Trans NIAID Clinical Research Toolkit, Selected References

Check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE. Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature. Clin Trials. 2013.

Flynn KE, HC, Kramer JM, Check DK, Dombeck CB, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS One. 2013;8.

Mascette AM, Bernard GR, Dimichele D, Goldner JA, Harrington R, Harris PA, Leeds HS, Pearson TA, Ramsey B, Wagner TH. Are central institutional review boards the solution? The National Heart, Lung, and Blood Institute working group's report on optimizing the IRB process. Acad Med. 2012 Oct 22.

Kramer JM, Smith PB, Califf RM. Impediments to clinical research in the United States. Clin Pharmacol Ther. 2012;91:535-41.

Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011;6:3-19.

Ravina B, Deuel L, Siderowf A, Dorsey ER. Local institutional review board (IRB) review of a multicenter trial: local costs without local context. Ann Neurol. 2010;67:258-60.

Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med. 2010;363:1591-3.

Goldman EB. Can multiple IRBs spoil the broth? Ann Neurol. 2010;67:149-50.

Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J. Costs and benefits of the National Cancer Institute central institutional review board. J Clin Oncol. 2010;28:662-6.

Pandemic paralysis: H1N1 influenza underscores barriers to timely research. IRB Advisor. 2009;9:85-7.

Burman W, Daum R. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts.Clin Infect Dis. 2009;49:328-35.

Bartlett EE. International analysis of institutional review boards registered with the U.S. Office for Human Research Protections. J Empir Res Hum Res Ethics. 2008;3:49-56.

Mastroianni AC. Sustaining public trust: falling short in the protection of human research participants. Hastings Cent Rep. 2008;38:8-9.

Emanuel EJ, Grady C. Four paradigms of clinical research and research oversight. Camb Q Healthc Ethics. 2007;16:82-96.

McNeil C. Debate over institutional review boards continues as alternative options emerge. J Natl Cancer Inst. 2007;99:502-3.

Sobolski GK, Flores L, Emanuel EJ. Institutional review board review of multicenter studies. Ann Intern Med. 2007;146:759.

Greene SM, Geiger AM. A review finds that multicenter studies face substantial challenges but strategies exist to achieve institutional review board approval. J Clin Epidemiol. 2006;59:784-90.

Greene SM, Geiger AM, Harris EL, et al. Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes.Ann Epidemiol. 2006;16:275-8.

Jester PM, Tilden SJ, Li Y, Whitley RJ, Sullender WM. Regulatory challenges: lessons from recent West Nile virus trials in the United States. Contemp Clin Trials. 2006;27:254-9.

Sugarman J, Getz K, Speckman JL, Byrne MM, Gerson J, Emanuel EJ. The cost of institutional review boards in academic medical centers. N Engl J Med. 2005;352:1825-7.

Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med. 2004;141:282-91.

Larson E, Bratts T, Zwanziger J, Stone P. A survey of IRB process in 68 U.S. hospitals. J Nurs Scholarsh. 2004;36:260-4.

Burman W, Breese P, Weis S, Bock N, Bernardo J, Vernon A. The effects of local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials. 2003;24:245-55.

Federman D, Hanna, Kathi, Rodriguez, Laura Lyman; Committee on Assessing the System for Protecting Human Research Participants. Responsible research: a systems approach to protecting research participants. Natl Acad Sci. 2003.

Humphreys K, Trafton J, Wagner TH. The cost of institutional review board procedures in multicenter observational research. Ann Intern Med. 2003;139:77.

Burman WJ, Reves RR, Cohn DL, Schooley RT. Breaking the camel's back: multicenter clinical trials and local institutional review boards. Ann Intern Med. 2001;134:152-7.

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.

Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Acad Emerg Med. 2001;8:636-41.​​

Content last reviewed on January 12, 2017