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.
Additional resources include the Evisions 424 Users Manual and the Evisions SP Users Manual. Please contact Tim Foley (firstname.lastname@example.org) with any questions.