Institutional Review Board Submission Research Articles

The Steel Jacket: Antecedents of Trauma A Pilot Nurse-Led Study to Examine Trauma Patients Existential Experience and the Impact of Empathic Nursing Care

This nurse-led, institutional review board-approved pilot study describes basic nursing research from the phenomenon of interest through institutional review board submission and approval process, study protocol development, study execution, and reporting both qualitative and quantitative finding. This study is underpinned with a novel nursing theory, The Steel Jacket: Antecedents of Trauma, inspired by the work of physicist David Bohm and nursing theorist Martha Rogers. The study involved 2 distinct sets of subject: nurses and trauma patients. Nurses were recruited to participate in a prestudy and poststudy of The Steel Jacket Theory. Trauma patients were interviewed to understand their lived experience of the meaning of trauma 1 year after the event. One hundred acute care nurses in a level 1 trauma center were emailed a survey about their level of empathic care and existential nursing approaches toward trauma patients. The intervention included a short module on The Steel Jacket Theory and an accompanying original 6-minute video. Simple statistics were used to tabulate findings. The second set of subjects were trauma patients who were consented and participated in 30-minute interviews. Spielberg's Phenomenological framework was used to describe themes from trauma patient's lived experiences: feeling lost, engaging in self-blame, internally fighting vulnerability and fear, marshalling inner resources to survive, and knowing that a moment in time changed their life forever. Trauma patients can benefit from Trauma Survivorship clinics and nurses need protected time to appreciate and cultivate the space to listen for what is said, perceive what is not said, and co-create a path of healing.

0594 Hybrid Decentralized Recruitment Approach to a Rare Disease Registry for Pediatric Patients With Narcolepsy: The CATNAP® Registry

Abstract Introduction Limited information is available on the natural history, presentation, and management of pediatric narcolepsy. CATNAP® is a retrospective and prospective, longitudinal, multicenter, web-based pediatric narcolepsy registry (NCT04899947). The primary objectives are to improve understanding of the natural history of pediatric narcolepsy, characterize symptom presentation and diagnosis, and understand treatment practices and outcomes. After registry initiation, an innovative decentralized approach was added to adapt to the post-COVID-19 environment and reach additional participants via social media. Methods Eligible children/adolescents (< 18 years) with confirmed narcolepsy were recruited. Participants, caregivers, and clinicians, leveraging web-based portals, answered questions on sociodemographic characteristics; diagnostic, medical, and treatment history; comorbidities; and disease progression. Participants continue to answer follow-up questions annually until they reach 25 years of age or decline to participate. Since registry initiation in September 2020, 17 sites have been activated, including a virtual site launched in August 2022. Hybrid decentralized recruitment required a new web interface, Institutional Review Board submissions, and 7-week social media campaign (press release, 5 targeted posts) to accompany the virtual site launch. Results A total of 126 participants have been enrolled (signed consent), including 75 participants at 16 physical sites over the first 2 years and 51 participants at the virtual site over 10.6 weeks. Rates of engagement (eg, clicks, likes, and shares) for Instagram (3.2%), LinkedIn (7.2%), and Twitter (2.4%) exceeded “good engagement rate” benchmarks for these platforms. Although the engagement rate for Facebook was below benchmarks (< 2%), the absolute number of “clicks” (29) was the largest among social media platforms in the campaign. Conclusion A hybrid recruitment approach for CATNAP demonstrates incorporation of patient-driven considerations into clinical trial design and increases access to future real-world data registries and studies. Decentralization likely increases enrollment and may enable representation from more diverse regions and populations. This is especially important for rare diseases. The CATNAP Registry provides valuable information on the experience and management of pediatric narcolepsy, which will benefit patients and caregivers, inform clinical decision-making, and potentially contribute to development of new treatments. This successful implementation of a hybrid approach with physical and virtual sites could inform design of future registries. Support (if any) Jazz Pharmaceuticals

Matching enrolled trial participants to disease demographics: Using IRB submissions to identify opportunities for researcher training.

