CHRI Research Bulletin - June 2024

Ruben Quiros, MD, Professor, Division of Gastroenterology, Hepatology and Nutrition

Alvaro Flores, MD, and Ruben Quiros-Tejeira, MD, both of the Division of Pediatric Gastroenterology, Hepatology and Nutrition, coauthored a new article in the Journal of Obesity.¹ The research team consisting of Children’s Nebraska, UNMC, and Creighton University investigators addressed a question about clinical management of children with nonalcoholic fatty liver disease (NAFLD). Non Alcoholic liver disease remains the common cause of liver disease in children and the most common cause of transplant in adults. Most children with NAFLD have obesity, and this liver disease can progress to fibrosis or cirrhosis. Previous research showed that adult patients with NAFLD who improve their body mass index usually see improvement in the biochemical disease biomarker alanine aminotransferase (ALT). The team developed a retrospective chart review to examine if a similar association holds true in a pediatric patient population. Their analyses showed that a decrease in BMI percent of at least 2.5% at 6 months is statistically associated with a clinically relevant decrease in ALT in children with NAFLD and obesity. As stated in the article’s conclusions, the study results provide clinicians with objective metrics of success for management of this complex but common condition affecting children mostly with obesity, which is already at epidemic levels.

¹ Flores Lopez AG, Quiros-Tejeira RE, Lyden E, McGill B, Dike CR. Association between BMI Change, Transaminases, and Other Metabolic Parameters in Children with Nonalcoholic Fatty Liver Disease. J Obes. 2024;2024:6997280.

Ann Anderson Berry, MD, PhD, Executive Director

Back to Research Basics

Hello everyone! Summer is here and the temperatures rose like a firecracker on the 4^th of July!

Just as quickly we will have a new cohort of trainees including summer students, medical students, residents, fellows, and graduate students all excited to embark on the next steps in their training. For many if not all these individuals we know that research will be a part of their training, and it is critical that we all are familiar with the basics of responsible conduct of research. Today I’ll take the time to review a few highlights and how CHRI resources are set up to ensure that your work is ethically conducted, performed in a timely manner and is impactful in furthering our knowledge of and improving outcomes in Child Health.

The first step in conducting research is to become CITI trained. You can find CITI training modules required by UNMC for research at either of our campuses here. https://www.unmc.edu/irb/resources/citi/index.html

Once training is complete, it is necessary to determine if your project is a research project (hypothesis driven) or a Quality Improvement project. (Implementation of a clinical practice that is based on someone else’s work) this can be done at this link. https://unmcredcap.unmc.edu/redcap/surveys/?s=XCC7FC4MPPEDR978

At this link you will find a guide to the UNMC IRB. https://guides.unmc.edu/books/research-handbook/page/institutional-review-board Many of your questions can be answered by referring to this page, but if you are in doubt about a process, it is always a great idea to call the UNMC IRB. They are very helpful, and want you to succeed the first time instead of taking unnecessary steps.

Feasibility: If you are considering a retrospective or prospective research project, it is not acceptable to search in the EMR to see if there are enough patients to perform your study. CHRI does have a resource to do this for you in a HIPPA and research compliant manner. You can reach out to REDi Core with this free request. https://app.smartsheet.com/b/form/70b1deef7dd54dbb9a46c6c0e5c0895d

Your IRB must be complete and final before you start any study activities. This is critical and the most important tenant of conduct of ethical research. Children’s Nebraska uses the UNMC IRB as it’s IRB of record. Some multi center studies will use a central IRB, but this must be approved by the UNMC IRB. CHRI will help you with this if you have questions.

If you are contacted by an industry company about a study in your subspeciality please loop in CHRI. We will help you with the initial confidentiality agreement and subsequent negotiations with the company and ensure that all research is conducted within the standards of our institution. We will also contract with those entities for the financial support to conduct the study. A faculty member should never sign a contract with any outside entity.

Finally, as faculty members we are completely responsible for the research actions of our trainees. Please communicate to them that they need to keep you updated on each step of their research and ensure that you double check that their IRB is complete and approved, that their data is stored in a secure manner and not shared inappropriately, and that this data is destroyed or transferred to you prior to their leaving the institution. If data must leave with them, we need an official Data Transfer Agreement (DTA) with their new institution.

Thanks for all you do for kids and their health in your research activities. If you have any questions please reach out to me at alanders@unmc.edu