Up, Up and Away: Salary Cap

Check your budgets, folks!  The Office of Personnel Management has released increased executive level compensations caps effective January 7, 2018.

 

  • Your new salary cap: $189,600.

 

If you are awarded with a budget that did not included the new cap, you’re welcome to rebudget using the new cap within the limitations of the award, but no new funds will be given by the agency.  If you’re submitting for the March 16 NIH deadline (hello out there, R03/R21 resubmissions and renewals!) now is a great time to revise those budgets and any associated cost sharing.

 

As always, drop us a note at RAS@med.wayne.edu with any questions, and take a look at the notice for more details.

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.

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.

 

 

O, What A Tangled Web

No one likes to admit defeat, and most are not particularly excited to shout a mistake from the rooftops.  Self-protection is human nature, but covering tracks in research can land you in some hot water.  HHS defines “research misconduct” as ” fabrication, falsification and plagiarism, and does not include honest error or differences of opinion.” NIH has procedures in place to handle research misconduct claims, but ultimately no power to investigate (except in the case of intramural research).  All research misconduct allegations involving NIH awards (or any agency under the umbrella of HHS) are forwarded to the HHS Office of Research Integrity (ORI) for their oversight.  Just to be clear:

 

  • Fabrication is making up data or results and recording or reporting them.
  • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  • Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

 

If a PI is found to have engaged in research misconduct, HHS can take action by means of debarment from eligibility to receive Federal funds for grants and contracts; prohibition from PHS service; certification of information sources by the respondent that is forwarded by the institution; certification of data by the institution; imposition of supervision; submission of a correction of published articles by the respondent; submission of a retraction of published articles; and more, including recalled funds and withdrawal of support for associated PIs.

 

WSU PIs are full of integrity and honor, but panic can blur a bright line. In your moments of most overwhelming, results-driven disappointment, make sure the object you cling to is a life raft and not an anchor.  ORI sanction happens (and just recently did), and it can ruin a career.

On-Again, Off-Again Relationship

Ah, the F&A rate portion of your awards: can’t live with them, can’t – quite literally – live without them.  The F&A rates here at WSU are variable as you well know (we’re in a 52.5% period on-campus right now), and that portion generated by awards is distributed according to the policies set forth in section 03-5 of the WSU Administrative Policy Manual.  Those funds pay the salaries, leases, capital projects, etc. etc. that keep our research infrastructure viable.  Many awards allow you to calculate and request F&A (or indirect costs) on top of a direct cost cap, but many do not.  When this is the case, that 52.5% can swiftly eat into your project budget.  That’s when the 26.0% off-campus rate sure starts to look good.  But when can you use it?

 

What is “Off-Campus” Research?

The definition of “off-campus” applicable to WSU is negotiated in our DHHS agreement. In our case, “off-campus” is agreed to mean:

 

For all activities performed in facilities not owned by the institution and to which rent is directly allocated to the project(s) the off-campus rate will apply.  Grants or contracts will not be subject to more than one F&A cost rate.  If more than 50% of a project is performed off-campus, the off-campus rate will apply to the entire project.

 

This is the standard for determining which rate you can use until our current agreement is renegotiated (in 2020, barring extenuating circumstances).

 

My research is done in a non-WSU facility; is it “off-campus”?

Whether your non-WSU facility research is considered “off-campus” is entirely dependent on the terms of your lease; the terms of your lease is the first place you should check.  If WSU is the responsible party for payment on your space, chances are you should be using the on-campus rate (as that cost is factored into the on-campus F&A rate).  If WSU is not the named responsible party, there is a possibility that the off-campus rate in effect at the time of submission could apply (be sure to build those costs into your proposal!).

 

Even after reading the contract, I’m not really sure who is responsible for my lease.  Who can help?

There are definitely murky circumstances, especially when it comes to leasing DMC space and our affiliation agreements. If you’re not sure,  be sure to contact SPA to find out how your space relates to certain existing blanket agreements. Once you’re sure, we can help you with any adjustments that may need to be made!

The Very Model of a Modern Major General Conditions Guideline

The NIH announced on February 5, 2015 their guide to NIH-specific implementation of the Office of Management and Budget (OMB)’s Uniform Guidelines (UG), in place since December 26, 2014.  The NIH Interim Grant General Conditions apply to all new and supplemental funding provided by Notices of Award issued on or after December 26, 2014; they contain no surprises if you’ve been keeping up with the road to implementation!  If you need a refresher on how we got here, take a look at some of our older posts, like Super Circular, Super Fun, which highlights some of the new provisions in the UG; and Ch-Ch-Changes, which also has a link to the NIH Administration Timeline.

 

To comb over the NIH Interim Guidelines yourself, the full document can be accessed here.  These will be in effect until an updated NIH Grants Policy Statement is published (which won’t be until after the HHS comment period closes).  NIH has provided a frequently asked questions page regarding the interim guidelines, on which you may be able to find an answer to any general questions you may have.  If your question is more specific than an FAQ page can handle, give us a try!  We’re always happy to help with interpretation and applicability!

 

Update: 03/05/15

Looking for some information on what, exactly, has changed? Check out our handy Uniform Guidance Changes: 2015 page!