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.
Hot off the presses from our friends at SPA:
The transition from Coeus to Evisions for proposal development and submission is underway!
In our continuing effort to provide the highest level of support of research at Wayne State University, Sponsored Program Administration will begin using Evisions SP/424 in place of Coeus in 2016. Evisions will track research proposal and award activity, provide for streamlined internal routing and approval of proposals, facilitate submission to sponsor systems (Grants.gov), and store proposal documents.
Evisions SP/424 will allow users expanded access to proposal development, submission, and award information through a very simple, user-friendly interface.
The system includes the following features:
- Extra validations and error checking to ensure proposal will be error free upon submission to Grants.gov
- System-to-system data transmission for >95% of all Grants.gov opportunities
- Budget builder tool includes fringe benefits, F&A rates, inflation rates, and multi-year replication
- Proposal development (budget, narrative, compliance questions)
- Re-use data and copy proposals
- Robust routing and approval
- Database of all sponsored program activity
- Tracking of proposals and awards to subcontractors
- Intuitive User Interface
Processes and navigation in Evisions are similar to Coeus. In order to provide for the most seamless transition possible, many group training sessions will be offered in the coming months for administrators and faculty. Additionally, SPA Training is happy to visit your department or college for individualized training. Please refer to the Research Events calendar for scheduled training session. Sessions will run every Thursday between September 1 and October 27.
We highly encourage faculty and administration staff to utilize the Evisions test environment for a hands-on experience. The test instance can be accessed here and users must use their Access ID and the password re85search. Again, this is a test instance and no current “active” information is contained within.
You know that moment when you’ve finally become comfortable using new-ish fringe rates on proposals, and then it changes again? Guess what: BAM! The moment has arrived (actually, it arrived a month ago).
The most current DHHS rate agreement was ratified on July 13, 2016 (use this date on your submissions, folks), and can be viewed on SPA’s website. If, for instance, you’re not using 24.2% for your non-administrative faculty, check you numbers before that proposal goes out! These are the numbers that must be used for projects beginning on October 1, 2016 and after; there’s nothing being submitted now that would start before that date, so here’s looking at you. 😉
Fiscal Affairs has also updated the Composite Fringe Benefit Rates to reflect the new agreement (you can check all of your employment classes here). As in the past, past composite rates are publicly archived for your reference. Questions on how to adjust your budget to the new rates? You know where to find us!
Indirect cost return monies of existing projects are likely a source of dependency by your department. As we move into budget season, be aware of the amounts flowing into your ICR accounts and check them for accuracy. 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 FY2017, which can be found here (previous versions are accessible on the Budget Book landing page if you need to check awards made before October 5, 2015). If you have a rate negotiated at less-than-on-campus (or, for instance, a specialized clinical trial that was externally managed), your distribution may be different so check with your GCO.
A few 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 LaShonda Cooley in SPA: 7-2142. If you have questions about interpreting your findings, drop us a note and we’ll do our best to help!
Ah, the resubmission. We all want to draw attention to the fact that we understand the concerns of the reviewers and really drive home the fact that the amended application addresses initial concerns (or maybe even did the first time around). It’s hard to assert your strength in writing, but that’s why we have bold! And italics! And underlines! And colors! But not so fast: should you be using these textual tools to identify the changes you have made since a previous submission?
While there is no outright rule against this, the NIH states:
You must include an introduction for all resubmission[s] that:
- summarizes substantial additions, deletions, and changes to the application
> individual changes do not need to be identified within other application attachments (e.g., do not need to bold or italicize changes in Research Strategy)
- responds to the issues and criticism raised in the summary statement
- is one page or less in length, unless specified otherwise in the FOA or is specified differently on our table of page limits.
(Preceding emphasis added, read more at Resubmission Applications.) When you’re crafting your resubmission, keep in mind that the NIH expects corrections to be addressed in the introduction, and not anywhere else. While it is not expressly forbidden, your reviewers may be less annoyed that you not only acknowledged previous concerns, but format direction as well. Happy writing!
Save yourself – and those with whom you collaborate – some valuable time: update your personal profile in eRA Commons. When you’re submitting an application through ASSIST, your senior/key personnel fields can autopopulate from your profile, as your Commons ID is linked. Keeping your personal profile updated ensures that the contact and personal information sent with any application has already been sanctioned by you. So where do you go to ensure you are up-to-date? First, log in to eRA Commons, and find the “Personal Profile” link in the blue menu bar:
This will take you to a menu that allows you to update all of your personal information. Some of this populates to ASSIST, some of it does not:
* note: “REVIEWER INFORMATION” is one place to find your Continuous Submission status 🙂
Here are some key points to keep in mind as you consider your personal profile:
- The “EMPLOYMENT” section populates your contact address, and NIH wants three years of history for PIs, and at least one entry for trainees and admins. NIH states, “this information is vital to NIH and its SROs for determining any conflicts of interest with applications.”
