The Cost of Institutional Review Board Procedures in Multicenter Observational Research

2003 ◽  
Vol 139 (1) ◽  
pp. 77 ◽  
Author(s):  
Keith Humphreys ◽  
Jodie Trafton ◽  
Todd H. Wagner
10.2196/22302 ◽  
2020 ◽  
Vol 22 (11) ◽  
pp. e22302
Author(s):  
Kenta Yagi ◽  
Kazuki Maeda ◽  
Satoshi Sakaguchi ◽  
Masayuki Chuma ◽  
Yasutaka Sato ◽  
...  

Background With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet. Objective This study aimed to elucidate the current status of IRB meetings conducted through web conference systems. Methods A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial. Results The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings. Conclusions Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members’ screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.


BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038084
Author(s):  
Rita Bosetti ◽  
Laila Tabatabai ◽  
George Naufal ◽  
Rosbel Brito ◽  
Bita Kash

IntroductionType 2 diabetes prevalence is increasing in the USA, especially in underserved populations. Patient outcomes can be improved by providing access to specialty care within Federally Qualified Health Centers, possibly improving the cost-effectiveness of diabetes care.Methods and analysisA new model of diabetes care based on multidisciplinary teams of clinical fellows, supported by an endocrinologist for underserved adult populations, is presented. The study uses a retrospective, non-randomised cohort of patients with diabetes who visited the community clinic between 1 January 2012 and 31 December 2018. A quasi-experimental method to analyse the causal evidence of the effect of the new model is presented. Discontinuity regression is used to compare two interventions, the intervention by a Clinical Fellow Endocrinology Programme and usual care by a primary care physician. Patients are referred to the Clinical Fellow Endocrinology Programme in case of uncontrolled diabetes (glycated haemoglobin (HbA1c)≥9%). The regression discontinuity design allows the construction of a treatment group for patients with an HbA1c equal or above the threshold in comparison with a control group for patients with an HbA1c below the threshold. The patient outcomes and cost-effectiveness of the new model are analysed. Regression models will be used to assess the differences between treatment and control groups.Ethics and disseminationQuantitative patient data are received by the study team in a de-identified format for analysis via an institutional review board-approved protocol. The quantitative study has been approved by the Houston Methodist Research Institute Institutional Review Board, Houston, Texas, USA. Anticipated results will not only provide evidence about the impact of patient outcomes in underserved diabetic populations, but also give an idea of the cost-effectiveness of the new model and whether or not cost savings can be attained for patients, third-party payers and society. The results will help set up evidence-based policy guidelines in diabetes care. Results will be disseminated through papers, conferences and public health/policy fora.


2018 ◽  
Vol 44 (6) ◽  
pp. 392-396 ◽  
Author(s):  
Angela Ballantyne ◽  
G Owen Schaefer

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency.


2020 ◽  
Author(s):  
Kenta Yagi ◽  
Kazuki Maeda ◽  
Satoshi Sakaguchi ◽  
Masayuki Chuma ◽  
Yasutaka Sato ◽  
...  

BACKGROUND With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet. OBJECTIVE This study aimed to elucidate the current status of IRB meetings conducted through web conference systems. METHODS A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial. RESULTS The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings. CONCLUSIONS Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members’ screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.


2020 ◽  
Author(s):  
Amy M Smith Slep ◽  
Richard E Heyman ◽  
Michael F Lorber ◽  
David J Linkh

Abstract Introduction We evaluated the effectiveness of New Orientation for Reducing Threats to Health from Secretive-problems That Affect Readiness (NORTH STAR), a community assessment, planning, and action framework to reduce the prevalence of suicidality, substance problems, intimate partner violence, and child abuse. Materials and Methods One-third of U.S. Air Force bases worldwide were randomly assigned to NORTH STAR (n = 12) or an assessment-and-feedback-only condition (n = 12). Two Air Force-wide, cross-sectional, anonymous, web-based surveys were conducted of randomly selected samples assessing risk/protective factors and outcomes. This study was reviewed and approved by the institutional review board at the investigators’ university and by the institutional review board at Fort Detrick. Results NORTH STAR, relative to control, bases experienced a 33% absolute risk reduction in hazardous drinking rates and cumulative risk, although, given the small number of bases, these effects were not statistically significant. Conclusions Given its relatively low cost, use of empirically supported light-touch interventions, and emphasis on sustainability with existing resources, NORTH STAR may be a useful system for prevention of a range of adult behavioral health problems that are difficult to impact.


2021 ◽  
Vol 12 ◽  
pp. 215013272110229
Author(s):  
Mostafa Abohelwa ◽  
Mohamed Elmassry ◽  
John Abdelmalek ◽  
Drew Payne ◽  
Kenneth Nugent

Background Coronavirus-2 (COVID-19) has caused a worldwide pandemic since December 2019. Since then, clinical trials with vaccines have been started and completed, and at present, 3 COVID-19 vaccines have been approved for use in the United States. Healthcare providers were among the first to get vaccinated, but the precise attitudes of healthcare workers toward vaccination are uncertain. Objective To understand residents and fellows’ attitudes toward vaccination and record any side effects after vaccination. Methods We conducted an anonymous survey that was open from 3-1-2021 to 3-12-2021 using distribution lists from the Graduate Medical Education office on the Lubbock campus of the Texas Tech University Health Sciences Center after getting approval from the Institutional Review Board (L21-088). Results Eighty-one residents and fellows (26.6% out of 304) responded to our survey. Among those who responded, 63 (77.8 %) were between 25 and 35 years old, and 41 (50.6%) were males. Seventy-seven (95.1%) received the vaccine (Pfizer-BioNTech), 78 (96.3%) reported that they supported vaccination, and 3 (3.7%) reported that they did not want vaccination. Eight members (9.8%) had tested positive for COVID-19 infection before vaccination, but only 1 (1.23%) had tested positive for COVID-19 antibodies. All residents and fellows reported side effects after the vaccination, including pain at the injection site (77; 100%), local redness (9; 11.6%), local swelling (13; 16.8%), fever (25; 32.5%), fatigue (25; 32.5%), chills (34; 44.1 %), headache (38; 49.4%). Conclusions Most medical trainees have a high interest in COVID-19 vaccination; however, a few reported that they did not want vaccination.


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