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• W2168553619 abstract "HomeCirculationVol. 118, No. 15Regulatory Challenges for the Resuscitation Outcomes Consortium Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplementary MaterialsFree AccessReview ArticlePDF/EPUBRegulatory Challenges for the Resuscitation Outcomes Consortium Samuel A. Tisherman, MD, Judy L. Powell, BSN, Terri A. Schmidt, MD, MS, Tom P. Aufderheide, MD, Peter J. Kudenchuk, MD, Julie Spence, MD, Dixie Climer, RN, BSN, MBA, Donna Kelly, RN, Angela Marcantonio, Todd Brown, MD, MSPH, George Sopko, MD, MPH, Richard Kerber, MD, Jeremy Sugarman, MD, MPH, MA, David Hoyt, MD and the Resuscitation Outcomes Consortium Investigators Samuel A. TishermanSamuel A. Tisherman From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Judy L. PowellJudy L. Powell From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Terri A. SchmidtTerri A. Schmidt From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Tom P. AufderheideTom P. Aufderheide From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Peter J. KudenchukPeter J. Kudenchuk From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Julie SpenceJulie Spence From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Dixie ClimerDixie Climer From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Donna KellyDonna Kelly From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Angela MarcantonioAngela Marcantonio From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Todd BrownTodd Brown From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , George SopkoGeorge Sopko From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Richard KerberRichard Kerber From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , Jeremy SugarmanJeremy Sugarman From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author , David HoytDavid Hoyt From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author and the Resuscitation Outcomes Consortium Investigators From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.). Search for more papers by this author Originally published7 Oct 2008https://doi.org/10.1161/CIRCULATIONAHA.107.764084Circulation. 2008;118:1585–1592Resuscitation research is challenging but vital because few effective therapies exist for a number of life-threatening conditions. Cardiovascular disease has been a leading cause of death and morbidity in the United States. Although estimates vary, the American Heart Association estimates >150 000 out-of-hospital cardiac arrests each year in the United States,1 with little improvement in survival (≈5%) despite medical advances.2 Traumatic injury, resulting in severe hemorrhagic shock or traumatic brain injury, is the leading cause of death in persons 1 to 44 years of age and is a leading cause of morbidity.3 For treatments to be effective in these life-threatening situations, they must be administered immediately, usually at the site of the event.4 Consequently, researchers and regulatory agencies find that typical standards for informed consent cannot be applied in the emergency setting.In 2004, the National Heart, Lung and Blood Institute organized the Resuscitation Outcomes Consortium (ROC) to conduct simultaneous prehospital studies of novel therapies for trauma and cardiac arrest. The consortium consists of 11 regional centers in the United States and Canada and a data coordinating center.It was anticipated that these trials would require extra effort from a regulatory perspective because of the need to administer treatments during a relatively brief therapeutic window, making the standard practice of obtaining informed consent from the subjects before enrollment impossible. Because of the nature of the medical conditions being studied, the potential subjects would not be competent to consent. In addition, surrogate decision makers are not commonly available at the scene, and when they are, the emotional nature of the situation makes obtaining consent infeasible.5,6 These challenges are compounded in a trial involving multiple emergency medical services (EMS) systems and hospitals within each regional center. Finally, such trials may be logistically challenging because of the need to comply with multiple regulatory issues, including federal wide assurances (FWAs), institutional review boards (IRBs)/research ethics boards (REBs), and the Food and Drug Administration (FDA).The first implemented ROC trial involves testing hypertonic fluid resuscitation in victims of life-threatening hemorrhagic shock or traumatic brain injury who are ≥15 years of age. The double-blind, randomized intervention, completed before hospital arrival, consists of the infusion of 250 mL normal saline (0.9%), hypertonic saline (7.5%), or hypertonic saline-dextran.Before patients were enrolled in this trial, the regulatory issues above had to be satisfied. A survey was completed by each center regarding this process. The primary objective of this article is to describe the experience of the ROC centers with regulatory