April 2022
IN THIS NEWSLETTER
Have an update to share? Research news, milestones, funding announcements, events and deadlines can be submitted via the Research Communications request form. In addition to the monthly newsletter, Manne Research Institute distributes a bi-weekly "Events and Deadlines" email featuring upcoming events, including virtual and in-person educational opportunities, and relevant research deadlines. All previous updates can be found in the Research Communications archive.
NEWS FROM THE CLINICAL AND
COMMUNITY TRIALS PILLAR
Study Finds Complex Relationships between Bacteria and Markers of Lower Airway Infection and Inflammation in Cystic Fibrosis
The lower airways of patients with cystic fibrosis (CF) have unique biochemical features that correlate with the complex communities of lung bacteria typical of this disease, according to a multicenter study led by researchers from Ann & Robert H. Lurie Children’s Hospital of Chicago. These findings offer insights into the underlying biological mechanisms driving infection and inflammation in the CF lungs, and may help develop novel targeted therapies and more precise diagnostics to improve the care of children with CF. Results were published in the journal Frontiers of Cellular and Infection Microbiology.

Chronic airway infection and inflammation resulting in progressive, obstructive lung disease is the leading cause of illness and death in people with CF. To better understand the biological mechanisms of infection and inflammation, in a study conducted Lurie Children’s in collaboration with researchers at Children’s Hospital Colorado and the University of Minnesota, several metabolites were measured in 90 bronchoalveolar lavage fluid (BALF) samples acquired from bronchoscopy. These lower airway samples were collected from children with and without CF. Researchers also used genetic sequencing to characterize the bacterial communities present in these samples, which were then correlated to the metabolites in the lungs.

“Our study was the first to both examine these metabolites in lower airway samples and identify networks of relationships between metabolites and lower airway bacterial communities,” said lead author Jack O’Connor from Lurie Children’s. “We discovered metabolite biomarkers that could be related to biochemical processes associated with increased inflammation and bacterial burden in the CF lung. These features that are unique to CF lung biology could eventually aid the development of new treatments and diagnostics.”

Pediatric research at Lurie Children’s is conducted through Stanley Manne Children's Research Institute. Read more about this study here.
Vagus Nerve Stimulation Lowers Costs of Care for Children with Uncontrolled Epilepsy

Vagus nerve stimulation (VNS), sometimes referred to as a “pacemaker for the brain,” involves a stimulator device that is implanted under the skin in the chest, with a wire that is wound around the vagus nerve in the neck. It helps prevent seizures by sending regular, mild electrical pulses to the brain. Typically, the patient is not aware the device is operating.

A new study from Ann & Robert H. Lurie Children’s Hospital of Chicago published in the journal Epilepsia examined a population of pediatric patients with drug-resistant epilepsy. For these patients, the study found that the patients who received VNS, when used with anti-seizure medications (ASM), had lower hospital costs compared to the use of ASM alone. The study found that the patients treated with ASM plus VNS had savings of over $3,000 of epilepsy-related annual costs per year, compared to treatment with ASM only. These findings mirror the team's previous report of children with drug-resistant epilepsy having significantly decreased inpatient healthcare utilization following VNS plus ASM compared to those treated with ASM alone. The study on healthcare utilization was published in Epilepsy & Behavior.

“We take a health services research perspective on the patients' journey with a challenging disease process of drug-resistant epilepsy that has not been met with a cure. For patients with drug-resistant epilepsy, reducing seizure burden and addressing quality of life are important goals. We quantify aspects of outcomes of surgical therapies and medical therapies, and we assess the impact on health care costs and utilization. To the patients, families, health care systems, health care advocates, and policymakers, these are important results,” said senior author Sandi Lam, MD, MBA, Division Head of Neurosurgery at Lurie Children’s and Professor of Neurological Surgery at Northwestern University Feinberg School of Medicine. “While we show lower costs to the health care system following VNS surgery, from a practical standpoint it means fewer hospital admissions because of seizures. Patients spend their days at home instead of in the hospital.”

