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OHSP and IRB Communications: News & Events

News and events of interest to the human research community will be contemporaneously posted on this page. Time-sensitive communications may be sent to the human research community through the IRB's listserve of researchers with active studies. Other news will be available through the Office of Research's monthly newsletter that is widely distributed across the University's research community.

On-going News:

Holidays and Winter Break Notice. As a reminder, FSU will be closed on the following dates:

  • Winter Break & Holidays, December 21, 2022-January 2, 2023

During these times, the OHSP office will be closed for business. The RAMP IRB system will, notwithstanding any unscheduled outages, remain online and functional for your use but submissions will not be processed. To promptly report any incident involving research subject safety, see our FAQ#7 under Specific FAQs: here or https://www.research.fsu.edu/research-offices/ohsp/investigator-resources/#Incident

Tutorials for using RAMP IRB. New video tutorials are now available to assist researchers with using RAMP IRB and navigating a study submission workspace. Tutorials last just a few minutes and include video captures of RAMP IRB workspaces. Additional tutorials will be added to reflect changes in the RAMP IRB system and popular demand. Access the tutorials under the Investigator Resources tab on the left or go here.

Decision Trees. New algorithms and workflow diagrams provide the FSU research community with high-level illustrations of various review processes, decision points and outcomes related to human research review, including when IRB review may be required; use of health information; clinical trials; and FDA-regulated products. Check out our Decision Trees tab on the left or use this link

National Institutes of Health (NIH)-funded Human Research and the new NIH Policy on Data Sharing and Management. Effective on January 25, 2023, the NIH Data Management & Sharing (DMS) Policy will go into effect for many funding proposals submitted on or after that date. The policy, which may be applicable to both proposals and NIH-funded human research, is intended in large part to "promote the management and sharing of scientific data generated from NIH-funded or conducted research" in the interest of ensuring improved public access to publicly funded research and enabling data reuse for future studies. The policy requires that FSU researchers submit a data sharing and management plan in their applications, and the plan must, for human research, address the protection of subjects' shared data. Visit our NIH DMS page to learn more. 

Post-IRB Approval Compliance. Our new Post Approval Compliance Monitoring page provides background and information about the scope and types of post-IRB approval monitoring, including what to expect if a study is selected for monitoring review or assessment. Additionally, the web page provides access to the applicable standard operating procedure HRP-059, and the detailed checklists that may be used by OHSP for conducting the monitoring assessment.

Conducting a Clinical Trial at FSU? Visit our Clinical Trials page for information about additional human subjects-related requirements that may apply when conducting a clinical trial. For a quick overview, check out our FAQ #10 under Specific Questions on our FAQ page.

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. Many restrictions have been relaxed. 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.

On-going Events:

IRB Meetings. Monthly meetings of the Institutional Review Board (IRB) are scheduled for the review of human research studies that in accordance with applicable federal law require such review (e.g., studies involving greater than minimal risk, clinical trials, FDA-regulated products/articles, vulnerable study participants); other research is reviewed on a rolling basis. See our Meeting Dates & Deadlines page for IRB meeting and deadline information. IRB meetings are confidential, may involve proprietary, trade secret, copyrighted and/or sensitive or protected information, not open to the public or non-IRB members, and are otherwise not generally announced.

FAQs:

New and revised Frequently Asked Questions (FAQs) have been posted on the Office for Human Subjects Protection (OHSP) web site, and are now organized in an easier more accessible format, including in 3 broad categories: general, RAMP IRB-related and specific FAQs. FAQs are drawn from the inquiries posed by the University research community. Answers include useful links and helpful graphics.

New or revised FAQs pertain to quality improvement, conflicts of interest (CAMS) reporting and disclosures, and clinical trials. Other topics include what research activities may be subject to IRB or other human research regulatory review, how IRB review is performed and review turn-around, and how to check the status of IRB submissions. To access the FAQs, visit OHSP's FAQ page, or go to https://www.research.fsu.edu/research-offices/ohsp/faqs/.

Conflict Administration Management System (CAMS) and Conflicts of Interest (COI):

The launch of FSU's new Conflicts Administration Management System (CAMS) will affect the IRB workflow and review of RAMP IRB submissions, including possible delay in IRB review and how any conflicts of interest (COI) must be disclosed to human research participants (human subjects); refer to the OHSP COI page for an overview and to our FAQ #9 under Specific Questions for additional, detailed information about these affects. While conflicts of interest disclosures to human research participants are subject to the IRB's review and approval, the CAMS module is not under the auspices of the OHSP or IRB; visit this CAMS project web site to learn more about CAMS.

RAMP System Upgrade(s):

NEW and UPCOMING! The RAMP IRB module will undergo a planned upgrade (RAMP IRB "10.5") around April 2023, and include several new features for end users, including updating studies, improving RNI (Report of New Information) submissions, and study tagging. Other RAMP modules (e.g., Grants, Agreements, ACUC) will also be upgraded with many improvements for those end users as well. See this RAMP IRB 10.5 Release Overview. Once available, a link to the FSU RAMP Support Office RAMP 10.5 Upgrade site and their training resources will be made available here.

RAMP IRB 9.1: The RAMP system had a system-wide upgrade, including to the RAMP IRB module. Several new features are intended to improve convenience and functionality for end users, including performing searches within one's own submissions or content to which one has permission to access; personalizing the appearance of tables in the RAMP IRB dashboard; and "pinning" certain recently viewed submissions for focused attention. For additional information and instructions, refer to pages 3 and 15-16 of the RAMP IRB Researcher's Guide, available in RAMP IRB, under the IRB and Help Center tabs. For additional upgrade information provided by the FSU RAMP Support Office, go here or to https://ramp.research.fsu.edu/upgrade-information/.

New Student-led Research Resources Published:

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; student-led research 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.

Federal Advisory Committee on Human Research Protections:

The DHHS Secretary's Advisory Committee on Human Research Protections (SACHRP) provides expert advice and recommendations to the Secretary, through the Assistant Secretary for Health (ASH), on leading edge and usually controversial issues and topics pertaining to or associated with the protection of human research subjects. Advice and recommendations often result in new or changed federal human research protection policy and law. Stay on top on these developments by tuning into SACHRP's tri-annual meetings and/or accessing past meeting webcasts as well as current, past and archived SACHRP meeting materials. 

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