PPM Section 240-60

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Medical Emergency

Circumstances

Informed Consent

HSRC Chair Concurrence

Required Reports

National Institutes of Health (NIH), Office for Protection From Research Risks (OPRR) Regulations

Non-Emergency Situations--No Approved Protocol

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Chapter 240, Research Involving Human Subjects
Section 60, Medical Emergency--No Approved Protocol
Approved: 9/8/95, renumbered 4/14/05
Supersedes: New

Responsible Department: Office of Research
Source Document: N/A

Medical Emergency

Federal regulations do not allow research involving human subjects to be initiated without prior review and approval by a duly constituted quorum of the Human Subjects Review Committee (HSRC) unless a medical emergency (life-threatening) situation exists.

In a medical emergency certified in writing by two licensed physicians (i.e., the investigating physician and a consulting faculty physician who is not otherwise participating in the clinical investigation), emergency use of an investigational drug or device may be undertaken without prior HSRC review and approval of a protocol.

Circumstances

The following circumstances must exist:

Life-Threatening Situation. The subject is confronted by a life-threatening situation necessitating the use of the test article.
No Alternative Treatment. No alternative method of approved or (generally) recognized therapy is available that may save the life of the subject.

Informed Consent

Written informed consent containing all the necessary elements (as described in Section 715) must be obtained from the subject, or if the subject is unable to provide consent, the subject's legally authorized representative.

In a situation where informed consent cannot be obtained, refer to Section 715, under Medical Emergency--No Consent Possible. Procedures described there, rather than in this section (745), apply.

HSRC Chair Concurrence

The investigator must obtain concurrence from the HSRC chairperson (or in the chair's absence, from a physician serving on the HSRC) prior to use of the test article unless, due to the nature of the emergency, prior concurrence is impossible. Contact the HSRC Coordinator (752-6838) for assistance in this process.

Required Reports

Both the investigating physician and the consulting faculty physician must certify in writing to the HSRC all the foregoing circumstances.

Documentation of the medical emergency, including a copy of the consent document used, must be submitted to the HSRC within 5 working days after use of the test article. Any subsequent use of the test article requires a protocol and approval by the HSRC.
If it was not possible to obtain a consulting opinion before emergency use of the test article, a written opinion shall be made within 5 working days by a faculty physician who is not participating in the clinical investigation.
If it was not possible to obtain concurrence of the HSRC chair prior to emergency use of the test article, the investigator must also submit a written explanation of the reason why concurrence could not be obtained.

National Institutes of Health (NIH), Office for Protection from Research Risks (OPRR) Regulations

Whenever emergency medical care is initiated without prior Institutional Review Board (IRB) review and approval, the patient may not be considered to be a research subject. Such emergency care may not be claimed as research, nor may the outcome of such care be included in any report of a research activity.

Non-Emergency Situations--No Approved Protocol

As stated above, Federal regulations do not allow research involving human subjects to be initiated without prior review and approval by a duly constituted quorum of the HSRC unless an emergency (life-threatening) situation exists.

Occasionally, circumstances may arise where a patient, although not in a life-threatening situation, would be best benefited by being promptly enrolled in a research study and/or by receiving an investigational drug or device.

If the activity involves minimal risk, refer to Section 720 for information regarding the expedited review process for protocols.
If the risk level is greater than minimal, and it can be established that the risk is greatly outweighed by the possible benefits, the investigator should contact the Office of Research and the chairperson of the HSRC to request that a special meeting or telephone conference be arranged.