Pediatric research at Lurie Children’s is conducted through Stanley Manne Children's Research Institute. Learn more about this unique study here.
Teens with Severe Obesity Forego Weight Loss Surgery due to Stigma, Lack of Information and Costs  
Adolescents with severe obesity may not pursue metabolic bariatric surgery for weight loss due to lack of information, difficulties with access to care, and because of social stigma, according to a newly published study led by a University of Colorado School of Medicine researcher.

Eric G. Campbell, PhD, professor of medicine at the CU School of Medicine and director of research at the University of Colorado Center for Bioethics and Humanities, and his co-authors interviewed 14 young adults between the ages of 19 years and 25 years who underwent metabolic bariatric surgery in the past five years. The goal of the study was to better understand issues that prevented these young adults from undergoing the surgery while they were adolescents.

The study identified a general lack of information about the surgery, social stigma, and issues with costs as primary factors limiting access. The article was published in the journal Surgery for Obesity and Related Diseases on March 22.

“Reduced access to metabolic bariatric surgery for adolescents with severe obesity removes care that could dramatically improve their quality of life and reduce mortality,” said Campbell. “Previous studies have shown that metabolic bariatric surgery is the most effective treatment for adolescents with severe obesity, so health care providers should make sure they are knowledgeable about this care option and recommend it in appropriate cases.”

Co-author Thomas Inge, MD, PhD, is the country’s foremost expert on metabolic bariatric surgery in adolescents and children. He was in Colorado when the research was conducted, and is now surgeon-in-chief at Lurie Children's and professor of surgery and pediatrics at Northwestern University Feinberg School of Medicine. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children's Research Institute. Read more about the study here.
Research Brief: Review Suggests Need for Consistency in Defining Kidney Abnormality Outcomes  
A systematic scoping review examined the variability in definitions of kidney abnormality outcomes in people with spina bifida and found that there is significant variability in how authors define kidney abnormality. The results were published in The Journal of Urology. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children's Research Institute.

In the spina bifida literature, kidney health outcomes have been defined by a wide variety of measures and modalities, but these have not been systematically captured. There is currently neither consensus on what defines a kidney health abnormality in this patient population nor a clear understanding of the most accurate and reliable means of assessing kidney health. Anecdotally, many authors rely on hydronephrosis on ultrasound as a marker of an adverse kidney outcome. “A recent study from our group showed hydronephrosis to have poor sensitivity for low estimated glomerular filtration rate, suggesting that high rates of under diagnosis of poor kidney health may occur with ultrasound assessment alone,” said senior author David Chu, MD, MSCE, Attending Physician, Urology, with Ann & Robert H. Lurie Children’s Hospital, and Assistant Professor of Urology with Northwestern University Feinberg School of Medicine. “Such variability in reporting, with the use of inaccurate and unreliable outcomes, was felt to be an obstacle to understanding the true risk of adverse kidney health outcomes in this population.” The researchers, led by first author James Rague, MD, Fellow, Urology, with Lurie Children’s, therefore sought to quantify the extent of variability in definitions of kidney abnormality and how specifically authors defined kidney outcomes within the literature through systematic assessment.

Key Takeaways

  • Within the spina bifida literature, there is wide heterogeneity in how authors define kidney abnormality, with authors rarely providing explicit definitions or thresholds to define abnormal outcomes.  
  • Hydronephrosis on ultrasound and serum-based creatinine testing, which have been identified to be unreliable measures of kidney health in patients with spina bifida, are most commonly used to define abnormal kidney outcomes. 
  • More studies have reported kidney health outcomes over time, suggesting an increased awareness of the importance of kidney health in patients with spina bifida.  