Many diseases are highly prevalent in older adults, yet older adults are often underrepresented in corresponding trials. Our objectives were to (1) determine alignment between Institutional Review Board (IRB) protocol age ranges and enrollment demographics to disease demographics pre- and post-implementation of the 2019 National Institutes of Health (NIH) Lifespan Policy and (2) raise awareness about inclusive recruitment to principal investigators (PIs). This was a pre-post study. We reviewed investigator-initiated studies meeting eligibility criteria at Oregon Health & Science University from 2017 to 2018 to determine baseline alignment. Alignment was defined by the level of matching between protocol/enrollment age and disease demographics: 2 points for full match, 1 point for partial match, and 0 points for mismatch. After the NIH policy implementation, we reviewed new studies for alignment. When a mismatch was determined, we contacted PIs (either at initial IRB protocol submission or during ongoing recruitment) to raise awareness and provide strategies to expand inclusion of older adults in their trials. Studies that matched IRB protocol ages to disease demographics significantly improved from 78% pre-implementation to 91.2% post-implementation. Similarly, study enrollment ages matching disease demographics increased by 13.4% following the implementation (74.5%-87.9%). Out of 18 post-implementation mismatched studies, 7 PIs accepted a meeting and 3 subsequently changed their protocol age ranges. This study highlights strategies that translational institutes and academic institutions could use to identify research studies whose participants do not align with disease demographics, offering opportunities for researcher awareness and training to enhance inclusion.

Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study.

Survey analysis of 188 investigators who participated in the VIRUS: COVID-19 registry, a prospective, observational global registry database of 287 sites. None. For each study site approved through December 8, 2020, we assessed the duration in days: 1) from institutional review board (IRB) submission to IRB approval, 2) from IRB approval to Research Electronic Data Capture (REDCap) access, 3) from REDCap access to first patient data entry in REDCap, and 4) total duration from IRB submission to first patient data entry in REDCap. Analysis of variance and Wilcoxon rank-sum test were used to compare time durations. Of 287 sites, 188 sites (United States = 155, non-United States = 33) provided complete administrative data. There was considerable variability in duration from IRB submission to first patient data entry with median (interquartile range) of 28 days (16-50 d), with differences not significantly different by country (United States: 30 [17-50] vs non-United States: 23 d [8-46 d]; p = 0.08) or previous "multisite trial experience" (experienced: 27 [15-51] vs not experienced: 29 d [13-47 d]; p = 0.67). The U.S. sites had a higher proportion of female principal investigators (n = 77; 50%), compared with non-U.S. sites (n = 7; 21%; p = 0.002). Non-U.S. sites had a significantly shorter time to first patient data entry after REDCap access: 7 (1-28) versus 3 days (1-6 d) (p = 0.02). In this Society of Critical Care Medicine global VIRUS: COVID-19 Registry, we identified considerable variability in time from IRB submission to first patient data entry with no significant differences by country or prior multicenter trial experience. However, there was a significant difference between US and non-U.S. sites in the time from REDCap access to first data entry.

Personalized Trial Ethics and Institutional Review Board Submissions.

The ethical and regulatory oversight of any clinical activity related to human subjects is commonly determined based on its categorization as either clinical practice or research. Prominent bioethicists have criticized the traditional distinctions used to delineate these categories, calling them counterproductive and outmoded, and arguing that learning and clinical practice should be deliberately and appropriately integrated. Personalized trials represent a clinical activity with characteristics that overlap both categories, making ethical and regulatory oversight requirements less straightforward. When the primary intent of the personalized trial is to assist in the conduct of individualized patient care with an emphasis on protecting the clinical decision from the biases inherent in usual clinical practice, how should this activity be regulated? In this article, we will explore the ethical underpinnings of personalized trials and propose various approaches to meeting regulatory requirements. Instead of imposing standard research regulations on the conduct of all personalized trials, we recommend that personalized trialists and IRB panels should consider whether participation in a personalized trial results in any foreseeable incremental increase in risk to the participant compared with usual care. This approach may reduce regulatory barriers, which could promote more widespread uptake of personalized trials.

Multicenter Analysis of Genomically Targeted Single Patient Use Requests for Pediatric Neoplasms.

