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Article ; Online: Demonstration Project: Transitioning a Research Network to New Single IRB Platforms.

Burr, Jeri S / Johnson, Ann / Risenmay, Annie / Bisping, Stephanie / Serdoz, Emily S / Coleman, Whit / Sward, Katherine A / Rothwell, Erin / Dean, J Michael

Ethics & human research

2023 Volume 44, Issue 6, Page(s) 32–38

Abstract: Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center ... ...

Abstract	Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center assisted the Collaborative Pediatric Critical Care Research Network to transition from using individually negotiated reliance agreements and paper-based documentation to a new sIRB master agreement and an informatics platform to capture reliance documentation. Lessons learned that can guide other academic institutions and IRBs as they operationalize sIRBs included the need for sites to understand what type of engagement or reliance is required and their need to understand the difference between reliance and activation. Requirements around local review remain poorly understood. Further research is needed to determine approaches that can achieve the NIH vision of reviews becoming more efficient and improving study start-up times, relieving administrative burden while advancing human research protections.
MeSH term(s)	United States ; Child ; Humans ; Ethics Committees, Research ; National Institutes of Health (U.S.)
Language	English
Publishing date	2023-11-22
Publishing country	United States
Document type	Multicenter Study ; Journal Article
ISSN	2578-2363
ISSN (online)	2578-2363
DOI	10.1002/eahr.500149
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Using single IRB consultations to meet the educational needs of investigative teams.

Johnson, Ann R / Pautler, Mary / Burr, Jeri S / Abdelsamad, Nael / VanBuren, John M / Rigtrup, Lisa M / Dean, J Michael / Rothwell, Erin

Contemporary clinical trials communications

2022 Volume 29, Page(s) 100971

Abstract: Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the ... ...

Abstract	Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.
Language	English
Publishing date	2022-08-11
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2022.100971
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Article ; Online: Implementing a Central IRB Model in a Multicenter Research Network.

Burr, Jeri S / Johnson, Ann R / Vasenina, Valeriya / Bisping, Stephanie / Coleman, R Whitney / Botkin, Jeffrey R / Dean, J Michael

Ethics & human research

2019 Volume 41, Issue 3, Page(s) 23–28

Abstract: Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their ... ...

Abstract	Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their processes for ceding review and developing procedures to handle local review when relying on a single IRB. This article describes an NIH-funded network that proactively instituted a central IRB (CIRB) in 2012, anticipating the NIH future mandate. Lessons learned are described. There was a steep learning curve for IRBs and participating sites. IRB submission workload burden shifted from study teams to the data coordinating center, which created new workflow challenges, especially preparing hundreds of consent documents centrally. Despite difficulties encountered with CIRB review, this network is now fully functioning under a CIRB model. Further review and experience are needed to determine whether this shift in IRB review has eliminated duplicative review or regulatory burden from study teams.
MeSH term(s)	Biomedical Research/ethics ; Biomedical Research/organization & administration ; Efficiency, Organizational ; Ethics Committees, Research/ethics ; Ethics Committees, Research/organization & administration ; Guideline Adherence/ethics ; Guideline Adherence/organization & administration ; Models, Organizational ; Multicenter Studies as Topic/ethics ; National Institutes of Health (U.S.)/ethics ; National Institutes of Health (U.S.)/organization & administration ; United States ; Workflow ; Workload
Language	English
Publishing date	2019-06-07
Publishing country	United States
Document type	Journal Article
ISSN	2578-2363
ISSN (online)	2578-2363
DOI	10.1002/eahr.500016
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

Lane, Karen / Palm, Marisha E / Marion, Eve / Kay, Marie T / Thompson, Dixie / Stroud, Mary / Boyle, Helen / Hillery, Shannon / Nanni, Angeline / Hildreth, Meghan / Nelson, Sarah / Burr, Jeri S / Edwards, Terri / Poole, Lori / Waddy, Salina P / Dunsmore, Sarah E / Harris, Paul / Wilkins, Consuelo / Bernard, Gordon R /

Dean, J Michael / Dwyer, Jamie / Benjamin, Daniel K / Selker, Harry P / Hanley, Daniel F / Ford, Daniel E

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e131

Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

Abstract	One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
Language	English
Publishing date	2023-05-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.560
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Article ; Online: Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

Hanley, Daniel F / Bernard, Gordon R / Wilkins, Consuelo H / Selker, Harry P / Dwyer, Jamie P / Dean, J Michael / Benjamin, Daniel Kelly / Dunsmore, Sarah E / Waddy, Salina P / Wiley, Kenneth L / Palm, Marisha E / Mould, W Andrew / Ford, Daniel F / Burr, Jeri S / Huvane, Jacqueline / Lane, Karen / Poole, Lori / Edwards, Terri L / Kennedy, Nan /

Boone, Leslie R / Bell, Jasmine / Serdoz, Emily / Byrne, Loretta M / Harris, Paul A

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e170

Abstract: New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by ... ...

