Most NIH announcements at this point have required the use of the Forms-C package, with two notable exceptions: PA-12-149 “Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)” and PA-12-150 “Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp)”.
As of last week, both of these programs do, in fact, require the Forms-C set. For more information, see NOT-OD-14-118. If you need clarification or guidance on the Forms C set, see our prior post, “Forms “C” and Fringe Rates and Agents, Oh My!” or contact RAS with specific questions!
It happens. Sometimes your lab floods, or your building is on fire, or you have to flee the country, or you are inundated with paper by your study section. And sometimes this happens very close to submission deadlines. What to do? Here’s what you must be aware of if you are under the gun:
- An error free application is successfully submitted to Grants.gov by 5 p.m. local time on the due date. This means that you must allow enough time to correct any errors that may be returned by 5:00pm on the deadline date; an application that was returned with an error at 4:55p and resubmitted with corrections at 5:02p is late and will not be accepted.
- When due dates fall on a weekend or Federal holiday, they are extended to the next business day. Free time!
- Permission to submit late is never granted in advance.
- On EXTREMELY RARE OCCASIONS, late applications may be accepted when accompanied by a cover letter that details compelling reasons for the delay. The NIH will decide what is “compelling.” Specific detail about the timing and cause of the delay should be provided so “an informed, objective decision can be made.” Only the explanatory letter is needed; no other documentation is expected. This letter is available only to NIH staff who have a “need to know” (such as those with referral or review responsibilities); it is not available to reviewers or other staff.
Examples of “compelling” reasons include: death of an immediate family member of the PD/PI, sudden acute severe illness of the PD/PI or immediate family member, or large scale natural disasters. Also, recent temporary or ad hoc service by a PD/PI that required a commitment of time that could have been used to prepare an application may be an acceptable reason (i.e.: serving on an NIH extramural review group, NIH Board of Scientific Counselors or an Advisory Board/Council).
Examples of unacceptable reasons for late submissions: failure to complete required registrations in advance of the due date, heavy teaching or administrative responsibilities, relocation of a laboratory, ongoing or non-severe health problems, personal events, review service for participants other than a PD/PI, participation in review activities for other Federal agencies or private organizations, attendance at scientific meetings, or having a very busy schedule. For electronic submissions, correction of errors or addressing warnings after the due date is not considered a valid reason for a late submission. However, if the problem is with Grants.gov or eRA Commons, grounds will be considered on a case-by-case basis. Be sure to follow the directions for documentation given be the NIH here.
- Late submissions to the NIH are are governed by NOT-OD-11-035.
- Most agencies follow policies similar to NIH. Check your RFP for specific details, or contact us to help you figure out specific guidelines for your agency.
WSU School of Medicine
- Any proposal submitted with fewer than the required internal three days lead time is considered late, and a late submission form is required to be filed with the SOM Office of Research.
- Proposals considered “late” by the School of Medicine that are still before the agency deadline may still be submitted; the late submission form serves as documentation of understanding of responsibility for outcomes. Assistance with late submissions by the RAS office is entirely dependent on volume of on-time submissions.
- The policy and late submission form for the School of Medicine can be found here.
Sponsored Program Administration (SPA)
- Proposals must be submitted to SPA a full three business days before the agency deadline.
- Proposals submitted less than three full University business days before the agency’s deadline will be handled on a first-come, first-served basis, following the completion of proposals submitted on time.
- Successful submissions of proposals submitted to SPA AFTER the three day window cannot be guaranteed.
- SPA’s policy is provided on their website, here.
Give yourself some space to breathe: allow yourself enough time to account for the unaccountable! If you have an emergency and you don’t know what to do, contact RAS – we’ll do our best to help you through!
In order to retain health professionals as researchers, the NIH is offering Research Loan Repayment Programs (LRP) in specific fields: clinical, pediatric, health disparities, contraception/infertility, and clinical research for individuals from disadvantaged backgrounds (click on the fields for their official NIH definitions). The basic premise is simple: you do the research, NIH repays your loans. In order to qualify, you must be researching in one of the highlighted areas and meet the basic eligibility requirements, summarized as:
- Status as a U.S. citizen, U.S. national, or permanent resident of the U.S.
