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Wayne State University

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Mar 28 / RAS

Show Me Where It Says That

“We’ve always done it that way.”

“That’s just the way we do it.”

“I don’t know what they want to see.”

“I don’t know who to ask.”

 

In an effort to have a jumping-off point for policy compliance, we at RAS have compiled a digital, (hopefully) handy School of Medicine Policy Handbook.  Some policies originate in the SoM, some are University-wide, all affect award submission and management.  The Policy Handbook is not exhaustive (we’ll keep adding and updating), but it’s a great place to start when crafting your award strategies (and figuring why, in fact, “that’s just the way we do it”).  Let us know if you have questions!

Mar 10 / RAS

Transitional Style: Postdoc to Faculty Fellowship Program

** Note: as of 03/22/17, the program has been updated to also actively seek mentors.**

 

The Graduate School recently announced a new initiative for post-doctoral students with a stated goal “to build a strong applicant pool of early-career, urban disparity scholars who will contribute to diversity and bolster academic excellence on our campus.”  Applications will be accepted starting April 1, 2017 for a September 1, 2017 start date; questions regarding application and further information are to be directed to Dr. Ambika Mathur (ambika.mathur@wayne.edu), Associate Provost for Scientific Training, Workforce Development and Diversity, and Dean of the Graduate School.  No deadline has been attached.

 

According to the announcement, fellows will receive stipends 20 percent above National Research Service Award levels, plus benefits. They will work with faculty mentors, participate in learning communities and receive funding for two national conferences for every appointment year. Fellows who obtain external grants during their postdocs will be eligible for tenure-track appointments at WSU with competitive compensation and startup packages.  Further application details will be released by targeted email shortly.

 

To read the announcement in its entirety, please follow this link: http://i.wayne.edu/view/58b5a041821e6 

 

 

Mar 9 / RAS

Live Wires: No Cost Extension and PI Changes Go Electronic

As of last Thursday, No Cost Extensions requiring a prior approval and requests to change a PD/PI are available to your GCO through the Prior Approval section in eRA Commons.  The electronic option through eRACommons is just that: optional.  You and your GCO can still make your requests the old-fashioned way if computers make you nervous (heck, even NIH says you should contact your awarding institute/center [IC] to determine the best method for making these requests).  How simple is this?  Once you sign in, here’s what you see:

And takes you here:

 

Not sure if you are eligible for a no cost extension (NCE) through prior approval?  Do a quick double-check:

  • You ARE eligible for a NCE through Prior Approval:
    • When an NCE under expanded authority has already been used and the grant is within 90 days of the project end date.
    • When the grantee is not under expanded authority and the grant is within 90 days of the project end date.
    • When the project end date has expired and has not been closed or has not entered unilateral closeout, whichever comes first.

 

  • You are NOT eligible for a NCE through Prior Approval:
    • When an NCE under expanded authority has never been requested and the grant is within 90 days of the project end date. In this case, the NCE will be processed normally through the Extension link in Status.
    • When the grant is closed.
    • When the grant is a fellowship grant.

 

  • What information will you need to provide to your GCO?
    • The NCE request form includes:
      • Request Detail – Here you will be asked such things as the number of months you wish to extend the project end date; the amount of unobligated money still available, etc.
      • Three PDF upload fields: Progress Report, Budget Document, Justification Document

 

RAS is here to help with interpretation if you have any questions!

Feb 8 / RAS

Cayuse Your Own Adventure: Cost Share Edition

Now that February 6 has come and gone, most everyone has had experience with what we’re looking for at the brand-spankin’-new School of Medicine level of approval.  One of our major review points is cost share, and whether an index has been identified if it exists.  Not sure how to record that on the SP side of Evisions?  Don’t fret; you’re not alone.  Here is a step-by-step guide to recording your index for approval (click on images to see full mark-up):

 

1. Go to proposal budget:

 

2. Find “Cost Sharing” heading; choose “Yes”

 

3. When the cost sharing options box appears, choose “Voluntary”

 

4. Choose “Salary Cap.” Enter the amount of cost share. Refer to calculations in the comments line. Don’t forget to actually upload the cost share calculations document to “Proposal Attachments.” (Note: SoM is not requiring signatures for over-the-cap cost sharing at this time.)

5. Click the “Add Unit” link to assign your department to cost share and record the index. Use the search icon to find your department. Note: you can add more than one unit of account if you are splitting the amount between departments or accounts.

 

 

6. Choose “Add Unit” once the appropriate information has been entered.

 

7.  Congratulations! You’ve added your cost share record to your proposal.

 

 

(Don’t forget to insert the number into the budget line by scrolling all the way down to the bottom of your page, so you don’t get the nasty error message.)

Let us know if you have any problems; we can walk you through it 🙂

Jan 25 / RAS

Six Things in Common

We all love hearing about changes to the federal register, amirite?  Well celebrate, one and all: last week, a new final version of the “Common Rule” for the protection of human subjects was published by fifteen federal agencies (including DHHS and NSF) in effort to strengthen the Federal Policy for the Protection of Human Subjects.  The intent is to both enhance protections and reduce administrative burden(!), and here’s what it means to you:

  • Consent forms are required a better understanding to provide potential research subjects of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • A single institutional review board (IRB) for multi-institutional research studies is required in many cases. (There is substantial flexibility in now allowing broad groups of studies, instead of just specific studies, to be removed from this requirement; this provision is delayed until 2020.)
  • Studies on stored identifiable data or identifiable biospecimens allow researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens. Aside: if you’ve been following along, you’ll note that this is a change of course from earlier intent to apply the principles of informed consent to all biospecimens.
  • New exempt categories of research are established based on the level of risk posed to participants. (For example, there is a new exemption for secondary research involving identifiable private information as regulated by and participants protected under HIPAA; the intent is to reduce regulatory burden to allow IRBs to focus their attention on higher risk studies.)
  • Continuing review of ongoing research studies is no longer required in instances where such review does little to protect subjects.
  • Consent forms for certain federally funded clinical trials are required to be posted on a public website.

