Information:

When research, or intended future research involves the acquisition or use of waste biological specimens it is considered to be human subjects research.  This section is intended to provide review and submission information for research involving biological specimens.

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

In an oddity of regulation, the device regulations found in 21 CFR 812.3 define a human subject as a person "on whose specimen" a study is done.  A clinical investigation with human subjects requires IRB review.

IRB review is governed by 21 CFR Part 56.  Part 56 requires the IRB to assess the informed consent process and documentation.  FDA allows very few waivers of consent and none that apply to use of waste specimens. Thus, the IRB should require consent from the original (presumably anonymous) donor.

FDA's guidance of April 25, 2006 [G] recognized that obtaining informed consent from the unidentified donor of a left-over specimen is difficult and that, while consent cannot be waived, they will use their "enforcement discretion" in inspections of device studies regarding the issue of informed consent.  This placed the responsibility on the IRB to decide how much discretion to use.

To do its job, the IRB needs sufficient information to determine that the required review elements can be met.  This form should accompany a protocol for the acquisition and use of the specimen.  We do not wish to receive a laboratory protocol.

Items required with Study submission:

• E&I Request for Expedited Review (Form 22)
• E&I Acquisition & Use of Waste Biological Specimens (Form 4.41D)            
• E&I Indemnification Form (Form 4.50)

• Sample Consent Form

The IRB has a regulatory obligation to consider the local perspective of where the study will take place.  As part of this consideration the board will determine whether or not the investigator's training and experience qualifies them to perform the designated functions required by the design of the study.  Before approving an investigator, the board must first obtain relevant information about the individual and their location.  This information is typically requested in a PI application form (also referred to as a submission or cover form.)

Item required with PI submission:

• E&I Principal Application Short Form (Form 4.41C)
• Current, dated CV
• Copy of current professional license
• Facility description or brochure

• Human Subject Training certification(s)

Based on the information provided in your E&I Application Forms, additional submission items, or supplemental forms may be required.

Items required only if applicable to your site/study:

• Copy of grant
• E&I Conflict of Interest Form 31
• E&I Satellite (Additional) Sites Form 32
• E&I Local IRB Waiver Form 33 or 34
• Letters of explanation as indicated on application form
• Documentation of FDA audits

Forms:

Standard Forms:

E&I Acquisition & Use of Waste Biological Specimens (Form 4.41D)

 To request IRB approval for acquisition and use of biological specimens

E&I Request for Expedited Review (Form 22)

To identify your request for the expedited review process for secondary use of specimens

Supplemental Forms (as indicated):

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

E&I Waiver of Informed Consent Process (Form 26A)

When the PI intends to waive informed consent for any or all participants.

E&I Waiver of Informed Consent Form (Form 26B)

When the PI intends to waive documentation of the informed consent process for any or all participants.

E&I Conflict of Interest (Form 31)

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

E&I Local IRB Waiver (Form 33 or 34)

To assure that your local IRB agrees to waive jurisdiction to E&I.

E&I Satellite (Additional) Sites (Form 32)

To identify any additional or satellite sites, which the PI intends to conduct study procedures.

E&I Indemnification form 

E&I may require completion of an indemnification form.