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ROC 101 - Research for EMS Providers


Consent

Informed consent is voluntary approval given by a person for participation in a study after being informed of the purpose, methods, procedures, benefits and risks. It is an ongoing process that allows the patient to decide whether to enter, continue, or withdraw from a research study.

In the prehospital setting, it is often impractical for patients to give consent. Therefore, under very special circumstances, provisions are made for emergency medical research to be conducted without voluntary informed consent. This is called an emergency exception from consent.

An emergency exception is allowed ONLY when the Institutional Review Board or Research Ethics Board has determined that a research study meets ALL seven of the following criteria:

1.  Situation is life-threatening
2.  Available treatments are unproven or unsatisfactory
3.  The research is necessary to determine best intervention
4.  Informed consent not feasible
5.  Patient may directly benefit
6.  Study could not otherwise be done
7.  Community consultation fulfilled

Your medical director or study coordinator will tell you if a research study has been approved to use an emergency exception from consent. In most cases where an emergency exception is used, the patient or family must later be notified and consent given to continue in the study.  The study coordinator is responsible for follow-up with the patient or family.

The requirements for informed consent are spelled out in laws and international standards that are rigorously enforced. When emergency exception from consent is NOT approved for use in a study, all patients must meet these requirements for informed consent:

• Voluntary
• Given prior to enrollment in the study
• With understanding of the potential risks and benefits
• Without fear of consequence
• Documented in writing


Click US Regulations for more information on U.S. lawregarding informaed consent of human subjects (FDA Website)


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