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Investigator Initiated Studies
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Information:

This section is designed to assist in the submission of investigator initiated milfs
research.
 

Note: Some types of investigator-initiated research may not require review by an IRB but may qualify for another type of review as identified under "Other Categories of Review."

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

 

Prior to beginning any study related activities, the investigator is responsible for obtaining IRB approval of their study in addition to gaining approval for their participation as the Principal Investigator.

In some cases, review by the full board may not be required for study conduct approval and the proposed protocol may be determined to meet specific regulatory criteria eligibility for review by an expedited review [G] process.  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.

There are many different types of projects that an investigator may wish to take part in.  The type of information the board will need to perform their review is directly related to the type of study the investigator will be conducting.  E&I specializes their application forms into two types, clinical and non-clinical research.

Items required with Study submission:                                        

  • Study Application Form, signed (21A or 21B)
  • Copy of Protocol detailing the research aspects [G]                            
  • Consent Process, or Waiver of Informed Consent Process [G]           
  • Consent document(s) or Waiver of Informed Consent Form [G]         
  • Form 1572 (if applicable)
  • Investigator Brochure or package insert (Drug studies)
  • Device Brochure (Studies involving a device)
  • Recruitment Materials, Ads, Screening Scripts [G]                              
  • Surveys, Interview outlines
  • Case Report Forms (review only, not approved by the board)
  • Anything else considered to be part of the protocol

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.)

Items required with PI submission:                                                

  • PI Application Form (30A or 30B)                                                    
  • Current, dated CV
  • Copy of current professional license
  • Facility description or brochure
  • Human Subject Training certification(s) [G]

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:      

  • E&I Request for Expedited Review Form 22
  • E&I Investigative Drug Form 24A
  • E&I Investigative Device Form 24B [G]                                                   
  • E&I Special Populations Form 25A-D
  • E&I Waiver of Informed Consent Process 26A
  • E&I Waiver of Informed Consent Form 26B
  • E&I Waiver of HIPAA 26C
  • E&I Waiver of FERPA 26D
  • 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:

For Non-Clinical (Social, Behavioral, Educational) Research These types of projects typically do not test safety or efficacy of a product, but may at times involve products or devices in their design.  Often non-clinical research will fall under the regulatory guidance of OHRP [G], which varies slightly from FDA regulatory language.

E&I Study Application Non-Clinical / SBER (Form 21A)

E&I Principal Investigator Application Non Clinical Investigation Bio-medical (Form 30A)

For Clinical (Drug and/or Device) Research Submissions for review of these types of studies typically include a clinical investigation of a product or device and usually fall under the regulatory requirements of the FDA.  These studies are often designed to test safety or efficacy of a product.

E&I Study Application Clinical Investigation Bio-medical (Form 21B)

E&I Principal Investigator Application Clinical Investigation Bio-medical (Form 30B)

 

Supplemental Forms (as indicated):

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

E&I Request for Expedited Review (Form 22)

To identify your request for the expedited review process and the category being claimed.

E&I Investigative Drug (Form 24A)

To provide additional information needed only for investigative drug studies.

E&I Investigative Device (Form 24B)

To provide additional information needed only for investigative device studies.

E&I Supplement Employees (Form 25A)

When the PI intends to include employees as study participants.

E&I Supplement Pregnant Women (Form 25B)

When the PI intends to include pregnant women as study participants.

E&I Supplement Prisoners (Form 25C)

When the PI intends to include prisoners as study participants.

E&I Supplement Children (Form 25D)

When the PI intends to include children as study participants.

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 Waiver of HIPAA (Form 26C)

When the PI is covered entity and intends to fully or partially waive HIPAA for any or all participants.

E&I Waiver of FERPA (Form 26D)

When the PI is covered entity and intends to fully or partially waive FERPA 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.

Last Updated ( Wednesday, 16 September 2015 14:28 )