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. 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.
Submission Requirements for Exempt Status
If your project qualifies for exempt status (Exempt v. Expedited v. Full Board), send an electronic version of each of the following documents as attachments in an email message requesting exempt review, toIRB@drake.edu:
Protocol or study design, including list of references
Questionnaires/surveys
Interview questions
Other materials as needed to allow a thorough review
Submission Requirements for Expedited Status
If your project qualifies for expedited status (Exempt v. Expedited v. Full Board),send an electronic version of each of the following documents in an e-mail message requesting expedited review toIRB@drake.edu:
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
Submission Requirements for Full Board Status
If your project requires full-board review (Exempt v. Expedited v. Full Board), 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 email message requesting full-board review toIRB@drake.edu:
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