The US Food and Drug Administration-expanded access program (EAP) uses a single patient use (SPU) mechanism to provide patient access to investigational agents in situations where no satisfactory or comparable therapy is available. Genomic profiling of de novo and relapsed or refractory childhood cancer has led to increased identification of new drug targets in the last decade. The aim of this study is to examine the SPU experience for genomically targeted therapies in patients with pediatric cancer. All genomically targeted therapeutic SPUs obtained over a 5-year period were evaluated at four large pediatric cancer programs. Data were collected on the type of neoplasm, agents requested, corresponding molecularly informed targets, and clinical outcomes. A total of 45 SPUs in 44 patients were identified. Requests were predominantly made for CNS and solid tumors (84.4%) compared with hematologic malignancies (15.6%). Lack of an available clinical trial was the main reason for SPU initiation (64.4%). The median time from US Food and Drug Administration submission to approval was 3 days (range, 0-12 days) and from Institutional Review Board submission to approval was 5 days (range, 0-50 days). Objective tumor response was seen in 39.5% (15 of 38) of all evaluable SPUs. Disease progression was the primary reason for discontinuation of drug (66.7%) followed by toxicity (13.3%). SPU requests remain an important mechanism for pediatric access to genomically targeted agents given the limited availability of targeted clinical trials for children with high-risk neoplasms. Furthermore, this subset of SPUs resulted in a substantial number of objective tumor responses. The development of a multi-institutional data registry of SPUs may enable systematic review of toxicity and clinical outcomes and provide evidence-based access to new drugs in rare pediatric cancers.

A Grant-Based Experiment to Train Clinical Investigators: The AACR/ASCO Methods in Clinical Cancer Research Workshop.

To address the need for clinical investigators in oncology, American Association for Cancer Research (AACR) and American Society for Clinical Oncology (ASCO) established the Methods in Clinical Cancer Research Workshop (MCCRW). The workshop's objectives were to: (i) provide training in the methods, design, and conduct of clinical trials; (ii) ensure that clinical trials met federal and international ethical guidelines; (iii) evaluate the effectiveness of the workshop; and (iv) create networking opportunities for young investigators with mentoring senior faculty. Educational methods included: (i) didactic lectures, (ii) Small Group Discussion Sessions, (iii) Protocol Development Groups, and (iv) one-on-one mentoring. Learning focused on the development of an Institutional Review Board (IRB)-ready protocol, which was submitted on the last day of the workshop. Evaluation methods included: (i) pre- and postworkshop tests, (ii) students' workshop evaluations, (iii) faculty's ratings of protocol development, (iv) students' productivity in clinical research after the workshop, and (v) an independent assessment of the workshop. From 1996 to 2014, 1,932 students from diverse backgrounds attended the workshop. There was a significant improvement in the students' level of knowledge from the pre- to the postworkshop exams (P < 0.001). Across the classes, student evaluations were very favorable. At the end of the workshop, faculty rated 92% to 100% of the students' protocols as ready for IRB submission. Intermediate and long-term follow-ups indicated that more than 92% of students were actively involved in patient-related research, and 66% had implemented five or more protocols. This NCI-sponsored MCCRW has had a major impact on the training of clinicians in their ability to design and implement clinical trials in cancer research.

Differentiating research and quality improvement activities: A scoping review and implications for clinical scholarship.

Differentiating activities that are research or quality improvement (QI) is challenging. Compare tools that distinguish research from QI and evaluate the utility of tools to determine whether institutional review board (IRB) approval is required for a test-project. Scoping review of the literature to identify tools that distinguish QI from research. Two reviewers independently screened records in PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science and Google Scholar and extracted information from tools. Inclusion criteria were English language peer-reviewed publications or publicly available tools with scoring systems to differentiate between research and QI. The reporting of this review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We then applied a test-project to evaluate the utility of the tools. One-hundred forty sources were reviewed; 13 met inclusion criteria. Tools consistently used project intent/purpose, design and intervention as differentiating criteria; additional criteria varied. Five studies described tool development, and one reported that the tool had been tested. Our application of a test-project proved challenging as tools commonly presented research and QI as discrete activities. Based on the core criteria common across tools to distinguish research from QI, we propose a simple four-criteria decision tool for assessing the need for IRB submission.