Moving forward, the researchers aim to work toward determining the best serum markers and glomerular filtration rate estimating equations to yield the most accurate and reliable picture of kidney function. Additionally, they will continue to participate in the ongoing CDC-funded Urologic Management to Preserve Initial Renal Function (UMPIRE) cohort study for children with spina bifida, which has standardized and protocolized kidney health measures to determine how best to preserve long-term renal health in their patients.

Article Citation 
Rague JT, Lai JD, Murphy P, Fawcett A, Walton R, Rosoklija L, Bowen DK, Yerkes EB, Cheng EY, Hodgkins KS, Routh JC, Isakova T, Chu DI. Variation in Definitions of Kidney Abnormality in Patients with Spina Bifida: A Systematic Scoping Review. The Journal of Urology. 2022 Jan. 20 (Epub ahead of print). doi: 10.1097/JU.0000000000002432 
NEWS FROM THE COMMUNITY, POPULATION HEALTH & OUTCOMES PILLAR
Research Brief: Intervention Helps Increase HIV Testing and Care Among High-Risk Youth and Young Men 
A new study published in JAMA Network Open found that an intervention using social media and peer navigation was associated with increased HIV testing and linkage to care among high-risk youth and young men (15–24 years old) in Nigeria. The research team from Ann & Robert H. Lurie Children’s Hospital in Chicago and hospitals in Nigeria are encouraged by these results because this population is socially stigmatized and having a way to increase testing and care is critical to controlling the HIV epidemic in Nigeria. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children's Research Institute.

“A few years ago, I had the opportunity to travel to Nigeria to give a lecture, and while I was there, I met with a group of young gay men to hear about their struggles in terms of accessing health care. It’s a criminalized environment for these young men, and they are often forgotten, overlooked, or even worse, discarded,” said Robert Garofalo, MD, MPH, Division Head of Adolescent and Young Adult Medicine and Potocsnak Family Professorship in Adolescent and Young Adult Medicine with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Professor of Pediatrics with Northwestern University Feinberg School of Medicine. “The work as part of the iCARE Nigeria intervention study is having a meaningful impact by helping these young men and other youth get tested for HIV and connected to care safely.”

Even though Nigeria has been dealing with the HIV epidemic for decades, little has been done about designing and implementing interventions to help youth and young men get access to HIV testing and health care services, added Garofalo. The current nonrandomized controlled study involved a pilot trial where peer navigators conducted social media outreach to 339 youth and young men in Nigeria promoting sexual health and providing individuals with HIV counseling and rapid testing options. The results found HIV testing increased by 30 to 42 percent, and among 36 subjects who tested positive for HIV, 31 (86 percent) were linked to care, which included visits to clinics. This shows the promise of common approaches such as social media and peer navigation, and Garofalo said the hopes are that this intervention strategy can be implemented across Nigeria and in other countries where same-sex behavior is stigmatized or criminalized to help curb the HIV epidemic.

Article Citation 
Garofalo R, Adetunji A, Kuhns LM, Omigbodun O, Johnson AK, Kuti K, Awolude OA, Berzins B, Janulis P, Okonkwor O, Oladeji B, Muldoon AL, Amoo OP, Atunde H, Kapogiannis B, Taiwo BO. Evaluation of the iCARE Nigeria pilot intervention using social media and peer navigation to promote HIV testing and linkage to care among high-risk young men. JAMA Network Open. 2022; 5(2): e220148. doi: 10.1001/jamanetworkopen.2022.0148 
SCIENCE SHOWCASE
A Leader in Sepsis Research
Sanchez-Pinto breaks new ground with clinical informatics to improve patient care
With his unique perspective and skills, critical care specialist Nelson Sanchez-Pinto, MD, MBI, FAMIA, is moving pediatric hospitals closer to a new era in effective sepsis treatments. His long-term work just took a tremendous leap ahead as he was awarded an R21/R33 grant from the National Institutes of Health.

