March 2022
Upcoming events, including virtual and in-person educational opportunities, and important Manne Research Institute deadlines are communicated to the Research Institute in a bi-weekly "Events and Deadlines" e-mail. You can view the most recent edition by clicking the Events & Deadlines button. Past updates can be found in the Research Communications archive. Have an item to share? Research news, milestones, funding announcements, events and deadlines can be submitted via the Research Communications request form.
Gain Valuable Insights into Your Research Question at Four I’s Sessions

Initiate, Inquire, Innovate, Inspire—the Four I’s sessions provide an opportunity to workshop your ideas related to health services, social/behavioral, outcomes, and clinical research. Smith Child Health Outcomes, Research, and Evaluation Center (SCHORE) invites researchers, research professionals, and trainees to join the next session on March 21. Sessions are co-hosted by the divisions of Advanced General Pediatrics and Primary Care, Emergency Medicine, and Hospital Based Medicine.

Sessions occur during the third week* of the month and rotate every three months.

  • March, June*, September, December: Mondays, 3:30–5:00 p.m. 
  • April, July, October, January: Tuesdays, 11:00 a.m.–noon 
  • May, August, November, February: Wednesdays, 4:00–5:00 p.m. 
*Session will be held the fourth week of June to observe the Juneteenth Holiday.

Sign up to workshop your ideas using this shared spreadsheet. There is no need to prep slides or have a polished presentation. Come prepared for excellent feedback and lively discussions about how to develop your research question, strengthen your specific aims, address challenges with project completion, and improve your analytic approach or presentation of results. The sessions are hosted on Zoom. Find the Zoom meeting details and information for upcoming presentations on the shared spreadsheet. Please direct questions to Roman Gomez.
First Potential Immunization Against RSV for Healthy Infants Found Highly Effective in Phase 3 Trial
Nirsevimab showed 74.5 percent efficacy against medically attended lower respiratory tract infections caused by respiratory syncytial virus (RSV) in healthy infants, according to an international, randomised, placebo-controlled Phase 3 clinical trial. It is the first potential immunization against RSV in the general infant population, with a single dose providing safe protection across the entire RSV season. Results were published in the New England Journal of Medicine.

“These exciting data show that nirsevimab has the potential to offer RSV protection for all infants, which would be a paradigm shift in the approach to this disease,” said site Principal Investigator and co-author William Muller, MD, PhD, Scientific Director of Clinical and Community Trials at Stanley Manne Children's Research Institute at Ann & Robert H. Lurie Children’s Hospital of Chicago, and Associate Professor of Pediatrics at Northwestern University Feinberg School of Medicine.

The trial involved healthy term and late preterm (gestational age ≥35 weeks) infants entering their first RSV season. Lurie Children’s was among the highest enrolling US sites in the trial. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

Nirsevimab is an investigational long-acting monoclonal antibody, being developed by AstraZeneca and Sanofi, designed to protect all infants through their first RSV season with a single dose. Monoclonal antibodies do not require the activation of the immune system to help offer rapid and direct protection against disease.
Currently, the only available preventative option for RSV is palivizumab, which is limited to high-risk infants and provides one-month protection, requiring five injections to cover an RSV season. Read more here.
Gene Therapy for Thalassemia Ends Need for Transfusions in Young Children

Over 90 percent of patients with transfusion-dependent thalassemia, an inherited blood disorder, no longer needed monthly blood transfusions years after receiving gene therapy, according to an international Phase 3 clinical trial that for the first time included children younger than 12 years of age. Twenty-two patients were evaluated (ranging in age 4–34 years), including pediatric patients enrolled at Ann & Robert H. Lurie Children’s Hospital of Chicago. Results were published in the New England Journal of Medicine. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

“It is impressive that so many patients in the study, including the youngest patients, acquired transfusion independence that was durable,” said study co-author Jennifer Schneiderman, MD, MS, from the Center for Cancer and Blood Disorders at Lurie Children’s and Associate Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “At Lurie Children’s, we have participated in these gene therapy trials from the earliest stages and have been enrolling patients for close to a decade. The current study represents the next step in moving this intervention into clinical practice, which will increase access to a potential cure for patients with transfusion-dependent thalassemia.”