Publication of Pharmacy Residency Research: A 12-Year Cohort From an Academic Medical Center

Background: Pharmacy residency programs provide research training experiences to residents, and publication is considered an indicator of high-quality research experiences. Objective: This study described attributes of pharmacy residents, residency programs, and residency major research projects and their associations with the outcome of publication in a peer-reviewed journal. Methods: Pharmacy residents who graduated from one academic medical center between 2001 and 2012 were invited to participate via an electronic survey distributed in February 2014. The survey collected attributes of the resident, residency program, and research project. The outcome of publication was self-reported by residents in 2014 and updated in July 2019 using a validated search strategy. Results: This study included 53 resident graduates representing 66 major pharmacy residency projects. Eighteen (27%) projects were published, occurring at an average of 13.8 months after residency graduation. The outcome of publication was more likely for residents with human subjects research experience prior to PGY1 training, residency programs that cultivated resident expertise in Institutional Review Board submission and statistical analysis, and projects with Institutional Review Board approval, a larger number of co-investigators, non-pharmacy co-investigators, and a larger sample size. Conclusion: This cohort of residents, programs, and projects at an academic medical center identified many modifiable attributes that were associated with successful publication of resident research projects. Unfortunately, residency projects rarely used study design features that attenuate bias. Residents and preceptors were perceived as having limited expertise with statistical analysis and database management, which underscores the need to develop research infrastructure to enhance research training for pharmacy students, residents, and preceptors.

Implementing a Review Process to Facilitate and Prioritize COVID-19 Research: Staying One Step Ahead of the Pandemic.

The first coronavirus disease 2019 (COVID-19) patient in the state of New Jersey (NJ) was admitted on March 2, 2020. With the number of hospitalized patients increasing exponentially in the following days and no established treatment approaches, research was to play a significant role in this fight. To facilitate review of all COVID-19 research proposals in a large health care network in NJ, we established the COVID-19 Research Review Committee (RRC) and implemented a peer-review process prior to the Institutional Review Board submission. The RRC was tasked with processing, soliciting, reviewing, and prioritizing research proposals and was comprised of a multidisciplinary group of reviewers. Within a 9-week period, three network-wide requests for proposals were released with 238 proposals submitted and 93 approved, an approval rate of 39%. The establishment of the RRC helped ensure scientific merit, better utilization of resources, collaborations across disciplines and network hospitals, and compliance with applicable regulatory and ethical standard.

Expanding pharmacy resident research capacity through integration of introductory pharmacy practice experience students into a prospective research study: A novel application of the layered learning practice model

AbstractIntroductionResearch and quality improvement projects are routine in contemporary pharmacy practice and are valuable components of experiential training for pharmacy students. There are descriptions of the layered learning practice model (LLPM) for expanding direct patient care activities, but its application in clinical research has not been described in the literature.ObjectivesThis case study provides a description of the novel integration of introductory pharmacy practice experience (IPPE) students into a prospective research study led by a pharmacy resident to expand screening, enrollment, and data collection capacity.MethodsIPPE students were integrated into a prospective, observational study evaluating the effect of time to restart of prior to admission psychotropic medications on the development of intensive care unit (ICU) delirium. Using the LLPM, attending pharmacist preceptors mentored the pharmacy resident, who then assumed the primary preceptor role for three IPPE students. Students were integrated into project activities including institutional review board submission, data collection, and data analysis. Study data were collected and managed using Research Electronic Data Capture (REDcap). Student contributions to longitudinal research activities were quantified using descriptive statistics.ResultsThere were 487 patients screened for study enrollment, and 112 patients were included in the study. Research team members completed 890 ICU delirium screenings using the Confusion Assessment Method for the ICU (CAM‐ICU) tool and inputted 243 prospective medication reconciliations. Collectively, the students, resident, and pharmacist preceptors completed 48.6%, 38.7%, and 12.7% of CAM‐ICU assessments, respectively. This study was associated with increased opportunities for pharmacy resident‐led and student‐led scholarly activities.ConclusionThe integration of IPPE students into a prospective research study was successful in using the LLPM in expanding resident research capacity while being mutually beneficial to the pharmacy students and residents.

The effect of the coronavirus disease 2019 lockdown on type A acute aortic dissection: Insights from Bologna.

This document is intended to provide an overview of the incidence and characteristics of acute type A aortic dissection in Bologna during the month of severe restrictions imposed by the National Italian government due to COVID-19 pandemic. Aspects on management and time to intervention are outlined.

Evaluation of a University's Institutional Review Board Based on Campus Feedback: A Cross-Sectional Study.

