Joseph Varon MD

The University of Texas Health Science Center

at Houston, TX, USA The University of Texas Medical Branch

at Galveston, TX, USA University General Hospital, Houston, TX, USA

doi:10.1016/j.ajem.2011.04.020

References

1. Stang M, Wysowski DK, Butler-Jones D. Incidence of lactic acidosis in metformin users. Diabetic Care 1999;22:925-7.
2. Mecher C, Rackow EC, Astiz ME, et al. Unaccounted for anion in metabolic acidosis in severe sepsis in humans. Crit Care Med 1991;19: 705-11.
3. Park M, Azevedo LC, Maciel AT, et al. Evolutive standard base excess and Serum lactate level in severe sepsis and septic shock patients resuscitated with early goal directed therapy: still outcome markers? Clinics 2006;61:47-52.
4. Scale T, Harvey JN. Diabetes, metformin and lactic acidosis. Clin Endocrinol 2011;74(2):191-6.
5. Bailey CJ, Turner RC. Metformin. N Engl J Med 1996;334:574-9.
6. Misbin RI, Green L, Studel BV, et al. Lactic acidosis in patient with diabetes treated with metformin. NEJM 1998;338:265-6.

An alternative approach to community consultation for emergency research without informed consent

To the Editor,

Critically ill or injured patients often cannot give informed consent to be enrolled in clinical trials. In 1996, the US government passed a rule (21 CRF 50.24) [1] to allow research without informed consent in emergency situations. One of the requirements of the rule is “community consultation” (CC), that is, advance disclosure of the research plan with the community where the study will be conducted and solicitation of opinions regarding the acceptability of the research. However, there are no clear definitions or guidance that helps investigators and institutional review boards decide how to perform CC properly. In the past, CC has been done with advertisements in print or electronic media, random dialing surveys [2], and/or town hall meetings [3]. These methodologies may be costly, time consuming, and may be ineffective (for 1 study in a catchment area of 1.5 million only 25 people attended the town hall meeting [4]). Because of these barriers, in recent years, few studies have been done using the rule [3]; and most of this type of research on critically ill patients has been conducted outside the United States.

We propose using the emergency department (ED) as the site for CC. This is appropriate because most critically ill and injured patients come to the ED. In addition, the number of annual ED visits in the United States is about one third of the population, so a large number of people are available in EDs for CC, especially if you include friends and family members who come with patients.

To explore the feasibility of performing CC in the ED, we distributed pamphlets describing research without informed consent to patients, family members, and staff in the ED of a suburban level I trauma center. To check whether the pamphlets were read and solicit opinions about the acceptability of this type of research, we asked the participants to fill out anonymously a questionnaire in the pamphlet regarding their support for research without informed consent. We used a 5-point Likert scale to analyze the responses and dichotomized the results (strongly agree and agree categories indicate “support”). We compared results among groups (patients, family members, and staff) using the ?2 test (? = .05).

Of the 400 questionnaires, 389 (97%) were completed. Of

these 29%, 19% and 52% were from patients, family members, and staff, respectively. Women comprised 53%, and 79% were whites. The average age was 46 +- 16 years. Of the responders, 95% supported research without informed consent, 54% would volunteer themselves for such research, and 79% would volunteer a family member. Differences among the 3 groups were not statistically significant (P =

.36). Printing the pamphlets costs $250.

We found a high level of support for research without informed consent and suggest a method for doing CC efficiently in the ED. We believe that this should satisfy the CC requirement under rule 21 CRF 50.24 and will allow more studies on critically ill patients to be done in the United States.

George Perdrizet MD, PhD Department of Surgery Morristown Medical Center Morristown, NJ 07962, USA

Barnet Eskin MD, PhD John Allegra MD, PhD Department of Emergency Medicine Morristown Medical

Center Emergency Medical Associates

Research Foundation Morristown, NJ 07962, USA

E-mail address: [email protected]

Melissa Kraynak

Department of Emergency Medicine Morristown Medical Center Morristown, NJ 07962, USA

Scott Shapiro BS Catherine Pocoroba MS, PA-C Francis Simons BS, MS Department of Surgery Morristown Medical Center Morristown, NJ 07962, USA

doi:10.1016/j.ajem.2011.04.022

References

1. Protection of human subjects: informed consent: FDA: final rule. Fed Regist 1996;61:51498-533.
2. Bulger EM, Schmidt TA, Cook AJ, et al. The random dialing survey as a tool for community consultation for research involving the emergency

medicine exception from informed consent. Ann Emerg Med 2009;53: 341-50.

1. Baren JM, Biros MH. The research on community consultation: an Annotated bibliography. Acad Emerg Med 2007;14:346-52.
2. Kremers MS, Whisnant DR, Loder LS, et al. Initial experiences using the food and drug administration guidelines for emergency research without consent. Ann Emerg Med 1999;33:224-9.