University of Delaware Research Office

For Research Administrators

Fall Effort Reports Now Available for Certification

The Fall effort reports covering the reporting period of 09/01/16 through 02/28/17 were distributed to units on March 10, 2017 and are now available for certification.

University employees whose salary or wages are directly charged to a sponsored project or are used as cost sharing for a sponsored project are required to certify his/her effort report in accordance with Federal OMB Circular A-21 or Uniform Guidance 2 CFR 200.

All Fall effort reports must be certified no later than Monday, May 29, 2017. To log into the Effort Reporting System, go to www.udel.edu/effortcert.

The federal government continues to be active in their review of effort reporting compliance. As a reminder, failure to meet the above deadline puts the University at risk for audit disallowances. Audit findings due to incomplete, inaccurate or late submission of certified effort reports can and have resulted in large cost disallowances and penalties at other universities.

Should you have any questions, please contact us at effortcert@udel.edu or at 302-831-4956.

Clinical trials

Important changes affecting NIH-funded studies and funding applications of research with human subjects have recently been adopted by NIH. Others will become effective in the upcoming months. Follow the link to learn more about those changes and to access resources to facilitate compliance with the new requirements.
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NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. In an effort to enhance its management and oversight of clinical trials NIH has implemented and announced several policies that affect NIH-funded and funding applications for clinical trials research.

  • Good clinical practice training: New NIH policies establish Good Clinical Practice (GCP) training expectations – effective January 1, 2017 — for investigators involved in NIH-supported trials, as well as for staff who design, oversee, manage, or conduct clinical trials. Training should be completed every three years. At UD, training must be completed from the CITI Program by selecting the available “CITI Good Clinical Practice – GCP” training course. Investigators are responsible for ensuring their research team members have completed the required GCP training in a timely fashion. The GCP training requirement is in addition to the requirement to complete Human Subjects Protections training.
  • Enhancing clinical trial registration and summary results information: An HHS rule  specifies requirements for clinical trial registration and summary results information reporting. Recently NIH issued a policy that complements and expands the federal regulation to all NIH-funded, in whole or in part, clinical trials regardless of study phase or type of intervention. Read more in a New England Journal of Medicine paper authored by NIH staff. Applicants for NIH funding are required to submit a plan outlining how they will comply with the clinical trial information dissemination expectations of the policy.  Consistent with the terms and conditions of their NIH funding, awardees undertaking clinical trials covered by the NIH Policy must ensure the submission and updating of the same type of registration and results information, and in the same timeframes, as responsible parties whose trials are subject to the Final Rule. The policy took effect on January 18, 2017, and applies to applications and proposals received and intramural clinical trials submitted for Institutional Review Board review on or after that date. To facilitate compliance with this new requirement the UD Research Office will disseminate further guidance and enhanced template documents for the submission of research to be reviewed by the UD Institutional Review Board (IRB).
  • Use of a single institutional review board (IRB) for multi-site studies: This NIH policy, issued in June 2016, is meant to streamline and expedite IRB review of clinical trials conducted across multiple sites. The policy established the expectation that a single IRB will be used for multi-site research as of May 25, 2017. The NIH recently agreed to postponing the implementation of the policy until September 25, 2017. UD is monitoring the NIH FAQs and guidance on this topic as we develop an implementation plan. In the meantime, we ask that any investigator preparing or collaborating in a future proposal that would be required to use a single IRB to contact the Director for Research Compliance, Dr. Maria Palazuelos, early during the planning phase.

Changes to clinical trial applications:  Another change to be adopted as NIH policy requires that the research community submit grant applications requesting support for clinical trials in response to clinical trial-specific funding opportunity announcements (FOAs). This policy is targeted to apply to applications submitted for due dates on or after January 25, 2018. This change will allow NIH to readily identify proposed clinical trials, to ensure that key pieces of trial-specific information are submitted with each application, and to ensure that trial-specific review criteria are uniformly applied. This change will mean that applications requesting support for a clinical trial on a NIH parent announcement will no longer be possible. Investigators will need to identify an FOA that clearly invites clinical trial appl

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