Abstract	New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Language	English
Publishing date	2023-07-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.597
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.

Harris, Paul A / Dunsmore, Sarah E / Atkinson, Jane C / Benjamin, Daniel Kelly / Bernard, Gordon R / Dean, J Michael / Dwyer, Jamie P / Ford, Daniel F / Selker, Harry P / Waddy, Salina P / Wiley, Kenneth L / Wilkins, Consuelo H / Cook, Sarah K / Burr, Jeri S / Edwards, Terri L / Huvane, Jacqueline / Kennedy, Nan / Lane, Karen / Majkowski, Ryan /

Nelson, Sarah / Palm, Marisha E / Stroud, Mary / Thompson, Dixie D / Busacca, Linda / Elkind, Mitchell S V / Kimberly, Robert P / Reilly, Muredach P / Hanley, Daniel F

JAMA network open

2023 Volume 6, Issue 10, Page(s) e2336470

Abstract: Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. ... ...

Abstract	Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN's challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support. Observations: The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN's impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic. Conclusions and relevance: The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.
MeSH term(s)	United States ; Humans ; COVID-19 ; Pandemics ; Translational Science, Biomedical ; Awards and Prizes ; Communication
Language	English
Publishing date	2023-10-02
Publishing country	United States
Document type	Multicenter Study ; Journal Article ; Research Support, N.I.H., Extramural
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2023.36470
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Cognitive Development One Year After Infantile Critical Pertussis.

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

2017 Volume 19, Issue 2, Page(s) 89–97

Abstract: Objectives: Pertussis can cause life-threatening illness in infants. Data regarding neurodevelopment after pertussis remain scant. The aim of this study was to assess cognitive development of infants with critical pertussis 1 year after PICU discharge.!# ...

Abstract	Objectives: Pertussis can cause life-threatening illness in infants. Data regarding neurodevelopment after pertussis remain scant. The aim of this study was to assess cognitive development of infants with critical pertussis 1 year after PICU discharge. Design: Prospective cohort study. Setting: Eight hospitals comprising the Eunice Kennedy Shriver National Institute for Child Health and Human Development Collaborative Pediatric Critical Care Research Network and 18 additional sites across the United States. Patients: Eligible patients had laboratory confirmation of pertussis infection, were less than 1 year old, and were admitted to the PICU for at least 24 hours. Interventions: The Mullen Scales of Early Learning was administered at a 1-year follow-up visit. Functional status was determined by examination and parental interview. Measurements and main results: Of 196 eligible patients, 111 (57%) completed the Mullen Scales of Early Learning. The mean scores for visual reception, receptive language, and expressive language domains were significantly lower than the norms (p < 0.001), but not fine and gross motor domains. Forty-one patients (37%) had abnormal scores in at least one domain and 10 (9%) had an Early Learning Composite score 2 or more SDs below the population norms. Older age (p < 0.003) and Hispanic ethnicity (p < 0.008) were associated with lower mean Early Learning Composite score, but presenting symptoms and PICU course were not. Conclusions: Infants who survive critical pertussis often have neurodevelopmental deficits. These infants may benefit from routine neurodevelopmental screening.
MeSH term(s)	Child Development ; Cognition ; Cohort Studies ; Developmental Disabilities/epidemiology ; Developmental Disabilities/etiology ; Female ; Follow-Up Studies ; Humans ; Infant ; Intensive Care Units, Pediatric ; Male ; Prospective Studies ; United States ; Whooping Cough/complications
Language	English
Publishing date	2017-11-07
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2052349-X
ISSN	1947-3893 ; 1529-7535
ISSN (online)	1947-3893
ISSN	1529-7535
DOI	10.1097/PCC.0000000000001367
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Article: The Collaborative Pediatric Critical Care Research Network Critical Pertussis Study: collaborative research in pediatric critical care medicine.

Burr, Jeri S / Jenkins, Tammara L / Harrison, Rick / Meert, Kathleen / Anand, K J S / Berger, John T / Zimmerman, Jerry / Carcillo, Joseph / Dean, J Michael / Newth, Christopher J L / Willson, Douglas F / Sanders, Ronald C / Pollack, Murray M / Harvill, Eric / Nicholson, Carol E

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

2010 Volume 12, Issue 4, Page(s) 387–392

Abstract: Objective: To provide an updated overview of critical pertussis to the pediatric critical care community and describe a study of critical pertussis recently undertaken.: Setting: The six sites, seven hospitals of the Collaborative Pediatric Critical ... ...