People with thalassemia do not make enough functional hemoglobin in their red blood cells, which interferes with oxygen getting to all parts of the body. Those with the most severe type of the disease require red blood cell transfusions every month for survival. Frequent transfusions, however, can cause serious complications due to iron overload and infections, especially if one’s spleen has been removed.

This gene therapy study uses the patient’s own stem cells that were treated in the lab with a modified virus to add functional copies of the gene that is defective in thalassemia. Before the new cells can be infused, the patients need to receive chemotherapy, which typically involves a hospital stay of at least four to five weeks for close monitoring for fevers, infections, and other potential complications. Patients typically reached transfusion-free status about one month after the autologous stem cell transplantation. Patients reported in this manuscript had been monitored for a range of 13 months to four years after receiving their new cells. Read more here.
Where Children Live Linked to Delayed Access to Surgical Care
A new study from Ann & Robert H. Lurie Children’s Hospital of Chicago found that children from less resourced neighborhoods were at increased odds of presenting with complicated appendicitis, an indicator of delayed access to surgical care. This is the first pediatric study to link many neighborhood-level factors that influence health – such as quality of schools, housing, safety, and economic opportunity – to timely surgical care access. Findings are published in the journal JAMA Network Open. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

“Timely access to pediatric surgical care may help reduce the need for emergency surgery, long hospital stays, or admission to the intensive care unit,” said co-author Fizan Abdullah, MD, PhD, Division Head of Pediatric Surgery at Lurie Children’s and Professor of Surgery at Northwestern University Feinberg School of Medicine. “Most importantly, our findings may help in developing policies and programs to increase community opportunity and ensure that all children, no matter where they live, gain equitable access to surgical care.”

For the retrospective, cohort study, the researchers examined the association between neighborhood factors and the odds of presenting with complicated appendicitis, as well as the likelihood of unplanned visits or readmissions to the emergency department with either simple or complicated appendicitis. Neighborhood-level social determinants of health (SDoH) were measured by the Child Opportunity Index (COI), a validated Zip code-level index score derived from 29 independent indicators that are known to affect children’s health and development.

The study examined 67,489 patients age 18 and younger who had appendicitis. The results showed that children from lower COI neighborhoods had up to 28 percent increased odds of presenting with complicated appendicitis compared to those from the highest COI neighborhoods. There was no significant association between neighborhood opportunity levels and the odds of unplanned post-discharge healthcare utilization. Read more here.
Research Brief: Assessing Outcomes of Transcanal Endoscopic Ear Surgery for Congenital Cholesteatoma  

A multi-national collaboration of researchers produced the world’s largest case series on excision of congenital cholesteatoma—a disease originating in the middle ear with presentations that range from a small pearl to an extensive open cyst—using minimally invasive, endoscopic techniques in pediatric patients. Ann & Robert H. Lurie Children’s Hospital of Chicago served as the lead center. Stephen R. Hoff, MD, FACS, FAAP, Attending Physician (Otorhinolaryngology) with Lurie Children’s and Associate Professor of Otolaryngology with Northwestern University Feinberg School of Medicine, co-authored the study, “Transcanal Endoscopic Ear Surgery for Congenital Cholesteatoma: A Multi-institutional Series,” published in Otolaryngology–Head and Neck Surgery. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

Key Takeaways 

  • By operating through the natural ear canal, the endoscopes provide a dynamic, wide-field view to address congenital cholesteatoma directly where it starts, usually without a visible incision. 
  • Outcomes for the disease were shown to be significantly better than previously reported, including recurrence and residual disease. Early-stage disease showed no recurrences. 
  • The researchers demonstrated that the minimally invasive techniques are viable even for very young pediatric patients (youngest patient was age 18 months).  

The researchers will continue to examine the outcomes and techniques for endoscopic ear surgery. This includes furthering the data for congenital cholesteatoma, as well as other topics including acquired cholesteatoma, tympanic reconstruction, and ossicular reconstruction.

