Research Performance Progress Report (RPPR)…I Don’t Need Time, I Need a Deadline

A Research Performance Project Report (RPPR) is required at least annually as part of the NIH non-competing renewal (type 5) award process and it must be submitted via the eRA Commons.

NIH has recently published a new resource “RPPRs: Who Can Do What?” which provides a quick look at the Annual, Interim and Final RPPRs.  Only the PI or their delegate may initiate an RPPR in the eRA Commons. The RPPR must be received and approved by the Institute’s Program and grants management staff prior to funding for each subsequent budget period within a previously approved competing project period.

To find out which progress reports are due over the next 4 months, click on this NIH link to Pending Progress Reports  to obtain a list of progress reports for a selected grantee institution.  For Wayne State University, use 9110501.  Note any project that shows a “Yes” to SNAP is actually due on the 15th of the month instead of the 1st as shown in the query results. This query will not include progress reports for Multi-Year Funded (MYF) awards which are always due on or before the anniversary of the budget/project period start date of the award and are uploaded as a PDF through the eRA Commons (see http://grants.nih.gov/grants/policy/myf.htm for instructions).

If you have questions or you’ve been told something different, you can reach out to RAS@med.wayne.edu.

FREE SLIDERS

If you came here looking for ways to get your hands on some delicious mini-burgers, this post is not for you.

 

If, however, you’re looking for a way to simplify unallowable cost determination under the Super Circular, rejoice!  Cost-allocation software company CostTree is giving away handy pocket sliders to aid you in your cost determination quests (and if you’re not into print materials, they have a digital version, too).

 

To get yours, head on over to the CostTree request site and input your vitals.  It’s helpful, it’s nice-looking, and it’s free for the low, low cost of being added to a mailing list.  Happy allocating!

Say Hello, Waiver Goodbye

In a department, administrators and PIs have a lot of room to negotiate with other institutions when it comes to budgets involving awards and subcontracts.  Personnel effort?  That’s a classic.  Materials and supplies?  Probably your first stop.  Indirect cost percentage?  Slow your roll, holmes.

 

If the project is federally-sponsored, chances are slim that you’ll be successful in  your quest F&A reduction below our negotiated 54%*.   There are times when a lower F&A rate is acceptable without waiver/permission; for instance, the funding opportunity announcement caps the rate at lower than our negotiated rate, or the award is being transferred from another entity with direct cost equivalency.  Anything else requires a waiver with approval from the Vice Dean and SPA.  You cannot negotiate a reduced F&A on your own.

 

Here at Wayne State, the waiver request process begins with an IDC Waiver form. The Research Administrator and the PI should initiate the request, and it must be approved by the PI, the department chair, and the Vice Dean for Research before being sent for approval to SPA. The Vice Dean for Research will consider requests for Indirect (F&A) cost waivers in very limited circumstances, so be sure your justification is sound.  Here are some examples that may be considered on a case-by-case basis:

  • Capped awards
  • Seed grants which may attract larger awards
  • Only available source of funds in an area
  • Strategic partnerships
  • Awards which include equipment or building funds

 

If you’re just trying to make a proposal look more competitive, or  the PI/department failed to submit the proposal via approved institutional channels (e.g., through the Vice Dean or SPA) prior to submission to the sponsor, you’re out of luck.  Wayne State’s acceptance of an award with an unapproved F&A reduction does not constitute acceptance of the rate.  If you are awarded with a reduced F&A that was not properly approved, you must renegotiate at the time of award, otherwise the department will be responsible for cost-sharing the portion of the F&A not paid by the sponsor.

 

Questions?  You know where to find us!

 


* 54% is our federally-negotiated rate at the time of this post.

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!

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!

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.

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.