Human Research Protection Program News

Amendments to Exempt Studies

Effective immediately amendments to exempt studies are again being accepted by the Institutional Review Board (IRB). If you wish to make changes to an exempt study, please refer to our guidance "Minor Changes Not Requiring Review" located on our website at http://www.irb.purdue.edu/policies.php. For changes requiring IRB review, please submit an Amendment to Approved Study form or Personnel Amendment to Study form, whichever is applicable, located on the forms page of our website www.irb.purdue.edu/forms.php. If you have any questions after reviewing the above-referenced guidance, please contact the Human Research Protection Program office 765-494-5942 or irb@purdue.edu.

Updated Forms and Required Signatures

The Human Research Protection Program (HRPP) is in the process of updating forms and guidance on our website. Please be certain to use the forms from our website when submitting new applications and amendments rather than use previously saved versions from past submissions. Additionally, new applications and amendments must be submitted with all required signatures (i.e., principal investigator, department head). Submissions without signatures or signed by someone other than the required signatories (i.e., principal investigator, department head or department head’s designee) will be returned. Past versions of currently posted forms and submissions without the required signature(s) will be returned to the investigator as of April 1, 2012.

All future revised forms will be announced on our website’s homepage and a grace period identified allowing the submission of that form's previous versions to be accepted by the IRB.

Minor Changes Not Requiring Review

The HRPP and IRB have identified common changes to research activities and materials that they have determined to be minor and result in no additional risks or burdens, nor decreased benefits, to participants. These specific changes need not be submitted to the IRB for review and approval prior to implementation. These changes are identified in our new guidance Minor Changes Not Requiring Review found on the Policies page of our website. Please note, any changes not listed in this guidance as being minor must be submitted to the IRB for review and approval. If you have any questions after reviewing the above-referenced guidance, please contact the Human Research Protection Program office 765-494-5942 or irb@purdue.edu.