In clinical trials with exception from informed consent, the Final Rule stipulates that investigators inform and consult with the community. A random-digit-dialing survey of 200 individuals assessed the effectiveness of public disclosure via press releases, notices in local newspapers, local radio and television stations and the host hospital's website, as well as a series of community meetings regarding a pending clinical trial of this kind. Results showed a 10% awareness level of the public trial, which is higher than surveys using convenience samples. Understanding of the nature of the trial was generally poor, while opinions about participating in this type of research were more favorable among individuals aware of the trial. Our findings suggest that adherence to the intent of the Final Rule is dependent on uniform guidelines for what constitute effective public disclosure methods and adequate community awareness and understanding and the use of rigorous sampling methods for evaluation.
AndersonM. & FienbergS. E. (1999). To sample or not to sample? The 2000 Census controversy. Journal of Interdisciplinary History. 30(1), 1–36.
2.
BarenJ.AnicettiJ.LedesmaS.BirosM.Mahabee-GittensM., & LewisR. (1999). An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent. Academic Emergency Medicine, 6(12), 1210–1215.
3.
BirosM.RungeJ., & LewisR. (1998). Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances. Academic Emergency Medicine, 5(5), 359–368.
4.
CurtinR.PresserS., & SingerE. (2005). Changes in telephone survey nonresponse over the past quarter century. Public Opinion Quarterly, 69(1), 87–98.
5.
DeIorioN. & McClureK. (2005). Does the emergency exception from informed consent process protect research subjects?Academic Emergency Medicine, 12(11), 1056–1059.
6.
DeIorioN.McClureK.NelsonM.McConnellJ., & SchmidtT. (2007). Ethics committee experience with emergency exception from informed consent protocols. Journal of Empirical Research on Human Research Ethics, 2(3), 23–30.
7.
DickertN. & SugarmanJ. (2005). Ethical goals of community consultation in research. American Journal of Public Health, 95(7), 1123–1127.
8.
DixE. S.EspositoD.SpinosaF.OlsonN., & ChapmanS. (2004). Implementation of community consultation for waiver of informed consent in emergency research: One Institutional Review Board's experience. Journal of Investigative Medicine, 52(2), 109–112.
9.
DureyA. & LockhartC. (2004). A review of community consultation in the development of a multi purpose service in rural and remote Australia. Australian Health Review, 28(1), 97–104.
10.
ErnstA. & FishS. (2005). Exception from informed consent: Viewpoint of institutional review boards–balancing risks to subjects, community consultation, and future directions. Academic Emergency Medicine, 12(11), 1050–1055.
11.
GlasserG. J. & MetzgerG. D. (1972). Random-digit dialing as a method of telephone sampling. Journal of Marketing Research, 9(1), 59–64.
12.
KishL.Survey Sampling. (1965). New York: John Wiley & Sons, Inc.
13.
MannN.SchmidtT., & RichardsonL. (2005). Confronting the ethical conduct of resuscitation research: A consensus opinion. Academic Emergency Medicine, 12(11), 1078–81.
14.
McClureK.DeIorioN.GunnelsM.OchsnerM.BirosM. & SchmidtT. (2003). Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification. Academic Emergency Medicine, 10(4), 352–359.
15.
McClureK.DeIorioN.SchmidtT.ChiodoG., & GormanP. (2007). A qualitative study of institutional board members' experience with research proposals using emergency exception from informed consent. Journal of Medical Ethics, 33(5), 289–293.
16.
McGeeM.McErleanM.TrinerW., & VerdileV. (2005). Keynote address: Toward a pragmatic model for community consultation in emergency research. Proceedings of the 2005 AEM Consensus Conference. Academic Emergency Medicine, 12(11), 1019–1021.
17.
MosessoV.Jr.BrownL.GreeneH.SchmidtT.AufderheideT.SayreM.StephensS.TraversA.CravenR.WeisfeldtM., & The PAD trial investigators. (2004). Conducting research using the emergency exception from informed consent: The Public Access Defibrillation (PAD) Trial experience. Resuscitation, 61, 29–36.
18.
QuinnS. (2004). Protecting human subjects: The role of community advisory boards. American Journal of Public Health, 94(6), 918–922.
19.
RichardsonL.WiletsI.RaginD.HolohanJ.SmirnoffM.RhodesR.WinkelG.RodriguezM., & RicciE. (2005). Research without consent: Community perspectives from the Community VOICES study. Academic Emergency Medicine, 12(11), 1082–1090.
20.
RosnowR. & RosenthalR. (1997). People studying people. Artifacts and Ethics in Behavioral Research. New York: W.H. Freeman and Company.
21.
SchmidtT.LewisR., & RichardsonL. (2005). Current status of research on the federal guidelines for performing research using an exception from informed consent. Academic Emergency Medicine, 12(11), 1022–1026.
22.
SmithW.CheyT.JalaludinB.SalkeldG., & CaponT. (1995). Increasing response rate in telephone surveys: A randomized trial. Journal of Public Health Medicine, 17(1), 33–38.
23.
SmithlineH. & GurstleM. (1998). Waiver of informed consent: A survey of emergency medicine patients. American Journal of Emergency Medicine, 16(1), 90–91.
24.
TrinerW.JacobyL.SheltonW.BurkM.ImarenakhueS.WattJ.LarkinG., & McGeeG. (2007). Exception from informed consent enrollment in emergency medical research: Attitudes and awareness. Academic Emergency Medicine, 14(2), 187–191.
U.S. Department of Health and Human Services. (1996). Code of Federal Regulations. Protection of Human Subjects: Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research: Final rules 21 CFR 50.24 & 45 CFR 46.10. Federal Register, 61(192), 51497–51531.
