usage of the mathematical inequality symbols; <, >, ≥, ≤ , within NIH
application text fields.
- In early 2015 NIH released a notice informing the grant seeking community of the support for the full Unicode Character Set, in the free-text form fields. http://unicode.org/charts/
According to the above notice and guidelines the mathematical inequality symbols are included within the acceptable/supported Unicode Character Set. However, it has come to our attention that usage of these particular symbols may delay if not prevent the successful submission of an NIH application. While the use of these symbols will not result in error notices within the University’s Cayuse system, the problem is encountered when the application is routed from Grants.gov to eRA Commons.
when entering text where these symbols may be used it is suggested that their
meaning be written in longhand, i.e.
< ( Less than), ≤ (Less than or equal to), etc.
To bring you up to speed, the use of OnCore is School of Medicine policy on all studies with human subjects. It’s canon. We need to see that you’ve accounted for this in your submissions. The use of OnCore is mandated to help track human subjects populations here at Wayne State and, until recently, OnCore fees were to be budgeted into all studies with human subjects. While a good portion of budgets still need to reflect this, the mandate has been altered slightly.
Going forward, investigators applying for funding from non-corporate (i.e., federal and foundation) sources no longer need to include OnCore fees in their budget. They DO, however, need to ensure that their protocol and human subjects populations are registered in the OnCore database at time of award. Please note that proposals and contracts with corporate entities (i.e. pharmaceuticals, biomarkers, and devices) that exceed $50,000 in total direct costs WILL still need to include OnCore fees in their budgets. For all funded studies (corporate and non-corporate) that wish to use OnCore as their Clinical Research Management tool, respective OnCore fees will apply.
This should bring some relief to federal and foundational proposal budgets that are often subject to caps. To reiterate, however: your human subjects populations must still be registered with OnCore (this includes non-clinical trial populations). Please be sure to contact the Clinical Research Services Center (CRSC) for assistance in registering your population, or for questions regarding study management capabilities.
May your June submissions be fruitful!
In a department, administrators and PIs have a lot of room to negotiate with other institutions when it comes to budgets involving awards and subcontracts. Personnel effort? That’s a classic. Materials and supplies? Probably your first stop. Indirect cost percentage? Slow your roll, holmes.
If the project is federally-sponsored, chances are slim that you’ll be successful in your quest F&A reduction below our negotiated 54%*. There are times when a lower F&A rate is acceptable without waiver/permission; for instance, the funding opportunity announcement caps the rate at lower than our negotiated rate, or the award is being transferred from another entity with direct cost equivalency. Anything else requires a waiver with approval from the Vice Dean and SPA. You cannot negotiate a reduced F&A on your own.
Here at Wayne State, the waiver request process begins with an IDC Waiver form. The Research Administrator and the PI should initiate the request, and it must be approved by the PI, the department chair, and the Vice Dean for Research before being sent for approval to SPA. The Vice Dean for Research will consider requests for Indirect (F&A) cost waivers in very limited circumstances, so be sure your justification is sound. Here are some examples that may be considered on a case-by-case basis:
- Capped awards
- Seed grants which may attract larger awards
- Only available source of funds in an area
- Strategic partnerships
- Awards which include equipment or building funds
If you’re just trying to make a proposal look more competitive, or the PI/department failed to submit the proposal via approved institutional channels (e.g., through the Vice Dean or SPA) prior to submission to the sponsor, you’re out of luck. Wayne State’s acceptance of an award with an unapproved F&A reduction does not constitute acceptance of the rate. If you are awarded with a reduced F&A that was not properly approved, you must renegotiate at the time of award, otherwise the department will be responsible for cost-sharing the portion of the F&A not paid by the sponsor.
Questions? You know where to find us!
* 54% is our federally-negotiated rate at the time of this post.
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.
With the major November NIH deadlines about to pass us by, many will turn their attention to their 2017 submissions. As you pursue your application strategies, chances are you’re considering the use of an appendix to bolster your argument for funding. Proceed with caution: the appendix rules for 2017 are not what they once were.
The only allowable appendix materials in 2017 are:
- Blank informed consent/assent forms
- Blank surveys, questionnaires, data collection instruments
- Funding opportunity announcement-specified items
Clinical trial applications may also include clinical trial protocols and/or investigator’s brochures from Investigational New Drug (IND), as appropriate.
Note that the revision of allowable appendix material has significantly reduced inclusion potential. If you weren’t sure before whether you could submit that manuscript, good news: under the new rules, you definitely cannot! No manuscripts allowed!
This announcement was made via NOT in August (check out the full text of NOT-OD-129). The penalties for submitting out-of-bounds material is withdrawal and non-review. Ouch. If you have questions about what this change means, or how it may affect your application, give us a shout and we’ll help you talk through it.
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.
In case you haven’t heard, DMC and Karmanos/McLaren have reached a collaboration agreement. In short, the collaboration settles all previous litigation and provides for the integration of Karmanos into McLaren. Karmanos Cancer Center will continue to operate out of DMC’s Harper-Hutzel hospitals, and McLaren, Karmanos and DMC intend to explore expansion at other DMC sites.
If you have research with any Karmanos component, be sure to check with their CTO to clarify how this may affect future renewals or submissions. If you have any other DMC components, also be sure you are using the latest DMC fringe rates, available here! If you’re not sure whether you’re affected, drop us a note and we’re happy to help you decipher your roles 🙂
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!