Articles

Completed NETT Trials

ALIAS

Ginsberg MD, Palesch YY, Hill MD, Martin RH, Moy CS, Barsan WG, Waldman BD, Tamariz D, Ryckborst KJ; ALIAS and Neurological Emergencies Treatment Trials (NETT) Investigators. High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a randomised, double-blind, phase 3, placebo-controlled trial. Lancet Neurol. 2013 Nov;12(11):1049-58. doi: 10.1016/S1474-4422(13)70223-0. Epub 2013 Sep 27. Read more.

PEER

Dickert NW, Mah VA, Baren JM, Biros MH, Govindarajan P, Pancioli A, Silbergleit R, Wright DW, Pentz RD. Enrollment in Research Under Exception from Informed Consent: The Patients' Experiences in Emergency Research (PEER) Study. Resuscitation. October 2013; 84 (10):1416-21. doi: 10.1016/j.resuscitation.2013.04.006. Epub 2013 Apr 16. Read more.

Dickert NW, Mah VA, Biros MH, Harney DM, Silbergleit R, Sugarman J, Veledar E, Weinfurt KP, Wright DW, Pentz RD. Consulting Communities When Patients Cannot Consent: A Multicenter Study of Community Consultation for Research in Emergency Settings. Critical Care Medicine. 2013 Oct 18. doi: 10.1097/CCM.0b013e3182a27759. Read more.

ProTECT

David W. Wright, M.D., Sharon D. Yeatts, Ph.D., Robert Silbergleit, M.D., Yuko Y. Palesch, Ph.D., Vicki S. Hertzberg, Ph.D., Michael Frankel, M.D., Felicia C. Goldstein, Ph.D., Angela F. Caveney, Ph.D., Harriet Howlett-Smith, R.N., Erin M. Bengelink, M.A., Geoffrey T. Manley, M.D., Ph.D., Lisa H. Merck, M.D., M.P.H., L. Scott Janis, Ph.D., and William G. Barsan, M.D. for the NETT Investigators. Very Early Administration of Progesterone for Acute Traumatic Brain Injury. New England Journal of Medicine. 2014. doi: 10.1056NEJMoa1404304. Read more.

Biros MH, Dickert NW, Wright DW, Scicluna VM, Harney D, Silbergleit R, Denninghoff K, Pentz RD. Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent. Acad Emerg Med. 2015 Feb 25. doi: 10.1111/acem.12602. [Epub ahead of print] Learn more.

RAMPART

Silbergleit R, Durkalski V, Lowenstein D. et al for the NETT Investigators, Biros, MH. Intramuscular versus Intravenous Therapy for Prehospital Status Epilepticus. New England Journal of Medicine, Feb 16, 2012; 366 (7): 591-600. Read more.

McMullan JT, Pinnawin A, Jones E, Denninghoff K, Siewart N, Spaite DW, Zaleski E, Silbergleit R; for the Neurological Emergencies Treatment Trials Investigators, Biros, MH. The 60-day temperature-dependent degradation of midazolam and Lorazepam in the prehospital environment. Prehospital Emergency Care. 2013 Jan-Mar;17 (1): 1-7. doi: 10.3109/10903127.2012.722177. Epub 2012 Nov 13. Read more.

Silbergleit R, Biros MH, Harney D, Dickert N, Baren J on behalf of the NETT Investigators. Implementation of the Exception from Informed Consent Regulations in a Large Multicenter Emergency Clinical Trials Network: The RAMPART Experience. Academic Emergency Medicine. April 2012; 19 (4): 448-454. Read more.

Bioethics and Exception from Informed Consent (EFIC)

Martel ML, Klein LR, Miner JR, Cole JB, Nystrom PC, Holm KM, Biros MH. A brief assessment of capacity to consent instrument in acutely intoxicated emergency department patients. Am J Emerg Med. 2017 Jun 26. pii: S0735-6757(17)30493-X. doi: 10.1016/j.ajem.2017.06.043. [Epub ahead of print] PubMed PMID: 28668177.