affairs in preparation for this trial and, on the basis of lessons learned, recommend future approaches.The FWAThe FWA is a formal agreement of compliance between the Office for Human Research Protections, the federal body in the United States now charged with safeguarding human subject research, and an agency, hospital, or institution conducting or participating in human subject research. This assurance describes the procedures and principles under which the research will be conducted to protect the rights and welfare of human subjects. The challenges for the ROC were the sheer number of FWAs required and the fact that some entities had not participated in research previously and did not already have FWAs.ROC ApproachFor the 11 ROC centers, 98 unique FWAs (1 to 13 per center) were required (Table 1), 56 for trauma centers and 56 for EMS agencies. Some hospital FWAs covered EMS agencies; some FWAs covered multiple EMS agencies. Five of the 11 ROC regional centers reported no major difficulties obtaining FWAs. Six centers reported major difficulties, including determining the IRB of record for EMS agencies (especially county EMS agencies), providing coverage for first responders, and establishing human subject administrators in hospitals without existing FWAs. Difficulties encountered with IRBs included a lack of familiarity with EMS, assuming responsibility for an agency outside their normal jurisdiction, and legal concerns. Furthermore, investigators had difficulty convincing administrators to take responsibility for the protection of human subjects in hospitals without existing FWAs. Providing adequate FWA coverage required restructuring the medical directorship of 2 EMS agencies and extensive education by the data coordinating center on the FWA application process. Table 1. FWA IssuesCenterTrauma CentersTrauma Center FWAsEMS AgenciesEMS Agency FWAsTotal Unique FWAsFWA Difficulty*There are fewer FWAs than the total numbers of hospitals and agencies because several hospitals have oversight over an EMS agency.US centers A229911*Main IRB cover EMS B44101014None C14 (plus 1 renewal pending)12 (2 duplicates)13 (plus 1 pending)1020 (some duplicates)IRB coverage of EMS not clear D3381 (1 FWA for all agencies)4None E44448IRB for EMS F449912 (1 EMS same as 1 trauma center)Unclear about human subject administrator G65 (2 have same FWA)371 (1 FWA for all agencies)5 (EMS same as main trauma center)Extending university FWA to EMS H1173 (4 EMS with same FWA)3 (1 EMS same as 1 trauma center)Canadian centers I14 (6 pending)1110 (3 pending)611 (all EMS same as trauma centers)Bureaucratic delays J54 (2 have same FWA)32 (2 EMS have same FWA)4 (EMS are same as 2 trauma centers)Restructure medical director under healthcare institute K256 (several duplicates)116 (EMS same as main trauma center)NoneTotal82561115698CommentaryThe responsibility of an FWA may have been daunting for an agency that had not previously conducted research. These difficulties were somewhat unexpected and contributed significantly to the time and resources needed to complete study preparation. More experience with multicenter, multihospital, and multi-EMS agency trials like ROC, along with increased communication between experienced centers and new centers, may help alleviate concerns for IRBs and administrators. Early engagement of the local medical community on all levels, from the EMS through receiving hospitals, is critical to timely acquisition of the FWA.Informed ConsentAlthough prospective, informed consent is fundamental to the protection of human research subjects,7 there are circumstances when it is not possible. The Declaration of Helsinki allows legally authorized representatives (LARs) to consent for research when subjects are unable.8 Adopted in 1991, the Common Rule9 governing human subjects research funded by US federal agencies provided 3 main protective measures: review of research by an IRB, informed consent of subjects, and institutional assurances of compliance. For research involving greater than minimal risk, there was no provision for consent for potential subjects unable to consent because of their acute medical conditions with no LAR available or for situations too time sensitive to allow an informed consent discussion with the LAR.After the Common Rule was adopted, the Office for the Protection From Research Risks (the federal agency that was, at that time, charged with enforcing the Common Rule) halted all resuscitation research in the United States in situations when there was no means of obtaining informed consent. In 1996, the US FDA and the Department of Health and Human Services developed the Final Rule to allow research to be performed without informed consent under limited circumstances (21CFR50.24).10 These federal regulations require that (1) the research subject is in a situation that is acutely life threatening, (2) currently available treatments are untested or believed to be unsatisfactory, (3) the potential subject must be unable to consent because of the