IntroductionMaintaining research ethics within a university and monitoring the campus Institutional Review Board (IRB) are essential responsibilities not to be taken lightly. IRBs occasionally need to be reviewed to see that they, as well as researchers, are adhering to rules and regulations on ethics through their submission and review procedures. Since there are no established measures for assessing IRB quality, it is unclear how to determine whether IRBs are achieving their intended aims. This study used the feedback and input of campus members at a newly-established, private, non-profit university within the Kingdom of Saudi Arabia (KSA) to evaluate their campus IRB.MethodsFollowing the university’s IRB approval, and in close collaboration with the Saudi National Committee of Bioethics (NCBE), this cross-sectional study was conducted from February through May of 2019. Self-administered surveys were sent out via university emails to faculty and students at Alfaisal University in Riyadh of Saudi Arabia. The questions in the surveys included inquiries on participants’ demographics, their familiarity with campus IRB research ethics, their satisfaction with IRB procedures, the challenges encountered during the IRB submission and review process, the effectiveness of a recent IRB-coordinated research ethics campaign, and any suggestions for IRB improvement. Surveys were sent to faculty members and students at five colleges on campus.ResultsOf the campus members who were sent surveys, 8% responded (175). Of those who responded, 29.7% had submitted at least one research proposal for IRB review during the past three years (2016-2019), and more than half of this group were satisfied with the IRB submission and review procedures. For those who had submitted at least one research proposal, respondents reported the more usual challenges that researchers tend to encounter, such as time-consuming and tedious IRB review processes and ambiguous IRB guidelines and regulations. The less typical IRB challenges that were reported, and that are unique to academia, include the IRB tendency to deny undergraduate student requests to serve as principal investigators of their research projects. Concerning IRB efforts to educate and train campus members on research ethics, only 26.3% of the participants were aware of the recently performed research ethics campaign, and 7.6% of the participants attended the end-of-campaign workshop. Of those who attended the workshop, 76.9% reported that the campaign and workshop effectively met their expectations.Conclusions This study revealed several issues encountered by university faculty and students seeking campus IRB approval for their research projects. The main academia-specific challenge was over whether undergraduate students could serve as PIs for research projects, and a universal one was that they find the IRB process to be very time-consuming and tedious, which is a situation that has already been relayed in several other articles on IRB issues. About two-thirds of respondents reported a lack of familiarity with the topic of research ethics. This challenge makes it clear that information on research ethics is not effectively reaching enough campus members in the busy environment of academia.

Innovation in Education Research: Creation of an Education Research Core.

Within academic medical centers, there is increasing interest among physicians to pursue education as a promotion pathway. Many medical schools and universities offer professional development opportunities for these individuals such as workshops and certificate and advanced degree programs. However, there exists a need for a more personalized support for clinician-educators to be successful in educational scholarship in the health care setting. In 2017, a departmental level educational research community was established within Anesthesiology and Critical Care Medicine at Johns Hopkins University to support faculty, staff, and trainees in creating, completing, and publishing educational scholarship. The research infrastructure includes administrative and institutional review board submission assistance, internal grant support, database management, statistical analysis, and consultation with professional educators. Also, integral to the education core is monthly education lab meetings that allow an opportunity for education researchers to present work in progress, conceive new projects, discuss relevant literature, and cultivate and sustain a community of educational scholars.This innovation in education demonstrates feasibility at a departmental level to successfully support educational research. We have initiated education meetings with a cohort of core education faculty who are interested in an educational promotion track. We present several metrics that can be used to evaluate the effectiveness of the programs similar to this innovation.

Implementing a Central IRB Model in a Multicenter Research Network.

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.

Use of single IRBs for multi-site studies: A case report and commentary from a National Drug Abuse Treatment Clinical Trials Network study.

