Not all research projects are designed for multiple participants.  This section will help to interpret the regulatory requirements, different review categories, and the submission instructions for categories of review of individual, or one time use available through E&I.  This section is intended as a starting point only, please contact E&I for more information on these types of review.

[G] indicates a link to more information about a requirement.  Additional guidance can be obtained under the Guidance menu on the website.

There are several different categories that a research project may fall into when considering whether or not IRB approval should be sought. 

Emergency Use

Treating a patient with an investigational drug or device requires IRB review.  Occasionally, however, there is an emergency situation in which use of the drug or device is ideal but there is no time to obtain approval.   If there is time, consult the IRB before use.  If there is insufficient time, send the report within 5 working days after use.

Emergency Use of an investigational item must be reported to the FDA within 5 days of use.

Note: E&I will provide the IRB of record only if you are a previously approved investigator or if E&I (IRC or ERC) has an on-going relationship with your site.

Items required with Study submission:

• E&I Notification of Emergency Use  (Form 18), completed
• Cover letter of explanation, with pertinent detail
• Current time line of project
• Copy of Informed Consent Document (if applicable)

Individual Use (Non-Emergency)

Humanitarian Use Device (HUD)

Humanitarian devices are cleared for marketing based on a claim that fewer than 4,000 patients per year in the U.S. have this indication. Basic safety information has been gathered but efficacy information may be weak. In order to use a humanitarian device the requesting physician must (unless
there is a medical emergency) obtain IRB review before use of the humanitarian device. 

Items required with Study submission:

• E&I Study Application HUD MD (Form 76), completed

• Risk Analysis

• Additional supporting documents, if any

Supplemental Forms (as indicated):

• IDE Letter 
• Report of prior investigations

E&I is always willing to discuss the specifics of any given study to assist an Investigator in determining what their review needs are in accordance with the regulations.

Forms:

Standard Study Review Forms:

E&I Notification of Emergency Use  (Form 18)

For submission following treatment of a patient with an investigational drug or device in an emergency situation.

E&I Study Application HUD MD (Form 76)

To request IRB approval prior to use of humanitarian device in non-emergency setting. 

Supplemental Forms (as indicated):

When indicated on the PI Application form, these forms should be completed and attached to the submission packet. 

E&I Conflict of Interest (Form 31)

To identify potential conflict of interest as well as possible plans to manage it.