In the U.S., sepsis is fatal in up to 30 percent of children and the most expensive inpatient hospital cost. Young patients often contract this infection when they are critically ill because they are immunosuppressed or have another infection that leads to sepsis. Worldwide, sepsis survival rates are even lower than in the U.S: the infection accounts for the most deaths in hospitals globally.

Sepsis rapidly overwhelms the body, and physicians need to immediately recognize it and respond. With today’s “one-size-fits-all” treatment approach, many sepsis infections cannot be controlled despite best efforts because they do not address each patient’s specific characteristics.

Solving this complex problem, Dr. Sanchez-Pinto is bringing Precision Medicine to critical care to identify the best treatment for each child with this extremely dangerous infection. The concept of Precision Medicine is often associated with oncology to customize treatment for each patient according to their type of cancer and unique biological characteristics, in addition to environmental and lifestyle factors. Dr. Sanchez-Pinto is applying the same strategy to sepsis, discerning subgroups of pediatric patients and specific treatments that each group will best respond to.

This is his second R21 grant in sepsis research and will be used to collect a wide range of biospecimens and electronic medical record data from patients across three children’s hospitals to complement the data he has collected from almost 40,000 patients in prior studies. Lurie Children's and Children’s Hospital of Philadelphia co-lead this research and will conduct a pilot trial to establish specimen collection from patients before they are treated, in addition to data collection. Another key part of this grant work will focus on standardizing study data so it can be accurately compared and reviewed between all sites.

Dr. Sanchez-Pinto is among a new breed of physician—part of the first group of Fellows of the American Medical Informatics Association (FAMIA). Established in 2018, this recognition attests to the expertise of medical professionals in clinical informatics, the science of using data analytics and technology to improve patient care. Dr. Sanchez-Pinto remains one of the few pediatric critical care physicians who holds this recognition.
Internal Grant Award Program Announces Awardees 
Stanley Manne Children's Research Institute is pleased to announce the winners of the Fall 2021 Internal Grant Award (IGA) Program. The IGA Program provides researchers with resources to develop projects that will lead to a highly competitive extramural application for sustained research support within 18 months of receiving the award. All awards are for a one-year period.

Congratulations to the recipients of the Fall 2021 Internal Grant Awards. Find the recipient list below, and read the full announcement here.
Attending Physician, Endocrinology with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Associate Professor of Pediatrics with Northwestern University Feinberg School of Medicine

  • IGA type: Proposal Revision Award 
  • Title: Revisions for Hyperglycemia and Adverse Pregnancy Outcomes Study—Cardiovascular Health of HAPO Offspring (HAPO CVH)
Attending Physician, Neonatology with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Professor of Pediatrics with Northwestern University Feinberg School of Medicine

  • IGA type: Proposal Revision Award 
  • Title: Novel Non-invasive Approach for Predicting Retinopathy of Prematurity in Premature Neonates
Attending Physician, Neurology, with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Professor of Pediatrics (Neurology) with Northwestern University Feinberg School of Medicine 

  • IGA type: Interdisciplinary Colloquia Award 
  • Title: Building a Translational Neurogenetics Forum 
Attending Physician, Infectious Diseases; Medical Director, Infection Prevention and Control; and Irene Heinz Given and John La Porte Given Professorship in Pediatrics with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Assistant Professor of Pediatrics with Northwestern University Feinberg School of Medicine 

  • IGA type: Visionary Award 
  • Title: Natural History of Clostridioides difficile Humoral Immunity in Children with Cancer 
Rachelle and Mark Gordon Endowed Professorship in Cancer Research with Ann & Robert H. Lurie Children’s Hospital of Chicago; Director of Pediatric Xenograft Modeling with Stanley Manne Children's Research Institute; and Professor of Pediatrics (Hematology, Oncology, and Stem Cell Transplantation) with Northwestern University Feinberg School of Medicine 

  • IGA type: Proposal Revision Award 
  • Title: Humanized PDOX Models for Novel Immune Therapies of Pediatric Brain Tumors 
Genetic Counselor III, Genetics, Birth Defects, and Metabolism with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Instructor of Pediatrics (Genetics, Birth Defects, and Metabolism) with Northwestern University Feinberg School of Medicine 

