Pediatric Research Resources

Do you have questions about getting started in research and QI? We're here to help.

Use this form to give us an idea about what kind of research or QI assistance you need from the Dept of Pediatrics so we can guide you to the most appropriate resources.

Examples: Study design, QI design (e.g., PDSA cycles), statistics plan, navigating the IRB and/or SAT processes, DRC (Department Review Committee) review, undergraduate research volunteer assistants (RV), data pull, other

• If you do not currently have a UT EID, please proceed to create one here.
• If you previously created a UT EID and need to look it up, please proceed here.

• The University of Texas at Austin requires faculty, staff, and students who are or will be involved in the conduct of human subjects research to complete human subjects research training (CITI) prior to IRB approval. This certification is good for 3 years and can be renewed after that with refresher courses online.
• CITI training is recommended but not required for individuals doing non-human subjects research such as QI chart reviews.
• https://about.citiprogram.org/
  
• Total time estimated to complete this web-based training is 10-15 hours.
  
• You must associate your account with UT as the institutional affiliation
• Take the course for either Biomedical Researchers or Social/Behavioral Researchers depending on your type of study (at least 1 of these modules is required for all studies). The best practice is to select your curriculum based on the type of human subject research you primarily conduct but both of the courses are acceptable training. In addition, consider the Good Clinical Practice module (optional; may be required depending on the study and sponsor).
• After affiliated with UT, from the curriculum screen (learner tools), click on Human Subjects/IRB training, Then click on Biomedical Researchers. Take Stage 1. Basic Course. Or click on the Social/Behavioral Researchers module.
• From the curriculum screen, choose GCP Good Clinical Practice course which will take you to GCP for Clinical Trials with Investigational Drugs and Medical Devices (optional).
• Click here to associate your CITI training to UT

UT faculty and professional research staff are required to complete or Update their Disclosure Profile in UT Research Management Suite COI Module (UTRMS-COI).

When am I required to complete/update my Disclosure Profile in UTRMS-COI?

The system will send email invitations to individuals when disclosure is required. An update to the Disclosure Profile is not possible without an invitation. Notifications will be sent by email with a link to the UTRMS-COI module when disclosure is required: within 30 days of initial employment (PI eligible faculty/staff only), prior to the submission of a PHS application for funding, when identified as a covered individual on an IRB proposal, when identified as a FCOI investigator on a research award, and at least annually.

Instructions for completing/updating the Disclosure Profile can be found in the COI User Guide
on the Resources and FAQs page under “COI”.

Link to COI FAQ

How to Check COI Status of Research Teams

• All QI and research projects are required to be reviewed by the Department Review Committee (DRC) before IRB approval.
• • If you plan to utilize research coordinators or other resources from the Dept of Peds, please send the proposed study to Keli Hawthorne for a feasibility discussion. We are eager to support your research efforts and want to be sure your potential study fits within the scope and vision for research held by the Dept of Pediatrics, along with determination of sufficient resources, research coordinator support, feasibility, potential enrollment numbers, locations involved, other divisions involved (ie, nursing, pharmacy), if statistics support is needed and how that will be funded, time commitment by potential subjects, and funding.
    
• The DRC scientific review and approval process will ensure standardization with the Dell Medical School’s DRC guidelines and a means of providing support for scientific growth of early career researchers, tracking all human subjects-related research activity, providing a level of scientific review that is not provided by the UT IRB, and keeping inventory of all departmental research activities.
  
• Click here to complete the online form and upload your study documents (UT IRB Template and all other materials going to the IRB) for departmental review prior to IRB review and approval.

• PIs with a regular UT faculty appointment are required to use the UT IRB (rather than the Ascension IRB). PIs without an affiliation with UT may use the Ascension IRB. Only submit to 1 IRB (either UT or Ascension).
• Make sure you are set up in the UT system to serve as a PI: Eligibility to Serve as a Principal Investigator on Human Research Projects
  • Students, residents, and fellows may not serve as a PI but can be involved as a Co-Investigator or listed as Study Personnel.
• Accessing the IRB system: https://research.utexas.edu/eraproject/ - In left sidebar menu, click on UT Research Management Suite (RMS) to launch online access
  • Visit https://irb.research.utexas.edu/ to log in with your University of Texas EID and password. You will be required to complete duo authentication to gain access. If you are unable to login, email research@utexas.edu to request access.
  • Click here for instructions on How to Set up a PI Proxy and Submitting as a PI Proxy
• Guidelines on Getting Started and Creating a New Study Submission
  • Study Proposal Templates can be found here.
    
