Institutional Review Board Approval Process Research Articles

Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial

Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

COVID-19: Mobilizing Quickly for a Rapid Response.

COVID-19: Mobilizing Quickly for a Rapid Response.

Establishing an Institutional Gonadal Tissue Cryopreservation Protocol for Patients with Differences of Sex Development.

Many individuals with differences of sex development experience subfertility. We describe a novel gonadal tissue cryopreservation protocol for those individuals. Before 2018 patients with differences of sex development electing gonadal tissue cryopreservation were enrolled in a cancer focused protocol. Thereafter, our hospital developed a protocol specifically for these patients undergoing gonadectomy due to neoplasia risk. Protocol development steps and procedures are reported. A retrospective chart review was conducted for patient characteristics and cryopreservation choices. During the institutional review board approval process there were multidisciplinary meetings with stakeholders. The main concerns discussed included preoperative counseling, pathological evaluation and final tissue disposition. Detailed multidisciplinary preoperative counseling is provided regarding potential gonadal tissue cryopreservation for patients undergoing gonadectomy. For enrolled patients the gonad is bisected after removal, with half being sent to pathology and half being processed for cryopreservation. If neoplasia is noted, cryopreserved tissue is recalled for further pathological analysis. Postoperative counseling is performed after pathology results are available, and the final gonadal tissue cryopreservation decision is made. During the study period 7 patients with 5 diagnoses and a median age of 10.99 years (IQR 1.29 to 14.84) elected to attempt gonadal tissue cryopreservation. Of the patients 4 (57%) had germ cells and elected to store tissue. Gonadal tissue cryopreservation at the time of gonadectomy is feasible for patients with differences of sex development at risk for gonadal neoplasia. The protocol described represents a template for institutions wishing to offer gonadal tissue cryopreservation to patients electing gonadectomy. More than half of patients thus far have cryopreserved gonadal tissue.

Association between Asthma and Developmental Disability and Delay in the United States Pediatric Population

Background. To date, few studies have systemically examined the association between asthma and various developmental disabilities and delays among pediatric populations. To address this scientific gap, we report here the asthma prevalence estimates by, and associations with, various disability categories and developmental delay in the United States (US) pediatric population. Methods: A total of 71 811 families with children/adolescents aged 0-to-17 years old who participated in the 2016-2017 National Survey of Children’s Health were included in this cross-sectional analytical sample. Weighted asthma prevalence estimates were calculated and compared between children with and without disabilities or delays. Disabilities included Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder, Cerebral Palsy, seizure, vision, hearing and speech, intellectual-, and learning disability. Delay was defined as not meeting growth milestones with unknown cause. Logistic regression analysis generated the odds of an asthma diagnosis by disability status adjusted for demographics and birth weight. Findings: Overall asthma prevalence estimates were 10% higher in children with a disability (~16%) versus children without a disability (~6%) (p<0·0001). The risk of asthma was nearly three times higher in children with a disability versus children with no disability (Odds Ratio [OR] 2·77, 95% Confidence Interval [CI] 2·39-3·21, p<0·0001) and two times higher among children with a developmental delay versus their peers with no delay (OR 2·22, 95% CI, 1·78-2·77, p<0·0001). Adjusted models remained significant for all disability categories (overall adjusted OR [aOR] 2·21, 95% CI 1·87-2·62, p<0.0001). Subgroup analyses showed ethnic minorities had a higher prevalence of concurrent asthma and developmental disabilities versus non-Hispanic whites. Interpretation: Results suggest that US children with various developmental disabilities or delay are at higher odds for asthma versus their typically developing peers. These findings support asthma screening in pediatric healthcare settings among patients with developmental disabilities and delays, and particularly among those from ethnic minority backgrounds. Funding Statement: This study was not supported by any funding. Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: Our research was exempted from the University of Texas Institutional Review Board approval process because it is publicly available data.

Applying quality improvement methodologies to decrease the time-to-activation of new clinical trials at an NCI-designated comprehensive cancer center.

296 Background: Initiating a new clinical trial is burdensome and complex. The time to activate a clinical trial can directly affect the ability to provide innovative, state-of-the-art care to patients. We sought to understand the process of activating an oncology clinical trial at a matrix National Cancer Institute-designated, comprehensive cancer center. Methods: A multidisciplinary team of stakeholders within the cancer center, university, and affiliate hospitals held a retreat to map out the process of activating a clinical trial from packet receipt to enrollment of the first patient. We applied classical QI and Six Sigma methodology to determine bottlenecks and redundancies in activating a clinical trial. During this process, particular attention was paid to time to pass through each step and perceived barriers and bottlenecks were identified through group discussions. The time to activation was measured from the day the trial packet was received until the time when the trial was open for enrollment. Results: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: 1) allow parallel scientific committee and institutional review board (IRB) review and 2) allow the clinical research coordination committee to review protocols for feasibility and university interest separate from the IRB approval process. These changes resulted in a mean time-to-activation change from 194 days at baseline to 135 days after these changes were implemented. The committee continues to track the activation time and this frame work is used to identify additional improvement steps. Conclusions: By applying quality improvement methodologies and Six Sigma principles, we were able to redesign redundant aspects of the process of activating a clinical trial at a matrix comprehensive cancer center. This was associated with a reduction of time to activation of trials. More importantly, the process map provides a framework to maintain these gains and implement further changes.

Using the Medicine Wheel Model to Study Polycystic Ovary Syndrome in American Indian Women.

Developing a nursing research project with American Indian tribes and navigating the institutional review board approval process can appear daunting to investigators because of tribal research requirements in addition to academic requirements. Nurse investigators conducted a research project exploring experiences of American Indian women with polycystic ovary syndrome. After successful implementation of the project, a model emerged to guide researchers working with tribal communities through project development and the institutional review board process. The model is based on the American Indian medicine wheel with each quadrant aligned with a season of the year: spring, summer, fall, and winter. The seasonal approach divides project development into sections that can be developed independently or simultaneously. The model emphasizes collaborative relationships between the research team and tribe. Researchers can adapt and customize the model for their projects based on their objectives and targeted populations. The purpose of this article is to describe the medicine wheel model and, as an exemplar, demonstrate application of the model in a project involving American Indian women with polycystic ovary syndrome. Additionally, potential implications of the model for nursing research, education, and practice are presented.

Ethical Issues and Practical Challenges in Suicide Research.

Research with human subjects represents a critical avenue for suicide prevention efforts; however, such research is not without its ethical and practical challenges. Specifically, given the nature of research with individuals at elevated risk for suicide (e.g., increased concerns regarding participant safety, adverse events, liability, difficulties often arise during the institutional review board (IRB) evaluation and approval process. This paper aims to discuss IRB-related issues associated with suicide prevention research, including researcher and IRB panel member responsibilities, suicide risk assessment and management ethics and procedures, informed consent considerations, preparation of study protocols, and education and training. Points to consider and components to potentially include in an IRB application for suicide-related research are additionally provided. Literature relevant to ethics in suicide research and suicide risk assessment and management was reviewed and synthesized. Suicide research can be conducted in accordance with ethical principles while also furthering the science of suicide prevention. Despite the challenging nature of suicide prevention research, empirically informed solutions exist to address difficulties that may emerge in interfacing with IRBs. There remain areas for improvement in the IRB approval process that warrant further investigation and work.

Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval

The University of Michigan Human Research Protection Program formed a six-member committee to analyze the nature of Institutional Review Board (IRB) staff and board contingencies for the approval of informed consent documents. Of the 100 studies examined, 87% had one or more informed consent contingencies. “Omissions” in documentation (40%) and “better clarity” (24%) accounted for the majority, while “word-smithing” accounted for only 10%. This is one of the first studies to examine the nature of IRB contingencies as they relate to informed consent documents. Educational efforts targeting completeness in documentation and clarity on the part of study teams, and discouraging “word-smithing” on the part of IRBs, could reduce the number of informed consent contingencies and expedite the IRB approval process.

Institutional Board Review for Clinical Investigations on Inflammatory Bowel Diseases: A Single-Center Study.

Background/AimsThe growing volume and the diversity of clinical research has led to related laws and regulations as well as the Institutional Review Board (IRB) approval process becoming more stringent. To conduct clinical research efficiently and while following regulations, information about the IRB approval process and feedback is important for investigators. This has yet to be studied.MethodsWe included 381 gastrointestinal disease research proposals (79 with inflammatory bowel disease [IBD], and 302 with non-IBD) reviewed by the IRB of Severance Hospital between January 2009 and December 2013. We retrospectively analyzed research characteristics including research risk levels, results of initial reviews, frequencies of continuing review, numbers of IRB comments, frequencies of IRB comments, and durations from submission to approval.ResultsInvestigators' decisions on risk level were higher in the IBD group than in the non-IBD group (P<0.05). Results of initial reviews, frequencies of continuing reviews, the numbers of IRB review comments, and durations from submission to approval were not different between the two groups, but IRB decisions on risk level were higher in the IBD group (P<0.05). In subgroup analysis, the number of IRB comments from initial review on informed consent forms and procedures as well were quest of more information were significantly higher in the IBD group than in the non-IBD group (P<0.001 and 0.01, respectively).ConclusionsIn Korea, rare diseases such as IBD require more information for the IRB process due to their distinct characteristics. IBD researchers should develop research protocols more carefully and make their research as subject-friendly as possible.