  • IGA type: Scientific Advocacy Award 
  • Title: International Pleuropulmonary Blastoma/DICER1 Registry LCH Site Opening 
Director, Pediatric Urological Regenerative Medicine with Ann & Robert H. Lurie Children’s Hospital of Chicago; Director of Surgical Research with Stanley Manne Children's Research Institute; and Research Associate Professor of Urology and Biomedical Engineering with Northwestern University Feinberg School of Medicine and McCormick School of Engineering

  • IGA type: Visionary Award 
  • Title: Self-Assembling Supramolecular Nanomolecules for Myocardium Repair Following Induced Myocardial Infarction
Carlos Prada Receives NIH R61 Grant Award 
Carlos Prada, MD, Division Head, Genetics, Birth Defects, and Metabolism, and Valerie and George D. Kennedy Research Professorship in Human Molecular Genetics with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Associate Professor of Pediatrics with Northwestern University Feinberg School of Medicine, received an R61 grant award from the National Institutes of Health—National Institute of Neurological Disorders and Stroke. The award will fund the study, “Developing Novel Biomarkers of Plexiform Neurofibroma Tumor Burden,” which aims to develop novel biomarkers for early detection of plexiform neurofibroma. Currently, there are no biomarkers clinically available for risk stratification in individuals with neurofibromatosis type 1, so this research will help facilitate early identification of patients at risk to develop complications related to plexiform neurofibromas. The award period is 2022–2024.
Task Force Publishes New Cochlear Implantation Guidelines 
Nancy M. Young, MD, FACS, FAAP, Medical Director of Audiology and Cochlear Implant Programs with Ann & Robert H. Lurie Children’s Hospital of Chicago and Professor of Otolaryngology with Northwestern University Feinberg School of Medicine, served on a task force to create evidence-based clinical guidelines for cochlear implantation of children with single-sided deafness. The guidelines were published in the March/April 2022 issue of Ear and Hearing.

Entitled “American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Cochlear Implantation in Children With Single-Sided Deafness,” the guidelines cover candidacy and assessment of children with unilateral hearing loss (often referred to as single-sided deafness). The publication also summarizes current literature, and highlights areas where further clinical research is needed.

The American Cochlear Implant Alliance (ACIA) is a not-for-profit that works to advance cochlear implantation through research, advocacy, and awareness. Dr. Young was a founding ACIA board member and Lurie Children’s Cochlear Implant Program is an organizational member.

Children with single-sided deafness have major hearing loss in only one ear that cannot be ameliorated by a hearing aid. Although these children can hear spoken language with their one normal hearing ear, they have difficulty hearing in background noise and lack spatial hearing (knowing where sound is coming from). Children with single-sided deafness often experience listening fatigue and are at risk for academic and behavioral problems. Cochlear implantation is the only treatment that can provide the advantages of binaural (two ear) hearing to this population. Lurie Children’s Cochlear Implant Program is currently participating in an FDA clinical trial of children with single-sided deafness. The Lurie Children’s Cochlear Implant Program is one of the largest and most experienced pediatric programs in the world.
MANNE RESEARCH INSTITUTE IN THE MEDIA
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UPDATES FROM RESEARCH ADMINISTRATION
Research Staff Additions and Promotions
Michael Almodovar
Behavioral Research Coordinator II, Potocsnak Family Division of Adolescent and Young Adult Medicine
 
