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Wayne State University

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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.

 

 

Sep 8 / RAS

Evision Quest

Hot off the presses from our friends at SPA:

The transition from Coeus to Evisions for proposal development and submission is underway!

In our continuing effort to provide the highest level of support of research at Wayne State University, Sponsored Program Administration will begin using Evisions SP/424 in place of Coeus in 2016. Evisions will track research proposal and award activity, provide for streamlined internal routing and approval of proposals, facilitate submission to sponsor systems (Grants.gov), and store proposal documents.

Evisions SP/424 will allow users expanded access to proposal development, submission, and award information through a very simple, user-friendly interface.

The system includes the following features:

  • Extra validations and error checking to ensure proposal will be error free upon submission to Grants.gov
  • System-to-system data transmission for >95% of all Grants.gov opportunities
  • Budget builder tool includes fringe benefits, F&A rates, inflation rates, and multi-year replication
  • Proposal development (budget, narrative, compliance questions)
  • Re-use data and copy proposals
  • Robust routing and approval
  • Database of all sponsored program activity
  • Tracking of proposals and awards to subcontractors
  • Intuitive User Interface

Processes and navigation in Evisions are similar to Coeus.  In order to provide for the most seamless transition possible, many group training sessions will be offered in the coming months for administrators and faculty. Additionally, SPA Training is happy to visit your department or college for individualized training.  Please refer to the Research Events calendar for scheduled training session.  Sessions will run every Thursday between September 1 and October 27.

We highly encourage faculty and administration staff to utilize the Evisions test environment for a hands-on experience.  The test instance can be accessed here and users must use their Access ID and the password re85search.  Again, this is a test instance and no current “active” information is contained within.

Additional resources include the Evisions 424 Users Manual and the Evisions SP Users Manual.  Please contact Tim Foley (tpfoley@wayne.edu) with any questions.

Aug 25 / RAS

Get Your Rates Straight

You know that moment when you’ve finally become comfortable using new-ish fringe rates on proposals, and then it changes again?  Guess what: BAM!  The moment has arrived (actually, it arrived a month ago).

 

The most current DHHS rate agreement was ratified on July 13, 2016 (use this date on your submissions, folks), and can be viewed on SPA’s website.  If, for instance, you’re not using 24.2% for your non-administrative faculty, check you numbers before that proposal goes out!  These are the numbers that must be used for projects beginning on October 1, 2016 and after; there’s nothing being submitted now that would start before that date, so here’s looking at you. 😉

 

Fiscal Affairs has also updated the Composite Fringe Benefit Rates to reflect the new agreement (you can check all of your employment classes here).  As in the past, past composite rates are publicly archived for your reference.  Questions on how to adjust your budget to the new rates?  You know where to find us!

Aug 2 / RAS

Hey Fellow[ship]: Don’t Keep Doin’ What You’re Doin’

It’s August 2; do you know where your tuition rates are?  If you’re planning to submit an F-series fellowship application for the August 8 deadline (or an F-31 on August 13/15), watch your bottom line when you are calculating your stipend; credit costs have changed, and so have the associated costs of health coverage.  To check your tuition base rates, be sure to visit the Tuition and Fees resource pages provided by WSU Records and Registration, and factor increases in your budget as averages.  Are you an MD/PhD candidate but not sure how to calculate your credits? Unsure which medical coverage to use in your calculations?  Just overwhelmed by the stipend calculations in general?  Reach out to RAS; we’ll help you figure out into which category you fall and which numbers to use!

 

Pay mind also to the changes present in the Forms-D iteration of the NIH fellowship packages. The following are five (yes, five!) new attachments:

  • Applicant’s Background and Goals for Fellowship Training (6 page limit; G.430 Guide, Section 2)
  • Letters of Support from Collaborators, Contributors, and Consultants (6 page limit; G.430 Guide, Section 10)
  • Description of Institutional Environment and Commitment to Training (2 page limit; G.430 Guide, Section 11; includes Additional Education Information section required for F30 and F31 applications which was previously included as an “Other Attachment” in FORMS-C applications)
  • Data Safety Monitoring Plan (G.430 Guide, Section 16; used with applications involving Clinical Trials)

Note that the “Authentication of Key Biological and/or Chemical Resources” attachment has been delayed for fellowships, even though it is listed as “required” in several resources;  don’t use it  yet, as implementation is delayed until after FY2017  (NOT-OD-16-034).

 

Biosketch instructions specifically for research, career development and fellowship applicants are now available as well; pay close attention especially to “D: Additional Information: Research Support and/or Scholastic Performance.”  Instead of “Research Support,” applicants for both predoctoral and postdoctoral fellowships should use this section to provide information on their scholastic performance.

 

We think that’s enough for one post, don’t you? 😉

Jul 6 / RAS

Your Amendment Rights for Right Amendments

Ah, the resubmission.  We all want to draw attention to the fact that we understand the concerns of the reviewers and really drive home the fact that the amended application addresses initial concerns (or maybe even did the first time around).  It’s hard to assert your strength in writing, but that’s why we have bold!  And italics!  And underlines!  And colors! But not so fast: should you be using these textual tools to identify the changes you have made since a previous submission?

 

While there is no outright rule against this, the NIH states:

You must include an introduction for all resubmission[s] that:

  • summarizes substantial additions, deletions, and changes to the application

               > individual changes do not need to be identified within other application attachments (e.g., do not need to bold or italicize changes in Research Strategy)

  • responds to the issues and criticism raised in the summary statement
  • is one page or less in length, unless specified otherwise in the FOA or is specified differently on our table of page limits.

 

(Preceding emphasis added, read more at Resubmission Applications.)  When you’re crafting your resubmission, keep in mind that the NIH expects corrections to be addressed in the introduction, and not anywhere else.  While it is not expressly forbidden, your reviewers may be less annoyed that you not only acknowledged previous concerns, but format direction as well.  Happy writing!

Jun 24 / RAS

Personal profiles: not just for online dating

Save yourself – and those with whom you collaborate – some valuable time: update your personal profile in eRA Commons.  When you’re submitting an application through ASSIST, your senior/key personnel fields can autopopulate from your profile, as your Commons ID is linked. Keeping your personal profile updated ensures that the contact and personal information sent with any application has already been sanctioned by you.  So where do you go to ensure you are up-to-date?  First, log in to eRA Commons, and find the “Personal Profile” link in the blue menu bar:

pp1

 

This will take you to a menu that allows you to update all of your personal information.  Some of this populates to ASSIST, some of it does not:

pp2

* note: “REVIEWER INFORMATION” is one place to find your Continuous Submission status 🙂 

 

Here are some key points to keep in mind as you consider your personal profile:

  • The “EMPLOYMENT” section populates your contact address, and NIH wants three years of history for PIs, and at least one entry for trainees and admins.  NIH states, “this information is vital to NIH and its SROs for determining any conflicts of interest with applications.”
  • Be sure your institutional affiliation is correct! Did you bring your Commons ID with you to Wayne State from a former institution?  You may have to change your affiliation. Go to the “Home” screen and check out your name and affiliation in the top right corner.  If the institution listed under your ID is static (no link), call SPA to have your affiliation switched. If your institution is incorrect and it is linked (blue underline), you may be able to change it yourself by clicking on it:

pp3

 

As an aside, when filling out your ASSIST applications: two fields that will NOT autopopulate from your profile are “Division” and “Department.”  To be sure that you get proper credit for each:

 

Confused by what you need to include?  Never fear, RAS is here to help walk you through the steps!