NEW! Updated HSC IRB Application Version is Live
Published: Tuesday, January 22, 2019
NEW! Updated HSC IRB Application Version is Live, Effective 1/22/2019:
A new version of the HSC IRB Application has been published. Users MUST convert to the new form version when prompted by iRIS.
Below is a summary of changes. Be sure to address all of the required action items below before submitting your revised application to the IRB. Any missed or incomplete questions will be returned for correction before IRB review of your submission can be completed.
- Section 1230, Waiver of Signed Written Consent: New Category 3 option added for new studies / post-RCR (post-2018 Common Rule) studies only!
- No action should be required for applications that branch to this section.
- Check this section and if your answer is erased, select the same category as before. The new option for Category 3 is only allowed for new studies that comply with the 2018 Common Rule (aka, Revised Common Rule), effective 1/21/2019.
- Section 1240, Waiver of Signed Written Consent: Replaced question with a new sub-form that is to be completed for ALL studies that branch to this section.
- ALL ongoing studies (and pending applications) that branch to this section MUST complete the new sub-form before submitting to the IRB.
- Section 1500, Review or Analysis of Records/Data/Biological Specimens: Replaced the 4th question in this section with a new question to identify whether any member of the study team will use identifiable information as part of the chart review.
- ALL ongoing studies (and pending applications) that branch to this section MUST answer this new question.
- Section 1600, Privacy & Confidentiality: Added a new question before the Certificate of Confidentiality question. It is the 4th question in this section and the remaining questions have moved down one.
- ALL ongoing studies (and pending applications) MUST answer this new question before submitting to the IRB.