Don’t’ Let These Characters Stop The Show

Discussing 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.    

So, 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.

Times of Trials: Rules and Registrations

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.