BACKGROUND: The Public Access Defibrillation (PAD) Trial, a prospective, multicenter, randomized clinical trial comparing two prehospital resuscitation strategies, was conducted under the regulations for exception from informed consent (21CFR50.24) in 24 communities in North America. These regulations place additional requirements for human subject protection on investigators and Institutional Review Boards (IRBs), including conducting community consultation (CC) and public disclosure (PD). OBJECTIVE: To describe the IRB approval process at study sites and the number and types of community consultation and public disclosure activities conducted. METHODS: The 24 study sites in the United States and Canada submitted IRB applications, CC and PD plans, and a structured report on IRB process and investigator perceptions to the Clinical Trial Center at the University of Washington. RESULTS: The primary IRBs for all 24 trial sites and a total of 101 IRBs approved the study. The median interval from submission to approval was 108 days (IQR 43-196), and the mean number of revisions was two (range 0-7). Investigators conducted nearly 12,000 activities to achieve CC and PD; activities varied greatly from site to site in both type and quantity. CONCLUSION: The length of time to obtain IRB approval and the extent of community consultation and public disclosure varied greatly among trial sites in meeting the current regulations for conducting emergency research with exception from informed consent. This suggests that more specific guidance may be useful and that determination of effective strategies for community consultation and public disclosure is needed.
RCT Entities:
BACKGROUND: The Public Access Defibrillation (PAD) Trial, a prospective, multicenter, randomized clinical trial comparing two prehospital resuscitation strategies, was conducted under the regulations for exception from informed consent (21CFR50.24) in 24 communities in North America. These regulations place additional requirements for human subject protection on investigators and Institutional Review Boards (IRBs), including conducting community consultation (CC) and public disclosure (PD). OBJECTIVE: To describe the IRB approval process at study sites and the number and types of community consultation and public disclosure activities conducted. METHODS: The 24 study sites in the United States and Canada submitted IRB applications, CC and PD plans, and a structured report on IRB process and investigator perceptions to the Clinical Trial Center at the University of Washington. RESULTS: The primary IRBs for all 24 trial sites and a total of 101 IRBs approved the study. The median interval from submission to approval was 108 days (IQR 43-196), and the mean number of revisions was two (range 0-7). Investigators conducted nearly 12,000 activities to achieve CC and PD; activities varied greatly from site to site in both type and quantity. CONCLUSION: The length of time to obtain IRB approval and the extent of community consultation and public disclosure varied greatly among trial sites in meeting the current regulations for conducting emergency research with exception from informed consent. This suggests that more specific guidance may be useful and that determination of effective strategies for community consultation and public disclosure is needed.
Authors: Maija Holsti; Roger Zemek; Jill Baren; Rachel M Stanley; Prashant Mahajan; Cheryl Vance; Kathleen M Brown; Victor Gonzalez; Denise King; Kammy Jacobsen; Kate Shreve; Katrina van de Bruinhorst; Anne Marie Jones; James M Chamberlain Journal: Clin Trials Date: 2014-11-04 Impact factor: 2.486
Authors: Jestin N Carlson; Dana Zive; Denise Griffiths; Karen N Brown; Robert H Schmicker; Heather Herren; George Sopko; Sara DiFiore; Dixie Climer; Caroline Herdeman; Ahamed Idris; Graham Nichol; Henry E Wang Journal: Resuscitation Date: 2018-12-17 Impact factor: 5.262
Authors: Theresa L Chin; Ernest E Moore; Marilyn E Coors; James G Chandler; Arsen Ghasabyan; Jeffrey N Harr; John R Stringham; Christopher R Ramos; Sarah Ammons; Anirban Banerjee; Angela Sauaia Journal: Surgery Date: 2014-10-14 Impact factor: 3.982
Authors: Shannon W Stephens; Carolyn Williams; Randal Gray; Jeffrey D Kerby; Henry E Wang; Patrick L Bosarge Journal: J Trauma Acute Care Surg Date: 2016-06 Impact factor: 3.313
Authors: Maria J Nelson; Nicole M Deiorio; Terri A Schmidt; Dana M Zive; Denise Griffiths; Craig D Newgard Journal: Resuscitation Date: 2013-02-08 Impact factor: 5.262