Article Citation 

Jenks CM, Purcell PL, Federici G, Villari D, Presutti L, James AL, Hoff SR. Transcanal endoscopic ear surgery for congenital cholesteatoma: a multi-institutional series. Otolaryngol Head Neck Surg. 2021 Dec. 21 (Epub ahead of print). doi: 10.1177/01945998211067502
Research Brief: Patients Treated for Myelocystocele Experience Long-term Favorable Outcomes  

Myelocystocele is a very complex, rare form of spina bifida, where the spinal cord ends in (and is tethered by) a large balloon of spinal fluid. Appropriate care for these children requires a multi-disciplinary approach to optimize their outcome. Ann & Robert H. Lurie Children’s Hospital of Chicago has cared for one of the largest cohorts of children afflicted with this disease since the early 1980s, many of whom are followed long term in Lurie Children’s multi-disciplinary spina bifida clinic. Robin Bowman, MD, Director of the Multidisciplinary Spina Bifida Center with Lurie Children’s and an Associate Professor of Pediatric Neurological Surgery with Northwestern University Feinberg School of Medicine, and her research team published its findings in Journal of Neurosurgery: Pediatrics. The study, “Surgical Management of Myelocystocele: A Single-center Experience with Long-term Functional Outcomes,” highlights the excellent orthopedic and urological outcomes that have been achieved by the team with early aggressive surgical untethering and expectant management throughout childhood. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

Key Takeaways 

  • Myelocystocele may occur alone or in conjunction with cloacal exstrophy. In both cases, aggressive medical and surgical management with coordinated multi-disciplinary care has allowed excellent function outcomes. Independent ambulation is achieved in 96 percent of those with myelocystocele only and two-thirds of children with myelocystocele and abnormalities of cloacal development. 
  • In the cohort, achieving bladder and bowel continence is a realistic goal. For patients with myelocystocele, those with an associated cloacal development require more intervention, such as intermittent catheterization or diversion procedures. Interestingly, multiple spinal cord untethering procedures do not negatively affect long-term continence.  
  • Although urological or orthopedic decline are indicators for retethering, a majority of those undergoing multiple untetherings (38 percent) retain community ambulation. Findings of favorable functional and urological outcomes support the researchers’ approach for early surgery and prospective, long-term management in all myelocystocele patients. 

This study provides long-term outcome data the researchers can share with expectant parents, as many of these congenital lesions are now diagnosed in utero. Dr. Bowman and the other researchers continue to track their spina bifida patients from prenatal diagnosis into adulthood. By assessing the long-term outcome of patients with all forms of spina bifida, they are better able to refine their treatment algorithms to provide the best possible outcomes for the children in their care.

Article Citation 

Behbahani M, Shlobin NA, Dziugan K, Callas H, Meyer T, Yerkes E, Swaroop VT, DeCuypere M, Lam S, McLone D, Bowman R. Surgical management of myelocystocele: a single-center experience with long-term functional outcomes. J Neurosurg Pediatr. 2022 Feb. 4 (Epub ahead of print). doi: 10.3171/2021.12.PEDS21371
Research Brief: Characterizing Sleep and Attention Problems in Young Children with Atopic Dermatitis

Older children with atopic dermatitis experience sleep and attention problems, but little is known about this in younger children. Anna B. Fishbein, MD, Attending Physician, Allergy & Immunology, with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Associate Professor of Pediatrics with Northwestern University Feinberg School of Medicine, and her research team characterized sleep health and attention dysregulation in young children (aged 1–4 years) using a new developmentally sensitive tool and assessed the associations of sleep health and attention dysregulation with atopic dermatitis severity. They found a correlation between more severe atopic dermatitis and poor sleep health and attention dysregulation. Additionally, they encourage clinicians to advise on ways to modify sleep hygiene practices and screen for attention dysregulation in young children. They published their study in Pediatric Dermatology. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

Key Takeaways

  • Eczema is associated with attention problems even in children as young as 1 year old. 
  • Common attention problems experienced by the children included trouble sitting still and trouble paying attention.  
  • 86% of children with moderate/severe eczema have poor sleep health with half having more than five nights of poor sleep per week. 
  • Sleep habits were examined, and suboptimal sleep environment (too much light, noise, or electronic device usage) was noted for several children.

