The IRB meets every Thursday, and there is a submission deadline every Friday. Assuming the transaction is complete and appropriate expertise is available to review, transactions submitted for a Friday deadline will go to the next meeting 9 business days hence. Full transactions are reviewed at the meeting. Expedited and exempt transactions are reviewed by subcommittee and documented in the minutes.

What types of submissions need to be signed off by a signing authority? Just initial submissions? Or do Continuing Review, Modifications, Study Closures, etc need to be signed off also?

Type of Transaction	Principal Investigator	Department Chair	Business Administrator	iRIS Submitter
New study:	X	X	X
Continuing Review:	X
Amendment:	X
Change of personnel:	X
Annual Check-in for exempt/NFCR:				X
External IRB Annual Check-in				X
Reliance follow-up:				X
Administrative acknowledgement:				X

Requirement for PI signature for CR, Amendment, and Personnel change can be re-routed to a co-investigator or the chair when PI is unavailable in the short-term. For new study applications, application can be submitted without PI signature, but it must be obtained prior to release of IRB approval letter. This signature requirement cannot be delegated.

If the PI is also the Department Chair, does someone else have to sign off on the submission in iRIS? Who would that person be?

PIs cannot sign for themselves as this represents a conflict of interest. Someone in the next highest level of leadership would need to sign for a PI.

Do you have a list of incidents or problems that need to be reported to the IRB promptly?

(For example, in addition to UPs, we required non-compliance, audits, written reports of study monitors and breach of confidentiality to also be reported. )

In general, the eSAEy and eaZUP reporting systems accessible on our website capture reportable events. These systems populate from JeffTrial, so if a reportable event occurs on a study not in JeffTrial, a report can be emailed to our office by use the OHR-10 (SAE) or OHR-20 (UAP). These forms are available under Standard Forms on the forms page of IRB website. Other events that do not meet reporting requirements can be reported in individual or aggregate at the time of continuing review. When in doubt, researchers should contact our office.

Do you require the Informed Consent Document to be on letterhead. If so, do you have an electronic version that you can provide?

Yes, we generally require all Informed Consent documents to follow the OHR-8 template format. Please see the IRB Forms & Submission Materials page for blank templates.

I'm assuming that some information in our current consents (ie IRB contact information, Privacy contact information, Greenphire Clincard, MCARE, etc) will need to be updated to more align with Jefferson's template. Do you suggest that study teams submit these changes immediately with a modification, or is with the next Continuing Review or Modification submission sufficient?

If study is open to enrollment, then consent form should be updated asap so that it can be used for new enrollment. For studies closed to enrollment, investigator should make determination as to whether some, none, or all of currently enrolled subjects need to be informed of specific changes. There may also be alternate mechanisms for notification, such as a simple update document that could be mailed or handed to a participant. This should be submitted as an amendment.

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