IRB Operations Manager Corey Zolondek recently released three new versions of institutional review board (IRB) forms to better reflect federal guidelines. For exempt review, both the Medical Exempt Protocol Summary form and the Behavioral/Social/Education Exempt Protocol Summary form are new versions, with questions rewritten to better indicate whether the proposed research meets the federal requirements for an exemption. For the appendices, Appendix C: Children as Research Participants has also been updated to include a request for a risk assessment for control/placebo groups with children; the form also more clearly presents federal requirements for research on wards. The use of these forms will be mandatory beginning January 15, 2015.
Though they still have October 2013 form dates, minor changes have been made to the following forms as well and it is strongly recommended that these versions are used; many questions have been rewritten to help investigators avoid common issues:
Medical/Behavioral Protocol Summary Form (Expedited and Full Board) | Expedited Medical/Behavioral Amendment Submission Form | Full Board Medical/Behavioral Amendment Submission Form | Appendix B: Internet Use in Research | Unexpected Problem Report Form
This is just a quick reminder to ensure that you are identifying the “Division” on your SF424 proposal packages as “Schools of Medicine”. This is the identifier category used when crediting the School of Medicine with award dollars, and any other unrecognized term will result in uncredited monies (thus dropping our rankings). “Schools of Medicine” is the recognized NIH “acceptable major component code.”
Stay tuned for more information in coming weeks about officially recognized department names!
November is quite a popular month for budget forecasting and cost projection among departments. Here are a few things to keep in mind when you’re doing your calculations:
- Remember, our fringe rates have changed! Gone are the days of 26.6%; we now have four rates that are divided in very different ways than they have been in the past. On sponsored projects, this is most often going to look like 21.4% for your faculty researchers and 33.0% for your non-faculty research personnel (research assistants, associates, etc.) There are, however, many different ways the rates will be applied! To make sure you are calculating your forecasts correctly, check the E-Class designation for each of your personnel and compare it to the current composite fringe benefit rates chart. Remember, just because it was awarded when the previous rates were in effect does not mean that the calculations stay the same for the life of the project.
- You don’t have to factor in termination payouts. If you have personnel on grants that you know will be retiring or leaving, there is a designated account for termination payouts so your project funds are not harshly impacted. for more information on this payout structure, contact SPA.
- Consider asking your PIs to do an inventory of their cages if they are working with animals. A per-cage charge may be inaccurately reflected in your projections if more or less cages are being used than originally anticipated at budget time.
- Tuition may not hit at the time of the grant. Make sure you account for future costs – such as tuition that is budgeted but not yet spent – that may not be projectable based on current/past expenditures.
For tips on calculations quasi-forensic forecasting, contact RAS anytime… we’ve all been here too!
Several departments currently have HRSA (Health Resources and Services Administration) funding, and should be aware that there is an upcoming to the log-in procedure for accessing the EHBs:
As of November 21st, 2014 you must use your EMAIL ADDRESS instead of your current EHB usernmame to log in to the system.
The HRSA Contact Center is available to help if are still having difficulty with access: 877-464-4772
As we draw nearer to the implementation of the Super Circular, our friends at NCURA continue to put out some very helpful vlogs (video logs) on some of the highlighted changes. There is a new rule for indirect cost rate negotiations, in fact, that now allows a one-time, four-year extension on current negotiated rates. This is governed by section 200.414 (linked, for your reading pleasure); you can check out the short NCURA video here:
The possibility of a rate extension theoretically saves universities (and other entities) time and negotiation resources by allowing for the postponement of the process. Of course, the costs associated with the preparation of the proposal for the extension itself are other other consideration factors. What is your opinion on the effect of this change; will it save administrative burden as intended? We’d love to hear your thoughts!
It’s that time of year again: effort reporting and certification is upon us. Wayne State relies upon effort reporting for faculty and staff on grants to confirm that salaries and wages charged to sponsored projects are reasonable for the agreements in place and the actual work performed. Without effort reporting and certification compliance, financial penalties and expenditure disallowances could result.
In order to help navigate the effort certification system, the folks at CLAS put together some very helpful materials:
And for further reading on the process itself, check out SPA’s effort reporting page. If you have any difficulty with the system or figuring out who needs to certify whom, RAS has been there and can offer guidance!
