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Human Subjects

Electronic Stamp

Beginning July 9, 2015 approval stamps on informed consent documents will be automatically applied by KC IRB and will take on a watermark format. The electronic approval stamp will no longer contain approval or expiration dates. The electronic stamp will not be applied to assent documents after July 9, 2015. These changes have been carefully analyzed and will end a long-standing convention; however, human subjects will continue to be protected by the consent and assent processes. In addition, the ability to identify and track approved forms will be maintained.

What you should know:

  • KC IRB will apply one of several different versions of the electronic stamp, depending on the status of the protocol. Electronic stamps will appear as follows:
    • For studies Open to Enrollment: Protocol 1501429309 IRB Approved
    • For studies Closed to Enrollment: Protocol 1501429309 IRB Approved for re-consenting only
    • For studies in Data Analysis Only: Protocol 1501429309 IRB Approved – Do Not Enroll Subjects
    • For disapproved studies: Protocol 1501429309 Disapproved
    • For expired studies: IRB Approval of Protocol 1501429309 Expired DD-Month-YYYY
    • For closed studies: Protocol 1501429309 Closed
    • For Applications for Non-Human Subjects Research: 1501429309 determined IU IRB Review Not Required DD-Month-YYYY
  • The electronic stamp will be applied by KC IRB to any unsecured PDF on the Notes & Attachments tab. This means that informed consent documents must remain unsecured, while any PDF documents that do not require a stamp should be secured. Study teams will be encouraged to secure any PDF documents that do not require a stamp prior to uploading to KC IRB, and HSO staff will work closely with study teams to ensure that existing documents that do not require stamps (i.e., not informed consent documents) are secured.
  • To protect PDF files in Office applications for Windows:
    • Click the Create PDF button in the Acrobat task ribbon.
    • Type a file name and select Restrict Editing.
    • In the Security dialog box that opens, set up a password and permissions as desired.
    • Click OK, and then click Save.
  • The electronic stamp is applied by KC IRB when the document is viewed and downloaded. The correct stamp, per protocol status, will be applied to the current informed consent document each time it is viewed.
  • If you view documents from the Notes & Attachments tab within a submission protocol (i.e. followed by A00X or R00X), any unsecured PDF which was not affected by the amendment or renewal will be marked with a stamp which reads “Invalid copy – not being modified with this Amendment or Renewal.”  Final, approved study documents should always be retrieved from the Notes & Attachments tab of the main protocol.

Versioning Your Documents

Since the stamp will no longer include approval or expiration dates, it is very important for study teams to utilize version dates and/or version numbers. A few tips to remember:

  • Be consistent. Develop a naming and versioning convention to be used by all members of the study team. Document your naming convention in your study files where all team members, monitors, and auditors can reference it.
  • Abbreviate standard document types to reduce the length of file names (e.g. Protocol = PRO, informed consent statement = ICS; assent = AST)
  • Include version dates/numbers in document footers and document file names.
  • Format dates consistently and choose a clear standard. Always include the year.
  • Be sure to update version dates/numbers in document footers each time the document is revised.

HSO staff will facilitate the transition to the new electronic stamp as much as possible.

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