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OHSP and IRB News

On-going News:

COVID-19 and Human Research. Research activities involving in-person interventions or interactions with human subjects are still subject to FSU COVID-19-related policy and restrictions that were approved by the Board of Governors of the State University System of Florida. For further information about the policy, restrictions, and tools to accordingly conform human research, ghere or click on the COVID-19 & Human Research tab on the left.

February 4, 2021:

The Office for Human Subjects Protection (OHSP) is please to announced availability of a new OHSP web page, guidance and other resources pertaining to student-led human research. Materials include an overview of how student-led research may require OHSP and IRB review, including an easy review algorithm; a guidance document for quick reference; FAQs, including a link to a RAMP IRB workflow explainer; and key tips. Click on the Student-Led Research tab on the left or use this link to access the Student-led Research web page.

February 3, 2021:

FSU Policy 7-IRB-0 (Human Subjects) has been revised effective February 3, 2021. Revisions primarily include rendering the University Human Subjects policy consistent with applicable and recently revised federal regulations; conforming to institutional changes in responsible executive and approving official; and, with regard to the prior version, clarifying responsibilities, reducing redundancy and removing ambiguity. Access the 7-IRB-0 University Human Subjects Policy here in the RAMP IRB Library or at here on the FSU's Policy page.

November 10, 2020:

James (Jim) Whyte, PhD has been appointed to replace Tom Jacobson as the next Chair of the FSU Institutional Review Board (IRB). Dr. Whyte’s appointment is effective December 10, 2020. Please join the IRB and OHSP in welcoming Dr. Whyte to his new IRB role. Dr. Whyte is Professor with Tenure in the FSU College of Nursing; he holds a Florida license to practice, has Board certification in 3 specialties, and is an elected Fellow of the American Academy of Nursing and Distinguished Scholar and Fellow of the National Academies of Practice. Dr. Whyte has a lengthy history of service, teaching, research, and clinical care, and is a recipient of numerous grant awards, including as Principal Investigator. Dr. Whyte has served on the FSU IRB for over 9 years. More about Dr. Whyte can be found at this College of Nursing faculty page.

October 21, 2020:

OHSP releases a substantially revised Determination of Human Subjects Research Form (HRP-503d - Template Determination Form) template for use. The template must be used to submit and request an official determination from OHSP about whether a proposed study or activity requires submission of a full protocol for regulatory or Institutional Review Board (IRB) review. To access the new template, go to this RAMP IRB template link.

September 1, 2020:

Creation and use of study volunteer repositories or registries for research purposes is subject to federal law and requires FSU IRB review, approval and on-going oversight. More detailed information, including applicable federal law and related guidance as well as resources and new templates for use may be found at this OHSP Volunteer Registries link.

August 18, 2020:

The Chair of the FSU Institutional Review Board (IRB), Thomas Jacobson, announced his planned retirement from FSU in December 2020, including after 15 years of IRB service. The IRB and the FSU Office for Human Subjects Protection extend their deepest appreciation for his dedicated service to human research protections at FSU. Please join us in congratulating and celebrating Mr. Jacobson on his retirement, and expressing our deepest thanks for his lengthy and devoted service on the IRB.

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Other Developments

Clinical Trial Consent Requirements 

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

Single IRB-of-Record (sIRB)

National Institutes of Health sIRB policy went into effect January 25, 2018 for: NIH grant applications (new, renewal, revision, resubmission) received on or after 1/25/18 and NIH contract solicitations issued on or after 1/25/18. NIH-funded multi-site studies involving non-exempt human subjects research will be required to utilize an sIRB for the review of human research. The NIH policy applies to: domestic NIH-sponsored multi-site studies (same protocol implemented at the sites). Only the IRB review functions will be handled centrally; related local functions (e.g., ancillary committee review, training completion verification) rest 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:

  • Whether the FSU PI holds the funding grant
  • sIRB designation by cooperative institutions and/or sponsor
  • Required IRB review expertise

NIH Clinical Trial Policies

The NIH has issued several other policies and guidance designed to "enhance the accountability and transparency of clinical research." For an overview of the changes, view the NIH Clinical Trials Requirements presentation. 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; see https://grants.nih.gov/policy/clinical-trials/definition.htm 

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.

NIH Policy for GCP (Good Clinical Practice)

Good Clinical Practice training requirements became effective on January 1, 2017. 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. FSU requires 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. GCP training must be refreshed every three years while the research is actively funded.

Links:

NIH single IRB requirements/policy and FAQs:

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

Good Clinical Practice Training Requirement changes:

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Other News for Researchers

Federal Policy for the Protection of Human Subjects

Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by signatory federal agencies on January 18, 2017; changes generally were effective January 19, 2018. The Common Rule is a set of federal regulations that apply to human research conducted at FSU.

Select Key Changes:

  • Continuing Review  No longer required for most 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.
  • Exemptions – New categories and clarification of existing categories. Four categories may require "limited IRB review" (similar to an expedited review process).
  • 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.
  • Single IRB-of-Record (sIRB) – IRB oversight for most federally-funded cooperative research projects conducted in the U.S.

NOTE: The new regulations do not impact studies approved prior to January 19, 2018 and that do not transition to the new rules. Related link: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

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