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Not all hot moms
research projects require review by an IRB at a full board meeting.  This section will help to interpret the regulatory requirements, different review categories, and the submission instructions for other categories of review available through E&I.

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

Information:

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

Grant or General Approval

A grant application envisioning involvement of human subjects is likely to need IRB approval at the time of submission.  Many applications however, have no subject involvment until later phases or years, or have multiple projects.  In fact, often the protocol cannot be written without information from the propriatory work. 

E&I offers a General Approval representing IRB acceptance of the ideas in the grant application with the condition that no subjects can be approached without IRB approval of the specific study.  To request this type of review the investigator's submission must include:

  • E&I Consideration of a Grant Application (Form 10), completed
  • Cover letter of explanation, with pertinent instruction or correspondence from funding agency
  • Current time line of project
  • Copy of grant application
  • Indemnification form 4-50, if not already on file 

Not Human Subjects Research

For a research project to require submission to an IRB it must be "research" involving "human subjects" as defined by regulation. [G]  If the project does not meet the regulatory definitions of "research" involving "human subjects" then IRB review is not required.  On occassion, a funding agency or journal will ask an applicant to provide an external determination that the activity does not, or did not consitute "Human Subjects Research."  Generally, this only occurs if the determination is a close call.

E&I offers reviews of an investigator's determination of "Not Human Subjects Research" and upon agreement, will proivde a written confirmation of the determination.  To request this type of review the investigator's submission must include the following:

  • E&I Request for Determination HSR (Form 11), completed
  • Copy of any associated grants
  • Additional supporting documents, if any

Human Subjects Research Exempt from IRB Review

If an activity subject to regulation is deemed to be research with human subjects, [G] it may be exempt from IRB review if it qualifies under an exemption category as defined in 45CFR46.101(b). [G]  Activities exempt from the IRB review process are often submitted to E&I for the purpose of having an uninvolved, third party assess that the exemption is claimed correctly.

E&I offers reviews of an investigator's assertion of exemption from IRB review, and upon agreement, will provide written certification of agreement.

  • E&I Request for Exemption from IRB Review (Form 12), completed
  • Copy of Applicant Investigator's current CV
  • Copy of grant or project description
  • Consent Docuement(s)
  • Additional supporting documents, if any

IRB Review Qualified for Expedited Process
 

In some cases, the regulations allow for an expedited review process to be used in lieu of a full board review.  When a study is determined to be less than minimal risk and the proposed protocol qualifies under one of seven pre-determined categories the study may be determined to be eligibility for an expedited review  process [G].  If you believe your study may qualify under the applicable regulatory requirements for expedited review, and would like your project reviewed utilizing this process, you will be asked to submit an E&I Expedited Review Request (Form 22) as part of the Study Application Form. 

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 "Other" Study Review Forms: 

E&I Consideration of a Grant Application (Form 10)

To apply for "General Approval" representing IRB acceptance of the ideas in a grant application with the condition that no subjects can be approached without IRB approval of the specific study.

E&I Request for Determination HSR (Form 11)

To apply for written confirmation of an investigator's determination of "Not Human Subjects Research," often upon request of funding agency or journal.

E&I Request for Exemption from IRB Review (Form 12)

To apply for written confirmation of an investigator's determination of "Not Human Subjects Research," often upon request of funding agency or journal.

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.

Last Updated ( Wednesday, 16 September 2015 14:26 )