The Potocsnak Family Division of Adolescent and Young Adult Medicine recently promoted Michael Almodovar to the position of Behavioral Research Coordinator II. His new responsibilities include coordinating a study called mLab Study, an mHealth combination intervention that provides HIV self-tests and real-time diagnostic feedback to young males who have sex with males and to young transgender women. In 2019, Almodovar began work with the Potocsnak Family Division of Adolescent and Young Adult Medicine as a Behavioral Research Coordinator I for the Positive STEPS Study, a randomized control trial to test the efficacy of a stepped-care “adaptive” HIV medication adherence intervention for HIV-infected adolescents and young adults, aged 16–29.
Ososese Enaholo, MPH
Behavioral Research Coordinator I, Potocsnak Family Division of Adolescent and Young Adult Medicine
 
The Potocsnak Family Division of Adolescent and Young Adult Medicine welcomes Ososese Enaholo to the role of Behavioral Research Coordinator I, where she will provide evaluation support to the researchers as they conduct various studies. Enaholo looks forward to learning more about young people in Chicago and increasing their accessibility to healthcare. Prior to joining the Potocsnak Family Division of Adolescent and Young Adult Medicine, Enaholo worked with Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University’s Center for Food Allergy and Asthma Research, focusing of racial and ethnic health disparities. She earned a Bachelor of Science in Public Health from Saint Louis University and a Master of Public Health with a concentration in Maternal and Child Health from Tulane University.
Anna Rose Peck-Block
Behavioral Research Coordinator I, Potocsnak Family Division of Adolescent and Young Adult Medicine
 
Anna Rose Peck-Block recently joined the Potocsnak Family Division of Adolescent and Young Adult Medicine as Behavioral Research Coordinator I. In her new role, Peck-Block is the primary coordinator for the Gender Journey Project and a co-coordinator for a multi-site grant studying the impact of pubertal suppression on adolescent neural and mental health trajectories
If your team has a staff addition, transition, or promotion to share, please use the button to the right to submit a short profile and photo.
Office of Research Business Operations
Workday Go Live Resources and Grants Reporting Training

Workday is now live at Lurie Children's. To access Workday, navigate to: https://www.myworkday.com/luriechildrens/login.htmld 

For immediate assistance, please follow the steps below:

  • To access the resources available on the At Hand Transformation, use the At Hand AllConnect site. 
  • To learn more about Workday, access our Learning Library which includes tip sheets with step-by-step instructions and many other trainings
  • If you have a question about a transaction in Workday, please view our Frequently Asked Questions (FAQs) to find answers. 
  • If you need further assistance, ServiceNow will serve as the point of entry for questions and issues. Please submit a ticket via ServiceNow or call the Service Desk at 312-227-3445. 
  • To access the new Finance Foundation Data Model (FDM) Crosswalk (with new Cost Centers, Grants, Gifts, and Project Numbers), please go to At Hand Financial Crosswalk

If you are in a role which manages grants and needs access to view financial data, the Workday training team has created a WeLearn training for a Grants Reporting ILT. Please login to WeLearn to sign up for one of these sessions.

  • This training is open to Principal Investigators, Grant Managers, Division/Department support roles, etc.  
  • The Workday training team will provide a MS Teams invite link to all attendees. If you are unable to attend, a separate recording will be turned into an eLearning module to be loaded into the Workday LMS at a later date.  
  • WD FIN Grants Reporting 
  • April 19 9:00 a.m.–10:00 a.m.
  • April 21 1:00 p.m.–2:00 p.m.
  • Registration will close April 12 and April 14 
Office of Research Integrity and Compliance
ORIC Tips Roundup

Every Tuesday, the Office of Research Integrity and Compliance (ORIC) releases "ORIC Tips" in Lurie Children's Global emails to keep the research community informed of relevant guidance and hot topics. Below is a roundup of recent tips. Please contact [email protected] for follow-up questions or to request guidance on any research compliance topic. Your questions help ORIC generate future tips for the research community.

Affiliating CITI Accounts & Completing Lurie Modules

The Lurie Children’s IRB requires Human Subjects Research (HSR) and Good Clinical Practice (GCP) trainings to be completed through the CITI Program. If you have an existing CITI account, you must affiliate it with Ann & Robert H. Lurie Children’s Hospital of Chicago.