Navigating the Institutional Review Board Approval Process in a Multicenter Observational Critical Care Study*

To characterize variation in the institutional review board application process of a multicenter, observational critical care study. Survey analysis of 36 investigators who applied for participation in the United States Critical Illness and Injury Trials Group: Critical Illness and Outcomes Study, an observational study of 69 adult ICUs. None. Analysis of investigator-specific characteristics, institutional review board process, application and approval dates, and level of difficulty in obtaining approval. Surveys were analyzed from 36 sites (95%) that applied for institutional review board approval. Level of review ranged from full board, expedited, to exempt. Seventy-five percent of applications were submitted by an experienced investigator while 25% were submitted by a less experienced investigator. Median time to institutional review board approval was 30 days (interquartile range, 14-54) and ranged from 5 days to 5.5 months. Time to approval was 29 days (interquartile range, 17-48) for applications submitted by an experienced investigator compared with 97 days (interquartile range, 25-159) for those submitted by a less experienced investigator (p = 0.08). Subjective level of difficulty was significantly higher for less experienced investigators (4 of 10; interquartile range, 2-8) vs experienced investigators (2 of 10; interquartile range, 1-3) (p = 0.04). Four sites cited institutional review board concern regarding waiver of consent as a major barrier to approval and were required to perform revisions or participate in board meetings regarding this concern. In a multicenter, observational critical care study, significant variation was observed between sites in all aspects of the institutional review board evaluation and approval process. The level of difficulty was significantly higher for less experienced investigators with a trend toward longer time to institutional review board approval. Variation in institutional review board interpretation of waiver of informed consent regulations was cited as a major barrier to approval.

Dissemination and Implementation

Application of research evidence in care delivery improves patient outcomes. Large gaps still exist, however, between recommended care and that used in practice. To increase the understanding of implementation studies, and dissemination of research findings, we present the perspective of investigators from seven Interdisciplinary Nursing Quality Research Initiative (INQRI)-funded studies. To describe implementation strategies, challenges, and lessons learned from conducting 5 INQRI-funded implementation studies, and present 2 case examples of other INQRI studies to illustrate dissemination strategies. Potential impact of study findings are set forth. Qualitative descriptive methods were used for the implementation studies. Case examples were set forth by investigators using reflection questions. Four of the 5 implementation studies focused on clinical topics and 1 on professional development of nurse managers, 4 were multisite studies. Common implementation strategies used across studies addressed education, ongoing interaction with sites, use of implementation tools, and visibility of the projects on the study units. Major challenges were the Institutional Review Board approval process and the short length of time allocated for implementation. Successes and lessons learned included creating excitement about research, packaging of study tools and resources for use by other organizations, and understanding the importance of context when conducting this type of research. Case examples revealed that study findings have been disseminated to study sites and to the health care community through publications and presentations. The potential impact of all 7 studies is far reaching. This study captures several nuanced perspectives from 5 Principal Investigators, who were completing INQRI-funded implementation studies. These nuanced perspectives are important lessons for other scientists embarking on implementation studies. The INQRI case examples illustrate important dissemination strategies and impact of findings on quality of care.