acute clinical condition, (4) there must not be time within the proposed therapeutic window to contact the LAR to obtain prospective consent, and (5) the possibility must exist that the subject will directly benefit from participation in the study. The regulations mandated the following protective measures. First, community consultation, a 2-way process involving the investigators and community representatives, is designed to provide the IRB with community attitudes and cultural beliefs regarding the research. Second, public disclosure is a 1-way process that informs the potential study population about the study. Options for members of the community to opt out of a study with some type of identification such as a bracelet, although not federally mandated, may be required by the local IRB. Third is subject notification, whereby either the subject or the LAR is informed of the participation in the research and afforded the opportunity to discontinue further participation or to consent for further treatment or follow-up if required. Finally, a Data Safety and Monitoring Board monitors the study for subject safety.11–13 Implementation of the Final Rule is open to interpretation by local IRBs, leading to significant variability in requirements.In Canada, similar regulations were developed for REBs as the TriCouncil Policy Statement (TCPS): Ethical Conduct for Research Involving Humans.13 The conduct of research in emergency situations with the exception from informed consent is guided by Article 2.8 of the TCPS,14 which includes criteria similar to those in the Final Rule (Table I of the online Data Supplement).10 Community consultation and public disclosure, however, are not required.A recent survey of US medical school IRBs found that a significant number of IRBs have reviewed at least 1 study of exception from informed consent and that the more funding a site receives from the National Institutes of Health, the more likely it was to have reviewed such a study.15 However, some researchers have suggested that the Final Rule hinders important research. A recent study found a decrease in US cardiac arrest trials in the past decade.16 Pediatric researchers report that since implementation of the Final Rule, no randomized controlled trials using it have been completed on children,17,18 although some are in progress. In contrast, several Canadian researchers have successfully completed cardiac trials using their policy for exception from informed consent.19–21ROC Approach to IRBs/REBsRecognizing the unique challenges for the consortium, the ROC established a Regulatory Committee to take a proactive approach to assisting local IRBs with the protocol review process. Before the first protocols were developed, the local principal investigators introduced their IRB leadership to the ROC mission. An introductory document was developed for distribution. A conference call with the ROC, National Institutes of Health, and local IRB leadership introduced the local IRBs to the ROC and established dialogue between the IRBs and ROC, as well as among local IRBs. The IRBs had an opportunity to share previous experiences with exception from consent trials.Ten of the 11 regional centers reported previous experience implementing studies involving exception from informed consent for emergency research. Six IRBs had reviewed <5 such trials (1 had reviewed 0), and 4 had reviewed 5 to 10; 1 site did not track this information.The 11 regional centers and the data coordinating center obtained approval from a total of 58 IRBs (range, 1 to 12 per center). The IRB of the principal investigator’s institution was classified as the primary IRB; the IRBs at other institutions were considered secondary. Before IRB submission, almost all centers had discussions with key local individuals to facilitate approval (online supplemental Table II), including a variety of university or medical center, EMS, and community leaders. One center used its public relations department to notify elected officials about the study to try to avoid the impact of changing administrations. The presubmission process took up to 18 months (median, 6 months) (Table 2). The US IRBs granted provisional approval pending completion of community consultation and public disclosure after a median of 2 months (range, 1 to 7 months). After provisional approval, the time to final IRB approval was 4 months (range, 3.5 to 13 months). Table 2. Overview of IRB/REB IssuesCenterIRB/REBs, nPresubmission Time, moIRB/REB Provisional Approval, moProvisional to Final Approval, moIRB/REB DifficultyPrevious IRB/REB Cases Using ExceptionIRB/REB DifficultiesAncillary IRB/REB ConcernsPTO indicates parent-teacher organization.US centers A3311335FWANone B3304Not knownNoneNone C1218410Translation into Spanish; PTO meetings; need for custom wrist bandsCoverage for first responders D2631134Preliminary data on children; focus groups with minorities E51438 F492612Multiple community groups requiredConfusion about modifying Epistry vs full board review; satisfy