Exception from Informed Consent for Planned Emergency Research
Description
The Office for Human Research Protections and the Food and Drug Administration has recognized an extremely limited emergency exception to standard informed consent requirements, applicable only in certain emergency life-threatening situations where standard therapies are unproven or unsatisfactory and certain conditions are met by the relevant investigators and IRB. Researchers are required to consult with representatives of the communities in which the research will be carried out and from which subjects will be drawn and publicly disclose to those communities the research plan and its potential risks and benefits.
Situations When It Is Used
The use of a waiver of consent in emergency research is rarely used. The first clinical trial conducted under the emergency research waiver rule was a widely publicized study of an oxygen-carrying blood substitute: Baxter Laboratories’ HemAssist. Another trial conducted under the rule involved placing automated defibrillators in public venues and tracking the outcome of their use from experimental and control sites.
Please consult with the IRB Office if this type of consent may apply to your research.