November 19, 2006
Notice Requirements for Research in Emergency Medicine
by Sigrid Fry-Revere
Sigrid Fry-Revere is director of bioethics studies for the Cato Institute.
"Public Disclosure and Notice" Comment filed with FDA regarding "Exception From Informed Consent Requirements for Emergency Research" Docket: 2006D-0331, Temp. Comment No. 97834. Filed 11/19/06.
NOTICE REQUIREMENTS: Each institution involved in research for which there is an exception to the informed consent requirement should post at the emergency room entrance a statement giving notice that the institution is involved in such research. Such notice could read: "This institution conducts emergency treatment studies which may involve experimental products. Given the nature of emergency medicine, we will not be able to ask your consent before initiating such experiments. More information can be obtained inside, at this hospital's website [list website] or from the FDA [list website]."
Discussion and disclosure to the community is vital, but so is notice to anyone who may not be directly involved in those discussions. Anyone who hasn't been informed through the institutions community outreach program, can nevertheless be informed when they come to the hospital for other reasons. Furthermore, those who may have been informed through other forms of public disclosure, can learn, or be reminded, through notice exactly which institutions are involved in such research. Such notice would allow individuals to actively seek or avoid such institutions, depending on their feelings regarding such research.
Another important consideration is that we live in a very mobile society. Someone may be aware of which institutions are involved in such research in their own community but not know such information for a neighboring community. By requiring each institution that is involved in such research to give clear notice at the facility, people who are brought to a facility outside their community can still be informed. This type of notice is important even if the actual patient may be unconscious because there may be caring relatives or friends available during the admissions process who know the patient's wishes regarding participation in such research.
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