scholarly journals Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Guillaume Marquis-Gravel ◽  
Holly Robertson ◽  
W. Schuyler Jones ◽  
Danielle Riley ◽  
Daniel E. Ford ◽  
...  
Keyword(s):  
Informed Consent ◽  
Patient Engagement ◽  
Randomized Clinical Trials ◽  
Lessons Learned ◽  
Institutional Review Board ◽  
Ethical Review ◽  
Atherosclerotic Cardiovascular Disease ◽  
Institutional Review ◽  
Patient Centric

Abstract Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic “Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)” randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. Main text ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. Conclusion Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.

scholarly journals Institutional Review Board (IRB): its role and responsibility in making research ethical

2014 ◽  
Vol 5 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Abu Sadat Mohammad Nurunnabi
Keyword(s):  
Institutional Review Board ◽  
Educational Activity ◽  
Systemic Review ◽  
Ethical Review ◽  
Institutional Research ◽  
Journal Articles ◽  
Research Strategies ◽  
Ethical Research ◽  
Roles And Responsibilities ◽  
Institutional Review

This is a review article prepared as a part of the assignment in the educational activity and training on research ethics titled “Ethical and Regulatory Aspects of Clinical Research” arranged by the Bangladesh Bioethics Society (BBS), Dhaka, Bangladesh, in collaboration with the Department of Bioethics of National Institutes of Health (NIH), Bethesda, Maryland, USA, through video conferencing between September 25 and November 13 of 2013. The search was confined to ‘Google’, ‘HINARI’ and ‘PubMed’ published articles. Besides, some guidelines on roles and responsibilities of Institutional Review Board (IRB) were taken into consideration. Key words used for searching were ‘institutional review board’, ‘ethical review committee’ and ‘ethical research’. A total of 18 journal articles and some guidelines were selected for this writing. The systemic review from the databases revealed some important discussions on research, ethical research, roles and responsibilities of IRB/ERC and its challenges, and national/institutional research strategies. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18442 Bangladesh Journal of Bioethics 2014 Vol.5(1): 5-10

scholarly journals Suitability of Placental Blood Samples of Newborns for Pre-Transfusion Testing

2021 ◽  
Vol 9 ◽  
Author(s):  
Rana Alissa ◽  
Patty D. Williams ◽  
Erika L. Baker ◽  
Jennifer A. Hipp ◽  
Jinous Saremian ◽  
...  
Keyword(s):  
Informed Consent ◽  
Categorical Data ◽  
Institutional Review Board ◽  
Abo Blood Group ◽  
Blood Samples ◽  
Rhesus Factor ◽  
Institutional Review ◽  
Antiglobulin Test ◽  
Placental Blood ◽  
Antibody Screen

Objective: To show concordance between heel stick and placental blood sample pairs for newborns' pre-transfusion testing and to validate placental blood's tube and gel methodology.Methods: Placental samples were collected for pre-transfusion testing at birth from 78 singleton and twin newborns admitted to our Mother–Baby Unit to compare with the results of heel stick samples taken from same newborns. Gestational age ≥35 weeks, weight ≥2,000 g. The study was approved by the Institutional Review Board (IRB). Informed consent was obtained from newborn parents. ABO blood group, Rhesus factor (Rh), direct antiglobulin test (DAT), and antibody screen were performed. Ortho ProVue Analyzer was used for tube and gel methods. McNemar's test for paired categorical data was performed.Results: One hundred percent concordance in 78 pairs for ABO and Rh. Seventy-four pairs were tested for antibodies, 72 were both negative, 1 was both positive, and 1 gave discordant result. Ninety-nine percent concordance, p = 0.999. Sixty-five pairs were both DAT negative, seven were both DAT positive, and six gave discordant results. Ninety-two percent concordance, p = 0.68. Placental blood gave identical results comparing tube with gel methods.Conclusions: Placental blood is suitable for pre-transfusion testing and can replace heel sticks. Placental blood tube and gel methods are validated.

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