Research ethics committee decision-making in relation to an efficient neonatal trial

Archives of Disease in Childhood: Fetal and Neonatal Edition

Volumn 102, Issue 4, 2017, Pages F291-F298

  Gale, C ^a   Hyde, M J ^a   Modi, N ^a  

^a CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

Author keywords

Electronic Health Records; Ethics Committees, Research; Ethics, Research; Informed Consent; Intensive Care, Neonatal

Indexed keywords

ARTICLE; BLOOD TRANSFUSION; CLINICAL PRACTICE; DECISION MAKING; ELECTRONIC PATIENT RECORD; GOLD STANDARD; HUMAN; METHODOLOGY; NEWBORN CARE; OUTCOMES RESEARCH; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; BLOOD SAMPLING; COMPARATIVE EFFECTIVENESS; ERYTHROCYTE TRANSFUSION; ETHICS; INFANT, NEWBORN, DISEASES; NEONATOLOGY; NEWBORN; PROCEDURES; RISK ASSESSMENT; RISK FACTOR; THERAPEUTIC RESEARCH; UNITED KINGDOM;

BLOOD SPECIMEN COLLECTION; COMPARATIVE EFFECTIVENESS RESEARCH; ERYTHROCYTE TRANSFUSION; HUMANS; INFANT, NEWBORN; INFANT, NEWBORN, DISEASES; NEONATOLOGY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; RISK FACTORS; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED KINGDOM;

EID: 84987910519     PISSN: 13592998     EISSN: 14682052     Source Type: Journal    
DOI: 10.1136/archdischild-2016-310935     Document Type: Article

References (30)

1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009; 374: 86-9.
2. Al-Shahi Salman R, Beller E, Kagan J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014; 383: 176-85.
3. Grossmann C, Sanders J, English RA. Large simple trials and knowledge generation in a learning healthcare system. In: Medicine Io, ed. Washington DC: The National Academies Press, 2013.
4. Lantos JD. The "inclusion benefit" in clinical trials. J Pediatr 1999; 134: 130-1.
5. Berry JG, Ryan P, Duszynski KM, et al. Parent perspectives on consent for the linkage of data to evaluate vaccine safety: a randomised trial of opt-in and opt-out consent. Clin Trials 2013; 10: 483-94.
6. Treweek S, Altman DG, Bower P, et al. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform. Trials 2015; 16: 261.
7. Man MS, Healthlines Study G, Rick J, et al. Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials. Trials 2015; 16: 309.
8. van Staa TP, Dyson L, McCann G, et al. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials. Health Technol Assess 2014; 18: 1-146.
9. Treweek S, Lockhart P, Pitkethly M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 2013; 3.
10. Fröbert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013; 369: 1587-97.
11. Duley L, Uhm S, Oliver S, Preterm Birth Priority Setting Partnership Steering Group. Top 15 UK research priorities for preterm birth. Lancet 2014; 383: 2041-2.
12. Gale C, Modi N, WHEAT Trial Development Group. Neonatal randomised point-of-care trials are feasible and acceptable in the UK: results from two national surveys. Arch Dis Child Fetal Neonatal Ed 2016; 101: F86-7.
13. Snowdon C, Elbourne D, Garcia J, Declining enrolment in a clinical trial and injurious misconceptions: is there a flipside to the therapeutic misconception? Clin Ethics 2007; 2: 193-200.
14. Junghans C, Feder G, Hemingway H, et al. Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies. BMJ 2005; 331: 940.
15. Chalmers, Im Bracken MB, Djulbegovis B, et al. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156-65.
16. Carlo WA, Bell EF, Walsh MC, Network SSGotEKSNNR. Oxygen-saturation targets in extremely preterm infants. N Engl J Med 2013; 368: 1949-50.
17. Schmidt B, Gillie P, Caco C, et al. Do sick newborn infants benefit from participation in a randomized clinical trial. J Pediatr 1999; 134: 151-5.
18. Braunholtz DA, Edwards SJL, Lilford RJ. Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect". J Clin Epidemiology 2001; 54: 217-24.
19. NREAP. Report of the National Research Ethics Advisory Panel (NREAP): Consistency in REC Review. In: Health Do, ed. London: Health Research Authority, 2014.
20. NREAP. Minutes of National Research Ethics Advisory Panel (NREAP) dated 17th October 2012. In: Health Do, ed. London: Health Research Authority, 2012.
21. HHS. Basic Health and Human Services (HHS) Policy for Protection of Human Research Subjects. In: Services HaH, ed. United States Department of Health and Human Services, 2009.
22. Carlo WA, Bell EF, Walsh MC, SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Oxygen-saturation targets in extremely preterm infants. N Engl J Med 2013; 368: 1949-50.
23. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research NetworkCarlo WA, Finer NN, et al. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med 2010; 362: 1959-69.
24. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191-4.
25. Lauer MS, D'Agostino RB Sr. The randomized registry trial-the next disruptive technology in clinical research? N Engl J Med 2013; 369: 1579-81.
26. Fiore LD, Brophy M, Ferguson RE, et al. A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen. Clin Trials 2011; 8: 183-95.
27. Stark AR, Tyson JE, Hibberd PL. Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol 2010; 30: 163-9.
28. Ravina B, Deuel L, Siderowf A, et al. Local institutional review board (IRB) review of a multicenter trial: local costs without local context. Ann Neurol 2010; 67: 258-60.
29. Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med 2001; 29: 235-41.
30. Lantos JD. Vindication for SUPPORT. N Engl J Med 2015; 373: 1393-5.