Dissemination and Implementation Research: Intersection between Nursing Science and Health Care Delivery

Dissemination is the targeted distribution of information and intervention materials to spread knowledge and evidence-based interventions to a larger audience (NIH, 2011). Implementation is the use of strategies to promote the systematic uptake of evidence-based practices into routine practice and healthcare policy to improve the quality and effectiveness of health services (IOM, 2012). The dissemination and implementation (D&I) lexicon includes many terms like translational research, knowledge translation, knowledge exchange, improvement science, and technology transfer. Dissemination and implementation researchers and practitioners must carefully consider strategies for translating evidence into practice to optimize health care delivery. D&I science focuses on translating knowledge into practice by facilitating stakeholder access to findings using a variety of strategies and designs that include pragmatic trials, evidence-based quality improvement, health technology assessment, systematic reviews, randomized clinical trials, and comparative effectiveness research. This collection of articles begins with broad-level perspectives such as priorities, collaboration, and IRB regulations and moves to specific examples of D&I research. Given the tremendous possibilities for D&I research, where should a nation or organization focus its resources? The manuscript by K. Stevens and J. Ovretveit addresses developing national improvement priorities for D&I research to guide researchers and funders. Results of this study suggest that, at least for the United States, the most important and urgent needs include care coordination, implementation of evidence-based practice, improving structure and clinical processes, and developing a culture of quality and safety. These types of research studies require transdisciplinary teams and an infrastructure that supports academic-practice partnerships. The article by F. Puga, K. Stevens, and D. Patel identifies best practices in developing a healthcare improvement research network that integrates various theories, methods, and perspectives of each discipline into a cohesive unit able to focus on complex research issues and topics. A companion article by D. Patel, K. Stevens, and F. Puga identifies variation in institutional review board approval process for D&I studies especially when these studies focus on quality improvement initiatives across multiple sites. Two manuscripts describe specific efforts to implement evidence-based practices. The manuscript by S. Daniels et al., describes the efforts of one Veterans Administration hospital to implement screening for dysphagia in patients who presented to the emergency department with symptoms of stroke. Multidisciplinary team cooperation and organizational support were major facilitators of this quality improvement study, while lack of adequate training perceived lack of time was seen as barriers to implementation. The manuscript by A. Wallace et al. describes the process and framework used to integrate diabetes self-management support into routine diabetes care provided in four community health clinics. The final manuscript by Y. Ogbolu et al. assessed the level of nurse compliance with evidence-based guidelines for preventing mother-to-child transmission of HIV in a resource-limited country. Although making up the greatest portion of the health care workface in most countries, educational and scope of practice barriers often hinder their effectiveness in improving health outcomes. By compiling these papers, we hope to enrich our readers with respect to the need for and variety of D&I studies. We also hope to stimulate thought for future studies to enhance the translation of evidence into practice and to improve health outcomes for populations. Deborah Vincent Marie Hastings-Tolsma Kathleen R. Stevens

Approaches to Facilitate Institutional Review Board Approval of Multicenter Research Studies

Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks. A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned. Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects. Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.

Students as Vital Participants in Research Projects

Inclusion of research coursework into a medical technology or clinical laboratory science program is currently viewed as a mark of a good degree program. Examples of this type of coursework are evaluation of scientific papers, techniques of scientific writing, application and performance of statistical analysis and introduction to research ethics (e.g., Institutional Review Board approval process). While many programs have the ability to recruit experienced scientists into research mentorship of medical technology/clinical laboratory science students, it is recognized that not all programs have this ability. It is also recognized that clinical laboratorians are performing critical diagnostic tests and, in this capacity, have the ability to identify research projects that are necessary, evidence-based and timely. It is hereby proposed that clinical laboratorians take advantage of this innate ability and create rich teaching experiences for students by including them in performance of research projects. Because of the fact that students are armed with up-to-date knowledge, have willing and enthusiastic spirits and are highly motivated to learn, they are vital participants in research. The students receive an invaluable active learning experience and possibly a future job; the clinical laboratorians meet and possibly exceed the research and scholarship expectations of their institutions; and the scientific community benefits by the science being shared through publication in scientific journals.

Notes from the Field: Jumpstarting the IRB Approval Process in Multicenter Studies

To identify strategies that facilitate readiness for local Institutional Review Board (IRB) review, in multicenter studies. Eleven acute care hospitals, as they applied to participate in a foundation-sponsored quality improvement collaborative. Case series. Participant observation, supplemented with review of written and oral communications. Applicant hospitals responded positively to efforts to engage them in early planning for the IRB review process. Strategies that were particularly effective were the provisions of application templates, a modular approach to study description, and reliance on conference calls to collectively engage prospective investigators, local IRB members, and the evaluation/national program office teams. Together, these strategies allowed early identification of problems, clarification of intent, and relatively timely completion of the local IRB review process, once hospitals were selected to participate in the learning collaborative. Engaging potential collaborators in planning for IRB review may help expedite and facilitate review, without compromising the fairness of the grant-making process or the integrity of human subjects protection.