  • For studies that will only utilize secondary data (i.e. retrospective or prospective chart reviews with no interactions with individuals or primary data collected), please use the HRP-UT903 – Template IRB Proposal Secondary Use Submission.
  • UT IRB hosts virtual office hours on Wednesdays, 10-11am: https://utexas.zoom.us/j/99072854072.

• Starting Summer 2024, Ascension requires a separate HIPAA form for all new studies. Please remove HIPAA language from the UT IRB consent form template. UT IRB is aware of this change and accepts the Ascension HIPAA form.

IRB Exempt does not mean that your study is exempt from all IRB oversight. An Exempt classification means the study is “human subjects research” but it meets certain federally mandated criteria that don’t require the review by a voting member of the IRB. The IRB Program Coordinator reviews the file and makes the determination about whether the study meets one of the exempt criteria. Exempt studies receive a three year determination (rather than one year) and only require an amendment submission for review if the protocol change increases the level of risk to the research subjects.

Expedited review studies require IRB review, but meet federally defined categories that allow one experienced voting board member to approve the study rather than the convened full board. The entire board is informed of these decisions at its monthly meeting. The review of these studies does not require the investigator to provide paper copies of the submission; they are handled electronically.

Frequently Used “Exempt” Categories

Remember – “Exempt” studies must meet the same ethical principles as “Expedited” studies; they are not “exempt” from obtaining informed consent!

Category 1 Exemption studies involve research in:

• Commonly accepted educational
  settings AND
• ONLY normal educational practice.

Category 2 Exemption studies involve: Interacting with subjects using educational tests, surveys, interviews or observation of public behavior UNLESS

• Information is recorded in such a manner that subjects can be identified AND
• Any disclosure outside the research setting will not damage their reputation or put them at legal risk.

Category 4 Exemption studies involve:

• Using existing data that is publicly available OR
• Using existing data but recording the information in such a manner that subjects cannot be identified.

For either Exempt or Expedited studies, you will need to complete:

• The online application (a faculty member must be listed as the PI of Exempt studies)
• A proposal in the IRB‐required format
• A template consent form

IRB Reliance is when one IRB agrees to rely on another IRB for the review and approval of a non-exempt research project. IRB Reliance can be established between institutions or between an institution and an independent IRB, such as Western IRB or the NCI Central IRB. A reliance arrangement is particularly useful when multiple study sites are following the same study protocol or procedures. Reliance arrangements can also be useful when some of the study sites or partners do not have their own IRB.

Reliance agreements may be put in place when:

• UT Austin has agreed to be a reviewing IRB for one or more other institutions / organizations. Each relying site must complete the form “HRP-UT931 – Template Site Specific Request to Rely on UT IRB Form.”
• UT Austin has agreed to rely on the IRB of another institution or an independent IRB. Complete HRP-UT930 Template Request to Rely on an External IRB Form and upload it the system.

More details and links for forms can be found here: IRB Reliance Guidance

As of Summer 2024, the following types of studies must be filed with the Ascension IRB. You do not need to file a duplicate submission with the UT IRB.

1) Compassionate Use
2) Emergency Use
3) Expanded Access
4) Humanitarian Use Devices (HUD)

See the attachment below for instructions for anyone listed on an Ascension eIRB study and links to access forms. Asc GUIDANCE Researcher Privileging requirements 4 2024

For Ascension Seton Contracts (If the PI is employed by Ascension Seton):

• For contracts such as LOI, CDA, DUA, or sub-award agreements, please email documents to Research-Contracts@seton.org for processing and signatures. Please allow at least 3 weeks for processing before your sub-award deadlines.
• All contracts and budget negotiations for studies involving Ascension employed faculty will be done through the SAT process (see below).
• If any Co-Investigators or other members of your team are employed by UT (ie, your research coordinator), you will need a Statement of Work (SOW) for UT for those salaries and related costs.

