scholarly journals A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials

Children ◽  
2015 ◽  
Vol 2 (2) ◽  
pp. 198-210 ◽  
Author(s):  
Klaus Rose ◽  
Hans Kummer
Keyword(s):  
Clinical Trials ◽  
Ethics Committees ◽  
Ethical Challenge ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

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

2018 ◽  
Vol 16 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michael P Diamond ◽  
Esther Eisenberg ◽  
Hao Huang ◽  
Christos Coutifaris ◽  
Richard S Legro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Child Health ◽  
Clinical Research ◽  
Human Development ◽  
Reproductive Medicine ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
Review Boards

Background/aims: 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. Methods: 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. Results: 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. Conclusion: 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.

scholarly journals Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e050413
Author(s):  
Ning Sun ◽  
Dong-Mei He ◽  
Xiangyin Ye ◽  
Lei Bin ◽  
Yuanfang Zhou ◽  
...  
Keyword(s):  
Pain Relief ◽  
Gallstone Disease ◽  
Ethics Committees ◽  
Acupuncture Group ◽  
Biliary Colic ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Ethical Approval ◽  
Randomised Controlled ◽  
Review Boards

IntroductionAs the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity.Methods and analysisThis is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients’ BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral–cerebral functional changes.Ethics and disseminationThis trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People’s Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters.Trial registration numberCTR2000034432.

scholarly journals Informed Consent and Approval by Institutional Review Boards in Published Reports on Clinical Trials

1999 ◽  
Vol 340 (14) ◽  
pp. 1114-1115 ◽  
Author(s):  
Miguel Ruiz-Canela ◽  
Miguel Ángel Martínez-González ◽  
Enrique Gómez-Gracia ◽  
Joaquín Fernández-Crehuet
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

Evaluation of Serious Adverse Event Reporting Forms for Clinical Trials: A Comparative Korean Study

2020 ◽  
Vol 15 (5) ◽  
pp. 415-424
Author(s):  
Heeyoung Lee ◽  
Cholong Park ◽  
Jinwon Choi ◽  
Seongeun Jeong ◽  
Hyunin Cho ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ethics Committees ◽  
Well Being ◽  
Adverse Event Reporting ◽  
Institutional Review Boards ◽  
Serious Adverse Events ◽  
Institutional Review ◽  
Current Content ◽  
Korean Study ◽  
Human Participants

Safety surveillance, using appropriately consistent review criteria, could improve human participants’ well-being in clinical trials. To establish a globally consistent framework, the quality of the current content for review by institutional review boards (IRBs), as mandatory oversight entities, requires evaluation. This study collected and analyzed forms reporting serious adverse events (SAEs) to IRBs/ Research Ethics Committees(RECs) to compare them with the well-structured form presented in the literature using completeness and accuracy scores. We found sub-optimal completeness and accuracy scores when compared with perfect scores ( p < .05). Less than half of the retrieved forms had queries on causality assessment (≤43.1%). Thus, contents of SAE forms require improvement for IRB oversight and, further, there is a need to develop a well-structured form that could improve international consistency.

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