Submission Standards and Checklist

Initial new study applications should be complete and “review-ready” when they are first submitted to the IRB.

If you have questions or concerns about your submission, please contact us before you submit your study at 502-852-5188 or at hsppofc@louisville.edu.

Initial Submission Checklist

Consent Documents Section -

Please include all applicable items:

  • Combined Consent & Research Authorization form (if viewing/collecting/disclosing PHI), including any parental consent forms
  • Assent form  (if applicable, for pediatric studies)
  • Partial Waiver  (if applicable, for viewing PHI to screen applicable subjects)
  • Complete Waiver (if requesting a waiver of informed consent, e.g. chart review studies)
  • Preamble (if applicable, e.g. survey study)

Template documents and instructions located online at: http://louisville.edu/research/humansubjects/templates/links-to-forms

     

    Other Study Documents Section-

    Please include all applicable items:

    • Final study protocol version (including IND # if applicable)
    • Investigator’s drug/device brochure
    • Recruitment materials, including copies of ads, flyers, etc.
    • Telephone scripts
    • Pamphlets and study handouts (e.g. subject diary)
    • Questionnaires and survey instruments (excluding standard questionnaires that would be done outside of the research study)
    • Focus group or interview guides
    • Federally funded studies only: Human Subjects section of grant, proposal, or progress report
    • Data collection sheets (required only for chart review studies)
    • IRB approval letters and/or letters of support from collaborating or cooperating sites
    • Notes on difficult ethical issues, special considerations for review, or requests for special handling (optional)

    Study Application Tips:

    • Provide the requested information in an easy to read summary of the study.
    • As much as possible, avoid the use of jargon, define acronyms, and provide context for uncommon procedures to help the committee members quickly understand what the research involves and assess risk.
    • Use care when sourcing information from the Sponsor’s Protocol – some protocols are well-written and brief while others include too much detail for the IRB review. Most content will need to be edited down.
    • Proof-read the entire application, checking for clarity, completeness and consistency throughout.
    • If you started with a copy of another study, pay careful attention to ensuring that any remnants of the original study have been removed and replaced with details about the new study. Leftover references to procedures and risks from other studies are a common cause for confusion and return by the committee.
    • Route the iRIS submission to your Scientific Scholarly Merit Reviewer and Department Chair (http://louisville.edu/research/humansubjects/lifecycle/initial-submissions)

    Consent Document Tips:

    Study Document Tips:

    • Remember to attach a partial waiver or complete waiver document (if research involves viewing or collecting protected health information)
    • Use easy to interpret document file names and categories so reviewers can quickly see what it is. (Include the version dates in your file names).
    • Proof-read & spell check the attachments. Ensure they are consistent with the Study Application.
    • Use version dates or version numbers in the footer & file name to track your documents and update them when submitting revisions.
    • Submit tracked and clean versions of documents that are being changed.
    • Remove instructions in RED from header/footer of IRB templates.

    Before You Submit:

    • Proof-read the submission to ensure there aren’t inconsistencies between sections or between the application and attachments.