For UT Contracts (If the PI is employed by UT Dell Med):

• See the DMS OOR Contracting page. The Agreement Submission Portal can be found on their webpage.
• To submit a new contract or amendment to an existing agreement, click here: https://agreements.research.utexas.edu/

Need an ERA Commons ID for your grant submission?

If your grant is going through UT, contact Mickey Roberts (Dell Med Office of Research, Assistant Director of Sponsored Projects).

If your grant is going through Ascension, contact Ruth Dewey (Ascension Research Grants Specialist).

Ascension Seton and UT Dell Med are separate entities, each with their own grants systems.

For Ascension Seton Grants (If the PI is employed by Ascension Seton):

• To get started: Complete the Ascension Grants Intake Form. This form should be used for new proposals, renewals, and subcontracts. Requires minimum of 14 days notice prior to grant deadline.
• At the link above you can also find the Ascension attachments: Budget Template, Budget Justification Template, Responsibility Matrix, and Submission Workflow & Approval Process.

For UT Grants (If the PI is employed by UT Dell Med):

• To get started: Complete the Dell Med School Sponsored Projects Proposal Notification form. This form must be submitted at least 3 weeks in advance of the sponsor deadline to give the office sufficient lead for assistance (exceptions may be considered for extenuating circumstances).
• The DMS OOR Grants Specialist for the Dept of Pediatrics is Arshad Javed (arshad.javed@austin.utexas.edu). Instructions are located here to find the link for submitting a new contract and to communicate your potential project to the Grants Specialist.
• If any Co-Investigators or other members of your team are employed by Ascension, you will need a sub-award for Ascension for those salaries and related costs. Please request a budget from Ascension Seton via the grants@ascension.org email.
• Once the budget and contract are approved, DMS OOR will coordinate a Kickoff Meeting with the PI, study team/CRC, and DMS OOR Post-awards to review the Trial Tracker document for invoicing and the budget.

Dell Med SPA Office Hours (Sponsored Projects Administration) - Bi-Monthly

The Dell Med SPA Bi-Monthly Office Hours will be held the first and third Thursday of the month from 2-3pm CT.

Office hours are provided on a zoom-in basis and do not require an appointment. If the university is closed on a day when office hours are scheduled, office hours will not be hosted on those days.

Zoom Link for SPA Office Hours: https://UTHealthAustin.zoom.us/j/3844756194 *Zoom link subject to change; check with the SPA Office to ensure you have the correct link for the week you are joining.

SAT approval is REQUIRED for all studies done at Ascension facilities or using Ascension patient data including chart reviews.

Whereas the UT IRB considers scientific merit, risks, and benefits of a study, the Ascension SAT (Site Approval Tool) system approval allows for Ascension to know what research is being conducted at their locations with Ascension patients and data. It also facilitates inter-division communication and the process is heavily engaged in budget negotiations with sponsors. The Ascension SAT approval is concurrent to IRB approval.

• Questions about SAT? Contact Research Support Services Site Approval Team at siteapproval@ascension.org.
  
• More questions about SAT? Attend SAT Office Hours every Tuesday from 10 - 11am. Study teams may join for assistance with the site approval tool.
  
• If you have a protocol in the SAT system, you're welcome to attend the weekly SAT Huddle virtual meeting where protocol status is discussed weekly until approval (Wednesdays, 2:30-3:30pm). Email the SAT to be added to the calendar invite.
  
• You can initiate the SAT process here: https://redcap.ascension.org/t.
• Google Meet Joining Info
  Video Call Link: https://meet.google.com/pxv-qxpm-nye
  Or Dial: ‪(US) +1 225-434-0305 PIN: ‪756 040 373#
  More phone numbers: https://tel.meet/pxv-qxpm-nye?pin=7105104828253

Finance/Post-Approval

• Standing Office Hours are every Tuesday from 9 - 10am. Study teams may join Michael Speck for assistance with Finance/Post-Approval guidance on a study. You may use these office hours to cover questions on the following items: Financial statements, Accounts receivable, invoice payments, post approval start-up, and liaison efforts between the study teams and research administration.
  • Office Hours: Tuesdays 9:00am-10:00am CDT
    Video call link: LINK
    Or dial: ‪(US) +1 563-562-6319 PIN: ‪458 052 909#

• Examples of activities that may or may not be human subjects research
• NIH Decision Tool: Am I doing human subjects research?