- Be sure your institutional affiliation is correct! Did you bring your Commons ID with you to Wayne State from a former institution? You may have to change your affiliation. Go to the “Home” screen and check out your name and affiliation in the top right corner. If the institution listed under your ID is static (no link), call SPA to have your affiliation switched. If your institution is incorrect and it is linked (blue underline), you may be able to change it yourself by clicking on it:
As an aside, when filling out your ASSIST applications: two fields that will NOT autopopulate from your profile are “Division” and “Department.” To be sure that you get proper credit for each:
- Division field: Be sure that you’re using an acceptable major component code (“School of Medicine” or “School of Public Health,” for instance). Not sure where your categorized? Check out the “NIH Acceptable Major Component Code and Major Component Combining Names.”
- Department field: This is where you use “NIH Acceptable Combining Code & Department Combining Names” (such as “Neurology” or “Microbiology/Immun/Virology”).
Confused by what you need to include? Never fear, RAS is here to help walk you through the steps!
The NIH modular budget format is attractive to PIs for a lovely, time-saving reason: the lack of a detailed budget justification. Modular budgeting may be used for research grant applications requesting up to $250,000 direct costs per year; funds are requested as direct costs in modules of $25,000. The logic behind modular budgeting is efficiency: less work for the PI, less work for the reviewers. Modular budgets give PIs a degree of flexibility during the course of the award (i.e. fewer rebudgeting requests).
If you are close to the $250,000 mark, however, modular budgeting may not be for you. Consider the following:
- Your competing renewal must be modular. This means, then, that you will be limited to $250,000 for the life AND future of the project. If your current submission is part of a grander plan, this could lead to some serious research growth-stunting. Additionally, if it is an NCI application, it generally cannot exceed an increase of 10% over the direct cost budget awarded for the last year of the prior project period. [NOT-CA-08-026]
- There will be no future year escalations. Annual modular budgets are average budgets for the entire award period; salary escalations may result in a request for more modules than needed for costs in the beginning years to cover escalations in future years.
- Underfunding is a reality. You may not have a firm grasp of the project costs at the time of submission, especially if you don’t do an internal detailed budget for yourself and/or SPA. Are costs of materials expected to increase in the out years? What about salaries? Space costs? Supply needs as the project grows? Without a full understanding of the totality of costs, the project could be faced with deficits as salaries and other costs increase annually. Increases in modules can be requested in exceptional circumstances, but the request must be thoroughly justified and acquiescence is rare.
Detailed budgets are nothing to be afraid of, and should be done internally anyway to ensure research is adequately funded. Modular budgets are a great tool for smaller projects but if you’re close to the border, check your figures again: the extra effort of a detailed budget could save you from the pain of future paucity. If you need help in auditing future needs or budget framework, RAS is here to help!
Researchers here at Wayne State with H1B visa status are not precluded from submitting proposals to the NIH. Grants given are technically awarded to the university, so submission is allowed as long as the H1B holder is officially employed by Wayne State.
You will need to remain at WSU long enough to finish your proposed project, and you’ll have to state in your application that your visa will allow you to be here long enough to be productive. As you know, H1B visas are held for a maximum of six years, and it may be issued in increments of up to three years by the USCIS.
While submissions and award are both possible, there ARE special procedures for funded foreign nationals to perform select agents and toxins research. If your proposed project has an agent or toxin that is considered “select” (go here to find out: http://www.selectagents.gov/SelectAgentsandToxins.html) we’re happy to walk you through the whys/hows.
By now you are most certainly aware that Forms D will be required for all NIH applications on or after May 25. If you are using ASSIST, you will automatically be directed to the Forms D cloud set (in the past few weeks, you were given a choice on the initiation screen, but now we’re very close to the no-option date). If you are still using the SF424 (why aren’t you using ASSIST?) be sure that any work you are doing is in the correct form set. The Forms D application guides are revamped and available on NIH’s website.
We first warned you of this back in October, so now is a great time to re-familiarize yourselves with the required changes: Brace Yourselves, Forms D Are Coming. For an exhaustive list of changes, NIH has provided a high-level list of FORMS-D pre-award form changes, as well as a landing page for all things Forms D. And, as always, drop us a note if anything looks murky; we’re always happy to help find clarification!