of birth (to 
calculate age at visit date), and medical diagnosis precipitating the need for the LP. Data will be coded 
and de-identified after the data preparation and collection stage.  A unique ID number will be 
assigned to each subject included in the study.  The PI will maintain a list correlating patient medical 
record numbers to the unique ID numbers to assist in quality control of the data.  This file will be 
stored separately from the health information in the analysis file. Electronic data will be stored in UT 
Box.   
 
Survey data and consent forms will be stored in the PEM Fellows office, which is accessible only via 
badge entry to authorized personnel, in a locked filing cabinet accessible only to study personnel.  
 
40 
Research Data/Records Destruction Details  
 
Confirm general research data/information (including consent forms, as applicable) destruction timeline. One of 
the following must be checked.  
☒ 
Research Data/Records will be retained for 3 years after study completion per 
UT record retention policy.  

Page 18 of 20 
 
 
42 Data Access 
 
If you plan on creating a repository, complete the repository form as well (download from in UTRMS-IRB). 
 
☒ Study Team 
Members 
☐ External Collaborators 
☐ Data coordinating center 
 
☐ Sponsor 
☐ Future Sharing with 
other researchers 
 
☐ Others 
 
 
     
 
 
 
☐ 
Research Data/Records will be retained for longer than 3 years and retention 
information is provided below.  
Describe data retention timeline below. To input text, click in the light grey area below. 
 
      
 
 
41 
Confirm identifiable data destruction details 
One of the following must be checked.  
☒ 
Identifiable data will be destroyed.  
If checked, ensure the below section describes identifiable data destruction plan and timeline.   
 
All identifiable data will be destroyed upon completion of the study. Consent forms will be 
retained for three years.  
 
 
☐ 
Identifiable data will not be destroyed.  
If checked, explain below the rationale for retaining identifiable data indefinitely.  
 
      
43 
Describe data sharing plan for each group checked above and state whether 
researchers plan on sharing identifiable, coded, or de-identified data. 
To input text, click in the light grey area below. Ensure that data sharing and future use is addressed in the 
consent form(s).  
Only the principal investigator, co-investigator, and research coordinator will have access to 
identifiable information. Data will not be shared outside the research team.  
44 
Certificate of Confidentiality 
Click on the check box (or double click and type an “X” if using Google Docs) to identify each element below that 
may require additional information to be disclosed in the consent form. 
If a Certificate of Confidentiality is not applicable for this study, skip this section.  
 
A 
☐ 
 
NIH has issued a Certificate of Confidentiality for this study. 
Ensure CoC language is included in the consent form(s).  
 
B 
☐ 
 
A Certificate of Confidentiality has not been obtained, but there are plans to 
apply for one. 

Page 19 of 20 
 
COMPENSATION AND COSTS 
 
Ensure appropriate CoC language is included in consent form(s). Apply for a CoC for non-NIH funded 
research here: NIH Certificate of Confidentiality System. Once CoC is granted by NIH, you must update 
the consent form language and ensure a copy of the CoC approval (only for non-NIH funded research) 
is uploaded to UTRMS-IRB.  
45 
Compensation  
Click on the check box (or double click and type an “X” if using Google Docs). A or B must be checked.  
 
A 
☐ Subjects receive compensation. 
 
i ☐ Confirm: Amount of compensation and its form is reasonable for this 
population for the activities requested of them. 
 
ii Total Amount of Compensation  
Include the total amount of compensation below.  
 
 
 
 
 
iii Type of Compensation  
 
 
☐ Cash  
☐ Check  
☐ Gift Card 
 
 
☐ Course Credit 
☐ ClinCard 
☐ Tango Card 
 
 
☐ Other 
 
 
 
Describe other form of compensation below.  
 
 
      
 
 
 
 
iv Proration Schedule  
Describe the proration schedule for multi-visit/session studies. Skip if not applicable.  
 
 
 
 
 
B 
☒ Subjects will not receive compensation. 
46 
Costs 
A or B must be checked.  
 
 
A 
☐ 
Participants will have no costs associated with this study 
 
B 
☒ 
Participants will have the following costs associated with this study.  

Page 20 of 20 
 
 
 
 
 
☒Standard of care procedures 
contributing to study data 
 
☐ Research procedures not 
associated with standard of care 
 
 
 
☐Administration of drugs / devices  ☐ Study drugs or devices 
 
 
 
☐Transportation and parking  
i 
Describe all costs below. 
To input text, click in the light grey area below. 
 
 
 
Patients or their insurance will be required to cover the cost of the visit as part of usual 
care. Uninsured patients will be given the option to enroll in Medicaid or another public 
program prior to discharge to minimize this cost.