Community consultation methods in a study using exception to informed consent

Prehosp Emerg Care. 2008 Oct-Dec;12(4):417-25. doi: 10.1080/10903120802290885.


Objective: The most effective means of community consultation is unknown. We evaluated differences in community opinion elicited by varying means of consultation.

Methods: We compared responses with a cross-sectional, standardized survey administered as part of the community consultation for the Resuscitation Outcomes Consortium (ROC) hypertonic saline trial. Surveys were obtained from four sources: two sets of random-digit dialing phone surveys, paper surveys from community meetings, and web-based surveys.

Results: Three hundred sixty-one usable surveys were obtained: 186 from phone survey 1; 86 from phone survey 2 (using slightly modified wording); 54 from community meetings (8 from open forums; 46 from existing meetings); and 35 from a web site. Demographics were similar between the sets except that the surveys obtained from community meetings had the highest minority representation (63.3% nonwhite). Community meeting respondents were more willing than phone or web respondents to receive experimental treatment for themselves (93.6% vs. 77.5% overall) and for a family member (95.2% vs. 74.9% overall). The web-based survey generated the least feedback and had the most higher-income responders.

Conclusions: Responses varied by method of consultation. The open forums were very poorly attended, despite heavy advertising by investigators. Furthermore, attendees at those meetings provided the least objection to proposed research without informed consent. Phone surveys elicited the most objections. We suggest that an efficient method of community consultation is random-digit dialing supplemented with discussion at already scheduled events to target special populations.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Aged
  • Biomedical Research
  • Cross-Sectional Studies
  • Female
  • Guidelines as Topic
  • Humans
  • Informed Consent* / ethics
  • Male
  • Middle Aged
  • Public Opinion*
  • Referral and Consultation*
  • United States
  • United States Food and Drug Administration
  • Young Adult