5.2 Submission Requirements and Review Process
        5.2.1 Determination of Exempt Status
        5.2.2 Expedited Review
        5.2.3 Full Board Review

5.2 SUBMISSION REQUIREMENTS AND REVIEW PROCESS
 Once you have determined which type of review is required for your project (Section 5.2), prepare your submission to the IRB accordingly, as described below.  The review process for each type of IRB review is also described in this section.

Throughout the review process and subsequent administration of the project, research investigators are responsible for complying with all IRB decisions, conditions and requirements.  If revisions in the proposed protocol or informed consent document are required by the IRB, these revisions must be submitted to and approved by the IRB before the research project can begin.

5.2.1 Determination of Exempt Status

Submission Requirements
If your project qualifies for exempt status, send an electronic version of each of the following documents as attachments in an e-mail message requesting exempt review, to IRB@drake.edu:

  • A completed "Application for Determination of Exempt Status" form
  • Protocol or study design, including list of references
  • Questionnaires/surveys
  • Interview questions
  • Other materials as needed to allow a thorough review

Review Process
 The IRB Chair is responsible for reviewing preliminary determinations of exempt status and making the final institutional determination about whether a research protocol qualifies for exemption from coverage under 45CFR46.101 or 21CFR56.104.  After you have submitted your application, the IRB Chair will review your submission and will notify you in writing of the official determination within approximately fourteen (14) days.  If the Chair determines that your project does not qualify for exempt status, you will be asked to submit your protocol for either expedited or full board review, as appropriate.

Exempt research is subject to continuing IRB review (See Section 5.2.6)

5.2.2 Expedited Review

Submission Requirements
If your project qualifies for expedited status send an electronic version of each of the following documents in an e-mail message requesting expedited review to IRB@drake.edu:

  • A completed "Application for Expedited Review" form
  • Protocol or study design, including list of references
  • Informed consent document
  • Assent document(s), if applicable
  • Parental consent document, if applicable
  • Questionnaires/surveys
  • Interview questions
  • Other material as needed to allow a thorough review
  • Advertising or information flyers, brochures or materials, if any
  • If the research project being submitted has been previously reviewed by a local or institutional IRB other than the Drake University IRB, a copy of the approval or disapproval notification from that IRB

Review Process
 After you have submitted your application for expedited review, your submission will be reviewed by the IRB Chair and/or one or more experienced IRB members designated by the Chair.  The reviewer(s) may exercise all of the authorities of the IRB except that the reviewer(s) may not disapprove the research.  The reviewer(s) will complete the review within 2-3 weeks and will make one of the following determinations:

  • Approved
  • Approved pending modifications
  • Requires full board review

You will be notified in writing of the determination.  If you are asked to make changes, allow one week for the IRB to respond once you have submitted the requested changes.

Activities approved through the expedited review process are recorded in the IRB meeting minutes, which are distributed to the full IRB five days prior to the next regularly scheduled IRB meeting.  At a convened IRB meeting, any member may request that an activity that has been approved under the expedited review procedure be reviewed by the full IRB in accordance with full board review procedures.  A vote of the members shall be taken concerning the request and the majority shall decide the issue.  Full IRB decision shall supercede any expedited review decisions.

5.2.3 Full Board Review

Submission Requirements
If your project requires full-board review,  then at least one week prior to the next scheduled full-board IRB meeting, send an electronic version of each of the following documents as attachments in an e-mail message requesting full-board review to IRB@drake.edu:

  • A completed "Application for Full Board Review" form
  • Protocol or study design, including list of references
  • Informed consent document
  • Assent document(s), if applicable
  • Parental consent document, if applicable
  • Questionnaires/surveys
  • Interview questions
  • Other material as needed to allow a thorough review
  • Advertising or information flyers, brochures or materials, if any
  • Any other documents that will be given to research subjects
  • If the research project being submitted has been previously reviewed by a local or institutional IRB other than the Drake University IRB, a copy of the approval or disapproval notification from that IRB

Review Process
If your project requires full-board review, you will need to submit your materials one week prior to the scheduled full-board meeting at which you wish to have your proposal considered. You should also contact the IRB Chair if you wish to personally present your proposal at that meeting.  In some cases,  the chair might contact a Principal Investigator to arrange for the PI to attend the meeting in order to address questions or concerns about a proposal.  IRB meetings only occur monthly, so it is important to make submissions on time.

IRB Review Responsibilities The IRB shall have the responsibility to review and authority to approve, require modification in, table, or disapprove all research activities.  Each board member will study the protocol under review to ensure that no unnecessary or unacceptable risks are present and that adequate precautions are provided for research subjects.  IRB members shall have access to all documents relating to the research protocol, including all information provided by the research investigator and others with a vested interest in the research (i.e. other institution, pharmaceutical company or corporation, etc., as applicable)

Presenting at the IRB Meeting The Principal Investigator or co-investigator may be asked to explain the purpose for, risks of, and alternatives to the proposed research, including subject selection and exclusion criteria at the IRB meeting  IRB members are then encouraged to ask clarifying questions concerning the protocol and consent process.  The investigator is dismissed from the inquiry and any IRB members who have a conflict of interest with the project are excused from the meeting.

IRB Action IRB members will make determinations regarding the category of risk, risk and benefit issues and whether informed consent procedures are adequate.  The IRB takes one of the following actions:

  • Approval The IRB informs the PrincipalInvestigator of its approval along with a copy of the approved informed consent document with the IRB date noted on each page.  The Principal Investigator may begin the research project upon receipt of IRB written approval.
  • Approval Subject to ModificationThe IRB shall provide written notice to the Principal Investigator of its approval subject to modification, identifying specific areas of modification required.  The Principal Investigator must provide the IRB with a revised protocol and/or informed consent document incorporating the modifications.  The IRB Chair or designated member of the IRB shall review the revised protocol and/or consent document within one week of receipt of the revised documents.  The IRB reviewer will then provide written notice to the Principal Investigator granting final approval of the protocol if the required modifications have been made.  The notice of final approval will include a copy of the approved informed consent document with the IRB date noted on each page.  The Principal Investigator may begin the research project upon receipt of IRB written approval.
  • Tabled The IRB requires additional information and has a concern regarding the proposed research project.  The Principal Investigator will be notified of the IRB decision and will be allowed to address the issue at the next regularly scheduled IRB meeting.
  • Disapproval If the IRB disapproves a research protocol, the IRB shall provide to the Principal Investigator, in writing, the reasons for the IRB decision and an opportunity for the Principal Investigator to appeal the decision. 

    APPEAL PROCESS The appeal process consists of resubmission of the project to the IRB, with or without modification, accompanied by a letter from the Principal Investigator indicating why he or she feels the project should be again considered by the IRB.

All actions taken are recorded in the minutes.  Minutes of the IRB meetings are forwarded to IRB members and the Provost and may be forwarded to other institutional officials or administrators.  Specific letters of instruction based on the IRB review are sent to each Principal Investigator.

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