The general effective/compliance date of the final rule is January 19, 2018; all studies without initial IRB review as of 1/20/18 will be subject to the new requirements. Any ongoing research at that time (i.e. studies with IRBs approved under the current version of the Common Rule) will continue to be subject to the current, pre-2018 version of the rule unless the university chooses to mandate compliance with the final version.  For more on the transition provisions, check out the final rule preamble, as well as  Section 101(l) of the regulatory text.

 

Stay tuned for further guidance; HHS intends to issue direction on specific provisions of the rule changes in the near future.

Dec 1 / RAS

Please Remember: It’s December

How are those January applications coming?  Fabulous?  Great! Send ’em our way nice and early!

As the holiday closures approach, keep in mind that our office closes with the rest of the University, so we won’t be around to assist between December 23-January 2.  We’ll be back at it on January 3, but if you are planning to work on your applications over the holidays, that only leaves one day in the new year before January 9 deadlines. (Remember: the SPA deadline is three business days before the agency deadline; you’ll need to have your application finalized by January 4.)  Consider working with us (or your administrator) to get all of the administrative elements together well before the closure (ideally by Tuesday, December 20).  This way, you’ll have your holiday break to work on the science if necessary, and we can pick back up  where we left off in the new year.  And to those of you who are planning to submit in January, will need our help, and haven’t yet reached out: what are you waiting for?!?  Please contact us right away so we can accommodate you as best we can!

For departments with internal administration: we’re pretty sure your staff would also appreciate a well-formulated submission plan accounting for the the holiday closure, as well 😉  Happy writing!

Nov 8 / RAS

Appendices 2017: Do Not Pass Go. Do Not Collect $200.

With the major November NIH deadlines about to pass us by, many will turn their attention to their 2017 submissions.  As you pursue your application strategies, chances are you’re considering the use of an appendix to bolster your argument for funding.  Proceed with caution: the appendix rules for 2017 are not what they once were.

 

The only allowable appendix materials in 2017 are:

  • Blank informed consent/assent forms
  • Blank surveys, questionnaires, data collection instruments
  • Funding opportunity announcement-specified items

Clinical trial applications may also include clinical trial protocols and/or investigator’s brochures from Investigational New Drug (IND), as appropriate.

 

Note that the revision of allowable appendix material has significantly reduced inclusion potential.  If you weren’t sure before whether you could submit that manuscript, good news: under the new rules, you definitely cannot!  No manuscripts allowed!

 

This announcement was made via NOT in August (check out the full text of NOT-OD-129). The penalties for submitting out-of-bounds material is withdrawal and non-review.  Ouch.   If you have questions about what this change means, or how it may affect your application, give us a shout and we’ll help you talk through it.

Oct 13 / RAS

Permission to Buzz the Budget

The stone-written commandments of NIH proposals have long included, “thou shalt request prior approval when requesting more than $500,000 in direct costs (excluding consortium F&A costs) in any one year of an unsolicited proposal.” As an aside: did you know you’re supposed to request that approval no later than 6 weeks before submission

 

Since the inception of this rule in the dark ages of 2002, these requests were required in writing or by telephone.  You now have the option of making the request by webform in a new “Prior Approval Module” through eRA Commons (NOT-17-005).  Of important note: you must request the form to be “opened” by your Program Officer before it will be accessible.  Once it is available, you complete the form and submit. As another aside: the word “option” appears to be used loosely here; it’s along the lines of being volun-told).

 

The logic behind the Prior Approval Module appears to be subsequent management of such requests.  The module allows PIs and GCOs to amend, modify and withdraw previously submitted requests as proposals shape up differently in the days leading to deadlines.  The module will appear between the “ASSIST” and “RPPR” tabs on your login screen:

prior_approval

 

 

If you have not yet contacted your Program Officer for access to the module, you will receive an error message (“We are sorry, you are not authorized to access this function”).  Not sure whether to request the limit stretch, or just not sure what to do next?  Drop us a note and we’ll be happy to help you sort through!

 

 

Sep 20 / RAS

Times of Trials: Rules and Registrations

This past Friday, new rules for clinical trials were published by HHS in the  Federal Register to expand the legal requirements for submitting registration and results; NIH issued a mirror policy at the same time.  PIs have been required to post results of experiments on ClinicalTrials.gov since 2007, but Friday’s changes now include experimental behavioral interventions (i.e. studies that compare diabetic diets) and Phase 1 drug trials supported by NIH funding.

 

Important elements of the rule include:

  • A checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information;
  • An expanded scope of trials for which summary results information must be submitted (includes trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA);
  • Requirement of additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol;
  • Additional types of adverse event information requirements; and
  • A list of potential legal consequences for non-compliance.

 

These rules are aimed not only at broadening resources for patients, but also at avoiding federal tax dollar waste associated with redundant studies.  A recent interview with Francis Collins, director of the National Institutes of Health, cited NIH is concerns over current levels of self-reporting in the scientific community when it comes to failures (they’re underreported), and the likelihood of other researchers unknowingly repeating the same ineffective strategies.  Institutions with studies that are regulated by the FDA can face fines of $10,000 a day for noncompliance.  The NIH will “consider” withholding funds on planned clinical trials at non-compliant universities until compliance is achieved.

 

The HHS rule in its entirety can be accessed here: HHS RULE and the complementary NIH rule can be accessed here: NIH RULE.  The new rules go into affect on January 18, 2017. There is a 90 day compliance grace period.