Ah, the “Credential” field in the SF424. This little line has sent many an administrator scrambling at the last second, calling for hasty assigning of eRA Commons log-ins for unregistered key personnel:
Not including the credential/login for Senior/Key Personnel is, after all one of the most generated sources of error in electronic submission. In fact, it is so prevalent that NIH lists it as #3 on their “Ten Checks to Help Avoid Common Errors.” And when a subawardee is also a key person and doesn’t have a login, we set outside instutions to scrambling for IDs as well. But here’s a little secret: your suncontract key person doesn’t necessarily have to have an eRA Commons login to include him/her as a “Senior/Key Person.”
Shock! Scandal! No really, it’s true. On the “Frequently Asked Questions” page for Applying Electronically, NIH states in section I.C.6:
6. For consortium/subawards, do the sub-awardees need to be registered with eRA Commons and Grants.gov?
Sub-awardees are not required to register. However, we do encourage them to be proactive and register to be ready to serve as primary awardees in the future.
That said, you can’t leave the “Credential” field blank if your subaward key person doesn’t have a login; you will still trigger the error and this could prevent your application from being submitted by the deadline. If you find yourself with a subaward key person with no login, the easiest workaround is to enter the person’s first initial and last name in the “Credential” field, so the system does not trigger an error for a blank requirement. If, for instance, you have a subaward to Dr. Sam Samson from the University of Madagascar (many investigators from Madagascar, we have found, do not have eRA Commons log-ins), in his credential field you can enter “SSAMSON”:
Please note that this only applies to subcontracts/subawards; signing officials and the PD/PI(s) must be registered in the NIH eRA Commons in order to submit. And, in the case of multi-project applications, the component leads must also be registered. Give us a shout if you are unclear as to whether you can submit without an agency credential on a certain person; we’re happy to help you troubleshoot!
Our friends in Sponsored Program Administration recently announced adjustments to the fringe benefit rates, based on the amendment to our Federal Rate Agreement. These changes are effective today (10/1/14); here are the highlights, in case you missed them:
- There are now only four fringe rate categories (reduced from the previous six).
- Employee classes are allocated by new role/function definitions.
- The “premium” rate that was previously applied to certain designated funds has been eliminated.
These changes will impact the charges to non-General Fund funds, depending on the categorical mix of employees that are charged to those funds. A schedule showing the “old” and “new” rates by employee class was provided by the Associate Vice President for Fiscal Operations and Controller (Jim Barbret), and is accessible here.
Mr. Barbret has indicated that the Fiscal Operations website will be updated as soon as the updated rate agreement is in hand. Gail Ryan, Assistant Vice President for SPA, has also offered to answer any questions that you may have. And, as always, RAS is here to help as well!
Is your department conducting (or planning to conduct) international, patient-oriented research? NIAID (National Institute of Allergy and Infectious Diseases) has a database of country-specific clinical research regulatory information called ClinRegs, and it is now live (beta)!
ClinRegs is a public resource designed to assist in the planning and implementation of international clinical research. The database is a tool that can be used to examine regulations within a country, and compare requirements across nations. Search countries currently include Brazil, China, India, Kenya, Malawi, Peru, United Kingdom, Tanzania, South Africa, Thailand, Uganda, and the United States; there are plans in place to incorporate regulations from Mali, Mexico, Vietnam, and Haiti in 2014. ClinRegs allows you to explore topic areas such as: clinical trial lifecycle, competent authority oversight, ethical review, informed consent, investigational products, specimens, and sponsorship.
ClinRegs is soliciting feedback through a survey (linked in the upper-right corner of their home page) or using their “Contact Us” feedback email address. Take it for a spin and let them – and us! – know what you think!
When utilizing subcontracts on a proposal, occasionally we run into domestic institutions who have no negotiated federal rate agreement. This means (among other things) that there is no F&A rate. If the subcontracting institution doesn’t require administrative overhead in their role on the project, it’s not necessary to grant them these costs. But what if they do require administrative costs? Scientists gotta science, administrators gotta administer!
For cases like these, there is a minimal threshold set by the federal government for institutions with no negotiated rate: it has been 8%, but has been increased by the OMB Uniform Guidance to 10% for domestic institutions, effective December 26, 2014 (as stated in Section 200.110). We have been successful here at using the 10% rate on proposals as of late. To view the full text of the Final OMB Uniform Guidance regarding the increase of the de minimis threshold, take a look at Subpart E, 200.414 on the Federal Register site. For a breakdown interpretation of the language (for this and other changes), check out the table produced by The Huron Consulting Group, or our post entitled “Super Circular, Super Fun“!
RAS is here to help if you have any questions on how to budget your subcontracts with no negotiated rate. Feel free to reach out if you need us!