To do this, you need to first log onto your account. Underneath the large gold “Welcome,” there is a link to “Add Institutional Affiliation.” Look for and select “Ann & Robert H. Lurie Children’s Hospital of Chicago.” In order to connect your education requirements to Cayuse IRB, your Lurie Children’s institutional email address on CITI must match the email address on your Cayuse account. This email address is case sensitive.

If you have already affiliated with Lurie Children’s on your CITI account, you can click on “View Courses” under Institutional Courses next to Lurie Children’s. Even if you have already completed human subjects research courses on CITI for another institution, it may not be identical to the Lurie module, and thus you may need to complete a refresher course or additional module. When the correct modules are completed, clicking on “View Courses” for Lurie Children’s will show that you have already passed the affiliated courses.

Additional details for account affiliation are available here. For more information on training requirements, please see the Lurie Children’s Research Education webpage.

Single IRB Reliance Resources

Are you interested in requesting that Lurie Children’s rely on an external IRB? Or are you considering serving as the IRB of Record for an upcoming multi-site study? ORIC maintains a dedicated webpage with information about the steps to take as well as answers to some of the most frequently asked questions about using a single IRB. You can access this website via the Toolkit --> IRB Resources -- > Single IRB or by clicking here.

To initiate the reliance process for either relying on an external IRB or Lurie serving as the IRB of Record for a multi-site study, please submit an email to [email protected] as early in the process as possible.

Research Related Injury Language

The regulations governing human subjects research prohibit consent language through which a participant is made to waive (or appear to waive) any of their legal rights, or release (or appear to release) the investigator, the sponsor, the institution, or its agents from liability for negligence (45 CFR 46.116 and 21 CFR 50.20). Please see this linked guidance for examples of prohibited exculpatory language.

Lurie Children’s IRB-approved Parental Permission and Adult Consent Form Templates contain a section titled “In the Event of Injury,” which is an essential part of the informed consent form for studies determined to be greater than minimal risk. The language within the Lurie Children’s IRB-approved Consent Form Templates must be used verbatim.

Please note that changes to this verbatim wording are not acceptable. If this template language is not accepted by the sponsor, please provide a copy of the Lurie Children’s policy found in Section 11 of the IRB Policies and Procedures Manual, which states that only this language may be used.
Resources from Research Partners
NUCATS Grant Repository Continues Collection of Recent Grants 
The NUCATS Center for Education and Career Development (CECD) continues to work on a targeted expansion of the collection of recent grants (within the last five years) hosted in Galter Library’s Digital Hub that serve as a resource for grant writing. The NUCATS Grant Repository is a private collection, accessible only via invitation to those who have a Northwestern NetID.

The goal of this repository is to demystify the grant-writing process for Northwestern’s early career investigators, so any contribution you can make is helpful. Recently, a new table of contents has been created so that researchers can search grants by federal non-NIH awards, F, K, R, T and U-Series, industry/foundation awards, budget justification, resubmissions, progress reports, and more.


Please note: If you decide you would like to make a contribution, it will be carefully redacted of any confidential information, including personnel salary, legal, and budgetary information and submitted back to you for final approval before being uploaded to the collection.

If you have any additional questions, please contact Jaime Ziegler.
NUCATS Offers Materials to Support Grant Submissions 

If you are preparing to submit an NIH funding proposal, NUCATS Institute offers services and resources to enhance your grant submission. The NUCATS Navigator Portal provides access to the following:

  • Editable Facilities and Other Resources document  
  • Request form for a letter of support from NUCATS Director Rich D'Aquila  
  • Request form for a NUCATS Grant Development and Implementation Studio  
  • Request form for a consultation or a First-Submission Studio  
  • NUCATS Navigator who is available to answer your questions about opportunities to leverage NUCATS' services and resources 

The NUCATS Institute maintains a suite of services and resources to support and enhance your grant submission and help you and your team through the process.
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