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. University Thanksgiving Holiday and Winter Break closures.
Tutorials for using RAMP IRB. 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.
Single IRB (sIRB) Review. Plan on using a single IRB to provide review for your cooperative or multi-site study involving FSU and other non-FSU institutions? Visit our Single IRB (sIRB) Review page for detailed and comprehensive information.
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.
On-going Events:
IRB Virtual Office Hours. Every Wednesday (except for the second Wednesday of each month, as well as when FSU is closed), the OHSP/IRB Office staff will host Zoom-based virtual office hours open to the FSU research community. The meeting will not be recorded. Your questions are welcomed but be sure to check out our FAQs or student FAQs or video tutorials for some specific human research regulatory- or IRB-related content that may also help with your questions! Those with sensitive questions may request a break-out room. Participation is limited to FSU Faculty, Staff, and Students, and authentication will require use of your FSU email when you register. At the beginning of the meeting registrants will be placed in a Zoom waiting room. We look forward to seeing you!
NEW! Human Subject Research Study Coordinators "Lunch and Learn" Series. Every 4th Wednesday of the month (unless a University Holiday or other exigency), the Office for Human Subjects Protection (OHSP) and Office for Clinical Research Advancement (OCRA), sponsored by the Office of Research, will offer a lunch and learn session. Each session will provide study coordinators with the opportunity to take part in collaborative learning, with a focus upon acquiring general knowledge and growing related skill sets. See our flier for session dates, times and topics. Feel free to share this information with your research faculty and other study coordinators. We also welcome your feedback on future topics and training needs. We are excited to meet your team members in person or via Zoom at the upcoming training/networking opportunity. Lunch and Learn registration link: https://ocra.fsu.edu/study-support-services/lunch-and-learn-series/. We look forward to seeing you!
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 international research 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.
The RAMP IRB module has undergone upgrades including several new features for end users, including updating studies and improving RNI (Report of New Information) submissions. Other RAMP modules (e.g., Grants, Agreements, ACUC) and CAMS were also upgraded with improvements for those end users as well. See this RAMP IRB 10.5 Release Overview. FSU's RAMP General Support Office is available at RAMP@fsu.edu for further information or to report issues.
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.
SACHRP: the 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.
Update: the federal Government Accounting Office (GAO) 2023 report, Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness, was recently published and was the focus of SACHRP deliberations and suggestions for federal agencies for better protecting human research participants. Discussions and recommendations from GAO's report include the need for more robust and sustainable federal agency (e.g., DHHS Office for Human Research Protections as well as Food and Drug Administration) auditing and inspections of IRBs, and more systematic evaluation of IRBs, including academic organizations’ IRBs, to measure their effectiveness in protecting human subjects. Additionally, development of the evaluations should include input by research stakeholders, including research sponsors and professional accreditation as well as credentialing organizations. SACHRP may release implementation recommendations. The FSU OHSP and IRB currently have such measures in place (e.g., metrics reporting; compliance monitoring), but as needed or based upon stakeholder input will implement additional measures for continuous quality improvement. Check out the full GAO report or report highlights.