Recent NIH policy stipulates that multi-site studies must use a single or IRB (Institutional Review Board) in order to streamline the review process while maintaining standards for human subjects protection. The Western States Node of the Clinical Trials Network (CTN) used a single IRB for protocol CTN-0067, a clinical trial testing the use of an opioid antagonist (extended-release naltrexone) versus opioid agonists (buprenorphine or methadone) for opioid use disorders among individuals living with HIV. This case study discusses the processes and challenges associated with use of a single IRB. These lessons are also informed by other single IRB experiences within the CTN. The intention of the NIH single IRB policy is to facilitate efficient IRB processes. Advanced planning and transparent communication, however, are critical to avoid stalling IRB approval and protocol implementation. Research teams need to account for local IRB willingness to cede to a single IRB and understand the variations in interpretations of abbreviated reviews. In order to facilitate the effective use of single IRBs, recommendations include assigning staff at each study site for IRB submission coordination and interaction with the lead site IRB staff, training investigators and key regulatory staff on expectations for working with single IRBs, dedicating a regulatory specialist at the lead site to manage the process, developing a communication plan, and supporting the development of strong working relationships with local regulatory staff and the single IRB. The CTN experiences with single IRBs may provide insights for other investigators.

A Collaborative Multidisciplinary and Without-Walls Research Curriculum in Global Health.

Longitudinal and collaborative global health research curricula to train a well-versed global health corps through skills building in assessment and evaluation are lacking. A without-walls research curriculum was offered to medical and public health students between 2007 and 2015. Mentored cross-disciplinary research projects were developed and implemented in partnership with communities. A multilevel mixed methods design, including semi-structured interviews, post-curriculum surveys, presentations, publications, postgraduation metrics, and feedback from project sites, evaluated educational outcomes. Students (N = 25; aged 27 ± 1.9 years; 90.5% female) participated in the studies in 12 countries, resulting in 26 national-level presentations and 24 peer-reviewed publications, including per student average and range of Institutional Review Board submission (0.95; 0-3), poster presentation (0.85; 0-3), oral presentation (0.65; 0-2), and peer-reviewed submission (1.05; 0-4). On average, the studies (40% mixed methods) lasted 2 years. Analyses and manuscript writing were the most challenging; data collection and presentations were the most rewarding. Majority of the participants strongly agreed with achieving skills in community engagement, interviewing techniques, research design and implementation, research dissemination, and career development. Interview themes included expectations and learning goals, effective mentorship, impact on career goals, and ethical learning. Mentorship qualities were accessibility, real-time problem solving, research expertise, advocate, and balancing guidance with independence. Project sites' feedback was overwhelmingly positive regarding the projects' impact. Postgraduation participants hold positions in humanitarian organizations, research programs serving the underserved, and primary care residencies, fellowships, and faculty. This experience illustrates the feasibility and effectiveness of mentored global health research and underlines the crucial link between community collaboration and scholarship for effective global health practice.

The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network-initiated clinical trials.

Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. While time required for actual institutional review board submission's review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7-24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health's goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

Institutional Review Board Basics for Pedagogy Research

The institutional review board (IRB) process is often protracted and can be a source of frustration, especially when you want your research and publications to move apace. However, because of historical events, the IRB is an important requirement for conducting research with human participants and is regulated by federal oversite. When conducting research as part of a pedagogical study, it is important to identify which level of IRB review (exempt, expedited, or full board) is required. The purpose of this article is to highlight IRB basics within the United States for pedagogy research. Although there are guidelines internationally, this article specifically focuses on U.S. IRBs, including a brief history of the IRB, pedagogical and community-based participatory research, IRB review, tips for IRB submissions, and example case studies.

Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience.

We examined the Institutional Review Board (IRB) process at 9 academic institutions in the electronic Medical Records and Genomics (eMERGE) Network, for proposed electronic health record-based genomic medicine studies, to identify common questions and concerns. Sequencing of 109 disease related genes and genotyping of 14 actionable variants is being performed in ~28,100 participants from the 9 sites. Pathogenic/likely pathogenic variants in actionable genes are being returned to study participants. We examined each site’s research protocols, informed-consent materials, and interactions with IRB staff. Research staff at each site completed questionnaires regarding their IRB interactions. The time to prepare protocols for IRB submission, number of revisions and time to approval ranged from 10–261 days, 0–11, and 11–90 days, respectively. IRB recommendations related to the readability of informed consent materials, specifying the full range of potential risks, providing options for receiving limited results or withdrawal, sharing of information with family members, and establishing the mechanisms to answer participant questions. IRBs reviewing studies that involve the return of results from genomic sequencing have a diverse array of concerns, and anticipating these concerns can help investigators to more effectively engage IRBs.