Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years

This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate. Of 396 protocols submitted, 98% were approved. Mean protocol review time decreased from 23 to 15 calendar days, 344 serious adverse events SAEs were reviewed, and 93 conflicts of interest (COIs) were disclosed. IRB quality and efficiency mechanisms improved. Remaining needs include increased monitoring of COIs and unanticipated problem involving risks to subjects or others, distinctions between research types, and cooperation with specialized committees.

Suboccipital craniectomy with bilateral cerebellomedullary fissure dissection for resection of a ruptured tonsillar/vermian AVM occupying the roof of the fourth ventricle in a pregnant patient

Posterior fossa arteriovenous malformations (AVMs) in pregnant patients can present unique considerations for surgical treatment, including positioning to minimize pressure on the fetus, minimization of radiation exposure, and ethical considerations regarding emergency surgery. This video outlines surgical treatment of a ruptured tonsillar/vermian AVM performed in a staged fashion after emergent suboccipital craniotomy with posterior fossa decompression in the setting of a life-threatening infratentorial hemorrhage. Later, bilateral cerebellomedullary fissure dissection, exposure and dissection of the tela choroidea and inferior medullary velum, and disconnection of arterial feeders from the posterior inferior cerebellar artery (PICA) allowed resection of this AVM occupying the roof of the fourth ventricle.This study was approved by the UCSF Human Research Protection Program IRB no. 18-26938.The video can be found here: https://youtu.be/rTYUGanopUEhttps://thejns.org/doi/abs/10.3171/2020.10.FOCVID2059

Development proposals of Human Research Protection Program

Background: China’s ethics committees alone are unable to meet the growing need for human participant protection. Several scandals in recent years indicate weaknesses in the protection of human participants in China. Objectives: The aim of the study is to summarize the status and problems of human research protection program in China and to explore its establishment proposals at national and hospital levels. Research design: To conduct literature retrieval, Chinese National Knowledge Infrastructure, Chinese Biomedical Document Database, and English databases Web of Science and PubMed were searched; laws, guidelines, and regulations were also searched on web by Google and Chinese search engine Baidu. Ethical considerations: No data were collected from human participants, and ethical review was not required. Findings: There are problems for China’s Human Research Protection Program, such as weak relevant legal systems, insufficient administrative supervision, and incompetent ethics committee capacities. To fully protect human participants, China should promote the development of Human Research Protection Program, which can formulate ethics-related laws, improve regulations for the protection of the safety and rights of human participants, strengthen supervision, and enforce compensation for human participants. Owing to the frequency with which human participants are recruited in hospitals in China, hospitals can utilize existing ethics committees and establish data and safety monitoring committees, quality control, fund and contract management, and conflict of interest management offices. Discussion: As a growing program, it remains necessary to learn from the experience of developed countries with high ethics standards and reformulate them to fit China’s conditions to explore potential future development. The program will also be an experience for other developing countries. Conclusion: Human Research Protection Program can strengthen communication and coordination among various hospital departments to effectively protect the rights and welfare of human participants.

The Blind Review: A quality assessment measure for review standardization of Institutional Review Boards

Background: As multinational trials are increasing, standardization of IRB review has become increasingly important. Though inconsistency is often inevitable due to varying opinions on ethics, standardization and understanding the differences are required to ensure IRB review quality. Thus, we aimed to develop and suggest a quality assessment measure of IRB named “blind review” by reviewing the same research protocols by multiple IRB panels. We further describe an analysis of differences to understand the mechanism of IRB standardization. Methods: Based on the HRPP (Human research Protection Program) SOPs (Standard of Procedure), eight blind review results from January 2010 to December 2018, at a single institution with multiple panels, were included using the Severance Hospital HRPP database. Review results were analyzed with review scores ranging from 0 to 60 points, including good clinical practice (GCP) requirements and protocol issues. Panel agreement was estimated by observed multiple rater agreement. Differences between review scores according to member expertise and IRB member duration were analyzed with the Wilcoxon rank-sum test and Kruskal-Wallis test. Results: Observed multiple raters’ agreement increased from 0.444 (95% CI: 0.167-1.000) in 2010 to 0.479 (95% CI: 0.271-0.708) in 2014~2018 as IRB review experiences increased. In order to analyze the review mechanism, three GCP requirements and three protocol issues were scored (range 0 to 60). Mean values for GCP requirements and protocol issues were 19.25±8.21 and 18.40±9.04, respectively. Mean score of the panels where experts participated (n=16, 28.13±10.47) was higher than the control group (n=32, 25.16±10.96) (p=0.93). According to IRB members’ experience, scores for the group whose career spanned less than 3 years was 25.0±10.0 (n=14), those whose career spanned 3-5 years was 26.3±9.6 (n=23), and those whose career spanned more than 5 years was 27.3±14.2 (n=11). These results were statistically significant (p=0.09). Conclusions: We suggest blind review as an effective measure for overseeing and ensuring IRB review quality and overall GCP compliance.