Further research is needed to better understand what can be done to combat inattention and sleep disturbance in these very young and vulnerable children. Potential research includes investigating the effectiveness of eczema treatment and implementing behavioral interventions.

Article Citation

Zhou NY, Nili A, Blackwell CK, Ogbuefi N, Cummings P, Lai JS, Griffith JW, Paller AS, Waskschlag LS, Fishbein AB. Parent report of sleep health and attention regulation in a cross-sectional study of infants and preschool aged children with atopic dermatitis. Pediatr Dermatol. 2022; 39:61–68. doi: 10.1111/pde.14889
Research Brief: Examining Skin Pain and Quality of Life in Children with Atopic Dermatitis

A recent study, “Burden and Characteristics of Skin Pain Among Children with Atopic Dermatitis,” provides insights into the clinical features and quality of life associated with atopic dermatitis-induced skin pain in children. This is the first paper to describe the presence of skin pain—an important and burdensome symptom of atopic dermatitis—in children with eczema, according to co-author Anna B. Fishbein, MD, Attending Physician, Allergy & Immunology, with Ann & Robert H. Lurie Children’s Hospital of Chicago, and Associate Professor of Pediatrics with Northwestern University Feinberg School of Medicine. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

Key Takeaways

  • About half of children had skin pain across disease severity groups. 
  • Having severe eczema or skin that bleeds, cracks, or is very itchy is associated with more pain intensity. 
  • Skin pain intensity is associated with significant decrements in quality of life, independent of eczema severity. 
  • Black or African American children experienced more pain intensity.

The researchers plan future studies that will focus on the mechanisms of skin pain, including how race and ethnicity influence the experience of skin pain. They also report that the findings could have practical applications in that they can be incorporated into clinical trials and clinical care to improve the treatment of children with eczema.

Article Citation

Cheng BT, Paller AS, Griffith JW, Silverberg JI, Fishbein AB. Burden and Characteristics of Skin Pain Among Children with Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Dec. 22 (Epub. ahead of print). doi: 10.1016/j.jaip.2021.12.012
Chicago Parents Have Evolving Attitudes About COVID-19 Vaccinations for Their Children
A new survey from Ann & Robert H. Lurie Children’s Hospital of Chicago has found that a majority of children and adolescents in the city are either already vaccinated against COVID-19 or very likely to be vaccinated if the vaccine is recommended for young children, according to their parents.

As vaccines have been authorized for younger children over the last year, more children have become eligible for immunization against COVID-19. At present, the COVID-19 vaccine is available for youth 518 years old, and studies are underway for children age 6 months through 4 years old.

Parent perspectives from the latest VOICES of Child Health in Chicago survey indicate that more than 3 in 5 children 1217 years old have already been vaccinated. However, many parents of very young children may be hesitant to have their child vaccinated.

The survey was conducted between October-November 2021, shortly after the COVID-19 vaccine became available for children 511 years old. Based on parents’ responses in the survey:
  • 61 percent of children 12 years and older were already vaccinated.
  • 12 percent of children 511 years old were already vaccinated, and 49 percent were very likely to be vaccinated.
  • 41 percent of children under 5 years old were very likely to be vaccinated, 22 percent were somewhat likely to be vaccinated, and 34 percent were not likely to be vaccinated.
Higher vaccination rates for adolescents 12 and older align with the fact that the vaccine has been available longer for this age group. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute. Read more here.
Manne Research Institute Team Awarded NIH R01 Grant
Study to build understanding of pathways to abnormal outcomes for premature birth
Survival of infants born extremely prematurely has improved, but these babies go on to experience high rates of childhood health problems including asthma, breathing abnormalities during sleep, and poor developmental outcomes. Currently, the mechanisms causing such outcomes remain unclear, impairing the ability of the clinician to identify both at-risk infants and targets for intervention. Investigators in the Center for Autonomic Medicine in Pediatrics (CAMP), NICU-Cardiac Neurodevelopmental Program: Early Childhood Clinic, the Division of Neonatology, and Data Analytics and Reporting at Ann & Robert H. Lurie Children’s Hospital, as well as several other sites recently received a $7.7 million R01 grant from the National Heart, Lung, and Blood Institute (NHLBI) with NIH to fund a Post-Vent study to further their understanding of the pathways leading to abnormal outcomes in these children, empowering early identification and targeted treatment to improve health outcomes. The main goal is to build prognostic models of asthma, sleep disordered breathing, and neurodevelopmental impairment at pre-school age in former extremely premature infants based on clinical characteristics and intermittent hypoxemia events on longitudinal physiologic waveforms in the neonatal intensive care unit. Pediatric research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute.

