Updates from OHRS - May 22, 2025

May 28, 2025

A few important reminders from OHRS:

Please Use the Current Informed Consent Form Template (Version 01.06.2025)

OHRS released a new version of the Informed Consent Form templates in January. Starting June 2nd, all New Protocol Applications will be required to use this updated version of the consent form. Any new protocol submissions submitted after this date using a prior consent version will be sent back to the research team as an IRB pre-review condition to be updated to the new version of the ICF. Please see below for a direct link to these templates which can also be found on the OHRS website.

Please note that while it will not be required to update previously approved versions of the consent form to this new template, research teams may opt to use the new template for amendments moving forward.

Amendments that Revise Informed Consent Forms Must be Downloaded from iRIS

As a reminder, when submitting an amendment that revises the ICF, the iRIS WIKI Instructions should be followed so that the most current IRB approved consent version is submitted with track changes as well as for the clean version of the ICF. Please do not edit and submit versions of documents saved on desktops and instead follow the iRIS WIKI instructions, so that we can easily identify it as the latest approved version of the ICF. ICF documents submitted in a different manner may be returned to the study team without review to follow our version control process.

Please see the link to the iRIS WIKI Instructions.

Translating Previously Approved Consent Documents

When sending the English version of ICFs to be translated, please remember to download the consent documents from iRIS as per the iRIS WIKI Instructions. Please do not download the documents from OncPro, as this will cause a date of download to appear at the top. The consent forms should not have the ODQ applied headers or footers included in the document when sending it to the translators. If allowed by the translation vendor, please request a Word version of the translated form, or an unlocked PDF to facilitate the Activation process where ODQ will apply a new header and footer.

Please let us know if you have any questions (OHRS@dfci.harvard.edu).