Read this to the tune of Pink’s Who Knew by clicking the link at the end of this blog.
Perhaps, we should have listened to Pink’s advice.
NIH NOT-OD-16-004 announced sweeping changes to the SF-424 application content requirements for NIH funded research. The changes are designed to enhance NIH’s ability to seek fundamental knowledge about the nature and behavior of living systems and applying that knowledge to enhance health, lengthen life, and reduce illness and disability (NIH Strategic Plan 2016-2020).
Before we talk about the actual application changes effective January 25, 2016, you should review the NIH Rigor and Transparency webinar on the purpose and content applications that a proposal will be reviewed under for applications submitted after this date. This information gets 4 Stars on clarifying the application content changes using concrete examples in areas such as scientific premise, sample size, study design and resource authentication.
NIH has implemented its changes in two Phases, some of which affect the current application package Forms-C (Phase I), but may not be clear to researchers submitting before the implementation of Phase II which will use Forms-D. The current application instructions have been updated, however, the forms have not yet been changed for Forms-C applications. It is important for researchers to be familiar with the changes that affect the content of their application. For detailed information on the content changes, watch the NIH Rigor and Transparency webinar and click on the topical links outlined below.
PHASE I – Currently Implemented Forms-C Changes (effective January 25, 2016):
Research Training Program Plan form PHS 398 additional reporting requirements
Biosketch clarifications on previously implemented changes
PHASE II – Additional Forms-D Changes (effective May 25, 2016):
Appendices (not announced yet, announcement anticipated in spring 2016)
Assignment Request, separate form to be introduced in Forms-D
Data Safety Monitoring Plan, separate form for all applications involving clinical trials to be introduced in Forms-D
With the advent of the Uniform Guidance (UG) December 26, 2014, there’s a lot of talk around campus about cost sharing. It’s a good time to take the opportunity to clear the air on a few cost sharing issues, some mythical, some fact…
1. MYTH: Cost share is unallowable under the new guidance. FACT: Cost share under the Uniform Guidance (UG) is required to be prescribed in the funding announcement if it is an item that determines eligibility for award (1). This was an issue that was not uniformly applied by federal funding agencies, which resulted in investigator questions, confusion, and potential disparity in proposal evaluation. Funding agencies are now required to outline the criteria for evaluating cost share, and whether and how it will be used in the review process. This clarification ideally will reduce the idiosyncratic practices across federal funding agencies and level the field for evaluating the merit of proposals (2). As a matter of fact, under the UG, a federal agency is not permitted to use cost share as a factor of evaluation for the merit portion of review of a research proposal (3). Correspondingly, the UG also provides that announcements must clearly state if cost sharing is not required.
2. MYTH: Waivers of indirect cost are not permitted under the new guidance. FACT: Waivers of indirect continue to require prior approval of the federal funding agency in order to be considered a source of match or cost share (4). Federal funding agencies are required to give the full negotiated rate to an awardee, unless statutory provision prescribes a different rate (5). Some of the more common agencies that utilize a statutory rate provision are some U.S. Department of Education and U.S. Department of Agriculture programs. Sponsors may limit the amount of funding provided in total for a program, have match requirements, impose limits by category of funding, or take other actions that effectively create a Catch-22 situation in crafting a realistic budget, however, it is still required that federal agencies provide full negotiated indirect. Proposers are free to offer waived indirect as cost share, the UG change is that this action requires prior approval. If a waiver is anticipated, prior approval of the sponsor is required either via either stated within the funding announcement or through specific permission granted by the program official.
3. MYTH: Salary above the cap is cost share. FACT: Salary above the cap is TREATED LIKE cost share. Salary above the cap is an unallowable cost for federal awards (6). Due to salary above the cap being an unallowable cost, it’s not entirely true that it is cost sharing. However, salary above the cap should be treated like cost share, as is the same for any unallowable cost item. Unallowable costs are placed into the base calculation for modified total direct costs. Salary above the cap receives this treatment and so does cost share. This is done so that all costs effectively capture the amount of associated indirect costs in the pool of modified total direct costs (7). Salary above the cap is kind of like a “diet” soda to the federal agency who gets the benefit of enjoying it, with none of the additional calories.