The Blind Review: A Quality Assessment Measure for Review Standardization of Institutional Review Boards

Background: Challenging research environment while the multinational trials are increasing, standardization of IRB review has become more important. The inconsistency is often inevitable in that opinions on the ethical part may be different, but the standardization and understanding the differences is required to assure IRB review quality. Thus, we aimed to develop and suggest quality assessment measure of IRB named “Blind review” by reviewing the same research protocols by multiple IRB panels. We further describe an analyzed result of differences to understand the mechanism of IRB standardization.Methods: We present a description of the Blind review process. Based on the HRPP (Human research Protection Program) SOPs (Standard of Procedure), eight blind review results from January 2010 to December 2018 at a single institution with multiple panels were included using Severance Hospital HRPP database. Review results were analyzed with review scores ranged 0 to 60 points including GCP requirements and protocol issues. Panel agreement was estimated by observed multiple rater agreement. Differences between review scores according to expertise member and IRB member duration were analysed with Wilcoxon rank-sum test and Kruskal-Wallis test.Results: Observed multiple raters’ agreement was increased from 0.444 (95% CI: 0.167-1.000) in 2010 to 0.479 (95% CI: 0.271-0.708) in 2014~2018 as IRB review experiences increases. In order to analyze the review mechanism, three GCP requirements and three protocol issues were scored (range 0 to 60). Mean values for GCP requirement and protocol issues were 19.25±8.21 and 18.40±9.04, respectively. Mean score of the panels where experts participated (n=16, 28.13±10.47) is higher than control group (n=32, 25.16±10.96) (p=0.93). According to career duration of IRB members’, scores of the group whose career is less than 3 years was 25.0±10.0 (n=14), the score of group whose career is 3-5 years was 26.3±9.6 (n=23). The mean score of the group whose career was more than 5 years shown 27.3±14.2 (n=11), and it is statistically significant. (p=0.09)Conclusions: We suggest Blind Review as an effective measure for overseeing and ensuring IRB’s review quality and overall GCP compliance.

Maintenance motives for physical activity among older adults: a protocol for a systematic review and meta-analysis

IntroductionPhysical activity (PA) is an important aspect for health and well-being, yet many older adults do not maintain their PA long term. The identification of key factors that are associated with, and likely causally related to, older adults’ PA maintenance is a crucial first step towards developing programmes that are effective at promoting long-term PA behaviour change. The purpose of this protocol is to outline a systematic review that will examine the relationship between four motives (ie, satisfaction, enjoyment, self-determination and identity) and older adults’ PA maintenance.Methods and analysisStudies that investigated PA maintenance with a sample mean age ≥55 years will be included. Five electronic databases (PubMed, Cumulative Index to Nursing and Allied Health Literature, SPORTDiscus, PsycINFO and ProQuest Dissertations and Theses) were searched on 6 April 2018 with no publication date limit (ie, from inception). One reviewer screened 100% of titles and abstracts (k=21 470) while a random subsample (20%) was screened independently by two reviewers. An update of the search was run on 1 October 2019. All studies for which the full text was retrieved will be independently screened by two reviewers. Data pertaining to study sample, design, motives, PA (eg, measurement validity evidence, study definition of maintenance) and essential bias domains (eg, bias due to missing data) will be extracted. Study-level effect sizes will be calculated, and if the number of studies is ≥5, a random-effects meta-analysis will be performed using inverse-variance methods; a narrative synthesis will be performed otherwise.Ethics and disseminationThe university’s Human Research Protection Program determined that the proposed study qualifies as exempt from the Institutional Review Board review under Exemption Category 4 (PROPEL #: 80047007). Results will be published in a peer-review journal, and the findings will help inform future interventions with older adults.PROSPERO registration numberCRD42018088161.

Enhancing Graduate Practicum Project Development and Selection at Schools of Public Health: A Case Study

Experiential learning is a core competency of curricula across accredited U.S. schools of public health, helping students to hone diverse skill sets that will enable them to readily join the workforce and contribute to solving complex public health problems. At the City University of New York (CUNY) Graduate School of Public Health and Health Policy (SPH), all master’s and doctoral students are required to complete a practicum during their degree programs; yet practicum development and selection processes are often overlooked. To enhance the experiential learning program and Human Research Protection Program processes surrounding student practica at the CUNY SPH, researchers mined an administrative database and analyzed characteristics of practicum projects undertaken by graduate students. Findings from this novel study will facilitate policy and procedural changes within the SPH Office of Experiential Learning, which oversees the practicum program, and across SPH offices, including the Human Research Protection Program, to promote an optimal, student-centered practicum experience. Additionally, these analyses will serve as a model for other schools of public health seeking to develop, refine, and strengthen their practicum programs.

Improving Compliance With Institutional Review Board Continuing Review Requirements

Continuing review of ongoing research is one way by which institutional review boards (IRBs) ensure protection of human subjects. Among the 25 Department of Veterans Affairs (VA) human research protection program performance metrics collected annually since 2010, lapse in IRB continuing reviews had the highest noncompliance rate. In 2013, 10 facilities with lapse rates higher than the VA national average for 3 consecutive years from 2011 to 2013 implemented remedial action plans. Using data from 2011 through 2018, we demonstrated that 70% of these facilities’ lapse rates remain significantly improved. In contrast, none of the 10 facilities with their lapse rates that were higher than the national averages in 2 out of 3 years from 2011 to 2013 and that did not implement remedial action plans showed any improvement. Thus, implementation of effective remedial measures in facilities with high lapse rates can result in long-lasting improvement in the majority of these facilities.

Assessing the Quality and Performance of Human Research Protection Programs to Guide Compliance Oversight Activities

Routine on-site reviews should focus primarily on facilities that are at risk of harming human subjects. Using human research protection program performance metric data from 107 facilities, we defined a facility to be at risk when one of its noncompliance/incident rates was among the top three highest rates of that performance metric. Based on 14 performance metrics with noncompliance and incidents in 2017, 27 facilities were identified to be at risk. These 27 facilities at risk, while constituting only 25% of all facilities, contributed to 70% ± 25% ( M ± SD; range = 32%-100%) of all reported noncompliance/incidents. Thus, performance metric data can be used to guide compliance oversight activities.