- Possession of a health professional doctoral degree* (M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., O.D., D.V.M., or equivalent; NOTE: the Contraception and Infertility Research LRP is also open to nurses, physician assistants, graduate students, and postgraduate research fellows training in the health professions)
- Educational debt equal to or in excess of 20 percent of your institutional base salary at the time of award
- Research supported by a domestic nonprofit foundation, university, professional association, or other nonprofit institution, or a U.S. government agency (federal, state, or local)
- Engagement in qualified research that represents 50 percent of your level of effort and consumes an average of at least 20 hours per week during each quarterly service period during the contract (2 years for the initial contract)
If this sounds like you, check out the details on the NIH Extramural LRP program information page for more details.
* Recipients of a Kirschstein (NRSA) fellowships and training grants can apply for and receive LRP awards but may have to defer their NRSA service payback until the completion of the LRP.
If you’re welcoming a new faculty member to your department, there’s a good chance that you’re welcoming a new project or two as well. Once you have received the NIH-approved relinquishing statement from the former institution, you’ll need to put together a new budget to satisfy both SPA and the Change of Grantee Organization SF 424. (On a related note, the NIH made some updates to the SF 424 Application Guide and released it last Friday, July 25, 2014. Edits are noted in purple.) When building your transfer budget, these points may be helpful:
- Your first year budget should match the amount on the approved relinquishing statement. Any following out years should match the awarded direct costs on the original Notice of Grant Award (NOGA).
- While direct costs must match the NOGA, indirects are permitted to be generated based on Wayne State University’s applicable F&A rates. This will change the overall dollar amounts awarded in each year; that’s OK.
- Modular submission is not permitted for a transfer/change of grantee organization. HOWEVER, if desired, an award that was submitted as modular during the proposal phase has the option during transfer to complete only the costs for the PD/PI (Section A), and include the remainder of the direct costs under Section F (Other Direct Costs) Item 8, and Section H (Indirect Costs). Otherwise, a detailed budget should be utilized.
As budget defense creeps upon us, indirect cost return monies of existing projects are likely a source of dependency by your department. Checking the accuracy of the amounts flowing into your ICR accounts is always a good idea, and there are a few tools that can help you do so.
The Wayne State University Current Funds Budget reports the current distribution of indirect cost recovery revenues on page G-3 of the Budget Book for FY2015, which can be found here. If you have a rate negotiated at less-than-on-campus or a clinical trial managed be PharmaSeek, your distribution may be different so check with your GCO.
A couple of reports exist to help you determine whether your department and/or PI are, indeed, receiving the correct portion of your project’s indirect costs. They are:
- FTMINDD in Banner. This form provides information used for indirect cost distribution. Here, you can view Banner org codes, accounts and percentages used to distribute indirect cost earnings. FTMINDD looks like this (click the photo for full size):
** You can also check to be sure that the correct indirect cost rate is being applied to your project by using FTMINDR.
- FMS007D1 in Cognos. This report allows you to see what indirect monies were distributed from a specific fund, and to where they were distributed. FMS007D1 can be found by navigating to Public Folders > Finance > Standard Certified Reports – Business Managers in the Cognos reporting interface (accessible from the Employee tab in Pipeline as “Business Intelligence Reporting System”). FMS007D1 appears this way (click the photo for full size):
If you suspect that you are not receiving the correct amount of indirect cost returns on your project, be sure to contact SPA’s Finance Team at (313) 577-2653. If you have questions about interpreting your findings, drop us a note and we’ll do our best to help!
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!
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.
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  periods:
- Project Period 1 (beginning [04/01/2015]): [52.5]% applies for  months, [53.0]% applies for  months
- Project Period 2 (beginning [04/01/2016]): [53.0]% applies for  months, [54.0]% applies for  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!
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!
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!