4. FACT: A de minimis indirect cost rate of 10% may be used for entities that have never had an indirect cost rate (8). This is true, and it may be used indefinitely without review of actual costs prior to award. However, post-award review of cost reimbursement grants and contracts are always on the table. A review would include determining whether direct and indirect costs have been consistently allocated, whether costs specifically pertaining to the award are segregated within the accounting system, and whether unallowable costs have been properly excluded. These are issues that should receive subawardee assurance of compliance prior to permitting use of the de minimis rate.
5. FACT: Fixed amount awards cannot be used where the award requires a mandatory match or cost share (9). Here’s why: Costs under fixed amount awards are generally not audited after the award. It is incumbent upon the proposer to provide accurate and complete proposed costs within the guidelines of the cost standards (10), and to record and report the costs as proposed under a fixed amount award because the costs are not audited subsequent to award. Match requirements are required to be reviewed in a compliance audit (previously an A-133 provision, now Sec. 200.500). Rather than change the historical treatment and requirements within the Federal Acquisition Regulations of fixed price awards (FAR 16.2), it seems that the feds opted instead to exclude awards types where incurred cost review is required.
6. MYTH: Summer effort may be used as voluntary committed cost share. FACT: Cost share must be verifiable and traceable to official business records. Therefore, summer effort as cost share should not be committed without an institutional payment source. You can only count as cost share the portion that is actually paid by an entity and has a basis in the accounting records (11). This rule continues to be in place as a cost allocation standard carryover from our old friend A-21 which incorporates certain of the federal Cost Accounting Standards (CAS), chiefly CAS 9905.501 which requires consistency in estimating, accumulating, and reporting costs. Correspondingly, if it’s an outside entity providing in-kind services, costs are also required to have a basis in that entity’s actual cost (12). The CAS are statutory provisions that continue under the Uniform Guidance. The more things change, the more they stay the same.
1. 78 FR 78674 Appendix I, C.2.
2. 78 FR 78675 Appendix I, E.1.
3. 78 FR 78626 200.306(a)
4. 78 FR 78626 200.306(c)
5. 78 FR 78642 200.414(c)(1)
6. 78 FR 78646 200.430(d)(2)
7. 78 FR 78642 200.413(e)
8. 78 FR 78643 200.414(f)
9. 78 FR 78621 200.201(b)(2)
10. 78 FR 78621 200.201(b)(1)
11. 78 FR 78647 200.430(h)(8)(i)(1)(ii-iii)
12. 78 FR 78651 200.434(d)
What Happened Over the Past Few Months?
During the past few months CLAS Research Support Services conducted informational and hands-on training sessions on several topics that were recorded if you missed live sessions. The sessions included NSF Career Proposal Preparation, NSF Fastlane, and NIH ASSIST for single submissions. Visit the CLAS Research website for resources under the topical areas. You’ll find useful templates and website links. You may request the recorded material by emailing CLASResearch@wayne.edu.
What’s Happening Right Now?
If you plan to submit an NSF Career proposal or for other sponsored funding, you may want to request a Mock Review to obtain collegial advice on your draft proposal. This option is available even if you are not submitting for a current deadline. Contact CLASResearch@wayne.edu for more information on this resource for proposal submissions.
What’s Coming Up Soon?
Upcoming sessions to support researchers are an Institutional Review Board (IRB) presentations on Social Media in Research, Research vs. Qualitative Improvement, and Secondary Use of Data (June 23, 2 -3:30 p.m. 2339 FAB). Library Services will present information on the H-Index, What It Is and Why It Matters (June 16, 2-3 p.m. 2339 FAB) and SciENcv and ORCID (June 30, 2-3:30 p.m. Lab B, DAUGL). Click on the hyperlinks to register.
CLAS Research Support Services will repeat workshops in July on the use of NSF Fastlane and NIH ASSIST for PI’s, and conduct a session on completing the Research Performance Progress Report (RPPR). For information on any upcoming or past topics, email CLASResearch@wayne.edu.
Who Do I Contact About This?
