The Mission of the Office for Human Subjects Protection (OHSP) & FSU Institutional Review Board (IRB) is to protect the rights and welfare of human subjects research participants by adherence to ethical principles and compliance with applicable laws governing the protection of human subjects.
OHSP and IRB Operating Status: The OHSP and IRB are open. Study submissions will generally be handled in order of receipt. Remember that FSU's RAMP IRB should be used for all study-related submissions and communications. Plan accordingly.
COVID-19 (CORONAVIRUS) & HUMAN RESEARCH
- The cessation of research that involves in-person/face-to-face interactions or interventions with human research participants remains in effect until further notice. Some exceptions apply. For further information, go here or click on the COVID-19 & Human Research tab on the left.
- All OHSP and IRB services and functions are performed remotely and fully staffed. The OHSP physical location is closed to visitors until further notice. RAMP IRB must be used for all research submissions and communications pertaining to studies therein. For general and other questions, use the Contact Us information or click on View Staff Listing tabs on the left.
COLLABORATION WITH NON-FSU SITES
Studies involving non-FSU sites, institutions or agencies, such as TMH, CRMC, FAMU, state agencies and other organizations, may require those sites' IRB or research review committee approvals. Before submitting your studies for FSU IRB review, you must contact such sites to ascertain their review requirements and comply accordingly. The FSU IRB may require documentation of such site contact and compliance. FSU IRB submissions will be needlessly delayed if these steps are not followed. Collaborations involving TMH are subject to specific requirements; click here for more information.
NEW CONSENT TEMPLATES
New consent-related templates for social, behavioral and educational research (SBER) are available for use. Go to this OHSP templates and forms page, or log into RAMP IRB and search for the SBER templates under the IRB, Library, and Templates tabs.
SUBMITTING RESEARCH FOR IRB REVIEW
FSU utilizes an electronic protocol management system (at FSU called RAMP IRB) for research review. ALL research submissions must use the RAMP IRB system and the templates therein. Click this link to view templates and documents required for RAMP IRB. For training resources, visit this link. For general information about all active and forthcoming FSU RAMP projects, click here.
Research Using Human Subjects
The Florida State University is committed to the ethical principles for the protection of human subjects in research as set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). The ethical principles are:
- Respect for persons – which includes the requirement of a voluntary informed consent process
- Beneficence – which entails an obligation to protect persons from harm by minimizing risks and maximizing benefits
- Justice – which requires that selection of subjects be fair and equitable, and that particular care be taken when working with vulnerable populations (e.g., children, economically or educationally disadvantaged).
Human Subjects Research—Identifying Intent
Federal law applicable to the protection of human subjects (45 CFR 46) requires Institutional Review Board (IRB) review and on-going oversight of research involving human subjects.
As defined by §46.102 of the Common Rule (45 CFR 46), "Research" means a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge. When evaluating a specific project, it is helpful to focus on two key elements:
- The project involves a systematic investigation, and
- The design – meaning the goal, purpose, or intent – of the investigation is to develop or contribute to generalizable knowledge.
A "Human Subject" is living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (even in the absence of intervention or interaction). Some examples include:
- Assessing students' academic performance or instructors' use of instructional techniques or content
- Surveying or interviewing persons about their lives, conditions, activities, status, habits or understanding
- Measuring individuals' human physical, physiological, behavioral or cognitive performance
- Evaluating service, program or treatment outcomes upon clients, beneficiaries, recipients or patients
Institutional Review Board
An IRB is a committee composed of scientists, non-scientists (e.g., professionals as well as laypersons) as well as unaffiliated (non-FSU) members that review proposed research involving human subjects to ensure the protection of their rights and welfare. Pursuant to federal law and FSU policy, the IRB has authority to approve, require modifications in (to secure approval), or disapprove all research activities covered federal law and FSU policy. Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by FSU officials; however, these officials may not approve the research if it has not been approved by the IRB.
Assurance and Jurisdiction of the IRB
FSU’s Assurance with the federal government, an agreement under which as a condition of receiving federal funds and support for human research FSU agrees to abide by the terms of the Assurance, with all applicable laws (federal, state, local and international) and The Belmont Report, requires that all research activities involving human subjects be reviewed by the IRB, regardless of funding source or sponsorship. This includes:
- Research conducted by or under the direction of any FSU employee (faculty, staff, student) or agent in connection with his or her institutional responsibilities
- Research conducted by or under the direction of any FSU employee (faculty, staff, student) or agent using any property or facility of this institution
- Research involves the use of FSU’s non-public information to identify or contact human research subjects or prospective subjects, or to conduct or support human subjects research
The Office for Human Subjects Protection (OHSP)
The FSU Office of Research, through the Office for Human Subjects Protection, or OHSP, provides the requisite reviews and on-going oversight of all exempt research involving human subjects; provides the research community with consultation on and regulatory determinations for activities that may involve research or research involving human subjects but that may not require OHSP or IRB reviews under applicable law or FSU policy; performs pre-IRB review of non-exempt research involving human subjects; provides post-approval monitoring to ensure compliance with applicable laws; provides professional, technical and administrative support to the IRB, its business, meetings and documentation; maintains the electronic protocol management systems that serve to document and archive OHSP and IRB reviews and determinations; provides FSU leadership, the research community, and the IRB with applicable law and policy information and resources; and provides or makes available initial, renewing and continuing training regarding human research regulatory requirements and related guidance. The OHSP staff also serve as a resource for investigators, IRB members and the research community, and has delegated authority to determine the initial appropriate level of review required for each research proposal submitted for IRB review.
For an explanation of the process at FSU for review of human subjects research, click on the Human Research Review tab on the left or click this link.