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.

 

 

O, What A Tangled Web

No one likes to admit defeat, and most are not particularly excited to shout a mistake from the rooftops.  Self-protection is human nature, but covering tracks in research can land you in some hot water.  HHS defines “research misconduct” as ” fabrication, falsification and plagiarism, and does not include honest error or differences of opinion.” NIH has procedures in place to handle research misconduct claims, but ultimately no power to investigate (except in the case of intramural research).  All research misconduct allegations involving NIH awards (or any agency under the umbrella of HHS) are forwarded to the HHS Office of Research Integrity (ORI) for their oversight.  Just to be clear:

 

  • Fabrication is making up data or results and recording or reporting them.
  • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  • Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

 

If a PI is found to have engaged in research misconduct, HHS can take action by means of debarment from eligibility to receive Federal funds for grants and contracts; prohibition from PHS service; certification of information sources by the respondent that is forwarded by the institution; certification of data by the institution; imposition of supervision; submission of a correction of published articles by the respondent; submission of a retraction of published articles; and more, including recalled funds and withdrawal of support for associated PIs.

 

WSU PIs are full of integrity and honor, but panic can blur a bright line. In your moments of most overwhelming, results-driven disappointment, make sure the object you cling to is a life raft and not an anchor.  ORI sanction happens (and just recently did), and it can ruin a career.

The Very Model of a Modern Major General Conditions Guideline

The NIH announced on February 5, 2015 their guide to NIH-specific implementation of the Office of Management and Budget (OMB)’s Uniform Guidelines (UG), in place since December 26, 2014.  The NIH Interim Grant General Conditions apply to all new and supplemental funding provided by Notices of Award issued on or after December 26, 2014; they contain no surprises if you’ve been keeping up with the road to implementation!  If you need a refresher on how we got here, take a look at some of our older posts, like Super Circular, Super Fun, which highlights some of the new provisions in the UG; and Ch-Ch-Changes, which also has a link to the NIH Administration Timeline.

 

To comb over the NIH Interim Guidelines yourself, the full document can be accessed here.  These will be in effect until an updated NIH Grants Policy Statement is published (which won’t be until after the HHS comment period closes).  NIH has provided a frequently asked questions page regarding the interim guidelines, on which you may be able to find an answer to any general questions you may have.  If your question is more specific than an FAQ page can handle, give us a try!  We’re always happy to help with interpretation and applicability!

 

Update: 03/05/15

Looking for some information on what, exactly, has changed? Check out our handy Uniform Guidance Changes: 2015 page!