The IRB structure and medical research reform

Babyar, Julie

doi:10.1186/s40169-018-0188-3

Cited by 6 publications

(3 citation statements)

References 6 publications

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“…Thus, clinical lipidomics is the utmost approach to evaluate the variation of lipids at a molecular level in several chronic diseases, including AID [ 91 ]. The aim of clinical lipidomics is to understand lipid metabolism and mechanisms and identify new putative diagnostic biomarkers and therapeutic targets [ 92 ]. Clinical lipidomics is a reliable source of information regarding lipidic alterations and, hopefully, it can be seen as a promising approach to disease diagnostics and therapy monitorization in the near future.…”

Section: Lipidomic Studies In Rheumatoid Arthritismentioning

confidence: 99%

Insights in the Role of Lipids, Oxidative Stress and Inflammation in Rheumatoid Arthritis Unveiled by New Trends in Lipidomic Investigations

et al. 2021

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Rheumatoid arthritis (RA) is a highly debilitating chronic inflammatory autoimmune disease most prevalent in women. The true etiology of this disease is complex, multifactorial, and is yet to be completely elucidated. However, oxidative stress and lipid peroxidation are associated with the development and pathogenesis of RA. In this case, oxidative damage biomarkers have been found to be significantly higher in RA patients, associated with the oxidation of biomolecules and the stimulation of inflammatory responses. Lipid peroxidation is one of the major consequences of oxidative stress, with the formation of deleterious lipid hydroperoxides and electrophilic reactive lipid species. Additionally, changes in the lipoprotein profile seem to be common in RA, contributing to cardiovascular diseases and a chronic inflammatory environment. Nevertheless, changes in the lipid profile at a molecular level in RA are still poorly understood. Therefore, the goal of this review was to gather all the information regarding lipid alterations in RA analyzed by mass spectrometry. Studies on the variation of lipid profile in RA using lipidomics showed that fatty acid and phospholipid metabolisms, especially in phosphatidylcholine and phosphatidylethanolamine, are affected in this disease. These promising results could lead to the discovery of new diagnostic lipid biomarkers for early diagnosis of RA and targets for personalized medicine.

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Section: Lipidomic Studies In Rheumatoid Arthritismentioning

confidence: 99%

Insights in the Role of Lipids, Oxidative Stress and Inflammation in Rheumatoid Arthritis Unveiled by New Trends in Lipidomic Investigations

et al. 2021

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“…Institutional review boards (IRBs), and local ethics committees (LEC), the latter also known as research ethics committees (RECs), are official bodies that work to safeguard research participants and ensure their rights, safety and well-being throughout research that involves human subjects [ 1 , 2 ]. Another important role of IRBs is to ensure that approved research are scientifically sound yet protecting the dignity and confidentiality of the participants [ 3 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations

et al. 2023

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Background Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. Conclusion Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

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“…Institutional Review Boards (IRBs) are an essential aspect of ethical medical research in the United States as they are responsible for the careful review of study protocols [ 2 , 10 ]. This review process involves many members of diverse working backgrounds to ensure a broad perspective [ 1 ]. In addition to the requirement that study review is overseen by an IRB, the National Cancer Institute requires NCI-designated cancer centers utilize a local institutional scientific review process as well [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Bolstering the complex study start-up process at NCI cancer centers using technology

Mudaranthakam¹,

Pepper²,

Alsup³

et al. 2022

Contemporary Clinical Trials Communications

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The IRB structure and medical research reform

Cited by 6 publications

References 6 publications

Insights in the Role of Lipids, Oxidative Stress and Inflammation in Rheumatoid Arthritis Unveiled by New Trends in Lipidomic Investigations

Insights in the Role of Lipids, Oxidative Stress and Inflammation in Rheumatoid Arthritis Unveiled by New Trends in Lipidomic Investigations

Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations

Bolstering the complex study start-up process at NCI cancer centers using technology

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