Whitesides LW, Baren JM, Biros MH, Fleischman RJ, Govindarajan PR, Jones EB, Pancioli AM, Pentz RD, Scicluna VM, Wright DW, Dickert NW. Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent. Clin Trials. 2017 Apr;14(2):180-186. doi:10.1177/1740774516677276. Epub 2016 Nov 15. PubMed PMID: 28359192; PubMed Central PMCID: PMC5380144.

Cole JB, Ho JD, Biros MH. Randomizing Patients without Consent: Waiver vs Exception from Informed Consent. Prehosp Disaster Med. 2016 Aug;31(4):457-8. doi:10.1017/S1049023X16000479. Epub 2016 May 26. PubMed PMID: 27225048.

Biros M. Never, always and maybe. Addressing attitudes of patients towards emergency medicine research. Emerg Med J. 2016 Jun;33(6):374-5. doi:10.1136/emermed-2016-205811. Epub 2016 Mar 11. PubMed PMID: 26969170.

Dickert NW, Scicluna VM, Baren JM, Biros MH, Fleischman RJ, Govindarajan PR, Jones EB, Pancioli AM, Wright DW, Pentz RD. Patients' perspectives of enrollment in research without consent: the patients' experiences in emergency research-progesterone for the treatment of traumatic brain injury study. Crit Care Med. 2015 Mar;43(3):603-12. doi: 10.1097/CCM.0000000000000747. Erratum in: Crit Care Med. 2016 Apr;44(4):e240. PubMed PMID: 25574795; PubMed Central PMCID: PMC5094912.

Biros MH, Dickert NW, Wright DW, Scicluna VM, Harney D, Silbergleit R, Denninghoff K, Pentz RD. Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent. Acad Emerg Med. 2015 Feb 25. doi: 10.1111/acem.12602. [Epub ahead of print] Learn more.

Dickert NW, Mah VA, Biros MH, Harney DM, Silbergleit R, Sugarman J, Veledar E, Weinfurt KP, Wright DW, Pentz RD. Consulting Communities When Patients Cannot Consent: A Multicenter Study of Community Consultation for Research in Emergency Settings. Critical Care Medicine. 2013 Oct 18. doi: 10.1097/CCM.0b013e3182a27759. Read more.

Biros M. The meaning of opt-out. Resuscitation. 2013; 84 (8): 1019-1020. Read more.

Biros MH. Does community consultation matter? Academic Emergency Medicine. 2013; 20 (1): 104-105. Read more.

Silbergleit R, Biros MH, Harney D, Dickert N, Baren J on behalf of the NETT Investigators. Implementation of the Exception from Informed Consent Regulations in a Large Multicenter Emergency Clinical Trials Network: The RAMPART Experience. Academic Emergency Medicine. April 2012; 19 (4): 448-454. Read more.

Biros M. The People Speak: Community Consultation in Emergency Research. Annals of Emergency Medicine. 2011; 57 (4): 355-356. DOI: 10.1016/j.annemergmed.2010.08.028. Read more.

Michelle H. Biros, MD, MS, Corey Sargent, MA NREMT-P, and Kathleen Miller, BSN, RN.  Community Attitudes towards Emergency Research and Exception from Informed Consent. Resuscitation. Dec 2009; 80(12): 1382–1387. Published online Oct 8, 2009. doi:  10.1016/j.resuscitation.2009.08.019. Read more.

Baren JM, Biros MH.  The research on community consultation: an annotated bibliography. Acad Emerg Med. 2007 Apr;14(4):346-52. Read more.

Biros MH. Research without consent: current status, 2003.  Ann Emerg Med. 2003 Oct;42(4):550-64. Read more.

University of Minnesota Collaboration

 Reshi R, Streib C, Ezzeddine M, Biros M, Miller B, Lakshminarayan K, Anderson D, Ardelt A. Hyperglycemia in acute ischemic stroke: Is it time to re-evaluate our understanding? Med Hypotheses. 2017 Sep;107:78-80. doi:10.1016/j.mehy.2017.08.017. Epub 2017 Aug 16. PubMed PMID: 28915969.