The impact of escalating regulatory requirements on the conduct of clinical research
- PMID: 12944237
- DOI: 10.1080/14653240310002225
The impact of escalating regulatory requirements on the conduct of clinical research
Abstract
A discussion of the impact of escalating regulatory requirements is provided, from the point of view of the administration of the institutional review board of an academic institution, and from clinical investigators who conduct studies at that same institution. Current and anticipated future issues are discussed.
Similar articles
-
Protecting research subjects--what must be done.N Engl J Med. 2000 Sep 14;343(11):808-10. doi: 10.1056/NEJM200009143431112. N Engl J Med. 2000. PMID: 10984573 No abstract available.
-
Institutional review board consideration of chart reviews, case reports, and observational studies.Respir Care. 2008 Oct;53(10):1350-3. Respir Care. 2008. PMID: 18811999 Review.
-
Financial conflicts of interest in human subjects research: proposals for a more effective regulatory scheme.Wash Lee Law Rev. 2003 Winter;60(1):15-109. Wash Lee Law Rev. 2003. PMID: 16273696 No abstract available.
-
The search for a cure: combating the problem of conflicts of interest that currently plagues biomedical research.Iowa Law Rev. 2003 Oct;89(1):235-71. Iowa Law Rev. 2003. PMID: 15732180 No abstract available.
-
Do healthy children deserve greater protection in medical research?J Pediatr. 2003 Feb;142(2):108-12. doi: 10.1067/mpd.2003.84. J Pediatr. 2003. PMID: 12584528 Review. No abstract available.
Cited by
-
Academic pediatric clinical research: factors associated with study implementation duration.BMC Med Res Methodol. 2016 Mar 29;16:36. doi: 10.1186/s12874-016-0138-y. BMC Med Res Methodol. 2016. PMID: 27025840 Free PMC article.
-
Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.J Empir Res Hum Res Ethics. 2017 Jul;12(3):131-139. doi: 10.1177/1556264617704294. Epub 2017 Apr 16. J Empir Res Hum Res Ethics. 2017. PMID: 28412874 Free PMC article.
-
Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.Milbank Q. 2011 Dec;89(4):599-627. doi: 10.1111/j.1468-0009.2011.00644.x. Milbank Q. 2011. PMID: 22188349 Free PMC article. Review.
-
How to improve the implementation of academic clinical pediatric trials involving drug therapy? A qualitative study of multiple stakeholders.PLoS One. 2013 May 28;8(5):e64516. doi: 10.1371/journal.pone.0064516. Print 2013. PLoS One. 2013. PMID: 23724056 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources