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Wayne State University

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Jul 16 / RAS

Amending Expectations

The kind folks at Wayne’s Institutional Review Board (IRB) has been holding sessions to remind, refresh and renew the understanding of our application and approval process.  One of the most common processes in IRB is amending a current approval to reflect a new or altered project.  When planning your project timeline, it’s helpful to know some of the most common issues that prevent a timely amendment approval:

  • Changes to a project that are not adequately explained
  • Reasons for the change are not adequately explained
  • Missing documents
  • Revisions are not highlighted
  • Wrong submission type

(These issues were highlighted by Wayne State University IRB in their July presentation.)

 

Remember that any time there is an increase in the population that would be exposed to the risks of a study, detailed explanation is required.  In addition to an account of changes (with references and details where necessary), you must also:

  • Use the exact, accurate project title
  • Note the expiration and continuation dates
  • Ensure the funding source is up to date
  • Revise all documents affected

 

Delays in IRB approval can materially affect data collection; make your life easier with a few precautionary steps to ensure the smoothest application possible!  If you would like some clarification on an IRB issue, send an email to RAS and we’ll arrange for an IRB representative to present at Tips & Tools.  If you have a specific IRB question on a specific study submission, Ray-Nitra Pugh, IRB Education Coordinator, is an excellent resource!

Jul 9 / RAS

Every Effort for Progress

The structure of effort reporting on the RPPR (Research Performance Progress Report) can be a bit tricky to decipher.  A few key points to keep in mind:

 

  • Effort must be rounded to the nearest whole person month on progress reports, even though proposals still use fractional requests.  This is mandated by the OMB. ** Note: even though NIH defines a PD/PI as having effort greater than zero, there may be some instances where the PD/PI has 0.4 person month or less.  In this case, it is appropriate to report zero person months in the RPPR
  • Persons reported on an RPPR must either be the PD/PI or have worked at least one person month during the reporting period.  In the case of a person who is not PD/PI and has worked less than one month, rounding is not appropriate.   A non-PD/PI who has worked 24 days, then, should not be reported on your RPPR even though the nearest whole person month is 1 month.
  • Keep in mind that effort reporting in section D.1 on an RPPR is retrospective; that is, you are reporting effort that took place in the past.  Rules pertaining to reductions in effort of 25% or more from the Notice of Award will, however, be applicable in section D.2.a; a “yes” answer here would require prior approval.  If reductions are forthcoming, you will need to get approval from your agency for current and future reporting periods.

 

If you are unclear as to how you should be reporting effort on your RPPR, RAS is here to help you sort it out.  The NIH RPPR FAQs page  is also a great resource for more information.

Jul 2 / RAS

Warning: Explicit Language

Most proposal project periods are not going to neatly start on October 1, and will therefore span multiple rate periods in our DHHS agreement.  In order to draw the necessary attention to Wayne State’s variable negotiated rates (and how to express them), you should include language in your budget justification under an “Indirect Costs” heading.  For a little guidance, take a look at the sample language provided here:

* Note:  The italicized portion of this language comes directly from our rate agreement.

 

Indirect Cost Calculations

Wayne State University uses Modified Total Direct Cost (MTDC) to calculate indirect costs.  Modified total direct costs, consisting of all salaries and wages, fringe benefits, materials, supplies, services, travel and subgrants and subcontracts up to the first $25,000 of each subgrant or subcontract (regardless of the period covered by the subgrant or subcontract).  Modified total direct costs shall exclude equipment, capital expenditures, charges for patient care, student tuition remission, rental costs of off-site facilities, scholarships, and fellowships as well as the portion of each subgrant and subcontract in excess of $25,000. The Wayne State University F&A Rate Agreement is negotiated with the Department of Health and Human Services (DHHS), fully executed on May 14, 2014. The agreement has varied rates per fiscal year (10/1 – 9/30). Two F&A rates are applicable to [NUMBER OF PERIODS THAT SPAN MORE THAN ONE RATE] periods:

  • Project Period [X] (beginning [PROJECT PERIOD X START DATE]): [RATE A]% applies for [FIRST NUMBER OF MONTHS] months, [RATE B]% applies for [REMAINING NUMBER OF MONTHS IN PERIOD] …

[APPLICABLE RATE]% applies to all remaining periods.

 

Practical Application: If, for instance, you have a project with 5 periods that beings on April 1, 2015, the indirect cost language included in your budget justification may look like this:

 

Indirect Cost Calculations

Wayne State University uses Modified Total Direct Cost (MTDC) to calculate indirect costs.  Modified total direct costs, consisting of all salaries and wages, fringe benefits, materials, supplies, services, travel and subgrants and subcontracts up to the first $25,000 of each subgrant or subcontract (regardless of the period covered by the subgrant or subcontract).  Modified total direct costs shall exclude equipment, capital expenditures, charges for patient care, student tuition remission, rental costs of off-site facilities, scholarships, and fellowships as well as the portion of each subgrant and subcontract in excess of $25,000. The Wayne State University F&A Rate Agreement is negotiated with the Department of Health and Human Services (DHHS), fully executed on May 14, 2014. The agreement has varied rates per fiscal year (10/1 – 9/30). Two F&A rates are applicable to [2] periods:

  • Project Period 1 (beginning [04/01/2015]): [52.5]% applies for [6] months, [53.0]% applies for [6] months
  • Project Period 2 (beginning [04/01/2016]): [53.0]% applies for [6] months, [54.0]% applies for [6] months

[54.0]% applies to all remaining periods.

 

Feel free to copy-and-paste and change the [BRACKETED/BOLDED] values to those that apply to your project; this material was intended to be shared!  In case you missed it earlier this week, our F&A calculation spreadsheet will help you figure out your own values.  Let us know if you have questions!

Jun 30 / RAS

One Simple Trick Will Get Your Money, and You Won’t Believe What Happened Next

In keeping with the topic from two weeks ago (“Hip Hip Hooray for New F&A“), we’d like to highlight the importance of correctly calculating your indirect costs using the new rates.  Remember:

 

  • Each year of your project is going to have differently applicable F&A rates
  • Each year of your project may have more than one applicable F&A rate, and should be proportionately weighted

 

If, for example, you have a project that begins on September 1, 2014, a 52% F&A rate will apply to the first month of your project, but the new 52.5% will apply to the remaining 11 months in that first project year.  On the second year of the project, 52.5% will apply to the first month, but the new 53% will apply to the remaining 11 months of that project period (and so on, and so forth).

 

The importance of calculating out each year correctly comes down to safeguarding against leaving money on the table.  Using a single F&A rate for all project years means leaving tens of thousands of dollars on the table when submitting your proposal budget.  On a five-year/modular project, for example, calculating the correct and proportional indirect costs based on the rate agreement will generate over $18,000 more in qualified project dollars than using a flat, single rate.

 

For help determining your multi-rate F&A calculation, check out the spreadsheet we developed; it will calculate your proportional F&A costs and highlight what needs to go into your SF424 (see the example tab for a visual explanation). Feel free to contact us with any questions!

 

Jun 25 / RAS

Aquiring Your PMCID By All Means Necessary

You may by now be familiar with the four proffered methods of bringing your publications compliant with the NIH Public Access Policy.  If you are not, you may want to check out our primer to familiarize yourself with the steps to becoming public access compliant (and, therefore, obtaining your PMCID number; for more information about the stages in which you can submit your publication, check out the NIH’s overview table).  Method A is the easiest, as it allows the journal itself to deposit your manuscript without your involvement.  Only certain journals have a “Method A relationship” with the NIH, however; if you have published in a journal that is not Method A, you’ll have to choose one of the author-initiated Methods B-D in order to bring your publication to compliance.

 

OR WILL YOU?

 

There is a less-publicized “gray area” means of submission that is not provided for in the infamous “Chart of Methods”.  Some publishers (Elsevier, Wiley-Blackwell, Sage, etc.) have relationships with the NIH that streamline the process of submission for journals in their houses, even if they are not Method A.  There are steps in place by these publishers as “author services” that allow you to use their channels to obtain your PMCID number, and therefore, your compliance.

 

In most cases, once your paper has been accepted for publication, you will be requested to fill out a funding form and identify yourself as a NIH author.  This will trigger an operational process that ensures that the publisher will send to PMC the final peer-reviewed manuscript, and authorize its public access posting.  In most cases, this happens within 12 months of final publication.  You should be contacted by NIH once your manuscript has been deposited.  Different publishers have different methods; be sure to check with yours!

 

In short, if your journal is not Method A, check with your publisher for any existing relationship with NIH regarding its public access policy before you begin processes for Methods B-D.  You may save yourself a lot of time and frustration!

Jun 11 / RAS

Hip Hip Hooray for New F&A

Wayne State University recently received its final Facilities and Administrative (F&A) costs rate agreement.  It’s very important that, when you are calculating your modified total direct costs, they reflect the following numbers for all forthcoming RESEARCH projects ON CAMPUS:

 

Project Period

F&A Rate

Now until 09/30/2014

52.00%

10/01/2014-09/30/2015**

52.50%

10/01/2015-09/30/2016

53.00%

10/01/2016-09/30/2018 (and later, until a new agreement is in place)

54.00%

 ** As most projects have an earliest start date of 04/2015 at this point, this will be the first-year rate for most projects at this point.  Please contact RAS if you are unsure.

 

Beginning 10/01/2014, the University fringe rate for faculty and administration will change as well, to 26.6%.

 

The new rate agreement (dated May 14, 2014)  in its entirety has been posted by SPA, and can be viewed here.  In addition to the commonly used rates posted here, you can also find the new rates for off-campus research, instruction, and other activities.  Fringe benefit rates are also provided for employee classes other than faculty and administration.  If you have any questions about calculating F&A costs for your upcoming submissions, drop us a note!

Jun 4 / RAS

It’s a bird! It’s a plane! It’s…! The new NIH Biosketch format.

Mark your calendars, the new format is expected to go into effect in early FY2015 (for projects expected to start in FY2016).  Here are some of the changes that you will see:

  • Length: A five page length will apply to the entire biosketch.  
  • Publications: Instead of listing publications, researchers will include a link to complete list of publications in SciENcv or My NCBI.
  • Significance: Description of up to five significant contributions to science, the associated influence of  each, and any subsequent effects on health or technology.
  • Role: Researchers are allowed to describe their specific role in listed significant discoveries, annotated their description with up to four publications.

Several entities (including Sally Rockey) suggest that you begin to familiarize yourself with SciENcv now, so you will be familiar with format by the time the new biosketches are required in approximately six months’ time. The first round of tests is already complete (NIH implemented this requirement on two RFAs already), and the second “fine-tuning” phase – involving more applications – will begin this month.  For more information, see the notice from NIH (NOT-OD-14-09) and/or the latest peer review notes from the Center for Scientific Review.  If you would like some assistance in setting up your SciENcv profile, or you have any questions about the new format, feel free to contact RAS anytime!

May 28 / RAS

Super Circular, Super Fun

It’s been around for nearly six months now, but the OMB Super Circular (also known as the “Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards, Final Rule”, and “Mega Circular”) is receiving some more attention as opportunities for its application increase.  Many of you who attended the most recent SPA meeting most likely received a copy of the Huron Group’s chart, “Assessing the OMB Uniform Guidance: Major Changes and Impacts.”  If you did not, it is available here and offers helpful visual reference as to how your strategies may change.  Some of the highlights include:

Length of Opportunity: The guidance indicates that RFAs and PAs have to be available 60 days before the opportunity closes.

