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This section provides guidance for the submission and timeline of the ACIRB process.  The principal investigator[i] must comply with the following procedures and complete the ACIRB Review form or the ACIRB Exempt Review Form and submitting one copy of the fully signed, original application with all supporting documents (e.g., recruitment materials, data collection materials, consent forms, letter of support from the client, etc.) electronically to:  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .  Forms submitted by student PIs must also include the contact information and signature of his/her supervising faculty member.

STEP ONE:   

IRB APPROVAL FROM OTHER INSTITUTIONS:  The PI must determine if there is an IRB associated with the institution where the project will take place and submit an application for review to that IRB. For example, projects conducted at Allen Hospital need to be reviewed by the ACIRB.  The IRB associated with the study setting must provide documentation stating the project has been approved or the project does not require review.  In the absence of an IRB associated with the study/project setting, the letter of cooperation (see STEP FIVE below) must state that the participating institution does not have an IRB.

STEP TWO:

Permission to access private records such as student, medical, or employment records, and so on that are protected by FERPA, HIPAA, or other confidentiality policies, must be obtained from the holders of those records.  The PI must obtain permission and provide documentation to the ACIRB from the institution(s) as required by their policies.  Please note that ACIRB approval in no way implies or guarantees that permission from these other entities will be granted.

STEP THREE:

Complete human subjects research protections training.  Allen College requires all PIs and key personnel whose projects or studies involve human participants to undergo training in the protection of human subjects.  Each ACIRB applicant must complete the training and submit an electronic copy of the completion certificate with the ACIRB application.  The recommended training website is as follows:

The National Institutes of Health: http://www.grants.nih.gov/grants/policy/hs/training.htm.  To access the training, go to this website and select the “Protecting Human Research Participants” link in the narrative (in the second paragraph).  You will be prompted to register.  There is no cost to register.  Once your course is completed, print the certificate and include the certificate with your application when you submit your protocol to the ACIRB for review.

STEP FOUR:

Complete the appropriate ACIRB application for human subjects review.  Two applications are available: 

  1. ACIRB Review Form; this form should be completed for projects that meet the definition of research that is eligible for expedited or full review.  If the PI anticipates the project will need full board ACIRB review, all materials must be submitted two full weeks (fourteen calendar days) in advance of the next scheduled ACIRB meeting.  Please refer to the ACIRB website for the meeting schedule.    
  2. ACIRB Exempt[ii] Review Form; this application may be used in place of the ACIRB Review Form for projects that are determined to be EBP/QI or qualify for exempt review.  (Note that the AICRB Review Form CAN be used for exempt projects.)  The ACIRB makes the final decision as to the appropriate level of review.  If the ACIRB Exempt Review Form is filled out but the ACIRB determines the review to be expedited or full, the PI must complete the ACIRB Review Form prior to the project being reviewed.  To assist PIs in making a decision about whether to fill out the ACIRB Review Form or the ACIRB Exempt Review Form, contact the ACIRB for assistance: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

STEP FIVE:

Include all supporting documents with the appropriate review form.  All PIs are required to submit the following:

1.   Documentation of approval from the IRB from the project setting if conducted outside of
      Allen Health System.
2.   Allen College students must submit the approved project proposal (i.e. the proposalf
      paper submitted to the faculty advisor or course instructor that details the project).
3.   Documentation of cooperation from the participating project setting.  Refer to the
      “ACIRB Sample Letter of Cooperation” for guidance in preparing this documentation.
      You are encouraged to share this letter with the representative official who will write
      the letter of cooperation.  Documentation should be provided using one of the following
      methods:
      a.   Letterhead from the participating institution signed by an individual authorized to
            approve the project at that institution..
      b.   An email sent from the email account of an individual authorized to approve the
            project at that institution.
4.   All surveys, questionnaires, and/or interview protocols that will be used during the
      project.
5.   All consent forms, cover letters, recruiting letters, signup sheets, recruiting posters/
      flyers, or any other documents needed to conduct the project.  Several ACIRB
      documents are available to help you prepare these documents appropriately.

STEP SIX:

Complete the ACIRB Application Checklist to verify that all items have been included in the submission.  Be sure to include the checklist when you submit your application to the ACIRB.     

STEP SEVEN:

When the documentation from steps one through six has been gathered, each file needs to be named using the following format:  PI Last Name-File Name-Date submitted.  (e.g. Jones-ACIRB Review Form-1-1-14).  Please remove all blank pages from any electronic files.  Please submit all documents in one email message to:  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .   

STEP EIGHT:

At the conclusion of the project, all PIs are required to complete the ACIRB Project Completion Form and submit to the ACIRB at:  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

STEP NINE:

If the project is not concluded within 365 days from the initial approval date, the ACIRB Project Continuation Form must be completed and submitted 30 days prior to the one year anniversary of the initial approval date and submitted to:  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

ADDITIONAL INFORMATION FOR PIs AND FACULTY ADVISORS: 

  1. The ACIRB is responsible for making the final decision on level of review (e.g. exempt, expedited, or full review). 
  2. The ACIRB reserves the right to request further information or to ask questions of the PI regarding information that was submitted.  Applications that need corrections or revisions will be returned to the PI from the ACIRB chair within 7 business days from the initial submission and will be reviewed after resubmission at a future meeting.  Applications that are not resubmitted within 90 days of original notification will be void.
  3. Student PIs are encouraged to carbon copy (CC) the faculty advisor on all electronic communication with the ACIRB and to work closely with the faculty advisor during the review process.
  4. Faculty advisors are required to CC the principal investigator on any submissions made to the ACIRB on behalf of the PI.

[i] Principal investigator is defined as a student, faculty/staff, or external investigator who plans, leads, manages, and conducts a project.

[ii] Projects determined to be ‘exempt’ are not ‘exempt’ from IRB review.  An exempt review is based on the ethical principles outlined in the Belmont Report (Respect for Persons, Beneficence, and Justice) and is only exempt from 45 CFR 46 (the Common Rule) during the IRB review process. 

 
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