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What Are the Informed Consent Requirements Related to ClinicalTrials.gov? (March 2018)

The following exact statement must be included in the informed consent documents of “applicable clinical trials”:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

FDA has issued guidance related to this new informed consent element. See below:

https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

News for NIH Researchers (December 2017)

FSU recently signed the SMART IRB Joinder Agreement that includes the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.  SMART IRB is a platform designed to ease common challenges and burdens associated with initiating multisite research and provides a roadmap for institutions to implement the NIH Single IRB Review policy.  Through a flexible Master IRB Reliance Agreement, Standard Operation Procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.

FSU Implementation: NIH Single IRB-of-Record (sIRB)

NIH sIRB policy in effect January 25, 2018 for:

  • NIH grant applications (new, renewal, revision, resubmission) received on or after 1/25/18
  • NIH contract solicitations issued on or after 1/25/18

Beginning January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research will be required to utilize a single IRB-of-Record (sIRB) for the review of human subject protections.  Use of an sIRB avoids duplicative review by multiple institutional review boards.  The NIH policy applies to:

  • NIH-sponsored multi-site studies, where the same protocol is used at multiple sites
  • Domestic research only

Only the IRB review functions will be handled centrally.  Related local functions (e.g., ancillary committee review, training fulfillment verification) remain with the individual participating institutions.  The conduct and reporting of the research remain the study team's responsibility.

Will FSU act as the sIRB?

The FSU IRB will evaluate on a case-by-case basis whether they can effectively serve as the sIRB for a proposed multi-site project.  The main evaluation criteria are:

  • The risk level to the human subjects
  • The number of sites
  • The experience level of the FSU PI/study team
  • The level of administrative resources available to the PI/study team to manage/coordinate the project
  • Whether the FSU PI holds the funding grant

Please check back to this Update News site for more information regarding implementation process for sIRB requirement in January 2018.

NIH Clinical Trial Policies

The NIH has issued several other policies and guidance designed to "enhance the accountability and transparency of clinical research":  

NIH Definition of a Clinical Trial

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.

https://grants.nih.gov/policy/clinical-trials/definition.htm

  • Revised clinical trial definition (1/25/2015) 
  • Required Good Clinical Practice training (1/18/2017)
  • ClinicalTrials.gov registration and reporting of results (1/18/2017)
  • Use of the new Human Subjects and Clinical Trial form (part of the NIH funding application package, Forms-E) (1/25/2018)

NIH's definition of a clinical trial is broad, encompassing a wide range of activity which now may include behavioral studies (e.g., studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process). Investigators are strongly encouraged to verify whether their proposal meets the definition of a clinical trial with the NIH program officer and document it accordingly. The proper processing of the proposal is contingent on this determinations. For an overview of the changes, view the NIH Clinical Trials Requirements presentation  

Where to Find Help

To help you identify whether your NIH-funded research would be considered a clinical trial under this definition and, therefore, subject to all the related policies (e.g., NIH sIRB, ClinicalTrials.gov registration and reporting, etc.), the NIH offers the following resources:

Effective October 1, 2017, all NIH funded research meeting certain criteria, that was commenced or ongoing on or after December 13, 2016, is deemed to be issued a Certificate of Confidentiality (“COC”) pursuant to a new NIH policy.  Therefore, researchers no longer have to proactively apply to the NIH for a COC.  Please note that this change may require an update/addendum to the COC consent form section.

New NIH Policy for GCP (Good Clinical Practice)

Good Clinical Practice training became effective on January 1, 2017.

FSU requests CITI GCP training for investigators on FDA regulated clinical trials.  The new NIH policy now requires GCP training for personnel or students that meet the NIH definition of clinical trial for NIH funded research.

A clinical trial is now defined by NIH 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.”

NIH now requires GCP training to be refreshed every three years. Note that the training must be renewed every three years while the research is actively funded.

Per the NIH policy website:

The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors.  GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials.

This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. GCP training includes the Principles of ICH GCP found in Section 2 of ICH E6.

Clinical trial staff:  Individuals identified by the investigators, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

Important Links regarding Updates:

NIH single IRB requirements/policy and FAQs:

NIH notice of changes to NIH Policy for Issuing Certificates of Confidentiality (COC):

NIH new definition of a Clinical Trial:

Why changes to Clinical Trial Policies?

Good Clinical Practice Training Requirement changes:

News for Researchers

Common Rule & Other Changes

Final revisions   to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by the Department of Health and Human Services (HHS) on January 18, 2017. The majority of changes will go into effect on January 19, 2018.

Major Regulation Changes

  • Continuing Review - No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. For details, see the FSU Common Rule Implementation Updates in January 2018.
  • Exemptions -New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (similar to an expedited review process). For details, see the FSU Common Rule Implementation Updates in January 2018.
  • Informed Consent - A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not. For details, see the FSU Common Rule Implementation Updates in January 2018.
  • Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB starting January 20, 2020.

NOTE: The new regulations do not impact studies approved prior to January 19, 2018.

Important Links regarding Updates:

Final Revisions and changes to the Common Rule from DHHS regarding research involving human subjects:

COGR letter updates:

Common Rule sIRB in effect January 2020

As of January 2020, all non-exempt, collaborative human subjects research (i.e., studies in addition to clinical trials) will be required to use a single IRB for research sponsored by other federal agencies following the Common Rule.