• Projects that are program evaluations and not intended to be generalizable are often QI and not considered human subjects research by the IRB. Please see OHRP's FAQ.
• If you are writing up a publication and the journal requires an official determination from the IRB, you can ask the IRB for a letter of determination of Not Human Subjects Research (NHSR) by following these steps:
  • When you submit to the UT IRB, you can ask them for a letter of determination of Not Human Subjects Research (NHSR). Complete this survey and save your responses as a .pdf file. Go the IRB system and create a new protocol. In the study title (long and short titles), include "QI; IRB Documentation Required" so that the IRB understands your intention. Upload the survey .pdf responses along with your completed template.
  • Complete the UT IRB Template HRP-UT902 – Template IRB Proposal Exempt Submission. Choose Category 2: Research involving surveys, interviews, observations of public behavior, and/or educational tests (cognitive, diagnostic, aptitude, achievement). This form doesn’t have a separate background section so please include your background in Section 3 (study purpose/hypothesis) to refer to previous work. This form doesn’t allow for waiver of consent but it does mention “providing research information”. Write up a process in which you’d inform the participants, “by completing and submitting this survey, you consent to participate”
  • Submit your completed IRB template and all other materials going to the IRB to the DRC (Departmental Review Committee, see above) PRIOR TO submitting to the IRB.
    
  • If your QI project and/or chart review involves Ascension patients, Ascension data, or is conducted at Ascension facilities, you need to submit to the Ascension SAT system for approval.

• Required by UT for consent forms:
  • Add PI's UT Dell Medical School affiliation and add injury language (if applicable): "Compensation for an injury resulting from your participation in this research is not available from The University of Texas at Austin. You are not waiving any of your legal rights by participating in this study."
• Required by Ascension for all sponsored clinical trial consent forms with research performed at Ascension facilities or with Ascension data:
  
  • Remove language stating that the study doctor/PI will be paid by the Sponsor to conduct this study, if applicable. If removal is not acceptable to the Sponsor, wording can be changed to indicate that the site is being paid by the Sponsor. Examples: "The Sponsor is paying for this study and the study site will be paid by the Sponsor." or "______ and its representatives (“sponsor”), are sponsoring this study and are paying Ascension Seton for their work in this study."
  • See attachment for guidance on financial and contraception language required by Ascension for consent forms: Ascension Required ICF Language Guidance Finance Contraception
  • If applicable, mileage is either the IRS Business or Medical Rate. Please confirm with method with the Sponsor. Add the following language: "You are also eligible for reimbursement for travel at the current IRS Business/Medical rate."

• Case Reports of 3 or fewer subjects do not require IRB approval. However, many journals require a parental consent form or release in order to publish.
• If you know the journal you want to submit to, check their website to see if they have a consent form for case reports that you can use.
• If you are unsure about where you plan to submit for publication, or if your targeted journal doesn’t have a template, we suggest you use this template from BMJ for parent signature. Link to Template.
• Your intended journal may also require a Letter of Determination of Non-Human Subjects Research (NHSR) from your local UT IRB. If so, submit the secondary use template and the BMJ consent form to the IRB and request a Letter of Determination.
• You may use the BMJ consent form and obtain consent prior to receiving the UT IRB Letter of Determination, provided that the case study meets the IRB's definition of NHSR as applicable to case studies (i.e., a single series of up to 3 medical case studies where there is no intent to conduct a systematic investigation and make generalizations based on case analysis). This consent form is obtaining consent to publish.
• Use the CARE Guidelines Checklist: Consensus-based Clinical Case Reporting Guideline Development for completeness, transparency and data analysis in case reports and data from the point of care.