The following researchers with Lurie Children’s are collaborating on this project.

Principal Investigators 
  • Debra E. Weese-Mayer, MD, Chief, Center for Autonomic Medicine in Pediatrics with Lurie Children’s, and Beatrice Cummings Mayer Professor in Pediatric Autonomic Medicine and Professor of Pediatrics (Critical Care) with Northwestern University Feinberg School of Medicine 
  • Raye-Ann deRegnier, MD, Attending Physician, Neonatology with Lurie Children’s, and Professor of Pediatrics (Neonatology) with Northwestern University Feinberg School of Medicine  

  • Aaron P. Hamvas, MD, Division Head, Neonatology with Lurie Children’s, and Raymond & Hazel Speck Berry Board Designated Professorship in Neonatology and a Professor of Pediatrics (Neonatology) with Northwestern University Feinberg School of Medicine 
  • Frank A. Zelko, PhD, Pediatric Neuropsychologist with Lurie Children’s, and Associate Professor of Psychiatry and Behavioral Sciences with Northwestern University Feinberg School of Medicine 
  • Narayan Krishnamurthi, PhD, Physiologic Data Scientist, CAMP 
  • Michael Carroll, PhD, Director, Computational Informatics and Visualization Laboratory with Lurie Children’s, and Research Assistant Professor of Pediatrics with Northwestern University Feinberg School of Medicine 
  • Lynn Boswell, Senior Physical Therapist, Clinician III, Neonatology 
  • Casey Rand, Manager, Clinical Research, CAMP 

Study Team Members 
  • Erin Smith, Clinical Research Coordinator III 
  • Jamie Vogl, Clinical Research Coordinator II  
  • Allaa Fadl-Alla, Clinical Research Coordinator II  

NIH funding for this cohort now includes four grants including a Diversity Supplement, Supplement, U01, and R01, and more than $10 million in funding across 11 years at Lurie Children’s. Consortium wide, this includes 14 grants and more than $20 million in funding over the same period.
Aalaa Abdallah Receives 2022 AACR Minority Scholar in Cancer Research Award 
Aalaa Abdallah, MS, a PhD candidate and Master of Public Health student at Northwestern University Feinberg School of Medicine, is a recipient of the 2022 Minority Scholar in Cancer Research Award from the American Association for Cancer Research (AACR). The award program, which is supported by AACR and the National Cancer Institute’s Center to Reduce Cancer Health Disparities, increases the scientific knowledge base of minority scientists and encourages them to pursue careers in cancer research. AACR will officially present the awards at its annual meeting in April.

Abdallah works in the lab of Xiao-Nan Li, MD, PhD, Director of Pediatric Xenograft Modeling with Stanley Manne Children’s Research Institute, and a Professor of Pediatrics and Rachelle and Mark Gordon Endowed Professorship in Cancer Research with Northwestern University Feinberg School of Medicine. Her research focuses on the mechanisms through which pediatric high-grade glioma “oncohistones” contribute to gliomagenesis. Specifically, her project uses genetically engineered mouse models of pediatric high-grade glioma to elucidate the transcriptomic and histopathological effects of the H3.3G34R mutation in the context of common co-occurring mutations.

