What You Need to Know for Conducting Clinical Trials

The 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. 

Clinical Trials

Your study is considered to meet the NIH definition of a clinical trial even if:

  • Your study uses healthy participants or does not include a comparison group (e.g., placebo or control)
  • Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
  • Your study utilizes a behavioral intervention
  • Your study uses an intervention for the purposes of understanding fundamental aspects of a phenomenon.
Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial? Decision Tool

Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial? Decision Tool

Posting Federally Funded Clinical Trial Consent Forms

Does the IRB charge a fee for IRB review of industry-sponsored clinical trials?

Universities are now charging a fee to commercial/industry sponsors of clinical trials for IRB-related expenses. This is either a single flat fee, or a fee for initial review. The funds generated by this fee are used to support the IRB and related expenses (e.g. educational initiatives). The industry sponsors are accustomed to this as an expected fee for clinical trial research projects.

University policy specified that budgets for commercially funded clinical projects should include a one-time fee of $3,000 (amount effective 2/1/17), listed as "IRB Review Fee". ORI sends a separate invoice to the company for this fee and the income will be deposited in an account other than the grant account.

This fee is separate from any start-up costs that the department may apply or any costs incurred through the UK Center for Clinical and Translational Science (CCTS). [HTML]

As we seek to accelerate UK's clinical research activities it is important that we have strong, well-supported systems for the protection of the individuals who participate in that research. By applying this fee we help support these vital activities and place UK in the mainstream of how such systems function and are supported.

Resources and Training

  • ORI's FDA-Regulated Research website (https://www.research.uky.edu/office-research-integrity/fda-regulated-research) provides resources for submitting and conducting FDA-regulated clinical trials.

  • For information or assistance with registering clinical trials, see the Office of Sponsored Projects Administration (OSPA) Clinicaltrials.gov websitehttps://www.research.uky.edu/office-sponsored-projects-administration/clinicaltrialsgov.  The website describes the requirements for clinical trials registration, and investigator responsibilities for clinical trials registration, and provides instructions on how to register clinical trials on ClinicalTrials.gov.

  • The Office of Sponsored Projects Administration (OSPA) is responsible for reviewing, negotiating, and legally accepting agreements from external funding sources. For information, see OSPA’s Clinical Trial Agreement websitehttps://www.research.uky.edu/office-sponsored-projects-administration/clinical-trial-agreements.

  • Sponsor-Investigator (GCP) Training FAQs [HTML]
    IRB policy requires mandatory training for investigators who are also serving as sponsors, (e.g., holding an Investigational New Drug (IND), Investigational Device Exemption (IDE), or abbreviated IDE), for an FDA-regulated clinical investigation. A Sponsor-Investigator must complete the applicable drug or device Good Clinical Practice training on CITI before final IRB approval is granted.

  • Good Clinical Practice Training - CTSA Funded Investigators & Staff [HTML]
    Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants. 

  • The Clinical Research Support Office supports investigators and clinical research study teams in departments, centers, and colleges across campus to conduct clinical research. The office aims to reduce administrative burdens, enhance compliance, and help remove barriers to enable efficiency, internal/external collaboration, cost recovery, and growth of clinical trials at the university. It offers support for the OnCore clinical trial management system, billing integrity and coverage analysis, as well as finance and regulatory assistance in partnership with the CCTS.