Submitting Documents

Submission Instructions

When submitting materials to the IRB for review, please review the information on this page to ensure a complete and accurate submission.

General Submission Requirements

  • It is important that each e-mail contain items for one project only. For example, the e-mail may contain the protocol, consent documents, and investigator brochure for one study.
  • Do not submit additional information regarding a study or protocol until the submission has been approved.
  • Do not submit hand written IRB applications as it makes it harder for the staff to provide the research team with and changes that are needed.
  • Submit only completed, fully-signed documents. An e-mail acknowledgement in place of a signature is prefered and acceptable.
  • Items that do not meet the submission requirements will be returned without review.
  • If the IRB requires changes to a submission, changes must be submitted to the IRB within 30 days of the pre-review email that is sent to the PI. If a response to the IRB or additional information is not provided within 30 days of the pre-review email, the submission will be withdrawn. If the PI decides after the submission has been withdrawn that they want the items to be reviewed then the submission will need to be resubmitted to the IRB and depending on signature dates it may require that new signatures be obtained.

Submission Email Requirements

  • The e-mail subject line must include:
  • IRB # (if assigned)
  • Principal Investigator’s last name
  • Type of Submission (new project, amendment, renewal, reportable item, etc.)
  • The body of the e-mail must include a list of the documents being submitted. Each document attached to the e-mail should be named to clearly reflect its content.

Attachment Requirements

  • Microsoft Word® documents are REQUIRED for:
  • Consents
  • Recruitment materials
  • Data collection instruments (if available)
  • Materials that are typically not revised by the IRB, such as investigator brochures, and sponsor protocols, may be submitted in PDF.
  • It is recommended that version dates be used when naming documents.

Please contact HSPP with questions.