“My long-term goals are to utilize both my PhD and Master of Public Health to conduct basic science and transitional research, which informs the development of new therapies, and advocate for equitable distribution of biomedical treatments,” said Abdallah.
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Research Staff Additions and Promotions
Welcome Michele Whitney, Director of Operations for Quantitative Science

Michele Whitney has been named Director of Operations for Quantitative Science. She is an experienced manager, researcher, and administrator with more than 20 years in the nonprofit, for-profit, and governmental sectors. Over the past 12 years, she has coordinated and facilitated various social science research programs involving health and healthcare, spending the last 5 ½ years with the United States Census Bureau managing survey research operations for several population-based studies.

Whitney earned an MBA from Keller Graduate School of Management and a Master of Science in Human Services from Capella University. She is currently working towards her PhD in Human Services with a specialization in Advanced Research. She has a passion for research in creating knowledge as one path for helping to facilitate and guide social change.
Akhil Aerra
Clinical Research Coordinator I, Clinical Trials Office 

Akhil Aerra has joined the Clinical Trials Office (CTO) as Clinical Research Coordinator I. As a member of the CTO, Aerra is committed to providing quality assistance to the researchers as they conduct various studies. He is excited to join the CTO team and looks forward to learning more about the community and people within the CTO. Prior to joining the CTO, Aerra worked with the Lurie Children’s Allergy and Immunology Department, with a focus on food allergies. He earned a Bachelor of Science in Molecular & Cellular Biology from University of Illinois at Urbana–Champaign.
Lucia de Almeida, PharmD, PhD
Research Scientist Navigator, Basic and Preclinical Science Pillar,
Office of Research Development 

Lucia de Almeida has joined the Research Navigation team in the Office of Research Development as a Research Scientist Navigator for the Basic and Preclinical Science Pillar. Previously, Almeida spent 14 years developing cutting-edge research and making major contributions to the understanding of immune regulation. She published more than 35 articles in peer-reviewed journals and is an author and co-author on numerous high-impact publications, including Immunity, Nature Communications, and Nature Immunology. In 2007, she joined Northwestern University, where her research was supported by the highly competitive American Heart Association, NIH T32 fellowships, and a supplement to promote diversity in health-related research. She was promoted to research assistant professor and oriented her research toward elucidating the molecular mechanisms of innate immune regulation. She earned a Master of Science and PhD in Biochemistry from Universidade Federal do Rio Grande do Sul, Brazil, and acquired her postdoctoral training at Northwestern University.
Christian Johnson, MPH
Clinical Research Coordinator III, Clinical Trials Office 
The Clinical Trials Office (CTO) welcomes Christian Johnson to the role of Clinical Research Coordinator III. Prior to joining the CTO, Johnson served as a Clinical Research Coordinator II at University of Chicago where he assisted with the expansion of harm reduction services to reduce transmission rates of HIV and Hepatitis C through drug use across 19 counties in Illinois. His previous experience includes working at NorthShore University HealthSystem, YMCA of Coastal Georgia, and Georgia Southern University. He earned a Master of Public Health with a concentration in Community Health Education and Behavior from Georgia Southern University and a Bachelor of Science in Health Sciences from University of Missouri–Columbia.
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
Updated Roles and Responsibilities Documents Available

The Office of Research Business Operations has released updated roles and responsibilities documents for pre and post award support at Manne Research Institute. Research Business Operations serves as centralized support for pre and post award financial management of grants and contracts at Manne Research Institute.

Please review the Roles & Responsibilities Matrix for Sponsored Awards and Industry Sponsored Clinical Trials for a high-level overview of how and when to engage with each of these teams as well as investigator and departmental responsibilities with regard to sponsored project submissions and award maintenance.

Please visit the Research Business Operations webpage to learn more about each office. You may also access the Support Staff Directory for a full Research Business Operations staff listing.

If you have questions about how to get started, please contact
Office of Research Development
Deadline Extended: Submit Profile Info for the New Stanley Manne Children’s Research Institute Website by March 31

The Stanley Manne Children’s Research Institute website will be launched in 2022. It will feature profiles for individual researchers and lab or program pages for affiliated research groups. The Office of Research Development invites you to submit information about yourself for your new profile page using this form.

