IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom? (bibtex)
by Michael C. Freed, Laura A. Novak, William D. S. Killgore, Sheila A. M. Rauch, Tracey P. Koehlmoos, J. P. Ginsberg, Janice L. Krupnick, Albert "Skip" Rizzo, Anne Andrews, Charles C. Engel
Abstract:
Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.
Reference:
IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom? (Michael C. Freed, Laura A. Novak, William D. S. Killgore, Sheila A. M. Rauch, Tracey P. Koehlmoos, J. P. Ginsberg, Janice L. Krupnick, Albert "Skip" Rizzo, Anne Andrews, Charles C. Engel), In The American Journal of Bioethics, volume 16, 2016.
Bibtex Entry:
@article{freed_irb_2016,
	title = {{IRB} and {Research} {Regulatory} {Delays} {Within} the {Military} {Health} {System}: {Do} {They} {Really} {Matter}? {And} {If} {So}, {Why} and for {Whom}?},
	volume = {16},
	issn = {1526-5161, 1536-0075},
	url = {http://www.tandfonline.com/doi/full/10.1080/15265161.2016.1187212},
	doi = {10.1080/15265161.2016.1187212},
	abstract = {Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.},
	number = {8},
	journal = {The American Journal of Bioethics},
	author = {Freed, Michael C. and Novak, Laura A. and Killgore, William D. S. and Rauch, Sheila A. M. and Koehlmoos, Tracey P. and Ginsberg, J. P. and Krupnick, Janice L. and Rizzo, Albert "Skip" and Andrews, Anne and Engel, Charles C.},
	month = aug,
	year = {2016},
	keywords = {MedVR, UARC},
	pages = {30--37}
}
Powered by bibtexbrowser