• If you are looking to do research at CommUnityCare, please refer to the process outlined in the CUC Research Portal. Once you submit the Research Proposal Form to the portal, our organization will match an internal expert to provide feedback and establish whether the project is aligned with our current initiatives. If the project aligns, it will move onto the next stages outlined in the portal flow chart.
• If you have any further questions, please contact the CUC Department of Education and Research at: educationandresearch@communitycaretx.org

• REDCap is a secure web platform for building and managing online databases and surveys. REDCap's streamlined process for rapidly creating and designing projects offers a vast array of tools that can be tailored to virtually any data collection strategy.
• REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields.
• For assistance with REDCap such as login access, authorization status, adding new people, improving your data collection tools, and other questions, please contact the REDCap group you’re using.

UT Dell Med REDCap: https://redcap.dellmed.utexas.edu/

To create a NEW project you must have an affiliation with DMS and complete online training.
• Complete the REDCap New User Training.
• After you've completed the training, you will receive a confirmation email. REDCap Admins will enable your ability to create projects within 1 business day.

Virtual Office hours: Wednesdays, 1:00-2:00PM

Email redcap@dellmed.utexas.edu for the office hours link and for any questions

Ascension REDCap: https://redcap.ascension.org/txaus/

To create a NEW project:
Please ensure you have logged into REDCap at least once prior to completing the "New User Training"
• Complete the REDCap New User Training.
• After you've completed the training, you will receive a confirmation email. REDCap Admins will enable your ability to create projects within 48 business hours.

Virtual office hours: Every Wednesday (except major holidays) from 11:00 AM to 12:00 PM Central Time. Link to Hangouts meeting meet.google.com/oon-bfxk-axv

Email redcap@seton.org for more questions

Dell Med Data Intelligence holds Office Hours via Teams Call on Wednesdays 1-2pm.

Data request form here.

Store all data sets on UT box (drive) – please do not save on your desktop for security reasons.

Have a data request? The Department of Pediatrics now has a dedicated data core team that can help you with the data services below. Click here to submit your request »

• Design dashboards and visualizations
• Provide actionable insights
• Tell stories through data
• Extract and clean data from CSV/Excel files

If you or your team are thinking about compensating participants for involvement in a study, please follow the recommendations below.

1. E-gift cards are the preferred payment method for compensation, not physical gift cards.
2. Please avoid mentioning your specific gift card vendor and format when advertising participant compensation.
   1. Instead of promoting a "$25 to Target given in person", consider saying "$25 e-gift card".

UT Libraries provides transcription services: https://captioning.lib.utexas.edu/.

There is a free version, where the transcription is generated by a bot (and you can clean it up yourself), and a paid-for-services version, where someone tries to accurately capture everything. Be sure to check out/ask about their pricing that fits your needs.

On the page, click on “Make a Request.” For the pay-for-services, click on the second option, “Transcription requests.”

If you want to test out the free/bot-generated version, click on the third option, “Automated caption or transcription requests,” upload a sound file and a transcript will be automatically generated within the hour.

A qualified translator is a person who has versatile knowledge and is able to render a text from one language into another thereby maintaining its tone and style, observing the cultural nuances, and remaining impartial to the content. For UT IRB purposes, a qualified translator can translate your IRB documents and have a 2nd foreign language speaker review the work and verify to its accuracy. This is attested to in your IRB submission.

If you do not have access to a qualified translator and reviewer, please review the Language Access: Translation and More page from Dell Med Communications for further assistance.

The Dell Med Dept of Pediatrics has partnered with Dell Med Dept of Neurology for our own statistician to provide statistical assistance for pediatric research projects on an as-needed basis.

Yingchao Yuan, MA is available to assist you and your team with several areas of statistical assistance. Assistance for study design may include helping you with the appropriate design (cohort, case-control, or RCT), choosing predictor and outcome variables, deciding on the most appropriate statistical approach, and/or sample size calculations. Yingchao’s expertise in statistical analysis includes quantitative analysis using standard parametric and non-parametric approaches (t-test, ANOVA, Chi-square, etc.), regression models (design and diagnosis multivariable linear, logistic, poisson, negative binomial, cox proportional hazards, ARIMA, etc.), and geospatial analysis (mapping).

Yingchao also has expertise in data management including SQL database design, designing SQL queries, exporting data from REDCap, and cleaning and analyzing study data. In addition, Yingchao can assist with data visualization for presentations, posters, and manuscripts.

We encourage you to utilize these resources early in your protocol development rather than after data collection is complete, but we will do our best to accommodate those requests also. To utilize Yingchao’s time, please contact Keli Hawthorne, Director of Clinical Research to be considered for these additional resources so that the Dept can track these resources.

For information about obtaining dry ice at HDB (Health Discovery Building) or DPRI, please see DMS OOR Intranet page on dry ice.

For investigator-initiated studies, you may be required to register your study at ClinicalTrials.gov. Many journals require ClinicalTrials.gov registration for publication. Registration must occur prior to enrollment of the first subject. Contact Dell Med Office of Research for assistance.

Click here to see which trials must be registered.

Connect with UT Undergrads for Research Assistance with Eureka

UT’s Eureka research database is students’ first destination when seeking research opportunities with UT faculty. We encourage research-active faculty to make use of Eureka’s listing of current projects and to provide information about the sorts of students they’re seeking to assist on research studies and projects. An updated Eureka profile can help you recruit students who can contribute to your research, while also reducing inquiries from students who aren’t a good match.

To update your Eureka profile, go to https://eureka.utexas.edu/. Once logged in with your EID, click “My Dashboard” to edit your profile, edit existing projects, or add a new one. The more information you can provide, the better!

If students need to access any Ascension patient data, they will also need to complete the Ascension Research Volunteer (RV) application and onboarding, once identified via Eureka.

If you have any questions about Eureka, student research funding, or ways of involving students in your research, please contact the Office of Undergraduate Research.

Looking for Student Research Assistants (known as Research Volunteers, RV)?

Attend RV Program Office Hours to learn how to find and onboard a RV: Every Wednesday from 10am-10:30am. Video call link: https://meet.google.com/yyc-znys-spi

Expectations: 5-10 hours/week volunteer time for summer and/or fall/spring semesters. Duties may include: data collection from EMR, phone follow-up or surveys, literature reviews, and more. Students can receive Ascension badge access and EMR access if needed.

1. Have the study monitor or your study staff (in conversation with the monitor) fill out this form, called the Ascension EHR Entity Agreement Intake Form. CRITICAL IMPORTANCE: Have whoever is filling out this form click the SAVE A SOPY OF MY RESPONSES button and forward that copy of their responses to the UT/Ascension CRC or appropriate study staff member. Once the study staff member has that copy of their responses, move to step 2.
   
   
2. The research coordinator or study staff should fill out the Ascension Remote HER Access Request form at this link: https://redcap.ascension.org/txaus/surveys/?s=H7NMF8R8DJPKYL7Y.

This access is for Cerner/Compass only. Currently, there is not a system to allow study monitors to review the Athena EHR. That system remains an over-the-shoulder access system.

Are you interested in learning more about grant writing but low on time? Podcasts are a great way to consume content and learn on the go efficiently. Listen on your smartphone or through a website. Find grant writing podcast listings on the Grantsmanship and Nonprofit Management Resources page.

You can request a lab website to promote your research and lab/unit activities.

Instructions here. Please contact Keli Hawthorne for questions and pro-tips.

To obtain assistance for poster printing please contact Keli Hawthorne at keli.hawthorne@austin.utexas.edu.

UT Document Solutions to order your poster: https://documentsolutions.utexas.edu/wideformat
Pricing and options available: https://utexas.app.box.com/s/5uegh4gbup3bhg3w7dip9j69wlbk037t

Research Resources

• Research Poster Template
• Research Poster Template (Seton Co-Branded)
• Study Recruitment Flyer
• Study Recruitment Flyer (No Image)
• Lab Website Template Instructions

Do you have an upcoming research publication about to come out?

Fill out this form from Dell Med Communications in order to get some publicity and recognition about it. Click here to email the citation and get it added to the Pediatrics Publications list.