If you are the head of a lab or research group, please visit the research communications page and select the appropriate form for your research pillar.

Please have submissions completed by March 31. If you have any questions, or would like to discuss the contents of your new Manne Research Institute profile in more detail, please contact the Office of Research Development.
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 tips from the previous month. Please contact for follow-up questions or to request guidance on any research compliance topic. Your questions help ORIC generate future tips for the research community.

March 2 ORIC TIP: When to add non-Lurie investigators in Cayuse IRB

All personnel engaged in research activity at a Lurie Children’s site must be listed as study personnel in the Cayuse IRB application. When considering whether to add non-Lurie investigators, whether they are engaged in the study activity at Lurie Children’s depends on certain details.

Non-Lurie Children’s employees are only added to Cayuse applications if they will be physically coming into a Lurie Children’s site to conduct research activities (e.g., securing consent from participants, conducting research procedures). If an outside investigator is coming into Lurie Children’s to conduct research, they should be listed as study personnel by requesting Cayuse access; more information is available here. First-time non-Lurie investigators may also need to secure a Lurie network ID before being added to Cayuse. A member of the Lurie research team can request this access through the Lurie Help Desk service catalogue (select “Non-Employee/Vendor Access”).

If the non-Lurie Children’s personnel is engaged in the research activities but will NOT conduct study activities at a Lurie Children’s site, they should not be listed in the Cayuse application. Instead, they must seek IRB approval from their “home” institution for their participation in the research.

Contact with additional questions about listing personnel in Cayuse IRB.

February 15 ORIC TIP: Do external safety reports from study sponsors need to be submitted to our IRB?

Investigators often receive reports of serious adverse events occurring at other study sites. These do not need to be reported to the IRB. However, any amendments to study protocols and related documents that result from such events require IRB submission and approval. (See IRB P&P Section 13.2 A ii.)

Study sponsors normally provide an annual progress report, which includes a listing of all adverse events (AE’s) and serious adverse events (SAE’s) that have taken place. The annual progress report is to be attached within your renewal submission every year for IRB for review.

Other Resources
  • Lurie Children’s Incident Assessment Tool (worksheet to aid in assessing reportability)
  • IRB Policies & Procedures Manual
• Section 5: Investigator Responsibilities
• Section 9: Types of Review and Submissions
• Section 13: Data Safety Monitoring and Regular Reporting Requirements

Contact the IRB staff at or Research Compliance staff at

February 8 ORIC TIP: Can I make a change to my study when submitting a renewal application in Cayuse?

When submitting a renewal in Cayuse IRB, you are submitting the current status of your study to be reviewed and renewed by the IRB. In this application no changes can be made to the study. If any changes need to be made to the study while a renewal is pending, please submit a separate modification with the changes being made. The renewal, in most instances, will be processed first to prevent any lapse in study coverage, however there may be rare instances where the modification is processed before the renewal if the modification directly impacts the renewal. If you are making an urgent modification to your study procedures at the time of your renewal, please contact your Analyst and let them know that you'd like the modification to take priority.
Resources from Research Partners
"NUCATS On Demand" Digital Tool Introduced  
NUCATS On Demand is a new digital tool that gives research staff and faculty 24/7 access to training and other educational resources.

NUCATS On Demand features:
  • Videos and recorded webinars from subject matter experts 
  • Full-length eLearning modules on a range of research topics along with a research compliance immersive case study 
  • Reference guides and regulatory templates for research staff looking to quickly learn more about a specific topic without having to watch a full-length workshop  
  • A clinical research glossary with common terms for staff and faculty new to research  
  • Extensive topic-specific pages on Data Management/REDCap, Conducting Research During COVID, Faculty Mentoring, and Good Clinical Practice  

This easy-to-navigate resource will be continually updated with tools and guidance. Bookmark the landing page and make NUCATS On Demand part of your onboarding toolkit. For questions or to suggest topics to add to NUCATS On Demand, email
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