Exception from informed consent enrollment in emergency medical research: attitudes and awareness.
OBJECTIVE
To explore attitudes surrounding exception from informed consent enrollment into research studies. In addition, the authors sought to determine the level of awareness of such an ongoing study among potential subjects, as defined by their presence in an emergency department (ED).


METHODS
A convenience sample of urban academic ED patients and visitors was surveyed during a visit regarding their attitudes and awareness of an emergency exception from informed consent, blood-substitute trial ongoing in the community.


RESULTS
There was a 13% refusal rate, and 32% of those approached had characteristics that met exclusion criteria. There were 497 surveys analyzed. There was a predominance of women, Caucasians, and persons with at least some college education. Only 39 (8%) of respondents reported awareness of the ongoing blood substitute trial, and only 19 (4%) were able to list a risk or benefit of participation. Education, income, and age were not associated with reported awareness. Male gender, younger age, awareness of the existing exception from informed consent study, and being married were associated with greater acceptability for such enrollment practices.


CONCLUSIONS
The overall awareness of an ongoing exception from informed consent trial after community consultation and notification was low. A population with potential for enrollment in such a study did not demonstrate a high degree of acceptance of such practices. There were differences among certain demographic groups in the degree of acceptance. These differences may guide institutional review boards and investigators in community-consultation strategies for future waiver of or exception from informed consent studies.
Triner
Wayne
W
Department of Emergency Medicine, Alden March Bioethics Institute, Albany Medical College, Albany, NY, USA. trinerw@mail.amc.edu
Jacoby
Liva
L
Shelton
Wayne
W
Burk
Mathew
M
Imarenakhue
Samual
S
Watt
James
J
Larkin
Gregory
G
McGee
Glenn
G
D000328:Adult; D000368:Aged; D001294:Attitude to Health; D001364:Awareness; D001802:Blood Substitutes / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000523:psychology*; D003430:Cross-Sectional Studies; D028744:Ethics Committees, Research; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D045808:Refusal to Participate / Q000706:statistics & numerical data*
D001802:Blood Substitutes