county IRB G5117421Community consultation; challenging experience with PolyHemeNone H10.52225Potential prisoners, pregnant subjectsNoneCanadian centers I11013.51Wording of information letterWanted to split into 2 studies J41NA37NoneNone K70.52NA12Access to medical records without consent; privacy issuesAccess to medical records without consent; privacy issuesTotal57Median4.524Six of the 11 regional centers addressed major issues with their primary IRB/REBs and 5 of 11 with their secondary IRB/REBs. These included requirements for increasing the number of community consultation meetings, the need for focus groups targeting minorities, the establishment of processes for subject/family notification, informed consent for continued participation in the trial after enrollment, access to hospital medical records, confidentiality/privacy issues, FWA coverage for hospitals and EMS agencies participating in the trial, and communication among multiple EMS agencies and hospitals. Sites generally were not allowed to begin enrollment until contracts and subcontracts had been finalized at secondary EMS agencies and hospitals.Three regional centers reported that the IRB/REB process for ROC was “significantly harder” than usual; 1, a little harder than usual; 6, neither harder nor easier than usual; and 1, a little easier than usual. The IRB/REBs at the centers that reported no increased difficulty with IRB/REB approval for this study had previously reviewed at least 4 studies with the exception from informed consent, suggesting that such studies may become easier for IRB/REBs to review once they have more experience.A unique aspect of the ROC study was the inclusion at some sites of individuals 15 to 17 years of age in a trial using exception from informed consent. For most studies, the consent process in the pediatric population requires informed consent from parents and assent of the minors. Because experience with using the rules for exception from consent with minors is very limited, some IRBs required inclusion of additional focus groups targeting children.CommentaryUncertainty in how to properly interpret and implement the Final Rule, the TCPS, and variable policies of IRBs/REBs may be limiting resuscitation research because detailed interpretations have not been specifically stipulated in the current federal policies and best practices have not been disseminated.22–24 Some IRBs/REBs have developed their own requirements through intuition and experience, which may or may not reflect specific characteristics of the local community. The experience from the recent Public Access Defibrillation (PAD) trial25 demonstrates that the responses from the investigators and the community were generally positive, although the process was labor intensive.In the ROC trial, the approval process at the center level likely was facilitated by the fact that the protocol underwent extensive multilevel review before it could be implemented. This included review at a national level by the National Heart, Lung and Blood Institute, an independent Protocol Review Committee, the Data Safety and Monitoring Board (national panels of resuscitation research experts), and the FDA. We believe that the groundwork laid by the early introduction of the ROC mission by the local principal investigators and the consortium-wide conference call with the IRB leadership was helpful.Although all of the ROC sites obtained approval, the challenges encountered significantly increased the amount of work required to prepare for study implementation, making it difficult to estimate the resources that would be necessary. Delays in IRB/REB approval delayed protocol implementation. These delays occurred despite the fact that all but 1 site had prior experience implementing studies using exception from informed consent under emergency circumstances. Budgets and timelines for future studies should take this into account.ROC Approach to Community Consultation and Public DisclosureAlthough each ROC center was given latitude, all sites adhered to the following general guidelines: (1) Each center was required to meet local IRB directives for community consultation; (2) details of community consultation activities were documented and provided to the data coordinating center and the FDA; (3) each center used a minimum set of information points for presentation to targeted community groups; and (4) information was translated into common languages based on target populations as directed by the local IRB.Community ConsultationEach regional center developed specific approaches for community consultation (Table 3). One approach was modeled after the traditional town hall meeting to which community members and IRB members were invited. The meetings involved presentations by the investigators and other study represent" @default.
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• W2168553619 title "Regulatory Challenges for the Resuscitation Outcomes Consortium" @default.
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