As always, just contact CLAS Research Support Services if you have a question on any research administration topic. You don’t need to contact Detective Columbo to find us or timely answers to your questions.
CLAS Research Support Services is doing a year end organization of some critical calendars, so you may start to notice communication that you haven’t seen before. You will begin to see:
1. Notifications of your progress report due dates if you have externally sponsored funding from sources other than the National Science Foundation or the National Institutes of Health. These sponsors do a spectacular job of communicating with awardees, so no additional help is needed. The notices that CLAS Research Support is automating include an attachment of the Award Terms that include any reporting information on format and content, as well as contact information on your program technical official, and a link for submittal of the progress report.
When you receive an upcoming due date notification, click on the UPDATE button to access any of the items mentioned above. If you want to turn off any future reminders, click on the CHECKBOX field in message, and you will not receive future notifications until your next progress report due date is near. This communication is sent via Smartsheet, so please don’t regard it as spam.
2. Notifications of WSU Internal Funding Deadlines for programs offered by the Office of the Provost, Office of the Vice President for Research, and the Humanities Center, as well as other programs that may open during the year. These notices will be distributed college-wide two weeks prior to the awarding office’s deadline. This communication is sent via the listserve from CLASResearch@wayne.edu, so please don’t regard it as spam.
To have a handy calendar anytime of these due dates, click on the INTERNAL FUNDING CALENDAR 2015.
As always, to reach us anytime CONTACT CLAS RESEARCH SUPPORT SERVICES
As part of its efforts to streamline and simultaneously enhance its application and review processes, NIH is changing the format for biosketches to permit applicants to describe significant contributions. The new biosketch page limit will also increase to 5 pages. NIH plans to roll out the new biosketch format for its FY2016 funding cycle (NOT-OD-14-091). Currently, NIH is in a pilot phase. The pilot directly impacts applicants applying to a few Funding Opportunity Announcements (FOAs) (e.g., RFA-NR-15-001), but there is an immediate indirect impact to all applicants as well. In order to accommodate the pilot applications, eRA has changed the way it systematically validates the biosketch page limit. A warning will fire if you submit a 5 page biosketch and an error will fire if your biosketch is over 5 pages. Applicants to pilot FOAs should ignore the 5-page warning, but others should conform to the previous 4 page limit or will risk post-submission rejection of the application. Applicants should read and follow all application instructions – even those that aren’t enforced by electronic systems.
You can take a sneak peek at the new biosketch format for the National Institutes of Health at http://nexus.od.nih.gov/all/2009/11/01/enhancing-peer-review-view-a-sample-of-the-new-biosketch-format/.
Data, data, who’s got the data?
It’s appropriate to begin the inaugural blog of CLAS RESEARCH with an important topic that is always at the fore of research; how do I responsibly manage data?
One thing is for certain, and two things are for sure: 1) Researchers need to manage data, and 2) handling of research data should be secure. You don’t need to be a cyber-security expert if you review and incorporate the prudent practices and resources available to you for data management. The Office of Research Integrity produces an exceptional primer on ethical considerations of data management that incorporates case study examples and comprehensive citations of relevant guidance. Although you won’t be a cyber-security expert, after reviewing the primer you will have a solid foundation in the ethics and practical considerations of data management in a university environment.
Data management is a required component to address in many sponsored applications, and it’s a part of everyday life in research. If you missed the WSU PAD presentation in January 2014 that outlined institutional resources available to plan for collection, access, and management of data, you may access the archived recording by clicking this link. If you’re short on time to view the recording today, and need quick access to specific information on data security and components of a data management plan, a good resource is Boston University Libraries site dedicated to Data Management. The site provides guidance through examples, templates, checklists, and specific guidance in Social Science data preparation and archival published by the Inter-University Consortium for Political and Social Research.
As an audit of your data plan, you may wish to use a standard template for review. John’s Hopkins provides a generic downloadable checklist that may be used if you’re reviewing a data management plan for yourself or performing a peer review. Funding agencies typically have specific requirements that must be addressed within a data management plan, so if you’re preparing a proposal be certain to confirm the most recent requirements to incorporate in a data management plan, and to consider implications of the type of data that will be collected and stored, along with the resources available to you for management of the data.