Abstract	Objective: To provide an updated overview of critical pertussis to the pediatric critical care community and describe a study of critical pertussis recently undertaken. Setting: The six sites, seven hospitals of the Collaborative Pediatric Critical Care Research Network, and 17 outside sites at academic medical centers with pediatric intensive care units. Results: Despite high coverage for childhood vaccination, pertussis causes substantial morbidity and mortality in US children, especially among infants. In pediatric intensive care units, Bordetella pertussis is a community-acquired pathogen associated with critical illness and death. The incidence of medical and developmental sequelae in critical pertussis survivors remains unknown, and the appropriate strategies for treatment and support remain unclear. The Collaborative Pediatric Critical Care Research Network Critical Pertussis Study has begun to evaluate critical pertussis in a prospective cohort. Conclusion: Research is urgently needed to provide an evidence base that might optimize management for critical pertussis, a serious, disabling, and too often fatal illness for U.S. children and those in the developing world.
MeSH term(s)	Anti-Bacterial Agents/therapeutic use ; Antibiotic Prophylaxis ; Child ; Cohort Studies ; Critical Care ; Humans ; Infection Control ; Intensive Care Units, Pediatric ; Pediatrics ; Research Design ; United States/epidemiology ; Whooping Cough/complications ; Whooping Cough/mortality ; Whooping Cough/prevention & control ; Whooping Cough/therapy
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2010-04-19
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2052349-X
ISSN	1947-3893 ; 1529-7535
ISSN (online)	1947-3893
ISSN	1529-7535
DOI	10.1097/PCC.0b013e3181fe4058
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Critical pertussis illness in children: a multicenter prospective cohort study.

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

2012 Volume 14, Issue 4, Page(s) 356–365

Abstract: Objective: Pertussis persists in the United States despite high immunization rates. This report characterizes the presentation and acute course of critical pertussis by quantifying demographic data, laboratory findings, clinical complications, and ... ...

Abstract	Objective: Pertussis persists in the United States despite high immunization rates. This report characterizes the presentation and acute course of critical pertussis by quantifying demographic data, laboratory findings, clinical complications, and critical care therapies among children requiring admission to the PICU. Design: Prospective cohort study. Setting: Eight PICUs comprising the Eunice Kennedy Shriver National Institute for Child Health and Human Development Collaborative Pediatric Critical Care Research Network and 17 additional PICUs across the United States. Patients: Eligible patients had laboratory confirmation of pertussis infection, were younger than 18 years old, and died in the PICU or were admitted to the PICU for at least 24 hours between June 2008 and August 2011. Interventions: None. Measurements and main results: A total of 127 patients were identified. Median age was 49 days, and 105 (83%) patients were less than 3 months old. Fifty-five (43%) patients required mechanical ventilation and 12 patients (9.4%) died during initial hospitalization. Pulmonary hypertension was found in 16 patients (12.5%) and was present in 75% of patients who died, compared with 6% of survivors (p < 0.001). Median WBC was significantly higher in those requiring mechanical ventilation (p < 0.001), those with pulmonary hypertension (p < 0.001), and nonsurvivors (p < 0.001). Age, sex, and immunization status did not differ between survivors and nonsurvivors. Fourteen patients received leukoreduction therapy (exchange transfusion [12], leukopheresis [1], or both [1]). Survival benefit was not apparent. Conclusions: Pulmonary hypertension may be associated with mortality in pertussis critical illness. Elevated WBC is associated with the need for mechanical ventilation, pulmonary hypertension, and mortality risk. Research is indicated to elucidate how pulmonary hypertension, immune responsiveness, and elevated WBC contribute to morbidity and mortality and whether leukoreduction might be efficacious.
MeSH term(s)	Bradycardia/microbiology ; Exchange Transfusion, Whole Blood ; Female ; Humans ; Hypertension, Pulmonary/blood ; Hypertension, Pulmonary/microbiology ; Hypertension, Pulmonary/mortality ; Infant ; Intensive Care Units, Pediatric/statistics & numerical data ; Leukapheresis ; Leukocyte Count ; Male ; Pneumonia/microbiology ; Premature Birth/epidemiology ; Prospective Studies ; Respiration, Artificial ; Survival Rate ; United States/epidemiology ; Whooping Cough/blood ; Whooping Cough/complications ; Whooping Cough/mortality ; Whooping Cough/therapy
Language	English
Publishing date	2012-11-16
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2052349-X
ISSN	1947-3893 ; 1529-7535
ISSN (online)	1947-3893
ISSN	1529-7535
DOI	10.1097/PCC.0b013e31828a70fe
Database	MEDical Literature Analysis and Retrieval System OnLINE

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