We all love hearing about changes to the federal register, amirite? Well celebrate, one and all: last week, a new final version of the “Common Rule” for the protection of human subjects was published by fifteen federal agencies (including DHHS and NSF) in effort to strengthen the Federal Policy for the Protection of Human Subjects. The intent is to both enhance protections and reduce administrative burden(!), and here’s what it means to you:
- Consent forms are required a better understanding to provide potential research subjects of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
- A single institutional review board (IRB) for multi-institutional research studies is required in many cases. (There is substantial flexibility in now allowing broad groups of studies, instead of just specific studies, to be removed from this requirement; this provision is delayed until 2020.)
- Studies on stored identifiable data or identifiable biospecimens allow researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens. Aside: if you’ve been following along, you’ll note that this is a change of course from earlier intent to apply the principles of informed consent to all biospecimens.
- New exempt categories of research are established based on the level of risk posed to participants. (For example, there is a new exemption for secondary research involving identifiable private information as regulated by and participants protected under HIPAA; the intent is to reduce regulatory burden to allow IRBs to focus their attention on higher risk studies.)
- Continuing review of ongoing research studies is no longer required in instances where such review does little to protect subjects.
- Consent forms for certain federally funded clinical trials are required to be posted on a public website.
The general effective/compliance date of the final rule is January 19, 2018; all studies without initial IRB review as of 1/20/18 will be subject to the new requirements. Any ongoing research at that time (i.e. studies with IRBs approved under the current version of the Common Rule) will continue to be subject to the current, pre-2018 version of the rule unless the university chooses to mandate compliance with the final version. For more on the transition provisions, check out the final rule preamble, as well as Section 101(l) of the regulatory text.
Stay tuned for further guidance; HHS intends to issue direction on specific provisions of the rule changes in the near future.
How are those January applications coming? Fabulous? Great! Send ’em our way nice and early!
As the holiday closures approach, keep in mind that our office closes with the rest of the University, so we won’t be around to assist between December 23-January 2. We’ll be back at it on January 3, but if you are planning to work on your applications over the holidays, that only leaves one day in the new year before January 9 deadlines. (Remember: the SPA deadline is three business days before the agency deadline; you’ll need to have your application finalized by January 4.) Consider working with us (or your administrator) to get all of the administrative elements together well before the closure (ideally by Tuesday, December 20). This way, you’ll have your holiday break to work on the science if necessary, and we can pick back up where we left off in the new year. And to those of you who are planning to submit in January, will need our help, and haven’t yet reached out: what are you waiting for?!? Please contact us right away so we can accommodate you as best we can!
For departments with internal administration: we’re pretty sure your staff would also appreciate a well-formulated submission plan accounting for the the holiday closure, as well 😉 Happy writing!
The stone-written commandments of NIH proposals have long included, “thou shalt request prior approval when requesting more than $500,000 in direct costs (excluding consortium F&A costs) in any one year of an unsolicited proposal.” As an aside: did you know you’re supposed to request that approval no later than 6 weeks before submission?
Since the inception of this rule in the dark ages of 2002, these requests were required in writing or by telephone. You now have the option of making the request by webform in a new “Prior Approval Module” through eRA Commons (NOT-17-005). Of important note: you must request the form to be “opened” by your Program Officer before it will be accessible. Once it is available, you complete the form and submit. As another aside: the word “option” appears to be used loosely here; it’s along the lines of being volun-told).
The logic behind the Prior Approval Module appears to be subsequent management of such requests. The module allows PIs and GCOs to amend, modify and withdraw previously submitted requests as proposals shape up differently in the days leading to deadlines. The module will appear between the “ASSIST” and “RPPR” tabs on your login screen:
If you have not yet contacted your Program Officer for access to the module, you will receive an error message (“We are sorry, you are not authorized to access this function”). Not sure whether to request the limit stretch, or just not sure what to do next? Drop us a note and we’ll be happy to help you sort through!
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!