July 2021 MRAM Q&A Follow Up

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NIH - Other Support eSign Update

Q1: When are e-signatures required?
A1: NIH will require as of January 25, 2022, see NOT-OD-21-110.

Q2: How do you flatten a PDF?
A2:There are many ways to flatten a PDF. NIH suggest the easiest is to print as a PDF.

Q3: Will other federal agencies will follow NIH in requiring e-signatures?
A3: With NIH's plan for SciENcv (a federal system) integration in January 2022, we would not be surprised to see this requirement adopted by other agencies (e.g. NSF). We’ll keep our eye out for any news and share with you.

Q4 : if another institution is asking for the new OS format, can we say UW has not yet adopted it or should we adapt to new format?
A4
: If a pass-through entity (PTE) sponsor requests Other Support Documentation in the new format; we recommend using the new format per their request. If you expect this to occur, we recommend you try out the new format with your PI/senior key personnel now.

Q5: Are Adobe certified e-signatures acceptable if a Division does not have DocuSign?
Q6: Are Adobe signatures acceptable on Other Support?
A5 & 6: This response is both for Q5 and Q6. We recommend DocuSign, or ink signature and scan method.

Why?

NIH uses the phrase “electronically sign”, however, their guidance for these electronically signed documents appears consistent with the federal requirement for a “digital signature” 21 CFR 11.3(b)(5).

A digital signature is one that includes a unique key embedded in the file as an additional layer, which makes it “verifiable”.

The NIH requirement to retain the original signed document and make it available on request (NIH  FAQ 14) is the type of requirement that applies to “digitally signed” documents.

NIH wants PI/Senior Key Personnel to certify accuracy and completeness (NIH FAQ 13) of their Other Support. Certifying is accomplished when additional measures (such as the "unique key") are included in the signature process. These measures help ensure NIH could trace who signed.

Adobe signatures do not appear to meet a strict read of NIH’s requirement, unless you purchase a personal certificate separately for each person and load them onto the specific computers being used.

 

SCRI Staff Assignments

Q1: What does SCRI stand for? 
A1: Seattle Children's Research Institute

Q2: Has the overhead rate now changed from 10% to 4%?
A2: The overheard rate has always been 4%. We believe you must be thinking about the Fred Hutch staff assignments.

Questions? email gcahelp@uw.edu

 

GCCR Records Retention

Q1: Can we use DocuSign to sign GCCRs? 
A1:The use of DocuSign to sign GCCRs is strongly encouraged. If you don’t already have one, contact UW-IT to submit an eSignatures Interest Form as the first step to setting up an account.

Q2: When did DocuSign/Adobe sign become allowable for GCCRs? We’ve been told for a long time that it must be ink signature.
A2: DocuSign had been used by the UW since at least 2016. Within the last year or two, MAA has included information about using it to sign GCCRs on the MAA website.

Q3: Do we need to recreate if we do not have any records prior to 2015? I believe we've shredded through 2013 in compliance with the 6 year policy.
A3: No.There is absolutely no need to recreate any records that have been destroyed according to a previously approved retention period. The goal is to apply this new 12-year retention period for any GCCRs you may still have. Remember this 12 year retention only applies to GCCRs.

Q4: Does an email verification from the PI qualify as an electronic signature?
A4: No, it needs to be signed either in ink and then it could be scanned and the paper destroyed, or it can be signed using DocuSign or Adobe.

Questions? email bbenson@uw.edu

 

Guidelines for Returning to In-Person Research

Q1: May the requirements be relaxed BEFORE the updated research plans are in place or are they contingent on the plan being updated?
A1: Return to Research Plans should be updated before in-person research is subject to relaxed requirements. Review guidance on updating Return to Research Plans.

Q2: Will these guidelines change with the Delta variant ?
A2: At this time, it is not anticipated that these guidelines will change because of the Delta variant. Of course, as more information about variants is available, all guidelines will be reviewed and are subject to change.

Q3: Is any part of the Health Sciences Building (HSB) considered a UW Medicine clinical area for masking purposes? Particularly SOM offices and labs close to the hospital (BB and RR wings)?
A3: With the exception of the dental clinics, HSB space has typically been considered non-clinical. Hospital floors 1, 2, and 3 go to the double doors prior to the UW Medicine Hospitals and Clinics President’s office. Hospital floors 4, 5, 6, end at the Pacific Ave elevator doorway leading into HSB. Plans are underway to post signage at entry points to UWMC from HSB. For more specific information, contact Steve Marty in the School of Medicine Dean’s Office.

Q4: Is the research on fomites and covid-19 evolving?
A4: As information becomes available, all guidelines will be reviewed and are subject to change.

Q5: What is the definition for a Research Group, are groups doing statistical research considered in this group?
A5: Generally speaking, a research group comprises all individuals involved in research in a team overseen by a Principal Investigator or Lab Director. Yes, researchers doing statistical work would fall under this definition and the relaxed requirements would apply.

Q6: Also, to confirm: symptom attestation is no longer required? Where can I find this information to pass along?
A6: Symptom attestation is no longer required. Review the COVID 19 Health and Safety Resources Information from EH&S.

Q7: Any idea when guidance from UW medicine will be rolled out?
A7: Communications are being developed. Specific questions may be directed to Steve Marty in the School of Medicine Dean’s Office.

Questions? email research@uw.edu