Accountability – Performance vs. Compliance: Results and outcomes that can be shared with other award recipients have strong emphasis in the new guidance.  Noncompliance is not merely overlooked, of course; but the government ostensibly does not wish to create oppressive rules that prevent an investigator or a collaborating team from attaining their research aims. As you read the guidance, you’ll see that this is the goal.

Administrative Costs as Direct Costs: Specific information is given on how to manage administrative costs as a direct cost. Administrative costs are usually charged as indirects, so this can be tricky.  If you’re unsure on how to do this, please contact RAS and we’ll help you figure out how you should be charging your admin costs.

Increasing Minimal Threshold for Indirect Costs to 10%:  Organizations that cannot afford to negotiate an indirect rate can budget a 10% de minimis indirect rate with the federal government (as opposed to the previous rate of 8%).

Payment Management : The super circular provides new information on maintaining consistency in cost allocation, and at what point you need written approval for assigning a cost to an award. The cost principles and audit sections assert that there is now a limit of three years for the federal government to review awards in order to disallow costs.  There is also a new 90 day rule for reporting on awards at the end of the project period.  Taken together, there is much latent encouragement to spend your money before it is taken back.

Family-Friendly Policies: The new guidance encourages federally-funded organizations to implement family-friendly policies, including family-friendly issues such as costs related to the identification of day-care providers, and allowance of parents to document out-of-workforce time on biosketches.

 

May 21 / RAS

Fanfare for the Common Access

There are many journals that are moving toward requirements closer to the NIH Public Access policy (notable and recently: the American Heart Association; be sure to note the exceptions!).  There has been some confusion as to the difference between open access journals, public access requirements, and how they apply to the mandates imposed by funded research over published results.  So, what is the difference between “open access” and “public access?”

Public Access: Public access sits somewhere in between these poles, encouraging broader readership by limiting access control periods, while ensuring that the use of the material remains subject to the copyright and/or related license terms of the respective authors or publishers. Many research funders considering access policies have viewed public access as a manageable first step toward full Open Access. Public access, unlike Open Access, usually does not demand the immediate availabilityof peer‐reviewed articles. Rather, it recognizes that the realities of the current publishing system allow for publishers to embargo access for some period of time (six to twelve months) in order to retain their subscription revenue stream. After that time, articles following the public access model are made freely available to readers in a trusted, persistent repository such as the NIH’s PubMed Central archive.

Open Access: Open Access is the free, immediate, online availability of peer‐reviewed research results, permitting any user to read, download, copy, distribute, print, search or link to the full text of these articles, crawl them for indexing, pass them as data to software and/or use them for any other lawful purpose. SPARC has good information on open access for further reading.

 

A journal, then, can be open access and by default automatically comply with a public access policy; but a journal does not have to be open access in order to comply.  In order to demonstrate compliance, many of you are becoming familiar with NIH’s NCBI system.  But what if you need to demonstrate compliance to a non-NIH funder?  Luckily, most non-NIH funders adopting the public access policy do so through participation in the Health Research Alliance (HRA) Public Access initiative.

Demonstrating Compliance for Non-NIH Research: Once your funder has uploaded the required information about your grant to the Grants in the Health Research Alliance Shared Portfolio database (gHRAsp), you will receive a reminder to visit the HRA Authentication Portal page in gHRAsp. Here, you will be asked to log in with your Gmail address or eRA Commons account (Google and eRA Commons both use the same Open ID technology). Once you log in, you will be asked to search for your grants, which will link them to your gmail or eRA Commons account. When you have an accepted manuscript to deposit to PubMed Central, you will use the NIH Manuscript Submission System just as you do for manuscripts resulting from NIH grants. When you log in with your gmail address or eRA Commons Account, you will then search for your grants in the NIH Manuscript Submission system. Your grant from your HRA-member funder should appear for you to link your publication to that grant.

 

If your funder requires adherence to a Public Access policy but does NOT participate in the HRA Public Access initiative, contact RAS and we’ll help walk you through your specific compliance issues.  If you need a refresher on the NIH Public Access and how to comply, check out our previous post: The ABCs of PMCID!